{"ID":77998,"post_author":"9208550","post_date":"2018-12-13 14:27:33","post_date_gmt":"0000-00-00 00:00:00","post_content":"","post_title":"Health Information Technology for the Physician Office Laboratory (POL)","post_excerpt":"","post_status":"draft","comment_status":"closed","ping_status":"closed","post_password":"","post_name":"","to_ping":"","pinged":"","post_modified":"2018-12-13 14:27:33","post_modified_gmt":"2018-12-13 19:27:33","post_content_filtered":"","post_parent":0,"guid":"https:\/\/www.limsforum.com\/?post_type=ebook&p=77998","menu_order":0,"post_type":"ebook","post_mime_type":"","comment_count":"0","filter":"","_ebook_metadata":{"enabled":"on","private":"0","guid":"21B547A3-C4AA-48A5-90D9-BF0D0A64DCC0","title":"Health Information Technology for the Physician Office Laboratory (POL)","subtitle":"","cover_theme":"nico_10","cover_image":"https:\/\/www.limsforum.com\/wp-content\/plugins\/rdp-ebook-builder\/pl\/cover.php?cover_style=nico_10&subtitle=&editor=Shawn+Douglas&title=Health+Information+Technology+for+the+Physician+Office+Laboratory+%28POL%29&title_image=https%3A%2F%2Fs3.limsforum.com%2Fwww.limsforum.com%2Fwp-content%2Fuploads%2FMedical_Laboratory_Scientist_US_NIH.jpg&publisher=LabLynx+Press","editor":"Shawn Douglas","publisher":"LabLynx Press","author_id":"26","image_url":"","items":{"e0bf845fb58d2bae05a846b47629e86f_type":"article","e0bf845fb58d2bae05a846b47629e86f_title":"Health Level 7","e0bf845fb58d2bae05a846b47629e86f_url":"https:\/\/www.limswiki.org\/index.php\/Health_Level_7","e0bf845fb58d2bae05a846b47629e86f_plaintext":"\n\n\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\n\t\t\t\tHealth Level 7\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\tFrom LIMSWiki\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\tJump to: navigation, search\n\n\t\t\t\t\t\n\t\t\t\t\t The Reference Information Model (RIM) is an important component of the HL7 v3.0 standard and is based on XML.\nHealth Level Seven (HL7) is an international non-profit volunteer-based organization involved with the development of international health care informatics interoperability standards.[1] The HL7 community consists of health care experts and information scientists collaborating to create standards for the exchange, management, and integration of electronic health care information.\nThe term \"HL7\" is also used to refer to some of the specific standards created by the organization (e.g., HL7 v2.x, v3.0, HL7 RIM).[2] HL7 and its members provide a framework (and related standards) for the exchange, integration, sharing, and retrieval of electronic health information. v2.x of the standards, which support clinical practice and the management, delivery, and evaluation of health services, are the most commonly used in the world.[3] \n\nContents\n\n1 History \n2 Standards \n\n2.1 Reference Information Model (RIM) \n2.2 Clinical Document Architecture (CDA) \n2.3 Clinical Context Object Workgroup (CCOW) \n2.4 Fast Healthcare Interoperability Resources (FHIR) \n\n\n3 Further reading \n4 External links \n5 References \n\n\n\nHistory \nThe International Organization for Standardization (ISO) got involved with standardizing network exchanges of data between computers around 1979, creating the Open Systems Interconnect (OSI) standards model. These formal OSI standards ranged across seven levels, from OSI Level 1 (physical layer, e.g. communication over coaxial cable) to OSI Level 7 (application layer, e.g. communication between clinical software). By 1981, researchers at University of California - San Francisco had created a proprietary protocol that unbeknownst to them at the time fit under the OSI Level 7 model. The protocol was developed for clinical purposes such that \"computers exchanged several core messages, including the synchronization of patient admission-discharge-transfer information, orders from clinical areas, and the display of textual results to the clinical areas.\"[4] \nBy 1985, Simborg Systems (which developed hospital information systems) sought to have a non-proprietary protocol created because \"standardization efforts at the time was either fragmented, in a different direction or with a different scope.\"[4] This led to a push to create a new standards organization, with initial meetings occurring at the end of March 1987. The meetings produced the term \"HL7\" and prompted a non-profit organization to be created, eventually known as Health Level Seven International. Version 1.0 of the HL7 specification was released in October 1987. The direction of HL7 was largely led by Simborg Systems; however, with greater practical use seen in furthering the protocol and non-profit, the first non-Simborg Systems chairperson, Ed Hammond, took the reigns in 1989.[4] By June 1990, Version 2.1 was published and included mechanisms for results reporting and billing. By the early- to mid-1990s news of HL7 was beginning to spread to international clinical sectors, particularly parts of Europe, including Netherlands, Germany, Canada, Japan, Australia, and the United Kingdom.[4][5]\nIn June 1994 the American National Standards Institute (ANSI) awarded Health Level 7 International status as an accredited standards developer. Version 2.2 became an official ANSI standard in February 1996. HL7 had roughly 1,700 members from various health care industries around the globe by the late 1990s.[5]\nVersion 3.0 of the HL7 standard was released in late 2005, which internationalized it and made it more consistent and precise.[6] Where the 2.x standards eventually received wide adoption for their flexibility and available implementation options, the 3.0 standards, in contrast, departed from that flexibility in order to be more \"definite and testable, and provide the ability to certify vendors' conformance.\"[7] In 2009, Corepoint Health reported that most HL7 messaging was occurring using 2.3 and 2.3.1 models, with 3.0-based messages representing only a tiny fraction of all interfaces[8]; in 2012 Corepoint Health's Rob Brull estimated that more than 90 percent of all healthcare systems were still utilizing 2.x models.[9] That trend continued, with several experts proclaiming the standard to be more or less a failure.[10][11]\nIn early 2012, HL7 announced the HL7 FHIR (Fast Healthcare Interoperability Resources) initiative, which would utilize the best aspects of both 2.x and 3.0 standards, optimally resulting in a standard that is 20 percent the size of 3.0 but still meet the operation requirements of 80 percent of systems using the standard.[12] FHIR is being built on RESTful web services and provides modular, extensible \"resources\" to provide some flexibility but within a more fixed framework.[13] In December 2014, HL7 announced the Argonaut Project, meant \"to hasten current FHIR development efforts in order to create practical and focused guidelines and profiles for FHIR by the spring of 2015.\"[14]\n\nStandards \nIn total HL7 develops conceptual standards (e.g., HL7 RIM), document standards (e.g., HL7 CDA), application standards (e.g., HL7 CCOW), and messaging standards (e.g., HL7 v2.x and v3.0). Messaging standards are particularly important because they define how information is packaged and communicated from one party to another. Such standards set the language, structure, and data types required for seamless integration from one system to another.[15] Business use of the HL7 standards requires a paid organizational membership in HL7, Inc. HL7 members can access standards for free, and non-members can buy the standards from HL7 or ANSI.\nHL7 v2.x and 3.0 are the primary standards from the organization. They provide a framework for data exchange among clinical and healthcare systems in an ideal format. The 2.x standards are flexible, with several implementation options, loosely geared towards \"clinical interface specialists\" working to move clinical data in the application space. The 3.0 standards are designed to be more fixed, precise, and international, geared towards governments and end users of clinical applications.[8] \nWhile HL7 v2.x and 3.0 are the primary standards, a few other important standards and components are associated with HL7, as detailed below.\n\nReference Information Model (RIM) \nThe Reference Information Model (RIM) is an important component of the HL7 Version 3 standard. RIM expresses the data content needed in a specific clinical or administrative context and provides an explicit representation of the semantic and lexical connections that exist between the information carried in the fields of HL7 messages.[16] The standard is accepted as official by the ISO as ISO\/HL7 21731; the original was approved in 2006, with a revised version appearing in 2014.[17]\n\nClinical Document Architecture (CDA) \nThe Clinical Document Architecture (CDA) is an XML-based markup standard intended to specify the encoding, structure, and semantics of clinical documents for exchange.[18] The standard is accepted as official by the ISO as ISO\/HL7 27932; the most current version comes from 2009.[19]\n\nClinical Context Object Workgroup (CCOW) \nThe Clinical Context Object Workgroup (CCOW) family of standards are designed to enable disparate applications to share user context and patient context in real-time, particularly at the user-interface level. CCOW implementations typically require a CCOW vault system to manage user security between applications. The primary standard under CCOW is the Context Management Specifications (CCOW), which \"serves as the basis for ensuring secure and consistent access to patient information from heterogeneous sources.\"[20] This standard is accepted as official by ANSI as ANSI\/HL7 CMS V1.6.\n\nFast Healthcare Interoperability Resources (FHIR) \nThe Fast Healthcare Interoperability Resources (FHIR) standard was announced in 2012 and has been in development since. FHIR is being built on RESTful web services and provides modular, extensible \"resources\" to provide some flexibility but within a more fixed framework. The fundamental principles of FHIR are[21]:\n\n prioritize implementers as the target user of the standard;\n provide a flexible framework for interoperability;\n limit complexity to where it's most needed;\n keep conformance requirement minimal but also provide varying degrees of rigor;\n leverage open source development principles;\n make the standard available without cost;\n support multiple exchange architectures;\n leverage common web technologies;\n make the standard forward and backward compatible; and\n design, publish, and implement associated specifications using widely available tools.\nFurther reading \n Introduction to HL7 Standards\n Spronk, Ren\u00e9 (05 September 2014). \"The Early History of Health Level 7\". Ringholm BV. http:\/\/www.ringholm.com\/docs\/the_early_history_of_health_level_7_HL7.htm .   \nExternal links \n Health Level 7 International\n HL7 Wiki\n HL7 FHIR\nReferences \n\n\u2191 \"About Health Level Seven International\". Health Level Seven International. http:\/\/www.hl7.org\/about\/index.cfm . Retrieved 02 March 2012 .   \n\n\u2191 \"Healthcare Interoperability Glossary\". Corepoint Health. http:\/\/www.corepointhealth.com\/resource-center\/healthcare-interoperability-glossary#H . Retrieved 02 March 2012 .   \n\n\u2191 Shaver, Dave. \"The HL7 Evolution - Comparing HL7 Versions 2 and 3\" (PDF). Corepoint Health. http:\/\/www.corepointhealth.com\/sites\/default\/files\/whitepapers\/hl7-v2-v3-evolution.pdf . Retrieved 02 March 2012 .   \n\n\u2191 4.0 4.1 4.2 4.3 Spronk, Ren\u00e9 (05 September 2014). \"The Early History of Health Level 7\". Ringholm BV. http:\/\/www.ringholm.com\/docs\/the_early_history_of_health_level_7_HL7.htm . Retrieved 17 February 2015 .   \n\n\u2191 5.0 5.1 Di Lima, Sara N.; Johns, Lisa T.; Liebler, Joan Gratto (1998). A Practical Introduction to Health Information Management. Jones & Bartlett Learning. ISBN 9780834212312. https:\/\/books.google.com\/books?id=vX_zVaMlR8sC&pg=PA90 . Retrieved 17 February 2015 .   \n\n\u2191 Shaver,Dave (17 February 2015). \"What Is HL7 Version 3 or V3?\". HL7 Standards. http:\/\/www.hl7standards.com\/blog\/2006\/10\/05\/what-is-hl7-version-3-or-v3\/ .   \n\n\u2191 \"HL7 Version 3 Product Suite\". Health Level 7 International. 15 May 2014. http:\/\/www.hl7.org\/implement\/standards\/product_brief.cfm?product_id=186 . Retrieved 18 February 2015 .   \n\n\u2191 8.0 8.1 Shaver, Dave (2009). \"The HL7 Evolution: Comparing HL7 Version 2 to Version 3, Including a History of Version 2\" (PDF). Corepoint Health. http:\/\/www.corepointhealth.com\/sites\/default\/files\/whitepapers\/hl7-v2-v3-evolution.pdf . Retrieved 18 February 2015 .   \n\n\u2191 McNickle, Michelle (25 April 2012). \"8 common questions about HL7\". Healthcare IT News. HIMSS Media. http:\/\/www.healthcareitnews.com\/news\/8-common-questions-about-hl7 . Retrieved 18 February 2015 .   \n\n\u2191 Morin, Jeanluc (04 January 2011). \"Will HL7 V3 Adoption Take Off in 2011? 5 Points and 1 Caveat\". Caristix Blog. Caristix. http:\/\/caristix.com\/blog\/2011\/01\/will-hl7-v3-adoption-take-off-in-2011\/ . Retrieved 18 February 2015 .   \n\n\u2191 Grieve, Grahame (15 August 2011). \"HL7 needs a fresh look because V3 has failed\". Health Intersections Blog. Health Intersections Pty. Ltd. http:\/\/www.healthintersections.com.au\/?p=476 . Retrieved 18 February 2015 .   \n\n\u2191 McKenzie, Lloyd (February 2012). \"HL7\u2019s Next Generation Standard is Coming: Keep Calm, Carry On\". Healthcare Information Management & Communications Canada 26 (1). http:\/\/www.healthcareimc.com\/node\/515 . Retrieved 18 February 2015 .   \n\n\u2191 Brull, Rob (26 March 2013). \"5 Things to Know About HL7 FHIR\". HL7 Standards Blog. HL7 Standards. http:\/\/www.hl7standards.com\/blog\/2013\/03\/26\/hl7-fhir\/ . Retrieved 18 February 2015 .   \n\n\u2191 Kern, Christine (12 December 2014). \"HL7 Advancing FHIR\". Health IT Outcomes. Jameson Publishing. http:\/\/www.healthitoutcomes.com\/doc\/hl-advancing-fhir-0001 . Retrieved 18 February 2015 .   \n\n\u2191 Kim, Katherine (July 2005). \"Creating Clinical Data Standards in Health Care: Five Case Studies\" (PDF). California HealthCare Foundation. http:\/\/www.kathykim.com\/sitebuildercontent\/sitebuilderfiles\/ClinicalDataStandardsInHealthCare.pdf . Retrieved 02 March 2012 .   \n\n\u2191 \"HL7 Reference Information Model\". Health Level 7 International. http:\/\/www.hl7.org\/implement\/standards\/rim.cfm . Retrieved 17 February 2015 .   \n\n\u2191 \"ISO\/HL7 21731:2006\". International Organization for Standardization. http:\/\/www.iso.org\/iso\/home\/store\/catalogue_ics\/catalogue_detail_ics.htm?csnumber=40399 . Retrieved 17 February 2015 .   \n\n\u2191 Boone, Keith W. (2011). The CDA Book. Springer Science & Business Media. pp. 17\u201321. http:\/\/books.google.com\/books?id=rwa6DDB4jY8C&pg=PA17 . Retrieved 17 February 2015 .   \n\n\u2191 \"ISO\/HL7 27932:2009\". International Organization for Standardization. http:\/\/www.iso.org\/iso\/iso_catalogue\/catalogue_tc\/catalogue_detail.htm?csnumber=44429 . Retrieved 17 February 2015 .   \n\n\u2191 \"Product CCOW\". HL7 Wiki. Health Level 7 International. 27 October 2010. http:\/\/wiki.hl7.org\/index.php?title=Product_CCOW . Retrieved 17 February 2015 .   \n\n\u2191 \"Fundamental Principles of FHIR\". HL7 Wiki. Health Level 7 International. 16 September 2014. http:\/\/wiki.hl7.org\/index.php?title=Fundamental_Principles_of_FHIR . Retrieved 18February 2015 .   \n\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Health_Level_7\">https:\/\/www.limswiki.org\/index.php\/Health_Level_7<\/a>\n\t\t\t\t\tCategories: Communication protocols and standardsHealth informaticsHealth standardsStandards organizationsHidden category: Pages using duplicate arguments in template calls\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\n\t\t\n\t\t\tNavigation menu\n\t\t\t\t\t\n\t\t\tViews\n\n\t\t\t\n\t\t\t\t\n\t\t\t\tPage\n\t\t\t\tDiscussion\n\t\t\t\tView source\n\t\t\t\tHistory\n\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\n\t\t\t\t\n\t\t\t\tPersonal tools\n\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\tLog in\n\t\t\t\t\t\t\t\t\t\t\t\t\tRequest account\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\t\t\n\t\tNavigation\n\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tMain page\n\t\t\t\t\t\t\t\t\t\t\tRecent changes\n\t\t\t\t\t\t\t\t\t\t\tRandom 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\r\n\n\t\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t This page was last modified on 24 August 2016, at 21:42.\n\t\t\t\t\t\t\t\t\tThis page has been accessed 7,020 times.\n\t\t\t\t\t\t\t\t\tContent is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.\n\t\t\t\t\t\t\t\t\tPrivacy policy\n\t\t\t\t\t\t\t\t\tAbout LIMSWiki\n\t\t\t\t\t\t\t\t\tDisclaimers\n\t\t\t\t\t\t\t\n\t\t\n\t\t\n\t\t\n\n","e0bf845fb58d2bae05a846b47629e86f_html":"<body class=\"mediawiki ltr sitedir-ltr ns-0 ns-subject page-Health_Level_7 skin-monobook action-view\">\n<div id=\"rdp-ebb-globalWrapper\">\n\t\t<div id=\"rdp-ebb-column-content\">\n\t\t\t<div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\">\n\t\t\t\t<a id=\"rdp-ebb-top\"><\/a>\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Health Level 7<\/h1>\n\t\t\t\t\n\t\t\t\t<div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\">\n\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\n\n\t\t\t\t\t<!-- start content -->\n\t\t\t\t\t<div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"thumb tright\"><div class=\"thumbinner\" style=\"width:552px;\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:HL7_Reference_Information_Model.jpg\" class=\"image wiki-link\" target=\"_blank\" data-key=\"b8e925aa26de89f4ff8ca5fc5541ac42\"><img alt=\"\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/f\/f8\/HL7_Reference_Information_Model.jpg\" class=\"thumbimage\" style=\"width: 100%;max-width: 400px;height: auto;\" \/><\/a> <div class=\"thumbcaption\"><div class=\"magnify\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:HL7_Reference_Information_Model.jpg\" class=\"internal wiki-link\" title=\"Enlarge\" target=\"_blank\" data-key=\"b8e925aa26de89f4ff8ca5fc5541ac42\"><\/a><\/div>The Reference Information Model (RIM) is an important component of the HL7 v3.0 standard and is based on XML.<\/div><\/div><\/div>\n<p><b>Health Level Seven<\/b> (<b>HL7<\/b>) is an international non-profit volunteer-based organization involved with the development of international health care informatics interoperability standards.<sup id=\"rdp-ebb-cite_ref-HL7About_1-0\" class=\"reference\"><a href=\"#cite_note-HL7About-1\" rel=\"external_link\">[1]<\/a><\/sup> The HL7 community consists of health care experts and information scientists collaborating to create standards for the exchange, management, and integration of electronic health care information.\n<\/p><p>The term \"HL7\" is also used to refer to some of the specific standards created by the organization (e.g., HL7 v2.x, v3.0, HL7 RIM).<sup id=\"rdp-ebb-cite_ref-HL7BatchProtocol_2-0\" class=\"reference\"><a href=\"#cite_note-HL7BatchProtocol-2\" rel=\"external_link\">[2]<\/a><\/sup> HL7 and its members provide a framework (and related standards) for the exchange, integration, sharing, and retrieval of electronic health information. v2.x of the standards, which support clinical practice and the management, delivery, and evaluation of health services, are the most commonly used in the world.<sup id=\"rdp-ebb-cite_ref-3\" class=\"reference\"><a href=\"#cite_note-3\" rel=\"external_link\">[3]<\/a><\/sup> \n<\/p>\n\n\n<h2><span class=\"mw-headline\" id=\"History\">History<\/span><\/h2>\n<p>The <a href=\"https:\/\/www.limswiki.org\/index.php\/International_Organization_for_Standardization\" title=\"International Organization for Standardization\" target=\"_blank\" class=\"wiki-link\" data-key=\"116defc5d89c8a55f5b7c1be0790b442\">International Organization for Standardization<\/a> (ISO) got involved with standardizing network exchanges of data between computers around 1979, creating the Open Systems Interconnect (OSI) standards model. These formal OSI standards ranged across seven levels, from OSI Level 1 (physical layer, e.g. communication over coaxial cable) to OSI Level 7 (application layer, e.g. communication between clinical software). By 1981, researchers at University of California - San Francisco had created a proprietary protocol that unbeknownst to them at the time fit under the OSI Level 7 model. The protocol was developed for clinical purposes such that \"computers exchanged several core messages, including the synchronization of patient admission-discharge-transfer information, orders from clinical areas, and the display of textual results to the clinical areas.\"<sup id=\"rdp-ebb-cite_ref-HL7Hist1_4-0\" class=\"reference\"><a href=\"#cite_note-HL7Hist1-4\" rel=\"external_link\">[4]<\/a><\/sup> \n<\/p><p>By 1985, Simborg Systems (which developed <a href=\"https:\/\/www.limswiki.org\/index.php\/Hospital_information_system\" title=\"Hospital information system\" target=\"_blank\" class=\"wiki-link\" data-key=\"d8385de7b1f39a39d793f8ce349b448d\">hospital information systems<\/a>) sought to have a non-proprietary protocol created because \"standardization efforts at the time was either fragmented, in a different direction or with a different scope.\"<sup id=\"rdp-ebb-cite_ref-HL7Hist1_4-1\" class=\"reference\"><a href=\"#cite_note-HL7Hist1-4\" rel=\"external_link\">[4]<\/a><\/sup> This led to a push to create a new standards organization, with initial meetings occurring at the end of March 1987. The meetings produced the term \"HL7\" and prompted a non-profit organization to be created, eventually known as Health Level Seven International. Version 1.0 of the HL7 specification was released in October 1987. The direction of HL7 was largely led by Simborg Systems; however, with greater practical use seen in furthering the protocol and non-profit, the first non-Simborg Systems chairperson, Ed Hammond, took the reigns in 1989.<sup id=\"rdp-ebb-cite_ref-HL7Hist1_4-2\" class=\"reference\"><a href=\"#cite_note-HL7Hist1-4\" rel=\"external_link\">[4]<\/a><\/sup> By June 1990, Version 2.1 was published and included mechanisms for results reporting and billing. By the early- to mid-1990s news of HL7 was beginning to spread to international clinical sectors, particularly parts of Europe, including Netherlands, Germany, Canada, Japan, Australia, and the United Kingdom.<sup id=\"rdp-ebb-cite_ref-HL7Hist1_4-3\" class=\"reference\"><a href=\"#cite_note-HL7Hist1-4\" rel=\"external_link\">[4]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-PractDiLama_5-0\" class=\"reference\"><a href=\"#cite_note-PractDiLama-5\" rel=\"external_link\">[5]<\/a><\/sup>\n<\/p><p>In June 1994 the <a href=\"https:\/\/www.limswiki.org\/index.php\/American_National_Standards_Institute\" title=\"American National Standards Institute\" target=\"_blank\" class=\"wiki-link\" data-key=\"9a3da6ae9a20adfa068187109b058ff4\">American National Standards Institute<\/a> (ANSI) awarded Health Level 7 International status as an accredited standards developer. Version 2.2 became an official ANSI standard in February 1996. HL7 had roughly 1,700 members from various health care industries around the globe by the late 1990s.<sup id=\"rdp-ebb-cite_ref-PractDiLama_5-1\" class=\"reference\"><a href=\"#cite_note-PractDiLama-5\" rel=\"external_link\">[5]<\/a><\/sup>\n<\/p><p>Version 3.0 of the HL7 standard was released in late 2005, which internationalized it and made it more consistent and precise.<sup id=\"rdp-ebb-cite_ref-HL730_6-0\" class=\"reference\"><a href=\"#cite_note-HL730-6\" rel=\"external_link\">[6]<\/a><\/sup> Where the 2.x standards eventually received wide adoption for their flexibility and available implementation options, the 3.0 standards, in contrast, departed from that flexibility in order to be more \"definite and testable, and provide the ability to certify vendors' conformance.\"<sup id=\"rdp-ebb-cite_ref-HL7Three_7-0\" class=\"reference\"><a href=\"#cite_note-HL7Three-7\" rel=\"external_link\">[7]<\/a><\/sup> In 2009, Corepoint Health reported that most HL7 messaging was occurring using 2.3 and 2.3.1 models, with 3.0-based messages representing only a tiny fraction of all interfaces<sup id=\"rdp-ebb-cite_ref-CH09_8-0\" class=\"reference\"><a href=\"#cite_note-CH09-8\" rel=\"external_link\">[8]<\/a><\/sup>; in 2012 Corepoint Health's Rob Brull estimated that more than 90 percent of all healthcare systems were still utilizing 2.x models.<sup id=\"rdp-ebb-cite_ref-8Common_9-0\" class=\"reference\"><a href=\"#cite_note-8Common-9\" rel=\"external_link\">[9]<\/a><\/sup> That trend continued, with several experts proclaiming the standard to be more or less a failure.<sup id=\"rdp-ebb-cite_ref-Cari11_10-0\" class=\"reference\"><a href=\"#cite_note-Cari11-10\" rel=\"external_link\">[10]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-HI11_11-0\" class=\"reference\"><a href=\"#cite_note-HI11-11\" rel=\"external_link\">[11]<\/a><\/sup>\n<\/p><p>In early 2012, HL7 announced the HL7 FHIR (Fast Healthcare Interoperability Resources) initiative, which would utilize the best aspects of both 2.x and 3.0 standards, optimally resulting in a standard that is 20 percent the size of 3.0 but still meet the operation requirements of 80 percent of systems using the standard.<sup id=\"rdp-ebb-cite_ref-FHIR12_12-0\" class=\"reference\"><a href=\"#cite_note-FHIR12-12\" rel=\"external_link\">[12]<\/a><\/sup> FHIR is being built on RESTful web services and provides modular, extensible \"resources\" to provide some flexibility but within a more fixed framework.<sup id=\"rdp-ebb-cite_ref-HL7StandardFHIR_13-0\" class=\"reference\"><a href=\"#cite_note-HL7StandardFHIR-13\" rel=\"external_link\">[13]<\/a><\/sup> In December 2014, HL7 announced the Argonaut Project, meant \"to hasten current FHIR development efforts in order to create practical and focused guidelines and profiles for FHIR by the spring of 2015.\"<sup id=\"rdp-ebb-cite_ref-FHIRArgo_14-0\" class=\"reference\"><a href=\"#cite_note-FHIRArgo-14\" rel=\"external_link\">[14]<\/a><\/sup>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"Standards\">Standards<\/span><\/h2>\n<p>In total HL7 develops conceptual standards (e.g., HL7 RIM), document standards (e.g., HL7 CDA), application standards (e.g., HL7 CCOW), and messaging standards (e.g., HL7 v2.x and v3.0). Messaging standards are particularly important because they define how information is packaged and communicated from one party to another. Such standards set the language, structure, and data types required for seamless integration from one system to another.<sup id=\"rdp-ebb-cite_ref-15\" class=\"reference\"><a href=\"#cite_note-15\" rel=\"external_link\">[15]<\/a><\/sup> Business use of the HL7 standards requires a paid organizational membership in HL7, Inc. HL7 members can access standards for free, and non-members can buy the standards from HL7 or <a href=\"https:\/\/www.limswiki.org\/index.php\/ANSI\" title=\"ANSI\" class=\"mw-redirect wiki-link\" target=\"_blank\" data-key=\"682431568a190846c1164f8943aedded\">ANSI<\/a>.\n<\/p><p>HL7 v2.x and 3.0 are the primary standards from the organization. They provide a framework for data exchange among clinical and healthcare systems in an ideal format. The 2.x standards are flexible, with several implementation options, loosely geared towards \"clinical interface specialists\" working to move clinical data in the application space. The 3.0 standards are designed to be more fixed, precise, and international, geared towards governments and end users of clinical applications.<sup id=\"rdp-ebb-cite_ref-CH09_8-1\" class=\"reference\"><a href=\"#cite_note-CH09-8\" rel=\"external_link\">[8]<\/a><\/sup> \n<\/p><p>While HL7 v2.x and 3.0 are the primary standards, a few other important standards and components are associated with HL7, as detailed below.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Reference_Information_Model_.28RIM.29\">Reference Information Model (RIM)<\/span><\/h3>\n<p>The Reference Information Model (RIM) is an important component of the HL7 Version 3 standard. RIM expresses the data content needed in a specific clinical or administrative context and provides an explicit representation of the semantic and lexical connections that exist between the information carried in the fields of HL7 messages.<sup id=\"rdp-ebb-cite_ref-RIM_16-0\" class=\"reference\"><a href=\"#cite_note-RIM-16\" rel=\"external_link\">[16]<\/a><\/sup> The standard is accepted as official by the ISO as ISO\/HL7 21731; the original was approved in 2006, with a revised version appearing in 2014.<sup id=\"rdp-ebb-cite_ref-ISO21731_17-0\" class=\"reference\"><a href=\"#cite_note-ISO21731-17\" rel=\"external_link\">[17]<\/a><\/sup>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Clinical_Document_Architecture_.28CDA.29\">Clinical Document Architecture (CDA)<\/span><\/h3>\n<p>The Clinical Document Architecture (CDA) is an XML-based markup standard intended to specify the encoding, structure, and semantics of clinical documents for exchange.<sup id=\"rdp-ebb-cite_ref-CDABook_18-0\" class=\"reference\"><a href=\"#cite_note-CDABook-18\" rel=\"external_link\">[18]<\/a><\/sup> The standard is accepted as official by the ISO as ISO\/HL7 27932; the most current version comes from 2009.<sup id=\"rdp-ebb-cite_ref-ISO27932_19-0\" class=\"reference\"><a href=\"#cite_note-ISO27932-19\" rel=\"external_link\">[19]<\/a><\/sup>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Clinical_Context_Object_Workgroup_.28CCOW.29\">Clinical Context Object Workgroup (CCOW)<\/span><\/h3>\n<p>The Clinical Context Object Workgroup (CCOW) family of standards are designed to enable disparate applications to share user context and patient context in real-time, particularly at the user-interface level. CCOW implementations typically require a CCOW vault system to manage user security between applications. The primary standard under CCOW is the Context Management Specifications (CCOW), which \"serves as the basis for ensuring secure and consistent access to patient information from heterogeneous sources.\"<sup id=\"rdp-ebb-cite_ref-CCOWWiki_20-0\" class=\"reference\"><a href=\"#cite_note-CCOWWiki-20\" rel=\"external_link\">[20]<\/a><\/sup> This standard is accepted as official by ANSI as ANSI\/HL7 CMS V1.6.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Fast_Healthcare_Interoperability_Resources_.28FHIR.29\">Fast Healthcare Interoperability Resources (FHIR)<\/span><\/h3>\n<p>The Fast Healthcare Interoperability Resources (FHIR) standard was announced in 2012 and has been in development since. FHIR is being built on RESTful web services and provides modular, extensible \"resources\" to provide some flexibility but within a more fixed framework. The fundamental principles of FHIR are<sup id=\"rdp-ebb-cite_ref-FHIRPrinc_21-0\" class=\"reference\"><a href=\"#cite_note-FHIRPrinc-21\" rel=\"external_link\">[21]<\/a><\/sup>:\n<\/p>\n<ul><li> prioritize implementers as the target user of the standard;<\/li>\n<li> provide a flexible framework for interoperability;<\/li>\n<li> limit complexity to where it's most needed;<\/li>\n<li> keep conformance requirement minimal but also provide varying degrees of rigor;<\/li>\n<li> leverage open source development principles;<\/li>\n<li> make the standard available without cost;<\/li>\n<li> support multiple exchange architectures;<\/li>\n<li> leverage common web technologies;<\/li>\n<li> make the standard forward and backward compatible; and<\/li>\n<li> design, publish, and implement associated specifications using widely available tools.<\/li><\/ul>\n<h2><span class=\"mw-headline\" id=\"Further_reading\">Further reading<\/span><\/h2>\n<ul><li> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.hl7.org\/implement\/standards\/index.cfm\" target=\"_blank\">Introduction to HL7 Standards<\/a><\/li>\n<li> <span class=\"citation web\">Spronk, Ren\u00e9 (05 September 2014). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ringholm.com\/docs\/the_early_history_of_health_level_7_HL7.htm\" target=\"_blank\">\"The Early History of Health Level 7\"<\/a>. Ringholm BV<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.ringholm.com\/docs\/the_early_history_of_health_level_7_HL7.htm\" target=\"_blank\">http:\/\/www.ringholm.com\/docs\/the_early_history_of_health_level_7_HL7.htm<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=The+Early+History+of+Health+Level+7&rft.atitle=&rft.aulast=Spronk%2C+Ren%C3%A9&rft.au=Spronk%2C+Ren%C3%A9&rft.date=05+September+2014&rft.pub=Ringholm+BV&rft_id=http%3A%2F%2Fwww.ringholm.com%2Fdocs%2Fthe_early_history_of_health_level_7_HL7.htm&rfr_id=info:sid\/en.wikipedia.org:Health_Level_7\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<h2><span class=\"mw-headline\" id=\"External_links\">External links<\/span><\/h2>\n<ul><li> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.hl7.org\/\" target=\"_blank\">Health Level 7 International<\/a><\/li>\n<li> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/wiki.hl7.org\/index.php?title=Main_Page\" target=\"_blank\">HL7 Wiki<\/a><\/li>\n<li> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/wiki.hl7.org\/index.php?title=FHIR\" target=\"_blank\">HL7 FHIR<\/a><\/li><\/ul>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<ol class=\"references\">\n<li id=\"cite_note-HL7About-1\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-HL7About_1-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.hl7.org\/about\/index.cfm\" target=\"_blank\">\"About Health Level Seven International\"<\/a>. Health Level Seven International<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.hl7.org\/about\/index.cfm\" target=\"_blank\">http:\/\/www.hl7.org\/about\/index.cfm<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 02 March 2012<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=About+Health+Level+Seven+International&rft.atitle=&rft.pub=Health+Level+Seven+International&rft_id=http%3A%2F%2Fwww.hl7.org%2Fabout%2Findex.cfm&rfr_id=info:sid\/en.wikipedia.org:Health_Level_7\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-HL7BatchProtocol-2\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-HL7BatchProtocol_2-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"#H\">\"Healthcare Interoperability Glossary\"<\/a>. Corepoint Health<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"#H\">http:\/\/www.corepointhealth.com\/resource-center\/healthcare-interoperability-glossary#H<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 02 March 2012<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Healthcare+Interoperability+Glossary&rft.atitle=&rft.pub=Corepoint+Health&rft_id=http%3A%2F%2Fwww.corepointhealth.com%2Fresource-center%2Fhealthcare-interoperability-glossary%23H&rfr_id=info:sid\/en.wikipedia.org:Health_Level_7\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-3\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-3\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Shaver, Dave. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.corepointhealth.com\/sites\/default\/files\/whitepapers\/hl7-v2-v3-evolution.pdf\" target=\"_blank\">\"The HL7 Evolution - Comparing HL7 Versions 2 and 3\"<\/a> (PDF). Corepoint Health<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.corepointhealth.com\/sites\/default\/files\/whitepapers\/hl7-v2-v3-evolution.pdf\" target=\"_blank\">http:\/\/www.corepointhealth.com\/sites\/default\/files\/whitepapers\/hl7-v2-v3-evolution.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 02 March 2012<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=The+HL7+Evolution+-+Comparing+HL7+Versions+2+and+3&rft.atitle=&rft.aulast=Shaver&rft.aufirst=Dave&rft.au=Shaver%2C%26%2332%3BDave&rft.pub=Corepoint+Health&rft_id=http%3A%2F%2Fwww.corepointhealth.com%2Fsites%2Fdefault%2Ffiles%2Fwhitepapers%2Fhl7-v2-v3-evolution.pdf&rfr_id=info:sid\/en.wikipedia.org:Health_Level_7\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-HL7Hist1-4\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-HL7Hist1_4-0\" rel=\"external_link\">4.0<\/a><\/sup> <sup><a href=\"#cite_ref-HL7Hist1_4-1\" rel=\"external_link\">4.1<\/a><\/sup> <sup><a href=\"#cite_ref-HL7Hist1_4-2\" rel=\"external_link\">4.2<\/a><\/sup> <sup><a href=\"#cite_ref-HL7Hist1_4-3\" rel=\"external_link\">4.3<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Spronk, Ren\u00e9 (05 September 2014). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ringholm.com\/docs\/the_early_history_of_health_level_7_HL7.htm\" target=\"_blank\">\"The Early History of Health Level 7\"<\/a>. Ringholm BV<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.ringholm.com\/docs\/the_early_history_of_health_level_7_HL7.htm\" target=\"_blank\">http:\/\/www.ringholm.com\/docs\/the_early_history_of_health_level_7_HL7.htm<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 17 February 2015<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=The+Early+History+of+Health+Level+7&rft.atitle=&rft.aulast=Spronk%2C+Ren%C3%A9&rft.au=Spronk%2C+Ren%C3%A9&rft.date=05+September+2014&rft.pub=Ringholm+BV&rft_id=http%3A%2F%2Fwww.ringholm.com%2Fdocs%2Fthe_early_history_of_health_level_7_HL7.htm&rfr_id=info:sid\/en.wikipedia.org:Health_Level_7\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-PractDiLama-5\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-PractDiLama_5-0\" rel=\"external_link\">5.0<\/a><\/sup> <sup><a href=\"#cite_ref-PractDiLama_5-1\" rel=\"external_link\">5.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation book\">Di Lima, Sara N.; Johns, Lisa T.; Liebler, Joan Gratto (1998). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=vX_zVaMlR8sC&pg=PA90\" target=\"_blank\"><i>A Practical Introduction to Health Information Management<\/i><\/a>. Jones & Bartlett Learning. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" target=\"_blank\">ISBN<\/a> 9780834212312<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=vX_zVaMlR8sC&pg=PA90\" target=\"_blank\">https:\/\/books.google.com\/books?id=vX_zVaMlR8sC&pg=PA90<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 17 February 2015<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=A+Practical+Introduction+to+Health+Information+Management&rft.aulast=Di+Lima%2C+Sara+N.%3B+Johns%2C+Lisa+T.%3B+Liebler%2C+Joan+Gratto&rft.au=Di+Lima%2C+Sara+N.%3B+Johns%2C+Lisa+T.%3B+Liebler%2C+Joan+Gratto&rft.date=1998&rft.pub=Jones+%26+Bartlett+Learning&rft.isbn=9780834212312&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DvX_zVaMlR8sC%26pg%3DPA90&rfr_id=info:sid\/en.wikipedia.org:Health_Level_7\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-HL730-6\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-HL730_6-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Shaver,Dave (17 February 2015). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.hl7standards.com\/blog\/2006\/10\/05\/what-is-hl7-version-3-or-v3\/\" target=\"_blank\">\"What Is HL7 Version 3 or V3?\"<\/a>. <i>HL7 Standards<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.hl7standards.com\/blog\/2006\/10\/05\/what-is-hl7-version-3-or-v3\/\" target=\"_blank\">http:\/\/www.hl7standards.com\/blog\/2006\/10\/05\/what-is-hl7-version-3-or-v3\/<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=What+Is+HL7+Version+3+or+V3%3F&rft.atitle=HL7+Standards&rft.aulast=Shaver%2CDave&rft.au=Shaver%2CDave&rft.date=17+February+2015&rft_id=http%3A%2F%2Fwww.hl7standards.com%2Fblog%2F2006%2F10%2F05%2Fwhat-is-hl7-version-3-or-v3%2F&rfr_id=info:sid\/en.wikipedia.org:Health_Level_7\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-HL7Three-7\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-HL7Three_7-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.hl7.org\/implement\/standards\/product_brief.cfm?product_id=186\" target=\"_blank\">\"HL7 Version 3 Product Suite\"<\/a>. Health Level 7 International. 15 May 2014<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.hl7.org\/implement\/standards\/product_brief.cfm?product_id=186\" target=\"_blank\">http:\/\/www.hl7.org\/implement\/standards\/product_brief.cfm?product_id=186<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 February 2015<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=HL7+Version+3+Product+Suite&rft.atitle=&rft.date=15+May+2014&rft.pub=Health+Level+7+International&rft_id=http%3A%2F%2Fwww.hl7.org%2Fimplement%2Fstandards%2Fproduct_brief.cfm%3Fproduct_id%3D186&rfr_id=info:sid\/en.wikipedia.org:Health_Level_7\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-CH09-8\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-CH09_8-0\" rel=\"external_link\">8.0<\/a><\/sup> <sup><a href=\"#cite_ref-CH09_8-1\" rel=\"external_link\">8.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Shaver, Dave (2009). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.corepointhealth.com\/sites\/default\/files\/whitepapers\/hl7-v2-v3-evolution.pdf\" target=\"_blank\">\"The HL7 Evolution: Comparing HL7 Version 2 to Version 3, Including a History of Version 2\"<\/a> (PDF). Corepoint Health<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.corepointhealth.com\/sites\/default\/files\/whitepapers\/hl7-v2-v3-evolution.pdf\" target=\"_blank\">http:\/\/www.corepointhealth.com\/sites\/default\/files\/whitepapers\/hl7-v2-v3-evolution.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 February 2015<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=The+HL7+Evolution%3A+Comparing+HL7+Version+2+to+Version+3%2C+Including+a+History+of+Version+2&rft.atitle=&rft.aulast=Shaver%2C+Dave&rft.au=Shaver%2C+Dave&rft.date=2009&rft.pub=Corepoint+Health&rft_id=http%3A%2F%2Fwww.corepointhealth.com%2Fsites%2Fdefault%2Ffiles%2Fwhitepapers%2Fhl7-v2-v3-evolution.pdf&rfr_id=info:sid\/en.wikipedia.org:Health_Level_7\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-8Common-9\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-8Common_9-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">McNickle, Michelle (25 April 2012). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.healthcareitnews.com\/news\/8-common-questions-about-hl7\" target=\"_blank\">\"8 common questions about HL7\"<\/a>. <i>Healthcare IT News<\/i>. HIMSS Media<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.healthcareitnews.com\/news\/8-common-questions-about-hl7\" target=\"_blank\">http:\/\/www.healthcareitnews.com\/news\/8-common-questions-about-hl7<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 February 2015<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=8+common+questions+about+HL7&rft.atitle=Healthcare+IT+News&rft.aulast=McNickle%2C+Michelle&rft.au=McNickle%2C+Michelle&rft.date=25+April+2012&rft.pub=HIMSS+Media&rft_id=http%3A%2F%2Fwww.healthcareitnews.com%2Fnews%2F8-common-questions-about-hl7&rfr_id=info:sid\/en.wikipedia.org:Health_Level_7\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-Cari11-10\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-Cari11_10-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Morin, Jeanluc (04 January 2011). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/caristix.com\/blog\/2011\/01\/will-hl7-v3-adoption-take-off-in-2011\/\" target=\"_blank\">\"Will HL7 V3 Adoption Take Off in 2011? 5 Points and 1 Caveat\"<\/a>. <i>Caristix Blog<\/i>. Caristix<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/caristix.com\/blog\/2011\/01\/will-hl7-v3-adoption-take-off-in-2011\/\" target=\"_blank\">http:\/\/caristix.com\/blog\/2011\/01\/will-hl7-v3-adoption-take-off-in-2011\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 February 2015<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Will+HL7+V3+Adoption+Take+Off+in+2011%3F+5+Points+and+1+Caveat&rft.atitle=Caristix+Blog&rft.aulast=Morin%2C+Jeanluc&rft.au=Morin%2C+Jeanluc&rft.date=04+January+2011&rft.pub=Caristix&rft_id=http%3A%2F%2Fcaristix.com%2Fblog%2F2011%2F01%2Fwill-hl7-v3-adoption-take-off-in-2011%2F&rfr_id=info:sid\/en.wikipedia.org:Health_Level_7\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-HI11-11\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-HI11_11-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Grieve, Grahame (15 August 2011). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.healthintersections.com.au\/?p=476\" target=\"_blank\">\"HL7 needs a fresh look because V3 has failed\"<\/a>. <i>Health Intersections Blog<\/i>. Health Intersections Pty. Ltd<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.healthintersections.com.au\/?p=476\" target=\"_blank\">http:\/\/www.healthintersections.com.au\/?p=476<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 February 2015<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=HL7+needs+a+fresh+look+because+V3+has+failed&rft.atitle=Health+Intersections+Blog&rft.aulast=Grieve%2C+Grahame&rft.au=Grieve%2C+Grahame&rft.date=15+August+2011&rft.pub=Health+Intersections+Pty.+Ltd&rft_id=http%3A%2F%2Fwww.healthintersections.com.au%2F%3Fp%3D476&rfr_id=info:sid\/en.wikipedia.org:Health_Level_7\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-FHIR12-12\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-FHIR12_12-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">McKenzie, Lloyd (February 2012). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.healthcareimc.com\/node\/515\" target=\"_blank\">\"HL7\u2019s Next Generation Standard is Coming: Keep Calm, Carry On\"<\/a>. <i>Healthcare Information Management & Communications Canada<\/i> <b>26<\/b> (1)<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.healthcareimc.com\/node\/515\" target=\"_blank\">http:\/\/www.healthcareimc.com\/node\/515<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 February 2015<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=HL7%E2%80%99s+Next+Generation+Standard+is+Coming%3A+Keep+Calm%2C+Carry+On&rft.jtitle=Healthcare+Information+Management+%26+Communications+Canada&rft.aulast=McKenzie%2C+Lloyd&rft.au=McKenzie%2C+Lloyd&rft.date=February+2012&rft.volume=26&rft.issue=1&rft_id=http%3A%2F%2Fwww.healthcareimc.com%2Fnode%2F515&rfr_id=info:sid\/en.wikipedia.org:Health_Level_7\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-HL7StandardFHIR-13\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-HL7StandardFHIR_13-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Brull, Rob (26 March 2013). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.hl7standards.com\/blog\/2013\/03\/26\/hl7-fhir\/\" target=\"_blank\">\"5 Things to Know About HL7 FHIR\"<\/a>. <i>HL7 Standards Blog<\/i>. HL7 Standards<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.hl7standards.com\/blog\/2013\/03\/26\/hl7-fhir\/\" target=\"_blank\">http:\/\/www.hl7standards.com\/blog\/2013\/03\/26\/hl7-fhir\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 February 2015<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=5+Things+to+Know+About+HL7+FHIR&rft.atitle=HL7+Standards+Blog&rft.aulast=Brull%2C+Rob&rft.au=Brull%2C+Rob&rft.date=26+March+2013&rft.pub=HL7+Standards&rft_id=http%3A%2F%2Fwww.hl7standards.com%2Fblog%2F2013%2F03%2F26%2Fhl7-fhir%2F&rfr_id=info:sid\/en.wikipedia.org:Health_Level_7\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-FHIRArgo-14\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-FHIRArgo_14-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Kern, Christine (12 December 2014). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.healthitoutcomes.com\/doc\/hl-advancing-fhir-0001\" target=\"_blank\">\"HL7 Advancing FHIR\"<\/a>. <i>Health IT Outcomes<\/i>. Jameson Publishing<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.healthitoutcomes.com\/doc\/hl-advancing-fhir-0001\" target=\"_blank\">http:\/\/www.healthitoutcomes.com\/doc\/hl-advancing-fhir-0001<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 February 2015<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=HL7+Advancing+FHIR&rft.atitle=Health+IT+Outcomes&rft.aulast=Kern%2C+Christine&rft.au=Kern%2C+Christine&rft.date=12+December+2014&rft.pub=Jameson+Publishing&rft_id=http%3A%2F%2Fwww.healthitoutcomes.com%2Fdoc%2Fhl-advancing-fhir-0001&rfr_id=info:sid\/en.wikipedia.org:Health_Level_7\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-15\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-15\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Kim, Katherine (July 2005). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.kathykim.com\/sitebuildercontent\/sitebuilderfiles\/ClinicalDataStandardsInHealthCare.pdf\" target=\"_blank\">\"Creating Clinical Data Standards in Health Care: Five Case Studies\"<\/a> (PDF). California HealthCare Foundation<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.kathykim.com\/sitebuildercontent\/sitebuilderfiles\/ClinicalDataStandardsInHealthCare.pdf\" target=\"_blank\">http:\/\/www.kathykim.com\/sitebuildercontent\/sitebuilderfiles\/ClinicalDataStandardsInHealthCare.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 02 March 2012<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Creating+Clinical+Data+Standards+in+Health+Care%3A+Five+Case+Studies&rft.atitle=&rft.aulast=Kim%2C+Katherine&rft.au=Kim%2C+Katherine&rft.date=July+2005&rft.pub=California+HealthCare+Foundation&rft_id=http%3A%2F%2Fwww.kathykim.com%2Fsitebuildercontent%2Fsitebuilderfiles%2FClinicalDataStandardsInHealthCare.pdf&rfr_id=info:sid\/en.wikipedia.org:Health_Level_7\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-RIM-16\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-RIM_16-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.hl7.org\/implement\/standards\/rim.cfm\" target=\"_blank\">\"HL7 Reference Information Model\"<\/a>. Health Level 7 International<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.hl7.org\/implement\/standards\/rim.cfm\" target=\"_blank\">http:\/\/www.hl7.org\/implement\/standards\/rim.cfm<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 17 February 2015<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=HL7+Reference+Information+Model&rft.atitle=&rft.pub=Health+Level+7+International&rft_id=http%3A%2F%2Fwww.hl7.org%2Fimplement%2Fstandards%2Frim.cfm&rfr_id=info:sid\/en.wikipedia.org:Health_Level_7\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-ISO21731-17\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-ISO21731_17-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.iso.org\/iso\/home\/store\/catalogue_ics\/catalogue_detail_ics.htm?csnumber=40399\" target=\"_blank\">\"ISO\/HL7 21731:2006\"<\/a>. International Organization for Standardization<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.iso.org\/iso\/home\/store\/catalogue_ics\/catalogue_detail_ics.htm?csnumber=40399\" target=\"_blank\">http:\/\/www.iso.org\/iso\/home\/store\/catalogue_ics\/catalogue_detail_ics.htm?csnumber=40399<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 17 February 2015<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=ISO%2FHL7+21731%3A2006&rft.atitle=&rft.pub=International+Organization+for+Standardization&rft_id=http%3A%2F%2Fwww.iso.org%2Fiso%2Fhome%2Fstore%2Fcatalogue_ics%2Fcatalogue_detail_ics.htm%3Fcsnumber%3D40399&rfr_id=info:sid\/en.wikipedia.org:Health_Level_7\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-CDABook-18\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CDABook_18-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Boone, Keith W. (2011). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/books.google.com\/books?id=rwa6DDB4jY8C&pg=PA17\" target=\"_blank\"><i>The CDA Book<\/i><\/a>. Springer Science & Business Media. pp. 17\u201321<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/books.google.com\/books?id=rwa6DDB4jY8C&pg=PA17\" target=\"_blank\">http:\/\/books.google.com\/books?id=rwa6DDB4jY8C&pg=PA17<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 17 February 2015<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=The+CDA+Book&rft.aulast=Boone%2C+Keith+W.&rft.au=Boone%2C+Keith+W.&rft.date=2011&rft.pages=pp.%26nbsp%3B17%E2%80%9321&rft.pub=Springer+Science+%26+Business+Media&rft_id=http%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3Drwa6DDB4jY8C%26pg%3DPA17&rfr_id=info:sid\/en.wikipedia.org:Health_Level_7\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-ISO27932-19\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-ISO27932_19-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.iso.org\/iso\/iso_catalogue\/catalogue_tc\/catalogue_detail.htm?csnumber=44429\" target=\"_blank\">\"ISO\/HL7 27932:2009\"<\/a>. International Organization for Standardization<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.iso.org\/iso\/iso_catalogue\/catalogue_tc\/catalogue_detail.htm?csnumber=44429\" target=\"_blank\">http:\/\/www.iso.org\/iso\/iso_catalogue\/catalogue_tc\/catalogue_detail.htm?csnumber=44429<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 17 February 2015<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=ISO%2FHL7+27932%3A2009&rft.atitle=&rft.pub=International+Organization+for+Standardization&rft_id=http%3A%2F%2Fwww.iso.org%2Fiso%2Fiso_catalogue%2Fcatalogue_tc%2Fcatalogue_detail.htm%3Fcsnumber%3D44429&rfr_id=info:sid\/en.wikipedia.org:Health_Level_7\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-CCOWWiki-20\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CCOWWiki_20-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/wiki.hl7.org\/index.php?title=Product_CCOW\" target=\"_blank\">\"Product CCOW\"<\/a>. <i>HL7 Wiki<\/i>. Health Level 7 International. 27 October 2010<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/wiki.hl7.org\/index.php?title=Product_CCOW\" target=\"_blank\">http:\/\/wiki.hl7.org\/index.php?title=Product_CCOW<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 17 February 2015<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Product+CCOW&rft.atitle=HL7+Wiki&rft.date=27+October+2010&rft.pub=Health+Level+7+International&rft_id=http%3A%2F%2Fwiki.hl7.org%2Findex.php%3Ftitle%3DProduct_CCOW&rfr_id=info:sid\/en.wikipedia.org:Health_Level_7\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-FHIRPrinc-21\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-FHIRPrinc_21-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/wiki.hl7.org\/index.php?title=Fundamental_Principles_of_FHIR\" target=\"_blank\">\"Fundamental Principles of FHIR\"<\/a>. <i>HL7 Wiki<\/i>. Health Level 7 International. 16 September 2014<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/wiki.hl7.org\/index.php?title=Fundamental_Principles_of_FHIR\" target=\"_blank\">http:\/\/wiki.hl7.org\/index.php?title=Fundamental_Principles_of_FHIR<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18February 2015<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Fundamental+Principles+of+FHIR&rft.atitle=HL7+Wiki&rft.date=16+September+2014&rft.pub=Health+Level+7+International&rft_id=http%3A%2F%2Fwiki.hl7.org%2Findex.php%3Ftitle%3DFundamental_Principles_of_FHIR&rfr_id=info:sid\/en.wikipedia.org:Health_Level_7\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<\/ol>\n\n<!-- \nNewPP limit report\nCached time: 20181213192759\nCache expiry: 86400\nDynamic content: false\nCPU time usage: 0.604 seconds\nReal time usage: 1.320 seconds\nPreprocessor visited node count: 13390\/1000000\nPreprocessor generated node count: 22117\/1000000\nPost\u2010expand include size: 80461\/2097152 bytes\nTemplate argument size: 31038\/2097152 bytes\nHighest expansion depth: 13\/40\nExpensive parser function count: 0\/100\n-->\n\n<!-- \nTransclusion expansion time report (%,ms,calls,template)\n100.00% 369.385 1 - -total\n 89.03% 328.864 22 - Template:Citation\/core\n 79.54% 293.815 19 - Template:Cite_web\n 12.40% 45.818 2 - Template:Cite_book\n 5.65% 20.886 1 - Template:Cite_journal\n 5.50% 20.331 30 - Template:Citation\/make_link\n 2.22% 8.200 1 - Template:Citation\/identifier\n 0.56% 2.073 2 - Template:Hide_in_print\n 0.53% 1.961 1 - Template:Only_in_print\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:3385-0!*!0!!en!5!* and timestamp 20181213192758 and revision id 27386\n -->\n<\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Health_Level_7\">https:\/\/www.limswiki.org\/index.php\/Health_Level_7<\/a><\/div>\n\t\t\t\t\t\t\t\t\t\t<!-- end content -->\n\t\t\t\t\t\t\t\t\t\t<div class=\"visualClear\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t<!-- end of the left (by default at least) column -->\n\t\t<div class=\"visualClear\"><\/div>\n\t\t\t\t\t\n\t\t<\/div>\n\t\t\n\n<\/body>","e0bf845fb58d2bae05a846b47629e86f_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/f\/f8\/HL7_Reference_Information_Model.jpg"],"e0bf845fb58d2bae05a846b47629e86f_timestamp":1544729278,"b70673a0117c21576016cb7498867153_type":"article","b70673a0117c21576016cb7498867153_title":"Health Insurance Portability and Accountability Act","b70673a0117c21576016cb7498867153_url":"https:\/\/www.limswiki.org\/index.php\/Health_Insurance_Portability_and_Accountability_Act","b70673a0117c21576016cb7498867153_plaintext":"\n\n\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\n\t\t\t\tHealth Insurance Portability and Accountability Act\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\tFrom LIMSWiki\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\tJump to: navigation, search\n\n\t\t\t\t\t\n\t\t\t\t\t\nThe Health Insurance Portability and Accountability Act of 1996 (HIPAA) was enacted by the United States Congress and signed by President Bill Clinton in 1996. Its intended purpose was \"to improve portability and continuity of health insurance coverage in the group and individual markets; to combat waste, fraud, and abuse in health insurance and health care delivery; to promote the use of medical savings accounts; to improve access to long-term care services and coverage; [and] to simplify the administration of health insurance.\"[1]\n\nContents\n\n1 History \n\n1.1 Initial \n1.2 Amendments \n\n\n2 Structure \n\n2.1 Description \n\n\n3 Enforcement \n4 Assessed impact \n5 Audit guidelines and checklist \n6 Further reading \n7 References \n\n\n\nHistory \nInitial \nIn 1994, U.S. President Bill Clinton attempted to overhaul the national health care system but didn't receive the support he needed. In 1995, Senators Nancy Kassebaum (R-KS) and Edward Kennedy (D-MA) introduced a comparatively pared down proposal called the Health Insurance Reform Act of 1995 (S 11028), later referred to informally as the Kassebaum\/Kennedy Bill. The proposal called for health insurance portability for employees, medical savings accounts, increased deductibility of health insurance for the self-employed, and tax breaks for long-term care insurance.[2][3] The legislation successfully made it out of the Senate Labor and Human Resources Committee on August 2, 1995[4], only to be stalled \"because of opposition from conservative senators who shared industry concerns over the group-to-individual portability provisions.\"[2] \nWith desire to get some sort of health care reform legislation passed, Clinton referenced the stalled bill in his January 1996 State of the Union address on several occasions. Though some feared the ploy by Clinton would ultimately sink the bill, it inevitably resulted in bipartisan cooperation so no one side could take credit for the bill.[4] On February 7, 1996, the two parties agreed to further discuss the legislation in the House and Senate. This resulted in several events: the House of Representatives created an alternative bill (HR 3103) that drew on characteristics of S 11028, passing on March 28; the Senate passed a version of the original S 11028 on April 23 but without controversial attachments like medical savings accounts. However, differences between the House and Senate bills caused problems. \"The House bill, for example, included provisions allowing for medical savings accounts, a limit on monetary damages in medical malpractice lawsuits and a reduction in states' authority to regulate health insurance purchasing pools created by small businesses.\"[2] Additionally, a provision on mental health coverage was found on the Senate bill that was omitted from the House version. It took several weeks of debating to make concessions on these topics. \nA Republican-led compromise was offered on June 10, however debate raged on. It wasn't until a July 25 compromise between Kennedy and Ways and Means Committee Chairman Bill Archer (R-TX) on medical savings accounts that momentum shifted. Provisions on mental illness and medical malpractice were eventually dropped from the proposal on July 31, with both House and Senate agreeing on the final version on August 1 and August 2 respectively.[2] On August 21, 1996, the legislation was signed into law by President Clinton and codified as Public Law 104-191, the Health Insurance Portability and Accountability Act of 1996 (HIPAA).[5][1]\n\nAmendments \nThe administrative simplification provisions in HIPAA meant more work had to be done in regards to the legislation. The U.S. Department of Health and Human Services (HHS) began work on the HIPAA Privacy Rule in 1999, \"which set out detailed regulations regarding the types of uses and disclosures of personally identifiable health information that are permitted by the covered entities.\"[6] However, large volumes of comments and Executive branch changes in 2000 slowed the process down.[6] Several more years of corrections and requests for comments followed, culminating in the release of the Final Rule on August 14, 2002 as 45 CFR Part 160 and Subparts A and E of Part 164.[7] Most health plans were expected to be in compliance by April 14, 2003, though some exceptions existed.\nDespite the Privacy Rule, many still argued that the legislation wasn't suitable enough to prevent mishandling of personal health information and that it was impeding research.[6] These concerns mixed with few incidents of enforcement in the first few years after the 2003 compliance date prompted additional review by the HHS.[8] On February 16, 2006, HHS issued the Final Rule regarding HIPAA enforcement, to be effective March 16, 2006.[9] \nAdditional updates to the enforcement rule came with the Health Information Technology for Economic and Clinical Health Act (HITECH) Act, enacted on February 17, 2009. The Act added \"several provisions that strengthen the civil and criminal enforcement of the HIPAA rules\" by adding categories of violations and tier levels of penalty amounts.[9] HIPAA and the HITECH statutes were further revised in January 2013 (effective March 26, 2013) \"to strengthen the privacy and security protection for individuals\u2019 health information,\" update the Breach Notification Rule, \"strengthen the privacy protections for genetic information,\" and revise other portions of HIPAA rules \"to improve their workability and effectiveness.\"[10]\n\nStructure \nHIPAA is divided into five titles, each with their own subtitles[1]:\nTitle I: Health Care Access, Portability, and Renewability\n\nSubtitle A - Group Market Rules\nSubtitle B - Individual Market Rules\nSubtitle C - General and Miscellaneous Provisions\nTitle II: Preventing Health Care Fraud and Abuse; Administrative Simplification; Medical Liability Reform\n\nSubtitle A - Fraud and Abuse Control Program\nSubtitle B - Revisions to Current Sanctions for Fraud and Abuse\nSubtitle C - Data Collection\nSubtitle D - Civil Monetary Penalties\nSubtitle E - Revisions to Criminal Law\nSubtitle F - Administrative Simplification\nSubtitle G - Duplication and Coordination of Medicare-Related Plans\nTitle III: Tax-Related Health Provisions\n\nSubtitle A - Medical Savings Accounts\nSubtitle B - Increase in Deduction for Health Insurance Costs of Self-Employed Individuals\nSubtitle C - Long-Term Care Services and Contracts\nSubtitle D - Treatment of Accelerated Death Benefits\nSubtitle E - State Insurance Pools\nSubtitle F - Organizations Subject to Section 833\nSubtitle G - IRA Distributions to the Unemployed\nSubtitle H - Organ and Tissue Donation Information Included With Income Tax Refund Payments\nTitle IV: Application and Enforcement of Group Health Plan Requirements\n\nSubtitle A - Application and Enforcement of Group Health Plan Requirements\nSubtitle B - Clarification of Certain Continuation Coverage Requirements\nTitle V: Revenue Offsets\n\nSubtitle A - Company-Owned Life Insurance\nSubtitle B - Treatment of Individuals Who Lose United States Citizenship\nSubtitle C - Repeal of Financial Institution Transition Rule to Interest Allocation Rules\nDescription \nTitle I of HIPAA contains three subtitles that protect health insurance coverage for workers and their families when they change or lose their jobs. \nTitle II of HIPAA contains seven subtitles. One of the most important for expanding HIPAA is Subtitle F, the Administrative Simplification (AS) provisions, requiring the establishment of national standards for electronic health care transactions and national identifiers for providers, health insurance plans, and employers. Title II also addresses the security and privacy of health data, with the intent of improving the efficiency and effectiveness of the nation's health care system by encouraging the widespread use of electronic data interchange in the U.S. health care system.\nTitle III of HIPAA modifies the Internal Revenue Code (IRC) to revise available tax deductions for health insurance, clarify how pre-tax money could be applied health payments, and regulate long-term care services and how they're contracted. Other tax-related issues like IRA distribution and organ donor tax refund payments are covered by this title, in total spread out over eight subtitles.\nTitle IV of HIPAA modifies both the IRC and the Public Health Service Act (PHSA) to describe requirements for and enforcement of how group health plans could legally manage and cover patients' pre-existing conditions as well as their continuation of coverage. This information is supplied over two subtitles.\nTitle V of HIPAA contains three subtitles that amend the IRC concerning miscellaneous issues such as interest deductions on loans related to company-owned life insurance, how individuals who lose their U.S. citizenship shall be treated tax-wise, and the removal of certain limitations on interest allocation.\n\nEnforcement \nOn February 16, 2006, HHS issued the Final Rule regarding HIPAA enforcement. It became effective on March 16, 2006. The Enforcement Rule set civil money penalties for violating HIPAA rules and established procedures for investigations and hearings for HIPAA violations. Before the enforcement rule, the deterrent effects of the legislation seemed negligible, with few prosecutions for violations.[8] Enforcement operations were ratcheted up further with the passage of the Health Information Technology for Economic and Clinical Health Act (HITECH) in 2009, which greatly increased the financial penalties that could be applied to entities in non-compliance.[11]\nBy the end of 2014, the U.S. Department of Health and Human Resources (HHS) reported investigating 106,522 HIPAA complaints against national pharmacy chains, major health care centers, insurance groups, hospital chains and other small providers since April 2003. The HHS reported 23,314 of those cases had been resolved by requiring changes in privacy practice or by corrective action. 10,566 cases were investigated and found that HIPAA was followed correctly. Another 68,412 cases were found to be ineligible for enforcement because, for example, a violation occurred before HIPAA became effective, a case was withdrawn by the pursuer, or an activity did not actually violate the rules.[12]\nAccording to the HHS, the most commonly investigated compliance issue, by order of frequency, have been[12]:\n\n incorrectly used or revealed protected health information (PHI);\n insufficient protection mechanisms for PHI;\n insufficient mechanisms for patients to access their PHI;\n insufficient administrative protections and tools for managing electronic PHI; and\n usage and disclosure of more PHI than minimally necessary.\nThe HHS also stated the entities most likely to be responsible for infractions, by order of frequency, have been[12]:\n\n private practices;\n general hospitals;\n outpatient facilities;\n pharmacies; and\n health plans (group health plans and health insurance issuers).\nAssessed impact \nThe enactment of HIPAA caused major changes in the way physicians and medical centers operate. The complex legalities and potentially stiff penalties associated with HIPAA, as well as the increase in paperwork and the cost of its implementation, were causes for concern among physicians and medical centers. Many of those concerns were expressed in an August 2006 paper published in the journal Annals of Internal Medicine.[13] It mentioned a University of Michigan study that demonstrated how the implementation of the HIPAA Privacy rule resulted in a drop from 96 percent to 34 percent in the proportion of follow-up surveys completed by study patients being followed after a heart attack.[14] \nBy 2013, views on the impact of HIPAA were mixed. Leon Rodriguez, director of the HHS' Office for Civil Rights said of HIPAA:\n\nWhereas many thought HIPAA would \"bankrupt\" healthcare, shut down research, and otherwise paralyze the industry, instead the industry has learned the benefits of the transaction and code set standards through the ease of electronic transactions. And the balance of the [HIPAA] Privacy and Security protections have paved the way to real benefits for consumers through greater access to quality care.[11] \nIn an article for the Houston Chronicle, writer and business consultant Lisa Dorward stated the following for patients requesting personal health information:\n\nDirect cost to patients is minimal; health care institutions can charge the patient only for copying and postage costs for delivery of the documents. On the other hand, costs to health care providers are high and can strain already overburdened budgets. Some clinics and hospitals have had to reconstruct or remodel existing registration areas to comply with HIPAA's privacy regulations.[15] \nWriting for the Loyola Consumer Law Review, attorney and legal writer Anna Colvert wrote:\n\nGenerally, HIPAA is considered a step in the right direction regarding patient privacy, and it has resulted in more descriptive and detailed privacy policies; however, it has not improved the online privacy practices of these organizations. While HIPAA is a solid foundation in protecting patients\u2019 healthcare information there is more work to be done...\"[16] \nA May 2013 Computerworld reported on a survey conducted by the Ponemon Institute that found 51 percent of respondents believed \"HIPAA compliance requirements can be a barrier to providing effective patient care\" and 59 percent \"cited the complexity of HIPAA requirements as a major barrier to modernizing the healthcare system.\"[17]\n\nAudit guidelines and checklist \nMain article: Health Insurance Portability and Accountability Act\/Audit guidelines and checklist\nFor those auditing computer systems and IT environments for their compliance with the Health Insurance Portability and Accountability Act and other regulations, a set of guidelines and checklist items may be useful. \n\r\n\nClick the link above for the full set of guidelines and checklist items as they relate to HIPAA.\n\nFurther reading \n \"Public Law 104 - 191 - Health Insurance Portability and Accountability Act of 1996\". U.S. Government Publishing Office. http:\/\/www.gpo.gov\/fdsys\/pkg\/PLAW-104publ191\/content-detail.html .   \n \"S. 1028 (104th): Health Insurance Reform Act of 1995\". GovTrack.us. Civic Impulse, LLC. https:\/\/www.govtrack.us\/congress\/bills\/104\/s1028 .   \n \"Bill Makes Health Insurance \u2018Portable\u2019\". CQ Almanac 1996 52: 6-28\u20136-39. 1997. http:\/\/library.cqpress.com\/cqalmanac\/document.php?id=cqal96-1092479 .   \nReferences \n\n\n\u2191 1.0 1.1 1.2 \"Public Law 104 - 191 - Health Insurance Portability and Accountability Act of 1996\". U.S. Government Publishing Office. http:\/\/www.gpo.gov\/fdsys\/pkg\/PLAW-104publ191\/content-detail.html . Retrieved 11 February 2015 .   \n\n\u2191 2.0 2.1 2.2 2.3 \"Bill Makes Health Insurance \u2018Portable\u2019\". CQ Almanac 1996 52: 6-28\u20136-39. 1997. http:\/\/library.cqpress.com\/cqalmanac\/document.php?id=cqal96-1092479 . Retrieved 12 February 2015 .   \n\n\u2191 \"S. 1028 (104th): Health Insurance Reform Act of 1995\". GovTrack.us. Civic Impulse, LLC. https:\/\/www.govtrack.us\/congress\/bills\/104\/s1028 . Retrieved 12 February 2015 .   \n\n\u2191 4.0 4.1 Hiebert-White, Jane (September-October 1996). \"Who Won What in the Kassebaum\/Kennedy Struggle?\" (PDF). Health Progress 77 (5). https:\/\/www.chausa.org\/docs\/default-source\/health-progress\/health-policy---who-won-what-in-the-kassebaumkennedy-struggle-pdf.pdf?sfvrsn=0 . Retrieved 12 February 2015 .   \n\n\u2191 Starr, Paul (22 August 1996). \"The Signing of the Kennedy-Kassebaum Bill\". The Electronic Policy Network. Archived from the original on 29 January 1998. https:\/\/web.archive.org\/web\/19980129180414\/http:\/\/epn.org\/library\/signing.html . Retrieved 12 February 2015 .   \n\n\u2191 6.0 6.1 6.2 Institute of Medicine (US) Committee on Health Research and the Privacy of Health Information: The HIPAA Privacy Rule (2009). Nass, S. J.; Levit, L. A.; Gostin, L. O.. ed. Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research. National Academies Press. Bookshelf ID NBK9576. http:\/\/www.ncbi.nlm.nih.gov\/books\/NBK9576\/ . Retrieved 12 February 2015 .   \n\n\u2191 \"The Privacy Rule\". U.S. Department of Health and Human Services. http:\/\/www.hhs.gov\/ocr\/privacy\/hipaa\/administrative\/privacyrule\/ . Retrieved 12 February 2015 .   \n\n\u2191 8.0 8.1 Stein, Rob (5 June 2006). \"Medical Privacy Law Nets No Fines\". The Washington Post. http:\/\/www.washingtonpost.com\/wp-dyn\/content\/article\/2006\/06\/04\/AR2006060400672.html . Retrieved 28 February 2012 .   \n\n\u2191 9.0 9.1 \"The HIPAA Enforcement Rule\". U.S. Department of Health and Human Services. http:\/\/www.hhs.gov\/ocr\/privacy\/hipaa\/administrative\/enforcementrule\/index.html . Retrieved 12 February 2015 .   \n\n\u2191 Office for Civil Rights, Department of Health and Human Services (25 January 2013). \"Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules Under the Health Information Technology for Economic and Clinical Health Act and the Genetic Information Nondiscrimination Act; Other Modifications to the HIPAA Rules\" (PDF). Federal Register 78 (17). http:\/\/www.gpo.gov\/fdsys\/pkg\/FR-2013-01-25\/pdf\/2013-01073.pdf . Retrieved 12 February 2015 .   \n\n\u2191 11.0 11.1 Solove, Daniel J. (April 2013). \"HIPAA Turns 10: Analyzing the Past, Present and Future Impact\". Journal of AHIMA 84 (4): 22\u201328. http:\/\/library.ahima.org\/xpedio\/groups\/public\/documents\/ahima\/bok1_050149.hcsp?dDocName=bok1_050149 . Retrieved 11 February 2015 .   \n\n\u2191 12.0 12.1 12.2 \"Enforcement Highlights\". U.S. Department of Health and Human Services. 15 January 2015. Archived from the original on 11 February 2015. https:\/\/web.archive.org\/web\/20150211170207\/http:\/\/www.hhs.gov\/ocr\/privacy\/hipaa\/enforcement\/highlights\/index.html . Retrieved 11 February 2015 .   \n\n\u2191 Wilson, Jennifer Fisher (2006). \"Health Insurance Portability and Accountability Act Privacy Rule Causes Ongoing Concerns among Clinicians and Researchers\". Annals of Internal Medicine 145 (4): 313\u20136. doi:10.7326\/0003-4819-145-4-200608150-00019. PMID 16908928.   \n\n\u2191 Armstrong, David; Kline-Rogers, Eva; Jani, Sandeep M.; Goldman, Edward B.; Fang, Jianming; Mukherjee, Debabrata; Nallamothu, Brahmajee N.; Eagle, Kim A. (2005). \"Potential Impact of the HIPAA Privacy Rule on Data Collection in a Registry of Patients With Acute Coronary Syndrome\". Archives of Internal Medicine 165 (10): 1125\u20139. doi:10.1001\/archinte.165.10.1125. PMID 15911725. http:\/\/archinte.jamanetwork.com\/article.aspx?articleid=486568 . Retrieved 11 February 2015 .   \n\n\u2191 Dorward, Lisa. \"The Positive and Negative Effects of HIPAA Employment Laws\". Houston Chronicle. Hearst Newspapers, LLC. http:\/\/smallbusiness.chron.com\/positive-negative-effects-hipaa-employment-laws-18500.html . Retrieved 11 February 2015 .   \n\n\u2191 Colvert, Anna (2013). \"HIPAA'S Influence on Consumers: Friend or Foe?\". Loyola Consumer Law Review 25 (4): 431\u2013447. http:\/\/lawecommons.luc.edu\/lclr\/vol25\/iss4\/6\/ . Retrieved 11 February 2015 .   \n\n\u2191 Mearian, Lucas (07 May 2013). \"HIPAA rules, outdated tech cost U.S. hospitals $8.3B a year\". Computerworld.com. Computerworld, Inc. http:\/\/www.computerworld.com\/article\/2496995\/healthcare-it\/hipaa-rules--outdated-tech-cost-u-s--hospitals--8-3b-a-year.html . Retrieved 11 February 2015 .   \n\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Health_Insurance_Portability_and_Accountability_Act\">https:\/\/www.limswiki.org\/index.php\/Health_Insurance_Portability_and_Accountability_Act<\/a>\n\t\t\t\t\tCategories: Health informaticsHealth standardsRegulatory information\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\n\t\t\n\t\t\tNavigation menu\n\t\t\t\t\t\n\t\t\tViews\n\n\t\t\t\n\t\t\t\t\n\t\t\t\tPage\n\t\t\t\tDiscussion\n\t\t\t\tView source\n\t\t\t\tHistory\n\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\n\t\t\t\t\n\t\t\t\tPersonal tools\n\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\tLog in\n\t\t\t\t\t\t\t\t\t\t\t\t\tRequest account\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\t\t\n\t\tNavigation\n\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tMain page\n\t\t\t\t\t\t\t\t\t\t\tRecent changes\n\t\t\t\t\t\t\t\t\t\t\tRandom page\n\t\t\t\t\t\t\t\t\t\t\tHelp\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\n\t\t\t\n\t\t\tSearch\n\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t \n\t\t\t\t\t\t\n\t\t\t\t\n\n\t\t\t\t\t\t\t\n\t\t\n\t\t\t\n\t\t\tTools\n\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tWhat links here\n\t\t\t\t\t\t\t\t\t\t\tRelated changes\n\t\t\t\t\t\t\t\t\t\t\tSpecial pages\n\t\t\t\t\t\t\t\t\t\t\tPermanent link\n\t\t\t\t\t\t\t\t\t\t\tPage information\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\n\t\t\n\t\tPrint\/export\n\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tCreate a book\n\t\t\t\t\t\t\t\t\t\t\tDownload as PDF\n\t\t\t\t\t\t\t\t\t\t\tDownload as Plain text\n\t\t\t\t\t\t\t\t\t\t\tPrintable version\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\n\t\t\n\t\tSponsors\n\t\t\n\t\t\t \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n \r\n\n\t\n\t\r\n\n \r\n\n\t\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t This page was last modified on 16 August 2016, at 20:55.\n\t\t\t\t\t\t\t\t\tThis page has been accessed 19,205 times.\n\t\t\t\t\t\t\t\t\tContent is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.\n\t\t\t\t\t\t\t\t\tPrivacy policy\n\t\t\t\t\t\t\t\t\tAbout LIMSWiki\n\t\t\t\t\t\t\t\t\tDisclaimers\n\t\t\t\t\t\t\t\n\t\t\n\t\t\n\t\t\n\n","b70673a0117c21576016cb7498867153_html":"<body class=\"mediawiki ltr sitedir-ltr ns-0 ns-subject page-Health_Insurance_Portability_and_Accountability_Act skin-monobook action-view\">\n<div id=\"rdp-ebb-globalWrapper\">\n\t\t<div id=\"rdp-ebb-column-content\">\n\t\t\t<div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\">\n\t\t\t\t<a id=\"rdp-ebb-top\"><\/a>\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Health Insurance Portability and Accountability Act<\/h1>\n\t\t\t\t\n\t\t\t\t<div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\">\n\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\n\n\t\t\t\t\t<!-- start content -->\n\t\t\t\t\t<div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:HIPAA_Screenshot.png\" class=\"image wiki-link\" target=\"_blank\" data-key=\"f43d76e7dcca207ca031bdff3314d856\"><img alt=\"HIPAA Screenshot.png\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/6\/66\/HIPAA_Screenshot.png\" style=\"width: 100%;max-width: 400px;height: auto;\" \/><\/a><\/div>\n<p>The <b>Health Insurance Portability and Accountability Act of 1996<\/b> (<b>HIPAA<\/b>) was enacted by the United States Congress and signed by President Bill Clinton in 1996. Its intended purpose was \"to improve portability and continuity of health insurance coverage in the group and individual markets; to combat waste, fraud, and abuse in health insurance and health care delivery; to promote the use of medical savings accounts; to improve access to long-term care services and coverage; [and] to simplify the administration of health insurance.\"<sup id=\"rdp-ebb-cite_ref-HIPAAGPO_1-0\" class=\"reference\"><a href=\"#cite_note-HIPAAGPO-1\" rel=\"external_link\">[1]<\/a><\/sup>\n<\/p>\n\n\n<h2><span class=\"mw-headline\" id=\"History\">History<\/span><\/h2>\n<h3><span class=\"mw-headline\" id=\"Initial\">Initial<\/span><\/h3>\n<p>In 1994, U.S. President Bill Clinton attempted to overhaul the national health care system but didn't receive the support he needed. In 1995, Senators Nancy Kassebaum (R-KS) and Edward Kennedy (D-MA) introduced a comparatively pared down proposal called the Health Insurance Reform Act of 1995 (S 11028), later referred to informally as the Kassebaum\/Kennedy Bill. The proposal called for health insurance portability for employees, medical savings accounts, increased deductibility of health insurance for the self-employed, and tax breaks for long-term care insurance.<sup id=\"rdp-ebb-cite_ref-CQHIPAAHist_2-0\" class=\"reference\"><a href=\"#cite_note-CQHIPAAHist-2\" rel=\"external_link\">[2]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-11028Legal_3-0\" class=\"reference\"><a href=\"#cite_note-11028Legal-3\" rel=\"external_link\">[3]<\/a><\/sup> The legislation successfully made it out of the Senate Labor and Human Resources Committee on August 2, 1995<sup id=\"rdp-ebb-cite_ref-HiebertHIPAA_4-0\" class=\"reference\"><a href=\"#cite_note-HiebertHIPAA-4\" rel=\"external_link\">[4]<\/a><\/sup>, only to be stalled \"because of opposition from conservative senators who shared industry concerns over the group-to-individual portability provisions.\"<sup id=\"rdp-ebb-cite_ref-CQHIPAAHist_2-1\" class=\"reference\"><a href=\"#cite_note-CQHIPAAHist-2\" rel=\"external_link\">[2]<\/a><\/sup> \n<\/p><p>With desire to get some sort of health care reform legislation passed, Clinton referenced the stalled bill in his January 1996 State of the Union address on several occasions. Though some feared the ploy by Clinton would ultimately sink the bill, it inevitably resulted in bipartisan cooperation so no one side could take credit for the bill.<sup id=\"rdp-ebb-cite_ref-HiebertHIPAA_4-1\" class=\"reference\"><a href=\"#cite_note-HiebertHIPAA-4\" rel=\"external_link\">[4]<\/a><\/sup> On February 7, 1996, the two parties agreed to further discuss the legislation in the House and Senate. This resulted in several events: the House of Representatives created an alternative bill (HR 3103) that drew on characteristics of S 11028, passing on March 28; the Senate passed a version of the original S 11028 on April 23 but without controversial attachments like medical savings accounts. However, differences between the House and Senate bills caused problems. \"The House bill, for example, included provisions allowing for medical savings accounts, a limit on monetary damages in medical malpractice lawsuits and a reduction in states' authority to regulate health insurance purchasing pools created by small businesses.\"<sup id=\"rdp-ebb-cite_ref-CQHIPAAHist_2-2\" class=\"reference\"><a href=\"#cite_note-CQHIPAAHist-2\" rel=\"external_link\">[2]<\/a><\/sup> Additionally, a provision on mental health coverage was found on the Senate bill that was omitted from the House version. It took several weeks of debating to make concessions on these topics. \n<\/p><p>A Republican-led compromise was offered on June 10, however debate raged on. It wasn't until a July 25 compromise between Kennedy and Ways and Means Committee Chairman Bill Archer (R-TX) on medical savings accounts that momentum shifted. Provisions on mental illness and medical malpractice were eventually dropped from the proposal on July 31, with both House and Senate agreeing on the final version on August 1 and August 2 respectively.<sup id=\"rdp-ebb-cite_ref-CQHIPAAHist_2-3\" class=\"reference\"><a href=\"#cite_note-CQHIPAAHist-2\" rel=\"external_link\">[2]<\/a><\/sup> On August 21, 1996, the legislation was signed into law by President Clinton and codified as Public Law 104-191, the Health Insurance Portability and Accountability Act of 1996 (HIPAA).<sup id=\"rdp-ebb-cite_ref-StarrHIPAA_5-0\" class=\"reference\"><a href=\"#cite_note-StarrHIPAA-5\" rel=\"external_link\">[5]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-HIPAAGPO_1-1\" class=\"reference\"><a href=\"#cite_note-HIPAAGPO-1\" rel=\"external_link\">[1]<\/a><\/sup>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Amendments\">Amendments<\/span><\/h3>\n<p>The administrative simplification provisions in HIPAA meant more work had to be done in regards to the legislation. The <a href=\"https:\/\/www.limswiki.org\/index.php\/United_States_Department_of_Health_and_Human_Services\" title=\"United States Department of Health and Human Services\" target=\"_blank\" class=\"wiki-link\" data-key=\"efa106bcbb93039b1a6c3c596daedec3\">U.S. Department of Health and Human Services<\/a> (HHS) began work on the HIPAA Privacy Rule in 1999, \"which set out detailed regulations regarding the types of uses and disclosures of personally identifiable health information that are permitted by the covered entities.\"<sup id=\"rdp-ebb-cite_ref-PrivRule_6-0\" class=\"reference\"><a href=\"#cite_note-PrivRule-6\" rel=\"external_link\">[6]<\/a><\/sup> However, large volumes of comments and Executive branch changes in 2000 slowed the process down.<sup id=\"rdp-ebb-cite_ref-PrivRule_6-1\" class=\"reference\"><a href=\"#cite_note-PrivRule-6\" rel=\"external_link\">[6]<\/a><\/sup> Several more years of corrections and requests for comments followed, culminating in the release of the Final Rule on August 14, 2002 as 45 CFR Part 160 and Subparts A and E of Part 164.<sup id=\"rdp-ebb-cite_ref-HHSFinalPriv_7-0\" class=\"reference\"><a href=\"#cite_note-HHSFinalPriv-7\" rel=\"external_link\">[7]<\/a><\/sup> Most health plans were expected to be in compliance by April 14, 2003, though some exceptions existed.\n<\/p><p>Despite the Privacy Rule, many still argued that the legislation wasn't suitable enough to prevent mishandling of personal health information and that it was impeding research.<sup id=\"rdp-ebb-cite_ref-PrivRule_6-2\" class=\"reference\"><a href=\"#cite_note-PrivRule-6\" rel=\"external_link\">[6]<\/a><\/sup> These concerns mixed with few incidents of enforcement in the first few years after the 2003 compliance date prompted additional review by the HHS.<sup id=\"rdp-ebb-cite_ref-SteinFines_8-0\" class=\"reference\"><a href=\"#cite_note-SteinFines-8\" rel=\"external_link\">[8]<\/a><\/sup> On February 16, 2006, HHS issued the Final Rule regarding HIPAA enforcement, to be effective March 16, 2006.<sup id=\"rdp-ebb-cite_ref-HHSEnfo_9-0\" class=\"reference\"><a href=\"#cite_note-HHSEnfo-9\" rel=\"external_link\">[9]<\/a><\/sup> \n<\/p><p>Additional updates to the enforcement rule came with the <a href=\"https:\/\/www.limswiki.org\/index.php\/Health_Information_Technology_for_Economic_and_Clinical_Health_Act\" title=\"Health Information Technology for Economic and Clinical Health Act\" target=\"_blank\" class=\"wiki-link\" data-key=\"89c9e20984bbda2e628b6d1d28ec3ad5\">Health Information Technology for Economic and Clinical Health Act<\/a> (HITECH) Act, enacted on February 17, 2009. The Act added \"several provisions that strengthen the civil and criminal enforcement of the HIPAA rules\" by adding categories of violations and tier levels of penalty amounts.<sup id=\"rdp-ebb-cite_ref-HHSEnfo_9-1\" class=\"reference\"><a href=\"#cite_note-HHSEnfo-9\" rel=\"external_link\">[9]<\/a><\/sup> HIPAA and the HITECH statutes were further revised in January 2013 (effective March 26, 2013) \"to strengthen the privacy and security protection for individuals\u2019 health information,\" update the Breach Notification Rule, \"strengthen the privacy protections for genetic information,\" and revise other portions of HIPAA rules \"to improve their workability and effectiveness.\"<sup id=\"rdp-ebb-cite_ref-FR01073_10-0\" class=\"reference\"><a href=\"#cite_note-FR01073-10\" rel=\"external_link\">[10]<\/a><\/sup>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"Structure\">Structure<\/span><\/h2>\n<p>HIPAA is divided into five titles, each with their own subtitles<sup id=\"rdp-ebb-cite_ref-HIPAAGPO_1-2\" class=\"reference\"><a href=\"#cite_note-HIPAAGPO-1\" rel=\"external_link\">[1]<\/a><\/sup>:\n<\/p><p><b>Title I<\/b>: Health Care Access, Portability, and Renewability\n<\/p>\n<dl><dd>Subtitle A - Group Market Rules<\/dd>\n<dd>Subtitle B - Individual Market Rules<\/dd>\n<dd>Subtitle C - General and Miscellaneous Provisions<\/dd><\/dl>\n<p><b>Title II<\/b>: Preventing Health Care Fraud and Abuse; Administrative Simplification; Medical Liability Reform\n<\/p>\n<dl><dd>Subtitle A - Fraud and Abuse Control Program<\/dd>\n<dd>Subtitle B - Revisions to Current Sanctions for Fraud and Abuse<\/dd>\n<dd>Subtitle C - Data Collection<\/dd>\n<dd>Subtitle D - Civil Monetary Penalties<\/dd>\n<dd>Subtitle E - Revisions to Criminal Law<\/dd>\n<dd>Subtitle F - Administrative Simplification<\/dd>\n<dd>Subtitle G - Duplication and Coordination of Medicare-Related Plans<\/dd><\/dl>\n<p><b>Title III<\/b>: Tax-Related Health Provisions\n<\/p>\n<dl><dd>Subtitle A - Medical Savings Accounts<\/dd>\n<dd>Subtitle B - Increase in Deduction for Health Insurance Costs of Self-Employed Individuals<\/dd>\n<dd>Subtitle C - Long-Term Care Services and Contracts<\/dd>\n<dd>Subtitle D - Treatment of Accelerated Death Benefits<\/dd>\n<dd>Subtitle E - State Insurance Pools<\/dd>\n<dd>Subtitle F - Organizations Subject to Section 833<\/dd>\n<dd>Subtitle G - IRA Distributions to the Unemployed<\/dd>\n<dd>Subtitle H - Organ and Tissue Donation Information Included With Income Tax Refund Payments<\/dd><\/dl>\n<p><b>Title IV<\/b>: Application and Enforcement of Group Health Plan Requirements\n<\/p>\n<dl><dd>Subtitle A - Application and Enforcement of Group Health Plan Requirements<\/dd>\n<dd>Subtitle B - Clarification of Certain Continuation Coverage Requirements<\/dd><\/dl>\n<p><b>Title V<\/b>: Revenue Offsets\n<\/p>\n<dl><dd>Subtitle A - Company-Owned Life Insurance<\/dd>\n<dd>Subtitle B - Treatment of Individuals Who Lose United States Citizenship<\/dd>\n<dd>Subtitle C - Repeal of Financial Institution Transition Rule to Interest Allocation Rules<\/dd><\/dl>\n<h3><span class=\"mw-headline\" id=\"Description\">Description<\/span><\/h3>\n<p>Title I of HIPAA contains three subtitles that protect health insurance coverage for workers and their families when they change or lose their jobs. \n<\/p><p>Title II of HIPAA contains seven subtitles. One of the most important for expanding HIPAA is Subtitle F, the Administrative Simplification (AS) provisions, requiring the establishment of national standards for electronic health care transactions and national identifiers for providers, health insurance plans, and employers. Title II also addresses the security and privacy of health data, with the intent of improving the efficiency and effectiveness of the nation's health care system by encouraging the widespread use of electronic data interchange in the U.S. health care system.\n<\/p><p>Title III of HIPAA modifies the Internal Revenue Code (IRC) to revise available tax deductions for health insurance, clarify how pre-tax money could be applied health payments, and regulate long-term care services and how they're contracted. Other tax-related issues like IRA distribution and organ donor tax refund payments are covered by this title, in total spread out over eight subtitles.\n<\/p><p>Title IV of HIPAA modifies both the IRC and the Public Health Service Act (PHSA) to describe requirements for and enforcement of how group health plans could legally manage and cover patients' pre-existing conditions as well as their continuation of coverage. This information is supplied over two subtitles.\n<\/p><p>Title V of HIPAA contains three subtitles that amend the IRC concerning miscellaneous issues such as interest deductions on loans related to company-owned life insurance, how individuals who lose their U.S. citizenship shall be treated tax-wise, and the removal of certain limitations on interest allocation.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"Enforcement\">Enforcement<\/span><\/h2>\n<p>On February 16, 2006, HHS issued the Final Rule regarding HIPAA enforcement. It became effective on March 16, 2006. The Enforcement Rule set civil money penalties for violating HIPAA rules and established procedures for investigations and hearings for HIPAA violations. Before the enforcement rule, the deterrent effects of the legislation seemed negligible, with few prosecutions for violations.<sup id=\"rdp-ebb-cite_ref-SteinFines_8-1\" class=\"reference\"><a href=\"#cite_note-SteinFines-8\" rel=\"external_link\">[8]<\/a><\/sup> Enforcement operations were ratcheted up further with the passage of the Health Information Technology for Economic and Clinical Health Act (HITECH) in 2009, which greatly increased the financial penalties that could be applied to entities in non-compliance.<sup id=\"rdp-ebb-cite_ref-Solove10_11-0\" class=\"reference\"><a href=\"#cite_note-Solove10-11\" rel=\"external_link\">[11]<\/a><\/sup>\n<\/p><p>By the end of 2014, the U.S. Department of Health and Human Resources (HHS) reported investigating 106,522 HIPAA complaints against national pharmacy chains, major health care centers, insurance groups, hospital chains and other small providers since April 2003. The HHS reported 23,314 of those cases had been resolved by requiring changes in privacy practice or by corrective action. 10,566 cases were investigated and found that HIPAA was followed correctly. Another 68,412 cases were found to be ineligible for enforcement because, for example, a violation occurred before HIPAA became effective, a case was withdrawn by the pursuer, or an activity did not actually violate the rules.<sup id=\"rdp-ebb-cite_ref-HHSEnforceArch_12-0\" class=\"reference\"><a href=\"#cite_note-HHSEnforceArch-12\" rel=\"external_link\">[12]<\/a><\/sup>\n<\/p><p>According to the HHS, the most commonly investigated compliance issue, by order of frequency, have been<sup id=\"rdp-ebb-cite_ref-HHSEnforceArch_12-1\" class=\"reference\"><a href=\"#cite_note-HHSEnforceArch-12\" rel=\"external_link\">[12]<\/a><\/sup>:\n<\/p>\n<ol><li> incorrectly used or revealed protected health information (PHI);<\/li>\n<li> insufficient protection mechanisms for PHI;<\/li>\n<li> insufficient mechanisms for patients to access their PHI;<\/li>\n<li> insufficient administrative protections and tools for managing electronic PHI; and<\/li>\n<li> usage and disclosure of more PHI than minimally necessary.<\/li><\/ol>\n<p>The HHS also stated the entities most likely to be responsible for infractions, by order of frequency, have been<sup id=\"rdp-ebb-cite_ref-HHSEnforceArch_12-2\" class=\"reference\"><a href=\"#cite_note-HHSEnforceArch-12\" rel=\"external_link\">[12]<\/a><\/sup>:\n<\/p>\n<ol><li> private practices;<\/li>\n<li> general hospitals;<\/li>\n<li> outpatient facilities;<\/li>\n<li> pharmacies; and<\/li>\n<li> health plans (group health plans and health insurance issuers).<\/li><\/ol>\n<h2><span class=\"mw-headline\" id=\"Assessed_impact\">Assessed impact<\/span><\/h2>\n<p>The enactment of HIPAA caused major changes in the way physicians and medical centers operate. The complex legalities and potentially stiff penalties associated with HIPAA, as well as the increase in paperwork and the cost of its implementation, were causes for concern among physicians and medical centers. Many of those concerns were expressed in an August 2006 paper published in the journal <i>Annals of Internal Medicine<\/i>.<sup id=\"rdp-ebb-cite_ref-WilsonAnnals_13-0\" class=\"reference\"><a href=\"#cite_note-WilsonAnnals-13\" rel=\"external_link\">[13]<\/a><\/sup> It mentioned a University of Michigan study that demonstrated how the implementation of the HIPAA Privacy rule resulted in a drop from 96 percent to 34 percent in the proportion of follow-up surveys completed by study patients being followed after a heart attack.<sup id=\"rdp-ebb-cite_ref-Armstrong_14-0\" class=\"reference\"><a href=\"#cite_note-Armstrong-14\" rel=\"external_link\">[14]<\/a><\/sup> \n<\/p><p>By 2013, views on the impact of HIPAA were mixed. Leon Rodriguez, director of the HHS' Office for Civil Rights said of HIPAA:\n<\/p>\n<blockquote>Whereas many thought HIPAA would \"bankrupt\" healthcare, shut down research, and otherwise paralyze the industry, instead the industry has learned the benefits of the transaction and code set standards through the ease of electronic transactions. And the balance of the [HIPAA] Privacy and Security protections have paved the way to real benefits for consumers through greater access to quality care.<sup id=\"rdp-ebb-cite_ref-Solove10_11-1\" class=\"reference\"><a href=\"#cite_note-Solove10-11\" rel=\"external_link\">[11]<\/a><\/sup><\/blockquote> \n<p>In an article for the <i>Houston Chronicle<\/i>, writer and business consultant Lisa Dorward stated the following for patients requesting personal health information:\n<\/p>\n<blockquote>Direct cost to patients is minimal; health care institutions can charge the patient only for copying and postage costs for delivery of the documents. On the other hand, costs to health care providers are high and can strain already overburdened budgets. Some clinics and hospitals have had to reconstruct or remodel existing registration areas to comply with HIPAA's privacy regulations.<sup id=\"rdp-ebb-cite_ref-DorwardHIPAA_15-0\" class=\"reference\"><a href=\"#cite_note-DorwardHIPAA-15\" rel=\"external_link\">[15]<\/a><\/sup><\/blockquote> \n<p>Writing for the <i>Loyola Consumer Law Review<\/i>, attorney and legal writer Anna Colvert wrote:\n<\/p>\n<blockquote>Generally, HIPAA is considered a step in the right direction regarding patient privacy, and it has resulted in more descriptive and detailed privacy policies; however, it has not improved the online privacy practices of these organizations. While HIPAA is a solid foundation in protecting patients\u2019 healthcare information there is more work to be done...\"<sup id=\"rdp-ebb-cite_ref-Colvert_16-0\" class=\"reference\"><a href=\"#cite_note-Colvert-16\" rel=\"external_link\">[16]<\/a><\/sup><\/blockquote> \n<p>A May 2013 <i>Computerworld<\/i> reported on a survey conducted by the Ponemon Institute that found 51 percent of respondents believed \"HIPAA compliance requirements can be a barrier to providing effective patient care\" and 59 percent \"cited the complexity of HIPAA requirements as a major barrier to modernizing the healthcare system.\"<sup id=\"rdp-ebb-cite_ref-Mearian_17-0\" class=\"reference\"><a href=\"#cite_note-Mearian-17\" rel=\"external_link\">[17]<\/a><\/sup>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"Audit_guidelines_and_checklist\">Audit guidelines and checklist<\/span><\/h2>\n<div class=\"rellink relarticle mainarticle\">Main article: <a href=\"https:\/\/www.limswiki.org\/index.php\/Health_Insurance_Portability_and_Accountability_Act\/Audit_guidelines_and_checklist\" title=\"Health Insurance Portability and Accountability Act\/Audit guidelines and checklist\" target=\"_blank\" class=\"wiki-link\" data-key=\"696695ca2ef0d0aa853c4e3efba250c4\">Health Insurance Portability and Accountability Act\/Audit guidelines and checklist<\/a><\/div>\n<p>For those auditing computer systems and IT environments for their compliance with the Health Insurance Portability and Accountability Act and other regulations, a set of guidelines and checklist items may be useful. \n<br \/>\n<\/p><p>Click the link above for the full set of guidelines and checklist items as they relate to HIPAA.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"Further_reading\">Further reading<\/span><\/h2>\n<ul><li> <span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.gpo.gov\/fdsys\/pkg\/PLAW-104publ191\/content-detail.html\" target=\"_blank\">\"Public Law 104 - 191 - Health Insurance Portability and Accountability Act of 1996\"<\/a>. U.S. Government Publishing Office<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.gpo.gov\/fdsys\/pkg\/PLAW-104publ191\/content-detail.html\" target=\"_blank\">http:\/\/www.gpo.gov\/fdsys\/pkg\/PLAW-104publ191\/content-detail.html<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Public+Law+104+-+191+-+Health+Insurance+Portability+and+Accountability+Act+of+1996&rft.atitle=&rft.pub=U.S.+Government+Publishing+Office&rft_id=http%3A%2F%2Fwww.gpo.gov%2Ffdsys%2Fpkg%2FPLAW-104publ191%2Fcontent-detail.html&rfr_id=info:sid\/en.wikipedia.org:Health_Insurance_Portability_and_Accountability_Act\"><span style=\"display: none;\"> <\/span><\/span><\/li>\n<li> <span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govtrack.us\/congress\/bills\/104\/s1028\" target=\"_blank\">\"S. 1028 (104th): Health Insurance Reform Act of 1995\"<\/a>. <i>GovTrack.us<\/i>. Civic Impulse, LLC<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.govtrack.us\/congress\/bills\/104\/s1028\" target=\"_blank\">https:\/\/www.govtrack.us\/congress\/bills\/104\/s1028<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=S.+1028+%28104th%29%3A+Health+Insurance+Reform+Act+of+1995&rft.atitle=GovTrack.us&rft.pub=Civic+Impulse%2C+LLC&rft_id=https%3A%2F%2Fwww.govtrack.us%2Fcongress%2Fbills%2F104%2Fs1028&rfr_id=info:sid\/en.wikipedia.org:Health_Insurance_Portability_and_Accountability_Act\"><span style=\"display: none;\"> <\/span><\/span><\/li>\n<li> <span class=\"citation Journal\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/library.cqpress.com\/cqalmanac\/document.php?id=cqal96-1092479\" target=\"_blank\">\"Bill Makes Health Insurance \u2018Portable\u2019\"<\/a>. <i>CQ Almanac 1996<\/i> <b>52<\/b>: 6-28\u20136-39. 1997<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/library.cqpress.com\/cqalmanac\/document.php?id=cqal96-1092479\" target=\"_blank\">http:\/\/library.cqpress.com\/cqalmanac\/document.php?id=cqal96-1092479<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Bill+Makes+Health+Insurance+%E2%80%98Portable%E2%80%99&rft.jtitle=CQ+Almanac+1996&rft.date=1997&rft.volume=52&rft.pages=6-28%E2%80%936-39&rft_id=http%3A%2F%2Flibrary.cqpress.com%2Fcqalmanac%2Fdocument.php%3Fid%3Dcqal96-1092479&rfr_id=info:sid\/en.wikipedia.org:Health_Insurance_Portability_and_Accountability_Act\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<ol class=\"references\">\n<li id=\"cite_note-HIPAAGPO-1\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-HIPAAGPO_1-0\" rel=\"external_link\">1.0<\/a><\/sup> <sup><a href=\"#cite_ref-HIPAAGPO_1-1\" rel=\"external_link\">1.1<\/a><\/sup> <sup><a href=\"#cite_ref-HIPAAGPO_1-2\" rel=\"external_link\">1.2<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.gpo.gov\/fdsys\/pkg\/PLAW-104publ191\/content-detail.html\" target=\"_blank\">\"Public Law 104 - 191 - Health Insurance Portability and Accountability Act of 1996\"<\/a>. U.S. Government Publishing Office<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.gpo.gov\/fdsys\/pkg\/PLAW-104publ191\/content-detail.html\" target=\"_blank\">http:\/\/www.gpo.gov\/fdsys\/pkg\/PLAW-104publ191\/content-detail.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 11 February 2015<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Public+Law+104+-+191+-+Health+Insurance+Portability+and+Accountability+Act+of+1996&rft.atitle=&rft.pub=U.S.+Government+Publishing+Office&rft_id=http%3A%2F%2Fwww.gpo.gov%2Ffdsys%2Fpkg%2FPLAW-104publ191%2Fcontent-detail.html&rfr_id=info:sid\/en.wikipedia.org:Health_Insurance_Portability_and_Accountability_Act\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-CQHIPAAHist-2\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-CQHIPAAHist_2-0\" rel=\"external_link\">2.0<\/a><\/sup> <sup><a href=\"#cite_ref-CQHIPAAHist_2-1\" rel=\"external_link\">2.1<\/a><\/sup> <sup><a href=\"#cite_ref-CQHIPAAHist_2-2\" rel=\"external_link\">2.2<\/a><\/sup> <sup><a href=\"#cite_ref-CQHIPAAHist_2-3\" rel=\"external_link\">2.3<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation Journal\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/library.cqpress.com\/cqalmanac\/document.php?id=cqal96-1092479\" target=\"_blank\">\"Bill Makes Health Insurance \u2018Portable\u2019\"<\/a>. <i>CQ Almanac 1996<\/i> <b>52<\/b>: 6-28\u20136-39. 1997<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/library.cqpress.com\/cqalmanac\/document.php?id=cqal96-1092479\" target=\"_blank\">http:\/\/library.cqpress.com\/cqalmanac\/document.php?id=cqal96-1092479<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 12 February 2015<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Bill+Makes+Health+Insurance+%E2%80%98Portable%E2%80%99&rft.jtitle=CQ+Almanac+1996&rft.date=1997&rft.volume=52&rft.pages=6-28%E2%80%936-39&rft_id=http%3A%2F%2Flibrary.cqpress.com%2Fcqalmanac%2Fdocument.php%3Fid%3Dcqal96-1092479&rfr_id=info:sid\/en.wikipedia.org:Health_Insurance_Portability_and_Accountability_Act\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-11028Legal-3\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-11028Legal_3-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govtrack.us\/congress\/bills\/104\/s1028\" target=\"_blank\">\"S. 1028 (104th): Health Insurance Reform Act of 1995\"<\/a>. <i>GovTrack.us<\/i>. Civic Impulse, LLC<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.govtrack.us\/congress\/bills\/104\/s1028\" target=\"_blank\">https:\/\/www.govtrack.us\/congress\/bills\/104\/s1028<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 12 February 2015<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=S.+1028+%28104th%29%3A+Health+Insurance+Reform+Act+of+1995&rft.atitle=GovTrack.us&rft.pub=Civic+Impulse%2C+LLC&rft_id=https%3A%2F%2Fwww.govtrack.us%2Fcongress%2Fbills%2F104%2Fs1028&rfr_id=info:sid\/en.wikipedia.org:Health_Insurance_Portability_and_Accountability_Act\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-HiebertHIPAA-4\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-HiebertHIPAA_4-0\" rel=\"external_link\">4.0<\/a><\/sup> <sup><a href=\"#cite_ref-HiebertHIPAA_4-1\" rel=\"external_link\">4.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Hiebert-White, Jane (September-October 1996). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.chausa.org\/docs\/default-source\/health-progress\/health-policy---who-won-what-in-the-kassebaumkennedy-struggle-pdf.pdf?sfvrsn=0\" target=\"_blank\">\"Who Won What in the Kassebaum\/Kennedy Struggle?\"<\/a> (PDF). <i>Health Progress<\/i> <b>77<\/b> (5)<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.chausa.org\/docs\/default-source\/health-progress\/health-policy---who-won-what-in-the-kassebaumkennedy-struggle-pdf.pdf?sfvrsn=0\" target=\"_blank\">https:\/\/www.chausa.org\/docs\/default-source\/health-progress\/health-policy---who-won-what-in-the-kassebaumkennedy-struggle-pdf.pdf?sfvrsn=0<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 12 February 2015<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Who+Won+What+in+the+Kassebaum%2FKennedy+Struggle%3F&rft.jtitle=Health+Progress&rft.aulast=Hiebert-White%2C+Jane&rft.au=Hiebert-White%2C+Jane&rft.date=September-October+1996&rft.volume=77&rft.issue=5&rft_id=https%3A%2F%2Fwww.chausa.org%2Fdocs%2Fdefault-source%2Fhealth-progress%2Fhealth-policy---who-won-what-in-the-kassebaumkennedy-struggle-pdf.pdf%3Fsfvrsn%3D0&rfr_id=info:sid\/en.wikipedia.org:Health_Insurance_Portability_and_Accountability_Act\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-StarrHIPAA-5\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-StarrHIPAA_5-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Starr, Paul (22 August 1996). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/web.archive.org\/web\/19980129180414\/http:\/\/epn.org\/library\/signing.html\" target=\"_blank\">\"The Signing of the Kennedy-Kassebaum Bill\"<\/a>. The Electronic Policy Network. Archived from <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/epn.org\/library\/signing.html\" target=\"_blank\">the original<\/a> on 29 January 1998<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/web.archive.org\/web\/19980129180414\/http:\/\/epn.org\/library\/signing.html\" target=\"_blank\">https:\/\/web.archive.org\/web\/19980129180414\/http:\/\/epn.org\/library\/signing.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 12 February 2015<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=The+Signing+of+the+Kennedy-Kassebaum+Bill&rft.atitle=&rft.aulast=Starr%2C+Paul&rft.au=Starr%2C+Paul&rft.date=22+August+1996&rft.pub=The+Electronic+Policy+Network&rft_id=https%3A%2F%2Fweb.archive.org%2Fweb%2F19980129180414%2Fhttp%3A%2F%2Fepn.org%2Flibrary%2Fsigning.html&rfr_id=info:sid\/en.wikipedia.org:Health_Insurance_Portability_and_Accountability_Act\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-PrivRule-6\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-PrivRule_6-0\" rel=\"external_link\">6.0<\/a><\/sup> <sup><a href=\"#cite_ref-PrivRule_6-1\" rel=\"external_link\">6.1<\/a><\/sup> <sup><a href=\"#cite_ref-PrivRule_6-2\" rel=\"external_link\">6.2<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation book\">Institute of Medicine (US) Committee on Health Research and the Privacy of Health Information: The HIPAA Privacy Rule (2009). Nass, S. J.; Levit, L. A.; Gostin, L. O.. ed. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/books\/NBK9576\/\" target=\"_blank\"><i>Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research<\/i><\/a>. National Academies Press. Bookshelf ID NBK9576<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/books\/NBK9576\/\" target=\"_blank\">http:\/\/www.ncbi.nlm.nih.gov\/books\/NBK9576\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 12 February 2015<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Beyond+the+HIPAA+Privacy+Rule%3A+Enhancing+Privacy%2C+Improving+Health+Through+Research&rft.aulast=Institute+of+Medicine+%28US%29+Committee+on+Health+Research+and+the+Privacy+of+Health+Information%3A+The+HIPAA+Privacy+Rule&rft.au=Institute+of+Medicine+%28US%29+Committee+on+Health+Research+and+the+Privacy+of+Health+Information%3A+The+HIPAA+Privacy+Rule&rft.date=2009&rft.pub=National+Academies+Press&rft_id=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fbooks%2FNBK9576%2F&rfr_id=info:sid\/en.wikipedia.org:Health_Insurance_Portability_and_Accountability_Act\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-HHSFinalPriv-7\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-HHSFinalPriv_7-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.hhs.gov\/ocr\/privacy\/hipaa\/administrative\/privacyrule\/\" target=\"_blank\">\"The Privacy Rule\"<\/a>. U.S. Department of Health and Human Services<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.hhs.gov\/ocr\/privacy\/hipaa\/administrative\/privacyrule\/\" target=\"_blank\">http:\/\/www.hhs.gov\/ocr\/privacy\/hipaa\/administrative\/privacyrule\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 12 February 2015<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=The+Privacy+Rule&rft.atitle=&rft.pub=U.S.+Department+of+Health+and+Human+Services&rft_id=http%3A%2F%2Fwww.hhs.gov%2Focr%2Fprivacy%2Fhipaa%2Fadministrative%2Fprivacyrule%2F&rfr_id=info:sid\/en.wikipedia.org:Health_Insurance_Portability_and_Accountability_Act\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-SteinFines-8\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-SteinFines_8-0\" rel=\"external_link\">8.0<\/a><\/sup> <sup><a href=\"#cite_ref-SteinFines_8-1\" rel=\"external_link\">8.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Stein, Rob (5 June 2006). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.washingtonpost.com\/wp-dyn\/content\/article\/2006\/06\/04\/AR2006060400672.html\" target=\"_blank\">\"Medical Privacy Law Nets No Fines\"<\/a>. The Washington Post<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.washingtonpost.com\/wp-dyn\/content\/article\/2006\/06\/04\/AR2006060400672.html\" target=\"_blank\">http:\/\/www.washingtonpost.com\/wp-dyn\/content\/article\/2006\/06\/04\/AR2006060400672.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 28 February 2012<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Medical+Privacy+Law+Nets+No+Fines&rft.atitle=&rft.aulast=Stein%2C+Rob&rft.au=Stein%2C+Rob&rft.date=5+June+2006&rft.pub=The+Washington+Post&rft_id=http%3A%2F%2Fwww.washingtonpost.com%2Fwp-dyn%2Fcontent%2Farticle%2F2006%2F06%2F04%2FAR2006060400672.html&rfr_id=info:sid\/en.wikipedia.org:Health_Insurance_Portability_and_Accountability_Act\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-HHSEnfo-9\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-HHSEnfo_9-0\" rel=\"external_link\">9.0<\/a><\/sup> <sup><a href=\"#cite_ref-HHSEnfo_9-1\" rel=\"external_link\">9.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.hhs.gov\/ocr\/privacy\/hipaa\/administrative\/enforcementrule\/index.html\" target=\"_blank\">\"The HIPAA Enforcement Rule\"<\/a>. U.S. Department of Health and Human Services<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.hhs.gov\/ocr\/privacy\/hipaa\/administrative\/enforcementrule\/index.html\" target=\"_blank\">http:\/\/www.hhs.gov\/ocr\/privacy\/hipaa\/administrative\/enforcementrule\/index.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 12 February 2015<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=The+HIPAA+Enforcement+Rule&rft.atitle=&rft.pub=U.S.+Department+of+Health+and+Human+Services&rft_id=http%3A%2F%2Fwww.hhs.gov%2Focr%2Fprivacy%2Fhipaa%2Fadministrative%2Fenforcementrule%2Findex.html&rfr_id=info:sid\/en.wikipedia.org:Health_Insurance_Portability_and_Accountability_Act\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-FR01073-10\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-FR01073_10-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Office for Civil Rights, Department of Health and Human Services (25 January 2013). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.gpo.gov\/fdsys\/pkg\/FR-2013-01-25\/pdf\/2013-01073.pdf\" target=\"_blank\">\"Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules Under the Health Information Technology for Economic and Clinical Health Act and the Genetic Information Nondiscrimination Act; Other Modifications to the HIPAA Rules\"<\/a> (PDF). <i>Federal Register<\/i> <b>78<\/b> (17)<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.gpo.gov\/fdsys\/pkg\/FR-2013-01-25\/pdf\/2013-01073.pdf\" target=\"_blank\">http:\/\/www.gpo.gov\/fdsys\/pkg\/FR-2013-01-25\/pdf\/2013-01073.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 12 February 2015<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Modifications+to+the+HIPAA+Privacy%2C+Security%2C+Enforcement%2C+and+Breach+Notification+Rules+Under+the+Health+Information+Technology+for+Economic+and+Clinical+Health+Act+and+the+Genetic+Information+Nondiscrimination+Act%3B+Other+Modifications+to+the+HIPAA+Rules&rft.jtitle=Federal+Register&rft.aulast=Office+for+Civil+Rights%2C+Department+of+Health+and+Human+Services&rft.au=Office+for+Civil+Rights%2C+Department+of+Health+and+Human+Services&rft.date=25+January+2013&rft.volume=78&rft.issue=17&rft_id=http%3A%2F%2Fwww.gpo.gov%2Ffdsys%2Fpkg%2FFR-2013-01-25%2Fpdf%2F2013-01073.pdf&rfr_id=info:sid\/en.wikipedia.org:Health_Insurance_Portability_and_Accountability_Act\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-Solove10-11\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-Solove10_11-0\" rel=\"external_link\">11.0<\/a><\/sup> <sup><a href=\"#cite_ref-Solove10_11-1\" rel=\"external_link\">11.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Solove, Daniel J. (April 2013). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/library.ahima.org\/xpedio\/groups\/public\/documents\/ahima\/bok1_050149.hcsp?dDocName=bok1_050149\" target=\"_blank\">\"HIPAA Turns 10: Analyzing the Past, Present and Future Impact\"<\/a>. <i>Journal of AHIMA<\/i> <b>84<\/b> (4): 22\u201328<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/library.ahima.org\/xpedio\/groups\/public\/documents\/ahima\/bok1_050149.hcsp?dDocName=bok1_050149\" target=\"_blank\">http:\/\/library.ahima.org\/xpedio\/groups\/public\/documents\/ahima\/bok1_050149.hcsp?dDocName=bok1_050149<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 11 February 2015<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=HIPAA+Turns+10%3A+Analyzing+the+Past%2C+Present+and+Future+Impact&rft.jtitle=Journal+of+AHIMA&rft.aulast=Solove%2C+Daniel+J.&rft.au=Solove%2C+Daniel+J.&rft.date=April+2013&rft.volume=84&rft.issue=4&rft.pages=22%E2%80%9328&rft_id=http%3A%2F%2Flibrary.ahima.org%2Fxpedio%2Fgroups%2Fpublic%2Fdocuments%2Fahima%2Fbok1_050149.hcsp%3FdDocName%3Dbok1_050149&rfr_id=info:sid\/en.wikipedia.org:Health_Insurance_Portability_and_Accountability_Act\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-HHSEnforceArch-12\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-HHSEnforceArch_12-0\" rel=\"external_link\">12.0<\/a><\/sup> <sup><a href=\"#cite_ref-HHSEnforceArch_12-1\" rel=\"external_link\">12.1<\/a><\/sup> <sup><a href=\"#cite_ref-HHSEnforceArch_12-2\" rel=\"external_link\">12.2<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/web.archive.org\/web\/20150211170207\/http:\/\/www.hhs.gov\/ocr\/privacy\/hipaa\/enforcement\/highlights\/index.html\" target=\"_blank\">\"Enforcement Highlights\"<\/a>. U.S. Department of Health and Human Services. 15 January 2015. Archived from <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.hhs.gov\/ocr\/privacy\/hipaa\/enforcement\/highlights\/index.html\" target=\"_blank\">the original<\/a> on 11 February 2015<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/web.archive.org\/web\/20150211170207\/http:\/\/www.hhs.gov\/ocr\/privacy\/hipaa\/enforcement\/highlights\/index.html\" target=\"_blank\">https:\/\/web.archive.org\/web\/20150211170207\/http:\/\/www.hhs.gov\/ocr\/privacy\/hipaa\/enforcement\/highlights\/index.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 11 February 2015<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Enforcement+Highlights&rft.atitle=&rft.date=15+January+2015&rft.pub=U.S.+Department+of+Health+and+Human+Services&rft_id=https%3A%2F%2Fweb.archive.org%2Fweb%2F20150211170207%2Fhttp%3A%2F%2Fwww.hhs.gov%2Focr%2Fprivacy%2Fhipaa%2Fenforcement%2Fhighlights%2Findex.html&rfr_id=info:sid\/en.wikipedia.org:Health_Insurance_Portability_and_Accountability_Act\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-WilsonAnnals-13\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-WilsonAnnals_13-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Wilson, Jennifer Fisher (2006). \"Health Insurance Portability and Accountability Act Privacy Rule Causes Ongoing Concerns among Clinicians and Researchers\". <i>Annals of Internal Medicine<\/i> <b>145<\/b> (4): 313\u20136. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" target=\"_blank\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.7326%2F0003-4819-145-4-200608150-00019\" target=\"_blank\">10.7326\/0003-4819-145-4-200608150-00019<\/a>. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" target=\"_blank\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/16908928\" target=\"_blank\">16908928<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Health+Insurance+Portability+and+Accountability+Act+Privacy+Rule+Causes+Ongoing+Concerns+among+Clinicians+and+Researchers&rft.jtitle=Annals+of+Internal+Medicine&rft.aulast=Wilson%2C+Jennifer+Fisher&rft.au=Wilson%2C+Jennifer+Fisher&rft.date=2006&rft.volume=145&rft.issue=4&rft.pages=313%E2%80%936&rft_id=info:doi\/10.7326%2F0003-4819-145-4-200608150-00019&rft_id=info:pmid\/16908928&rfr_id=info:sid\/en.wikipedia.org:Health_Insurance_Portability_and_Accountability_Act\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-Armstrong-14\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-Armstrong_14-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Armstrong, David; Kline-Rogers, Eva; Jani, Sandeep M.; Goldman, Edward B.; Fang, Jianming; Mukherjee, Debabrata; Nallamothu, Brahmajee N.; Eagle, Kim A. (2005). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/archinte.jamanetwork.com\/article.aspx?articleid=486568\" target=\"_blank\">\"Potential Impact of the HIPAA Privacy Rule on Data Collection in a Registry of Patients With Acute Coronary Syndrome\"<\/a>. <i>Archives of Internal Medicine<\/i> <b>165<\/b> (10): 1125\u20139. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" target=\"_blank\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1001%2Farchinte.165.10.1125\" target=\"_blank\">10.1001\/archinte.165.10.1125<\/a>. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" target=\"_blank\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/15911725\" target=\"_blank\">15911725<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/archinte.jamanetwork.com\/article.aspx?articleid=486568\" target=\"_blank\">http:\/\/archinte.jamanetwork.com\/article.aspx?articleid=486568<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 11 February 2015<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Potential+Impact+of+the+HIPAA+Privacy+Rule+on+Data+Collection+in+a+Registry+of+Patients+With+Acute+Coronary+Syndrome&rft.jtitle=Archives+of+Internal+Medicine&rft.aulast=Armstrong%2C+David%3B+Kline-Rogers%2C+Eva%3B+Jani%2C+Sandeep+M.%3B+Goldman%2C+Edward+B.%3B+Fang%2C+Jianming%3B+Mukherjee%2C+Debabrata%3B+Nallamothu%2C+Brahmajee+N.%3B+Eagle%2C+Kim+A.&rft.au=Armstrong%2C+David%3B+Kline-Rogers%2C+Eva%3B+Jani%2C+Sandeep+M.%3B+Goldman%2C+Edward+B.%3B+Fang%2C+Jianming%3B+Mukherjee%2C+Debabrata%3B+Nallamothu%2C+Brahmajee+N.%3B+Eagle%2C+Kim+A.&rft.date=2005&rft.volume=165&rft.issue=10&rft.pages=1125%E2%80%939&rft_id=info:doi\/10.1001%2Farchinte.165.10.1125&rft_id=info:pmid\/15911725&rft_id=http%3A%2F%2Farchinte.jamanetwork.com%2Farticle.aspx%3Farticleid%3D486568&rfr_id=info:sid\/en.wikipedia.org:Health_Insurance_Portability_and_Accountability_Act\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-DorwardHIPAA-15\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-DorwardHIPAA_15-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Dorward, Lisa. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/smallbusiness.chron.com\/positive-negative-effects-hipaa-employment-laws-18500.html\" target=\"_blank\">\"The Positive and Negative Effects of HIPAA Employment Laws\"<\/a>. <i>Houston Chronicle<\/i>. Hearst Newspapers, LLC<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/smallbusiness.chron.com\/positive-negative-effects-hipaa-employment-laws-18500.html\" target=\"_blank\">http:\/\/smallbusiness.chron.com\/positive-negative-effects-hipaa-employment-laws-18500.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 11 February 2015<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=The+Positive+and+Negative+Effects+of+HIPAA+Employment+Laws&rft.atitle=Houston+Chronicle&rft.aulast=Dorward%2C+Lisa&rft.au=Dorward%2C+Lisa&rft.pub=Hearst+Newspapers%2C+LLC&rft_id=http%3A%2F%2Fsmallbusiness.chron.com%2Fpositive-negative-effects-hipaa-employment-laws-18500.html&rfr_id=info:sid\/en.wikipedia.org:Health_Insurance_Portability_and_Accountability_Act\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-Colvert-16\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-Colvert_16-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Colvert, Anna (2013). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/lawecommons.luc.edu\/lclr\/vol25\/iss4\/6\/\" target=\"_blank\">\"HIPAA'S Influence on Consumers: Friend or Foe?\"<\/a>. <i>Loyola Consumer Law Review<\/i> <b>25<\/b> (4): 431\u2013447<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/lawecommons.luc.edu\/lclr\/vol25\/iss4\/6\/\" target=\"_blank\">http:\/\/lawecommons.luc.edu\/lclr\/vol25\/iss4\/6\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 11 February 2015<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=HIPAA%27S+Influence+on+Consumers%3A+Friend+or+Foe%3F&rft.jtitle=Loyola+Consumer+Law+Review&rft.aulast=Colvert%2C+Anna&rft.au=Colvert%2C+Anna&rft.date=2013&rft.volume=25&rft.issue=4&rft.pages=431%E2%80%93447&rft_id=http%3A%2F%2Flawecommons.luc.edu%2Flclr%2Fvol25%2Fiss4%2F6%2F&rfr_id=info:sid\/en.wikipedia.org:Health_Insurance_Portability_and_Accountability_Act\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-Mearian-17\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-Mearian_17-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Mearian, Lucas (07 May 2013). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.computerworld.com\/article\/2496995\/healthcare-it\/hipaa-rules--outdated-tech-cost-u-s--hospitals--8-3b-a-year.html\" target=\"_blank\">\"HIPAA rules, outdated tech cost U.S. hospitals $8.3B a year\"<\/a>. <i>Computerworld.com<\/i>. Computerworld, Inc<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.computerworld.com\/article\/2496995\/healthcare-it\/hipaa-rules--outdated-tech-cost-u-s--hospitals--8-3b-a-year.html\" target=\"_blank\">http:\/\/www.computerworld.com\/article\/2496995\/healthcare-it\/hipaa-rules--outdated-tech-cost-u-s--hospitals--8-3b-a-year.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 11 February 2015<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=HIPAA+rules%2C+outdated+tech+cost+U.S.+hospitals+%248.3B+a+year&rft.atitle=Computerworld.com&rft.aulast=Mearian%2C+Lucas&rft.au=Mearian%2C+Lucas&rft.date=07+May+2013&rft.pub=Computerworld%2C+Inc&rft_id=http%3A%2F%2Fwww.computerworld.com%2Farticle%2F2496995%2Fhealthcare-it%2Fhipaa-rules--outdated-tech-cost-u-s--hospitals--8-3b-a-year.html&rfr_id=info:sid\/en.wikipedia.org:Health_Insurance_Portability_and_Accountability_Act\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<\/ol><\/div>\n\n<!-- \nNewPP limit report\nCached time: 20181213192757\nCache expiry: 86400\nDynamic content: false\nCPU time usage: 0.465 seconds\nReal time usage: 1.338 seconds\nPreprocessor visited node count: 12940\/1000000\nPreprocessor generated node count: 23405\/1000000\nPost\u2010expand include size: 96062\/2097152 bytes\nTemplate argument size: 39210\/2097152 bytes\nHighest expansion depth: 15\/40\nExpensive parser function count: 0\/100\n-->\n\n<!-- \nTransclusion expansion time report (%,ms,calls,template)\n100.00% 387.531 1 - -total\n 83.67% 324.239 20 - Template:Citation\/core\n 81.40% 315.443 1 - Template:Reflist\n 47.57% 184.366 11 - Template:Cite_web\n 37.53% 145.436 8 - Template:Cite_journal\n 5.38% 20.863 1 - Template:Cite_book\n 4.95% 19.199 26 - Template:Citation\/make_link\n 2.93% 11.346 4 - Template:Citation\/identifier\n 1.92% 7.425 1 - Template:Main\n 0.96% 3.718 1 - Template:Rellink\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:3374-0!*!0!!en!5!* and timestamp 20181213192756 and revision id 27076\n -->\n<\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Health_Insurance_Portability_and_Accountability_Act\">https:\/\/www.limswiki.org\/index.php\/Health_Insurance_Portability_and_Accountability_Act<\/a><\/div>\n\t\t\t\t\t\t\t\t\t\t<!-- end content -->\n\t\t\t\t\t\t\t\t\t\t<div class=\"visualClear\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t<!-- end of the left (by default at least) column -->\n\t\t<div class=\"visualClear\"><\/div>\n\t\t\t\t\t\n\t\t<\/div>\n\t\t\n\n<\/body>","b70673a0117c21576016cb7498867153_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/6\/66\/HIPAA_Screenshot.png"],"b70673a0117c21576016cb7498867153_timestamp":1544729276,"64bdae1dc17c40c28e0c560396a6ae35_type":"article","64bdae1dc17c40c28e0c560396a6ae35_title":"Clinical Laboratory Improvement Amendments","64bdae1dc17c40c28e0c560396a6ae35_url":"https:\/\/www.limswiki.org\/index.php\/Clinical_Laboratory_Improvement_Amendments","64bdae1dc17c40c28e0c560396a6ae35_plaintext":"\n\n\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\n\t\t\t\tClinical Laboratory Improvement Amendments\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\tFrom LIMSWiki\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\tJump to: navigation, search\n\n\t\t\t\t\t\n\t\t\t\t\t \nThe Clinical Laboratory Improvement Amendments (CLIA) of 1988 is a United States federal statute and regulatory standards program that applies to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research.[1] \n\r\n\n\nContents\n\n1 History \n2 CLIA program \n3 CLIA waived tests \n\n3.1 List of tests \n\n\n4 See also \n5 Further reading \n6 External links \n7 Notes \n8 References \n\n\n\nHistory \nOn December 5, 1967, the U.S. enacted Public Law 90-174, which included in Section 5 the \"Clinical Laboratories Improvement Act of 1967.\" CLIA '67 set regulations on the licensing of clinical laboratories and the movement of samples in and out of them across state lines. Laboratories would be eligible for a full, partial, or exempt CLIA-67 license, depending on the laboratory's conducted tests.[2] \nHowever, by the mid-1980s the relevancy of CLIA '67 to a vastly changed procedural and technological clinical laboratory landscape began to be questioned. The Office of the Assistant Secretary for Health for Planning\nand Evaluation (ASPE) of the U.S. Department of Health and Human Services commissioned a study to assess the effectiveness of federal regulations affecting clinical laboratories and their goal of protecting the public health. On April 8, 1986, the Final Report on Assessment of Clinical Laboratory Regulations by Michael L. Kenney and Don P. Greenberg was submitted to the ASPE.[3]\n\nThe analysis found that many federal regulations are technically obsolescent and many may be operationally unnecessary as a result of changing laboratory technology and changed federal reimbursement policies. Among changes recommended by the HHS-funded analysis are: (a) the regulatory classification system based upon physical location of laboratories is no longer appropriate and should be replaced with a classification system reflecting laboratory functions; (b) a single, uniform set of federal regulations should be developed that covers all civilian laboratories receiving federal reimbursement or operating in interstate commerce; (c) a revised federal regulatory system should emphasize measures of performance such as personnel and inspection requirements; and (d) clinical laboratory regulations should be based upon objective data to the maximum extent possible.[3]\nOn August 5, 1988, a new set of proposed regulations were put forth by the Health Care Financing Administration as Medicare, Medicaid and CLIA Programs; Revision of the Clinical Laboratory Regulations for the Medicare, Medicaid, and Clinical Laboratories Improvement Act of 1967 Programs. The proposal aspired \"to remove outdated, obsolete and redundant requirements, make provision for new technologies, place increased reliance on outcome measures of performance, and emphasize the responsibilities and duties of personnel rather than the formal credentialing requirements and detailed personnel standards in existing regulations.\"[4] This ultimately led to the proposal becoming law on October 31, 1988 under Public Law 100-578 as the Clinical Laboratory Improvement Amendments of 1988.[5] \nRegulations for implementing CLIA continued to be developed afterwards, with the Department of Health and Human Services considering thousands of comments to the proposed regulations. The final regulations were published February 28, 1992, set to be effective on September 1 of the same year. The new CLIA '88 put into place regulations concerning test complexity, certification, proficiency testing, patient test management, personnel requirements, quality assurance, and other processes in the clinical laboratory.[6] However, phase-in effective dates were extended on several occasions afterwards: on December 6, 1994 in the Federal Register (59 FR 62606), May 12, 1997 in the Federal Register (62 FR 25855), October 14, 1998 in the Federal Register (63 FR 55031), and December 29, 2000 in the Federal Register (65 FR 82941).[7]\nOn January 24, 2003, the Centers for Medicare and Medicaid Services submitted their final rule (68 FR 3639), effective April 24, 2003, affecting QC requirements for laboratories and qualification requirements for lab directors. The final rule also made revisions to 42 CFR 493, including the renaming, reorganizing, and consolidation of similar requirements into one section, the deletion of duplicate requirements, and the rewording of the requirements to better clarify their original intent. It also addressed requirements regarding the entire testing process, making those requirement better correlate with the workflow of a lab specimen in the laboratory, from acquisition to reporting of results, including the subdivision of testing into pre-analytic, analytic, and post-analytic phases.[7][8]\n\nCLIA program \nThe CLIA program sets standards and issues certificates for clinical laboratory testing. CLIA defines a clinical laboratory as any facility which performs laboratory testing on specimens derived from humans for the purpose of providing information for:\n\n diagnosis, prevention, or treatment of disease or impairment.\n health assessments.\nThe CLIA program is designed to ensure the accuracy, reliability, and timeliness of test results regardless of where the test was performed. Each specific laboratory system, assay, and examination is graded for level of complexity by assigning scores of \"1,\" \"2,\" or \"3\" for each of seven criteria. A test scored as a \"1\" is the lowest level of complexity, while a test scored \"3\" indicates the highest level. A score of \"2\" is assigned when the characteristics for a particular test are ranked primarily between low- and high-level in description.[9]\nThe seven criteria for categorization are:\n\n Knowledge\n Training and experience\n Reagents and materials preparation\n Characteristics of operational steps\n Calibration, quality control, and proficiency testing materials\n Test system troubleshooting and equipment maintenance\n Interpretation and judgment\nThe Centers for Medicare and Medicaid Services (CMS) has the primary responsibility for the operation of the CLIA program. Within CMS, the program is implemented by the Center for Medicaid and State Operations, Survey and Certification Group, and the Division of Laboratory Services.\nThe CLIA Program is funded by user fees collected from over 244,000 laboratories[10], most located in the United States.[11]\n\nCLIA waived tests \nUnder CLIA, tests and test systems that meet risk, error, and complexity requirements are issued a CLIA certificate of waiver.[12][11] In its 2014 document Administrative Procedures for CLIA Categorization - Guidance for Industry and Food and Drug Administration Staff, the U.S. Food and Drug Administration (FDA) advises its staff that a medical testing device originally rated moderately complex could receive a waiver \"if the device is simple to use and the sponsor demonstrates in studies conducted at the intended use sites that the test is accurate and poses an insignificant risk of erroneous results.\"[13]\nWhile a waived test is deemed to have an acceptably low level of risk, the Centers for Disease Control and Prevention (CDC) reminds administrators and recipients of such tests that no test is 100 percent safe[12]:\n\nAlthough CLIA requires that waived tests must be simple and have a low risk for erroneous results, this does not mean that waived tests are completely error-proof. Errors can occur anywhere in the testing process, particularly when the manufacturer's instructions are not followed and when testing personnel are not familiar with all aspects of the test system. Some waived tests have potential for serious health impacts if performed incorrectly... To decrease the risk of erroneous results, the test needs to be performed correctly, by trained personnel and in an environment where good laboratory practices are followed. \nIn November 2007, the CLIA waiver provisions were revised by the United States Congress to make it clear that tests approved by the FDA for home use automatically qualify for CLIA waiver.[14]\n\nList of tests \nA list of tests categorized by the FDA as waived since 2000 can be found at the FDA website. As of February 17, 2015, the list included 6,669 separate test devices.\n\nSee also \n Centers for Medicare and Medicaid Services\n Clinical laboratory\nFurther reading \n Kenney, Michael L. (February 1987). \"Quality Assurance in Changing Times: Proposals for Reform and Research in the Clinical Laboratory Field\" (PDF). Clinical Chemistry 33 (2): 328\u2013336. PMID 3542302. http:\/\/www.clinchem.org\/content\/33\/2\/328.full.pdf .   \nExternal links \n 42 CFR 493 at the U.S. Government Printing Office\n CLIA Law & Regulations at CDC\n Chronology of CLIA Related Documents in the Federal Register & Code of Federal Regulations\nNotes \nA couple elements of this article are reused from the Wikipedia article.\n\nReferences \n\n\u2191 \"Clinical Laboratory Improvement Amendments (CLIA)\". Centers for Medicare and Medicaid Services. http:\/\/www.cms.gov\/Regulations-and-Guidance\/Legislation\/CLIA\/index.html . Retrieved 23 March 2014 .   \n\n\u2191 \"Public Law 90-174\" (PDF). United States Statutes at Large, Volume 81. 1967. http:\/\/www.gpo.gov\/fdsys\/pkg\/STATUTE-81\/pdf\/STATUTE-81-Pg533.pdf . Retrieved 24 March 2014 .   \n\n\u2191 3.0 3.1 Kenney, Michael L. (February 1987). \"Quality Assurance in Changing Times: Proposals for Reform and Research in the Clinical Laboratory Field\" (PDF). Clinical Chemistry 33 (2): 328\u2013336. PMID 3542302. http:\/\/www.clinchem.org\/content\/33\/2\/328.full.pdf .   \n\n\u2191 Singer, Donald C.; Upton, Ronald P. (1993). \"Appendix F: Proposed Revision of the Clinical Laboratory Regulations for Medicare, Medicaid, and Clinical Laboratories Improvement Act of 1967 - Department of Health and Human Services: Health Care Financing Administration\". Guidelines for Laboratory Quality Auditing. CRC Press. pp. 273\u2013402. ISBN 9780824787844. http:\/\/books.google.ca\/books?id=tTm3hfom96sC&pg=PA273&lpg=PA273 .   \n\n\u2191 \"Public Law 100-578\" (PDF). United States Statutes at Large, Volume 102. 1988. http:\/\/www.gpo.gov\/fdsys\/pkg\/STATUTE-102\/pdf\/STATUTE-102-Pg2903.pdf . Retrieved 24 March 2014 .   \n\n\u2191 \"Regulations for Implementing the Clinical Laboratory Improvement Amendments of 1988: A Summary\". Morbidity and Mortality Weekly Report 41 (RR-2): 1\u201317. 28 February 1992. PMID 1538689. http:\/\/www.cdc.gov\/mmwr\/preview\/mmwrhtml\/00016177.htm . Retrieved 24 March 2014 .   \n\n\u2191 7.0 7.1 \"Medicare, Medicaid, and CLIA Programs; Laboratory Requirements Relating to Quality Systems and Certain Personnel Qualifications; Final Rule\". Federal Register 68 (16): 3639\u20133714. 24 January 2003. PMID 12545998. http:\/\/www.gpo.gov\/fdsys\/pkg\/FR-2003-01-24\/html\/03-1230.htm . Retrieved 24 March 2014 .   \n\n\u2191 \"Clinical Laboratory Improvement Act (CLIA) - Legislative History\". New Mexico Department of Health. http:\/\/dhi.health.state.nm.us\/CLIA\/clia_history.php . Retrieved 24 March 2014 .   \n\n\u2191 \"CLIA Categorization Criteria\". U.S. Food and Drug Administration. 6 March 2014. http:\/\/www.fda.gov\/MedicalDevices\/DeviceRegulationandGuidance\/IVDRegulatoryAssistance\/ucm124208.htm . Retrieved 23 March 2014 .   \n\n\u2191 \"CLIA Update \u2013 December 2013 - Laboratories by Type of Facility\" (PDF). Centers for Medicare and Medicaid Services. December 2013. https:\/\/www.cms.gov\/Regulations-and-Guidance\/Legislation\/CLIA\/downloads\/factype.pdf . Retrieved 23 March 2014 .   \n\n\u2191 11.0 11.1 \"Clinical Laboratory Improvement Amendments (CLIA)\" (PDF). Centers for Medicare and Medicaid Services. May 2013. https:\/\/www.cms.gov\/Outreach-and-Education\/Medicare-Learning-Network-MLN\/MLNProducts\/downloads\/CLIABrochure.pdf . Retrieved 23 March 2014 .   \n\n\u2191 12.0 12.1 \"Clinical Laboratory Improvement Amendments (CLIA) - CLIA Waived Tests\". Centers for Disease Control and Prevention. 14 March 2014. http:\/\/wwwn.cdc.gov\/clia\/Resources\/WaivedTests\/default.aspx . Retrieved 23 March 2014 .   \n\n\u2191 \"Administrative Procedures for CLIA Categorization - Guidance for Industry and Food and Drug Administration Staff\". U.S. Food and Drug Administration. 12 March 2014. http:\/\/www.fda.gov\/MedicalDevices\/DeviceRegulationandGuidance\/GuidanceDocuments\/ucm070762.htm . Retrieved 17 February 2015 .   \n\n\u2191 \"IVD Regulatory Assistance - CLIA Waivers\". U.S. Food and Drug Administration. 19 June 2009. http:\/\/www.fda.gov\/medicaldevices\/deviceregulationandguidance\/ivdregulatoryassistance\/ucm124202.htm . Retrieved 23 March 2014 .   \n\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Clinical_Laboratory_Improvement_Amendments\">https:\/\/www.limswiki.org\/index.php\/Clinical_Laboratory_Improvement_Amendments<\/a>\n\t\t\t\t\tCategories: Health standardsRegulatory information\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\n\t\t\n\t\t\tNavigation menu\n\t\t\t\t\t\n\t\t\tViews\n\n\t\t\t\n\t\t\t\t\n\t\t\t\tPage\n\t\t\t\tDiscussion\n\t\t\t\tView source\n\t\t\t\tHistory\n\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\n\t\t\t\t\n\t\t\t\tPersonal tools\n\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\tLog in\n\t\t\t\t\t\t\t\t\t\t\t\t\tRequest account\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\t\t\n\t\tNavigation\n\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tMain page\n\t\t\t\t\t\t\t\t\t\t\tRecent changes\n\t\t\t\t\t\t\t\t\t\t\tRandom page\n\t\t\t\t\t\t\t\t\t\t\tHelp\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\n\t\t\t\n\t\t\tSearch\n\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t \n\t\t\t\t\t\t\n\t\t\t\t\n\n\t\t\t\t\t\t\t\n\t\t\n\t\t\t\n\t\t\tTools\n\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tWhat links here\n\t\t\t\t\t\t\t\t\t\t\tRelated changes\n\t\t\t\t\t\t\t\t\t\t\tSpecial pages\n\t\t\t\t\t\t\t\t\t\t\tPermanent link\n\t\t\t\t\t\t\t\t\t\t\tPage information\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\n\t\t\n\t\tPrint\/export\n\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tCreate a book\n\t\t\t\t\t\t\t\t\t\t\tDownload as PDF\n\t\t\t\t\t\t\t\t\t\t\tDownload as Plain text\n\t\t\t\t\t\t\t\t\t\t\tPrintable version\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\n\t\t\n\t\tSponsors\n\t\t\n\t\t\t \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n \r\n\n\t\n\t\r\n\n \r\n\n\t\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t This page was last modified on 19 May 2015, at 17:29.\n\t\t\t\t\t\t\t\t\tThis page has been accessed 16,264 times.\n\t\t\t\t\t\t\t\t\tContent is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.\n\t\t\t\t\t\t\t\t\tPrivacy policy\n\t\t\t\t\t\t\t\t\tAbout LIMSWiki\n\t\t\t\t\t\t\t\t\tDisclaimers\n\t\t\t\t\t\t\t\n\t\t\n\t\t\n\t\t\n\n","64bdae1dc17c40c28e0c560396a6ae35_html":"<body class=\"mediawiki ltr sitedir-ltr ns-0 ns-subject page-Clinical_Laboratory_Improvement_Amendments skin-monobook action-view\">\n<div id=\"rdp-ebb-globalWrapper\">\n\t\t<div id=\"rdp-ebb-column-content\">\n\t\t\t<div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\">\n\t\t\t\t<a id=\"rdp-ebb-top\"><\/a>\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Clinical Laboratory Improvement Amendments<\/h1>\n\t\t\t\t\n\t\t\t\t<div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\">\n\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\n\n\t\t\t\t\t<!-- start content -->\n\t\t\t\t\t<div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"thumb tright\"><div class=\"thumbinner\" style=\"width:252px;\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:CLIA_Logo.gif\" class=\"image wiki-link\" target=\"_blank\" data-key=\"95937dc5e763206f7c10a9d5e85eb6d9\"><img alt=\"CLIA Logo.gif\" src=\"https:\/\/www.limswiki.org\/images\/8\/8b\/CLIA_Logo.gif\" width=\"250\" height=\"250\" class=\"thumbimage\" \/><\/a> <div class=\"thumbcaption\"><div class=\"magnify\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:CLIA_Logo.gif\" class=\"internal wiki-link\" title=\"Enlarge\" target=\"_blank\" data-key=\"95937dc5e763206f7c10a9d5e85eb6d9\"><\/a><\/div><\/div><\/div><\/div>\n<p>The <b>Clinical Laboratory Improvement Amendments<\/b> (<b>CLIA<\/b>) of 1988 is a United States federal statute and regulatory standards program that applies to all <a href=\"https:\/\/www.limswiki.org\/index.php\/Clinical_laboratory\" title=\"Clinical laboratory\" target=\"_blank\" class=\"wiki-link\" data-key=\"307bcdf1bdbcd1bb167cee435b7a5463\">clinical laboratory<\/a> testing performed on humans in the United States, except clinical trials and basic research.<sup id=\"rdp-ebb-cite_ref-CMSAboutCLIA_1-0\" class=\"reference\"><a href=\"#cite_note-CMSAboutCLIA-1\" rel=\"external_link\">[1]<\/a><\/sup> \n<\/p><p><br \/>\n<\/p>\n\n\n<h2><span class=\"mw-headline\" id=\"History\">History<\/span><\/h2>\n<p>On December 5, 1967, the U.S. enacted Public Law 90-174, which included in Section 5 the \"Clinical Laboratories Improvement Act of 1967.\" CLIA '67 set regulations on the licensing of clinical laboratories and the movement of samples in and out of them across state lines. Laboratories would be eligible for a full, partial, or exempt CLIA-67 license, depending on the laboratory's conducted tests.<sup id=\"rdp-ebb-cite_ref-CLIA67Doc_2-0\" class=\"reference\"><a href=\"#cite_note-CLIA67Doc-2\" rel=\"external_link\">[2]<\/a><\/sup> \n<\/p><p>However, by the mid-1980s the relevancy of CLIA '67 to a vastly changed procedural and technological clinical laboratory landscape began to be questioned. The Office of the Assistant Secretary for Health for Planning\nand Evaluation (ASPE) of the U.S. Department of Health and Human Services commissioned a study to assess the effectiveness of federal regulations affecting clinical laboratories and their goal of protecting the public health. On April 8, 1986, the <i>Final Report on Assessment of Clinical Laboratory Regulations<\/i> by Michael L. Kenney and Don P. Greenberg was submitted to the ASPE.<sup id=\"rdp-ebb-cite_ref-KenneyQACLIA_3-0\" class=\"reference\"><a href=\"#cite_note-KenneyQACLIA-3\" rel=\"external_link\">[3]<\/a><\/sup>\n<\/p>\n<blockquote>The analysis found that many federal regulations are technically obsolescent and many may be operationally unnecessary as a result of changing laboratory technology and changed federal reimbursement policies. Among changes recommended by the HHS-funded analysis are: (a) the regulatory classification system based upon physical location of laboratories is no longer appropriate and should be replaced with a classification system reflecting laboratory functions; (b) a single, uniform set of federal regulations should be developed that covers all civilian laboratories receiving federal reimbursement or operating in interstate commerce; (c) a revised federal regulatory system should emphasize measures of performance such as personnel and inspection requirements; and (d) clinical laboratory regulations should be based upon objective data to the maximum extent possible.<sup id=\"rdp-ebb-cite_ref-KenneyQACLIA_3-1\" class=\"reference\"><a href=\"#cite_note-KenneyQACLIA-3\" rel=\"external_link\">[3]<\/a><\/sup><\/blockquote>\n<p>On August 5, 1988, a new set of proposed regulations were put forth by the Health Care Financing Administration as <i>Medicare, Medicaid and CLIA Programs; Revision of the Clinical Laboratory Regulations for the Medicare, Medicaid, and Clinical Laboratories Improvement Act of 1967 Programs<\/i>. The proposal aspired \"to remove outdated, obsolete and redundant requirements, make provision for new technologies, place increased reliance on outcome measures of performance, and emphasize the responsibilities and duties of personnel rather than the formal credentialing requirements and detailed personnel standards in existing regulations.\"<sup id=\"rdp-ebb-cite_ref-SingerGLQA_4-0\" class=\"reference\"><a href=\"#cite_note-SingerGLQA-4\" rel=\"external_link\">[4]<\/a><\/sup> This ultimately led to the proposal becoming law on October 31, 1988 under Public Law 100-578 as the <i>Clinical Laboratory Improvement Amendments of 1988<\/i>.<sup id=\"rdp-ebb-cite_ref-CLIA88Doc_5-0\" class=\"reference\"><a href=\"#cite_note-CLIA88Doc-5\" rel=\"external_link\">[5]<\/a><\/sup> \n<\/p><p>Regulations for implementing CLIA continued to be developed afterwards, with the <a href=\"https:\/\/www.limswiki.org\/index.php\/United_States_Department_of_Health_and_Human_Services\" title=\"United States Department of Health and Human Services\" target=\"_blank\" class=\"wiki-link\" data-key=\"efa106bcbb93039b1a6c3c596daedec3\">Department of Health and Human Services<\/a> considering thousands of comments to the proposed regulations. The final regulations were published February 28, 1992, set to be effective on September 1 of the same year. The new CLIA '88 put into place regulations concerning test complexity, certification, proficiency testing, patient test management, personnel requirements, quality assurance, and other processes in the clinical laboratory.<sup id=\"rdp-ebb-cite_ref-MMERFeb2892_6-0\" class=\"reference\"><a href=\"#cite_note-MMERFeb2892-6\" rel=\"external_link\">[6]<\/a><\/sup> However, phase-in effective dates were extended on several occasions afterwards: on December 6, 1994 in the Federal Register (59 FR 62606), May 12, 1997 in the Federal Register (62 FR 25855), October 14, 1998 in the Federal Register (63 FR 55031), and December 29, 2000 in the Federal Register (65 FR 82941).<sup id=\"rdp-ebb-cite_ref-68FR3639_7-0\" class=\"reference\"><a href=\"#cite_note-68FR3639-7\" rel=\"external_link\">[7]<\/a><\/sup>\n<\/p><p>On January 24, 2003, the <a href=\"https:\/\/www.limswiki.org\/index.php\/Centers_for_Medicare_and_Medicaid_Services\" title=\"Centers for Medicare and Medicaid Services\" target=\"_blank\" class=\"wiki-link\" data-key=\"654b4449e4816e190325b420c264df1a\">Centers for Medicare and Medicaid Services<\/a> submitted their final rule (68 FR 3639), effective April 24, 2003, affecting QC requirements for laboratories and qualification requirements for lab directors. The final rule also made revisions to 42 CFR 493, including the renaming, reorganizing, and consolidation of similar requirements into one section, the deletion of duplicate requirements, and the rewording of the requirements to better clarify their original intent. It also addressed requirements regarding the entire testing process, making those requirement better correlate with the workflow of a lab specimen in the laboratory, from acquisition to reporting of results, including the subdivision of testing into pre-analytic, analytic, and post-analytic phases.<sup id=\"rdp-ebb-cite_ref-68FR3639_7-1\" class=\"reference\"><a href=\"#cite_note-68FR3639-7\" rel=\"external_link\">[7]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-NewMexH_8-0\" class=\"reference\"><a href=\"#cite_note-NewMexH-8\" rel=\"external_link\">[8]<\/a><\/sup>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"CLIA_program\">CLIA program<\/span><\/h2>\n<p>The CLIA program sets standards and issues certificates for clinical laboratory testing. CLIA defines a clinical laboratory as any facility which performs <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory\" title=\"Laboratory\" target=\"_blank\" class=\"wiki-link\" data-key=\"c57fc5aac9e4abf31dccae81df664c33\">laboratory<\/a> testing on specimens derived from humans for the purpose of providing information for:\n<\/p>\n<ul><li> diagnosis, prevention, or treatment of disease or impairment.<\/li>\n<li> health assessments.<\/li><\/ul>\n<p>The CLIA program is designed to ensure the accuracy, reliability, and timeliness of test results regardless of where the test was performed. Each specific laboratory system, <a href=\"https:\/\/www.limswiki.org\/index.php\/Assay\" title=\"Assay\" target=\"_blank\" class=\"wiki-link\" data-key=\"ea17cf4415e898e1838538495235ef71\">assay<\/a>, and examination is graded for level of complexity by assigning scores of \"1,\" \"2,\" or \"3\" for each of seven criteria. A test scored as a \"1\" is the lowest level of complexity, while a test scored \"3\" indicates the highest level. A score of \"2\" is assigned when the characteristics for a particular test are ranked primarily between low- and high-level in description.<sup id=\"rdp-ebb-cite_ref-FDAIVDReg_9-0\" class=\"reference\"><a href=\"#cite_note-FDAIVDReg-9\" rel=\"external_link\">[9]<\/a><\/sup>\n<\/p><p>The seven criteria for categorization are:\n<\/p>\n<ol><li> Knowledge<\/li>\n<li> Training and experience<\/li>\n<li> Reagents and materials preparation<\/li>\n<li> Characteristics of operational steps<\/li>\n<li> Calibration, quality control, and proficiency testing materials<\/li>\n<li> Test system troubleshooting and equipment maintenance<\/li>\n<li> Interpretation and judgment<\/li><\/ol>\n<p>The <a href=\"https:\/\/www.limswiki.org\/index.php\/Centers_for_Medicare_and_Medicaid_Services\" title=\"Centers for Medicare and Medicaid Services\" target=\"_blank\" class=\"wiki-link\" data-key=\"654b4449e4816e190325b420c264df1a\">Centers for Medicare and Medicaid Services<\/a> (CMS) has the primary responsibility for the operation of the CLIA program. Within CMS, the program is implemented by the Center for Medicaid and State Operations, Survey and Certification Group, and the Division of Laboratory Services.\n<\/p><p>The CLIA Program is funded by user fees collected from over 244,000 laboratories<sup id=\"rdp-ebb-cite_ref-CLIADec13_10-0\" class=\"reference\"><a href=\"#cite_note-CLIADec13-10\" rel=\"external_link\">[10]<\/a><\/sup>, most located in the United States.<sup id=\"rdp-ebb-cite_ref-CLIABroch_11-0\" class=\"reference\"><a href=\"#cite_note-CLIABroch-11\" rel=\"external_link\">[11]<\/a><\/sup>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"CLIA_waived_tests\">CLIA waived tests<\/span><\/h2>\n<p>Under CLIA, tests and test systems that meet risk, error, and complexity requirements are issued a CLIA certificate of waiver.<sup id=\"rdp-ebb-cite_ref-CDCWaived_12-0\" class=\"reference\"><a href=\"#cite_note-CDCWaived-12\" rel=\"external_link\">[12]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-CLIABroch_11-1\" class=\"reference\"><a href=\"#cite_note-CLIABroch-11\" rel=\"external_link\">[11]<\/a><\/sup> In its 2014 document <i>Administrative Procedures for CLIA Categorization - Guidance for Industry and Food and Drug Administration Staff<\/i>, the U.S. Food and Drug Administration (FDA) advises its staff that a medical testing device originally rated moderately complex could receive a waiver \"if the device is simple to use and the sponsor demonstrates in studies conducted at the intended use sites that the test is accurate and poses an insignificant risk of erroneous results.\"<sup id=\"rdp-ebb-cite_ref-APCC_13-0\" class=\"reference\"><a href=\"#cite_note-APCC-13\" rel=\"external_link\">[13]<\/a><\/sup>\n<\/p><p>While a waived test is deemed to have an acceptably low level of risk, the <a href=\"https:\/\/www.limswiki.org\/index.php\/Centers_for_Disease_Control_and_Prevention\" title=\"Centers for Disease Control and Prevention\" target=\"_blank\" class=\"wiki-link\" data-key=\"176aa9c9513251c328d864d1e724e814\">Centers for Disease Control and Prevention<\/a> (CDC) reminds administrators and recipients of such tests that no test is 100 percent safe<sup id=\"rdp-ebb-cite_ref-CDCWaived_12-1\" class=\"reference\"><a href=\"#cite_note-CDCWaived-12\" rel=\"external_link\">[12]<\/a><\/sup>:\n<\/p>\n<blockquote>Although CLIA requires that waived tests must be simple and have a low risk for erroneous results, this does not mean that waived tests are completely error-proof. Errors can occur anywhere in the testing process, particularly when the manufacturer's instructions are not followed and when testing personnel are not familiar with all aspects of the test system. Some waived tests have potential for serious health impacts if performed incorrectly... To decrease the risk of erroneous results, the test needs to be performed correctly, by trained personnel and in an environment where good laboratory practices are followed. <\/blockquote>\n<p>In November 2007, the CLIA waiver provisions were revised by the United States Congress to make it clear that tests approved by the FDA for home use automatically qualify for CLIA waiver.<sup id=\"rdp-ebb-cite_ref-FDAWaivers_14-0\" class=\"reference\"><a href=\"#cite_note-FDAWaivers-14\" rel=\"external_link\">[14]<\/a><\/sup>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"List_of_tests\">List of tests<\/span><\/h3>\n<p>A list of tests categorized by the FDA as waived since 2000 can be found at the <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfClia\/testswaived.cfm\" target=\"_blank\">FDA website<\/a>. As of February 17, 2015, the list included 6,669 separate test devices.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"See_also\">See also<\/span><\/h2>\n<ul><li> <a href=\"https:\/\/www.limswiki.org\/index.php\/Centers_for_Medicare_and_Medicaid_Services\" title=\"Centers for Medicare and Medicaid Services\" target=\"_blank\" class=\"wiki-link\" data-key=\"654b4449e4816e190325b420c264df1a\">Centers for Medicare and Medicaid Services<\/a><\/li>\n<li> <a href=\"https:\/\/www.limswiki.org\/index.php\/Clinical_laboratory\" title=\"Clinical laboratory\" target=\"_blank\" class=\"wiki-link\" data-key=\"307bcdf1bdbcd1bb167cee435b7a5463\">Clinical laboratory<\/a><\/li><\/ul>\n<h2><span class=\"mw-headline\" id=\"Further_reading\">Further reading<\/span><\/h2>\n<ul><li> <span class=\"citation Journal\">Kenney, Michael L. (February 1987). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.clinchem.org\/content\/33\/2\/328.full.pdf\" target=\"_blank\">\"Quality Assurance in Changing Times: Proposals for Reform and Research in the Clinical Laboratory Field\"<\/a> (PDF). <i>Clinical Chemistry<\/i> <b>33<\/b> (2): 328\u2013336. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" target=\"_blank\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/3542302\" target=\"_blank\">3542302<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.clinchem.org\/content\/33\/2\/328.full.pdf\" target=\"_blank\">http:\/\/www.clinchem.org\/content\/33\/2\/328.full.pdf<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Quality+Assurance+in+Changing+Times%3A+Proposals+for+Reform+and+Research+in+the+Clinical+Laboratory+Field&rft.jtitle=Clinical+Chemistry&rft.aulast=Kenney%2C+Michael+L.&rft.au=Kenney%2C+Michael+L.&rft.date=February+1987&rft.volume=33&rft.issue=2&rft.pages=328%E2%80%93336&rft_id=info:pmid\/3542302&rft_id=http%3A%2F%2Fwww.clinchem.org%2Fcontent%2F33%2F2%2F328.full.pdf&rfr_id=info:sid\/en.wikipedia.org:Clinical_Laboratory_Improvement_Amendments\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<h2><span class=\"mw-headline\" id=\"External_links\">External links<\/span><\/h2>\n<ul><li> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.gpo.gov\/fdsys\/granule\/CFR-2011-title42-vol5\/CFR-2011-title42-vol5-part493\/content-detail.html\" target=\"_blank\">42 CFR 493 at the U.S. Government Printing Office<\/a><\/li>\n<li> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/wwwn.cdc.gov\/clia\/Regulatory\/default.aspx\" target=\"_blank\">CLIA Law & Regulations at CDC<\/a><\/li>\n<li> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/wwwn.cdc.gov\/CLIA\/Regulatory\/Chronology.aspx\" target=\"_blank\">Chronology of CLIA Related Documents in the Federal Register & Code of Federal Regulations<\/a><\/li><\/ul>\n<h2><span class=\"mw-headline\" id=\"Notes\">Notes<\/span><\/h2>\n<p>A couple elements of this article are reused from <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/Clinical_Laboratory_Improvement_Amendments\" target=\"_blank\">the Wikipedia article<\/a>.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<ol class=\"references\">\n<li id=\"cite_note-CMSAboutCLIA-1\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CMSAboutCLIA_1-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.cms.gov\/Regulations-and-Guidance\/Legislation\/CLIA\/index.html\" target=\"_blank\">\"Clinical Laboratory Improvement Amendments (CLIA)\"<\/a>. Centers for Medicare and Medicaid Services<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.cms.gov\/Regulations-and-Guidance\/Legislation\/CLIA\/index.html\" target=\"_blank\">http:\/\/www.cms.gov\/Regulations-and-Guidance\/Legislation\/CLIA\/index.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 23 March 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Clinical+Laboratory+Improvement+Amendments+%28CLIA%29&rft.atitle=&rft.pub=Centers+for+Medicare+and+Medicaid+Services&rft_id=http%3A%2F%2Fwww.cms.gov%2FRegulations-and-Guidance%2FLegislation%2FCLIA%2Findex.html&rfr_id=info:sid\/en.wikipedia.org:Clinical_Laboratory_Improvement_Amendments\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-CLIA67Doc-2\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CLIA67Doc_2-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.gpo.gov\/fdsys\/pkg\/STATUTE-81\/pdf\/STATUTE-81-Pg533.pdf\" target=\"_blank\">\"Public Law 90-174\"<\/a> (PDF). <i>United States Statutes at Large, Volume 81<\/i>. 1967<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.gpo.gov\/fdsys\/pkg\/STATUTE-81\/pdf\/STATUTE-81-Pg533.pdf\" target=\"_blank\">http:\/\/www.gpo.gov\/fdsys\/pkg\/STATUTE-81\/pdf\/STATUTE-81-Pg533.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 24 March 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Public+Law+90-174&rft.atitle=United+States+Statutes+at+Large%2C+Volume+81&rft.date=1967&rft_id=http%3A%2F%2Fwww.gpo.gov%2Ffdsys%2Fpkg%2FSTATUTE-81%2Fpdf%2FSTATUTE-81-Pg533.pdf&rfr_id=info:sid\/en.wikipedia.org:Clinical_Laboratory_Improvement_Amendments\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-KenneyQACLIA-3\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-KenneyQACLIA_3-0\" rel=\"external_link\">3.0<\/a><\/sup> <sup><a href=\"#cite_ref-KenneyQACLIA_3-1\" rel=\"external_link\">3.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Kenney, Michael L. (February 1987). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.clinchem.org\/content\/33\/2\/328.full.pdf\" target=\"_blank\">\"Quality Assurance in Changing Times: Proposals for Reform and Research in the Clinical Laboratory Field\"<\/a> (PDF). <i>Clinical Chemistry<\/i> <b>33<\/b> (2): 328\u2013336. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" target=\"_blank\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/3542302\" target=\"_blank\">3542302<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.clinchem.org\/content\/33\/2\/328.full.pdf\" target=\"_blank\">http:\/\/www.clinchem.org\/content\/33\/2\/328.full.pdf<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Quality+Assurance+in+Changing+Times%3A+Proposals+for+Reform+and+Research+in+the+Clinical+Laboratory+Field&rft.jtitle=Clinical+Chemistry&rft.aulast=Kenney%2C+Michael+L.&rft.au=Kenney%2C+Michael+L.&rft.date=February+1987&rft.volume=33&rft.issue=2&rft.pages=328%E2%80%93336&rft_id=info:pmid\/3542302&rft_id=http%3A%2F%2Fwww.clinchem.org%2Fcontent%2F33%2F2%2F328.full.pdf&rfr_id=info:sid\/en.wikipedia.org:Clinical_Laboratory_Improvement_Amendments\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-SingerGLQA-4\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-SingerGLQA_4-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Singer, Donald C.; Upton, Ronald P. (1993). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/books.google.ca\/books?id=tTm3hfom96sC&pg=PA273&lpg=PA273\" target=\"_blank\">\"Appendix F: Proposed Revision of the Clinical Laboratory Regulations for Medicare, Medicaid, and Clinical Laboratories Improvement Act of 1967 - Department of Health and Human Services: Health Care Financing Administration\"<\/a>. <i>Guidelines for Laboratory Quality Auditing<\/i>. CRC Press. pp. 273\u2013402. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" target=\"_blank\">ISBN<\/a> 9780824787844<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/books.google.ca\/books?id=tTm3hfom96sC&pg=PA273&lpg=PA273\" target=\"_blank\">http:\/\/books.google.ca\/books?id=tTm3hfom96sC&pg=PA273&lpg=PA273<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Appendix+F%3A+Proposed+Revision+of+the+Clinical+Laboratory+Regulations+for+Medicare%2C+Medicaid%2C+and+Clinical+Laboratories+Improvement+Act+of+1967+-+Department+of+Health+and+Human+Services%3A+Health+Care+Financing+Administration&rft.atitle=Guidelines+for+Laboratory+Quality+Auditing&rft.aulast=Singer%2C+Donald+C.%3B+Upton%2C+Ronald+P.&rft.au=Singer%2C+Donald+C.%3B+Upton%2C+Ronald+P.&rft.date=1993&rft.pages=pp.%26nbsp%3B273%E2%80%93402&rft.pub=CRC+Press&rft.isbn=9780824787844&rft_id=http%3A%2F%2Fbooks.google.ca%2Fbooks%3Fid%3DtTm3hfom96sC%26pg%3DPA273%26lpg%3DPA273&rfr_id=info:sid\/en.wikipedia.org:Clinical_Laboratory_Improvement_Amendments\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-CLIA88Doc-5\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CLIA88Doc_5-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.gpo.gov\/fdsys\/pkg\/STATUTE-102\/pdf\/STATUTE-102-Pg2903.pdf\" target=\"_blank\">\"Public Law 100-578\"<\/a> (PDF). <i>United States Statutes at Large, Volume 102<\/i>. 1988<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.gpo.gov\/fdsys\/pkg\/STATUTE-102\/pdf\/STATUTE-102-Pg2903.pdf\" target=\"_blank\">http:\/\/www.gpo.gov\/fdsys\/pkg\/STATUTE-102\/pdf\/STATUTE-102-Pg2903.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 24 March 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Public+Law+100-578&rft.atitle=United+States+Statutes+at+Large%2C+Volume+102&rft.date=1988&rft_id=http%3A%2F%2Fwww.gpo.gov%2Ffdsys%2Fpkg%2FSTATUTE-102%2Fpdf%2FSTATUTE-102-Pg2903.pdf&rfr_id=info:sid\/en.wikipedia.org:Clinical_Laboratory_Improvement_Amendments\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-MMERFeb2892-6\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MMERFeb2892_6-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.cdc.gov\/mmwr\/preview\/mmwrhtml\/00016177.htm\" target=\"_blank\">\"Regulations for Implementing the Clinical Laboratory Improvement Amendments of 1988: A Summary\"<\/a>. <i>Morbidity and Mortality Weekly Report<\/i> <b>41<\/b> (RR-2): 1\u201317. 28 February 1992. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" target=\"_blank\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/1538689\" target=\"_blank\">1538689<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.cdc.gov\/mmwr\/preview\/mmwrhtml\/00016177.htm\" target=\"_blank\">http:\/\/www.cdc.gov\/mmwr\/preview\/mmwrhtml\/00016177.htm<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 24 March 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Regulations+for+Implementing+the+Clinical+Laboratory+Improvement+Amendments+of+1988%3A+A+Summary&rft.jtitle=Morbidity+and+Mortality+Weekly+Report&rft.date=28+February+1992&rft.volume=41&rft.issue=RR-2&rft.pages=1%E2%80%9317&rft_id=info:pmid\/1538689&rft_id=http%3A%2F%2Fwww.cdc.gov%2Fmmwr%2Fpreview%2Fmmwrhtml%2F00016177.htm&rfr_id=info:sid\/en.wikipedia.org:Clinical_Laboratory_Improvement_Amendments\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-68FR3639-7\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-68FR3639_7-0\" rel=\"external_link\">7.0<\/a><\/sup> <sup><a href=\"#cite_ref-68FR3639_7-1\" rel=\"external_link\">7.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation Journal\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.gpo.gov\/fdsys\/pkg\/FR-2003-01-24\/html\/03-1230.htm\" target=\"_blank\">\"Medicare, Medicaid, and CLIA Programs; Laboratory Requirements Relating to Quality Systems and Certain Personnel Qualifications; Final Rule\"<\/a>. <i>Federal Register<\/i> <b>68<\/b> (16): 3639\u20133714. 24 January 2003. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" target=\"_blank\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/12545998\" target=\"_blank\">12545998<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.gpo.gov\/fdsys\/pkg\/FR-2003-01-24\/html\/03-1230.htm\" target=\"_blank\">http:\/\/www.gpo.gov\/fdsys\/pkg\/FR-2003-01-24\/html\/03-1230.htm<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 24 March 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Medicare%2C+Medicaid%2C+and+CLIA+Programs%3B+Laboratory+Requirements+Relating+to+Quality+Systems+and+Certain+Personnel+Qualifications%3B+Final+Rule&rft.jtitle=Federal+Register&rft.date=24+January+2003&rft.volume=68&rft.issue=16&rft.pages=3639%E2%80%933714&rft_id=info:pmid\/12545998&rft_id=http%3A%2F%2Fwww.gpo.gov%2Ffdsys%2Fpkg%2FFR-2003-01-24%2Fhtml%2F03-1230.htm&rfr_id=info:sid\/en.wikipedia.org:Clinical_Laboratory_Improvement_Amendments\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-NewMexH-8\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-NewMexH_8-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dhi.health.state.nm.us\/CLIA\/clia_history.php\" target=\"_blank\">\"Clinical Laboratory Improvement Act (CLIA) - Legislative History\"<\/a>. New Mexico Department of Health<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/dhi.health.state.nm.us\/CLIA\/clia_history.php\" target=\"_blank\">http:\/\/dhi.health.state.nm.us\/CLIA\/clia_history.php<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 24 March 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Clinical+Laboratory+Improvement+Act+%28CLIA%29+-+Legislative+History&rft.atitle=&rft.pub=New+Mexico+Department+of+Health&rft_id=http%3A%2F%2Fdhi.health.state.nm.us%2FCLIA%2Fclia_history.php&rfr_id=info:sid\/en.wikipedia.org:Clinical_Laboratory_Improvement_Amendments\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-FDAIVDReg-9\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-FDAIVDReg_9-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.fda.gov\/MedicalDevices\/DeviceRegulationandGuidance\/IVDRegulatoryAssistance\/ucm124208.htm\" target=\"_blank\">\"CLIA Categorization Criteria\"<\/a>. U.S. Food and Drug Administration. 6 March 2014<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.fda.gov\/MedicalDevices\/DeviceRegulationandGuidance\/IVDRegulatoryAssistance\/ucm124208.htm\" target=\"_blank\">http:\/\/www.fda.gov\/MedicalDevices\/DeviceRegulationandGuidance\/IVDRegulatoryAssistance\/ucm124208.htm<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 23 March 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=CLIA+Categorization+Criteria&rft.atitle=&rft.date=6+March+2014&rft.pub=U.S.+Food+and+Drug+Administration&rft_id=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FDeviceRegulationandGuidance%2FIVDRegulatoryAssistance%2Fucm124208.htm&rfr_id=info:sid\/en.wikipedia.org:Clinical_Laboratory_Improvement_Amendments\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-CLIADec13-10\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CLIADec13_10-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cms.gov\/Regulations-and-Guidance\/Legislation\/CLIA\/downloads\/factype.pdf\" target=\"_blank\">\"CLIA Update \u2013 December 2013 - Laboratories by Type of Facility\"<\/a> (PDF). Centers for Medicare and Medicaid Services. December 2013<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cms.gov\/Regulations-and-Guidance\/Legislation\/CLIA\/downloads\/factype.pdf\" target=\"_blank\">https:\/\/www.cms.gov\/Regulations-and-Guidance\/Legislation\/CLIA\/downloads\/factype.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 23 March 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=CLIA+Update+%E2%80%93+December+2013+-+Laboratories+by+Type+of+Facility&rft.atitle=&rft.date=December+2013&rft.pub=Centers+for+Medicare+and+Medicaid+Services&rft_id=https%3A%2F%2Fwww.cms.gov%2FRegulations-and-Guidance%2FLegislation%2FCLIA%2Fdownloads%2Ffactype.pdf&rfr_id=info:sid\/en.wikipedia.org:Clinical_Laboratory_Improvement_Amendments\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-CLIABroch-11\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-CLIABroch_11-0\" rel=\"external_link\">11.0<\/a><\/sup> <sup><a href=\"#cite_ref-CLIABroch_11-1\" rel=\"external_link\">11.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cms.gov\/Outreach-and-Education\/Medicare-Learning-Network-MLN\/MLNProducts\/downloads\/CLIABrochure.pdf\" target=\"_blank\">\"Clinical Laboratory Improvement Amendments (CLIA)\"<\/a> (PDF). Centers for Medicare and Medicaid Services. May 2013<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cms.gov\/Outreach-and-Education\/Medicare-Learning-Network-MLN\/MLNProducts\/downloads\/CLIABrochure.pdf\" target=\"_blank\">https:\/\/www.cms.gov\/Outreach-and-Education\/Medicare-Learning-Network-MLN\/MLNProducts\/downloads\/CLIABrochure.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 23 March 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Clinical+Laboratory+Improvement+Amendments+%28CLIA%29&rft.atitle=&rft.date=May+2013&rft.pub=Centers+for+Medicare+and+Medicaid+Services&rft_id=https%3A%2F%2Fwww.cms.gov%2FOutreach-and-Education%2FMedicare-Learning-Network-MLN%2FMLNProducts%2Fdownloads%2FCLIABrochure.pdf&rfr_id=info:sid\/en.wikipedia.org:Clinical_Laboratory_Improvement_Amendments\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-CDCWaived-12\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-CDCWaived_12-0\" rel=\"external_link\">12.0<\/a><\/sup> <sup><a href=\"#cite_ref-CDCWaived_12-1\" rel=\"external_link\">12.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/wwwn.cdc.gov\/clia\/Resources\/WaivedTests\/default.aspx\" target=\"_blank\">\"Clinical Laboratory Improvement Amendments (CLIA) - CLIA Waived Tests\"<\/a>. Centers for Disease Control and Prevention. 14 March 2014<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/wwwn.cdc.gov\/clia\/Resources\/WaivedTests\/default.aspx\" target=\"_blank\">http:\/\/wwwn.cdc.gov\/clia\/Resources\/WaivedTests\/default.aspx<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 23 March 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Clinical+Laboratory+Improvement+Amendments+%28CLIA%29+-+CLIA+Waived+Tests&rft.atitle=&rft.date=14+March+2014&rft.pub=Centers+for+Disease+Control+and+Prevention&rft_id=http%3A%2F%2Fwwwn.cdc.gov%2Fclia%2FResources%2FWaivedTests%2Fdefault.aspx&rfr_id=info:sid\/en.wikipedia.org:Clinical_Laboratory_Improvement_Amendments\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-APCC-13\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-APCC_13-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.fda.gov\/MedicalDevices\/DeviceRegulationandGuidance\/GuidanceDocuments\/ucm070762.htm\" target=\"_blank\">\"Administrative Procedures for CLIA Categorization - Guidance for Industry and Food and Drug Administration Staff\"<\/a>. U.S. Food and Drug Administration. 12 March 2014<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.fda.gov\/MedicalDevices\/DeviceRegulationandGuidance\/GuidanceDocuments\/ucm070762.htm\" target=\"_blank\">http:\/\/www.fda.gov\/MedicalDevices\/DeviceRegulationandGuidance\/GuidanceDocuments\/ucm070762.htm<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 17 February 2015<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Administrative+Procedures+for+CLIA+Categorization+-+Guidance+for+Industry+and+Food+and+Drug+Administration+Staff&rft.atitle=&rft.date=12+March+2014&rft.pub=U.S.+Food+and+Drug+Administration&rft_id=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FDeviceRegulationandGuidance%2FGuidanceDocuments%2Fucm070762.htm&rfr_id=info:sid\/en.wikipedia.org:Clinical_Laboratory_Improvement_Amendments\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-FDAWaivers-14\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-FDAWaivers_14-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.fda.gov\/medicaldevices\/deviceregulationandguidance\/ivdregulatoryassistance\/ucm124202.htm\" target=\"_blank\">\"IVD Regulatory Assistance - CLIA Waivers\"<\/a>. U.S. Food and Drug Administration. 19 June 2009<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.fda.gov\/medicaldevices\/deviceregulationandguidance\/ivdregulatoryassistance\/ucm124202.htm\" target=\"_blank\">http:\/\/www.fda.gov\/medicaldevices\/deviceregulationandguidance\/ivdregulatoryassistance\/ucm124202.htm<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 23 March 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=IVD+Regulatory+Assistance+-+CLIA+Waivers&rft.atitle=&rft.date=19+June+2009&rft.pub=U.S.+Food+and+Drug+Administration&rft_id=http%3A%2F%2Fwww.fda.gov%2Fmedicaldevices%2Fdeviceregulationandguidance%2Fivdregulatoryassistance%2Fucm124202.htm&rfr_id=info:sid\/en.wikipedia.org:Clinical_Laboratory_Improvement_Amendments\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<\/ol>\n\n<!-- \nNewPP limit report\nCached time: 20181213192756\nCache expiry: 86400\nDynamic content: false\nCPU time usage: 0.292 seconds\nReal time usage: 0.317 seconds\nPreprocessor visited node count: 9264\/1000000\nPreprocessor generated node count: 21015\/1000000\nPost\u2010expand include size: 68358\/2097152 bytes\nTemplate argument size: 27017\/2097152 bytes\nHighest expansion depth: 13\/40\nExpensive parser function count: 0\/100\n-->\n\n<!-- \nTransclusion expansion time report (%,ms,calls,template)\n100.00% 263.207 1 - -total\n 87.74% 230.948 15 - Template:Citation\/core\n 51.99% 136.831 10 - Template:Cite_web\n 36.21% 95.302 4 - Template:Cite_journal\n 8.77% 23.087 1 - Template:Cite_book\n 5.13% 13.512 5 - Template:Citation\/identifier\n 5.10% 13.436 18 - Template:Citation\/make_link\n 1.34% 3.534 10 - Template:Hide_in_print\n 1.12% 2.944 5 - Template:Only_in_print\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:4907-0!*!0!!en!5!* and timestamp 20181213192756 and revision id 21625\n -->\n<\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Clinical_Laboratory_Improvement_Amendments\">https:\/\/www.limswiki.org\/index.php\/Clinical_Laboratory_Improvement_Amendments<\/a><\/div>\n\t\t\t\t\t\t\t\t\t\t<!-- end content -->\n\t\t\t\t\t\t\t\t\t\t<div class=\"visualClear\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t<!-- end of the left (by default at least) column -->\n\t\t<div class=\"visualClear\"><\/div>\n\t\t\t\t\t\n\t\t<\/div>\n\t\t\n\n<\/body>","64bdae1dc17c40c28e0c560396a6ae35_images":["https:\/\/www.limswiki.org\/images\/8\/8b\/CLIA_Logo.gif"],"64bdae1dc17c40c28e0c560396a6ae35_timestamp":1544729276,"23b167bed768658047c44710d3c186d1_type":"article","23b167bed768658047c44710d3c186d1_title":"LIS feature","23b167bed768658047c44710d3c186d1_url":"https:\/\/www.limswiki.org\/index.php\/LIS_feature","23b167bed768658047c44710d3c186d1_plaintext":"\n\n\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\n\t\t\t\tLIS feature\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\tFrom LIMSWiki\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\tJump to: navigation, search\n\n\t\t\t\t\t\n\t\t\t\t\t\n\n\n \n You can find a listing of all LIS vendors \u2014 and by extension, the features their products offer \u2014 on the LIS vendor page. \n\n\n Thousands of hospital laboratories like this one benefit from the use of a laboratory information system.A LIS feature is one or more pieces of functionality that appear within a laboratory information system (LIS).\nThe LIS has traditionally been utilized in clinical, pathology, and medical research laboratories as well as numerous public health institutions.[1] Yet as laboratory demands have changed and technological progress has continued, the functions of a LIS have also changed, with the distinction between a LIS and a laboratory information management system (LIMS) fading as some LIMS vendors have adopted the case-centric information management normally reserved for a LIS.[2][3].\nDespite the blurring of distinction between a LIS and a LIMS, the LIS generally continues to feature the following[4]:\n\n patient management, including admission date, admitting physician, ordering department, specimen type, etc.\n patient data tracking\n decision support, including comparisons of lab orders with their respective ICD codes\n quality assurance of ordered tests\n workload and management reporting\nOf course, there are LIS features that are difficult to categorize or simply contribute to the whole of the LIS rather than add a function. For example, multilingual support allows users to interact with the LIS in more than one language. Some functionality may also overlap several research phases, making it difficult to firmly classify. \nThe features described below come from an analysis of freely available LIS product information on vendor websites. An attempt was made to discover the features most utilized in vendors' LIS products and collect information on those features for each LIS. Not every possible feature is referenced here; some LIS products fill specific niches, utilizing unique functionality to solve a specific problem. \nThat said, keep in mind the categorization of features below is very loose. It may be viable to argue a feature belongs under a different section or multiple sections. For the purposes of organizing this information in an uncomplicated manner, however, some liberty has been taken in the categorizing of features.\n\nContents\n\n1 Experiment, patient, and data management \n\n1.1 Sample login and management \n1.2 Sample tracking \n1.3 Sample and result batching \n1.4 Task and event scheduling \n1.5 Option for manual result entry \n1.6 Multiple data viewing methods \n1.7 Configurable templates and forms \n1.8 Data and trend analysis \n1.9 Data and equipment sharing \n1.10 Data mining \n1.11 Customizable fields and\/or interface \n1.12 Query capability \n1.13 Import data \n1.14 Internal file or data linking \n1.15 External file or data linking \n1.16 ELN support or integration \n1.17 Export to MS Excel \n1.18 Raw data management \n1.19 Data warehouse \n1.20 Project and\/or task management \n1.21 Test, experiment, and\/or trial management \n1.22 Inventory management \n1.23 Document and\/or image management \n1.24 Patient and case management \n1.25 Workflow management \n1.26 Specification management \n1.27 Customer, supplier, and physician management \n1.28 Billing and revenue management \n\n\n2 Quality, security, and compliance \n\n2.1 Regulatory compliance \n2.2 QA\/QC functions \n2.3 Performance evaluation \n2.4 Audit trail \n2.5 Chain of custody \n2.6 Configurable roles and security \n2.7 Data normalization \n2.8 Data validation \n2.9 Data encryption \n2.10 Version control \n2.11 Automatic data backup \n2.12 Environmental monitoring \n\n\n3 Reporting, barcoding, and printing \n\n3.1 Custom reporting \n3.2 Synoptic reporting \n3.3 Report printing \n3.4 Label support \n3.5 Barcode and\/or RFID support \n3.6 Export to PDF \n3.7 Export to MS Word \n3.8 Export to HTML or XML \n3.9 Fax integration \n3.10 Email integration \n\n\n4 Base functionality \n\n4.1 Administrator management \n4.2 Modular \n4.3 Instrument interfacing and management \n4.4 Mobile device integration \n4.5 Third-party software integration \n4.6 Alarms and\/or alerts \n4.7 Work-related time tracking \n4.8 Voice recognition system \n4.9 External monitoring \n4.10 Messaging \n4.11 Commenting \n4.12 Multilingual \n4.13 Network-capable \n4.14 Web client or portal \n4.15 Online or integrated help \n4.16 Software as a service delivery model \n4.17 Usage-based cost \n\n\n5 References \n\n\n\nExperiment, patient, and data management \nTo hide the contents of this section for easier reading of other sections, click the \"Collapse\" link to the right.\n\n\n \nSample login and management \nSample login and management \u2014 often referred to as accessioning or specimen management \u2014 is an important component of the clinical laboratory, whether it's a molecular pathology lab testing samples for disease indicators or a contract lab running pharmacokinetic and biomarker analysis on samples from a clinical trial.[5][6] As such, researchers and technicians who work in these types of labs are unable to complete their tasks without an effective method of managing samples. The process of sample management and accessioning includes, but is not limited to[7][5]:\n\n storing related sample information, including demographics, dates, and external links\n creating and documenting viewable sample container schemas with name and status\n assigning sample access rights\n assigning custom sample ID or accessioning numbers based on a specification\n applying additional processing to the sample before storage and\/or analysis\nAdditional functionality that could potentially fall under this feature:\n\n barcoding or RFID tagging of samples\n defining sample points and series\n creating data associations for samples - such as pedigree for sample\/aliquot relationships or relationships based on experiment, etc.\n issuing sample receipts\nSample tracking \n Where's sample 20110512_122GJH? Sample tracking functionality will let you know which lab oven it's in.For most laboratory personnel, knowing that a sample has arrived to the lab isn't good enough; they need to know where it's located and what is being done with it. Enter the sample tracking feature. Without it, many problems arise. In the forensic world, for example, many samples are linked to a criminal investigation. In this case, misidentification, contamination, or duplication can become significant issues: a lost sample is essentially missing evidence, while a duplicated sample can render it useless as evidence.[8]\nAfter sample reception and its initial handling procedures, many LIS can then track sample location as well as chain of custody. Location tracking usually involves assigning the sample to a particular freezer, oven, or other location, often down to the granular level of shelf, rack, box, row, and column. The process of tracking a sample has become more streamlined with increasing support of 2-D barcode or radio-frequency identification (RFID) technology. While handwritten labels were the norm, now barcode and RDIF support in a LIS can \"tie together a vast amount of information, clearly relating each sample to a specific case.\"[8] Other event tracking such as freeze and thaw cycles that a sample undergoes in the laboratory may also be required. As each laboratory's needs for tracking additional data points can vary widely, many modern LIMS and LIS have implemented extensive configurability to compensate for varying environments.[9]\nThe functionality of sample tracking strongly ties into the audit trail and chain of custody features of a LIS.\n\nSample and result batching \nWhat is batching? The United States Environmental Protection Agency (EPA) defines a batch as \"a group of samples which behave similarly with respect to the sampling or testing procedures being employed and which are processed as a unit.\"[10] This definition can be applied to many laboratories which handle large quantities of samples for some form of analysis or processing. A LIS that has the ability to check in, link, and track groups of samples across one or multiple facilities is valuable to such laboratories. Additionally, batching the analysis results of multiple samples or groups of samples gives laboratories more flexibility with how they manage their data. Batching also offers the benefit of mimicking the production groups of samples while also capturing quality control data for the entire group.\n\nTask and event scheduling \nWithin the context of a LIS, the ability to schedule a task or event is a natural extension of how work was done in a laboratory before the advent of data management systems. Sample processing, data analysis, equipment maintenance, and case management follow-ups are assigned to technicians and other personnel. Outpatient scheduling is another aspect of some clinical atmospheres, better handled with computerized scheduling functionality. While these tasks have in the past been performed without the LIS, a modern data management system can now optimize those tasks and provide additional scheduling functionality to streamline the operation of a lab. Some LISs like Elekta AB's IntelliLab include a scheduling calendar for recurring test orders, rules-based orders, and pre-defined selection lists.[11] Additional functionality within this feature group includes the ability to configure automated assignments of experiment requests, establish recurring events, and in most cases, create printable reports.\nExamples of tasks and events that can feasibly be scheduled in a LIS include:\n\n production of reports\n creation and sending of e-mails and alerts\n maintenance of equipment\n assignment of accessioning tasks to technicians\n scheduling outpatient visits\nOption for manual result entry \nWhile many LIS vendors tout the ability of their product to automate the entry of sample analysis results into LIS' or other databases, the need for manual data entry of analysis results still exists. This feature is important to laboratories obtaining analysis results from multiple sources, including non-digital paper-based results and instruments that can't be connected to the LIS. Additional functionality associated with this feature includes a customizable spell-check dictionary and the ability to add comments, notes, and narratives to many of the data items in the LIS.\n\nMultiple data viewing methods \nHospitals, physicians, and clinical research facilities produce reams of data, and the LIS exists to help organize and distribute that data to the necessary entities. Additionally, even before the existence of the LIS, scientists have had a corresponding need for visually representing that data for clearer analysis and hypothesis creation. Today a LIS can not only collect and analyze data, but it also can represent that data in reports, graphs, gradients, and spreadsheets. Depending on the LIS, more than one way to visually represent the data may exist. \nThis category ties in with the custom templates and forms functionality apparent in some LIS, providing both custom and standardized ways to present information across a healthcare or medical research enterprise.\n\nConfigurable templates and forms \nSimilar to an electronic laboratory notebook (ELN), a template in a LIS is a functionality item which allows users to increase the productivity and quality of their work by allowing for the creation of a standardized analysis page, patient page, or reporting process across a healthcare or medical research enterprise. These templates allow researchers to maintain more consistent data representation for similar tasks in the LIS and save time by not needing to manually input common data outputs or recreate experiments. Templates and forms typically utilize a wide field library, and the data that is posted to those template fields can also be normalized to a specific standard. Types of templates that may be created include those for renal and blood pressure analysis, patient demographics, test ordering, and department-level reports.[12]\n\nData and trend analysis \n Some LISs allow users to analyze patient test results or clinical research data with built-in software tools. For public health centers and pharmaceutical research centers alike, data analysis plays an important role in their operations, helping clinicians and researchers make better sense of their collected data and reach valuable conclusions about them. While this important phase of laboratory work has often been done externally from the LIS, it's now more common to see basic analysis tools being included. Such tools allow raw data to be imported directly to the LIS, which then can store, process, and display it in a shareable form. Vendors may include data analysis functionality by simply including Microsoft Excel compatibility or providing advanced reporting tools, or they may take a more advanced approach by programming and including their own custom data and trend analysis tools in their informatics software. As sample analysis is increasingly an important part of most if not all laboratories, such functionality \u2014 which has often come in the form of a separate application or analysis device \u2014 will likely continue to merge into software like LIS, LIMS, and other laboratory informatics solutions.[13]\nData and equipment sharing \nAside from data storage and sample registration, a modern LIS's major contribution to the laboratory is aiding in the sharing of test results, reports, and patient data with other entities across the clinical and research enterprise. Rather than pieces of information becoming misplaced or locked away in a physician's office or pathology lab, the LIS makes it easier to test results and increase the efficiency of patient-doctor-lab collaboration in general. Yet data is more than just test results; it also can come in the form of charts, reports, policy and procedure, and other documents. Additionally, the need for controlling who has access to those types of data is also an important consideration. As such, this feature is at least partially tied to other features like document management and configurable security.\n\nData mining \nData mining, in the field of computational science, involves \"the process of discovering interesting and useful patterns and relationships in large volumes of data\" and includes three computational steps: model-learning, model evaluation, and model usage.[14] As informatics software allows both research and clinical laboratories to collect and manage increasing quantities of data, a corresponding demand for tools capable of modeling that data is appearing.[15] For example, public health laboratories may wish to utilize data mining for statistical analysis and surveillance of populations for specific diseases. LIMSs like LabWare LIMS and LISs like Orchard Harvest are examples of laboratory informatics software which incorporate data mining and reporting tools.[16][17]\n\nCustomizable fields and\/or interface \nAs thorough as some user interface (UI) developers may be in adding relevant fields and interface options for end users, there are at times options that are either omitted or unanticipated. This has traditionally required the end user to contact the vendor and ask if the needed option(s) can be added in the next release. However, many modern LIS vendors have responded instead by adding functionality that gives end users and\/or LIS administrators more control over the user interface. \nAspects of the LIS's user interface that are often customizable by the end user include:\n\n report interface and display\n patient profile display\n project and experiment display\nNote in many cases an interface may be customized through the use of templates and forms, and as such, this functionality may be closely tied to the configurable templates and forms functionality.\n\nQuery capability \nAs was the case before the advent of databases and electronic data management solutions, today researchers must search through test results, patient notes, and other types of data to better draw conclusions from experiments, diagnose patient illnesses, and plan pharmaceutical research activities. Whereas this used to mean browsing through laboratory notebooks, Excel spreadsheets, or Access databases, now powerful query tools exists within data management tools like the LIS and ELN. A flexible search algorithm can be implemented to allow users to search a dataset by patient name (full or partial) or by any accessioning number. Or more advanced query tools may be implemented to collate and search across multiple datasets.\nQuery functionality often includes the ability to:\n\n search both transactional data and archived data tables\n search multiple databases via an application programming interface (API) or open database connectivity (ODBC) connection \n filter and sort data\n collate queried data for further analysis and visualization\n create ad-hoc queries\nImport data \nData can originate from numerous places in the laboratory. The ability to import that data into a LIS can be beneficial, especially when an instrument can't be connected or external clients collaborating on a project need to submit relevant data. Of course instrument interfacing allows for even more importation options. Additional data validation procedures may be applied to the imported data to guarantee information homogeneity. For the LIS, one of the common sources of importing data is a separate electronic medical record (EMR) system, for collecting patient data and test orders.[18][19]\n\nInternal file or data linking \n Many informatics systems allow for internal linking of data; however, entities outside of the system often need to access the data housed within. A LIS is often capable of such external data linking.This feature allows research collaborators using a LIS to link together sample batches, reports, protocols, results, and more, providing greater contextual clarity to projects and datasets. Examples include:\n linking a sample batch to a test or sample preparation methodology\n linking a test process to a particular experiment\n linking a report to a sample batch\n linking a group of experiment results to a raw data file\n linking multiple images to a patient record\n linking all experiment results with the correct reporting test methods\nExternal file or data linking \nThis feature allows research collaborators using a LIS to link together data and files housed in the database with data, files, and customers outside the LIS's domain. Examples include:\n\n linking to an external practice management or electronic medical record (EMR) system using an an HL7-compliant interface\n linking one public health data source with others to pool demographic and medical information for better disease modeling\n linking to separate clinical trial laboratory data files within a report\nELN support or integration \nThe functionality of a LIMS and an ELN began to blur in the 2000s, with both types of software incorporating features from the other.[20][21] It has been more common to see a LIMS take on some sort of ELN support (or vice versa), but less common in the LIS. Though uncommon, some LIS may include some sort of integration or compatibility with an ELN, and thusly this functionality is at least mentioned.\n\nExport to MS Excel \nWhile Microsoft Excel has long been used within the laboratory setting, a slow shift towards relational databases and LIMS occurred in the late 1990s and early 2000s.[22] Additional concerns with the difficulties of Excel's validation and compliance with FDA 21 CFR Part 11 and other regulations have led many labs to turn to data management solutions that are easier to validate.[23] Nevertheless, laboratories continue to use Excel in some fashion, and thus Excel integration or data exportation in Excel format is a real need for LIS customers. LISs with this feature allow raw, processed, or imported data to be exported in the Excel format for further analysis and dissemination elsewhere in the LIS or externally from it.\n\nRaw data management \nWhile not described as a feature on most LIS vendor websites, a few indicate their product is capable of managing (import, export, editing, etc.) data in its raw format for future analysis and dissemination.\n\nData warehouse \nAn LIS's data warehouse serves the important function of storing, extracting, and managing the data that laboratories, physician offices, and other facilities produce for the purposes of analysis, reporting, and dissemination, typically separate from the primary storage database. Data warehouses also offer the benefit of speeding up queries, making queries and data mining more user-friendly, and smoothing out data gaps.[24]\n\nProject and\/or task management \nProject and task management within a LIS typically involves the scheduling of tasks to technicians and organizing associated tasks into a more cohesive unit for better tracking and management. While the functionality of task and event scheduling can also be found in project and task management, many LISs include functionality beyond scheduling that warrants the addition of the project and\/or task management feature. This functionality includes:\n\n job allocation and rescheduling\n instrument workload tracking\n pending workload verification\n project- and experiment-based workflow management\n sample, batch, and document linking\n work template sharing\n recurring event management\nSee also: Patient and case management\n\nTest, experiment, and\/or trial management \nSpecimen or sample test management is a common component of a LIS, while experiment and research trial management functionality is a component of some LISs, often limited to those that are designed to help manage clinical trials. Test, experiment, and trial management can cover a wide variety of tasks, from setting up the design of a clinical trial to specimen task assignments, from ordering tests for patients to planning trial experiments. Note: this may also be referred to as \"order management\" with some vendors.\nIt's worth noting this functionality category may seem broad in scope and include other functionality listed on this page, including workflow management and project and task management. Its inclusion when reviewing software functionality is primarily to indicate when a vendor or project team indicates the existence of specific test, experiment, or trial management tools in their software.\n\nInventory management \nLaboratories use a wide array of inventory, from reagents to glassware, from radiopharmaceuticals to laboratory baths. With that comes the need to know how much\/many and the frequency of use. For this, some LIS products (especially those for pathology labs) now offer limited or full-featured inventory management functionality, which may include the ability to:\n\n register the origin and demographics of incoming materials.\n track used and in-use items via barcodes or RFID tags.\n track inventory reduction based on usage and shipping out of the lab.\n create alerts for when items reach a certain stock level.\n calculate inventory cost and fluctuation.\n manage transportation and routing.\n manual incrementing\/decrementing of items.\n track location and usage of laboratory equipment.\n track location and usage of reagents.\n assign storage locations.\n track forensic evidence.\nIt should be noted electronic equipment may also be considered inventory, and thus there is likely some functionality crossover with instrument management features.\n\nDocument and\/or image management \n Standard operating procedures, workflow diagrams, and business models can all be handled effectively with document management functionality.Standard operation procedures, (SOPs), specifications, reports, graphs, images, and receipts are all collected and used in the average laboratory. With a LIS already designed to reference and store test and patient data of all types, it makes sense to include functionality to create, import, export, and manage other sorts of data files. As experimental data can be indexed, queried, and linked, so too can document data. Functionality of a typical document management system includes the ability to:\n upload and index documents.\n add images and photos inline to a patient or case entry.\n enforce version control.\n provide full text searches.\n export to PDF, XML, or other relevant formats.\n add documents as attachments.\nPatient and case management \nThe laboratory information system (LIS) has played an important role in the case management tasks of patient-centric and clinical laboratories. LIS products have included patient or case management tools suitable for the clinical, public health, and veterinary industries, as well as the fields of law enforcement and forensic science. Functionality seen in the patient and case management feature includes:\n\n case accessioning and assignment\n disease tracking\n trend analysis\n clinical history follow-up\n out-of-range result alerts\n document and result association\n evidence control\n study management\n collating of patient data across multiple spectrum\nWorkflow management \n Capturing workflow in the lab is becoming more commonplace for laboratory informatics products.Workflow management is common in the laboratory, acting as a graphical representation of planned sequential steps to either automate or clarify a process or experiment within the lab. Separate standards-based workflow management systems (in the form of a software component) have traditionally performed this task.[25] However, in the 2000s vendors began incorporating workflow management functionality into their laboratory informatics software, reducing customization headaches in the process.[26] \nModern commercial and open-source LIS solutions recognize clinical laboratory workflow often has its own share of requirements, requiring specific workflow management functionality, including[27]:\n\n managing the request cycle within a laboratory\n organizing and executing diagnostic testing\n managing specific chemistry- and biology-related procedures\n defining activity attributes\n managing automation tools to better workflows\n re-route samples based on changes to a process\n dynamically modifying workflow in case of future changes\n receiving notification of changes to the workflow\nSpecification management \nSpecification (spec) management is vital to not only the manufacturing and research industries but also to a host of other laboratories requiring precise measurements and infallible test methods. Just as the ASTM offers standards and specs for laboratory informatics software[28], so too do users have standards and specs for their laboratory. \nSpec management has primarily been seen in a manufacturing execution system (MES) or a LIMS, but occasionally a LIS may appear which includes such functionality. With spec management in place, laboratories can then:\n\n enforce standard operating procedures and business rules.\n create specs down to a project or sample level.\n validate recipes and procedures.\n accept or reject sample batches.\n document internal and external spec history.\nNote some of the functionality of spec management may cross over into the realm of quality control and data validation.\n\nCustomer, supplier, and physician management \nUnless a laboratory is conducting internalized independent research, in most cases it will do business with external entities such as contract labs, physician offices, equipment providers, and reagent suppliers. In some cases, even internal employees may be considered a customer, necessitating documentation of who is using the system and in what ways. For a veterinary lab, the customer may be the animal and handler. For a forensic lab the customer may be more complex: internal staff, university staff, police departments, and maintainers of nationwide crime databases may all at some point act as customers. In these cases, documenting these various points of contact and linking them to tests, equipment, and patients becomes vital. Managing demographics, complaints, correspondence, and history are all feasible with customer, supplier, and physician management functionality. This process is often made simpler through the use of a more context-neutral entity creation system, which allows for more flexible management of contacts.\nThis feature may also be referred to as contact management, an address book module, or a customer service module.\n\nBilling and revenue management \nWhile the finances of a laboratory are important, they've typically been handled separately as a business process. However, some LISs include additional functionality to make handling financial transactions and documentation of all sorts possible within the LIS. In theory, such functionality brings the possibility of keeping more of a laboratory's data centrally located and queryable. This feature may include[11][29]:\n\n payment processing\n expense reporting\n price quotes\n revenue management\n workload tracking of billable hours\n bill of materials\n sales team and client management\n profitability analysis\n medical necessity checks\n\n \nQuality, security, and compliance \nTo hide the contents of this section for easier reading of other sections, click the \"Collapse\" link to the right.\n\n\n \nRegulatory compliance \nThe topic of whether or not a LIS meets regulatory compliance is often a complex one. While Title 21 CFR Part 11 has arguably had the largest influence on an electronic data management system's compliance, other influential standards have shaped the way laboratory informatics systems handle and store data.[30][31][32] Other compliance-based codes, standards, and regulations include:\n\n ASTM \n ASCLD\/LAB \n Classified data\n Freedom of information legislation (various)\n GALP and GAMP \n HIPAA \n Health Level 7\t\n ICD\n ISO\/IEC 17025\n ISO 9000\/9001\n ISO\/TS 16949\n ODBC\n TNI and NELAP \n Title 40 CFR Part 3\nWith so many codes, standards, and regulations, LIS consumers are advised to contact vendors with their user requirements and ask how the vendor's software meets and\/or exceeds those requirements.\n\nQA\/QC functions \nThe quality management functions of a LIS allow users to maintain a level of necessary quality across many of the functions in a laboratory. Some of the activities quality assurance \/ quality control functionality allows for includes[33][34][35]:\n\n force random review of cases by second pathologist before case verification\n receive and process QC results from laboratory analyzers\n create user rules\n set up custom alerts and flags for out-of-range results\n observe standard deviations in outcome research\n review and sign off on data electronically\n delta checking\nPerformance evaluation \nAs document and file management plays an important role in clinical and research laboratories, it only makes sense to collate and store all the associated data for future reference, including documentation relating to individual training and performance. Changes to laboratory techniques, scientific understanding, and business practices force lab technicians and researchers to learn, reevaluate, and demonstrate competency in order to maintain quality levels in the laboratory. Evaluations can frequently extend beyond staff members, however. Clinics, visit types, vendors, or test species can also be tracked and evaluated based on custom criteria. The performance evaluation functionality of a LIS makes this possible. \nThat functionality typically includes the ability to maintain training records and history, and also to link that training to a technique or piece of equipment. Afterwards, the staff member, vendor, etc. can be marked as competent or certified in the equipment, knowledge, or process. Periodical assessment of the training and its practical effectiveness can later be performed. Productivity of an entity or process can also be gauged over a certain date range based on tracked time, pre-determined milestones, or some other criteria.\n\nAudit trail \n Whether validating an instrument's data or an entire LIS, maintaining an audit trail is an important part of 21 CFR Part 11 compliance. As codes and regulations like Title 21 CFR Part 11 mandate \"computer systems (including hardware and software), controls, and attendant documentation\" utilize electronic signatures and audit trails[36], LIS developers must put serious thought into how their software handles audit trail functionality. The audit trail \u2014 documentation of the sequence of activities that have affected an action \u2014 must be thorough and seamlessly integrated into the software. \n\r\n\nInformation recorded in the audit trail typically includes:\n\n operator code\t\n time stamp\t\n location\n case number\n accessioning number\n transaction type\n amount and quantity prior to change\n user notes\n\r\n\n\nChain of custody \nThe chain of custody (COC) of an item is of varying importance, depending on the type of laboratory. A highly regulated laboratory that works under Code of Federal Regulation or other guidelines makes tracking COC a vital part of its operations. This is especially true in forensic labs, which depend on continuous accountability of their evidence collection, retention, and disposal procedures.[37] As with an audit trail, a laboratory depends on recorded information like user ID, time stamp, and location ID to maintain a robust and accurate COC. Barcodes and RFID tags, inventory management, and configurable security roles all play an important part in maintaining chain of custody.\n\nConfigurable roles and security \nMany roles exist within the clinical and research setting, each with its own set of responsibilities. And just as the role an individual plays within the laboratory may change, so may the responsibilities associated with each role. This sort of change necessitates a flexible and configurable security system, one that allows for the placement of individual LIS users into standardized security roles which provide role-specific access to certain functionality. Additionally, as responsibilities change within roles, that same flexible configuration is necessary for assigning or restricting access to specific functionality for each existing or newly created role. \nOf course, roles aren't always assigned on an individual level. Often large groups of individuals may need to be assigned to roles, necessitating group assignments for security purposes. For example, a group of hospital laboratory trainees may not be given access to the inventory management functionality of the system through a custom \"Trainees\" group role, while the head of the lab may be given the \"Administrator\" role, which allows that individual to access a much broader spectrum of the LIS's functionality.\n\nData normalization \nFor the purposes of describing LIS functionality, \"data normalization\" specifically refers to the process of ensuring incoming\/imported data into the LIS is standardized to the same format of existing data. \nHere's an example to better explain this issue. When a LIS is initially configured, in most if not all cases a clear standard can be set for how logged test results and their associated measurements pre- and post-analysis are recorded in the system. Perhaps all temperatures will be recorded in Celsius to three decimal places. If temperature data imported from a spreadsheet or a lab instrument is not in this format, the LIS can normalize the incoming data to match the standard already set for existing temperature data. This ensures consistency within the database and typically leads to better data validation efforts later on.\nNote: Some LIS developers may include data normalization functionality within what they may refer to as data validation functionality. The line between these two may be blurred or not exist at all.\n\nData validation \n In a LIS, data and data models can be forced through a validation process to remove errors and reconcile that those data and models.For the purposes of describing LIS functionality, \"data validation\" specifically refers to the process of ensuring existing data in the LIS \u2014 either pre-analysis or post-analysis \u2014 sufficiently meets any number of standards or thresholds set for any given data management process. This validation process may be completely automatic and system-based, or it may also include additional steps on the part of the user base utilizing additional LIS functionality, including verification of standard operating procedures (SOPs), QC samples, and QA approval.[38][39]\nNote: This functionality shouldn't be confused with the process of validating the application itself, which is an entirely different process partially falling under regulatory compliance and involves the process of ensuring \"the software is performing in a manner for which it was designed.\"[40]\n\nData encryption \nThe existence of this functionality in a LIS indicates the software has the ability to protect the integrity and authenticity of its housed data through the use of a variety of technologies which makes data unreadable except to those possessing a key\/right\/etc. to unlock\/read the data. This functionality is especially vital to the web-enabled LIS, which transfers information over the Internet in a client-server relationship. As a wide variety of encryption technologies exist, it's generally a good idea to consult with the developers of a LIS to determine the strengths and weaknesses of their employed encryption methods.\n\nVersion control \nVersion control is a form of safeguard which helps preserve data integrity and thus ties in with the topic of regulatory compliance. This is typically done by creating a modifiable new version of a piece of information rather than allowing the original to be modified. Such versioning may be applied to a wide variety of digital information housed in the LIS, including templates, training certifications, instrument logs, specifications, and process and procedure (P&P) documentation. Information tracked with such revisions includes attributes like user name, time the edit was made, and what exactly was edited. This also benefits those managing audit trails and chains of custody.\nOther LIS vendors may employ a different form of version control called file locking, which simply puts the affected information into a read-only mode for users while someone else is busy editing it. Another popular strategy is to, rather than locking the file, allow multiple people to edit a piece of information, later merging the various edits. Potential LIS buyers may need to inquire with developers to determine what type of versioning scheme is used in the vendor's software.\n\nAutomatic data backup \nThe existence of this piece of functionality in a LIS usually means information contained in one or more associated databases or data warehouses can be automatically preserved in an additional backup file. The save location for that file as well as the scheduled backup time is configurable, typically through the administrative module of the software.\n\nEnvironmental monitoring \nWhile not common at all, a few LIS may allow users to monitor the environmental conditions of not only sample storage containers but also the entire laboratory itself. Attributes like humidity, air quality, and temperature may be monitored to ensure sample storage units and experiments maintain desired conditions. This monitoring may be done by treating the storage container as a device, which must be interfaced with the LIS. Alarms may be able to be configured to notify staff if a storage container's environmental attributes go beyond a certain threshold.\n\n\n \nReporting, barcoding, and printing \nTo hide the contents of this section for easier reading of other sections, click the \"Collapse\" link to the right.\n\n\n \nCustom reporting \nReporting often provides useful information representation for gaining a clearer picture of collected data and potential trends. At a minimum, a number of pre-configured report templates typically come standard with a LIS. However, other systems are more flexible than others, offering the ability to customize reports in numerous ways. The most popular attributes of custom reporting include custom headers, custom information placement, charts, pivot tables, and multiple output formats.\nNote: Some LIS vendors may offer custom reporting as an option as an added cost, depending on the level of customization required.\n\nSynoptic reporting \nSynoptic reporting is a specific type of reporting applicable to pathology and other associated laboratories. Synoptic reporting essentially involves a structured, pre-formatted \"checklist\" of clinically and morphologically relevant data elements (ideally passed to a relational database where they are efficiently organized, searched, and retrieved), with the intent of making reporting more efficient, uniform, and relevant to internal and external researchers. This style of reporting has the advantage of obviating the need for transcription services, reducing specimen turnaround time, and prioritizing the presentation of large amounts of diagnostic information. [41] Some LISs, especially those oriented towards pathology, may include this specialized functionality. In some cases, a configurable templates or form may be utilized to structure a report in a synoptic format, providing similar functionality to a separate synoptic reporting module.\n\nReport printing \nToday's software almost universally offers the ability to print reports and other materials, so this feature may seem a bit redundant to list. Nonetheless, printer support is a feature worth confirming when considering a piece of laboratory informatics software.\n\nLabel support \nThe label \u2014 typically affixed to a sample container or piece of equipment \u2014 is a vital part of many laboratory operations.[42] Identifying information such as sample number, batch number, and barcodes are printed on such labels to ensure optimize managing the location of items in a lab. As such, numerous LISs allow users to design and print labels directly from the software.\n\n The word \"Wikipedia\" encoded in Code 128 and Code 39\nBarcode and\/or RFID support \nBarcodes offer many advantages to laboratory techs handling samples, including more accurate data input, tighter sample\/instrument associations, tighter sample\/study associations, and more room for human-readable information on a label.[42] Given such advantages, many laboratory informatics developers have integrated barcode support into their software, including support for symbologies like Code 128, Code 39, and Interleaved 2 of 5. Aside from printing options, a LISmay also offer support for a variety of barcode readers.\nAdditionally, some LIS include the ability to handle radio-frequency identification (RFID) tags, which have several advantages over a more traditional label-based approach to accessioning.[43]\nBarcode support and label support are typically found together in LIS software, but not always, thus their separation into two features.\n\nExport to PDF \nA LIS with this feature is able to collect and save information into a Portable Document Format (PDF).\n\nExport to MS Word \nA LIS with this feature is able to collect and save information into a Microsoft Office Word format.\n\nExport to HTML or XML \nA LIS with this feature is able to collect and save information into a HyperText Markup Language (HTML) and\/or Extensible Markup Language (XML) format.\n\nFax integration \nA LIS with this feature is able to connect with a fax machine and send information to it via manual input, automatically, and\/or at scheduled intervals.\n\nEmail integration \nA LIS with this feature is able to integrate with and use the electronic mail information exchange method to send reports, alerts, and more manually, automatically, and\/or at scheduled intervals.\n\n\n \nBase functionality \nTo hide the contents of this section for easier reading of other sections, click the \"Collapse\" link to the right.\n\n\n \nAdministrator management \nThe administrator management tools of a LIS allows researchers to set up the software most optimally for the facility and its projects. Through the administrator management interface, other features may be accessed like setting up user roles and scheduling automatic data backups.\nLike report printing, administrator management is nearly ubiquitous in laboratory informatics software, generally considered a mandatory feature. However, for the purposes of being thorough, it's important to point out its existence.\n\nModular \nThis feature indicates that a LIS has an intentional modular design, which separates some functionality into manageable components of the overall system. Generally speaking, a modular design allows for 1. the structured addition of new functionality to a LIS and 2. the limiting of overall effects on the system design as new functionality is added.\n\nInstrument interfacing and management \nIn laboratories there are instruments, and with those instruments comes scientific measurements which produce data. It's therefor natural a researcher would want to connect those instruments to a laboratory information system, which is already organizing and storing laboratory data for hospitals and medical research facilities. This sort of interfacing is typically handled with instrument-to-software interfaces, which started out as merely data-transfer mechanisms. Later that interface mechanism became much more robust as a data management tool, though often at great expense with heavy involvement from third parties.[44] Today, \"vendors can act as single source providers of the entire instrument interfacing solution,\"[45], providing a cheaper and smoother solution to laboratory informatics customers. In the clinical laboratory setting, a LIS vendor may have additional considerations to make, such as Health Level 7 (HL7) triggers, messages, and segments transported across communication interfaces.[46]\n\nFile:Mobile devices DSC 0988.JPG In some cases mobile devices like these may access and utilize a LIS, typically through a Web portal or special mobile version of the software.\nMobile device integration \nWhile not ubiquitous by any means, LIS developers are increasingly including support for mobile devices in their software, usually in the form of a separate mobile version of the software. Research and development labs, for example, potentially can put mobile technology to use in the laboratory as remotely monitoring a lab or using mobile phone microscopy.[47] Those uses aside, the relatively simple action of recording and reviewing laboratory research results while on the move or at a conference gives researchers flexibility, and LIS developers like McKesson are beginning to include that functionality.[48]\n\nThird-party software integration \nA few LIS vendors either incorporate third-party software into their product or they provide the means to integrate the LIS with other applications. The most typical integration involves simply communicating with common authoring tools like Microsoft Word, allowing users to work directly from the third-party application and then transferring the information to the LIS.\n\nAlarms and\/or alerts \nAlarms and alerts in a LIS can be automatic or scheduled, and they can come in the form of an e-mail, a pop-up message, or a mobile text message. For example, when a test result goes out-of-range, an automatic warning message can appear on the screen of the lab analyst responsible for the test. Another example: a scheduled alert can be e-mailed to a lab technician every month indicating a piece of laboratory equipment needs routine maintenance. Both scenarios represent a tiny fraction of the possible implementation of alarms and alerts in a LIS, highlighting how powerful (yet easy to take for granted) this feature is.\n\nWork-related time tracking \nThis feature specifically refers to a LIS' ability to track the amount of time an employee spends at work in general (for payroll purposes) or on more specific projects and tasks (as part of an employee work evaluation program). May also be referred to as \"workload tracking\" or \"workload tracking.\"\n\nVoice recognition system \nA LIS with this feature allows some functions of the software (for example, accessing test results) to be accessed via voice commands.\n\nExternal monitoring \nThis feature allows clients and\/or collaborators outside the laboratory to monitor the status of experiments, test results, and more via an online web portal or, less commonly, as activity alerts sent via e-mail or SMS.\n\n An instant messaging client built into a LIS often makes it easier to collaborate.\nMessaging \nThe messaging feature of a LIS may refer to one of two (or both) things:\n\n a built-in instant messaging system that allows users to converse with each other through text messages real-time\n an SMS text messaging integration that allows the users or the LIS itself to send messages or alerts to one or more user's mobile or smart phone\nCommenting \nClinical data collection and research collaboration require data sharing and communication tools to be most effective. One of the collaborative communication features of some LISs is commenting on test results, patient records, or study protocols.\n\nMultilingual \nIf a LIS is listed as multilingual, its an indication the software interface can be configured to display more than one language depending on the preference a user or administrator chooses. Some LIS interfaces can only be displayed in one of two languages (English or German, for example), while others come configured with support for dozens of languages.\n\nNetwork-capable \nThis feature is perhaps archaic and\/or obvious, but it is mentioned nonetheless. It's generally applied to a non-web-based LIS installed over a local or wide-area computer network, essentially indicating the LIS is not an isolated application, but rather one that can interface with other instances or other networked instruments.\n\nWeb client or portal \nA LIS with a web client or portal is either a web-based LIS (one that is not installed on every computer, but rather is hosted on a server and accessed via a web browser) or a non-web-based LIS with an included portal to access it via the Internet.\n\nOnline or integrated help \nThis indicates a LIS has help infrastructure integrated into the software, support documentation via the vendor's website, or both.\n\nSoftware as a service delivery model \nThis indicates the software can be licensed and utilized via the software as a service (SaaS) delivery model.\n\nUsage-based cost \nWhile rare, some software vendors allow potential clients to license and utilize the vendor's software under a usage-based cost model. An example of this model in use is Bytewize AB's O3 LimsXpress, which has a cost directly related to the amount of samples processed each month.[49]\n\n\n \nReferences \n\n\n\u2191 \"Quick Start Guide to Laboratory Information System (LIS) Implementation\" (PDF). Association of Public Health Laboratories. http:\/\/www.aphl.org\/aphlprograms\/global\/initiatives\/Documents\/LISQuickStartGuide.pdf . Retrieved 27 April 2013 .   \n\n\u2191 Hice, Randy (01 July 2009). \"Swimming in the Clinical Pool: Why LIMS are supplanting old-school clinical LIS applications\". STARLIMS' Laboratory Informatics Blog. http:\/\/blog.starlims.com\/2009\/07\/01\/swimming-in-the-clinical-pool-why-lims-are-supplanting-old-school-clinical-lis-applications\/ . Retrieved 27 April 2013 .   \n\n\u2191 \"How Do I Find the Right LIMS \u2014 And How Much Will It Cost?\" (PDF). Laboratory Informatics Institute, Inc. http:\/\/files.limstitute.com\/share\/lbgprofiles\/findlims.pdf . Retrieved 27 April 2013 .   \n\n\u2191 \"Laboratory Information Systems\". Biohealthmatics.com. 10 August 2006. http:\/\/www.biohealthmatics.com\/technologies\/his\/lis.aspx . Retrieved 27 April 2013 .   \n\n\u2191 5.0 5.1 Leonard, Debra G. B.; Bagg, Adam, ed. (2007). Molecular Pathology in Clinical Practice (Illustrated ed.). Springer. p. 567. ISBN 0387332278. http:\/\/books.google.com\/books?id=Z2YNhh51SmQC&pg=PA567 . Retrieved 27 April 2013 .   \n\n\u2191 \"PPD - Clinical Trial Sample Management\". Pharmaceutical Product Development, LLC. http:\/\/www.ppdi.com\/Services\/Laboratories\/Central-Labs\/Operational-Excellence\/Specimen-Management.aspx . Retrieved 27 April 2013 .   \n\n\u2191 Esteridge, Barbara H.; Reynolds, Anna P.; Walters, Norma J. (2000). Basic Medical Laboratory Techniques (4th, revised ed.). Cengage Learning. p. 8. ISBN 0766812065. http:\/\/books.google.com\/books?id=qMgAbOHSlsMC&pg=PA8&lpg=PA8 . 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Retrieved 27 April 2013 .   \n\n\u2191 Park, Seung Lyung; Pantanowitz, Liron; Sharma, Gaurav; Parwani, Anil Vasdev (March 2012). \"Anatomic Pathology Laboratory Information Systems: A Review\" (PDF). Advances in Anatomic Pathology 19 (2): 81\u201396. doi:10.1097\/PAP.0b013e318248b787. http:\/\/bpa-pathology.com\/uploads\/file\/docs\/Anatomic%20Pathology%20Laboratory%20Information%20Systems%20-%20A%20Review%20-%20SLPark%20et%20all.%20-%20Adv%20Anat%20Pathol%202012.pdf . Retrieved 27 April 2013 .   \n\n\u2191 Macneil, Rory (2011). \"The benefits of integrated systems for managing both samples and experimental data: An opportunity for labs in universities and government research institutions to lead the way\". Automated Experimentation 3 (2). doi:10.1186\/1759-4499-3-2. http:\/\/www.aejournal.net\/content\/3\/1\/2 .   \n\n\u2191 \"data mining\". Encyclop\u00e6dia Britannica. Encyclop\u00e6dia Britannica, Inc. http:\/\/www.britannica.com\/EBchecked\/topic\/1056150\/data-mining . Retrieved 29 April 2013 .   \n\n\u2191 Sepulveda, Jorge L.; Young, Donald S. (05 Decemeber 2012). \"The Ideal Laboratory Information System\". Archives of Pathology and Laboratory Medicine preprint. PMID 23216205. http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/23216205 . Retrieved 29 April 2013 .   \n\n\u2191 \"LabWare LIMS - Public Health\". LabWare, Inc. http:\/\/www.labware.com\/LWCLWeb.nsf\/lp\/en0203 . Retrieved 29 April 2013 .   \n\n\u2191 \"Orchard Software - Data Mining\". Orchard Software Corporation. http:\/\/www.orchardsoft.com\/product\/h_dataMining.html . Retrieved 29 April 2013 .   \n\n\u2191 \"LabDAQ Laboratory Information System (LIS)\". CompuGroup Medical AG. http:\/\/cgmus.com\/products--solutions\/laboratory\/labdaq_lis.aspx . Retrieved 29 April 2013 .   \n\n\u2191 Foster, Kerry (February 2006). \"Which comes first - the EMR or LIS?\" (PDF). ADVANCE for Medical Laboratory Professionals. Merion Matters. http:\/\/www.orchardsoft.com\/news_links\/WhichComesFirstEMRorLIS.pdf . Retrieved 29 April 2013 .   \n\n\u2191 Elliot, Michael H. (December 2006\u2013January 2007). \"The state of the ELN Market\". Scientific Computing World. http:\/\/www.scientific-computing.com\/features\/feature.php?feature_id=50 . Retrieved 04 May 2011 .   \n\n\u2191 Elliot, Michael H. (October 2011). \"Informatics Convergence Presents Opportunities and Challenges\". Scientific Computing. http:\/\/www.scientificcomputing.com\/articles-IN-Informatics-Convergence-Presents-Opportunities-and-Challenges-111111.aspx . Retrieved 25 February 2012 .   \n\n\u2191 Williams, Robert W. (2003). \"Managing Your Lab Data Flux: Getting Beyond Excel\" (PDF). The Bioinformatics of Brains: From Genes and Proteins to Behaviors. Washington, DC: Society for Neuroscience. http:\/\/www.sfn.org\/skins\/main\/pdf\/ShortCourses\/2003\/sc1_9.pdf . Retrieved 17 February 2012 .   \n\n\u2191 Howard, David A.; David Harrison (2007). \"A Pragmatic Approach to the Validation of Excel Spreadsheets \u2013 Overview\" (PDF). Pharma IT 1 (2): 30\u201335. http:\/\/www.spreadsheetvalidation.com\/pdf\/Excel_Spreadsheet_Validation_Overview.pdf .   \n\n\u2191 Vannest, Jeff (11 February 2011). \"Advantages of a Data Warehouse\". LABVANTAGE Solutions, Inc. http:\/\/www.labvantage.com\/blog\/?p=79 . Retrieved 12 February 2013 .   \n\n\u2191 \"Workflow Management Coalition Terminology & Glossary\" (PDF). Workflow Management Coalition. February 1999. pp. 9. http:\/\/www.wfmc.org\/standards\/docs\/TC-1011_term_glossary_v3.pdf . Retrieved 20 February 2012 .   \n\n\u2191 Maxwell, Glen (1 November 2003). \"Using Workflows in LIMS to Reduce Customization\". Scientific Computing and Instrumentation. http:\/\/www.scientificcomputing.com\/using-workflows-in-lims-to-reduce.aspx . Retrieved 20 February 2012 .   \n\n\u2191 Feist, Kelly (22 July 2011). \"Harnessing Laboratory Information Systems to Support Increased Capacity and Staff Productivity\". LabCompare. http:\/\/www.labcompare.com\/10-Featured-Articles\/19389-Harnessing-Laboratory-Information-Systems-to-Support-Increased-Capacity-and-Staff-Productivity\/ . Retrieved 29 April 2013 .   \n\n\u2191 \"ASTM E1578 - 06 Standard Guide for Laboratory Information Management Systems (LIMS)\". ASTM International. http:\/\/www.astm.org\/Standards\/E1578.htm . Retrieved 22 February 2012 .   \n\n\u2191 \"Horizon Lab Financials\". McKesson Corporation. http:\/\/www.mckesson.com\/en_us\/McKesson.com\/For%2BHealthcare%2BProviders\/Hospitals\/Laboratory%2BSolutions\/Horizon%2BLab%2BFinancials.html . Retrieved 29 April 2013 .   \n\n\u2191 \"ELN Reduces Regulatory Compliance Costs\" (PDF). Labtronics Inc. January 2005. http:\/\/www.vialis.ch\/fileadmin\/files\/imgs\/pdf\/Newsletter\/q2-09\/ELN_LAB.pdf . Retrieved 12 February 2013 .   \n\n\u2191 Price, Michael (17 August 2012). \"How an ELN Mitigates the Risks Associated with Regulatory Compliance\". KineMatik Ltd. http:\/\/www.kinematik.com\/blog\/bid\/207452\/How-an-ELN-Mitigates-the-Risks-Associated-with-Regulatory-Compliance . Retrieved 12 February 2013 .   \n\n\u2191 Proffitt, Allison (22 February 2012). \"ELN Excellence: The New Lab Notebooks\". BioIT World. http:\/\/www.bio-itworld.com\/2012\/02\/22\/eln-excellence-new-lab-notebooks.html . Retrieved 12 February 2013 .   \n\n\u2191 Owens, S.R.; Dhir, R.; Yousem, S.A.; Kelly, S.M.; Piccoli, A.; Wiehagen, L.; Lassige, K.; Parwani, A.V. (June 2010). \"The development and testing of a laboratory information system-driven tool for pre-sign-out quality assurance of random surgical pathology reports\". American Journal of Clinical Pathology 133 (6): 836\u201341. doi:10.1309\/AJCPLN9DU9LNXSXA. http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/20472840 . Retrieved 29 April 2013 .   \n\n\u2191 \"Netlims - AutoQuality\". NeTLIMS NJ, LLC. http:\/\/www.netlims.com\/lis_software_autoquality.asp . Retrieved 29 April 2013 .   \n\n\u2191 \"CLIN1 Laboratory Quality Control Software\". Clin1, LLC. http:\/\/www.clin1.net\/Quality_Control.htm . Retrieved 29 April 2013 .   \n\n\u2191 \"Electronic Code of Federal Regulations - Title 21: Food and Drugs - Part 11: Electronic Records; Electronic Signatures\". U.S. Government Printing Office. http:\/\/ecfr.gpoaccess.gov\/cgi\/t\/text\/text-idx?c=ecfr&sid=5ff3a0efed913ef8fae9e225869688a2&rgn=div5&view=text&node=21:1.0.1.1.7&idno=21 . Retrieved 02 March 2012 .   \n\n\u2191 Jones, Andrew; Craig Valli (2008). \"Chapter 1: An Introduction to Digital Forensics\". Building a Digital Forensic Laboratory: Establishing and Managing a Successful Facility. Butterworth-Heinemann. pp. 11. ISBN 1856175103. http:\/\/books.google.com\/books?id=F5IU7XXKwCQC .   \n\n\u2191 \"Quality Assurance - Data Management\" (PDF). Stable Isotope Ratio Facility for Environmental Research (SIRFER) at the University of Utah. http:\/\/sirfer.utah.edu\/qaqc.pdf . Retrieved 07 May 2012 .   \n\n\u2191 Hitchcock, Noel (2005). \"Chapter 10: Efficient utilization of LIMS data and integration with mining process management systems\". In Dessureault, Sean D.; Rajive Ganguli; Vladislav Kecojevic; Jami Girard Dwyer. Application of Computers and Operations Research in the Mineral Industry. Taylor & Francis. pp. 85\u201388. doi:10.1201\/9781439833407.ch10. ISBN 9780415374491. http:\/\/www.crcnetbase.com\/doi\/abs\/10.1201\/9781439833407.ch10 .   \n\n\u2191 Turner, Elizabeth; Jojean Bolton (2001). \"Required steps for the validation of a Laboratory Information Management System\". Quality Assurance 9 (3\u20134): 217\u2013224. PMID 12553085. http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/12553085 .   \n\n\u2191 Amin, Waqas; Sirintrapun, S. Joseph; Parwani, Anil V. (August 2010). \"Utility and applications of synoptic reporting in pathology\" (PDF). Open Access Bioinformatics 2010 (2): 105\u201312. doi:http:\/\/dx.doi.org\/10.2147\/OAB.S12295. http:\/\/www.dovepress.com\/getfile.php?fileID=7293 . Retrieved 29 April 2013 .   \n\n\u2191 42.0 42.1 Gilles, Clarence (1 July 2008). \"Bar Code and Sample Tracking: It All Starts with the Label\". Scientific Computing. http:\/\/www.scientificcomputing.com\/bar-code-and-sample-tracking.aspx . Retrieved 8 May 2012 .   \n\n\u2191 Davidowitz, Hanan (31 July 2012). \"Use of Radio Frequency Identification (RFID) for Sample Tracking\". American Laboratory. http:\/\/www.americanlaboratory.com\/913-Technical-Articles\/118171-Use-of-Radio-Frequency-Identification-RFID-for-Sample-Tracking\/ . Retrieved 29 April 2013 .   \n\n\u2191 Pavlis, Robert (May\/June 2004). \"Trends in instrument-to-LIMS interfacing\". Scientific Computing World. http:\/\/www.scientific-computing.com\/features\/feature.php?feature_id=88 . Retrieved 8 May 2012 .   \n\n\u2191 DeHeer, Larry (1 October 2009). \"Instrument Interfacing - The Great Paradox of LIMS?\". LIMSfinder.com. http:\/\/www.limsfinder.com\/BlogDetail.aspx?id=33851_0_2_0_C . Retrieved 8 May 2012 .   \n\n\u2191 \"Section 3: Clinical and Administrative Domains - HL7 Version 2.7 Standard: Chapter 13 - Clinical Laboratory Automation\". HL7. http:\/\/www.hl7.org\/implement\/standards\/product_brief.cfm?product_id=203 . Retrieved 29 April 2013 .   \n\n\u2191 \"Mobile Devices: On the Move from Laboratories to Clinics\". Society for Laboratory Automation and Screening. 02 July 2012. http:\/\/www.eln.slas.org\/story\/1\/69-mobile-devices-on-the-move-from-laboratories-to-clinics . Retrieved 13 February 2013 .   \n\n\u2191 \"Horizon MobileCare Phlebotomy\". McKesson Corporation. http:\/\/www.mckesson.com\/en_us\/McKesson.com\/For%2BHealthcare%2BProviders\/Hospitals\/Laboratory%2BSolutions\/Horizon%2BMobileCare%2BPhlebotomy.html . Retrieved 29 April 2013 .   \n\n\u2191 \"Modern web based Lims from 10 Euro cent\/sample\". Bytewize AB. http:\/\/www.bytewize.com\/o3lims-xpress\/prices\/?lang=en . Retrieved 8 May 2012 .   \n\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LIS_feature\">https:\/\/www.limswiki.org\/index.php\/LIS_feature<\/a>\n\t\t\t\t\tCategories: Pages with broken file linksLaboratory informatics\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\n\t\t\n\t\t\tNavigation menu\n\t\t\t\t\t\n\t\t\tViews\n\n\t\t\t\n\t\t\t\t\n\t\t\t\tPage\n\t\t\t\tDiscussion\n\t\t\t\tView source\n\t\t\t\tHistory\n\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\n\t\t\t\t\n\t\t\t\tPersonal tools\n\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\tLog in\n\t\t\t\t\t\t\t\t\t\t\t\t\tRequest account\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\t\t\n\t\tNavigation\n\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tMain page\n\t\t\t\t\t\t\t\t\t\t\tRecent changes\n\t\t\t\t\t\t\t\t\t\t\tRandom page\n\t\t\t\t\t\t\t\t\t\t\tHelp\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\n\t\t\t\n\t\t\tSearch\n\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t \n\t\t\t\t\t\t\n\t\t\t\t\n\n\t\t\t\t\t\t\t\n\t\t\n\t\t\t\n\t\t\tTools\n\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tWhat links here\n\t\t\t\t\t\t\t\t\t\t\tRelated changes\n\t\t\t\t\t\t\t\t\t\t\tSpecial pages\n\t\t\t\t\t\t\t\t\t\t\tPermanent link\n\t\t\t\t\t\t\t\t\t\t\tPage information\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\n\t\t\n\t\tPrint\/export\n\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tCreate a book\n\t\t\t\t\t\t\t\t\t\t\tDownload as PDF\n\t\t\t\t\t\t\t\t\t\t\tDownload as Plain text\n\t\t\t\t\t\t\t\t\t\t\tPrintable version\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\n\t\t\n\t\tSponsors\n\t\t\n\t\t\t \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n \r\n\n\t\n\t\r\n\n \r\n\n\t\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t This page was last modified on 12 February 2016, at 18:02.\n\t\t\t\t\t\t\t\t\tThis page has been accessed 63,839 times.\n\t\t\t\t\t\t\t\t\tContent is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.\n\t\t\t\t\t\t\t\t\tPrivacy policy\n\t\t\t\t\t\t\t\t\tAbout LIMSWiki\n\t\t\t\t\t\t\t\t\tDisclaimers\n\t\t\t\t\t\t\t\n\t\t\n\t\t\n\t\t\n\n","23b167bed768658047c44710d3c186d1_html":"<body class=\"mediawiki ltr sitedir-ltr ns-0 ns-subject page-LIS_feature skin-monobook action-view\">\n<div id=\"rdp-ebb-globalWrapper\">\n\t\t<div id=\"rdp-ebb-column-content\">\n\t\t\t<div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\">\n\t\t\t\t<a id=\"rdp-ebb-top\"><\/a>\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">LIS feature<\/h1>\n\t\t\t\t\n\t\t\t\t<div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\">\n\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\n\n\t\t\t\t\t<!-- start content -->\n\t\t\t\t\t<div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\">\n<div class=\"thumb tright\"><div class=\"thumbinner\" style=\"width:302px;\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Hospital_Laboratory.JPG\" class=\"image wiki-link\" target=\"_blank\" data-key=\"343175bb6f7198b1c792ec0f3ee9b350\"><img alt=\"\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/0\/00\/Hospital_Laboratory.JPG\" width=\"300\" height=\"225\" class=\"thumbimage\" \/><\/a> <div class=\"thumbcaption\"><div class=\"magnify\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Hospital_Laboratory.JPG\" class=\"internal wiki-link\" title=\"Enlarge\" target=\"_blank\" data-key=\"343175bb6f7198b1c792ec0f3ee9b350\"><\/a><\/div>Thousands of hospital laboratories like this one benefit from the use of a laboratory information system.<\/div><\/div><\/div>A <b>LIS feature<\/b> is one or more pieces of functionality that appear within a <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_information_system\" title=\"Laboratory information system\" target=\"_blank\" class=\"wiki-link\" data-key=\"37add65b4d1c678b382a7d4817a9cf64\">laboratory information system<\/a> (LIS).\n<p>The LIS has traditionally been utilized in clinical, pathology, and medical research laboratories as well as numerous public health institutions.<sup id=\"rdp-ebb-cite_ref-APHLandLIS_1-0\" class=\"reference\"><a href=\"#cite_note-APHLandLIS-1\" rel=\"external_link\">[1]<\/a><\/sup> Yet as laboratory demands have changed and technological progress has continued, the functions of a LIS have also changed, with the distinction between a LIS and a <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_information_management_system\" title=\"Laboratory information management system\" target=\"_blank\" class=\"wiki-link\" data-key=\"8ff56a51d34c9b1806fcebdcde634d00\">laboratory information management system<\/a> (LIMS) fading as some LIMS vendors have adopted the case-centric information management normally reserved for a LIS.<sup id=\"rdp-ebb-cite_ref-starlimsBlogLIS_2-0\" class=\"reference\"><a href=\"#cite_note-starlimsBlogLIS-2\" rel=\"external_link\">[2]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-HowDoIFindLII_3-0\" class=\"reference\"><a href=\"#cite_note-HowDoIFindLII-3\" rel=\"external_link\">[3]<\/a><\/sup>.\n<\/p><p>Despite the blurring of distinction between a LIS and a LIMS, the LIS generally continues to feature the following<sup id=\"rdp-ebb-cite_ref-biohealth_4-0\" class=\"reference\"><a href=\"#cite_note-biohealth-4\" rel=\"external_link\">[4]<\/a><\/sup>:\n<\/p>\n<ul><li> patient management, including admission date, admitting physician, ordering department, specimen type, etc.<\/li>\n<li> patient data tracking<\/li>\n<li> decision support, including comparisons of lab orders with their respective <a href=\"https:\/\/www.limswiki.org\/index.php\/International_Statistical_Classification_of_Diseases_and_Related_Health_Problems\" title=\"International Statistical Classification of Diseases and Related Health Problems\" target=\"_blank\" class=\"wiki-link\" data-key=\"1de9af67005dfe2895e5d8cf6de57d4a\">ICD<\/a> codes<\/li>\n<li> quality assurance of ordered tests<\/li>\n<li> workload and management reporting<\/li><\/ul>\n<p>Of course, there are LIS features that are difficult to categorize or simply contribute to the whole of the LIS rather than add a function. For example, <a href=\"#Multilingual\" rel=\"external_link\">multilingual support<\/a> allows users to interact with the LIS in more than one language. Some functionality may also overlap several research phases, making it difficult to firmly classify. \n<\/p><p>The features described below come from an analysis of freely available LIS product information on vendor websites. An attempt was made to discover the features most utilized in vendors' LIS products and collect information on those features for each LIS. Not every possible feature is referenced here; some LIS products fill specific niches, utilizing unique functionality to solve a specific problem. \n<\/p><p>That said, keep in mind the categorization of features below is very loose. It may be viable to argue a feature belongs under a different section or multiple sections. For the purposes of organizing this information in an uncomplicated manner, however, some liberty has been taken in the categorizing of features.\n<\/p>\n\n\n<h2><span class=\"mw-headline\" id=\"Experiment.2C_patient.2C_and_data_management\">Experiment, patient, and data management<\/span><\/h2>\n<p><i>To hide the contents of this section for easier reading of other sections, click the \"Collapse\" link to the right.<\/i>\n<\/p>\n<div class=\"mw-collapsible\" style=\"width:100%; background-color:white;\">\n<p> <\/p>\n<h3><span class=\"mw-headline\" id=\"Sample_login_and_management\">Sample login and management<\/span><\/h3>\n<p>Sample login and management \u2014 often referred to as <a href=\"https:\/\/www.limswiki.org\/index.php\/Accessioning_(medical)\" title=\"Accessioning (medical)\" target=\"_blank\" class=\"wiki-link\" data-key=\"d3a1f1a5d35fd9152d82893878bf9aa1\">accessioning<\/a> or specimen management \u2014 is an important component of the clinical laboratory, whether it's a molecular pathology lab testing samples for disease indicators or a contract lab running pharmacokinetic and biomarker analysis on samples from a clinical trial.<sup id=\"rdp-ebb-cite_ref-MolPath_5-0\" class=\"reference\"><a href=\"#cite_note-MolPath-5\" rel=\"external_link\">[5]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-PPDiClinTrial_6-0\" class=\"reference\"><a href=\"#cite_note-PPDiClinTrial-6\" rel=\"external_link\">[6]<\/a><\/sup> As such, researchers and technicians who work in these types of labs are unable to complete their tasks without an effective method of managing samples. The process of sample management and accessioning includes, but is not limited to<sup id=\"rdp-ebb-cite_ref-LabTechBook_7-0\" class=\"reference\"><a href=\"#cite_note-LabTechBook-7\" rel=\"external_link\">[7]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MolPath_5-1\" class=\"reference\"><a href=\"#cite_note-MolPath-5\" rel=\"external_link\">[5]<\/a><\/sup>:\n<\/p>\n<ul><li> storing related sample information, including demographics, dates, and external links<\/li>\n<li> creating and documenting viewable sample container schemas with name and status<\/li>\n<li> assigning sample <a href=\"https:\/\/www.limswiki.org\/index.php\/LIS_feature#Configurable_roles_and_security\" title=\"LIS feature\" target=\"_blank\" class=\"wiki-link\" data-key=\"472befa27a67279b2d9818a15d649ef0\">access rights<\/a><\/li>\n<li> assigning custom sample ID or accessioning numbers based on a specification<\/li>\n<li> applying additional processing to the sample before storage and\/or analysis<\/li><\/ul>\n<p>Additional functionality that could potentially fall under this feature:\n<\/p>\n<ul><li> <a href=\"https:\/\/www.limswiki.org\/index.php\/LIS_feature#Barcode_support\" title=\"LIS feature\" target=\"_blank\" class=\"wiki-link\" data-key=\"18070de9d8004d989632cb309a165182\">barcoding<\/a> or RFID tagging of samples<\/li>\n<li> defining sample points and series<\/li>\n<li> creating data associations for samples - such as pedigree for sample\/aliquot relationships or relationships based on experiment, etc.<\/li>\n<li> issuing sample receipts<\/li><\/ul>\n<h3><span class=\"mw-headline\" id=\"Sample_tracking\">Sample tracking<\/span><\/h3>\n<div class=\"thumb tright\"><div class=\"thumbinner\" style=\"width:302px;\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Laboratory_oven_for_samples-01.jpg\" class=\"image wiki-link\" target=\"_blank\" data-key=\"d31bc29a848fcb586a58e3aa4f9822bb\"><img alt=\"\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/5\/51\/Laboratory_oven_for_samples-01.jpg\" class=\"thumbimage\" style=\"width: 100%;max-width: 400px;height: auto;\" \/><\/a> <div class=\"thumbcaption\"><div class=\"magnify\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Laboratory_oven_for_samples-01.jpg\" class=\"internal wiki-link\" title=\"Enlarge\" target=\"_blank\" data-key=\"d31bc29a848fcb586a58e3aa4f9822bb\"><\/a><\/div>Where's sample 20110512_122GJH? Sample tracking functionality will let you know which lab oven it's in.<\/div><\/div><\/div>For most laboratory personnel, knowing that a sample has arrived to the lab isn't good enough; they need to know where it's located and what is being done with it. Enter the sample tracking feature. Without it, many problems arise. In the forensic world, for example, many samples are linked to a criminal investigation. In this case, misidentification, contamination, or duplication can become significant issues: a lost sample is essentially missing evidence, while a duplicated sample can render it useless as evidence.<sup id=\"rdp-ebb-cite_ref-ForensicSamp_8-0\" class=\"reference\"><a href=\"#cite_note-ForensicSamp-8\" rel=\"external_link\">[8]<\/a><\/sup>\n<p>After sample reception and its initial handling procedures, many LIS can then track sample location as well as <a href=\"https:\/\/www.limswiki.org\/index.php\/LIS_feature#Chain_of_custody\" title=\"LIS feature\" target=\"_blank\" class=\"wiki-link\" data-key=\"f949e83daf78d8368f040cea9a8ca188\">chain of custody<\/a>. Location tracking usually involves assigning the sample to a particular freezer, oven, or other location, often down to the granular level of shelf, rack, box, row, and column. The process of tracking a sample has become more streamlined with increasing support of 2-D <a href=\"https:\/\/www.limswiki.org\/index.php\/LIS_feature#Barcode_and.2For_RFID_support\" title=\"LIS feature\" target=\"_blank\" class=\"wiki-link\" data-key=\"3029c1eb2ffdf072fdcf93dfb60f7c49\">barcode<\/a> or radio-frequency identification (RFID) technology. While handwritten labels were the norm, now barcode and RDIF support in a LIS can \"tie together a vast amount of information, clearly relating each sample to a specific case.\"<sup id=\"rdp-ebb-cite_ref-ForensicSamp_8-1\" class=\"reference\"><a href=\"#cite_note-ForensicSamp-8\" rel=\"external_link\">[8]<\/a><\/sup> Other event tracking such as freeze and thaw cycles that a sample undergoes in the laboratory may also be required. As each laboratory's needs for tracking additional data points can vary widely, many modern LIMS and LIS have implemented extensive configurability to compensate for varying environments.<sup id=\"rdp-ebb-cite_ref-PP0102_9-0\" class=\"reference\"><a href=\"#cite_note-PP0102-9\" rel=\"external_link\">[9]<\/a><\/sup>\n<\/p><p>The functionality of sample tracking strongly ties into the <a href=\"https:\/\/www.limswiki.org\/index.php\/LIS_feature#Audit_trail\" title=\"LIS feature\" target=\"_blank\" class=\"wiki-link\" data-key=\"e4b71f1bc0b254fbb9dba4acb2c453ae\">audit trail<\/a> and chain of custody features of a LIS.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Sample_and_result_batching\">Sample and result batching<\/span><\/h3>\n<p>What is batching? The United States Environmental Protection Agency (EPA) defines a batch as \"a group of samples which behave similarly with respect to the sampling or testing procedures being employed and which are processed as a unit.\"<sup id=\"rdp-ebb-cite_ref-EPABatch_10-0\" class=\"reference\"><a href=\"#cite_note-EPABatch-10\" rel=\"external_link\">[10]<\/a><\/sup> This definition can be applied to many laboratories which handle large quantities of samples for some form of analysis or processing. A LIS that has the ability to check in, link, and track groups of samples across one or multiple facilities is valuable to such laboratories. Additionally, batching the analysis results of multiple samples or groups of samples gives laboratories more flexibility with how they manage their data. Batching also offers the benefit of mimicking the production groups of samples while also capturing quality control data for the entire group.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Task_and_event_scheduling\">Task and event scheduling<\/span><\/h3>\n<p>Within the context of a LIS, the ability to schedule a task or event is a natural extension of how work was done in a laboratory before the advent of data management systems. Sample processing, data analysis, equipment maintenance, and case management follow-ups are assigned to technicians and other personnel. Outpatient scheduling is another aspect of some clinical atmospheres, better handled with computerized scheduling functionality. While these tasks have in the past been performed without the LIS, a modern data management system can now optimize those tasks and provide additional scheduling functionality to streamline the operation of a lab. Some LISs like <a href=\"https:\/\/www.limswiki.org\/index.php\/Elekta_AB\" title=\"Elekta AB\" target=\"_blank\" class=\"wiki-link\" data-key=\"4d41e088186488cc85f2a04a78f2c6e4\">Elekta AB<\/a>'s IntelliLab include a scheduling calendar for recurring test orders, rules-based orders, and pre-defined selection lists.<sup id=\"rdp-ebb-cite_ref-ILAbout_11-0\" class=\"reference\"><a href=\"#cite_note-ILAbout-11\" rel=\"external_link\">[11]<\/a><\/sup> Additional functionality within this feature group includes the ability to configure automated assignments of experiment requests, establish recurring events, and in most cases, create printable reports.\n<\/p><p>Examples of tasks and events that can feasibly be scheduled in a LIS include:\n<\/p>\n<ul><li> production of reports<\/li>\n<li> creation and sending of e-mails and alerts<\/li>\n<li> maintenance of equipment<\/li>\n<li> assignment of accessioning tasks to technicians<\/li>\n<li> scheduling outpatient visits<\/li><\/ul>\n<h3><span class=\"mw-headline\" id=\"Option_for_manual_result_entry\">Option for manual result entry<\/span><\/h3>\n<p>While many LIS vendors tout the ability of their product to automate the entry of sample analysis results into LIS' or other databases, the need for manual data entry of analysis results still exists. This feature is important to laboratories obtaining analysis results from multiple sources, including non-digital paper-based results and instruments that can't be connected to the LIS. Additional functionality associated with this feature includes a customizable spell-check dictionary and the ability to add comments, notes, and narratives to many of the data items in the LIS.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Multiple_data_viewing_methods\">Multiple data viewing methods<\/span><\/h3>\n<p><a href=\"https:\/\/www.limswiki.org\/index.php\/Hospital\" title=\"Hospital\" target=\"_blank\" class=\"wiki-link\" data-key=\"b8f070c66d8123fe91063594befebdff\">Hospitals<\/a>, physicians, and clinical research facilities produce reams of data, and the LIS exists to help organize and distribute that data to the necessary entities. Additionally, even before the existence of the LIS, scientists have had a corresponding need for visually representing that data for clearer analysis and hypothesis creation. Today a LIS can not only collect and analyze data, but it also can represent that data in reports, graphs, gradients, and spreadsheets. Depending on the LIS, more than one way to visually represent the data may exist. \n<\/p><p>This category ties in with the <a href=\"#Configurable_templates_and_forms\" rel=\"external_link\">custom templates and forms<\/a> functionality apparent in some LIS, providing both custom and standardized ways to present information across a healthcare or medical research enterprise.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Configurable_templates_and_forms\">Configurable templates and forms<\/span><\/h3>\n<p>Similar to an <a href=\"https:\/\/www.limswiki.org\/index.php\/Electronic_laboratory_notebook\" title=\"Electronic laboratory notebook\" target=\"_blank\" class=\"wiki-link\" data-key=\"a9fbbd5e0807980106763fab31f1e72f\">electronic laboratory notebook<\/a> (ELN), a template in a LIS is a functionality item which allows users to increase the productivity and quality of their work by allowing for the creation of a standardized analysis page, patient page, or reporting process across a healthcare or medical research enterprise. These templates allow researchers to maintain more consistent data representation for similar tasks in the LIS and save time by not needing to manually input common data outputs or recreate experiments. Templates and forms typically utilize a wide field library, and the data that is posted to those template fields can also be <a href=\"https:\/\/www.limswiki.org\/index.php\/LIS_feature#Data_normalization\" title=\"LIS feature\" target=\"_blank\" class=\"wiki-link\" data-key=\"d4fc9126c76ada2445b393acd0406bd2\">normalized<\/a> to a specific standard. Types of templates that may be created include those for renal and blood pressure analysis, patient demographics, test ordering, and department-level reports.<sup id=\"rdp-ebb-cite_ref-AnPathRev_12-0\" class=\"reference\"><a href=\"#cite_note-AnPathRev-12\" rel=\"external_link\">[12]<\/a><\/sup>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Data_and_trend_analysis\">Data and trend analysis<\/span><\/h3>\n<div class=\"thumb tleft\"><div class=\"thumbinner\" style=\"width:262px;\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Analyse_residus.png\" class=\"image wiki-link\" target=\"_blank\" data-key=\"0e109757f723abf3b557ade246e65a88\"><img alt=\"\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/5\/58\/Analyse_residus.png\" width=\"260\" height=\"94\" class=\"thumbimage\" \/><\/a> <div class=\"thumbcaption\"><div class=\"magnify\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Analyse_residus.png\" class=\"internal wiki-link\" title=\"Enlarge\" target=\"_blank\" data-key=\"0e109757f723abf3b557ade246e65a88\"><\/a><\/div>Some LISs allow users to analyze patient test results or clinical research data with built-in software tools.<\/div><\/div><\/div> For public health centers and pharmaceutical research centers alike, <a href=\"https:\/\/www.limswiki.org\/index.php\/Data_analysis\" title=\"Data analysis\" target=\"_blank\" class=\"wiki-link\" data-key=\"545c95e40ca67c9e63cd0a16042a5bd1\">data analysis<\/a> plays an important role in their operations, helping clinicians and researchers make better sense of their collected data and reach valuable conclusions about them. While this important phase of laboratory work has often been done externally from the LIS, it's now more common to see basic analysis tools being included. Such tools allow raw data to be imported directly to the LIS, which then can store, process, and display it in a shareable form. Vendors may include data analysis functionality by simply including Microsoft Excel compatibility or providing advanced reporting tools, or they may take a more advanced approach by programming and including their own custom data and trend analysis tools in their informatics software. As sample analysis is increasingly an important part of most if not all laboratories, such functionality \u2014 which has often come in the form of a separate application or analysis device \u2014 will likely continue to merge into software like LIS, LIMS, and other <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_informatics\" title=\"Laboratory informatics\" target=\"_blank\" class=\"wiki-link\" data-key=\"00edfa43edcde538a695f6d429280301\">laboratory informatics<\/a> solutions.<sup id=\"rdp-ebb-cite_ref-AE0302_13-0\" class=\"reference\"><a href=\"#cite_note-AE0302-13\" rel=\"external_link\">[13]<\/a><\/sup>\n<h3><span class=\"mw-headline\" id=\"Data_and_equipment_sharing\">Data and equipment sharing<\/span><\/h3>\n<p>Aside from data storage and sample registration, a modern LIS's major contribution to the laboratory is aiding in the sharing of test results, reports, and patient data with other entities across the clinical and research enterprise. Rather than pieces of information becoming misplaced or locked away in a physician's office or pathology lab, the LIS makes it easier to test results and increase the efficiency of patient-doctor-lab collaboration in general. Yet data is more than just test results; it also can come in the form of charts, reports, policy and procedure, and other documents. Additionally, the need for controlling who has access to those types of data is also an important consideration. As such, this feature is at least partially tied to other features like <a href=\"https:\/\/www.limswiki.org\/index.php\/LIS_feature#Document_creation_and_management\" title=\"LIS feature\" target=\"_blank\" class=\"wiki-link\" data-key=\"5b1d04112bbc7ff839617189de2a11ea\">document management<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/LIS_feature#Configurable_roles_and_security\" title=\"LIS feature\" target=\"_blank\" class=\"wiki-link\" data-key=\"472befa27a67279b2d9818a15d649ef0\">configurable security<\/a>.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Data_mining\">Data mining<\/span><\/h3>\n<p>Data mining, in the field of computational science, involves \"the process of discovering interesting and useful patterns and relationships in large volumes of data\" and includes three computational steps: model-learning, model evaluation, and model usage.<sup id=\"rdp-ebb-cite_ref-DataMEnBrit_14-0\" class=\"reference\"><a href=\"#cite_note-DataMEnBrit-14\" rel=\"external_link\">[14]<\/a><\/sup> As informatics software allows both research and clinical laboratories to collect and manage increasing quantities of data, a corresponding demand for tools capable of modeling that data is appearing.<sup id=\"rdp-ebb-cite_ref-IdealLIS_15-0\" class=\"reference\"><a href=\"#cite_note-IdealLIS-15\" rel=\"external_link\">[15]<\/a><\/sup> For example, public health laboratories may wish to utilize data mining for statistical analysis and surveillance of populations for specific diseases. <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_information_management_system\" title=\"Laboratory information management system\" target=\"_blank\" class=\"wiki-link\" data-key=\"8ff56a51d34c9b1806fcebdcde634d00\">LIMSs<\/a> like <a href=\"https:\/\/www.limswiki.org\/index.php\/LabWare,_Inc.#LabWare_LIMS\" title=\"LabWare, Inc.\" target=\"_blank\" class=\"wiki-link\" data-key=\"ebcf51e648458d511e5cdee899eda5f0\">LabWare LIMS<\/a> and LISs like <a href=\"https:\/\/www.limswiki.org\/index.php\/Orchard_Software_Corporation#Orchard_Harvest\" title=\"Orchard Software Corporation\" target=\"_blank\" class=\"wiki-link\" data-key=\"282d8bd34a579b527714e64d0e6ffecc\">Orchard Harvest<\/a> are examples of <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_informatics\" title=\"Laboratory informatics\" target=\"_blank\" class=\"wiki-link\" data-key=\"00edfa43edcde538a695f6d429280301\">laboratory informatics<\/a> software which incorporate data mining and reporting tools.<sup id=\"rdp-ebb-cite_ref-LWDM_16-0\" class=\"reference\"><a href=\"#cite_note-LWDM-16\" rel=\"external_link\">[16]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-OSDM_17-0\" class=\"reference\"><a href=\"#cite_note-OSDM-17\" rel=\"external_link\">[17]<\/a><\/sup>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Customizable_fields_and.2For_interface\">Customizable fields and\/or interface<\/span><\/h3>\n<p>As thorough as some user interface (UI) developers may be in adding relevant fields and interface options for end users, there are at times options that are either omitted or unanticipated. This has traditionally required the end user to contact the vendor and ask if the needed option(s) can be added in the next release. However, many modern LIS vendors have responded instead by adding functionality that gives end users and\/or LIS administrators more control over the user interface. \n<\/p><p>Aspects of the LIS's user interface that are often customizable by the end user include:\n<\/p>\n<ul><li> report interface and display<\/li>\n<li> patient profile display<\/li>\n<li> project and experiment display<\/li><\/ul>\n<p>Note in many cases an interface may be customized through the use of templates and forms, and as such, this functionality may be closely tied to the <a href=\"#Configurable_templates_and_forms\" rel=\"external_link\">configurable templates and forms<\/a> functionality.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Query_capability\">Query capability<\/span><\/h3>\n<p>As was the case before the advent of databases and electronic data management solutions, today researchers must search through test results, patient notes, and other types of data to better draw conclusions from experiments, diagnose patient illnesses, and plan pharmaceutical research activities. Whereas this used to mean browsing through laboratory notebooks, Excel spreadsheets, or Access databases, now powerful query tools exists within data management tools like the LIS and <a href=\"https:\/\/www.limswiki.org\/index.php\/Electronic_laboratory_notebook\" title=\"Electronic laboratory notebook\" target=\"_blank\" class=\"wiki-link\" data-key=\"a9fbbd5e0807980106763fab31f1e72f\">ELN<\/a>. A flexible search algorithm can be implemented to allow users to search a dataset by patient name (full or partial) or by any accessioning number. Or more advanced query tools may be implemented to collate and search across multiple datasets.\n<\/p><p>Query functionality often includes the ability to:\n<\/p>\n<ul><li> search both transactional data and archived data tables<\/li>\n<li> search multiple databases via an application programming interface (API) or open database connectivity (ODBC) connection <\/li>\n<li> filter and sort data<\/li>\n<li> collate queried data for further <a href=\"https:\/\/www.limswiki.org\/index.php\/LIS_feature#Data_and_trend_analysis\" title=\"LIS feature\" target=\"_blank\" class=\"wiki-link\" data-key=\"b53cd61b96525d390e8e857f55feaf59\">analysis<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/LIS_feature#Multiple_data_viewing_methods\" title=\"LIS feature\" target=\"_blank\" class=\"wiki-link\" data-key=\"a3157377edc9fb475bb6fff589f77f16\">visualization<\/a><\/li>\n<li> create ad-hoc queries<\/li><\/ul>\n<h3><span class=\"mw-headline\" id=\"Import_data\">Import data<\/span><\/h3>\n<p>Data can originate from numerous places in the laboratory. The ability to import that data into a LIS can be beneficial, especially when an instrument can't be connected or external clients collaborating on a project need to submit relevant data. Of course <a href=\"https:\/\/www.limswiki.org\/index.php\/LIS_feature#Instrument_interfacing_and_management\" title=\"LIS feature\" target=\"_blank\" class=\"wiki-link\" data-key=\"7f2d7a1f94d82fdd1d60f467fb261e9e\">instrument interfacing<\/a> allows for even more importation options. Additional <a href=\"https:\/\/www.limswiki.org\/index.php\/LIS_feature#Data_validation\" title=\"LIS feature\" target=\"_blank\" class=\"wiki-link\" data-key=\"d3fc44e00d7686bffee4879207d83579\">data validation<\/a> procedures may be applied to the imported data to guarantee information homogeneity. For the LIS, one of the common sources of importing data is a separate <a href=\"https:\/\/www.limswiki.org\/index.php\/Electronic_medical_record\" title=\"Electronic medical record\" target=\"_blank\" class=\"wiki-link\" data-key=\"99a695d2af23397807da0537d29d0be7\">electronic medical record<\/a> (EMR) system, for collecting patient data and test orders.<sup id=\"rdp-ebb-cite_ref-LabDaqFeats_18-0\" class=\"reference\"><a href=\"#cite_note-LabDaqFeats-18\" rel=\"external_link\">[18]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-EMRLIS_19-0\" class=\"reference\"><a href=\"#cite_note-EMRLIS-19\" rel=\"external_link\">[19]<\/a><\/sup>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Internal_file_or_data_linking\">Internal file or data linking<\/span><\/h3>\n<div class=\"thumb tright\"><div class=\"thumbinner\" style=\"width:302px;\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Linking-Open-Data-diagram_2007-09.png\" class=\"image wiki-link\" target=\"_blank\" data-key=\"e331ad282405cb5c1a330e17d7c28294\"><img alt=\"\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/8\/89\/Linking-Open-Data-diagram_2007-09.png\" width=\"300\" height=\"237\" class=\"thumbimage\" \/><\/a> <div class=\"thumbcaption\"><div class=\"magnify\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Linking-Open-Data-diagram_2007-09.png\" class=\"internal wiki-link\" title=\"Enlarge\" target=\"_blank\" data-key=\"e331ad282405cb5c1a330e17d7c28294\"><\/a><\/div>Many informatics systems allow for internal linking of data; however, entities outside of the system often need to access the data housed within. A LIS is often capable of such external data linking.<\/div><\/div><\/div>This feature allows research collaborators using a LIS to link together sample batches, reports, protocols, results, and more, providing greater contextual clarity to projects and datasets. Examples include:\n<ul><li> linking a sample batch to a test or sample preparation methodology<\/li>\n<li> linking a test process to a particular experiment<\/li>\n<li> linking a report to a sample batch<\/li>\n<li> linking a group of experiment results to a raw data file<\/li>\n<li> linking multiple images to a patient record<\/li>\n<li> linking all experiment results with the correct reporting test methods<\/li><\/ul>\n<h3><span class=\"mw-headline\" id=\"External_file_or_data_linking\">External file or data linking<\/span><\/h3>\n<p>This feature allows research collaborators using a LIS to link together data and files housed in the database with data, files, and customers outside the LIS's domain. Examples include:\n<\/p>\n<ul><li> linking to an external practice management or electronic medical record (EMR) system using an an <a href=\"https:\/\/www.limswiki.org\/index.php\/Health_Level_7\" title=\"Health Level 7\" target=\"_blank\" class=\"wiki-link\" data-key=\"e0bf845fb58d2bae05a846b47629e86f\">HL7<\/a>-compliant interface<\/li>\n<li> linking one public health data source with others to pool demographic and medical information for better disease modeling<\/li>\n<li> linking to separate clinical trial laboratory data files within a report<\/li><\/ul>\n<h3><span class=\"mw-headline\" id=\"ELN_support_or_integration\">ELN support or integration<\/span><\/h3>\n<p>The functionality of a LIMS and an <a href=\"https:\/\/www.limswiki.org\/index.php\/Electronic_laboratory_notebook\" title=\"Electronic laboratory notebook\" target=\"_blank\" class=\"wiki-link\" data-key=\"a9fbbd5e0807980106763fab31f1e72f\">ELN<\/a> began to blur in the 2000s, with both types of software incorporating features from the other.<sup id=\"rdp-ebb-cite_ref-SciCompWorld1_20-0\" class=\"reference\"><a href=\"#cite_note-SciCompWorld1-20\" rel=\"external_link\">[20]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-SciCompELN_21-0\" class=\"reference\"><a href=\"#cite_note-SciCompELN-21\" rel=\"external_link\">[21]<\/a><\/sup> It has been more common to see a LIMS take on some sort of ELN support (or vice versa), but less common in the LIS. Though uncommon, some LIS may include some sort of integration or compatibility with an ELN, and thusly this functionality is at least mentioned.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Export_to_MS_Excel\">Export to MS Excel<\/span><\/h3>\n<p>While Microsoft Excel has long been used within the laboratory setting, a slow shift towards relational databases and LIMS occurred in the late 1990s and early 2000s.<sup id=\"rdp-ebb-cite_ref-WilliamsExcel_22-0\" class=\"reference\"><a href=\"#cite_note-WilliamsExcel-22\" rel=\"external_link\">[22]<\/a><\/sup> Additional concerns with the difficulties of Excel's validation and compliance with FDA <a href=\"https:\/\/www.limswiki.org\/index.php\/21_CFR_Part_11\" title=\"21 CFR Part 11\" target=\"_blank\" class=\"wiki-link\" data-key=\"0ec495c20a8f17894bd0c1388eda8e7a\">21 CFR Part 11<\/a> and other regulations have led many labs to turn to data management solutions that are easier to validate.<sup id=\"rdp-ebb-cite_ref-PragmaticExcelIntro_23-0\" class=\"reference\"><a href=\"#cite_note-PragmaticExcelIntro-23\" rel=\"external_link\">[23]<\/a><\/sup> Nevertheless, laboratories continue to use Excel in some fashion, and thus Excel integration or data exportation in Excel format is a real need for LIS customers. LISs with this feature allow raw, processed, or imported data to be exported in the Excel format for further analysis and dissemination elsewhere in the LIS or externally from it.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Raw_data_management\">Raw data management<\/span><\/h3>\n<p>While not described as a feature on most LIS vendor websites, a few indicate their product is capable of managing (import, export, editing, etc.) data in its raw format for future analysis and dissemination.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Data_warehouse\">Data warehouse<\/span><\/h3>\n<p>An LIS's <a href=\"https:\/\/www.limswiki.org\/index.php\/Data_warehouse\" title=\"Data warehouse\" target=\"_blank\" class=\"wiki-link\" data-key=\"ca506499cdf544371c0a0d549ff0e9ee\">data warehouse<\/a> serves the important function of storing, extracting, and managing the data that laboratories, physician offices, and other facilities produce for the purposes of analysis, reporting, and dissemination, typically separate from the primary storage database. Data warehouses also offer the benefit of speeding up queries, making queries and data mining more user-friendly, and smoothing out data gaps.<sup id=\"rdp-ebb-cite_ref-LVAdvantages_24-0\" class=\"reference\"><a href=\"#cite_note-LVAdvantages-24\" rel=\"external_link\">[24]<\/a><\/sup>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Project_and.2For_task_management\">Project and\/or task management<\/span><\/h3>\n<p>Project and task management within a LIS typically involves the scheduling of tasks to technicians and organizing associated tasks into a more cohesive unit for better tracking and management. While the functionality of <a href=\"https:\/\/www.limswiki.org\/index.php\/LIS_feature#Task_and_event_scheduling\" title=\"LIS feature\" target=\"_blank\" class=\"wiki-link\" data-key=\"7c25ec5bd3625a184d1f2accde264bef\">task and event scheduling<\/a> can also be found in project and task management, many LISs include functionality beyond scheduling that warrants the addition of the project and\/or task management feature. This functionality includes:\n<\/p>\n<ul><li> job allocation and rescheduling<\/li>\n<li> instrument workload tracking<\/li>\n<li> pending workload verification<\/li>\n<li> project- and experiment-based <a href=\"https:\/\/www.limswiki.org\/index.php\/LIS_feature#Workflow_management\" title=\"LIS feature\" target=\"_blank\" class=\"wiki-link\" data-key=\"5e5a749677e03c808d551148f8a56ca8\">workflow management<\/a><\/li>\n<li> sample, batch, and document <a href=\"https:\/\/www.limswiki.org\/index.php\/LIS_feature#Internal_file_or_data_linking\" title=\"LIS feature\" target=\"_blank\" class=\"wiki-link\" data-key=\"9c689e34a1ba032aeb13d1af1cdd1df5\">linking<\/a><\/li>\n<li> work template sharing<\/li>\n<li> recurring event management<\/li><\/ul>\n<p>See also: <a href=\"https:\/\/www.limswiki.org\/index.php\/LIS_feature#Patient_and_case_management\" title=\"LIS feature\" target=\"_blank\" class=\"wiki-link\" data-key=\"f42818d5e7b03ceb7b8662bd6b136dca\">Patient and case management<\/a>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Test.2C_experiment.2C_and.2For_trial_management\">Test, experiment, and\/or trial management<\/span><\/h3>\n<p>Specimen or sample test management is a common component of a LIS, while experiment and research trial management functionality is a component of some LISs, often limited to those that are designed to help manage clinical trials. Test, experiment, and trial management can cover a wide variety of tasks, from setting up the design of a clinical trial to specimen task assignments, from ordering tests for patients to planning trial experiments. <b>Note<\/b>: this may also be referred to as \"order management\" with some vendors.\n<\/p><p>It's worth noting this functionality category may seem broad in scope and include other functionality listed on this page, including <a href=\"https:\/\/www.limswiki.org\/index.php\/LIS_feature#Workflow_management\" title=\"LIS feature\" target=\"_blank\" class=\"wiki-link\" data-key=\"5e5a749677e03c808d551148f8a56ca8\">workflow management<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/LIS_feature#Project_and_task_management\" title=\"LIS feature\" target=\"_blank\" class=\"wiki-link\" data-key=\"9ab10d8804cc7760a8dbb976681e0ced\">project and task management<\/a>. Its inclusion when reviewing software functionality is primarily to indicate when a vendor or project team indicates the existence of specific test, experiment, or trial management tools in their software.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Inventory_management\">Inventory management<\/span><\/h3>\n<p>Laboratories use a wide array of inventory, from <a href=\"https:\/\/www.limswiki.org\/index.php\/Reagent\" title=\"Reagent\" target=\"_blank\" class=\"wiki-link\" data-key=\"39ef926218accd8f01f4c68c5a82f9dc\">reagents<\/a> to glassware, from <a href=\"https:\/\/www.limswiki.org\/index.php\/Radiopharmacology\" title=\"Radiopharmacology\" target=\"_blank\" class=\"wiki-link\" data-key=\"c05f4c40cbd311d197b3e45faaed0146\">radiopharmaceuticals<\/a> to <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_bath\" title=\"Laboratory bath\" class=\"mw-disambig wiki-link\" target=\"_blank\" data-key=\"ef20b7240457dba2d8433e9dca6047f7\">laboratory baths<\/a>. With that comes the need to know how much\/many and the frequency of use. For this, some LIS products (especially those for pathology labs) now offer limited or full-featured inventory management functionality, which may include the ability to:\n<\/p>\n<ul><li> register the origin and demographics of incoming materials.<\/li>\n<li> track used and in-use items via <a href=\"https:\/\/www.limswiki.org\/index.php\/LIS_feature#Barcode_support\" title=\"LIS feature\" target=\"_blank\" class=\"wiki-link\" data-key=\"18070de9d8004d989632cb309a165182\">barcodes<\/a> or RFID tags.<\/li>\n<li> track inventory reduction based on usage and shipping out of the lab.<\/li>\n<li> create alerts for when items reach a certain stock level.<\/li>\n<li> calculate inventory cost and fluctuation.<\/li>\n<li> manage transportation and routing.<\/li>\n<li> manual incrementing\/decrementing of items.<\/li>\n<li> track location and usage of laboratory equipment.<\/li>\n<li> track location and usage of reagents.<\/li>\n<li> assign storage locations.<\/li>\n<li> track forensic evidence.<\/li><\/ul>\n<p>It should be noted electronic equipment may also be considered inventory, and thus there is likely some functionality crossover with <a href=\"https:\/\/www.limswiki.org\/index.php\/LIS_feature#Instrument_interfacing_and_management\" title=\"LIS feature\" target=\"_blank\" class=\"wiki-link\" data-key=\"7f2d7a1f94d82fdd1d60f467fb261e9e\">instrument management<\/a> features.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Document_and.2For_image_management\">Document and\/or image management<\/span><\/h3>\n<div class=\"thumb tright\"><div class=\"thumbinner\" style=\"width:322px;\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Process_and_data_modeling.svg\" class=\"image wiki-link\" target=\"_blank\" data-key=\"1b1691d96fc9879bacbb744b20201ffd\"><img alt=\"\" src=\"https:\/\/www.limswiki.org\/images\/thumb\/0\/01\/Process_and_data_modeling.svg\/320px-Process_and_data_modeling.svg.png\" width=\"320\" height=\"254\" class=\"thumbimage\" \/><\/a> <div class=\"thumbcaption\"><div class=\"magnify\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Process_and_data_modeling.svg\" class=\"internal wiki-link\" title=\"Enlarge\" target=\"_blank\" data-key=\"1b1691d96fc9879bacbb744b20201ffd\"><\/a><\/div>Standard operating procedures, workflow diagrams, and business models can all be handled effectively with document management functionality.<\/div><\/div><\/div>Standard operation procedures, (SOPs), specifications, reports, graphs, images, and receipts are all collected and used in the average laboratory. With a LIS already designed to reference and store test and patient data of all types, it makes sense to include functionality to create, import, export, and manage other sorts of data files. As experimental data can be indexed, queried, and linked, so too can document data. Functionality of a typical document management system includes the ability to:\n<ul><li> upload and index documents.<\/li>\n<li> add images and photos inline to a patient or case entry.<\/li>\n<li> enforce <a href=\"https:\/\/www.limswiki.org\/index.php\/LIS_feature#Version_control\" title=\"LIS feature\" target=\"_blank\" class=\"wiki-link\" data-key=\"b3b24e66cee2120d37f65974e08f901a\">version control<\/a>.<\/li>\n<li> provide full text searches.<\/li>\n<li> export to PDF, XML, or other relevant formats.<\/li>\n<li> add documents as attachments.<\/li><\/ul>\n<h3><span class=\"mw-headline\" id=\"Patient_and_case_management\">Patient and case management<\/span><\/h3>\n<p>The <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_information_system\" title=\"Laboratory information system\" target=\"_blank\" class=\"wiki-link\" data-key=\"37add65b4d1c678b382a7d4817a9cf64\">laboratory information system<\/a> (LIS) has played an important role in the case management tasks of patient-centric and clinical laboratories. LIS products have included patient or case management tools suitable for the clinical, public health, and veterinary industries, as well as the fields of law enforcement and forensic science. Functionality seen in the patient and case management feature includes:\n<\/p>\n<ul><li> case accessioning and assignment<\/li>\n<li> disease tracking<\/li>\n<li> trend analysis<\/li>\n<li> clinical history follow-up<\/li>\n<li> out-of-range result <a href=\"https:\/\/www.limswiki.org\/index.php\/LIS_feature#Alarms_and.2For_alerts\" title=\"LIS feature\" target=\"_blank\" class=\"wiki-link\" data-key=\"7e85e4aa70013668fcee5950de3afbbb\">alerts<\/a><\/li>\n<li> document and result association<\/li>\n<li> evidence control<\/li>\n<li> study management<\/li>\n<li> collating of patient data across multiple spectrum<\/li><\/ul>\n<h3><span class=\"mw-headline\" id=\"Workflow_management\">Workflow management<\/span><\/h3>\n<div class=\"thumb tleft\"><div class=\"thumbinner\" style=\"width:302px;\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Workflow_IA.png\" class=\"image wiki-link\" target=\"_blank\" data-key=\"00653041ded02667b937fcc40d1624d4\"><img alt=\"\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/2\/2e\/Workflow_IA.png\" width=\"300\" height=\"240\" class=\"thumbimage\" \/><\/a> <div class=\"thumbcaption\"><div class=\"magnify\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Workflow_IA.png\" class=\"internal wiki-link\" title=\"Enlarge\" target=\"_blank\" data-key=\"00653041ded02667b937fcc40d1624d4\"><\/a><\/div>Capturing workflow in the lab is becoming more commonplace for laboratory informatics products.<\/div><\/div><\/div><a href=\"https:\/\/www.limswiki.org\/index.php\/Workflow\" title=\"Workflow\" target=\"_blank\" class=\"wiki-link\" data-key=\"92bd8748272e20d891008dcb8243e8a8\">Workflow<\/a> management is common in the laboratory, acting as a graphical representation of planned sequential steps to either automate or clarify a process or experiment within the lab. Separate standards-based workflow management systems (in the form of a software component) have traditionally performed this task.<sup id=\"rdp-ebb-cite_ref-WfMC1_25-0\" class=\"reference\"><a href=\"#cite_note-WfMC1-25\" rel=\"external_link\">[25]<\/a><\/sup> However, in the 2000s vendors began incorporating workflow management functionality into their laboratory informatics software, reducing customization headaches in the process.<sup id=\"rdp-ebb-cite_ref-SciCompWF_26-0\" class=\"reference\"><a href=\"#cite_note-SciCompWF-26\" rel=\"external_link\">[26]<\/a><\/sup> \n<p>Modern commercial and open-source LIS solutions recognize clinical laboratory workflow often has its own share of requirements, requiring specific workflow management functionality, including<sup id=\"rdp-ebb-cite_ref-WFLIS_27-0\" class=\"reference\"><a href=\"#cite_note-WFLIS-27\" rel=\"external_link\">[27]<\/a><\/sup>:\n<\/p>\n<ul><li> managing the request cycle within a laboratory<\/li>\n<li> organizing and executing diagnostic testing<\/li>\n<li> managing specific chemistry- and biology-related procedures<\/li>\n<li> defining activity attributes<\/li>\n<li> managing automation tools to better workflows<\/li>\n<li> re-route samples based on changes to a process<\/li>\n<li> dynamically modifying workflow in case of future changes<\/li>\n<li> receiving notification of changes to the workflow<\/li><\/ul>\n<h3><span class=\"mw-headline\" id=\"Specification_management\">Specification management<\/span><\/h3>\n<p><a href=\"https:\/\/www.limswiki.org\/index.php\/Specification_(technical_standard)\" title=\"Specification (technical standard)\" target=\"_blank\" class=\"wiki-link\" data-key=\"dc2050725de4ea7ca520800e4f969b20\">Specification<\/a> (spec) management is vital to not only the manufacturing and research industries but also to a host of other laboratories requiring precise measurements and infallible test methods. Just as the <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_International\" title=\"ASTM International\" target=\"_blank\" class=\"wiki-link\" data-key=\"dfeafbac63fa786e77b472c3f86d07ed\">ASTM<\/a> offers standards and specs for laboratory informatics software<sup id=\"rdp-ebb-cite_ref-ASTM_LIMS_28-0\" class=\"reference\"><a href=\"#cite_note-ASTM_LIMS-28\" rel=\"external_link\">[28]<\/a><\/sup>, so too do users have standards and specs for their laboratory. \n<\/p><p>Spec management has primarily been seen in a manufacturing execution system (MES) or a LIMS, but occasionally a LIS may appear which includes such functionality. With spec management in place, laboratories can then:\n<\/p>\n<ul><li> enforce standard operating procedures and business rules.<\/li>\n<li> create specs down to a project or sample level.<\/li>\n<li> validate recipes and procedures.<\/li>\n<li> accept or reject sample batches.<\/li>\n<li> document internal and external spec history.<\/li><\/ul>\n<p>Note some of the functionality of spec management may cross over into the realm of <a href=\"https:\/\/www.limswiki.org\/index.php\/LIS_feature#QA.2FQC_functions\" title=\"LIS feature\" target=\"_blank\" class=\"wiki-link\" data-key=\"47bc2def1727b39e330a321323ca99d0\">quality control<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/LIS_feature#Data_validation\" title=\"LIS feature\" target=\"_blank\" class=\"wiki-link\" data-key=\"d3fc44e00d7686bffee4879207d83579\">data validation<\/a>.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Customer.2C_supplier.2C_and_physician_management\">Customer, supplier, and physician management<\/span><\/h3>\n<p>Unless a laboratory is conducting internalized independent research, in most cases it will do business with external entities such as contract labs, physician offices, equipment providers, and reagent suppliers. In some cases, even internal employees may be considered a customer, necessitating documentation of who is using the system and in what ways. For a veterinary lab, the customer may be the animal and handler. For a forensic lab the customer may be more complex: internal staff, university staff, police departments, and maintainers of nationwide crime databases may all at some point act as customers. In these cases, documenting these various points of contact and linking them to tests, equipment, and patients becomes vital. Managing demographics, complaints, correspondence, and history are all feasible with customer, supplier, and physician management functionality. This process is often made simpler through the use of a more context-neutral entity creation system, which allows for more flexible management of contacts.\n<\/p><p>This feature may also be referred to as contact management, an address book module, or a customer service module.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Billing_and_revenue_management\">Billing and revenue management<\/span><\/h3>\n<p>While the finances of a laboratory are important, they've typically been handled separately as a business process. However, some LISs include additional functionality to make handling financial transactions and documentation of all sorts possible within the LIS. In theory, such functionality brings the possibility of keeping more of a laboratory's data centrally located and queryable. This feature may include<sup id=\"rdp-ebb-cite_ref-ILAbout_11-1\" class=\"reference\"><a href=\"#cite_note-ILAbout-11\" rel=\"external_link\">[11]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-McKessHori_29-0\" class=\"reference\"><a href=\"#cite_note-McKessHori-29\" rel=\"external_link\">[29]<\/a><\/sup>:\n<\/p>\n<ul><li> payment processing<\/li>\n<li> expense reporting<\/li>\n<li> price quotes<\/li>\n<li> revenue management<\/li>\n<li> workload tracking of billable hours<\/li>\n<li> bill of materials<\/li>\n<li> sales team and client management<\/li>\n<li> profitability analysis<\/li>\n<li> medical necessity checks<\/li><\/ul>\n<\/div>\n<p> <\/p>\n<h2><span class=\"mw-headline\" id=\"Quality.2C_security.2C_and_compliance\">Quality, security, and compliance<\/span><\/h2>\n<p><i>To hide the contents of this section for easier reading of other sections, click the \"Collapse\" link to the right.<\/i>\n<\/p>\n<div class=\"mw-collapsible\" style=\"width:100%; background-color:white;\">\n<p> <\/p>\n<h3><span class=\"mw-headline\" id=\"Regulatory_compliance\">Regulatory compliance<\/span><\/h3>\n<p>The topic of whether or not a LIS meets regulatory compliance is often a complex one. While Title <a href=\"https:\/\/www.limswiki.org\/index.php\/21_CFR_Part_11\" title=\"21 CFR Part 11\" target=\"_blank\" class=\"wiki-link\" data-key=\"0ec495c20a8f17894bd0c1388eda8e7a\">21 CFR Part 11<\/a> has arguably had the largest influence on an electronic data management system's compliance, other influential standards have shaped the way laboratory informatics systems handle and store data.<sup id=\"rdp-ebb-cite_ref-LTELNCompPDF_30-0\" class=\"reference\"><a href=\"#cite_note-LTELNCompPDF-30\" rel=\"external_link\">[30]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-KMHowELN_31-0\" class=\"reference\"><a href=\"#cite_note-KMHowELN-31\" rel=\"external_link\">[31]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-BioITNewELNS_32-0\" class=\"reference\"><a href=\"#cite_note-BioITNewELNS-32\" rel=\"external_link\">[32]<\/a><\/sup> Other compliance-based codes, standards, and regulations include:\n<\/p>\n<ul><li> <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_International\" title=\"ASTM International\" target=\"_blank\" class=\"wiki-link\" data-key=\"dfeafbac63fa786e77b472c3f86d07ed\">ASTM<\/a> <\/li>\n<li> <a href=\"https:\/\/www.limswiki.org\/index.php\/The_American_Society_of_Crime_Laboratory_Directors\/Laboratory_Accreditation_Board\" title=\"The American Society of Crime Laboratory Directors\/Laboratory Accreditation Board\" target=\"_blank\" class=\"wiki-link\" data-key=\"f364a7d9dca831de0caaaba41cf0b7ea\">ASCLD\/LAB<\/a> <\/li>\n<li> Classified data<\/li>\n<li> Freedom of information legislation (various)<\/li>\n<li> <a href=\"https:\/\/www.limswiki.org\/index.php\/Good_Automated_Laboratory_Practices\" title=\"Good Automated Laboratory Practices\" target=\"_blank\" class=\"wiki-link\" data-key=\"bef4ea1fa3e792ccf7471f9f09b804e6\">GALP<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/Good_Automated_Manufacturing_Practice\" title=\"Good Automated Manufacturing Practice\" target=\"_blank\" class=\"wiki-link\" data-key=\"a0f3d9c5bc4e330dbaec137fbe7f5dbb\">GAMP<\/a> <\/li>\n<li> <a href=\"https:\/\/www.limswiki.org\/index.php\/Health_Insurance_Portability_and_Accountability_Act\" title=\"Health Insurance Portability and Accountability Act\" target=\"_blank\" class=\"wiki-link\" data-key=\"b70673a0117c21576016cb7498867153\">HIPAA<\/a> <\/li>\n<li> <a href=\"https:\/\/www.limswiki.org\/index.php\/Health_Level_7\" title=\"Health Level 7\" target=\"_blank\" class=\"wiki-link\" data-key=\"e0bf845fb58d2bae05a846b47629e86f\">Health Level 7<\/a>\t<\/li>\n<li> <a href=\"https:\/\/www.limswiki.org\/index.php\/International_Statistical_Classification_of_Diseases_and_Related_Health_Problems\" title=\"International Statistical Classification of Diseases and Related Health Problems\" target=\"_blank\" class=\"wiki-link\" data-key=\"1de9af67005dfe2895e5d8cf6de57d4a\">ICD<\/a><\/li>\n<li> <a href=\"https:\/\/www.limswiki.org\/index.php\/ISO\/IEC_17025\" title=\"ISO\/IEC 17025\" target=\"_blank\" class=\"wiki-link\" data-key=\"0a89cebb34370dd860cce86881cbf29c\">ISO\/IEC 17025<\/a><\/li>\n<li> <a href=\"https:\/\/www.limswiki.org\/index.php\/ISO_9000\" title=\"ISO 9000\" target=\"_blank\" class=\"wiki-link\" data-key=\"53ace2d12e80a7d890ce881bc6fe244a\">ISO 9000\/9001<\/a><\/li>\n<li> <a href=\"https:\/\/www.limswiki.org\/index.php\/ISO\/TS_16949\" title=\"ISO\/TS 16949\" target=\"_blank\" class=\"wiki-link\" data-key=\"98e43baa168925d15899a66e9c9f0b8f\">ISO\/TS 16949<\/a><\/li>\n<li> <a href=\"https:\/\/www.limswiki.org\/index.php\/ODBC\" title=\"ODBC\" target=\"_blank\" class=\"wiki-link\" data-key=\"d58229ca4974143c9d42736a040160be\">ODBC<\/a><\/li>\n<li> <a href=\"https:\/\/www.limswiki.org\/index.php\/The_NELAC_Institute\" title=\"The NELAC Institute\" target=\"_blank\" class=\"wiki-link\" data-key=\"8c3143a94da249329391b763571f1991\">TNI<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/The_NELAC_Institute#National_Environmental_Laboratory_Accreditation_Program\" title=\"The NELAC Institute\" target=\"_blank\" class=\"wiki-link\" data-key=\"4413d2879e883354b99ce8cb3f57240d\">NELAP<\/a> <\/li>\n<li> Title <a href=\"https:\/\/www.limswiki.org\/index.php\/40_CFR_Part_3\" title=\"40 CFR Part 3\" target=\"_blank\" class=\"wiki-link\" data-key=\"f6e16cb8df3738dee667b175cc486cef\">40 CFR Part 3<\/a><\/li><\/ul>\n<p>With so many codes, standards, and regulations, LIS consumers are advised to contact vendors with their user requirements and ask how the vendor's software meets and\/or exceeds those requirements.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"QA.2FQC_functions\">QA\/QC functions<\/span><\/h3>\n<p>The quality management functions of a LIS allow users to maintain a level of necessary quality across many of the functions in a laboratory. Some of the activities quality assurance \/ quality control functionality allows for includes<sup id=\"rdp-ebb-cite_ref-RandomQAPaper_33-0\" class=\"reference\"><a href=\"#cite_note-RandomQAPaper-33\" rel=\"external_link\">[33]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-NLQC_34-0\" class=\"reference\"><a href=\"#cite_note-NLQC-34\" rel=\"external_link\">[34]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-Clin1_35-0\" class=\"reference\"><a href=\"#cite_note-Clin1-35\" rel=\"external_link\">[35]<\/a><\/sup>:\n<\/p>\n<ul><li> force random review of cases by second pathologist before case verification<\/li>\n<li> receive and process QC results from laboratory analyzers<\/li>\n<li> create user rules<\/li>\n<li> set up custom alerts and flags for out-of-range results<\/li>\n<li> observe standard deviations in outcome research<\/li>\n<li> review and sign off on data electronically<\/li>\n<li> delta checking<\/li><\/ul>\n<h3><span class=\"mw-headline\" id=\"Performance_evaluation\">Performance evaluation<\/span><\/h3>\n<p>As <a href=\"https:\/\/www.limswiki.org\/index.php\/LIS_feature#Document_creation_and_management\" title=\"LIS feature\" target=\"_blank\" class=\"wiki-link\" data-key=\"5b1d04112bbc7ff839617189de2a11ea\">document and file management<\/a> plays an important role in clinical and research laboratories, it only makes sense to collate and store all the associated data for future reference, including documentation relating to individual training and performance. Changes to laboratory techniques, scientific understanding, and business practices force lab technicians and researchers to learn, reevaluate, and demonstrate competency in order to maintain quality levels in the laboratory. Evaluations can frequently extend beyond staff members, however. Clinics, visit types, vendors, or test species can also be tracked and evaluated based on custom criteria. The performance evaluation functionality of a LIS makes this possible. \n<\/p><p>That functionality typically includes the ability to maintain training records and history, and also to link that training to a technique or piece of equipment. Afterwards, the staff member, vendor, etc. can be marked as competent or certified in the equipment, knowledge, or process. Periodical assessment of the training and its practical effectiveness can later be performed. Productivity of an entity or process can also be gauged over a certain date range based on <a href=\"https:\/\/www.limswiki.org\/index.php\/LIS_feature#Work-related_time_tracking\" title=\"LIS feature\" target=\"_blank\" class=\"wiki-link\" data-key=\"2fe1134841ad00fdec9398c85a7818e9\">tracked time<\/a>, pre-determined milestones, or some other criteria.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Audit_trail\">Audit trail<\/span><\/h3>\n<div class=\"thumb tleft\"><div class=\"thumbinner\" style=\"width:282px;\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Syvalidate_screen.jpg\" class=\"image wiki-link\" target=\"_blank\" data-key=\"5b19e0089cab173f0bf3d99af53437ab\"><img alt=\"\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/2\/25\/Syvalidate_screen.jpg\" width=\"280\" height=\"202\" class=\"thumbimage\" \/><\/a> <div class=\"thumbcaption\"><div class=\"magnify\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Syvalidate_screen.jpg\" class=\"internal wiki-link\" title=\"Enlarge\" target=\"_blank\" data-key=\"5b19e0089cab173f0bf3d99af53437ab\"><\/a><\/div>Whether validating an instrument's data or an entire LIS, maintaining an audit trail is an important part of <a href=\"https:\/\/www.limswiki.org\/index.php\/21_CFR_Part_11\" title=\"21 CFR Part 11\" target=\"_blank\" class=\"wiki-link\" data-key=\"0ec495c20a8f17894bd0c1388eda8e7a\">21 CFR Part 11<\/a> compliance.<\/div><\/div><\/div> As codes and regulations like Title <a href=\"https:\/\/www.limswiki.org\/index.php\/21_CFR_Part_11\" title=\"21 CFR Part 11\" target=\"_blank\" class=\"wiki-link\" data-key=\"0ec495c20a8f17894bd0c1388eda8e7a\">21 CFR Part 11<\/a> mandate \"computer systems (including hardware and software), controls, and attendant documentation\" utilize electronic signatures and <a href=\"https:\/\/www.limswiki.org\/index.php\/Audit_trail\" title=\"Audit trail\" target=\"_blank\" class=\"wiki-link\" data-key=\"96a617b543c5b2f26617288ba923c0f0\">audit trails<\/a><sup id=\"rdp-ebb-cite_ref-36\" class=\"reference\"><a href=\"#cite_note-36\" rel=\"external_link\">[36]<\/a><\/sup>, LIS developers must put serious thought into how their software handles audit trail functionality. The audit trail \u2014 documentation of the sequence of activities that have affected an action \u2014 must be thorough and seamlessly integrated into the software. \n<p><br \/>\nInformation recorded in the audit trail typically includes:\n<\/p>\n<ul><li> operator code\t<\/li>\n<li> time stamp\t<\/li>\n<li> location<\/li>\n<li> case number<\/li>\n<li> accessioning number<\/li>\n<li> transaction type<\/li>\n<li> amount and quantity prior to change<\/li>\n<li> user notes<\/li><\/ul>\n<p><br \/>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Chain_of_custody\">Chain of custody<\/span><\/h3>\n<p>The <a href=\"https:\/\/www.limswiki.org\/index.php\/Chain_of_custody\" title=\"Chain of custody\" target=\"_blank\" class=\"wiki-link\" data-key=\"6ba04fe2bb1c8375e133455821aa3894\">chain of custody<\/a> (COC) of an item is of varying importance, depending on the type of laboratory. A highly regulated laboratory that works under Code of Federal Regulation or other guidelines makes tracking COC a vital part of its operations. This is especially true in forensic labs, which depend on continuous accountability of their evidence collection, retention, and disposal procedures.<sup id=\"rdp-ebb-cite_ref-DigForLabBook_37-0\" class=\"reference\"><a href=\"#cite_note-DigForLabBook-37\" rel=\"external_link\">[37]<\/a><\/sup> As with an <a href=\"https:\/\/www.limswiki.org\/index.php\/Audit_trail\" title=\"Audit trail\" target=\"_blank\" class=\"wiki-link\" data-key=\"96a617b543c5b2f26617288ba923c0f0\">audit trail<\/a>, a laboratory depends on recorded information like user ID, time stamp, and location ID to maintain a robust and accurate COC. <a href=\"https:\/\/www.limswiki.org\/index.php\/LIS_feature#Barcode_and.2For_RFID_support\" title=\"LIS feature\" target=\"_blank\" class=\"wiki-link\" data-key=\"3029c1eb2ffdf072fdcf93dfb60f7c49\">Barcodes and RFID tags<\/a>, <a href=\"https:\/\/www.limswiki.org\/index.php\/ELN_feature#Inventory_management\" title=\"ELN feature\" target=\"_blank\" class=\"wiki-link\" data-key=\"0390addc2f3c011f198e9b004bd66145\">inventory management<\/a>, and <a href=\"https:\/\/www.limswiki.org\/index.php\/ELN_feature#Configurable_roles_and_security\" title=\"ELN feature\" target=\"_blank\" class=\"wiki-link\" data-key=\"b611be44c734e1d585e1c47835dd445a\">configurable security roles<\/a> all play an important part in maintaining chain of custody.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Configurable_roles_and_security\">Configurable roles and security<\/span><\/h3>\n<p>Many roles exist within the clinical and research setting, each with its own set of responsibilities. And just as the role an individual plays within the laboratory may change, so may the responsibilities associated with each role. This sort of change necessitates a flexible and configurable security system, one that allows for the placement of individual LIS users into standardized security roles which provide role-specific access to certain functionality. Additionally, as responsibilities change within roles, that same flexible configuration is necessary for assigning or restricting access to specific functionality for each existing or newly created role. \n<\/p><p>Of course, roles aren't always assigned on an individual level. Often large groups of individuals may need to be assigned to roles, necessitating group assignments for security purposes. For example, a group of hospital laboratory trainees may not be given access to the <a href=\"https:\/\/www.limswiki.org\/index.php\/LIS_feature#Inventory_management\" title=\"LIS feature\" target=\"_blank\" class=\"wiki-link\" data-key=\"26e788179e056c8553e0070eff323cb5\">inventory management<\/a> functionality of the system through a custom \"Trainees\" group role, while the head of the lab may be given the \"Administrator\" role, which allows that individual to access a much broader spectrum of the LIS's functionality.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Data_normalization\">Data normalization<\/span><\/h3>\n<p>For the purposes of describing LIS functionality, \"data normalization\" specifically refers to the process of ensuring incoming\/imported data into the LIS is standardized to the same format of existing data. \n<\/p><p>Here's an example to better explain this issue. When a LIS is initially configured, in most if not all cases a clear standard can be set for how logged test results and their associated measurements pre- and post-analysis are recorded in the system. Perhaps all temperatures will be recorded in Celsius to three decimal places. If temperature data imported from a spreadsheet or a lab instrument is not in this format, the LIS can normalize the incoming data to match the standard already set for existing temperature data. This ensures consistency within the database and typically leads to better <a href=\"https:\/\/www.limswiki.org\/index.php\/LIS_feature#Data_validation\" title=\"LIS feature\" target=\"_blank\" class=\"wiki-link\" data-key=\"d3fc44e00d7686bffee4879207d83579\">data validation<\/a> efforts later on.\n<\/p><p><i>Note<\/i>: Some LIS developers may include data normalization functionality within what they may refer to as data validation functionality. The line between these two may be blurred or not exist at all.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Data_validation\">Data validation<\/span><\/h3>\n<div class=\"thumb tright\"><div class=\"thumbinner\" style=\"width:302px;\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Scheme_reconciliation.jpg\" class=\"image wiki-link\" target=\"_blank\" data-key=\"0ee24bca4f268fa5e308fec9d3fbb761\"><img alt=\"\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/4\/44\/Scheme_reconciliation.jpg\" width=\"300\" height=\"300\" class=\"thumbimage\" \/><\/a> <div class=\"thumbcaption\"><div class=\"magnify\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Scheme_reconciliation.jpg\" class=\"internal wiki-link\" title=\"Enlarge\" target=\"_blank\" data-key=\"0ee24bca4f268fa5e308fec9d3fbb761\"><\/a><\/div>In a LIS, data and data models can be forced through a validation process to remove errors and reconcile that those data and models.<\/div><\/div><\/div>For the purposes of describing LIS functionality, \"data validation\" specifically refers to the process of ensuring existing data in the LIS \u2014 either pre-analysis or post-analysis \u2014 sufficiently meets any number of standards or thresholds set for any given data management process. This validation process may be completely automatic and system-based, or it may also include additional steps on the part of the user base utilizing additional LIS functionality, including verification of standard operating procedures (SOPs), QC samples, and QA approval.<sup id=\"rdp-ebb-cite_ref-SIRFERQA_38-0\" class=\"reference\"><a href=\"#cite_note-SIRFERQA-38\" rel=\"external_link\">[38]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-CompMinIndBook_39-0\" class=\"reference\"><a href=\"#cite_note-CompMinIndBook-39\" rel=\"external_link\">[39]<\/a><\/sup>\n<p><i>Note<\/i>: This functionality shouldn't be confused with the process of validating the application itself, which is an entirely different process partially falling under <a href=\"https:\/\/www.limswiki.org\/index.php\/LIS_feature#Regulatory_compliance\" title=\"LIS feature\" target=\"_blank\" class=\"wiki-link\" data-key=\"637370746c4cbf4112f108bda0601950\">regulatory compliance<\/a> and involves the process of ensuring \"the software is performing in a manner for which it was designed.\"<sup id=\"rdp-ebb-cite_ref-QAJournValid_40-0\" class=\"reference\"><a href=\"#cite_note-QAJournValid-40\" rel=\"external_link\">[40]<\/a><\/sup>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Data_encryption\">Data encryption<\/span><\/h3>\n<p>The existence of this functionality in a LIS indicates the software has the ability to protect the integrity and authenticity of its housed data through the use of a variety of technologies which makes data unreadable except to those possessing a key\/right\/etc. to unlock\/read the data. This functionality is especially vital to the web-enabled LIS, which transfers information over the Internet in a client-server relationship. As a wide variety of encryption technologies exist, it's generally a good idea to consult with the developers of a LIS to determine the strengths and weaknesses of their employed encryption methods.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Version_control\">Version control<\/span><\/h3>\n<p>Version control is a form of safeguard which helps preserve data integrity and thus ties in with the topic of <a href=\"https:\/\/www.limswiki.org\/index.php\/LIS_feature#Regulatory_compliance\" title=\"LIS feature\" target=\"_blank\" class=\"wiki-link\" data-key=\"637370746c4cbf4112f108bda0601950\">regulatory compliance<\/a>. This is typically done by creating a modifiable new version of a piece of information rather than allowing the original to be modified. Such versioning may be applied to a wide variety of digital information housed in the LIS, including templates, training certifications, instrument logs, specifications, and process and procedure (P&P) documentation. Information tracked with such revisions includes attributes like user name, time the edit was made, and what exactly was edited. This also benefits those managing <a href=\"https:\/\/www.limswiki.org\/index.php\/LIS_feature#Audit_trail\" title=\"LIS feature\" target=\"_blank\" class=\"wiki-link\" data-key=\"e4b71f1bc0b254fbb9dba4acb2c453ae\">audit trails<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/LIS_feature#Chain_of_custody\" title=\"LIS feature\" target=\"_blank\" class=\"wiki-link\" data-key=\"f949e83daf78d8368f040cea9a8ca188\">chains of custody<\/a>.\n<\/p><p>Other LIS vendors may employ a different form of version control called file locking, which simply puts the affected information into a read-only mode for users while someone else is busy editing it. Another popular strategy is to, rather than locking the file, allow multiple people to edit a piece of information, later merging the various edits. Potential LIS buyers may need to inquire with developers to determine what type of versioning scheme is used in the vendor's software.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Automatic_data_backup\">Automatic data backup<\/span><\/h3>\n<p>The existence of this piece of functionality in a LIS usually means information contained in one or more associated databases or <a href=\"https:\/\/www.limswiki.org\/index.php\/LIS_feature#Data_warehouse\" title=\"LIS feature\" target=\"_blank\" class=\"wiki-link\" data-key=\"cd87679a8bb1ef4b395e8150dfa4001b\">data warehouses<\/a> can be automatically preserved in an additional backup file. The save location for that file as well as the scheduled backup time is configurable, typically through the <a href=\"https:\/\/www.limswiki.org\/index.php\/LIS_feature#Administrator_management\" title=\"LIS feature\" target=\"_blank\" class=\"wiki-link\" data-key=\"9b4b4d8fa11691f07c422b85add85bd6\">administrative module<\/a> of the software.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Environmental_monitoring\">Environmental monitoring<\/span><\/h3>\n<p>While not common at all, a few LIS may allow users to monitor the environmental conditions of not only sample storage containers but also the entire laboratory itself. Attributes like humidity, air quality, and temperature may be monitored to ensure sample storage units and experiments maintain desired conditions. This monitoring may be done by treating the storage container as a device, which must be interfaced with the LIS. Alarms may be able to be configured to notify staff if a storage container's environmental attributes go beyond a certain threshold.\n<\/p>\n<\/div>\n<p> <\/p>\n<h2><span class=\"mw-headline\" id=\"Reporting.2C_barcoding.2C_and_printing\">Reporting, barcoding, and printing<\/span><\/h2>\n<p><i>To hide the contents of this section for easier reading of other sections, click the \"Collapse\" link to the right.<\/i>\n<\/p>\n<div class=\"mw-collapsible\" style=\"width:100%; background-color:white;\">\n<p> <\/p>\n<h3><span class=\"mw-headline\" id=\"Custom_reporting\">Custom reporting<\/span><\/h3>\n<p>Reporting often provides useful information representation for gaining a clearer picture of collected data and potential trends. At a minimum, a number of pre-configured report templates typically come standard with a LIS. However, other systems are more flexible than others, offering the ability to customize reports in numerous ways. The most popular attributes of custom reporting include custom headers, custom information placement, charts, pivot tables, and multiple output formats.\n<\/p><p>Note: Some LIS vendors may offer custom reporting as an option as an added cost, depending on the level of customization required.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Synoptic_reporting\">Synoptic reporting<\/span><\/h3>\n<p>Synoptic reporting is a specific type of reporting applicable to pathology and other associated laboratories. Synoptic reporting essentially involves a structured, pre-formatted \"checklist\" of clinically and morphologically relevant data elements (ideally passed to a relational database where they are efficiently organized, searched, and retrieved), with the intent of making reporting more efficient, uniform, and relevant to internal and external researchers. This style of reporting has the advantage of obviating the need for transcription services, reducing specimen turnaround time, and prioritizing the presentation of large amounts of diagnostic information. <sup id=\"rdp-ebb-cite_ref-SynRepoPaper_41-0\" class=\"reference\"><a href=\"#cite_note-SynRepoPaper-41\" rel=\"external_link\">[41]<\/a><\/sup> Some LISs, especially those oriented towards pathology, may include this specialized functionality. In some cases, a <a href=\"#Configurable_templates_and_forms\" rel=\"external_link\">configurable templates or form<\/a> may be utilized to structure a report in a synoptic format, providing similar functionality to a separate synoptic reporting module.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Report_printing\">Report printing<\/span><\/h3>\n<p>Today's software almost universally offers the ability to print reports and other materials, so this feature may seem a bit redundant to list. Nonetheless, printer support is a feature worth confirming when considering a piece of laboratory informatics software.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Label_support\">Label support<\/span><\/h3>\n<p>The label \u2014 typically affixed to a sample container or piece of equipment \u2014 is a vital part of many laboratory operations.<sup id=\"rdp-ebb-cite_ref-SCLabel_42-0\" class=\"reference\"><a href=\"#cite_note-SCLabel-42\" rel=\"external_link\">[42]<\/a><\/sup> Identifying information such as sample number, batch number, and barcodes are printed on such labels to ensure optimize managing the location of items in a lab. As such, numerous LISs allow users to design and print labels directly from the software.\n<\/p>\n<div class=\"thumb tleft\"><div class=\"thumbinner\" style=\"width:302px;\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Code_barres.png\" class=\"image wiki-link\" target=\"_blank\" data-key=\"23481b6010df77bcb0ef723e7bef48fd\"><img alt=\"\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/b\/ba\/Code_barres.png\" width=\"300\" height=\"282\" class=\"thumbimage\" \/><\/a> <div class=\"thumbcaption\"><div class=\"magnify\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Code_barres.png\" class=\"internal wiki-link\" title=\"Enlarge\" target=\"_blank\" data-key=\"23481b6010df77bcb0ef723e7bef48fd\"><\/a><\/div>The word \"Wikipedia\" encoded in Code 128 and Code 39<\/div><\/div><\/div>\n<h3><span class=\"mw-headline\" id=\"Barcode_and.2For_RFID_support\">Barcode and\/or RFID support<\/span><\/h3>\n<p>Barcodes offer many advantages to laboratory techs handling samples, including more accurate data input, tighter sample\/instrument associations, tighter sample\/study associations, and more room for human-readable information on a label.<sup id=\"rdp-ebb-cite_ref-SCLabel_42-1\" class=\"reference\"><a href=\"#cite_note-SCLabel-42\" rel=\"external_link\">[42]<\/a><\/sup> Given such advantages, many laboratory informatics developers have integrated barcode support into their software, including support for symbologies like Code 128, Code 39, and Interleaved 2 of 5. Aside from printing options, a LISmay also offer support for a variety of barcode readers.\n<\/p><p>Additionally, some LIS include the ability to handle radio-frequency identification (RFID) tags, which have several advantages over a more traditional label-based approach to accessioning.<sup id=\"rdp-ebb-cite_ref-ALRFID_43-0\" class=\"reference\"><a href=\"#cite_note-ALRFID-43\" rel=\"external_link\">[43]<\/a><\/sup>\n<\/p><p>Barcode support and <a href=\"https:\/\/www.limswiki.org\/index.php\/ELN_feature#Label_support\" title=\"ELN feature\" target=\"_blank\" class=\"wiki-link\" data-key=\"ca0b39bae009797fe0b5600557171f11\">label support<\/a> are typically found together in LIS software, but not always, thus their separation into two features.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Export_to_PDF\">Export to PDF<\/span><\/h3>\n<p>A LIS with this feature is able to collect and save information into a Portable Document Format (PDF).\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Export_to_MS_Word\">Export to MS Word<\/span><\/h3>\n<p>A LIS with this feature is able to collect and save information into a Microsoft Office Word format.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Export_to_HTML_or_XML\">Export to HTML or XML<\/span><\/h3>\n<p>A LIS with this feature is able to collect and save information into a HyperText Markup Language (HTML) and\/or Extensible Markup Language (XML) format.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Fax_integration\">Fax integration<\/span><\/h3>\n<p>A LIS with this feature is able to connect with a fax machine and send information to it via manual input, automatically, and\/or at scheduled intervals.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Email_integration\">Email integration<\/span><\/h3>\n<p>A LIS with this feature is able to integrate with and use the electronic mail information exchange method to send reports, alerts, and more manually, automatically, and\/or at scheduled intervals.\n<\/p>\n<\/div>\n<p> <\/p>\n<h2><span class=\"mw-headline\" id=\"Base_functionality\">Base functionality<\/span><\/h2>\n<p><i>To hide the contents of this section for easier reading of other sections, click the \"Collapse\" link to the right.<\/i>\n<\/p>\n<div class=\"mw-collapsible\" style=\"width:100%; background-color:white;\">\n<p> <\/p>\n<h3><span class=\"mw-headline\" id=\"Administrator_management\">Administrator management<\/span><\/h3>\n<p>The administrator management tools of a LIS allows researchers to set up the software most optimally for the facility and its projects. Through the administrator management interface, other features may be accessed like setting up <a href=\"https:\/\/www.limswiki.org\/index.php\/LIS_feature#Configurable_roles_and_security\" title=\"LIS feature\" target=\"_blank\" class=\"wiki-link\" data-key=\"472befa27a67279b2d9818a15d649ef0\">user roles<\/a> and scheduling <a href=\"https:\/\/www.limswiki.org\/index.php\/LIS_feature#Automatic_data_backup\" title=\"LIS feature\" target=\"_blank\" class=\"wiki-link\" data-key=\"be1c63e511a98314049c8c1840a19f63\">automatic data backups<\/a>.\n<\/p><p>Like <a href=\"https:\/\/www.limswiki.org\/index.php\/LIS_feature#Report_printing\" title=\"LIS feature\" target=\"_blank\" class=\"wiki-link\" data-key=\"a0f5f619daf147205f94caf0ee824bb2\">report printing<\/a>, administrator management is nearly ubiquitous in laboratory informatics software, generally considered a mandatory feature. However, for the purposes of being thorough, it's important to point out its existence.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Modular\">Modular<\/span><\/h3>\n<p>This feature indicates that a LIS has an intentional modular design, which separates some functionality into manageable components of the overall system. Generally speaking, a modular design allows for 1. the structured addition of new functionality to a LIS and 2. the limiting of overall effects on the system design as new functionality is added.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Instrument_interfacing_and_management\">Instrument interfacing and management<\/span><\/h3>\n<p>In laboratories there are instruments, and with those instruments comes scientific measurements which produce data. It's therefor natural a researcher would want to connect those instruments to a laboratory information system, which is already organizing and storing laboratory data for hospitals and medical research facilities. This sort of interfacing is typically handled with instrument-to-software interfaces, which started out as merely data-transfer mechanisms. Later that interface mechanism became much more robust as a data management tool, though often at great expense with heavy involvement from third parties.<sup id=\"rdp-ebb-cite_ref-SciCompInstr_44-0\" class=\"reference\"><a href=\"#cite_note-SciCompInstr-44\" rel=\"external_link\">[44]<\/a><\/sup> Today, \"vendors can act as single source providers of the entire instrument interfacing solution,\"<sup id=\"rdp-ebb-cite_ref-45\" class=\"reference\"><a href=\"#cite_note-45\" rel=\"external_link\">[45]<\/a><\/sup>, providing a cheaper and smoother solution to laboratory informatics customers. In the clinical laboratory setting, a LIS vendor may have additional considerations to make, such as <a href=\"https:\/\/www.limswiki.org\/index.php\/Health_Level_7\" title=\"Health Level 7\" target=\"_blank\" class=\"wiki-link\" data-key=\"e0bf845fb58d2bae05a846b47629e86f\">Health Level 7<\/a> (HL7) triggers, messages, and segments transported across communication interfaces.<sup id=\"rdp-ebb-cite_ref-HL7Auto_46-0\" class=\"reference\"><a href=\"#cite_note-HL7Auto-46\" rel=\"external_link\">[46]<\/a><\/sup>\n<\/p>\n<div class=\"thumb tleft\"><div class=\"thumbinner\" style=\"width:182px;\">File:Mobile devices DSC 0988.JPG <div class=\"thumbcaption\">In some cases mobile devices like these may access and utilize a LIS, typically through a Web portal or special mobile version of the software.<\/div><\/div><\/div>\n<h3><span class=\"mw-headline\" id=\"Mobile_device_integration\">Mobile device integration<\/span><\/h3>\n<p>While not ubiquitous by any means, LIS developers are increasingly including support for mobile devices in their software, usually in the form of a separate mobile version of the software. Research and development labs, for example, potentially can put mobile technology to use in the laboratory as remotely monitoring a lab or using mobile phone microscopy.<sup id=\"rdp-ebb-cite_ref-SLASMobileDevs_47-0\" class=\"reference\"><a href=\"#cite_note-SLASMobileDevs-47\" rel=\"external_link\">[47]<\/a><\/sup> Those uses aside, the relatively simple action of recording and reviewing laboratory research results while on the move or at a conference gives researchers flexibility, and LIS developers like <a href=\"https:\/\/www.limswiki.org\/index.php\/McKesson_Corporation\" title=\"McKesson Corporation\" target=\"_blank\" class=\"wiki-link\" data-key=\"fbbabd25f3d7fe9c82924c55dfa8d44c\">McKesson<\/a> are beginning to include that functionality.<sup id=\"rdp-ebb-cite_ref-McKMobilePhleb_48-0\" class=\"reference\"><a href=\"#cite_note-McKMobilePhleb-48\" rel=\"external_link\">[48]<\/a><\/sup>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Third-party_software_integration\">Third-party software integration<\/span><\/h3>\n<p>A few LIS vendors either incorporate third-party software into their product or they provide the means to integrate the LIS with other applications. The most typical integration involves simply communicating with common authoring tools like Microsoft Word, allowing users to work directly from the third-party application and then transferring the information to the LIS.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Alarms_and.2For_alerts\">Alarms and\/or alerts<\/span><\/h3>\n<p>Alarms and alerts in a LIS can be automatic or scheduled, and they can come in the form of an e-mail, a pop-up message, or a mobile text message. For example, when a test result goes out-of-range, an automatic warning message can appear on the screen of the lab analyst responsible for the test. Another example: a scheduled alert can be e-mailed to a lab technician every month indicating a piece of laboratory equipment needs routine maintenance. Both scenarios represent a tiny fraction of the possible implementation of alarms and alerts in a LIS, highlighting how powerful (yet easy to take for granted) this feature is.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Work-related_time_tracking\">Work-related time tracking<\/span><\/h3>\n<p>This feature specifically refers to a LIS' ability to track the amount of time an employee spends at work in general (for payroll purposes) or on more specific projects and tasks (as part of an employee work evaluation program). May also be referred to as \"workload tracking\" or \"workload tracking.\"\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Voice_recognition_system\">Voice recognition system<\/span><\/h3>\n<p>A LIS with this feature allows some functions of the software (for example, accessing test results) to be accessed via voice commands.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"External_monitoring\">External monitoring<\/span><\/h3>\n<p>This feature allows clients and\/or collaborators outside the laboratory to monitor the status of experiments, test results, and more via an online web portal or, less commonly, as activity alerts sent via e-mail or SMS.\n<\/p>\n<div class=\"thumb tleft\"><div class=\"thumbinner\" style=\"width:217px;\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Example_of_Telecommunication_Presence_Information.png\" class=\"image wiki-link\" target=\"_blank\" data-key=\"4ae3b5e41e0c11ff4ca1baf0b7d4352f\"><img alt=\"\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/b\/b6\/Example_of_Telecommunication_Presence_Information.png\" width=\"215\" height=\"243\" class=\"thumbimage\" \/><\/a> <div class=\"thumbcaption\"><div class=\"magnify\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Example_of_Telecommunication_Presence_Information.png\" class=\"internal wiki-link\" title=\"Enlarge\" target=\"_blank\" data-key=\"4ae3b5e41e0c11ff4ca1baf0b7d4352f\"><\/a><\/div>An instant messaging client built into a LIS often makes it easier to collaborate.<\/div><\/div><\/div>\n<h3><span class=\"mw-headline\" id=\"Messaging\">Messaging<\/span><\/h3>\n<p>The messaging feature of a LIS may refer to one of two (or both) things:\n<\/p>\n<ul><li> a built-in instant messaging system that allows users to converse with each other through text messages real-time<\/li>\n<li> an SMS text messaging integration that allows the users or the LIS itself to send messages or alerts to one or more user's mobile or smart phone<\/li><\/ul>\n<h3><span class=\"mw-headline\" id=\"Commenting\">Commenting<\/span><\/h3>\n<p>Clinical data collection and research collaboration require data sharing and communication tools to be most effective. One of the collaborative communication features of some LISs is commenting on test results, patient records, or study protocols.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Multilingual\">Multilingual<\/span><\/h3>\n<p>If a LIS is listed as multilingual, its an indication the software interface can be configured to display more than one language depending on the preference a user or administrator chooses. Some LIS interfaces can only be displayed in one of two languages (English or German, for example), while others come configured with support for dozens of languages.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Network-capable\">Network-capable<\/span><\/h3>\n<p>This feature is perhaps archaic and\/or obvious, but it is mentioned nonetheless. It's generally applied to a non-web-based LIS installed over a local or wide-area computer network, essentially indicating the LIS is not an isolated application, but rather one that can interface with other instances or other networked instruments.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Web_client_or_portal\">Web client or portal<\/span><\/h3>\n<p>A LIS with a web client or portal is either a web-based LIS (one that is not installed on every computer, but rather is hosted on a server and accessed via a web browser) or a non-web-based LIS with an included portal to access it via the Internet.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Online_or_integrated_help\">Online or integrated help<\/span><\/h3>\n<p>This indicates a LIS has help infrastructure integrated into the software, support documentation via the vendor's website, or both.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Software_as_a_service_delivery_model\">Software as a service delivery model<\/span><\/h3>\n<p>This indicates the software can be licensed and utilized via the <a href=\"https:\/\/www.limswiki.org\/index.php\/Software_as_a_service\" title=\"Software as a service\" target=\"_blank\" class=\"wiki-link\" data-key=\"ae8c8a7cd5ee1a264f4f0bbd4a4caedd\">software as a service<\/a> (SaaS) delivery model.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Usage-based_cost\">Usage-based cost<\/span><\/h3>\n<p>While rare, some software vendors allow potential clients to license and utilize the vendor's software under a usage-based cost model. An example of this model in use is Bytewize AB's <a href=\"https:\/\/www.limswiki.org\/index.php\/Bytewize_AB#O3_Lims_and_O3_LimsXpress\" title=\"Bytewize AB\" target=\"_blank\" class=\"wiki-link\" data-key=\"65bc566848b41a14e430d1bedd8eb6ac\">O3 LimsXpress<\/a>, which has a cost directly related to the amount of samples processed each month.<sup id=\"rdp-ebb-cite_ref-O3Prices_49-0\" class=\"reference\"><a href=\"#cite_note-O3Prices-49\" rel=\"external_link\">[49]<\/a><\/sup>\n<\/p>\n<\/div>\n<p> <\/p>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-count references-column-count-2\" style=\"-moz-column-count: 2; -webkit-column-count: 2; column-count: 2; list-style-type: decimal;\">\n<ol class=\"references\">\n<li id=\"cite_note-APHLandLIS-1\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-APHLandLIS_1-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.aphl.org\/aphlprograms\/global\/initiatives\/Documents\/LISQuickStartGuide.pdf\" target=\"_blank\">\"Quick Start Guide to Laboratory Information System (LIS) Implementation\"<\/a> (PDF). Association of Public Health Laboratories<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.aphl.org\/aphlprograms\/global\/initiatives\/Documents\/LISQuickStartGuide.pdf\" target=\"_blank\">http:\/\/www.aphl.org\/aphlprograms\/global\/initiatives\/Documents\/LISQuickStartGuide.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 27 April 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Quick+Start+Guide+to+Laboratory+Information+System+%28LIS%29+Implementation&rft.atitle=&rft.pub=Association+of+Public+Health+Laboratories&rft_id=http%3A%2F%2Fwww.aphl.org%2Faphlprograms%2Fglobal%2Finitiatives%2FDocuments%2FLISQuickStartGuide.pdf&rfr_id=info:sid\/en.wikipedia.org:LIS_feature\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-starlimsBlogLIS-2\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-starlimsBlogLIS_2-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Hice, Randy (01 July 2009). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/blog.starlims.com\/2009\/07\/01\/swimming-in-the-clinical-pool-why-lims-are-supplanting-old-school-clinical-lis-applications\/\" target=\"_blank\">\"Swimming in the Clinical Pool: Why LIMS are supplanting old-school clinical LIS applications\"<\/a>. STARLIMS' Laboratory Informatics Blog<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/blog.starlims.com\/2009\/07\/01\/swimming-in-the-clinical-pool-why-lims-are-supplanting-old-school-clinical-lis-applications\/\" target=\"_blank\">http:\/\/blog.starlims.com\/2009\/07\/01\/swimming-in-the-clinical-pool-why-lims-are-supplanting-old-school-clinical-lis-applications\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 27 April 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Swimming+in+the+Clinical+Pool%3A+Why+LIMS+are+supplanting+old-school+clinical+LIS+applications&rft.atitle=&rft.aulast=Hice%2C+Randy&rft.au=Hice%2C+Randy&rft.date=01+July+2009&rft.pub=STARLIMS%27+Laboratory+Informatics+Blog&rft_id=http%3A%2F%2Fblog.starlims.com%2F2009%2F07%2F01%2Fswimming-in-the-clinical-pool-why-lims-are-supplanting-old-school-clinical-lis-applications%2F&rfr_id=info:sid\/en.wikipedia.org:LIS_feature\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-HowDoIFindLII-3\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-HowDoIFindLII_3-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/files.limstitute.com\/share\/lbgprofiles\/findlims.pdf\" target=\"_blank\">\"How Do I Find the Right LIMS \u2014 And How Much Will It Cost?\"<\/a> (PDF). Laboratory Informatics Institute, Inc<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/files.limstitute.com\/share\/lbgprofiles\/findlims.pdf\" target=\"_blank\">http:\/\/files.limstitute.com\/share\/lbgprofiles\/findlims.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 27 April 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=How+Do+I+Find+the+Right+LIMS+%E2%80%94+And+How+Much+Will+It+Cost%3F&rft.atitle=&rft.pub=Laboratory+Informatics+Institute%2C+Inc&rft_id=http%3A%2F%2Ffiles.limstitute.com%2Fshare%2Flbgprofiles%2Ffindlims.pdf&rfr_id=info:sid\/en.wikipedia.org:LIS_feature\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-biohealth-4\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-biohealth_4-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.biohealthmatics.com\/technologies\/his\/lis.aspx\" target=\"_blank\">\"Laboratory Information Systems\"<\/a>. Biohealthmatics.com. 10 August 2006<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.biohealthmatics.com\/technologies\/his\/lis.aspx\" target=\"_blank\">http:\/\/www.biohealthmatics.com\/technologies\/his\/lis.aspx<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 27 April 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Laboratory+Information+Systems&rft.atitle=&rft.date=10+August+2006&rft.pub=Biohealthmatics.com&rft_id=http%3A%2F%2Fwww.biohealthmatics.com%2Ftechnologies%2Fhis%2Flis.aspx&rfr_id=info:sid\/en.wikipedia.org:LIS_feature\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-MolPath-5\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-MolPath_5-0\" rel=\"external_link\">5.0<\/a><\/sup> <sup><a href=\"#cite_ref-MolPath_5-1\" rel=\"external_link\">5.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation book\">Leonard, Debra G. B.; Bagg, Adam, ed. (2007). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/books.google.com\/books?id=Z2YNhh51SmQC&pg=PA567\" target=\"_blank\"><i>Molecular Pathology in Clinical Practice<\/i><\/a> (Illustrated ed.). Springer. p. 567. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" target=\"_blank\">ISBN<\/a> 0387332278<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/books.google.com\/books?id=Z2YNhh51SmQC&pg=PA567\" target=\"_blank\">http:\/\/books.google.com\/books?id=Z2YNhh51SmQC&pg=PA567<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 27 April 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Molecular+Pathology+in+Clinical+Practice&rft.date=2007&rft.pages=p.%26nbsp%3B567&rft.edition=Illustrated&rft.pub=Springer&rft.isbn=0387332278&rft_id=http%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DZ2YNhh51SmQC%26pg%3DPA567&rfr_id=info:sid\/en.wikipedia.org:LIS_feature\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-PPDiClinTrial-6\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-PPDiClinTrial_6-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ppdi.com\/Services\/Laboratories\/Central-Labs\/Operational-Excellence\/Specimen-Management.aspx\" target=\"_blank\">\"PPD - Clinical Trial Sample Management\"<\/a>. Pharmaceutical Product Development, LLC<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.ppdi.com\/Services\/Laboratories\/Central-Labs\/Operational-Excellence\/Specimen-Management.aspx\" target=\"_blank\">http:\/\/www.ppdi.com\/Services\/Laboratories\/Central-Labs\/Operational-Excellence\/Specimen-Management.aspx<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 27 April 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=PPD+-+Clinical+Trial+Sample+Management&rft.atitle=&rft.pub=Pharmaceutical+Product+Development%2C+LLC&rft_id=http%3A%2F%2Fwww.ppdi.com%2FServices%2FLaboratories%2FCentral-Labs%2FOperational-Excellence%2FSpecimen-Management.aspx&rfr_id=info:sid\/en.wikipedia.org:LIS_feature\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-LabTechBook-7\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-LabTechBook_7-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Esteridge, Barbara H.; Reynolds, Anna P.; Walters, Norma J. (2000). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/books.google.com\/books?id=qMgAbOHSlsMC&pg=PA8&lpg=PA8\" target=\"_blank\"><i>Basic Medical Laboratory Techniques<\/i><\/a> (4th, revised ed.). Cengage Learning. p. 8. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" target=\"_blank\">ISBN<\/a> 0766812065<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/books.google.com\/books?id=qMgAbOHSlsMC&pg=PA8&lpg=PA8\" target=\"_blank\">http:\/\/books.google.com\/books?id=qMgAbOHSlsMC&pg=PA8&lpg=PA8<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 27 April 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Basic+Medical+Laboratory+Techniques&rft.aulast=Esteridge%2C+Barbara+H.%3B+Reynolds%2C+Anna+P.%3B+Walters%2C+Norma+J.&rft.au=Esteridge%2C+Barbara+H.%3B+Reynolds%2C+Anna+P.%3B+Walters%2C+Norma+J.&rft.date=2000&rft.pages=p.%26nbsp%3B8&rft.edition=4th%2C+revised&rft.pub=Cengage+Learning&rft.isbn=0766812065&rft_id=http%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DqMgAbOHSlsMC%26pg%3DPA8%26lpg%3DPA8&rfr_id=info:sid\/en.wikipedia.org:LIS_feature\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-ForensicSamp-8\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-ForensicSamp_8-0\" rel=\"external_link\">8.0<\/a><\/sup> <sup><a href=\"#cite_ref-ForensicSamp_8-1\" rel=\"external_link\">8.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Murthy, Tal; Brian Hewson (01 September 2010). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/new.americanlaboratory.com\/914-Application-Notes\/506-Effective-Forensic-Sample-Tracking-and-Handling\/\" target=\"_blank\">\"Effective Forensic Sample Tracking and Handling\"<\/a>. American Laboratory<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/new.americanlaboratory.com\/914-Application-Notes\/506-Effective-Forensic-Sample-Tracking-and-Handling\/\" target=\"_blank\">http:\/\/new.americanlaboratory.com\/914-Application-Notes\/506-Effective-Forensic-Sample-Tracking-and-Handling\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 10 February 2012<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Effective+Forensic+Sample+Tracking+and+Handling&rft.atitle=&rft.aulast=Murthy%2C+Tal%3B+Brian+Hewson&rft.au=Murthy%2C+Tal%3B+Brian+Hewson&rft.date=01+September+2010&rft.pub=American+Laboratory&rft_id=http%3A%2F%2Fnew.americanlaboratory.com%2F914-Application-Notes%2F506-Effective-Forensic-Sample-Tracking-and-Handling%2F&rfr_id=info:sid\/en.wikipedia.org:LIS_feature\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-PP0102-9\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-PP0102_9-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Muntean, Edwarda; Nicoleta Munteanb; Tania Mih\u0103iescua; Radu Mih\u0103iescuc (2008). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/journals.usamvcluj.ro\/index.php\/promediu\/article\/download\/2835\/2696\" target=\"_blank\">\"LIMS use in laboratory data management\"<\/a> (PDF). <i>ProEnvironment\/Promediu<\/i> <b>1<\/b> (2): 19\u201323<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/journals.usamvcluj.ro\/index.php\/promediu\/article\/download\/2835\/2696\" target=\"_blank\">http:\/\/journals.usamvcluj.ro\/index.php\/promediu\/article\/download\/2835\/2696<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=LIMS+use+in+laboratory+data+management&rft.jtitle=ProEnvironment%2FPromediu&rft.aulast=Muntean%2C+Edwarda%3B+Nicoleta+Munteanb%3B+Tania+Mih%C4%83iescua%3B+Radu+Mih%C4%83iescuc&rft.au=Muntean%2C+Edwarda%3B+Nicoleta+Munteanb%3B+Tania+Mih%C4%83iescua%3B+Radu+Mih%C4%83iescuc&rft.date=2008&rft.volume=1&rft.issue=2&rft.pages=19%E2%80%9323&rft_id=http%3A%2F%2Fjournals.usamvcluj.ro%2Findex.php%2Fpromediu%2Farticle%2Fdownload%2F2835%2F2696&rfr_id=info:sid\/en.wikipedia.org:LIS_feature\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-EPABatch-10\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-EPABatch_10-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.epa.gov\/osw\/hazard\/testmethods\/faq\/faqs_qc.htm\" target=\"_blank\">\"Batch Sizes And QC Questions\"<\/a>. U.S. EPA. 27 July 2011<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.epa.gov\/osw\/hazard\/testmethods\/faq\/faqs_qc.htm\" target=\"_blank\">http:\/\/www.epa.gov\/osw\/hazard\/testmethods\/faq\/faqs_qc.htm<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 27 April 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Batch+Sizes+And+QC+Questions&rft.atitle=&rft.date=27+July+2011&rft.pub=U.S.+EPA&rft_id=http%3A%2F%2Fwww.epa.gov%2Fosw%2Fhazard%2Ftestmethods%2Ffaq%2Ffaqs_qc.htm&rfr_id=info:sid\/en.wikipedia.org:LIS_feature\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-ILAbout-11\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-ILAbout_11-0\" rel=\"external_link\">11.0<\/a><\/sup> <sup><a href=\"#cite_ref-ILAbout_11-1\" rel=\"external_link\">11.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.elekta.com\/healthcare-professionals\/products\/elekta-software\/clinical-laboratory\/laboratory-information-system.html\" target=\"_blank\">\"Elekta - Laboratory Information System\"<\/a>. Elekta AB<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.elekta.com\/healthcare-professionals\/products\/elekta-software\/clinical-laboratory\/laboratory-information-system.html\" target=\"_blank\">http:\/\/www.elekta.com\/healthcare-professionals\/products\/elekta-software\/clinical-laboratory\/laboratory-information-system.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 27 April 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Elekta+-+Laboratory+Information+System&rft.atitle=&rft.pub=Elekta+AB&rft_id=http%3A%2F%2Fwww.elekta.com%2Fhealthcare-professionals%2Fproducts%2Felekta-software%2Fclinical-laboratory%2Flaboratory-information-system.html&rfr_id=info:sid\/en.wikipedia.org:LIS_feature\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-AnPathRev-12\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-AnPathRev_12-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Park, Seung Lyung; Pantanowitz, Liron; Sharma, Gaurav; Parwani, Anil Vasdev (March 2012). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/bpa-pathology.com\/uploads\/file\/docs\/Anatomic%20Pathology%20Laboratory%20Information%20Systems%20-%20A%20Review%20-%20SLPark%20et%20all.%20-%20Adv%20Anat%20Pathol%202012.pdf\" target=\"_blank\">\"Anatomic Pathology Laboratory Information Systems: A Review\"<\/a> (PDF). <i>Advances in Anatomic Pathology<\/i> <b>19<\/b> (2): 81\u201396. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" target=\"_blank\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1097%2FPAP.0b013e318248b787\" target=\"_blank\">10.1097\/PAP.0b013e318248b787<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/bpa-pathology.com\/uploads\/file\/docs\/Anatomic%20Pathology%20Laboratory%20Information%20Systems%20-%20A%20Review%20-%20SLPark%20et%20all.%20-%20Adv%20Anat%20Pathol%202012.pdf\" target=\"_blank\">http:\/\/bpa-pathology.com\/uploads\/file\/docs\/Anatomic%20Pathology%20Laboratory%20Information%20Systems%20-%20A%20Review%20-%20SLPark%20et%20all.%20-%20Adv%20Anat%20Pathol%202012.pdf<\/a><\/span><span class=\"reference-accessdate\">. 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Retrieved 20 February 2012<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Workflow+Management+Coalition+Terminology+%26+Glossary&rft.atitle=&rft.date=February+1999&rft.pages=pp.+9&rft.pub=Workflow+Management+Coalition&rft_id=http%3A%2F%2Fwww.wfmc.org%2Fstandards%2Fdocs%2FTC-1011_term_glossary_v3.pdf&rfr_id=info:sid\/en.wikipedia.org:LIS_feature\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-SciCompWF-26\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-SciCompWF_26-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Maxwell, Glen (1 November 2003). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.scientificcomputing.com\/using-workflows-in-lims-to-reduce.aspx\" target=\"_blank\">\"Using Workflows in LIMS to Reduce Customization\"<\/a>. Scientific Computing and Instrumentation<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.scientificcomputing.com\/using-workflows-in-lims-to-reduce.aspx\" target=\"_blank\">http:\/\/www.scientificcomputing.com\/using-workflows-in-lims-to-reduce.aspx<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 20 February 2012<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Using+Workflows+in+LIMS+to+Reduce+Customization&rft.atitle=&rft.aulast=Maxwell%2C+Glen&rft.au=Maxwell%2C+Glen&rft.date=1+November+2003&rft.pub=Scientific+Computing+and+Instrumentation&rft_id=http%3A%2F%2Fwww.scientificcomputing.com%2Fusing-workflows-in-lims-to-reduce.aspx&rfr_id=info:sid\/en.wikipedia.org:LIS_feature\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-WFLIS-27\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-WFLIS_27-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Feist, Kelly (22 July 2011). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.labcompare.com\/10-Featured-Articles\/19389-Harnessing-Laboratory-Information-Systems-to-Support-Increased-Capacity-and-Staff-Productivity\/\" target=\"_blank\">\"Harnessing Laboratory Information Systems to Support Increased Capacity and Staff Productivity\"<\/a>. LabCompare<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.labcompare.com\/10-Featured-Articles\/19389-Harnessing-Laboratory-Information-Systems-to-Support-Increased-Capacity-and-Staff-Productivity\/\" target=\"_blank\">http:\/\/www.labcompare.com\/10-Featured-Articles\/19389-Harnessing-Laboratory-Information-Systems-to-Support-Increased-Capacity-and-Staff-Productivity\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 29 April 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Harnessing+Laboratory+Information+Systems+to+Support+Increased+Capacity+and+Staff+Productivity&rft.atitle=&rft.aulast=Feist%2C+Kelly&rft.au=Feist%2C+Kelly&rft.date=22+July+2011&rft.pub=LabCompare&rft_id=http%3A%2F%2Fwww.labcompare.com%2F10-Featured-Articles%2F19389-Harnessing-Laboratory-Information-Systems-to-Support-Increased-Capacity-and-Staff-Productivity%2F&rfr_id=info:sid\/en.wikipedia.org:LIS_feature\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-ASTM_LIMS-28\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-ASTM_LIMS_28-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">\"ASTM E1578 - 06 Standard Guide for Laboratory Information Management Systems (LIMS)\"<\/a>. ASTM International<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.astm.org\/Standards\/E1578.htm\" target=\"_blank\">http:\/\/www.astm.org\/Standards\/E1578.htm<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 22 February 2012<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=ASTM+E1578+-+06+Standard+Guide+for+Laboratory+Information+Management+Systems+%28LIMS%29&rft.atitle=&rft.pub=ASTM+International&rft_id=http%3A%2F%2Fwww.astm.org%2FStandards%2FE1578.htm&rfr_id=info:sid\/en.wikipedia.org:LIS_feature\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-McKessHori-29\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-McKessHori_29-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.mckesson.com\/en_us\/McKesson.com\/For%2BHealthcare%2BProviders\/Hospitals\/Laboratory%2BSolutions\/Horizon%2BLab%2BFinancials.html\" target=\"_blank\">\"Horizon Lab Financials\"<\/a>. McKesson Corporation<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.mckesson.com\/en_us\/McKesson.com\/For%2BHealthcare%2BProviders\/Hospitals\/Laboratory%2BSolutions\/Horizon%2BLab%2BFinancials.html\" target=\"_blank\">http:\/\/www.mckesson.com\/en_us\/McKesson.com\/For%2BHealthcare%2BProviders\/Hospitals\/Laboratory%2BSolutions\/Horizon%2BLab%2BFinancials.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 29 April 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Horizon+Lab+Financials&rft.atitle=&rft.pub=McKesson+Corporation&rft_id=http%3A%2F%2Fwww.mckesson.com%2Fen_us%2FMcKesson.com%2FFor%252BHealthcare%252BProviders%2FHospitals%2FLaboratory%252BSolutions%2FHorizon%252BLab%252BFinancials.html&rfr_id=info:sid\/en.wikipedia.org:LIS_feature\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-LTELNCompPDF-30\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-LTELNCompPDF_30-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.vialis.ch\/fileadmin\/files\/imgs\/pdf\/Newsletter\/q2-09\/ELN_LAB.pdf\" target=\"_blank\">\"ELN Reduces Regulatory Compliance Costs\"<\/a> (PDF). Labtronics Inc. January 2005<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.vialis.ch\/fileadmin\/files\/imgs\/pdf\/Newsletter\/q2-09\/ELN_LAB.pdf\" target=\"_blank\">http:\/\/www.vialis.ch\/fileadmin\/files\/imgs\/pdf\/Newsletter\/q2-09\/ELN_LAB.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 12 February 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=ELN+Reduces+Regulatory+Compliance+Costs&rft.atitle=&rft.date=January+2005&rft.pub=Labtronics+Inc&rft_id=http%3A%2F%2Fwww.vialis.ch%2Ffileadmin%2Ffiles%2Fimgs%2Fpdf%2FNewsletter%2Fq2-09%2FELN_LAB.pdf&rfr_id=info:sid\/en.wikipedia.org:LIS_feature\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-KMHowELN-31\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-KMHowELN_31-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Price, Michael (17 August 2012). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.kinematik.com\/blog\/bid\/207452\/How-an-ELN-Mitigates-the-Risks-Associated-with-Regulatory-Compliance\" target=\"_blank\">\"How an ELN Mitigates the Risks Associated with Regulatory Compliance\"<\/a>. KineMatik Ltd<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.kinematik.com\/blog\/bid\/207452\/How-an-ELN-Mitigates-the-Risks-Associated-with-Regulatory-Compliance\" target=\"_blank\">http:\/\/www.kinematik.com\/blog\/bid\/207452\/How-an-ELN-Mitigates-the-Risks-Associated-with-Regulatory-Compliance<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 12 February 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=How+an+ELN+Mitigates+the+Risks+Associated+with+Regulatory+Compliance&rft.atitle=&rft.aulast=Price%2C+Michael&rft.au=Price%2C+Michael&rft.date=17+August+2012&rft.pub=KineMatik+Ltd&rft_id=http%3A%2F%2Fwww.kinematik.com%2Fblog%2Fbid%2F207452%2FHow-an-ELN-Mitigates-the-Risks-Associated-with-Regulatory-Compliance&rfr_id=info:sid\/en.wikipedia.org:LIS_feature\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-BioITNewELNS-32\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-BioITNewELNS_32-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Proffitt, Allison (22 February 2012). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.bio-itworld.com\/2012\/02\/22\/eln-excellence-new-lab-notebooks.html\" target=\"_blank\">\"ELN Excellence: The New Lab Notebooks\"<\/a>. BioIT World<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.bio-itworld.com\/2012\/02\/22\/eln-excellence-new-lab-notebooks.html\" target=\"_blank\">http:\/\/www.bio-itworld.com\/2012\/02\/22\/eln-excellence-new-lab-notebooks.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 12 February 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=ELN+Excellence%3A+The+New+Lab+Notebooks&rft.atitle=&rft.aulast=Proffitt%2C+Allison&rft.au=Proffitt%2C+Allison&rft.date=22+February+2012&rft.pub=BioIT+World&rft_id=http%3A%2F%2Fwww.bio-itworld.com%2F2012%2F02%2F22%2Feln-excellence-new-lab-notebooks.html&rfr_id=info:sid\/en.wikipedia.org:LIS_feature\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-RandomQAPaper-33\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-RandomQAPaper_33-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Owens, S.R.; Dhir, R.; Yousem, S.A.; Kelly, S.M.; Piccoli, A.; Wiehagen, L.; Lassige, K.; Parwani, A.V. (June 2010). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/20472840\" target=\"_blank\">\"The development and testing of a laboratory information system-driven tool for pre-sign-out quality assurance of random surgical pathology reports\"<\/a>. <i>American Journal of Clinical Pathology<\/i> <b>133<\/b> (6): 836\u201341. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" target=\"_blank\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1309%2FAJCPLN9DU9LNXSXA\" target=\"_blank\">10.1309\/AJCPLN9DU9LNXSXA<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/20472840\" target=\"_blank\">http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/20472840<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 29 April 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=The+development+and+testing+of+a+laboratory+information+system-driven+tool+for+pre-sign-out+quality+assurance+of+random+surgical+pathology+reports&rft.jtitle=American+Journal+of+Clinical+Pathology&rft.aulast=Owens%2C+S.R.%3B+Dhir%2C+R.%3B+Yousem%2C+S.A.%3B+Kelly%2C+S.M.%3B+Piccoli%2C+A.%3B+Wiehagen%2C+L.%3B+Lassige%2C+K.%3B+Parwani%2C+A.V.&rft.au=Owens%2C+S.R.%3B+Dhir%2C+R.%3B+Yousem%2C+S.A.%3B+Kelly%2C+S.M.%3B+Piccoli%2C+A.%3B+Wiehagen%2C+L.%3B+Lassige%2C+K.%3B+Parwani%2C+A.V.&rft.date=June+2010&rft.volume=133&rft.issue=6&rft.pages=836%E2%80%9341&rft_id=info:doi\/10.1309%2FAJCPLN9DU9LNXSXA&rft_id=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fpubmed%2F20472840&rfr_id=info:sid\/en.wikipedia.org:LIS_feature\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-NLQC-34\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-NLQC_34-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.netlims.com\/lis_software_autoquality.asp\" target=\"_blank\">\"Netlims - AutoQuality\"<\/a>. NeTLIMS NJ, LLC<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.netlims.com\/lis_software_autoquality.asp\" target=\"_blank\">http:\/\/www.netlims.com\/lis_software_autoquality.asp<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 29 April 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Netlims+-+AutoQuality&rft.atitle=&rft.pub=NeTLIMS+NJ%2C+LLC&rft_id=http%3A%2F%2Fwww.netlims.com%2Flis_software_autoquality.asp&rfr_id=info:sid\/en.wikipedia.org:LIS_feature\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-Clin1-35\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-Clin1_35-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.clin1.net\/Quality_Control.htm\" target=\"_blank\">\"CLIN1 Laboratory Quality Control Software\"<\/a>. Clin1, LLC<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.clin1.net\/Quality_Control.htm\" target=\"_blank\">http:\/\/www.clin1.net\/Quality_Control.htm<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 29 April 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=CLIN1+Laboratory+Quality+Control+Software&rft.atitle=&rft.pub=Clin1%2C+LLC&rft_id=http%3A%2F%2Fwww.clin1.net%2FQuality_Control.htm&rfr_id=info:sid\/en.wikipedia.org:LIS_feature\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-36\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-36\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/ecfr.gpoaccess.gov\/cgi\/t\/text\/text-idx?c=ecfr&sid=5ff3a0efed913ef8fae9e225869688a2&rgn=div5&view=text&node=21:1.0.1.1.7&idno=21\" target=\"_blank\">\"Electronic Code of Federal Regulations - Title 21: Food and Drugs - Part 11: Electronic Records; Electronic Signatures\"<\/a>. U.S. Government Printing Office<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/ecfr.gpoaccess.gov\/cgi\/t\/text\/text-idx?c=ecfr&sid=5ff3a0efed913ef8fae9e225869688a2&rgn=div5&view=text&node=21:1.0.1.1.7&idno=21\" target=\"_blank\">http:\/\/ecfr.gpoaccess.gov\/cgi\/t\/text\/text-idx?c=ecfr&sid=5ff3a0efed913ef8fae9e225869688a2&rgn=div5&view=text&node=21:1.0.1.1.7&idno=21<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 02 March 2012<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Electronic+Code+of+Federal+Regulations+-+Title+21%3A+Food+and+Drugs+-+Part+11%3A+Electronic+Records%3B+Electronic+Signatures&rft.atitle=&rft.pub=U.S.+Government+Printing+Office&rft_id=http%3A%2F%2Fecfr.gpoaccess.gov%2Fcgi%2Ft%2Ftext%2Ftext-idx%3Fc%3Decfr%26sid%3D5ff3a0efed913ef8fae9e225869688a2%26rgn%3Ddiv5%26view%3Dtext%26node%3D21%3A1.0.1.1.7%26idno%3D21&rfr_id=info:sid\/en.wikipedia.org:LIS_feature\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-DigForLabBook-37\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-DigForLabBook_37-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Jones, Andrew; Craig Valli (2008). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/books.google.com\/books?id=F5IU7XXKwCQC\" target=\"_blank\">\"Chapter 1: An Introduction to Digital Forensics\"<\/a>. <i>Building a Digital Forensic Laboratory: Establishing and Managing a Successful Facility<\/i>. Butterworth-Heinemann. pp. 11. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" target=\"_blank\">ISBN<\/a> 1856175103<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/books.google.com\/books?id=F5IU7XXKwCQC\" target=\"_blank\">http:\/\/books.google.com\/books?id=F5IU7XXKwCQC<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Chapter+1%3A+An+Introduction+to+Digital+Forensics&rft.atitle=Building+a+Digital+Forensic+Laboratory%3A+Establishing+and+Managing+a+Successful+Facility&rft.aulast=Jones%2C+Andrew%3B+Craig+Valli&rft.au=Jones%2C+Andrew%3B+Craig+Valli&rft.date=2008&rft.pages=pp.%26nbsp%3B11&rft.pub=Butterworth-Heinemann&rft.isbn=1856175103&rft_id=http%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DF5IU7XXKwCQC&rfr_id=info:sid\/en.wikipedia.org:LIS_feature\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-SIRFERQA-38\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-SIRFERQA_38-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/sirfer.utah.edu\/qaqc.pdf\" target=\"_blank\">\"Quality Assurance - Data Management\"<\/a> (PDF). Stable Isotope Ratio Facility for Environmental Research (SIRFER) at the University of Utah<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/sirfer.utah.edu\/qaqc.pdf\" target=\"_blank\">http:\/\/sirfer.utah.edu\/qaqc.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 07 May 2012<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Quality+Assurance+-+Data+Management&rft.atitle=&rft.pub=Stable+Isotope+Ratio+Facility+for+Environmental+Research+%28SIRFER%29+at+the+University+of+Utah&rft_id=http%3A%2F%2Fsirfer.utah.edu%2Fqaqc.pdf&rfr_id=info:sid\/en.wikipedia.org:LIS_feature\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-CompMinIndBook-39\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CompMinIndBook_39-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Hitchcock, Noel (2005). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.crcnetbase.com\/doi\/abs\/10.1201\/9781439833407.ch10\" target=\"_blank\">\"Chapter 10: Efficient utilization of LIMS data and integration with mining process management systems\"<\/a>. In Dessureault, Sean D.; Rajive Ganguli; Vladislav Kecojevic; Jami Girard Dwyer. <i>Application of Computers and Operations Research in the Mineral Industry<\/i>. Taylor & Francis. pp. 85\u201388. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" target=\"_blank\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1201%2F9781439833407.ch10\" target=\"_blank\">10.1201\/9781439833407.ch10<\/a>. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" target=\"_blank\">ISBN<\/a> 9780415374491<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.crcnetbase.com\/doi\/abs\/10.1201\/9781439833407.ch10\" target=\"_blank\">http:\/\/www.crcnetbase.com\/doi\/abs\/10.1201\/9781439833407.ch10<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Chapter+10%3A+Efficient+utilization+of+LIMS+data+and+integration+with+mining+process+management+systems&rft.atitle=Application+of+Computers+and+Operations+Research+in+the+Mineral+Industry&rft.aulast=Hitchcock%2C+Noel&rft.au=Hitchcock%2C+Noel&rft.date=2005&rft.pages=pp.%26nbsp%3B85%E2%80%9388&rft.pub=Taylor+%26+Francis&rft_id=info:doi\/10.1201%2F9781439833407.ch10&rft.isbn=9780415374491&rft_id=http%3A%2F%2Fwww.crcnetbase.com%2Fdoi%2Fabs%2F10.1201%2F9781439833407.ch10&rfr_id=info:sid\/en.wikipedia.org:LIS_feature\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-QAJournValid-40\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-QAJournValid_40-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Turner, Elizabeth; Jojean Bolton (2001). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/12553085\" target=\"_blank\">\"Required steps for the validation of a Laboratory Information Management System\"<\/a>. <i>Quality Assurance<\/i> <b>9<\/b> (3\u20134): 217\u2013224. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" target=\"_blank\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/12553085\" target=\"_blank\">12553085<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/12553085\" target=\"_blank\">http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/12553085<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Required+steps+for+the+validation+of+a+Laboratory+Information+Management+System&rft.jtitle=Quality+Assurance&rft.aulast=Turner%2C+Elizabeth%3B+Jojean+Bolton&rft.au=Turner%2C+Elizabeth%3B+Jojean+Bolton&rft.date=2001&rft.volume=9&rft.issue=3%E2%80%934&rft.pages=217%E2%80%93224&rft_id=info:pmid\/12553085&rft_id=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fpubmed%2F12553085&rfr_id=info:sid\/en.wikipedia.org:LIS_feature\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-SynRepoPaper-41\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-SynRepoPaper_41-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Amin, Waqas; Sirintrapun, S. Joseph; Parwani, Anil V. (August 2010). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.dovepress.com\/getfile.php?fileID=7293\" target=\"_blank\">\"Utility and applications of synoptic reporting in pathology\"<\/a> (PDF). <i>Open Access Bioinformatics<\/i> <b>2010<\/b> (2): 105\u201312. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" target=\"_blank\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/http%3A%2F%2Fdx.doi.org%2F10.2147%2FOAB.S12295\" target=\"_blank\">http:\/\/dx.doi.org\/10.2147\/OAB.S12295<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.dovepress.com\/getfile.php?fileID=7293\" target=\"_blank\">http:\/\/www.dovepress.com\/getfile.php?fileID=7293<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 29 April 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Utility+and+applications+of+synoptic+reporting+in+pathology&rft.jtitle=Open+Access+Bioinformatics&rft.aulast=Amin%2C+Waqas%3B+Sirintrapun%2C+S.+Joseph%3B+Parwani%2C+Anil+V.&rft.au=Amin%2C+Waqas%3B+Sirintrapun%2C+S.+Joseph%3B+Parwani%2C+Anil+V.&rft.date=August+2010&rft.volume=2010&rft.issue=2&rft.pages=105%E2%80%9312&rft_id=info:doi\/http%3A%2F%2Fdx.doi.org%2F10.2147%2FOAB.S12295&rft_id=http%3A%2F%2Fwww.dovepress.com%2Fgetfile.php%3FfileID%3D7293&rfr_id=info:sid\/en.wikipedia.org:LIS_feature\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-SCLabel-42\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-SCLabel_42-0\" rel=\"external_link\">42.0<\/a><\/sup> <sup><a href=\"#cite_ref-SCLabel_42-1\" rel=\"external_link\">42.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Gilles, Clarence (1 July 2008). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.scientificcomputing.com\/bar-code-and-sample-tracking.aspx\" target=\"_blank\">\"Bar Code and Sample Tracking: It All Starts with the Label\"<\/a>. Scientific Computing<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.scientificcomputing.com\/bar-code-and-sample-tracking.aspx\" target=\"_blank\">http:\/\/www.scientificcomputing.com\/bar-code-and-sample-tracking.aspx<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 8 May 2012<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Bar+Code+and+Sample+Tracking%3A+It+All+Starts+with+the+Label&rft.atitle=&rft.aulast=Gilles%2C+Clarence&rft.au=Gilles%2C+Clarence&rft.date=1+July+2008&rft.pub=Scientific+Computing&rft_id=http%3A%2F%2Fwww.scientificcomputing.com%2Fbar-code-and-sample-tracking.aspx&rfr_id=info:sid\/en.wikipedia.org:LIS_feature\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-ALRFID-43\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-ALRFID_43-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Davidowitz, Hanan (31 July 2012). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.americanlaboratory.com\/913-Technical-Articles\/118171-Use-of-Radio-Frequency-Identification-RFID-for-Sample-Tracking\/\" target=\"_blank\">\"Use of Radio Frequency Identification (RFID) for Sample Tracking\"<\/a>. American Laboratory<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.americanlaboratory.com\/913-Technical-Articles\/118171-Use-of-Radio-Frequency-Identification-RFID-for-Sample-Tracking\/\" target=\"_blank\">http:\/\/www.americanlaboratory.com\/913-Technical-Articles\/118171-Use-of-Radio-Frequency-Identification-RFID-for-Sample-Tracking\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 29 April 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Use+of+Radio+Frequency+Identification+%28RFID%29+for+Sample+Tracking&rft.atitle=&rft.aulast=Davidowitz%2C+Hanan&rft.au=Davidowitz%2C+Hanan&rft.date=31+July+2012&rft.pub=American+Laboratory&rft_id=http%3A%2F%2Fwww.americanlaboratory.com%2F913-Technical-Articles%2F118171-Use-of-Radio-Frequency-Identification-RFID-for-Sample-Tracking%2F&rfr_id=info:sid\/en.wikipedia.org:LIS_feature\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-SciCompInstr-44\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-SciCompInstr_44-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Pavlis, Robert (May\/June 2004). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.scientific-computing.com\/features\/feature.php?feature_id=88\" target=\"_blank\">\"Trends in instrument-to-LIMS interfacing\"<\/a>. Scientific Computing World<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.scientific-computing.com\/features\/feature.php?feature_id=88\" target=\"_blank\">http:\/\/www.scientific-computing.com\/features\/feature.php?feature_id=88<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 8 May 2012<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Trends+in+instrument-to-LIMS+interfacing&rft.atitle=&rft.aulast=Pavlis%2C+Robert&rft.au=Pavlis%2C+Robert&rft.date=May%2FJune+2004&rft.pub=Scientific+Computing+World&rft_id=http%3A%2F%2Fwww.scientific-computing.com%2Ffeatures%2Ffeature.php%3Ffeature_id%3D88&rfr_id=info:sid\/en.wikipedia.org:LIS_feature\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-45\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-45\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">DeHeer, Larry (1 October 2009). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.limsfinder.com\/BlogDetail.aspx?id=33851_0_2_0_C\" target=\"_blank\">\"Instrument Interfacing - The Great Paradox of LIMS?\"<\/a>. LIMSfinder.com<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.limsfinder.com\/BlogDetail.aspx?id=33851_0_2_0_C\" target=\"_blank\">http:\/\/www.limsfinder.com\/BlogDetail.aspx?id=33851_0_2_0_C<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 8 May 2012<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Instrument+Interfacing+-+The+Great+Paradox+of+LIMS%3F&rft.atitle=&rft.aulast=DeHeer%2C+Larry&rft.au=DeHeer%2C+Larry&rft.date=1+October+2009&rft.pub=LIMSfinder.com&rft_id=http%3A%2F%2Fwww.limsfinder.com%2FBlogDetail.aspx%3Fid%3D33851_0_2_0_C&rfr_id=info:sid\/en.wikipedia.org:LIS_feature\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-HL7Auto-46\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-HL7Auto_46-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.hl7.org\/implement\/standards\/product_brief.cfm?product_id=203\" target=\"_blank\">\"Section 3: Clinical and Administrative Domains - HL7 Version 2.7 Standard: Chapter 13 - Clinical Laboratory Automation\"<\/a>. HL7<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.hl7.org\/implement\/standards\/product_brief.cfm?product_id=203\" target=\"_blank\">http:\/\/www.hl7.org\/implement\/standards\/product_brief.cfm?product_id=203<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 29 April 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Section+3%3A+Clinical+and+Administrative+Domains+-+HL7+Version+2.7+Standard%3A+Chapter+13+-+Clinical+Laboratory+Automation&rft.atitle=&rft.pub=HL7&rft_id=http%3A%2F%2Fwww.hl7.org%2Fimplement%2Fstandards%2Fproduct_brief.cfm%3Fproduct_id%3D203&rfr_id=info:sid\/en.wikipedia.org:LIS_feature\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-SLASMobileDevs-47\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-SLASMobileDevs_47-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.eln.slas.org\/story\/1\/69-mobile-devices-on-the-move-from-laboratories-to-clinics\" target=\"_blank\">\"Mobile Devices: On the Move from Laboratories to Clinics\"<\/a>. Society for Laboratory Automation and Screening. 02 July 2012<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.eln.slas.org\/story\/1\/69-mobile-devices-on-the-move-from-laboratories-to-clinics\" target=\"_blank\">http:\/\/www.eln.slas.org\/story\/1\/69-mobile-devices-on-the-move-from-laboratories-to-clinics<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 13 February 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Mobile+Devices%3A+On+the+Move+from+Laboratories+to+Clinics&rft.atitle=&rft.date=02+July+2012&rft.pub=Society+for+Laboratory+Automation+and+Screening&rft_id=http%3A%2F%2Fwww.eln.slas.org%2Fstory%2F1%2F69-mobile-devices-on-the-move-from-laboratories-to-clinics&rfr_id=info:sid\/en.wikipedia.org:LIS_feature\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-McKMobilePhleb-48\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-McKMobilePhleb_48-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.mckesson.com\/en_us\/McKesson.com\/For%2BHealthcare%2BProviders\/Hospitals\/Laboratory%2BSolutions\/Horizon%2BMobileCare%2BPhlebotomy.html\" target=\"_blank\">\"Horizon MobileCare Phlebotomy\"<\/a>. McKesson Corporation<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.mckesson.com\/en_us\/McKesson.com\/For%2BHealthcare%2BProviders\/Hospitals\/Laboratory%2BSolutions\/Horizon%2BMobileCare%2BPhlebotomy.html\" target=\"_blank\">http:\/\/www.mckesson.com\/en_us\/McKesson.com\/For%2BHealthcare%2BProviders\/Hospitals\/Laboratory%2BSolutions\/Horizon%2BMobileCare%2BPhlebotomy.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 29 April 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Horizon+MobileCare+Phlebotomy&rft.atitle=&rft.pub=McKesson+Corporation&rft_id=http%3A%2F%2Fwww.mckesson.com%2Fen_us%2FMcKesson.com%2FFor%252BHealthcare%252BProviders%2FHospitals%2FLaboratory%252BSolutions%2FHorizon%252BMobileCare%252BPhlebotomy.html&rfr_id=info:sid\/en.wikipedia.org:LIS_feature\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-O3Prices-49\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-O3Prices_49-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.bytewize.com\/o3lims-xpress\/prices\/?lang=en\" target=\"_blank\">\"Modern web based Lims from 10 Euro cent\/sample\"<\/a>. <a href=\"https:\/\/www.limswiki.org\/index.php\/Bytewize_AB\" title=\"Bytewize AB\" target=\"_blank\" class=\"wiki-link\" data-key=\"2b7e72632dace83ccc9312311dc06e57\">Bytewize AB<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.bytewize.com\/o3lims-xpress\/prices\/?lang=en\" target=\"_blank\">http:\/\/www.bytewize.com\/o3lims-xpress\/prices\/?lang=en<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 8 May 2012<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Modern+web+based+Lims+from+10+Euro+cent%2Fsample&rft.atitle=&rft.pub=%5B%5BBytewize+AB%5D%5D&rft_id=http%3A%2F%2Fwww.bytewize.com%2Fo3lims-xpress%2Fprices%2F%3Flang%3Den&rfr_id=info:sid\/en.wikipedia.org:LIS_feature\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<\/ol><\/div>\n\n<!-- \nNewPP limit report\nCached time: 20181213192755\nCache expiry: 86400\nDynamic content: false\nCPU time usage: 2.090 seconds\nReal time usage: 10.498 seconds\nPreprocessor visited node count: 30384\/1000000\nPreprocessor generated node count: 27955\/1000000\nPost\u2010expand include size: 210534\/2097152 bytes\nTemplate argument size: 84120\/2097152 bytes\nHighest expansion depth: 14\/40\nExpensive parser function count: 0\/100\n-->\n\n<!-- \nTransclusion expansion time report (%,ms,calls,template)\n100.00% 924.672 1 - -total\n 94.22% 871.268 1 - Template:Reflist\n 81.35% 752.182 49 - Template:Citation\/core\n 60.61% 560.470 37 - Template:Cite_web\n 15.84% 146.487 8 - Template:Cite_journal\n 10.02% 92.613 4 - Template:Cite_book\n 4.17% 38.530 54 - Template:Citation\/make_link\n 2.39% 22.146 11 - Template:Citation\/identifier\n 0.90% 8.288 1 - Template:Ombox\n 0.74% 6.866 22 - Template:Hide_in_print\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:4219-0!*!0!!en!5!* and timestamp 20181213192745 and revision id 23897\n -->\n<\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LIS_feature\">https:\/\/www.limswiki.org\/index.php\/LIS_feature<\/a><\/div>\n\t\t\t\t\t\t\t\t\t\t<!-- end content -->\n\t\t\t\t\t\t\t\t\t\t<div class=\"visualClear\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t<!-- end of the left (by default at least) column -->\n\t\t<div class=\"visualClear\"><\/div>\n\t\t\t\t\t\n\t\t<\/div>\n\t\t\n\n<\/body>","23b167bed768658047c44710d3c186d1_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/0\/00\/Hospital_Laboratory.JPG","https:\/\/upload.wikimedia.org\/wikipedia\/commons\/5\/51\/Laboratory_oven_for_samples-01.jpg","https:\/\/upload.wikimedia.org\/wikipedia\/commons\/5\/58\/Analyse_residus.png","https:\/\/upload.wikimedia.org\/wikipedia\/commons\/8\/89\/Linking-Open-Data-diagram_2007-09.png","https:\/\/www.limswiki.org\/images\/thumb\/0\/01\/Process_and_data_modeling.svg\/640px-Process_and_data_modeling.svg.png","https:\/\/upload.wikimedia.org\/wikipedia\/commons\/2\/2e\/Workflow_IA.png","https:\/\/upload.wikimedia.org\/wikipedia\/commons\/2\/25\/Syvalidate_screen.jpg","https:\/\/upload.wikimedia.org\/wikipedia\/commons\/4\/44\/Scheme_reconciliation.jpg","https:\/\/upload.wikimedia.org\/wikipedia\/commons\/b\/ba\/Code_barres.png","https:\/\/upload.wikimedia.org\/wikipedia\/commons\/b\/b6\/Example_of_Telecommunication_Presence_Information.png"],"23b167bed768658047c44710d3c186d1_timestamp":1544729265,"37add65b4d1c678b382a7d4817a9cf64_type":"article","37add65b4d1c678b382a7d4817a9cf64_title":"Laboratory information system","37add65b4d1c678b382a7d4817a9cf64_url":"https:\/\/www.limswiki.org\/index.php\/Laboratory_information_system","37add65b4d1c678b382a7d4817a9cf64_plaintext":"\n\n\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\n\t\t\t\tLaboratory information system\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\tFrom LIMSWiki\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\tJump to: navigation, search\n\n\t\t\t\t\t\n\t\t\t\t\t Hospitals and labs around the world depend on a laboratory information system to manage and report patient data and test results.\nA laboratory information system (LIS) is a software system that records, manages, and stores data for clinical laboratories. A LIS has traditionally been most adept at sending laboratory test orders to lab instruments, tracking those orders, and then recording the results, typically to a searchable database.[1] The standard LIS has supported the operations of public health institutions (like hospitals and clinics) and their associated labs by managing and reporting critical data concerning \"the status of infection, immunology, and care and treatment status of patients.\"[2]\n\nContents\n\n1 History of the LIS \n2 Common LIS functions \n\n2.1 Clinical vs. anatomic pathology LIS \n\n\n3 Differences between a LIS and LIMS \n4 LIS vendors \n5 See also \n6 Further reading \n7 References \n\n\n\nHistory of the LIS \nAdvances in computational technology in the early 1960s led some to experiment with time and data management functions in the healthcare setting. Company Bolt Beranek Newman and the Massachusetts General Hospital worked together to create a system that \"included time-sharing and multiuser techniques that would later be essential to the implementation of the modern LIS.\"[3] At around the same time General Electric announced plans to program a hospital information system (HIS), though those plans eventually fell through.[4] \nAside from the Massachusetts General Hospital experiment, the idea of a software system capable of managing time and data management functions wasn't heavily explored until the late 1960s, primarily because of the lack of proper technology and of communication between providers and end-users. The development of the Massachusetts General Hospital Utility Multi-Programming System (MUMPS) in the mid-'60s certainly helped as it suddenly allowed for a multi-user interface and a hierarchical system for persistent storage of data.[3] Yet due to its advanced nature, fragmented use across multiple entities, and inherent difficulty in extracting and analyzing data from the database, development of healthcare and laboratory systems on MUMPS was sporadic at best.[4] By the 1980s, however, the advent of Structured Query Language (SQL), relational database management systems (RDBMS), and Health Level 7 (HL7) allowed software developers to expand the functionality and interoperability of the LIS, including the application of business analytics and business intelligence techniques to clinical data.[5] \nIn the early 2010s, web-based and database-centric internet applications of laboratory informatics software changed the way researchers and technicians interacted with data, with web-driven data formatting technologies like Extensible Markup Language (XML) making LIS and electronic medical record (EMR) interoperability a much-needed reality.[6] SaaS and cloud computing technologies have since further changed how the LIS is implemented, while at the same time raising new questions about security and stability.[3] \nThe modern LIS has evolved to take on new functionalities not previously seen, including configurable clinical decision support rules, system integration, laboratory outreach tools, and support for point-of-care testing (POCT) data. LIS modules have also begun to show up in EMR and EHR products, giving some laboratories the option to have an enterprise-wide solution that can cover multiple aspects of the lab.[7] Additionally, the distinction between a LIS and laboratory information management system (LIMS) has blurred somewhat, with some vendors choosing to use the \"LIMS\" acronym to market their clinical laboratory data management system. \n\nCommon LIS functions \nFunctions that a LIS has historically performed include, but are not limited to[1][7][8][9]:\n\n patient management, including admission date, admitting physician, ordering department, specimen type, etc.\n patient data tracking\n decision support, including comparisons of lab orders with their respective ICD-9 codes\n standard test ordering and specimen tracking\n test ordering for point-of-care, molecular, and genetic testing\n quality assurance\n workload and management reporting\n analytical reporting\n workflow management\n billing\n third-party software integration\nClinical vs. anatomic pathology LIS \nThe laboratory information system has been primarily segmented into two broad categories (though other variations exist): the clinical pathology and anatomic pathology LIS.[8][9][10]\nIn clinical pathology the chemical, hormonal, and biochemical components of body fluids are analyzed and interpreted to determine if a disease is present, while anatomic pathology tends to focus on the analysis and interpretation of a wide variety of tissue structures, from small slivers via biopsy to complete organs from a surgery or autopsy.[11] These differences may appear to be small, but the differentiation in laboratory workflow of these two medical specialties has led to the creation of different functionalities within LISs. Specimen collection, receipt, and tracking; work distribution; and report generation may vary \u2014 sometimes significantly \u2014 between the two types of labs, requiring targeted functionality in the LIS.[10][12] Other differences include[3]:\n\n Specific dictionary-driven tests are found in clinical pathology environments but not so much in anatomic pathology environments.\n Ordered anatomic pathology tests typically require more information than clinical pathology tests.\n A single anatomic pathology order may be comprised of several tissues from several organs; clinical pathology orders usually do not.\n Anatomic pathology specimen collection may be a very procedural, multi-step processes, while clinical pathology specimen collection is routinely more simple.\nDifferences between a LIS and LIMS \nThere is often confusion regarding the difference between a LIS and a LIMS. While the two laboratory informatics components are related, their purposes diverged early in their existences. Up until recently, the LIS and LIMS have exhibited a few key differences[13]:\n1. A LIS has been designed primarily for processing and reporting data related to individual patients in a clinical setting. A LIMS has traditionally been designed to process and report data related to batches of samples from drug trials, water treatment facilities, and other entities that handle complex batches of data.[14][15]\n2. A LIS must satisfy the reporting and auditing needs of hospital accreditation agencies, HIPAA, and other clinical medical practitioners. A LIMS, however, needs to satisfy good manufacturing practice (GMP) and meet the reporting and audit needs of the U.S. Food and Drug Administration and research scientists in many different industries.[14]\n3. A LIS is usually most competitive in patient-centric settings (dealing with \"subjects\" and \"specimens\") and clinical labs, whereas a LIMS is most competitive in group-centric settings (dealing with \"batches\" and \"samples\") that often deal with mostly anonymous research-specific laboratory data.[15][16][17]\nHowever, these distinctions began to fade somewhat in the early 2010s as some LIMS vendors began to adopt the case-centric information management normally reserved for a LIS, blurring the lines between the two components further.[17] Thermo Scientific's Clinical LIMS was an example of this merger of the LIS with LIMS, with Dave Champagne, informatics vice president and general manager, stating: \"Routine molecular diagnostics requires a convergence of the up-to-now separate systems that have managed work in the lab (the LIMS) and the clinic (the LIS). The industry is asking for, and the science is requiring, a single lab-centric solution that delivers patient-centric results.\"[18] Abbott Informatics Corporation's STARLIMS product was another example of this LIS\/LIMS merger.[13] With the distinction between the two entities becoming less clear, discussions within the laboratory informatics community began to includes the question of whether or not the two entities should be considered the same.[19][20] As of 2017[update], vendors continue to recognize the historical differences between the two products while also continuing to acknowledge that some developed LIMS are taking on more of the clinical aspects usually reserved for a LIS.[21][22][23]\n\nLIS vendors \nSee the LIS vendor page for a list of LIS vendors past and present.\n\nSee also \nLaboratory informatics\nCommon LIS features\nFurther reading \n Henricks, W.H. (09 October 2012). \"LIS Basics: CP and AP LIS Design and Operations\" (PDF). Pathology Informatics 2012. University of Pittsburgh. http:\/\/www.pathinformatics.pitt.edu\/sites\/default\/files\/2012Powerpoints\/01HenricksTues.pdf .   \n Park, S.L.; Pantanowitz, L.; Sharma, G.; Parwani, A.V. (2012). \"Anatomic Pathology Laboratory Information Systems: A Review\". Advances in Anatomic Pathology 19 (2): 81\u201396. doi:10.1097\/PAP.0b013e318248b787.   \nReferences \n\n\n\u2191 1.0 1.1 \"Laboratory Information Systems\". Biohealthmatics.com. Biomedical Informatics Ltd. 10 August 2006. http:\/\/www.biohealthmatics.com\/technologies\/his\/lis.aspx . Retrieved 06 May 2011 .   \n\n\u2191 \"Quick Start Guide to Laboratory Information System (LIS) Implementation\" (PDF). Association of Public Health Laboratories. October 2005. https:\/\/www.aphl.org\/MRC\/Documents\/GH_2005Oct_LIS-Quick-Start-Guide.pdf . Retrieved 19 September 2017 .   \n\n\u2191 3.0 3.1 3.2 3.3 Park, S.L.; Pantanowitz, L.; Sharma, G.; Parwani, A.V. (2012). \"Anatomic Pathology Laboratory Information Systems: A Review\". Advances in Anatomic Pathology 19 (2): 81\u201396. doi:10.1097\/PAP.0b013e318248b787.   \n\n\u2191 4.0 4.1 Blum, B.I.; Duncan, K.A. (1990). A History of Medical Informatics. ACM Press. pp. 141\u201353. ISBN 9780201501287. http:\/\/books.google.com\/books\/about\/A_History_of_medical_informatics.html?id=AR5rAAAAMAAJ .   \n\n\u2191 Sinard, J.H. (2006). Practical Pathology Informatics: Demstifying Informatics for the Practicing Anatomic Pathologist. Springer. pp. 393. ISBN 0387280588. https:\/\/books.google.com\/books?id=WerUyK618fcC .   \n\n\u2191 Kumar, S.; Aldrich, K. (2011). \"Overcoming barriers to electronic medical record (EMR) implementation in the US healthcare system: A comparative study\". Health Informatics Journal 16 (4). doi:10.1177\/1460458210380523.   \n\n\u2191 7.0 7.1 Futrell, K. (23 January 2017). \"What's new in today's LIS?\". Medical Laboratory Observer. NP Communications, LLC. https:\/\/www.mlo-online.com\/what%E2%80%99s-new-today%E2%80%99s-lis . Retrieved 19 September 2017 .   \n\n\u2191 8.0 8.1 Pantanowitz, L.; Henricks, W.H.; Beckwith, B.A. (2007). \"Medical Laboratory Informatics\". Clinics in Laboratory Medicine 27 (4): 823\u201343. doi:10.1016\/j.cll.2007.07.011.   \n\n\u2191 9.0 9.1 \"Medical laboratory informatics\". ClinfoWiki. 19 November 2011. http:\/\/clinfowiki.org\/wiki\/index.php\/Medical_laboratory_informatics . Retrieved 03 June 2013 .   \n\n\u2191 10.0 10.1 Henricks, W.H. (09 October 2012). \"LIS Basics: CP and AP LIS Design and Operations\" (PDF). Pathology Informatics 2012. University of Pittsburgh. http:\/\/www.pathinformatics.pitt.edu\/sites\/default\/files\/2012Powerpoints\/01HenricksTues.pdf . Retrieved 03 June 2013 .   \n\n\u2191 Adelman, H.C. (2009). Forensic Medicine. Infobase Publishing. pp. 3\u20134. ISBN 1438103816. https:\/\/books.google.com\/books?id=x5FftcZOv1UC&pg=PA3 . Retrieved 03 June 2013 .   \n\n\u2191 Clifford, L.-J. (01 August 2011). \"The evolving LIS needs to be \"everything\" for today's laboratories\". Medical Laboratory Observer. NP Communications, LLC. https:\/\/www.mlo-online.com\/the-evolving-lis-needs-to-be-everything-for-todays-laboratories.php . Retrieved 19 September 2017 .   \n\n\u2191 13.0 13.1 \"Adding \"Management\" to Your LIS\". STARLIMS Corporation. 2012. Archived from the original on 28 April 2014. https:\/\/web.archive.org\/web\/20140428060811\/http:\/\/www.starlims.com\/en-us\/resources\/white-papers\/lis-vs-lims\/ . Retrieved 14 September 2017 .   \n\n\u2191 14.0 14.1 Friedman, B. (04 November 2008). \"LIS vs. LIMS: It's Time to Blend the Two Types of Lab Information Systems\". Lab Soft News. http:\/\/labsoftnews.typepad.com\/lab_soft_news\/2008\/11\/liss-vs-limss-its-time-to-consider-merging-the-two-types-of-systems.html . Retrieved 07 November 2012 .   \n\n\u2191 15.0 15.1 \"LIMS\/LIS Market and POCT Supplement\". analytica-world.com. 20 February 2004. http:\/\/www.analytica-world.com\/en\/news\/35566\/lims-lis-market-and-poct-supplement.html . Retrieved 07 November 2012 .   \n\n\u2191 Friedman, B. (19 November 2008). \"LIS vs. LIMS: Some New Insights\". Lab Soft News. http:\/\/labsoftnews.typepad.com\/lab_soft_news\/2008\/11\/lis-vs-lims.html . Retrieved 07 November 2012 .   \n\n\u2191 17.0 17.1 Hice, R. (01 July 2009). \"Swimming in the Clinical Pool: Why LIMS are supplanting old-school clinical LIS applications\". STARLIMS Corporation. Archived from the original on 13 March 2011. https:\/\/web.archive.org\/web\/20110313145726\/http:\/\/blog.starlims.com\/2009\/07\/01\/swimming-in-the-clinical-pool-why-lims-are-supplanting-old-school-clinical-lis-applications\/ . Retrieved 14 September 2017 .   \n\n\u2191 Tufel, G. (01 February 2012). \"Convergence of LIMS and LIS\". Clinical Lab Products. MEDQOR. http:\/\/www.clpmag.com\/2012\/02\/convergence-of-lims-and-lis\/ . Retrieved 14 September 2017 .   \n\n\u2191 Jones, J. (March 2012). \"What is the difference between a LIS and a LIMS?\". LinkedIn. https:\/\/www.linkedin.com\/groups\/2069898\/2069898-98494737 . Retrieved 14 September 2017 .   \n\n\u2191 Jones, John (September 2012). \"Are LIMS and LIS the same thing?\". LinkedIn. http:\/\/www.linkedin.com\/groups\/Are-LIMS-LIS-same-thing-2069898.S.147132083 . Retrieved 07 November 2012 .   \n\n\u2191 \"FAQ: What is the difference between a LIMS and a medical laboratory quality system?\". AgiLab SAS. http:\/\/agilab.com\/faq\/ . Retrieved 14 September 2017 .   \n\n\u2191 \"Difference Between LIS and LIMS\". CloudLIMS.com, LLC. 01 October 2016. https:\/\/cloudlims.com\/lims\/lims-vs-lis.html . Retrieved 14 September 2017 .   \n\n\u2191 Reisenwitz, C. (11 May 2017). \"What Is a Laboratory Information Management System?\". Capterra Medical Software Blog. Capterra, Inc. http:\/\/blog.capterra.com\/what-is-a-laboratory-information-management-system\/ . Retrieved 14 September 2017 .   \n\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_information_system\">https:\/\/www.limswiki.org\/index.php\/Laboratory_information_system<\/a>\n\t\t\t\t\tCategories: Articles containing potentially dated statements from 2017Articles with invalid date parameter in templateAll articles containing potentially dated statementsLaboratory informaticsSoftware systems\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\n\t\t\n\t\t\tNavigation menu\n\t\t\t\t\t\n\t\t\tViews\n\n\t\t\t\n\t\t\t\t\n\t\t\t\tPage\n\t\t\t\tDiscussion\n\t\t\t\tView source\n\t\t\t\tHistory\n\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\n\t\t\t\t\n\t\t\t\tPersonal tools\n\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\tLog in\n\t\t\t\t\t\t\t\t\t\t\t\t\tRequest account\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\t\t\n\t\tNavigation\n\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tMain page\n\t\t\t\t\t\t\t\t\t\t\tRecent changes\n\t\t\t\t\t\t\t\t\t\t\tRandom page\n\t\t\t\t\t\t\t\t\t\t\tHelp\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\n\t\t\t\n\t\t\tSearch\n\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t \n\t\t\t\t\t\t\n\t\t\t\t\n\n\t\t\t\t\t\t\t\n\t\t\n\t\t\t\n\t\t\tTools\n\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tWhat links here\n\t\t\t\t\t\t\t\t\t\t\tRelated changes\n\t\t\t\t\t\t\t\t\t\t\tSpecial pages\n\t\t\t\t\t\t\t\t\t\t\tPermanent link\n\t\t\t\t\t\t\t\t\t\t\tPage information\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\n\t\t\n\t\tPrint\/export\n\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tCreate a book\n\t\t\t\t\t\t\t\t\t\t\tDownload as PDF\n\t\t\t\t\t\t\t\t\t\t\tDownload as Plain text\n\t\t\t\t\t\t\t\t\t\t\tPrintable version\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\n\t\t\n\t\tSponsors\n\t\t\n\t\t\t \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n \r\n\n\t\n\t\r\n\n \r\n\n\t\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t This page was last modified on 19 September 2017, at 20:02.\n\t\t\t\t\t\t\t\t\tThis page has been accessed 38,323 times.\n\t\t\t\t\t\t\t\t\tContent is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.\n\t\t\t\t\t\t\t\t\tPrivacy policy\n\t\t\t\t\t\t\t\t\tAbout LIMSWiki\n\t\t\t\t\t\t\t\t\tDisclaimers\n\t\t\t\t\t\t\t\n\t\t\n\t\t\n\t\t\n\n","37add65b4d1c678b382a7d4817a9cf64_html":"<body class=\"mediawiki ltr sitedir-ltr ns-0 ns-subject page-Laboratory_information_system skin-monobook action-view\">\n<div id=\"rdp-ebb-globalWrapper\">\n\t\t<div id=\"rdp-ebb-column-content\">\n\t\t\t<div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\">\n\t\t\t\t<a id=\"rdp-ebb-top\"><\/a>\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Laboratory information system<\/h1>\n\t\t\t\t\n\t\t\t\t<div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\">\n\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\n\n\t\t\t\t\t<!-- start content -->\n\t\t\t\t\t<div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"thumb tright\"><div class=\"thumbinner\" style=\"width:252px;\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Nurse_ict_uganda.jpg\" class=\"image wiki-link\" target=\"_blank\" data-key=\"a8418397f19714ba4f68ec98fd183293\"><img alt=\"\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/f\/f5\/Nurse_ict_uganda.jpg\" width=\"250\" height=\"333\" class=\"thumbimage\" \/><\/a> <div class=\"thumbcaption\"><div class=\"magnify\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Nurse_ict_uganda.jpg\" class=\"internal wiki-link\" title=\"Enlarge\" target=\"_blank\" data-key=\"a8418397f19714ba4f68ec98fd183293\"><\/a><\/div>Hospitals and labs around the world depend on a laboratory information system to manage and report patient data and test results.<\/div><\/div><\/div>\n<p>A <b>laboratory information system<\/b> (LIS) is a software system that records, manages, and stores data for clinical <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory\" title=\"Laboratory\" target=\"_blank\" class=\"wiki-link\" data-key=\"c57fc5aac9e4abf31dccae81df664c33\">laboratories<\/a>. A LIS has traditionally been most adept at sending laboratory test orders to lab instruments, tracking those orders, and then recording the results, typically to a searchable database.<sup id=\"rdp-ebb-cite_ref-biohealth_1-0\" class=\"reference\"><a href=\"#cite_note-biohealth-1\" rel=\"external_link\">[1]<\/a><\/sup> The standard LIS has supported the operations of public health institutions (like <a href=\"https:\/\/www.limswiki.org\/index.php\/Hospital\" title=\"Hospital\" target=\"_blank\" class=\"wiki-link\" data-key=\"b8f070c66d8123fe91063594befebdff\">hospitals<\/a> and clinics) and their associated labs by managing and reporting critical data concerning \"the status of infection, immunology, and care and treatment status of patients.\"<sup id=\"rdp-ebb-cite_ref-APHLLIS_2-0\" class=\"reference\"><a href=\"#cite_note-APHLLIS-2\" rel=\"external_link\">[2]<\/a><\/sup>\n<\/p>\n\n\n<h2><span class=\"mw-headline\" id=\"History_of_the_LIS\">History of the LIS<\/span><\/h2>\n<p>Advances in computational technology in the early 1960s led some to experiment with time and data management functions in the healthcare setting. Company Bolt Beranek Newman and the Massachusetts General Hospital worked together to create a system that \"included time-sharing and multiuser techniques that would later be essential to the implementation of the modern LIS.\"<sup id=\"rdp-ebb-cite_ref-APLISReview_3-0\" class=\"reference\"><a href=\"#cite_note-APLISReview-3\" rel=\"external_link\">[3]<\/a><\/sup> At around the same time General Electric announced plans to program a <a href=\"https:\/\/www.limswiki.org\/index.php\/Hospital_information_system\" title=\"Hospital information system\" target=\"_blank\" class=\"wiki-link\" data-key=\"d8385de7b1f39a39d793f8ce349b448d\">hospital information system<\/a> (HIS), though those plans eventually fell through.<sup id=\"rdp-ebb-cite_ref-HistMedInfo_4-0\" class=\"reference\"><a href=\"#cite_note-HistMedInfo-4\" rel=\"external_link\">[4]<\/a><\/sup> \n<\/p><p>Aside from the Massachusetts General Hospital experiment, the idea of a software system capable of managing time and data management functions wasn't heavily explored until the late 1960s, primarily because of the lack of proper technology and of communication between providers and end-users. The development of the Massachusetts General Hospital Utility Multi-Programming System (MUMPS) in the mid-'60s certainly helped as it suddenly allowed for a multi-user interface and a hierarchical system for persistent storage of data.<sup id=\"rdp-ebb-cite_ref-APLISReview_3-1\" class=\"reference\"><a href=\"#cite_note-APLISReview-3\" rel=\"external_link\">[3]<\/a><\/sup> Yet due to its advanced nature, fragmented use across multiple entities, and inherent difficulty in extracting and analyzing data from the database, development of healthcare and laboratory systems on MUMPS was sporadic at best.<sup id=\"rdp-ebb-cite_ref-HistMedInfo_4-1\" class=\"reference\"><a href=\"#cite_note-HistMedInfo-4\" rel=\"external_link\">[4]<\/a><\/sup> By the 1980s, however, the advent of Structured Query Language (SQL), relational database management systems (RDBMS), and <a href=\"https:\/\/www.limswiki.org\/index.php\/Health_Level_7\" title=\"Health Level 7\" target=\"_blank\" class=\"wiki-link\" data-key=\"e0bf845fb58d2bae05a846b47629e86f\">Health Level 7<\/a> (HL7) allowed software developers to expand the functionality and interoperability of the LIS, including the application of business analytics and business intelligence techniques to clinical data.<sup id=\"rdp-ebb-cite_ref-PractPathInfo_5-0\" class=\"reference\"><a href=\"#cite_note-PractPathInfo-5\" rel=\"external_link\">[5]<\/a><\/sup> \n<\/p><p>In the early 2010s, web-based and database-centric internet applications of <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_informatics\" title=\"Laboratory informatics\" target=\"_blank\" class=\"wiki-link\" data-key=\"00edfa43edcde538a695f6d429280301\">laboratory informatics<\/a> software changed the way researchers and technicians interacted with data, with web-driven data formatting technologies like <a href=\"https:\/\/www.limswiki.org\/index.php\/Extensible_Markup_Language\" title=\"Extensible Markup Language\" target=\"_blank\" class=\"wiki-link\" data-key=\"f7c17028e7fb39d8b39c6d31504411a8\">Extensible Markup Language<\/a> (XML) making LIS and <a href=\"https:\/\/www.limswiki.org\/index.php\/Electronic_medical_record\" title=\"Electronic medical record\" target=\"_blank\" class=\"wiki-link\" data-key=\"99a695d2af23397807da0537d29d0be7\">electronic medical record<\/a> (EMR) interoperability a much-needed reality.<sup id=\"rdp-ebb-cite_ref-OverBarEMR_6-0\" class=\"reference\"><a href=\"#cite_note-OverBarEMR-6\" rel=\"external_link\">[6]<\/a><\/sup> <a href=\"https:\/\/www.limswiki.org\/index.php\/Software_as_a_service\" title=\"Software as a service\" target=\"_blank\" class=\"wiki-link\" data-key=\"ae8c8a7cd5ee1a264f4f0bbd4a4caedd\">SaaS<\/a> and cloud computing technologies have since further changed how the LIS is implemented, while at the same time raising new questions about security and stability.<sup id=\"rdp-ebb-cite_ref-APLISReview_3-2\" class=\"reference\"><a href=\"#cite_note-APLISReview-3\" rel=\"external_link\">[3]<\/a><\/sup> \n<\/p><p>The modern LIS has evolved to take on new functionalities not previously seen, including configurable <a href=\"https:\/\/www.limswiki.org\/index.php\/Clinical_decision_support_system\" title=\"Clinical decision support system\" target=\"_blank\" class=\"wiki-link\" data-key=\"095141425468d057aa977016869ca37d\">clinical decision support<\/a> rules, system integration, laboratory outreach tools, and support for point-of-care testing (POCT) data. LIS modules have also begun to show up in EMR and <a href=\"https:\/\/www.limswiki.org\/index.php\/Electronic_health_record\" title=\"Electronic health record\" target=\"_blank\" class=\"wiki-link\" data-key=\"f2e31a73217185bb01389404c1fd5255\">EHR<\/a> products, giving some laboratories the option to have an enterprise-wide solution that can cover multiple aspects of the lab.<sup id=\"rdp-ebb-cite_ref-FutrellWhatsNew17_7-0\" class=\"reference\"><a href=\"#cite_note-FutrellWhatsNew17-7\" rel=\"external_link\">[7]<\/a><\/sup> Additionally, the distinction between a LIS and <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_information_management_system\" title=\"Laboratory information management system\" target=\"_blank\" class=\"wiki-link\" data-key=\"8ff56a51d34c9b1806fcebdcde634d00\">laboratory information management system<\/a> (LIMS) has blurred somewhat, with some vendors choosing to use the \"LIMS\" acronym to market their clinical laboratory data management system. \n<\/p>\n<h2><span class=\"mw-headline\" id=\"Common_LIS_functions\">Common LIS functions<\/span><\/h2>\n<p>Functions that a LIS has historically performed include, but are not limited to<sup id=\"rdp-ebb-cite_ref-biohealth_1-1\" class=\"reference\"><a href=\"#cite_note-biohealth-1\" rel=\"external_link\">[1]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-FutrellWhatsNew17_7-1\" class=\"reference\"><a href=\"#cite_note-FutrellWhatsNew17-7\" rel=\"external_link\">[7]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MedLabInfoPaper_8-0\" class=\"reference\"><a href=\"#cite_note-MedLabInfoPaper-8\" rel=\"external_link\">[8]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MedLabInfoDesc_9-0\" class=\"reference\"><a href=\"#cite_note-MedLabInfoDesc-9\" rel=\"external_link\">[9]<\/a><\/sup>:\n<\/p>\n<ul><li> patient management, including admission date, admitting physician, ordering department, specimen type, etc.<\/li>\n<li> patient data tracking<\/li>\n<li> decision support, including comparisons of lab orders with their respective <a href=\"https:\/\/www.limswiki.org\/index.php\/ICD-9\" title=\"ICD-9\" class=\"mw-redirect wiki-link\" target=\"_blank\" data-key=\"4c97d7b65be8dc20134c311ac80a2ce1\">ICD-9<\/a> codes<\/li>\n<li> standard test ordering and specimen tracking<\/li>\n<li> test ordering for point-of-care, molecular, and genetic testing<\/li>\n<li> quality assurance<\/li>\n<li> workload and management reporting<\/li>\n<li> analytical reporting<\/li>\n<li> workflow management<\/li>\n<li> billing<\/li>\n<li> third-party software integration<\/li><\/ul>\n<h3><span class=\"mw-headline\" id=\"Clinical_vs._anatomic_pathology_LIS\">Clinical vs. anatomic pathology LIS<\/span><\/h3>\n<p>The laboratory information system has been primarily segmented into two broad categories (though other variations exist): the <a href=\"https:\/\/www.limswiki.org\/index.php\/Clinical_pathology\" title=\"Clinical pathology\" target=\"_blank\" class=\"wiki-link\" data-key=\"9b0b91aa13ae0209e073db6f30493daf\">clinical pathology<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/Anatomical_pathology\" title=\"Anatomical pathology\" target=\"_blank\" class=\"wiki-link\" data-key=\"5668db6faf37e8c1432a1d7953f30cb7\">anatomic pathology<\/a> LIS.<sup id=\"rdp-ebb-cite_ref-MedLabInfoPaper_8-1\" class=\"reference\"><a href=\"#cite_note-MedLabInfoPaper-8\" rel=\"external_link\">[8]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MedLabInfoDesc_9-1\" class=\"reference\"><a href=\"#cite_note-MedLabInfoDesc-9\" rel=\"external_link\">[9]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-CPAPLISDiffs_10-0\" class=\"reference\"><a href=\"#cite_note-CPAPLISDiffs-10\" rel=\"external_link\">[10]<\/a><\/sup>\n<\/p><p>In clinical pathology the chemical, hormonal, and biochemical components of body fluids are analyzed and interpreted to determine if a disease is present, while anatomic pathology tends to focus on the analysis and interpretation of a wide variety of tissue structures, from small slivers via biopsy to complete organs from a surgery or autopsy.<sup id=\"rdp-ebb-cite_ref-ForensicMedBook_11-0\" class=\"reference\"><a href=\"#cite_note-ForensicMedBook-11\" rel=\"external_link\">[11]<\/a><\/sup> These differences may appear to be small, but the differentiation in laboratory workflow of these two medical specialties has led to the creation of different functionalities within LISs. Specimen collection, receipt, and tracking; work distribution; and report generation may vary \u2014 sometimes significantly \u2014 between the two types of labs, requiring targeted functionality in the LIS.<sup id=\"rdp-ebb-cite_ref-CPAPLISDiffs_10-1\" class=\"reference\"><a href=\"#cite_note-CPAPLISDiffs-10\" rel=\"external_link\">[10]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-EvolvingLIS_12-0\" class=\"reference\"><a href=\"#cite_note-EvolvingLIS-12\" rel=\"external_link\">[12]<\/a><\/sup> Other differences include<sup id=\"rdp-ebb-cite_ref-APLISReview_3-3\" class=\"reference\"><a href=\"#cite_note-APLISReview-3\" rel=\"external_link\">[3]<\/a><\/sup>:\n<\/p>\n<ul><li> Specific dictionary-driven tests are found in clinical pathology environments but not so much in anatomic pathology environments.<\/li>\n<li> Ordered anatomic pathology tests typically require more <a href=\"https:\/\/www.limswiki.org\/index.php\/Information\" title=\"Information\" target=\"_blank\" class=\"wiki-link\" data-key=\"6300a14d9c2776dcca0999b5ed940e7d\">information<\/a> than clinical pathology tests.<\/li>\n<li> A single anatomic pathology order may be comprised of several tissues from several organs; clinical pathology orders usually do not.<\/li>\n<li> Anatomic pathology specimen collection may be a very procedural, multi-step processes, while clinical pathology specimen collection is routinely more simple.<\/li><\/ul>\n<h2><span class=\"mw-headline\" id=\"Differences_between_a_LIS_and_LIMS\">Differences between a LIS and LIMS<\/span><\/h2>\n<p>There is often confusion regarding the difference between a LIS and a LIMS. While the two laboratory informatics components are related, their purposes diverged early in their existences. Up until recently, the LIS and LIMS have exhibited a few key differences<sup id=\"rdp-ebb-cite_ref-StarlimsLimsLis_13-0\" class=\"reference\"><a href=\"#cite_note-StarlimsLimsLis-13\" rel=\"external_link\">[13]<\/a><\/sup>:\n<\/p><p>1. A LIS has been designed primarily for processing and reporting data related to individual patients in a clinical setting. A LIMS has traditionally been designed to process and report data related to batches of samples from drug trials, water treatment facilities, and other entities that handle complex batches of data.<sup id=\"rdp-ebb-cite_ref-lislims1_14-0\" class=\"reference\"><a href=\"#cite_note-lislims1-14\" rel=\"external_link\">[14]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-analytica_15-0\" class=\"reference\"><a href=\"#cite_note-analytica-15\" rel=\"external_link\">[15]<\/a><\/sup>\n<\/p><p>2. A LIS must satisfy the reporting and auditing needs of hospital accreditation agencies, <a href=\"https:\/\/www.limswiki.org\/index.php\/HIPAA\" title=\"HIPAA\" class=\"mw-redirect wiki-link\" target=\"_blank\" data-key=\"70050974d1eda9ff8cf9ecf7e4fcd015\">HIPAA<\/a>, and other clinical medical practitioners. A LIMS, however, needs to satisfy <a href=\"https:\/\/www.limswiki.org\/index.php\/Good_manufacturing_practice\" title=\"Good manufacturing practice\" target=\"_blank\" class=\"wiki-link\" data-key=\"50b520c825b1702be310362c66e0343f\">good manufacturing practice<\/a> (GMP) and meet the reporting and audit needs of the U.S. <a href=\"https:\/\/www.limswiki.org\/index.php\/Food_and_Drug_Administration\" title=\"Food and Drug Administration\" target=\"_blank\" class=\"wiki-link\" data-key=\"e2be8927071ac419c0929f7aa1ede7fe\">Food and Drug Administration<\/a> and research scientists in many different industries.<sup id=\"rdp-ebb-cite_ref-lislims1_14-1\" class=\"reference\"><a href=\"#cite_note-lislims1-14\" rel=\"external_link\">[14]<\/a><\/sup>\n<\/p><p>3. A LIS is usually most competitive in patient-centric settings (dealing with \"subjects\" and \"specimens\") and clinical labs, whereas a LIMS is most competitive in group-centric settings (dealing with \"batches\" and \"samples\") that often deal with mostly anonymous research-specific laboratory data.<sup id=\"rdp-ebb-cite_ref-analytica_15-1\" class=\"reference\"><a href=\"#cite_note-analytica-15\" rel=\"external_link\">[15]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-lislims2_16-0\" class=\"reference\"><a href=\"#cite_note-lislims2-16\" rel=\"external_link\">[16]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-starlims_17-0\" class=\"reference\"><a href=\"#cite_note-starlims-17\" rel=\"external_link\">[17]<\/a><\/sup>\n<\/p><p>However, these distinctions began to fade somewhat in the early 2010s as some LIMS vendors began to adopt the case-centric information management normally reserved for a LIS, blurring the lines between the two components further.<sup id=\"rdp-ebb-cite_ref-starlims_17-1\" class=\"reference\"><a href=\"#cite_note-starlims-17\" rel=\"external_link\">[17]<\/a><\/sup> <a href=\"https:\/\/www.limswiki.org\/index.php\/Thermo_Scientific\" title=\"Thermo Scientific\" target=\"_blank\" class=\"wiki-link\" data-key=\"e914753f99d483d4577b35fed71b3c94\">Thermo Scientific<\/a>'s Clinical LIMS was an example of this merger of the LIS with LIMS, with Dave Champagne, informatics vice president and general manager, stating: \"Routine molecular diagnostics requires a convergence of the up-to-now separate systems that have managed work in the lab (the LIMS) and the clinic (the LIS). The industry is asking for, and the science is requiring, a single lab-centric solution that delivers patient-centric results.\"<sup id=\"rdp-ebb-cite_ref-ConvergeLimsLis_18-0\" class=\"reference\"><a href=\"#cite_note-ConvergeLimsLis-18\" rel=\"external_link\">[18]<\/a><\/sup> <a href=\"https:\/\/www.limswiki.org\/index.php\/Abbott_Informatics_Corporation\" title=\"Abbott Informatics Corporation\" target=\"_blank\" class=\"wiki-link\" data-key=\"90479bab12020c96864541696a62156f\">Abbott Informatics Corporation<\/a>'s STARLIMS product was another example of this LIS\/LIMS merger.<sup id=\"rdp-ebb-cite_ref-StarlimsLimsLis_13-1\" class=\"reference\"><a href=\"#cite_note-StarlimsLimsLis-13\" rel=\"external_link\">[13]<\/a><\/sup> With the distinction between the two entities becoming less clear, discussions within the laboratory informatics community began to includes the question of whether or not the two entities should be considered the same.<sup id=\"rdp-ebb-cite_ref-LinkedInDifLisLims_19-0\" class=\"reference\"><a href=\"#cite_note-LinkedInDifLisLims-19\" rel=\"external_link\">[19]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-LinkedInLisLimsSame_20-0\" class=\"reference\"><a href=\"#cite_note-LinkedInLisLimsSame-20\" rel=\"external_link\">[20]<\/a><\/sup> As of 2017<sup class=\"plainlinks noprint asof-tag update\" style=\"display:none;\"><\/sup>, vendors continue to recognize the historical differences between the two products while also continuing to acknowledge that some developed LIMS are taking on more of the clinical aspects usually reserved for a LIS.<sup id=\"rdp-ebb-cite_ref-AgilabFAQ_21-0\" class=\"reference\"><a href=\"#cite_note-AgilabFAQ-21\" rel=\"external_link\">[21]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-CloudLISDifference16_22-0\" class=\"reference\"><a href=\"#cite_note-CloudLISDifference16-22\" rel=\"external_link\">[22]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-ReisenwitzWhatIs17_23-0\" class=\"reference\"><a href=\"#cite_note-ReisenwitzWhatIs17-23\" rel=\"external_link\">[23]<\/a><\/sup>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"LIS_vendors\">LIS vendors<\/span><\/h2>\n<p>See the <a href=\"https:\/\/www.limswiki.org\/index.php\/LIS_vendor\" title=\"LIS vendor\" target=\"_blank\" class=\"wiki-link\" data-key=\"28459eb218e1163e19c62c819c9c4b34\">LIS vendor<\/a> page for a list of LIS vendors past and present.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"See_also\">See also<\/span><\/h2>\n<ul><li><a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_informatics\" title=\"Laboratory informatics\" target=\"_blank\" class=\"wiki-link\" data-key=\"00edfa43edcde538a695f6d429280301\">Laboratory informatics<\/a><\/li>\n<li><a href=\"https:\/\/www.limswiki.org\/index.php\/LIS_feature\" title=\"LIS feature\" target=\"_blank\" class=\"wiki-link\" data-key=\"23b167bed768658047c44710d3c186d1\">Common LIS features<\/a><\/li><\/ul>\n<h2><span class=\"mw-headline\" id=\"Further_reading\">Further reading<\/span><\/h2>\n<ul><li> <span class=\"citation web\">Henricks, W.H. (09 October 2012). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pathinformatics.pitt.edu\/sites\/default\/files\/2012Powerpoints\/01HenricksTues.pdf\" target=\"_blank\">\"LIS Basics: CP and AP LIS Design and Operations\"<\/a> (PDF). <i>Pathology Informatics 2012<\/i>. University of Pittsburgh<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pathinformatics.pitt.edu\/sites\/default\/files\/2012Powerpoints\/01HenricksTues.pdf\" target=\"_blank\">http:\/\/www.pathinformatics.pitt.edu\/sites\/default\/files\/2012Powerpoints\/01HenricksTues.pdf<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=LIS+Basics%3A+CP+and+AP+LIS+Design+and+Operations&rft.atitle=Pathology+Informatics+2012&rft.aulast=Henricks%2C+W.H.&rft.au=Henricks%2C+W.H.&rft.date=09+October+2012&rft.pub=University+of+Pittsburgh&rft_id=http%3A%2F%2Fwww.pathinformatics.pitt.edu%2Fsites%2Fdefault%2Ffiles%2F2012Powerpoints%2F01HenricksTues.pdf&rfr_id=info:sid\/en.wikipedia.org:Laboratory_information_system\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li> <span class=\"citation Journal\">Park, S.L.; Pantanowitz, L.; Sharma, G.; Parwani, A.V. (2012). \"Anatomic Pathology Laboratory Information Systems: A Review\". <i>Advances in Anatomic Pathology<\/i> <b>19<\/b> (2): 81\u201396. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" target=\"_blank\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1097%2FPAP.0b013e318248b787\" target=\"_blank\">10.1097\/PAP.0b013e318248b787<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Anatomic+Pathology+Laboratory+Information+Systems%3A+A+Review&rft.jtitle=Advances+in+Anatomic+Pathology&rft.aulast=Park%2C+S.L.%3B+Pantanowitz%2C+L.%3B+Sharma%2C+G.%3B+Parwani%2C+A.V.&rft.au=Park%2C+S.L.%3B+Pantanowitz%2C+L.%3B+Sharma%2C+G.%3B+Parwani%2C+A.V.&rft.date=2012&rft.volume=19&rft.issue=2&rft.pages=81%E2%80%9396&rft_id=info:doi\/10.1097%2FPAP.0b013e318248b787&rfr_id=info:sid\/en.wikipedia.org:Laboratory_information_system\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<ol class=\"references\">\n<li id=\"cite_note-biohealth-1\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-biohealth_1-0\" rel=\"external_link\">1.0<\/a><\/sup> <sup><a href=\"#cite_ref-biohealth_1-1\" rel=\"external_link\">1.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.biohealthmatics.com\/technologies\/his\/lis.aspx\" target=\"_blank\">\"Laboratory Information Systems\"<\/a>. <i>Biohealthmatics.com<\/i>. Biomedical Informatics Ltd. 10 August 2006<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.biohealthmatics.com\/technologies\/his\/lis.aspx\" target=\"_blank\">http:\/\/www.biohealthmatics.com\/technologies\/his\/lis.aspx<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 06 May 2011<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Laboratory+Information+Systems&rft.atitle=Biohealthmatics.com&rft.date=10+August+2006&rft.pub=Biomedical+Informatics+Ltd&rft_id=http%3A%2F%2Fwww.biohealthmatics.com%2Ftechnologies%2Fhis%2Flis.aspx&rfr_id=info:sid\/en.wikipedia.org:Laboratory_information_system\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-APHLLIS-2\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-APHLLIS_2-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/MRC\/Documents\/GH_2005Oct_LIS-Quick-Start-Guide.pdf\" target=\"_blank\">\"Quick Start Guide to Laboratory Information System (LIS) Implementation\"<\/a> (PDF). Association of Public Health Laboratories. October 2005<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.aphl.org\/MRC\/Documents\/GH_2005Oct_LIS-Quick-Start-Guide.pdf\" target=\"_blank\">https:\/\/www.aphl.org\/MRC\/Documents\/GH_2005Oct_LIS-Quick-Start-Guide.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 19 September 2017<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Quick+Start+Guide+to+Laboratory+Information+System+%28LIS%29+Implementation&rft.atitle=&rft.date=October+2005&rft.pub=Association+of+Public+Health+Laboratories&rft_id=https%3A%2F%2Fwww.aphl.org%2FMRC%2FDocuments%2FGH_2005Oct_LIS-Quick-Start-Guide.pdf&rfr_id=info:sid\/en.wikipedia.org:Laboratory_information_system\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-APLISReview-3\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-APLISReview_3-0\" rel=\"external_link\">3.0<\/a><\/sup> <sup><a href=\"#cite_ref-APLISReview_3-1\" rel=\"external_link\">3.1<\/a><\/sup> <sup><a href=\"#cite_ref-APLISReview_3-2\" rel=\"external_link\">3.2<\/a><\/sup> <sup><a href=\"#cite_ref-APLISReview_3-3\" rel=\"external_link\">3.3<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Park, S.L.; Pantanowitz, L.; Sharma, G.; Parwani, A.V. (2012). \"Anatomic Pathology Laboratory Information Systems: A Review\". <i>Advances in Anatomic Pathology<\/i> <b>19<\/b> (2): 81\u201396. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" target=\"_blank\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1097%2FPAP.0b013e318248b787\" target=\"_blank\">10.1097\/PAP.0b013e318248b787<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Anatomic+Pathology+Laboratory+Information+Systems%3A+A+Review&rft.jtitle=Advances+in+Anatomic+Pathology&rft.aulast=Park%2C+S.L.%3B+Pantanowitz%2C+L.%3B+Sharma%2C+G.%3B+Parwani%2C+A.V.&rft.au=Park%2C+S.L.%3B+Pantanowitz%2C+L.%3B+Sharma%2C+G.%3B+Parwani%2C+A.V.&rft.date=2012&rft.volume=19&rft.issue=2&rft.pages=81%E2%80%9396&rft_id=info:doi\/10.1097%2FPAP.0b013e318248b787&rfr_id=info:sid\/en.wikipedia.org:Laboratory_information_system\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-HistMedInfo-4\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-HistMedInfo_4-0\" rel=\"external_link\">4.0<\/a><\/sup> <sup><a href=\"#cite_ref-HistMedInfo_4-1\" rel=\"external_link\">4.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation book\">Blum, B.I.; Duncan, K.A. (1990). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/books.google.com\/books\/about\/A_History_of_medical_informatics.html?id=AR5rAAAAMAAJ\" target=\"_blank\"><i>A History of Medical Informatics<\/i><\/a>. ACM Press. pp. 141\u201353. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" target=\"_blank\">ISBN<\/a> 9780201501287<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/books.google.com\/books\/about\/A_History_of_medical_informatics.html?id=AR5rAAAAMAAJ\" target=\"_blank\">http:\/\/books.google.com\/books\/about\/A_History_of_medical_informatics.html?id=AR5rAAAAMAAJ<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=A+History+of+Medical+Informatics&rft.aulast=Blum%2C+B.I.%3B+Duncan%2C+K.A.&rft.au=Blum%2C+B.I.%3B+Duncan%2C+K.A.&rft.date=1990&rft.pages=pp.%26nbsp%3B141%E2%80%9353&rft.pub=ACM+Press&rft.isbn=9780201501287&rft_id=http%3A%2F%2Fbooks.google.com%2Fbooks%2Fabout%2FA_History_of_medical_informatics.html%3Fid%3DAR5rAAAAMAAJ&rfr_id=info:sid\/en.wikipedia.org:Laboratory_information_system\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-PractPathInfo-5\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-PractPathInfo_5-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Sinard, J.H. (2006). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=WerUyK618fcC\" target=\"_blank\"><i>Practical Pathology Informatics: Demstifying Informatics for the Practicing Anatomic Pathologist<\/i><\/a>. Springer. pp. 393. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" target=\"_blank\">ISBN<\/a> 0387280588<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=WerUyK618fcC\" target=\"_blank\">https:\/\/books.google.com\/books?id=WerUyK618fcC<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Practical+Pathology+Informatics%3A+Demstifying+Informatics+for+the+Practicing+Anatomic+Pathologist&rft.aulast=Sinard%2C+J.H.&rft.au=Sinard%2C+J.H.&rft.date=2006&rft.pages=pp.%26nbsp%3B393&rft.pub=Springer&rft.isbn=0387280588&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DWerUyK618fcC&rfr_id=info:sid\/en.wikipedia.org:Laboratory_information_system\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-OverBarEMR-6\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-OverBarEMR_6-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Kumar, S.; Aldrich, K. (2011). \"Overcoming barriers to electronic medical record (EMR) implementation in the US healthcare system: A comparative study\". <i>Health Informatics Journal<\/i> <b>16<\/b> (4). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" target=\"_blank\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1177%2F1460458210380523\" target=\"_blank\">10.1177\/1460458210380523<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Overcoming+barriers+to+electronic+medical+record+%28EMR%29+implementation+in+the+US+healthcare+system%3A+A+comparative+study&rft.jtitle=Health+Informatics+Journal&rft.aulast=Kumar%2C+S.%3B+Aldrich%2C+K.&rft.au=Kumar%2C+S.%3B+Aldrich%2C+K.&rft.date=2011&rft.volume=16&rft.issue=4&rft_id=info:doi\/10.1177%2F1460458210380523&rfr_id=info:sid\/en.wikipedia.org:Laboratory_information_system\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-FutrellWhatsNew17-7\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-FutrellWhatsNew17_7-0\" rel=\"external_link\">7.0<\/a><\/sup> <sup><a href=\"#cite_ref-FutrellWhatsNew17_7-1\" rel=\"external_link\">7.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Futrell, K. (23 January 2017). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.mlo-online.com\/what%E2%80%99s-new-today%E2%80%99s-lis\" target=\"_blank\">\"What's new in today's LIS?\"<\/a>. <i>Medical Laboratory Observer<\/i>. NP Communications, LLC<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.mlo-online.com\/what%E2%80%99s-new-today%E2%80%99s-lis\" target=\"_blank\">https:\/\/www.mlo-online.com\/what%E2%80%99s-new-today%E2%80%99s-lis<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 19 September 2017<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=What%27s+new+in+today%27s+LIS%3F&rft.atitle=Medical+Laboratory+Observer&rft.aulast=Futrell%2C+K.&rft.au=Futrell%2C+K.&rft.date=23+January+2017&rft.pub=NP+Communications%2C+LLC&rft_id=https%3A%2F%2Fwww.mlo-online.com%2Fwhat%25E2%2580%2599s-new-today%25E2%2580%2599s-lis&rfr_id=info:sid\/en.wikipedia.org:Laboratory_information_system\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-MedLabInfoPaper-8\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-MedLabInfoPaper_8-0\" rel=\"external_link\">8.0<\/a><\/sup> <sup><a href=\"#cite_ref-MedLabInfoPaper_8-1\" rel=\"external_link\">8.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Pantanowitz, L.; Henricks, W.H.; Beckwith, B.A. (2007). \"Medical Laboratory Informatics\". <i>Clinics in Laboratory Medicine<\/i> <b>27<\/b> (4): 823\u201343. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" target=\"_blank\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1016%2Fj.cll.2007.07.011\" target=\"_blank\">10.1016\/j.cll.2007.07.011<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Medical+Laboratory+Informatics&rft.jtitle=Clinics+in+Laboratory+Medicine&rft.aulast=Pantanowitz%2C+L.%3B+Henricks%2C+W.H.%3B+Beckwith%2C+B.A.&rft.au=Pantanowitz%2C+L.%3B+Henricks%2C+W.H.%3B+Beckwith%2C+B.A.&rft.date=2007&rft.volume=27&rft.issue=4&rft.pages=823%E2%80%9343&rft_id=info:doi\/10.1016%2Fj.cll.2007.07.011&rfr_id=info:sid\/en.wikipedia.org:Laboratory_information_system\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-MedLabInfoDesc-9\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-MedLabInfoDesc_9-0\" rel=\"external_link\">9.0<\/a><\/sup> <sup><a href=\"#cite_ref-MedLabInfoDesc_9-1\" rel=\"external_link\">9.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/clinfowiki.org\/wiki\/index.php\/Medical_laboratory_informatics\" target=\"_blank\">\"Medical laboratory informatics\"<\/a>. <i>ClinfoWiki<\/i>. 19 November 2011<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/clinfowiki.org\/wiki\/index.php\/Medical_laboratory_informatics\" target=\"_blank\">http:\/\/clinfowiki.org\/wiki\/index.php\/Medical_laboratory_informatics<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 03 June 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Medical+laboratory+informatics&rft.atitle=ClinfoWiki&rft.date=19+November+2011&rft_id=http%3A%2F%2Fclinfowiki.org%2Fwiki%2Findex.php%2FMedical_laboratory_informatics&rfr_id=info:sid\/en.wikipedia.org:Laboratory_information_system\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-CPAPLISDiffs-10\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-CPAPLISDiffs_10-0\" rel=\"external_link\">10.0<\/a><\/sup> <sup><a href=\"#cite_ref-CPAPLISDiffs_10-1\" rel=\"external_link\">10.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Henricks, W.H. (09 October 2012). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pathinformatics.pitt.edu\/sites\/default\/files\/2012Powerpoints\/01HenricksTues.pdf\" target=\"_blank\">\"LIS Basics: CP and AP LIS Design and Operations\"<\/a> (PDF). <i>Pathology Informatics 2012<\/i>. University of Pittsburgh<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pathinformatics.pitt.edu\/sites\/default\/files\/2012Powerpoints\/01HenricksTues.pdf\" target=\"_blank\">http:\/\/www.pathinformatics.pitt.edu\/sites\/default\/files\/2012Powerpoints\/01HenricksTues.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 03 June 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=LIS+Basics%3A+CP+and+AP+LIS+Design+and+Operations&rft.atitle=Pathology+Informatics+2012&rft.aulast=Henricks%2C+W.H.&rft.au=Henricks%2C+W.H.&rft.date=09+October+2012&rft.pub=University+of+Pittsburgh&rft_id=http%3A%2F%2Fwww.pathinformatics.pitt.edu%2Fsites%2Fdefault%2Ffiles%2F2012Powerpoints%2F01HenricksTues.pdf&rfr_id=info:sid\/en.wikipedia.org:Laboratory_information_system\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-ForensicMedBook-11\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-ForensicMedBook_11-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Adelman, H.C. (2009). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=x5FftcZOv1UC&pg=PA3\" target=\"_blank\"><i>Forensic Medicine<\/i><\/a>. Infobase Publishing. pp. 3\u20134. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" target=\"_blank\">ISBN<\/a> 1438103816<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=x5FftcZOv1UC&pg=PA3\" target=\"_blank\">https:\/\/books.google.com\/books?id=x5FftcZOv1UC&pg=PA3<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 03 June 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Forensic+Medicine&rft.aulast=Adelman%2C+H.C.&rft.au=Adelman%2C+H.C.&rft.date=2009&rft.pages=pp.%26nbsp%3B3%E2%80%934&rft.pub=Infobase+Publishing&rft.isbn=1438103816&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3Dx5FftcZOv1UC%26pg%3DPA3&rfr_id=info:sid\/en.wikipedia.org:Laboratory_information_system\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-EvolvingLIS-12\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-EvolvingLIS_12-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Clifford, L.-J. (01 August 2011). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.mlo-online.com\/the-evolving-lis-needs-to-be-everything-for-todays-laboratories.php\" target=\"_blank\">\"The evolving LIS needs to be \"everything\" for today's laboratories\"<\/a>. <i>Medical Laboratory Observer<\/i>. NP Communications, LLC<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.mlo-online.com\/the-evolving-lis-needs-to-be-everything-for-todays-laboratories.php\" target=\"_blank\">https:\/\/www.mlo-online.com\/the-evolving-lis-needs-to-be-everything-for-todays-laboratories.php<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 19 September 2017<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=The+evolving+LIS+needs+to+be+%22everything%22+for+today%27s+laboratories&rft.atitle=Medical+Laboratory+Observer&rft.aulast=Clifford%2C+L.-J.&rft.au=Clifford%2C+L.-J.&rft.date=01+August+2011&rft.pub=NP+Communications%2C+LLC&rft_id=https%3A%2F%2Fwww.mlo-online.com%2Fthe-evolving-lis-needs-to-be-everything-for-todays-laboratories.php&rfr_id=info:sid\/en.wikipedia.org:Laboratory_information_system\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-StarlimsLimsLis-13\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-StarlimsLimsLis_13-0\" rel=\"external_link\">13.0<\/a><\/sup> <sup><a href=\"#cite_ref-StarlimsLimsLis_13-1\" rel=\"external_link\">13.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/web.archive.org\/web\/20140428060811\/http:\/\/www.starlims.com\/en-us\/resources\/white-papers\/lis-vs-lims\/\" target=\"_blank\">\"Adding \"Management\" to Your LIS\"<\/a>. STARLIMS Corporation. 2012. Archived from <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.starlims.com\/en-us\/services-and-resources\/resources\/lis-vs-lims\/\" target=\"_blank\">the original<\/a> on 28 April 2014<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/web.archive.org\/web\/20140428060811\/http:\/\/www.starlims.com\/en-us\/resources\/white-papers\/lis-vs-lims\/\" target=\"_blank\">https:\/\/web.archive.org\/web\/20140428060811\/http:\/\/www.starlims.com\/en-us\/resources\/white-papers\/lis-vs-lims\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 September 2017<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Adding+%22Management%22+to+Your+LIS&rft.atitle=&rft.date=2012&rft.pub=STARLIMS+Corporation&rft_id=https%3A%2F%2Fweb.archive.org%2Fweb%2F20140428060811%2Fhttp%3A%2F%2Fwww.starlims.com%2Fen-us%2Fresources%2Fwhite-papers%2Flis-vs-lims%2F&rfr_id=info:sid\/en.wikipedia.org:Laboratory_information_system\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-lislims1-14\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-lislims1_14-0\" rel=\"external_link\">14.0<\/a><\/sup> <sup><a href=\"#cite_ref-lislims1_14-1\" rel=\"external_link\">14.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Friedman, B. (04 November 2008). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/labsoftnews.typepad.com\/lab_soft_news\/2008\/11\/liss-vs-limss-its-time-to-consider-merging-the-two-types-of-systems.html\" target=\"_blank\">\"LIS vs. LIMS: It's Time to Blend the Two Types of Lab Information Systems\"<\/a>. <i>Lab Soft News<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/labsoftnews.typepad.com\/lab_soft_news\/2008\/11\/liss-vs-limss-its-time-to-consider-merging-the-two-types-of-systems.html\" target=\"_blank\">http:\/\/labsoftnews.typepad.com\/lab_soft_news\/2008\/11\/liss-vs-limss-its-time-to-consider-merging-the-two-types-of-systems.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 07 November 2012<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=LIS+vs.+LIMS%3A+It%27s+Time+to+Blend+the+Two+Types+of+Lab+Information+Systems&rft.atitle=Lab+Soft+News&rft.aulast=Friedman%2C+B.&rft.au=Friedman%2C+B.&rft.date=04+November+2008&rft_id=http%3A%2F%2Flabsoftnews.typepad.com%2Flab_soft_news%2F2008%2F11%2Fliss-vs-limss-its-time-to-consider-merging-the-two-types-of-systems.html&rfr_id=info:sid\/en.wikipedia.org:Laboratory_information_system\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-analytica-15\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-analytica_15-0\" rel=\"external_link\">15.0<\/a><\/sup> <sup><a href=\"#cite_ref-analytica_15-1\" rel=\"external_link\">15.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.analytica-world.com\/en\/news\/35566\/lims-lis-market-and-poct-supplement.html\" target=\"_blank\">\"LIMS\/LIS Market and POCT Supplement\"<\/a>. <i>analytica-world.com<\/i>. 20 February 2004<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.analytica-world.com\/en\/news\/35566\/lims-lis-market-and-poct-supplement.html\" target=\"_blank\">http:\/\/www.analytica-world.com\/en\/news\/35566\/lims-lis-market-and-poct-supplement.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 07 November 2012<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=LIMS%2FLIS+Market+and+POCT+Supplement&rft.atitle=analytica-world.com&rft.date=20+February+2004&rft_id=http%3A%2F%2Fwww.analytica-world.com%2Fen%2Fnews%2F35566%2Flims-lis-market-and-poct-supplement.html&rfr_id=info:sid\/en.wikipedia.org:Laboratory_information_system\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-lislims2-16\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-lislims2_16-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Friedman, B. (19 November 2008). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/labsoftnews.typepad.com\/lab_soft_news\/2008\/11\/lis-vs-lims.html\" target=\"_blank\">\"LIS vs. LIMS: Some New Insights\"<\/a>. <i>Lab Soft News<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/labsoftnews.typepad.com\/lab_soft_news\/2008\/11\/lis-vs-lims.html\" target=\"_blank\">http:\/\/labsoftnews.typepad.com\/lab_soft_news\/2008\/11\/lis-vs-lims.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 07 November 2012<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=LIS+vs.+LIMS%3A+Some+New+Insights&rft.atitle=Lab+Soft+News&rft.aulast=Friedman%2C+B.&rft.au=Friedman%2C+B.&rft.date=19+November+2008&rft_id=http%3A%2F%2Flabsoftnews.typepad.com%2Flab_soft_news%2F2008%2F11%2Flis-vs-lims.html&rfr_id=info:sid\/en.wikipedia.org:Laboratory_information_system\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-starlims-17\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-starlims_17-0\" rel=\"external_link\">17.0<\/a><\/sup> <sup><a href=\"#cite_ref-starlims_17-1\" rel=\"external_link\">17.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Hice, R. (01 July 2009). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/web.archive.org\/web\/20110313145726\/http:\/\/blog.starlims.com\/2009\/07\/01\/swimming-in-the-clinical-pool-why-lims-are-supplanting-old-school-clinical-lis-applications\/\" target=\"_blank\">\"Swimming in the Clinical Pool: Why LIMS are supplanting old-school clinical LIS applications\"<\/a>. STARLIMS Corporation. Archived from <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/blog.starlims.com\/2009\/07\/01\/swimming-in-the-clinical-pool-why-lims-are-supplanting-old-school-clinical-lis-applications\/\" target=\"_blank\">the original<\/a> on 13 March 2011<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/web.archive.org\/web\/20110313145726\/http:\/\/blog.starlims.com\/2009\/07\/01\/swimming-in-the-clinical-pool-why-lims-are-supplanting-old-school-clinical-lis-applications\/\" target=\"_blank\">https:\/\/web.archive.org\/web\/20110313145726\/http:\/\/blog.starlims.com\/2009\/07\/01\/swimming-in-the-clinical-pool-why-lims-are-supplanting-old-school-clinical-lis-applications\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 September 2017<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Swimming+in+the+Clinical+Pool%3A+Why+LIMS+are+supplanting+old-school+clinical+LIS+applications&rft.atitle=&rft.aulast=Hice%2C+R.&rft.au=Hice%2C+R.&rft.date=01+July+2009&rft.pub=STARLIMS+Corporation&rft_id=https%3A%2F%2Fweb.archive.org%2Fweb%2F20110313145726%2Fhttp%3A%2F%2Fblog.starlims.com%2F2009%2F07%2F01%2Fswimming-in-the-clinical-pool-why-lims-are-supplanting-old-school-clinical-lis-applications%2F&rfr_id=info:sid\/en.wikipedia.org:Laboratory_information_system\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-ConvergeLimsLis-18\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-ConvergeLimsLis_18-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Tufel, G. (01 February 2012). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.clpmag.com\/2012\/02\/convergence-of-lims-and-lis\/\" target=\"_blank\">\"Convergence of LIMS and LIS\"<\/a>. <i>Clinical Lab Products<\/i>. MEDQOR<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.clpmag.com\/2012\/02\/convergence-of-lims-and-lis\/\" target=\"_blank\">http:\/\/www.clpmag.com\/2012\/02\/convergence-of-lims-and-lis\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 September 2017<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Convergence+of+LIMS+and+LIS&rft.atitle=Clinical+Lab+Products&rft.aulast=Tufel%2C+G.&rft.au=Tufel%2C+G.&rft.date=01+February+2012&rft.pub=MEDQOR&rft_id=http%3A%2F%2Fwww.clpmag.com%2F2012%2F02%2Fconvergence-of-lims-and-lis%2F&rfr_id=info:sid\/en.wikipedia.org:Laboratory_information_system\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-LinkedInDifLisLims-19\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-LinkedInDifLisLims_19-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Jones, J. (March 2012). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.linkedin.com\/groups\/2069898\/2069898-98494737\" target=\"_blank\">\"What is the difference between a LIS and a LIMS?\"<\/a>. LinkedIn<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.linkedin.com\/groups\/2069898\/2069898-98494737\" target=\"_blank\">https:\/\/www.linkedin.com\/groups\/2069898\/2069898-98494737<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 September 2017<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=What+is+the+difference+between+a+LIS+and+a+LIMS%3F&rft.atitle=&rft.aulast=Jones%2C+J.&rft.au=Jones%2C+J.&rft.date=March+2012&rft.pub=LinkedIn&rft_id=https%3A%2F%2Fwww.linkedin.com%2Fgroups%2F2069898%2F2069898-98494737&rfr_id=info:sid\/en.wikipedia.org:Laboratory_information_system\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-LinkedInLisLimsSame-20\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-LinkedInLisLimsSame_20-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Jones, John (September 2012). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.linkedin.com\/groups\/Are-LIMS-LIS-same-thing-2069898.S.147132083\" target=\"_blank\">\"Are LIMS and LIS the same thing?\"<\/a>. LinkedIn<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.linkedin.com\/groups\/Are-LIMS-LIS-same-thing-2069898.S.147132083\" target=\"_blank\">http:\/\/www.linkedin.com\/groups\/Are-LIMS-LIS-same-thing-2069898.S.147132083<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 07 November 2012<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Are+LIMS+and+LIS+the+same+thing%3F&rft.atitle=&rft.aulast=Jones%2C+John&rft.au=Jones%2C+John&rft.date=September+2012&rft.pub=LinkedIn&rft_id=http%3A%2F%2Fwww.linkedin.com%2Fgroups%2FAre-LIMS-LIS-same-thing-2069898.S.147132083&rfr_id=info:sid\/en.wikipedia.org:Laboratory_information_system\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-AgilabFAQ-21\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-AgilabFAQ_21-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/agilab.com\/faq\/\" target=\"_blank\">\"FAQ: What is the difference between a LIMS and a medical laboratory quality system?\"<\/a>. AgiLab SAS<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/agilab.com\/faq\/\" target=\"_blank\">http:\/\/agilab.com\/faq\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 September 2017<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=FAQ%3A+What+is+the+difference+between+a+LIMS+and+a+medical+laboratory+quality+system%3F&rft.atitle=&rft.pub=AgiLab+SAS&rft_id=http%3A%2F%2Fagilab.com%2Ffaq%2F&rfr_id=info:sid\/en.wikipedia.org:Laboratory_information_system\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-CloudLISDifference16-22\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CloudLISDifference16_22-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cloudlims.com\/lims\/lims-vs-lis.html\" target=\"_blank\">\"Difference Between LIS and LIMS\"<\/a>. CloudLIMS.com, LLC. 01 October 2016<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/cloudlims.com\/lims\/lims-vs-lis.html\" target=\"_blank\">https:\/\/cloudlims.com\/lims\/lims-vs-lis.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 September 2017<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Difference+Between+LIS+and+LIMS&rft.atitle=&rft.date=01+October+2016&rft.pub=CloudLIMS.com%2C+LLC&rft_id=https%3A%2F%2Fcloudlims.com%2Flims%2Flims-vs-lis.html&rfr_id=info:sid\/en.wikipedia.org:Laboratory_information_system\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-ReisenwitzWhatIs17-23\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-ReisenwitzWhatIs17_23-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Reisenwitz, C. (11 May 2017). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/blog.capterra.com\/what-is-a-laboratory-information-management-system\/\" target=\"_blank\">\"What Is a Laboratory Information Management System?\"<\/a>. <i>Capterra Medical Software Blog<\/i>. Capterra, Inc<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/blog.capterra.com\/what-is-a-laboratory-information-management-system\/\" target=\"_blank\">http:\/\/blog.capterra.com\/what-is-a-laboratory-information-management-system\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 September 2017<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=What+Is+a+Laboratory+Information+Management+System%3F&rft.atitle=Capterra+Medical+Software+Blog&rft.aulast=Reisenwitz%2C+C.&rft.au=Reisenwitz%2C+C.&rft.date=11+May+2017&rft.pub=Capterra%2C+Inc&rft_id=http%3A%2F%2Fblog.capterra.com%2Fwhat-is-a-laboratory-information-management-system%2F&rfr_id=info:sid\/en.wikipedia.org:Laboratory_information_system\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<\/ol><\/div>\n\n<!-- \nNewPP limit report\nCached time: 20181213192745\nCache expiry: 86400\nDynamic content: false\nCPU time usage: 0.532 seconds\nReal time usage: 1.254 seconds\nPreprocessor visited node count: 16107\/1000000\nPreprocessor generated node count: 24643\/1000000\nPost\u2010expand include size: 109605\/2097152 bytes\nTemplate argument size: 44119\/2097152 bytes\nHighest expansion depth: 15\/40\nExpensive parser function count: 1\/100\n-->\n\n<!-- \nTransclusion expansion time report (%,ms,calls,template)\n100.00% 467.091 1 - -total\n 82.41% 384.938 1 - Template:Reflist\n 81.82% 382.185 25 - Template:Citation\/core\n 59.66% 278.661 18 - Template:Cite_web\n 16.80% 78.457 4 - Template:Cite_journal\n 11.65% 54.428 3 - Template:Cite_book\n 5.36% 25.025 38 - Template:Citation\/make_link\n 3.32% 15.489 1 - Template:As_of\n 3.12% 14.555 7 - Template:Citation\/identifier\n 2.49% 11.649 1 - Template:DMCA\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:316-0!*!0!!en!5!* and timestamp 20181213192743 and revision id 31763\n -->\n<\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_information_system\">https:\/\/www.limswiki.org\/index.php\/Laboratory_information_system<\/a><\/div>\n\t\t\t\t\t\t\t\t\t\t<!-- end content -->\n\t\t\t\t\t\t\t\t\t\t<div class=\"visualClear\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t<!-- end of the left (by default at least) column -->\n\t\t<div class=\"visualClear\"><\/div>\n\t\t\t\t\t\n\t\t<\/div>\n\t\t\n\n<\/body>","37add65b4d1c678b382a7d4817a9cf64_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/f\/f5\/Nurse_ict_uganda.jpg"],"37add65b4d1c678b382a7d4817a9cf64_timestamp":1544729263,"055eb51f53cfdbacc08ed150b266c9f4_type":"article","055eb51f53cfdbacc08ed150b266c9f4_title":"Health informatics","055eb51f53cfdbacc08ed150b266c9f4_url":"https:\/\/www.limswiki.org\/index.php\/Health_informatics","055eb51f53cfdbacc08ed150b266c9f4_plaintext":"\n\n\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\n\t\t\t\tHealth informatics\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\tFrom LIMSWiki\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\tJump to: navigation, search\n\n\t\t\t\t\t\n\t\t\t\t\t Health informatics helps manage, analyze, and integrate patient data from physician to specialist and beyond.\nHealth informatics (also called health care informatics, healthcare informatics, medical informatics, nursing informatics, clinical informatics, or biomedical informatics) is a discipline at the intersection of information science, computer science, and health care. It deals with the resources, devices, and methods required to optimize the \"collection, storage, retrieval, [and] communication ... of health-related data, information, and knowledge.\"[1] Health informatics is applied to the areas of nursing, clinical care, dentistry, pharmacy, public health, occupational therapy, and biomedical research. Health informatics resources include not only computers but also clinical guidelines, formal medical terminologies, and information and communication systems. \nEarly names for health informatics included medical information data processing, medical information science, medical informatics[2][1], medical computer science, and medical computing.[3]\n\nContents\n\n1 History \n\n1.1 Health informatics in North America \n\n1.1.1 Argentina \n1.1.2 Brazil \n1.1.3 Canada \n1.1.4 United States \n\n\n1.2 Health informatics in Europe \n\n1.2.1 In the United Kingdom \n\n1.2.1.1 England \n1.2.1.2 Scotland \n\n\n\n\n1.3 Health informatics in Asia and Oceania \n\n1.3.1 Australia \n1.3.2 China \n1.3.3 New Zealand \n\n\n1.4 Health informatics in the Middle East \n\n1.4.1 Saudi Arabia \n\n\n\n\n2 Regulation and standards \n\n2.1 In the United States \n\n\n3 Clinical informatics \n4 Further reading \n5 See also \n6 Notes \n7 References \n\n\n\nHistory \nWorldwide use of technology in medicine began in the early 1950s with the rise of computers.[4] In 1949, Gustav Wager established the first professional organization for informatics in Germany.[5] The prehistory, history, and future of medical information and health information technology are discussed in reference.[6] Specialized university departments and Informatics training programs began during the 1960s in France, Germany, Belgium and The Netherlands. Medical informatics research units began to appear during the 1970s in Poland and in the U.S.[5], with medical informatics conferences springing up as early as 1974.[1] Since then the development of high-quality health informatics research, education, and infrastructure has been the goal of the U.S. and the European Union.[5][1]\nBy the mid-2000s, work in the U.K. by the voluntary registration body the UK Council of Health Informatics Professions led to the creation of eight key constituencies within the domain of health informatics: information and communication technologies; health records; information management; knowledge management; health informatics service and project management; clinical informatics; education, training, and development; and research.[7] Those constituencies \u2014 already based on U.K. National Health Service standards (NHS) \u2014 later found their way into the NHS' Health Informatics Career Framework in a slightly modified format.[8] As of 2013[update] tens of datasets, publications, guidelines, specifications, meetings, conferences, and organizations around the world continue to shape what health informatics is today.[9]\n\nHealth informatics in North America \nArgentina \nSince 1996, the International Medical Informatics Association's Latin America and the Caribbean regional group has sought to develop health informatics within the region, including Argentina's Asociaci\u00f3n Argentina de Inform\u00e1tica M\u00e9dica (AAIM).[10]\nSince 1997, the not-for-profit Buenos Aires Biomedical Informatics Group has represented the interests of a broad range of clinical and non-clinical professionals working within the health informatics sphere. The group strives to promote informatics technology and related content within the research and health administration spheres, especially those relating to the biomedical field.[11]\n\nBrazil \n\"In 1968 the Pan American Health Organization set up the Regional Library of Medicine and Health Sciences (BIREME) in the Paulista Medical School in S\u00e3o Paulo under an agreement with the Government of Brazil.\"[12] The library also made possible access to the MEDLINE and MEDLARS systems[13], and it would eventually go on to become the \"hub of the Latin American network of biomedical and health information.\"[12]\nIn 1986 the Brazilian Society of Health Informatics (Sociedade Brasileira de Inform\u00e1tica em Sa\u00fade) was founded to better expand the use of informatics technology within the country. The same year saw the first Brazilian Congress of Health Informatics held, and the first Brazilian Journal of Health Informatics was published.[14]\nSince 1996, the International Medical Informatics Association's Latin America and the Caribbean regional group has sought to develop health informatics within the region, including Brazil's Sociedade Brasileira de Inform\u00e1tica em Sa\u00fade (SBIS).[10]\n\nCanada \nHealth Informatics projects in Canada are implemented provincially, with different provinces creating different systems. A national, federally-funded, not-for-profit organization called Canada Health Infoway was created in 2001 to foster the development and adoption of electronic health records across Canada. As of July 2013[update] there were 380 health informatics projects under way in Canadian hospitals, health-care facilities, pharmacies, and laboratories, with an investment value of $2.1 billion since its inception.[15]\nProvincial and territorial programs include the following: \n\neHealth Ontario was created as an Ontario provincial government agency in September 2008. It has been plagued by delays, and its CEO was fired over a multi-million dollar contract scandal in 2009.[16]\nAlberta Netcare Portal was created in 2006 by the Government of Alberta. The Netcare portal is used daily by thousands of clinicians. It provides access to demographic data, prescribed\/dispensed drugs, known allergies\/intolerances, immunizations, laboratory test results, diagnostic imaging reports, the diabetes registry and other medical reports. Netcare interface capabilities are being included in electronic medical record products which are being funded by the provincial government.[17]\nUnited States \nEven though the idea of using computers in medicine sprouted as technology advanced in the early twentieth century, it was not until the 1950s that informatics made a realistic impact in the United States.[4] Robert Ledley led the charge in the 1950s with his early use of medical computation in his dental projects at the United States National Bureau of Standards.[18]\nBy the mid-1950s expert systems such as MYCIN and INTERNIST-I were developed, and the National Library of Medicine started using even the even more advanced MEDLINE and MEDLARS systems by 1965. Around this same time a flurry of activity occurred. At the University of Utah, Dr. Homer R. Warner, one of the fathers of medical informatics[19], was already offering graduate-level classes in medical computer applications. Meanwhile Neil Pappalardo, Curtis Marble, and Robert Greenes were developing the Massachusetts General Hospital Utility Multi-Programming System (MUMPS) in Octo Barnett's Laboratory of Computer Science at Massachusetts General Hospital in Boston.[20][21] Yet due to its advanced nature, fragmented use across multiple entities, and inherent difficulty in extracting and analyzing data from the database, development of healthcare and laboratory systems on MUMPS was sporadic at best.[22] \nBy the 1980s, however, the advent of Structured Query Language (SQL), relational database management systems (RDBMS), and Health Level 7 (HL7) allowed software developers to expand the functionality and interoperability of health informatics systems, including the application of business analytics and business intelligence techniques to clinical data.[23] As of 2013[update] web-based and database-centric Internet applications of laboratory informatics software have further changed the way researchers and technicians interact with data, with web-driven data formatting technologies like Extensible Markup Language (XML) making interoperability of health and laboratory informatics software a much-needed reality.[24] SaaS and cloud computing technologies have further changed how informatics systems are implemented in the U.S and worldwide, while at the same time raising new questions about security and stability.[20]\n\nHealth informatics in Europe \nThe European Union's Member States are committed to sharing their best practices and experiences to create a European eHealth Area, thereby improving access to and quality health care at the same time as stimulating growth in a promising new industrial sector. The associated European eHealth programs plays a fundamental role in the European Union's strategy. Work on this initiative involves a collaborative approach among several parts of the Commission services.[25] Additionally, the not-for-profit European Institute for Health Records or EuroRec has promoted the use of high quality electronic health record systems in the European Union since its foundation in late 2002.[26][27]\nepSOS (European Patients - Smart Open Services) represents another key European initiative to \"build and evaluate a service infrastructure that demonstrates cross-border interoperability between electronic health record systems in Europe.\"[28] Co-funded by the European Commission Competitiveness and Innovation Programme since 2008, the initiative (scheduled to finish on December 31, 2013) was devised with the vision of giving patients in Europe the opportunity to use cross-border electronic medical record services for healthcare-related activities in participating epSOS pilot countries.[28]\n\nIn the United Kingdom \nThe U.K. health informatics community has long played a key role in international activity, joining Technical Committee Four (TC 4) of the International Federation of Information Processing in 1968[29], which eventually became the International Medical Informatics Association (IMIA) in 1979.[30][31] In 1978, the Medical Specialist Group of the British Computer Society organized the first European Federation for Medical Informatics (EFMI) Medical Informatics Europe (MIE) conference in Cambridge.[31]\nIn 2002, the idea of a profession of health informatics across the U.K. was first implemented as the U.K. Council for Health Informatics Professions (UKCHIP), which has a formal Code of Professional Conduct, standards for expressing competences which are used for entry, confirmation of fitness to practice, re-grading and personal development. Consistent standards express competences of health informatics professionals in both domain-specific and generic informatics professional areas. The consistency is intended to apply in operational care delivery organizations, academia, and the commercial service and solution providers.[7] \nThe broad history of health informatics in the U.K. has been captured in the 2008 book U.K. Health Computing : Recollections and Reflections by Glyn M. Hayes and Denise E. Barnett. The book describes the early development of health informatics in the country as \"unorganized and idiosyncratic.\"\n\nEngland \nIn 2002 the National Health Service (NHS) in England contracted several vendors for a national health informatics system called the National Programme for IT or \"NPfIT.\" By 2010, however, the project drastically behind schedule, forcing a wide consultation to be launched as part of a wider \"Liberating the NHS\" plan. \"Following three reports on the National Programme by both the National Audit Office and this Committee, and a review by the Major Projects Authority, the Government announced in September 2011 that it would dismantle the National Programme but keep the component parts in place with separate management and accountability structures.\"[32] The program was officially dismantled in September 2013, officially dubbed \"one of the worst and most expensive contracting fiascos in the history of the public sector.\"[32] \n\nScotland \nIn 1984, Scotland saw the implementation of the General Practice Administration System (GPASS), developed and controlled by NHS Scotland.[33] It was provided free to all general practitioners in Scotland. However, an agreement was reached in 2008 to shut down the electronic system due to \"a series of problems and critical reports.\"[34] The system was formally shut down in August 2012, with all practices having moved to new systems called EMIS and INPS.\n\nHealth informatics in Asia and Oceania \nIn Asia, Australia, and New Zealand, the regional group called the Asia Pacific Association for Medical Informatics (APAMI) was established in 1993 and now consists of more than 15 member regions in the Asia Pacific Region.[35]\n\nAustralia \nFounded in 2002, the Australasian College of Health Informatics (ACHI) is the professional association for health informatics in the Asia-Pacific region. It represents the interests of a broad range of clinical and non-clinical professionals working within the health informatics sphere through a commitment to quality, standards, and ethical practice.[36] ACHI is a sponsor of the e-Journal for Health Informatics[37], an indexed and peer-reviewed professional journal. ACHI has also supported the Australian Health Informatics Education Council (AHIEC) since its founding in 2009.[38]\nAlthough there are a number of health informatics organizations in Australia, the Health Informatics Society of Australia (HISA) is regarded as the major umbrella group and is a member of the International Medical Informatics Association (IMIA). Nursing informaticians were the driving force behind the formation of HISA, which is now a company limited by guarantee of the members. The membership comes from across the informatics spectrum that is from students to corporate affiliates. HISA has a number of branches (Queensland, New South Wales, Victoria and Western Australia) as well as special interest groups such as nursing (NIA), pathology, aged and community care, industry, and medical imaging.[39]\n\nChina \nIn Hong Kong a computerized patient record system called the Clinical Management System (CMS) has been developed by the Hospital Authority since 1994. This system has been deployed at all the sites of the Authority (40 hospitals and 120 clinics) and is used by all 30,000 clinical staff on a daily basis, with a daily transaction of up to 2 millions. The comprehensive records of 7 million patients are available online in the Electronic Patient Record (ePR), with data integrated from all sites. Since 2004, radiology image viewing has been added to the ePR, with radiography images from any HA site being available as part of the ePR.\nThe Hong Kong Hospital Authority placed particular attention to the governance of clinical systems development, with input from hundreds of clinicians being incorporated through a structured process. The health informatics section of the Hong Kong Hospital Authority has close relationship with the information technology department and clinicians to develop healthcare systems for the organization to support the service to all public hospitals and clinics in the region.[40]\nThe Hong Kong Society of Medical Informatics (HKSMI) was established in 1987 to promote the use of information technology in healthcare. The eHealth Consortium has been formed to bring together clinicians from both the private and public sectors, medical informatics professionals, and the IT industry to further promote IT in healthcare in Hong Kong.[41]\n\nNew Zealand \nHealth Informatics is taught at five New Zealand universities. The most mature and established is the Otago program, which has been offered since the mid-1990s.[42] Health Informatics New Zealand (HINZ) is the national organization that advocates for health informatics. HINZ organizes a conference every year and also publishes the online journal Healthcare Informatics Review Online.\n\nHealth informatics in the Middle East \nSaudi Arabia \nThe Saudi Association for Health Information (SAHI) was established in 2006 to work under direct supervision of King Saud University for Health Sciences to practice public activities, develop theoretical and applicable knowledge, and provide scientific and applicable studies.[43]\n\nRegulation and standards \nThe international standards on the subject are covered by ICS 35.240.80[44] in which ISO 27799:2008 is one of the core components.[45]\n\nIn the United States \nIn 2004 the U.S. Department of Health and Human Services (HHS) formed the Office of the National Coordinator for Health Information Technology (ONCHIT). The mission of this office is widespread adoption of interoperable electronic health records (EHRs) in the US within 10 years.\nThe Certification Commission for Healthcare Information Technology (CCHIT), a private nonprofit group, was funded in 2005 by the U.S. Department of Health and Human Services to develop a set of standards for electronic health records (EHR) and supporting networks, and certify vendors who meet them. In July, 2006 CCHIT released its first list of 22 certified ambulatory EHR products, in two different announcements.[46]\n\nClinical informatics \nWhile health informatics and clinical informatics are often considered the same, some make a distinction between the two. The American Medical Informatics Association, for example, states clinical informatics is concerned with the use of information in health care by clinicians.[47] By extension, clinical informaticians analyze, design, implement, and evaluate information and communication systems that enhance individual and population health outcomes, improve patient care, and strengthen the clinician-patient relationship.\nClinical informaticians use their knowledge of patient care combined with their understanding of informatics concepts, methods, and health informatics tools to:\n\n assess information and knowledge needs of health care professionals and patients.\n characterize, evaluate, and refine clinical processes.\n develop, implement, and refine clinical decision support systems.\n lead or participate in the procurement, customization, development, implementation, management, evaluation, and continuous improvement of clinical information systems.\nClinicians collaborate with other health care and information technology professionals to develop health informatics tools which promote patient care that is safe, efficient, effective, timely, patient-centered, and equitable.\n\nFurther reading \n De Moor, Georges J. E. ; McDonald, Clement J.; van Goor, J. M. Noothoven, ed. (1993). Progress in Standardization in Health Care Informatics. IOS Press. pp. 215. ISBN 9051991142. http:\/\/books.google.com\/books?id=DHzOJaNaOYkC .   \n Hovenga, Evelyn J. S., ed. (2010). Health Informatics: An Overview. IOS Press. ISBN 1607500922. http:\/\/books.google.com\/books?id=eckD3fSrPagC .   \n Hoyt, Robert E.; Bailey, Nora; Yoshihashi, Ann, ed. (2012). Health Informatics: Practical Guide For Healthcare And Information Technology Professionals. Lulu Enterprises Incorporated. pp. 492. ISBN 1105437558. http:\/\/books.google.com\/books?id=6bqruAAACAAJ .   \n Smith, Jack (1999). Health Management Information Systems: A Handbook for Decision Makers (2nd ed.). McGraw-Hill International. pp. 348. ISBN 0335205658. http:\/\/books.google.com\/books?id=8YjlAAAAQBAJ .   \nSee also \n Informatics (academic field)\n Category:Health informatics\n Hospital information system\n Laboratory information system\nNotes \nSome elements of this article are reused from the Wikipedia article.\n\nReferences \n\n\n\u2191 1.0 1.1 1.2 1.3 Hovenga, Evelyn J. S., ed. (2010). \"Chapter 2: Health Informatics - An Introduction\". Health Informatics: An Overview. IOS Press. p. 9\u201315. ISBN 1607500922. http:\/\/books.google.com\/books?id=eckD3fSrPagC .   \n\n\u2191 Blum, Bruce I.; Kent, Allen (ed.); Williams, James G. (ed.) (1990). \"Medical Informatics\". Encyclopedia of Computer Science and Technology. 22. CRC Press. p. 205\u2013224. ISBN 0824722728. http:\/\/books.google.com\/books?id=L7NOABDqaMcC .   \n\n\u2191 Dayyani, Basel; Griffiths, Paul (ed.) (2006). \"Knowledge Informatics: A New Academic Discipline Underpinning Knowledge-based Organisations and Contributing to the Transformation from the Information Age to the Knowledge Age\". Proceedings of the 3rd International Conference on Intellectual Capital and Knowledge Management. Academic Conferences Limited. p. 127\u2013138. ISBN 1905305362. http:\/\/books.google.com\/books?id=hD4I12296jYC .   \n\n\u2191 4.0 4.1 \"The History of Health Informatics\". Health Informatics Guide - The History of Health Informatics. University of Illinois at Chicago. Archived from the original on 26 November 2012. http:\/\/web.archive.org\/web\/20121126102550\/http:\/\/healthinformatics.uic.edu\/history-of-health-informatics\/ . Retrieved 05 January 2015 .   \n\n\u2191 5.0 5.1 5.2 \"NYU Graduate Training Program in Biomedical Informatics (BMI): A Brief History of Biomedical Informatics as a Discipline\". www.nyuinformatics.org. NYU Langone Medical Center. http:\/\/www.nyuinformatics.org\/education\/degree-programs . Retrieved 11 November 2010 .   \n\n\u2191 Robson, B.; Baek, O. K. (2009). The engines of Hippocrates: From the Dawn of Medicine to Medical and Pharmaceutical Informatics. Hoboken, NJ: John Wiley & Sons. ISBN 9780470289532.   \n\n\u2191 7.0 7.1 \"UK Council for Health Informatics Professions (UKCHIP): Registration Standards Mapping Update\" (PDF). UKCHIP. 12 June 2006. http:\/\/www.bcs.org\/upload\/pdf\/mappingupdate.pdf\u200e . Retrieved 30 October 2013 .   \n\n\u2191 \"About the Health Informatics Career Framework (HICF)\". National Health Service. https:\/\/www.hicf.org.uk\/AboutHICF.aspx . Retrieved 30 October 2013 .   \n\n\u2191 \"HSRIC: Health Informatics\". U.S. National Library of Medicine. http:\/\/www.nlm.nih.gov\/hsrinfo\/informatics.html . Retrieved 30 October 2013 .   \n\n\u2191 10.0 10.1 \"IMIA LAC: Regional Federation of Health Informatics for Latin America and the Caribbean\". International Medical Informatics Association. http:\/\/www.imia-medinfo.org\/new2\/node\/159 . Retrieved 30 October 2013 .   \n\n\u2191 \"Grupo de Inform\u00e1tica Biom\u00e9dica de Buenos Aires - GIBBA\". GIBBA. http:\/\/www.gibba.org.ar\/GIBBAWEB2009\/index.php . Retrieved 30 October 2013 .   \n\n\u2191 12.0 12.1 Sonis, A. (1981). \"The Latin American network of biomedical and health information: experience and future development\". Educaci\u00f3n M\u00e9dica y Salud 15 (4): 474\u2013493. PMID 7030712. http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/7030712\/ .   \n\n\u2191 Garcia, Maria L\u00facia Andrade; Kent, Allen (ed.) (1987). \"Brazil, The Organization Of Scientific and Technological Information In\". Encyclopedia of Library and Information Science. 43. CRC Press. pp. 38\u201347. http:\/\/books.google.com\/books?id=sFqds9V6heMC .   \n\n\u2191 \"A Hist\u00f3ria da SBIS\". Sociedade Brasileira de Inform\u00e1tica em Sa\u00fade. http:\/\/www.sbis.org.br\/site\/site.dll\/view?pagina=5 . Retrieved 30 October 2013 .   \n\n\u2191 \"Canada Health Infoway Annual Report 2012\u201313\" (PDF). Canada Health Infoway. 26 July 2013. https:\/\/www.infoway-inforoute.com\/index.php\/resources\/infoway-corporate\/annual-reports\/doc_download\/1876-annual-report-2012-2013 . Retrieved 30 October 2013 .   \n\n\u2191 \"Head of eHealth Ontario is fired amid contracts scandal, gets big package\". CBC News. 07 June 2009. http:\/\/www.cbc.ca\/news\/canada\/head-of-ehealth-ontario-is-fired-amid-contracts-scandal-gets-big-package-1.797216 . Retrieved 30 October 2013 .   \n\n\u2191 \"Alberta Netcare: The History of the EHR\". Government of Alberta. http:\/\/www.albertanetcare.ca\/History.htm . Retrieved 30 October 2013 .   \n\n\u2191 Sittig, Dean F.; Ash, Joan S.; Ledley, Robert S. (2006). \"The Story Behind the Development of the First Whole-body Computerized Tomography Scanner as Told by Robert S. Ledley\". Journal of the American Medical Informatics Association 13 (5): 465\u20139. doi:10.1197\/jamia.M2127. PMC 1561796. PMID 16799115. http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC1561796\/ .   \n\n\u2191 Patton, Gregory A., Gardner, Reed M. (1999). \"Medical Informatics Education: The University of Utah Experience\". Journal of the American Medical Informatics Association 6 (6): 457\u201365. PMC 61389. PMID 10579604. http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC61389\/ .   \n\n\u2191 20.0 20.1 Park, Seung Lyung; Pantanowitz, Liron; Sharma, Guarav; Parwani, Anil Vasdev (March 2012). \"Anatomic Pathology Laboratory Information Systems: A Review\". Advances in Anatomic Pathology 19 (2): 81\u201396. doi:10.1097\/PAP.0b013e318248b787. http:\/\/ebookbrowse.com\/anatomic-pathology-laboratory-information-systems-a-review-slpark-et-all-adv-anat-pathol-2012-pdf-d344405134 . Retrieved 03 June 2013 .   \n\n\u2191 Reilly, Edwin D. (2003). Milestones in Computer Science and Information Technology. Greenwood Publishing Group. pp. 161. ISBN 9781573565219. http:\/\/books.google.com\/books?id=JTYPKxug49IC .   \n\n\u2191 Blum, Bruce I.; Duncan, Karen A. (1990). A History of Medical Informatics. ACM Press. pp. 141\u201353. ISBN 0201501287. http:\/\/books.google.com\/books\/about\/A_History_of_medical_informatics.html?id=AR5rAAAAMAAJ .   \n\n\u2191 Sinard, John H. (2006). Practical Pathology Informatics: Demstifying Informatics for the Practicing Anatomic Pathologist. Springer. pp. 393. ISBN 0387280588. http:\/\/books.google.com\/books?id=WerUyK618fcC .   \n\n\u2191 Kumar, Sameer; Aldrich, Krista (December 2010). \"Overcoming barriers to electronic medical record (EMR) implementation in the US healthcare system: A comparative study\". Health Informatics Journal 16 (4). doi:10.1177\/1460458210380523. http:\/\/jhi.sagepub.com\/content\/16\/4\/306.abstract . Retrieved 03 June 2013 .   \n\n\u2191 \"Digital Agenda for Europe: Research in eHealth\". European Commission. http:\/\/ec.europa.eu\/digital-agenda\/en\/research-ehealth . Retrieved 30 October 2013 .   \n\n\u2191 \"Electronic Health Records for Europe\". European Space Agency. 30 March 2005. http:\/\/www.esa.int\/SPECIALS\/Telemedicine_Alliance\/SEMWC7SMD6E_0.html . Retrieved 30 October 2013 .   \n\n\u2191 Mennerat, Fran\u00e7ois (10 October 2006). \"The EuroRec Institute: Its Structure, Activities and New Services\" (PPT). EuroRec. http:\/\/www.eurorec.org\/files\/filesPublic\/EuroRec2006_FrancoisMennerat.ppt\u200e . Retrieved 30 October 2013 .   \n\n\u2191 28.0 28.1 \"About epSOS\". European Commission. http:\/\/www.epsos.eu\/home\/about-epsos.html . Retrieved 30 October 2013 .   \n\n\u2191 Zemanek, H.; Brunnstein, K. (31 March 2011). \"Chart 0: IFIP at a Glance\". A Quarter Century of IFIP. IFIP. http:\/\/www.ifip.org\/50th_anni\/Chart0.htm . Retrieved 31 October 2013 .   \n\n\u2191 Nedkov, Plamen; Rosenfeld, Jack L. (ed.) (2002). \"The IFIP Presidents\". IFIP Newsletter 19 (1\u20133): 7. http:\/\/www.ifip.org\/newsletters\/News2002\/News_Sep_2002.pdf\u200e .   \n\n\u2191 31.0 31.1 Dezelic, Gjuro; Adlassnig, Klaus-Peter (ed.) (2009). \"After Three Decades of Medical Informatics Europe Congresses\". Medical Informatics in a United and Healthy Europe. IOS Press. pp. 3\u20137. ISBN 1607500442. http:\/\/books.google.com\/books?id=pGHWtG5_xIgC .   \n\n\u2191 32.0 32.1 \"MPs publish report on the dismantled National Programme for IT in the NHS\". U.K. Parliament. 18 September 2013. http:\/\/www.parliament.uk\/business\/committees\/committees-a-z\/commons-select\/public-accounts-committee\/news\/npfit-report\/ . Retrieved 30 October 2013 .   \n\n\u2191 \"Scotland\u2019s doctors welcome review of GPASS\". BMA Scotland. 11 June 2002. http:\/\/web.bma.org.uk\/pressrel.nsf\/wlu\/GGRT-5AZK3T . Retrieved 01 November 2013 .   \n\n\u2191 Todd, Rebecca (20 August 2012). \"Scotland's GPASS is no more\". EHealth Insider. EHealth Media Limited. http:\/\/www.ehi.co.uk\/news\/ehi\/8005\/scotland's-gpass-is-no-more . Retrieved 01 November 2013 .   \n\n\u2191 \"About Asia Pacific Association of Medical Informatics\". APAMI. http:\/\/www.apami.org\/about.html . Retrieved 01 November 2013 .   \n\n\u2191 \"Australasian College of Health Informatics\". ACHI. http:\/\/www.achi.org.au . Retrieved 01 November 2013 .   \n\n\u2191 \"eJHI - Journal Sponsorship\". eJHI. http:\/\/www.ejhi.net\/ojs\/index.php\/ejhi\/about\/journalSponsorship . Retrieved 01 November 2013 .   \n\n\u2191 \"Australian Health Informatics Education Council\". AHIEC. http:\/\/www.ahiec.org.au\/ . Retrieved 01 November 2013 .   \n\n\u2191 \"About Health Informatics Society of Australia\". HISA. http:\/\/www.hisa.org.au\/?about . Retrieved 01 November 2013 .   \n\n\u2191 \"Hong Kong Hospital Authority and Health Informatics Section\". Hong Kong Hospital Authority. http:\/\/www3.ha.org.hk\/hi\/Welcome.html . Retrieved 01 November 2013 .   \n\n\u2191 \"eHealth Consortium\". IPROA. http:\/\/www.iproa.org\/index.php\/en-GB\/other-projects\/227-ehealth-consortium.html . Retrieved 01 November 2013 .   \n\n\u2191 Karolyn Kerr; Cullen, Rowena; Duke, Jan; Holt, Alec; Kirk, Ray; Komisarczuk, Peter; Warren, Jim; Wilson, Shona (2006). \"Health Informatics Capability Development In New Zealand - A Report to the Tertiary Education Commission\" (PDF). National Steering Committee for Health Informatics Education in New Zealand. http:\/\/homepages.mcs.vuw.ac.nz\/~peterk\/healthinformatics\/tec-hi-report-06.pdf . Retrieved 01 November 2013 .   \n\n\u2191 \"Saudi Association for Health Informatics (SAHI)\". SAHI. 25 May 2011. http:\/\/www.sahi.org.sa\/objectives.php . Retrieved 01 November 2013 .   \n\n\u2191 \"35.240.80: IT applications in health care technology\". ISO. http:\/\/www.iso.org\/iso\/products\/standards\/catalogue_ics_browse.htm?ICS1=35&ICS2=240&ICS3=80& . Retrieved 01 November 2013 .   \n\n\u2191 Fraser, Ross (06 June 2006). \"ISO 27799: Security management in health using ISO\/IEC 17799\" (PDF). Ross Fraser. http:\/\/sl.infoway-inforoute.ca\/downloads\/Ross_Fraser_-_ISO_27799.pdf . Retrieved 01 November 2013 .   \n\n\u2191 Certification Commission for Healthcare Information Technology (18 July 2006). \"CCHIT Announces First Certified Electronic Health Record Products\". Virtual Medical Worlds. http:\/\/www.hoise.com\/vmw\/06\/articles\/vmw\/LV-VM-08-06-22.html . Retrieved 01 November 2013 .   \n\n\u2191 Gardner, Reed M.; Overhage J. Mark; Steen, Elaine B.; Holmes, John H.; Munger, Benson S.; Williamson, Jeffrey J.; Detmer, Don E. (2009). \"Core content for the subspecialty of clinical informatics\". Journal of the American Medical Informatics Association 16 (2): 153\u20137. doi:10.1197\/jamia.M3045. PMC 2649328. PMID 19074296. http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC2649328 .   \n\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Health_informatics\">https:\/\/www.limswiki.org\/index.php\/Health_informatics<\/a>\n\t\t\t\t\tCategories: Articles containing potentially dated statements from 2013Articles with invalid date parameter in templateAll articles containing potentially dated statementsArticles containing potentially dated statements from July 2013Informatics\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\n\t\t\n\t\t\tNavigation menu\n\t\t\t\t\t\n\t\t\tViews\n\n\t\t\t\n\t\t\t\t\n\t\t\t\tPage\n\t\t\t\tDiscussion\n\t\t\t\tView source\n\t\t\t\tHistory\n\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\n\t\t\t\t\n\t\t\t\tPersonal tools\n\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\tLog in\n\t\t\t\t\t\t\t\t\t\t\t\t\tRequest account\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\t\t\n\t\tNavigation\n\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tMain page\n\t\t\t\t\t\t\t\t\t\t\tRecent changes\n\t\t\t\t\t\t\t\t\t\t\tRandom page\n\t\t\t\t\t\t\t\t\t\t\tHelp\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\n\t\t\t\n\t\t\tSearch\n\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t \n\t\t\t\t\t\t\n\t\t\t\t\n\n\t\t\t\t\t\t\t\n\t\t\n\t\t\t\n\t\t\tTools\n\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tWhat links here\n\t\t\t\t\t\t\t\t\t\t\tRelated changes\n\t\t\t\t\t\t\t\t\t\t\tSpecial pages\n\t\t\t\t\t\t\t\t\t\t\tPermanent link\n\t\t\t\t\t\t\t\t\t\t\tPage information\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\n\t\t\n\t\tPrint\/export\n\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tCreate a book\n\t\t\t\t\t\t\t\t\t\t\tDownload as PDF\n\t\t\t\t\t\t\t\t\t\t\tDownload as Plain text\n\t\t\t\t\t\t\t\t\t\t\tPrintable version\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\n\t\t\n\t\tSponsors\n\t\t\n\t\t\t \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n \r\n\n\t\n\t\r\n\n \r\n\n\t\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t This page was last modified on 3 December 2018, at 22:34.\n\t\t\t\t\t\t\t\t\tThis page has been accessed 40,136 times.\n\t\t\t\t\t\t\t\t\tContent is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.\n\t\t\t\t\t\t\t\t\tPrivacy policy\n\t\t\t\t\t\t\t\t\tAbout LIMSWiki\n\t\t\t\t\t\t\t\t\tDisclaimers\n\t\t\t\t\t\t\t\n\t\t\n\t\t\n\t\t\n\n","055eb51f53cfdbacc08ed150b266c9f4_html":"<body class=\"mediawiki ltr sitedir-ltr ns-0 ns-subject page-Health_informatics skin-monobook action-view\">\n<div id=\"rdp-ebb-globalWrapper\">\n\t\t<div id=\"rdp-ebb-column-content\">\n\t\t\t<div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\">\n\t\t\t\t<a id=\"rdp-ebb-top\"><\/a>\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Health informatics<\/h1>\n\t\t\t\t\n\t\t\t\t<div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\">\n\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\n\n\t\t\t\t\t<!-- start content -->\n\t\t\t\t\t<div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"thumb tright\"><div class=\"thumbinner\" style=\"width:362px;\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Doctor_review_brain_images.jpg\" class=\"image wiki-link\" target=\"_blank\" data-key=\"76e3f41757c618e87fedbb3ec1415e20\"><img alt=\"\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/0\/0b\/Doctor_review_brain_images.jpg\" width=\"360\" height=\"286\" class=\"thumbimage\" \/><\/a> <div class=\"thumbcaption\"><div class=\"magnify\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Doctor_review_brain_images.jpg\" class=\"internal wiki-link\" title=\"Enlarge\" target=\"_blank\" data-key=\"76e3f41757c618e87fedbb3ec1415e20\"><\/a><\/div>Health informatics helps manage, analyze, and integrate patient data from physician to specialist and beyond.<\/div><\/div><\/div>\n<p><b>Health informatics<\/b> (also called <b>health care informatics<\/b>, <b>healthcare informatics<\/b>, <b>medical informatics<\/b>, <b>nursing informatics<\/b>, <b>clinical informatics<\/b>, or <b>biomedical informatics<\/b>) is a discipline at the intersection of , computer science, and health care. It deals with the resources, devices, and methods required to optimize the \"collection, storage, retrieval, [and] communication ... of health-related data, <a href=\"https:\/\/www.limswiki.org\/index.php\/Information\" title=\"Information\" target=\"_blank\" class=\"wiki-link\" data-key=\"6300a14d9c2776dcca0999b5ed940e7d\">information<\/a>, and knowledge.\"<sup id=\"rdp-ebb-cite_ref-Hovenga1_1-0\" class=\"reference\"><a href=\"#cite_note-Hovenga1-1\" rel=\"external_link\">[1]<\/a><\/sup> Health informatics is applied to the areas of nursing, clinical care, dentistry, pharmacy, public health, occupational therapy, and biomedical research. Health informatics resources include not only computers but also clinical guidelines, formal medical terminologies, and information and communication systems. \n<\/p><p>Early names for health informatics included medical information data processing, medical information science, medical informatics<sup id=\"rdp-ebb-cite_ref-EncyCompSci_2-0\" class=\"reference\"><a href=\"#cite_note-EncyCompSci-2\" rel=\"external_link\">[2]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-Hovenga1_1-1\" class=\"reference\"><a href=\"#cite_note-Hovenga1-1\" rel=\"external_link\">[1]<\/a><\/sup>, medical computer science, and medical computing.<sup id=\"rdp-ebb-cite_ref-3rdKnoMan_3-0\" class=\"reference\"><a href=\"#cite_note-3rdKnoMan-3\" rel=\"external_link\">[3]<\/a><\/sup>\n<\/p>\n\n\n<h2><span class=\"mw-headline\" id=\"History\">History<\/span><\/h2>\n<p>Worldwide use of technology in medicine began in the early 1950s with the rise of computers.<sup id=\"rdp-ebb-cite_ref-univ_4-0\" class=\"reference\"><a href=\"#cite_note-univ-4\" rel=\"external_link\">[4]<\/a><\/sup> In 1949, Gustav Wager established the first professional organization for informatics in Germany.<sup id=\"rdp-ebb-cite_ref-nyu_5-0\" class=\"reference\"><a href=\"#cite_note-nyu-5\" rel=\"external_link\">[5]<\/a><\/sup> The prehistory, history, and future of medical information and <a href=\"https:\/\/www.limswiki.org\/index.php\/Health_information_technology\" title=\"Health information technology\" target=\"_blank\" class=\"wiki-link\" data-key=\"9c8ef822470559f757db89f3fa234cc0\">health information technology<\/a> are discussed in reference.<sup id=\"rdp-ebb-cite_ref-Robson_first_6-0\" class=\"reference\"><a href=\"#cite_note-Robson_first-6\" rel=\"external_link\">[6]<\/a><\/sup> Specialized university departments and Informatics training programs began during the 1960s in France, Germany, Belgium and The Netherlands. Medical informatics research units began to appear during the 1970s in Poland and in the U.S.<sup id=\"rdp-ebb-cite_ref-nyu_5-1\" class=\"reference\"><a href=\"#cite_note-nyu-5\" rel=\"external_link\">[5]<\/a><\/sup>, with medical informatics conferences springing up as early as 1974.<sup id=\"rdp-ebb-cite_ref-Hovenga1_1-2\" class=\"reference\"><a href=\"#cite_note-Hovenga1-1\" rel=\"external_link\">[1]<\/a><\/sup> Since then the development of high-quality health informatics research, education, and infrastructure has been the goal of the U.S. and the European Union.<sup id=\"rdp-ebb-cite_ref-nyu_5-2\" class=\"reference\"><a href=\"#cite_note-nyu-5\" rel=\"external_link\">[5]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-Hovenga1_1-3\" class=\"reference\"><a href=\"#cite_note-Hovenga1-1\" rel=\"external_link\">[1]<\/a><\/sup>\n<\/p><p>By the mid-2000s, work in the U.K. by the voluntary registration body the UK Council of Health Informatics Professions led to the creation of eight key constituencies within the domain of health informatics: information and communication technologies; health records; information management; knowledge management; health informatics service and project management; clinical informatics; education, training, and development; and research.<sup id=\"rdp-ebb-cite_ref-8HIConst_7-0\" class=\"reference\"><a href=\"#cite_note-8HIConst-7\" rel=\"external_link\">[7]<\/a><\/sup> Those constituencies \u2014 already based on U.K. National Health Service standards (NHS) \u2014 later found their way into the NHS' Health Informatics Career Framework in a slightly modified format.<sup id=\"rdp-ebb-cite_ref-HICF_8-0\" class=\"reference\"><a href=\"#cite_note-HICF-8\" rel=\"external_link\">[8]<\/a><\/sup> As of 2013<sup class=\"plainlinks noprint asof-tag update\" style=\"display:none;\"><\/sup> tens of datasets, publications, guidelines, specifications, meetings, conferences, and organizations around the world continue to shape what health informatics is today.<sup id=\"rdp-ebb-cite_ref-HSRIC_9-0\" class=\"reference\"><a href=\"#cite_note-HSRIC-9\" rel=\"external_link\">[9]<\/a><\/sup>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Health_informatics_in_North_America\">Health informatics in North America<\/span><\/h3>\n<h4><span class=\"mw-headline\" id=\"Argentina\">Argentina<\/span><\/h4>\n<p>Since 1996, the International Medical Informatics Association's Latin America and the Caribbean regional group has sought to develop health informatics within the region, including Argentina's Asociaci\u00f3n Argentina de Inform\u00e1tica M\u00e9dica (AAIM).<sup id=\"rdp-ebb-cite_ref-IMIA_LAC_10-0\" class=\"reference\"><a href=\"#cite_note-IMIA_LAC-10\" rel=\"external_link\">[10]<\/a><\/sup>\n<\/p><p>Since 1997, the not-for-profit Buenos Aires Biomedical Informatics Group has represented the interests of a broad range of clinical and non-clinical professionals working within the health informatics sphere. The group strives to promote informatics technology and related content within the research and health administration spheres, especially those relating to the biomedical field.<sup id=\"rdp-ebb-cite_ref-GIBBA_11-0\" class=\"reference\"><a href=\"#cite_note-GIBBA-11\" rel=\"external_link\">[11]<\/a><\/sup>\n<\/p>\n<h4><span class=\"mw-headline\" id=\"Brazil\">Brazil<\/span><\/h4>\n<p>\"In 1968 the Pan American Health Organization set up the Regional Library of Medicine and Health Sciences (BIREME) in the Paulista Medical School in S\u00e3o Paulo under an agreement with the Government of Brazil.\"<sup id=\"rdp-ebb-cite_ref-LatAmerNet_12-0\" class=\"reference\"><a href=\"#cite_note-LatAmerNet-12\" rel=\"external_link\">[12]<\/a><\/sup> The library also made possible access to the MEDLINE and MEDLARS systems<sup id=\"rdp-ebb-cite_ref-EnLiInfo43_8_13-0\" class=\"reference\"><a href=\"#cite_note-EnLiInfo43_8-13\" rel=\"external_link\">[13]<\/a><\/sup>, and it would eventually go on to become the \"hub of the Latin American network of biomedical and health information.\"<sup id=\"rdp-ebb-cite_ref-LatAmerNet_12-1\" class=\"reference\"><a href=\"#cite_note-LatAmerNet-12\" rel=\"external_link\">[12]<\/a><\/sup>\n<\/p><p>In 1986 the Brazilian Society of Health Informatics (Sociedade Brasileira de Inform\u00e1tica em Sa\u00fade) was founded to better expand the use of informatics technology within the country. The same year saw the first Brazilian Congress of Health Informatics held, and the first <i>Brazilian Journal of Health Informatics<\/i> was published.<sup id=\"rdp-ebb-cite_ref-SBISHist_14-0\" class=\"reference\"><a href=\"#cite_note-SBISHist-14\" rel=\"external_link\">[14]<\/a><\/sup>\n<\/p><p>Since 1996, the International Medical Informatics Association's Latin America and the Caribbean regional group has sought to develop health informatics within the region, including Brazil's Sociedade Brasileira de Inform\u00e1tica em Sa\u00fade (SBIS).<sup id=\"rdp-ebb-cite_ref-IMIA_LAC_10-1\" class=\"reference\"><a href=\"#cite_note-IMIA_LAC-10\" rel=\"external_link\">[10]<\/a><\/sup>\n<\/p>\n<h4><span class=\"mw-headline\" id=\"Canada\">Canada<\/span><\/h4>\n<p>Health Informatics projects in Canada are implemented provincially, with different provinces creating different systems. A national, federally-funded, not-for-profit organization called Canada Health Infoway was created in 2001 to foster the development and adoption of electronic health records across Canada. As of July 2013<sup class=\"plainlinks noprint asof-tag update\" style=\"display:none;\"><\/sup> there were 380 health informatics projects under way in Canadian <a href=\"https:\/\/www.limswiki.org\/index.php\/Hospital\" title=\"Hospital\" target=\"_blank\" class=\"wiki-link\" data-key=\"b8f070c66d8123fe91063594befebdff\">hospitals<\/a>, health-care facilities, pharmacies, and laboratories, with an investment value of $2.1 billion since its inception.<sup id=\"rdp-ebb-cite_ref-CHIReport12-13_15-0\" class=\"reference\"><a href=\"#cite_note-CHIReport12-13-15\" rel=\"external_link\">[15]<\/a><\/sup>\n<\/p><p>Provincial and territorial programs include the following: \n<\/p>\n<ul><li><b>eHealth Ontario<\/b> was created as an Ontario provincial government agency in September 2008. It has been plagued by delays, and its CEO was fired over a multi-million dollar contract scandal in 2009.<sup id=\"rdp-ebb-cite_ref-16\" class=\"reference\"><a href=\"#cite_note-16\" rel=\"external_link\">[16]<\/a><\/sup><\/li><\/ul>\n<ul><li><b>Alberta Netcare<\/b> Portal was created in 2006 by the Government of Alberta. The Netcare portal is used daily by thousands of clinicians. It provides access to demographic data, prescribed\/dispensed drugs, known allergies\/intolerances, immunizations, laboratory test results, diagnostic imaging reports, the diabetes registry and other medical reports. Netcare interface capabilities are being included in electronic medical record products which are being funded by the provincial government.<sup id=\"rdp-ebb-cite_ref-NetcareHist_17-0\" class=\"reference\"><a href=\"#cite_note-NetcareHist-17\" rel=\"external_link\">[17]<\/a><\/sup><\/li><\/ul>\n<h4><span class=\"mw-headline\" id=\"United_States\">United States<\/span><\/h4>\n<p>Even though the idea of using computers in medicine sprouted as technology advanced in the early twentieth century, it was not until the 1950s that informatics made a realistic impact in the United States.<sup id=\"rdp-ebb-cite_ref-univ_4-1\" class=\"reference\"><a href=\"#cite_note-univ-4\" rel=\"external_link\">[4]<\/a><\/sup> Robert Ledley led the charge in the 1950s with his early use of medical computation in his dental projects at the United States National Bureau of Standards.<sup id=\"rdp-ebb-cite_ref-Ledley_18-0\" class=\"reference\"><a href=\"#cite_note-Ledley-18\" rel=\"external_link\">[18]<\/a><\/sup>\n<\/p><p>By the mid-1950s expert systems such as <a href=\"https:\/\/www.limswiki.org\/index.php\/MYCIN\" title=\"MYCIN\" target=\"_blank\" class=\"wiki-link\" data-key=\"4ea15fec1c33edc9b5f1b300bd6f51f9\">MYCIN<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/INTERNIST-I\" title=\"INTERNIST-I\" target=\"_blank\" class=\"wiki-link\" data-key=\"ab2f56ea93f9b33dc53239f9d13a064d\">INTERNIST-I<\/a> were developed, and the National Library of Medicine started using even the even more advanced MEDLINE and MEDLARS systems by 1965. Around this same time a flurry of activity occurred. At the University of Utah, Dr. Homer R. Warner, one of the fathers of medical informatics<sup id=\"rdp-ebb-cite_ref-MedInfoEd_19-0\" class=\"reference\"><a href=\"#cite_note-MedInfoEd-19\" rel=\"external_link\">[19]<\/a><\/sup>, was already offering graduate-level classes in medical computer applications. Meanwhile Neil Pappalardo, Curtis Marble, and Robert Greenes were developing the Massachusetts General Hospital Utility Multi-Programming System (MUMPS) in Octo Barnett's Laboratory of Computer Science at Massachusetts General Hospital in Boston.<sup id=\"rdp-ebb-cite_ref-APLISReview_20-0\" class=\"reference\"><a href=\"#cite_note-APLISReview-20\" rel=\"external_link\">[20]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MileCompSci_21-0\" class=\"reference\"><a href=\"#cite_note-MileCompSci-21\" rel=\"external_link\">[21]<\/a><\/sup> Yet due to its advanced nature, fragmented use across multiple entities, and inherent difficulty in extracting and analyzing data from the database, development of healthcare and laboratory systems on MUMPS was sporadic at best.<sup id=\"rdp-ebb-cite_ref-HistMedInfo_22-0\" class=\"reference\"><a href=\"#cite_note-HistMedInfo-22\" rel=\"external_link\">[22]<\/a><\/sup> \n<\/p><p>By the 1980s, however, the advent of Structured Query Language (SQL), relational database management systems (RDBMS), and <a href=\"https:\/\/www.limswiki.org\/index.php\/Health_Level_7\" title=\"Health Level 7\" target=\"_blank\" class=\"wiki-link\" data-key=\"e0bf845fb58d2bae05a846b47629e86f\">Health Level 7<\/a> (HL7) allowed software developers to expand the functionality and interoperability of health informatics systems, including the application of business analytics and business intelligence techniques to clinical data.<sup id=\"rdp-ebb-cite_ref-PractPathInfo_23-0\" class=\"reference\"><a href=\"#cite_note-PractPathInfo-23\" rel=\"external_link\">[23]<\/a><\/sup> As of 2013<sup class=\"plainlinks noprint asof-tag update\" style=\"display:none;\"><\/sup> web-based and database-centric Internet applications of <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_informatics\" title=\"Laboratory informatics\" target=\"_blank\" class=\"wiki-link\" data-key=\"00edfa43edcde538a695f6d429280301\">laboratory informatics<\/a> software have further changed the way researchers and technicians interact with data, with web-driven data formatting technologies like <a href=\"https:\/\/www.limswiki.org\/index.php\/Extensible_Markup_Language\" title=\"Extensible Markup Language\" target=\"_blank\" class=\"wiki-link\" data-key=\"f7c17028e7fb39d8b39c6d31504411a8\">Extensible Markup Language<\/a> (XML) making interoperability of health and laboratory informatics software a much-needed reality.<sup id=\"rdp-ebb-cite_ref-OverBarEMR_24-0\" class=\"reference\"><a href=\"#cite_note-OverBarEMR-24\" rel=\"external_link\">[24]<\/a><\/sup> <a href=\"https:\/\/www.limswiki.org\/index.php\/Software_as_a_service\" title=\"Software as a service\" target=\"_blank\" class=\"wiki-link\" data-key=\"ae8c8a7cd5ee1a264f4f0bbd4a4caedd\">SaaS<\/a> and cloud computing technologies have further changed how informatics systems are implemented in the U.S and worldwide, while at the same time raising new questions about security and stability.<sup id=\"rdp-ebb-cite_ref-APLISReview_20-1\" class=\"reference\"><a href=\"#cite_note-APLISReview-20\" rel=\"external_link\">[20]<\/a><\/sup>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Health_informatics_in_Europe\">Health informatics in Europe<\/span><\/h3>\n<p>The European Union's Member States are committed to sharing their best practices and experiences to create a European eHealth Area, thereby improving access to and quality health care at the same time as stimulating growth in a promising new industrial sector. The associated European eHealth programs plays a fundamental role in the European Union's strategy. Work on this initiative involves a collaborative approach among several parts of the Commission services.<sup id=\"rdp-ebb-cite_ref-ResearchIneHealth_25-0\" class=\"reference\"><a href=\"#cite_note-ResearchIneHealth-25\" rel=\"external_link\">[25]<\/a><\/sup> Additionally, the not-for-profit European Institute for Health Records or EuroRec has promoted the use of high quality <a href=\"https:\/\/www.limswiki.org\/index.php\/Electronic_health_record\" title=\"Electronic health record\" target=\"_blank\" class=\"wiki-link\" data-key=\"f2e31a73217185bb01389404c1fd5255\">electronic health record<\/a> systems in the European Union since its foundation in late 2002.<sup id=\"rdp-ebb-cite_ref-EHREuro_26-0\" class=\"reference\"><a href=\"#cite_note-EHREuro-26\" rel=\"external_link\">[26]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-EuroRecPPT_27-0\" class=\"reference\"><a href=\"#cite_note-EuroRecPPT-27\" rel=\"external_link\">[27]<\/a><\/sup>\n<\/p><p>epSOS (European Patients - Smart Open Services) represents another key European initiative to \"build and evaluate a service infrastructure that demonstrates cross-border interoperability between electronic health record systems in Europe.\"<sup id=\"rdp-ebb-cite_ref-epSOSAbout_28-0\" class=\"reference\"><a href=\"#cite_note-epSOSAbout-28\" rel=\"external_link\">[28]<\/a><\/sup> Co-funded by the European Commission Competitiveness and Innovation Programme since 2008, the initiative (scheduled to finish on December 31, 2013) was devised with the vision of giving patients in Europe the opportunity to use cross-border <a href=\"https:\/\/www.limswiki.org\/index.php\/Electronic_medical_record\" title=\"Electronic medical record\" target=\"_blank\" class=\"wiki-link\" data-key=\"99a695d2af23397807da0537d29d0be7\">electronic medical record<\/a> services for healthcare-related activities in participating epSOS pilot countries.<sup id=\"rdp-ebb-cite_ref-epSOSAbout_28-1\" class=\"reference\"><a href=\"#cite_note-epSOSAbout-28\" rel=\"external_link\">[28]<\/a><\/sup>\n<\/p>\n<h4><span class=\"mw-headline\" id=\"In_the_United_Kingdom\">In the United Kingdom<\/span><\/h4>\n<p>The U.K. health informatics community has long played a key role in international activity, joining Technical Committee Four (TC 4) of the International Federation of Information Processing in 1968<sup id=\"rdp-ebb-cite_ref-IFIP50Chart_29-0\" class=\"reference\"><a href=\"#cite_note-IFIP50Chart-29\" rel=\"external_link\">[29]<\/a><\/sup>, which eventually became the International Medical Informatics Association (IMIA) in 1979.<sup id=\"rdp-ebb-cite_ref-IFIPNL2002_30-0\" class=\"reference\"><a href=\"#cite_note-IFIPNL2002-30\" rel=\"external_link\">[30]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MIEuro_31-0\" class=\"reference\"><a href=\"#cite_note-MIEuro-31\" rel=\"external_link\">[31]<\/a><\/sup> In 1978, the Medical Specialist Group of the British Computer Society organized the first European Federation for Medical Informatics (EFMI) Medical Informatics Europe (MIE) conference in Cambridge.<sup id=\"rdp-ebb-cite_ref-MIEuro_31-1\" class=\"reference\"><a href=\"#cite_note-MIEuro-31\" rel=\"external_link\">[31]<\/a><\/sup>\n<\/p><p>In 2002, the idea of a profession of health informatics across the U.K. was first implemented as the U.K. Council for Health Informatics Professions (UKCHIP), which has a formal Code of Professional Conduct, standards for expressing competences which are used for entry, confirmation of fitness to practice, re-grading and personal development. Consistent standards express competences of health informatics professionals in both domain-specific and generic informatics professional areas. The consistency is intended to apply in operational care delivery organizations, academia, and the commercial service and solution providers.<sup id=\"rdp-ebb-cite_ref-8HIConst_7-1\" class=\"reference\"><a href=\"#cite_note-8HIConst-7\" rel=\"external_link\">[7]<\/a><\/sup> \n<\/p><p>The broad history of health informatics in the U.K. has been captured in the 2008 book <i>U.K. Health Computing : Recollections and Reflections<\/i> by Glyn M. Hayes and Denise E. Barnett. The book describes the early development of health informatics in the country as \"unorganized and idiosyncratic.\"\n<\/p>\n<h5><span class=\"mw-headline\" id=\"England\">England<\/span><\/h5>\n<p>In 2002 the National Health Service (NHS) in England contracted several vendors for a national health informatics system called the National Programme for IT or \"NPfIT.\" By 2010, however, the project drastically behind schedule, forcing a wide consultation to be launched as part of a wider \"Liberating the NHS\" plan. \"Following three reports on the National Programme by both the National Audit Office and this Committee, and a review by the Major Projects Authority, the Government announced in September 2011 that it would dismantle the National Programme but keep the component parts in place with separate management and accountability structures.\"<sup id=\"rdp-ebb-cite_ref-DismantleNPfIT_32-0\" class=\"reference\"><a href=\"#cite_note-DismantleNPfIT-32\" rel=\"external_link\">[32]<\/a><\/sup> The program was officially dismantled in September 2013, officially dubbed \"one of the worst and most expensive contracting fiascos in the history of the public sector.\"<sup id=\"rdp-ebb-cite_ref-DismantleNPfIT_32-1\" class=\"reference\"><a href=\"#cite_note-DismantleNPfIT-32\" rel=\"external_link\">[32]<\/a><\/sup> \n<\/p>\n<h5><span class=\"mw-headline\" id=\"Scotland\">Scotland<\/span><\/h5>\n<p>In 1984, Scotland saw the implementation of the General Practice Administration System (GPASS), developed and controlled by NHS Scotland.<sup id=\"rdp-ebb-cite_ref-BMAGPASS_33-0\" class=\"reference\"><a href=\"#cite_note-BMAGPASS-33\" rel=\"external_link\">[33]<\/a><\/sup> It was provided free to all general practitioners in Scotland. However, an agreement was reached in 2008 to shut down the electronic system due to \"a series of problems and critical reports.\"<sup id=\"rdp-ebb-cite_ref-GPASSNoMo_34-0\" class=\"reference\"><a href=\"#cite_note-GPASSNoMo-34\" rel=\"external_link\">[34]<\/a><\/sup> The system was formally shut down in August 2012, with all practices having moved to new systems called EMIS and INPS.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Health_informatics_in_Asia_and_Oceania\">Health informatics in Asia and Oceania<\/span><\/h3>\n<p>In Asia, Australia, and New Zealand, the regional group called the Asia Pacific Association for Medical Informatics (APAMI) was established in 1993 and now consists of more than 15 member regions in the Asia Pacific Region.<sup id=\"rdp-ebb-cite_ref-APAMIAbout_35-0\" class=\"reference\"><a href=\"#cite_note-APAMIAbout-35\" rel=\"external_link\">[35]<\/a><\/sup>\n<\/p>\n<h4><span class=\"mw-headline\" id=\"Australia\">Australia<\/span><\/h4>\n<p>Founded in 2002, the Australasian College of Health Informatics (ACHI) is the professional association for health informatics in the Asia-Pacific region. It represents the interests of a broad range of clinical and non-clinical professionals working within the health informatics sphere through a commitment to quality, standards, and ethical practice.<sup id=\"rdp-ebb-cite_ref-ACHI_36-0\" class=\"reference\"><a href=\"#cite_note-ACHI-36\" rel=\"external_link\">[36]<\/a><\/sup> ACHI is a sponsor of the <i>e-Journal for Health Informatics<\/i><sup id=\"rdp-ebb-cite_ref-eJSpons_37-0\" class=\"reference\"><a href=\"#cite_note-eJSpons-37\" rel=\"external_link\">[37]<\/a><\/sup>, an indexed and peer-reviewed professional journal. ACHI has also supported the Australian Health Informatics Education Council (AHIEC) since its founding in 2009.<sup id=\"rdp-ebb-cite_ref-AHIEC_38-0\" class=\"reference\"><a href=\"#cite_note-AHIEC-38\" rel=\"external_link\">[38]<\/a><\/sup>\n<\/p><p>Although there are a number of health informatics organizations in Australia, the Health Informatics Society of Australia (HISA) is regarded as the major umbrella group and is a member of the International Medical Informatics Association (IMIA). Nursing informaticians were the driving force behind the formation of HISA, which is now a company limited by guarantee of the members. The membership comes from across the informatics spectrum that is from students to corporate affiliates. HISA has a number of branches (Queensland, New South Wales, Victoria and Western Australia) as well as special interest groups such as nursing (NIA), pathology, aged and community care, industry, and medical imaging.<sup id=\"rdp-ebb-cite_ref-HISAAbout_39-0\" class=\"reference\"><a href=\"#cite_note-HISAAbout-39\" rel=\"external_link\">[39]<\/a><\/sup>\n<\/p>\n<h4><span class=\"mw-headline\" id=\"China\">China<\/span><\/h4>\n<p>In Hong Kong a computerized patient record system called the Clinical Management System (CMS) has been developed by the Hospital Authority since 1994. This system has been deployed at all the sites of the Authority (40 hospitals and 120 clinics) and is used by all 30,000 clinical staff on a daily basis, with a daily transaction of up to 2 millions. The comprehensive records of 7 million patients are available online in the Electronic Patient Record (ePR), with data integrated from all sites. Since 2004, radiology image viewing has been added to the ePR, with radiography images from any HA site being available as part of the ePR.\n<\/p><p>The Hong Kong Hospital Authority placed particular attention to the governance of clinical systems development, with input from hundreds of clinicians being incorporated through a structured process. The health informatics section of the Hong Kong Hospital Authority has close relationship with the information technology department and clinicians to develop healthcare systems for the organization to support the service to all public hospitals and clinics in the region.<sup id=\"rdp-ebb-cite_ref-HKHosp_40-0\" class=\"reference\"><a href=\"#cite_note-HKHosp-40\" rel=\"external_link\">[40]<\/a><\/sup>\n<\/p><p>The Hong Kong Society of Medical Informatics (HKSMI) was established in 1987 to promote the use of information technology in healthcare. The eHealth Consortium has been formed to bring together clinicians from both the private and public sectors, medical informatics professionals, and the IT industry to further promote IT in healthcare in Hong Kong.<sup id=\"rdp-ebb-cite_ref-IPROA_41-0\" class=\"reference\"><a href=\"#cite_note-IPROA-41\" rel=\"external_link\">[41]<\/a><\/sup>\n<\/p>\n<h4><span class=\"mw-headline\" id=\"New_Zealand\">New Zealand<\/span><\/h4>\n<p>Health Informatics is taught at five New Zealand universities. The most mature and established is the Otago program, which has been offered since the mid-1990s.<sup id=\"rdp-ebb-cite_ref-HINZRepo_42-0\" class=\"reference\"><a href=\"#cite_note-HINZRepo-42\" rel=\"external_link\">[42]<\/a><\/sup> Health Informatics New Zealand (HINZ) is the national organization that advocates for health informatics. HINZ organizes a conference every year and also publishes the online journal <i>Healthcare Informatics Review Online<\/i>.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Health_informatics_in_the_Middle_East\">Health informatics in the Middle East<\/span><\/h3>\n<h4><span class=\"mw-headline\" id=\"Saudi_Arabia\">Saudi Arabia<\/span><\/h4>\n<p>The Saudi Association for Health Information (SAHI) was established in 2006 to work under direct supervision of King Saud University for Health Sciences to practice public activities, develop theoretical and applicable knowledge, and provide scientific and applicable studies.<sup id=\"rdp-ebb-cite_ref-SAHIObj_43-0\" class=\"reference\"><a href=\"#cite_note-SAHIObj-43\" rel=\"external_link\">[43]<\/a><\/sup>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"Regulation_and_standards\">Regulation and standards<\/span><\/h2>\n<p>The international standards on the subject are covered by ICS 35.240.80<sup id=\"rdp-ebb-cite_ref-itah_44-0\" class=\"reference\"><a href=\"#cite_note-itah-44\" rel=\"external_link\">[44]<\/a><\/sup> in which ISO 27799:2008 is one of the core components.<sup id=\"rdp-ebb-cite_ref-isosm_45-0\" class=\"reference\"><a href=\"#cite_note-isosm-45\" rel=\"external_link\">[45]<\/a><\/sup>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"In_the_United_States\">In the United States<\/span><\/h3>\n<p>In 2004 the <a href=\"https:\/\/www.limswiki.org\/index.php\/United_States_Department_of_Health_and_Human_Services\" title=\"United States Department of Health and Human Services\" target=\"_blank\" class=\"wiki-link\" data-key=\"efa106bcbb93039b1a6c3c596daedec3\">U.S. Department of Health and Human Services<\/a> (HHS) formed the Office of the National Coordinator for Health Information Technology (ONCHIT). The mission of this office is widespread adoption of interoperable electronic health records (EHRs) in the US within 10 years.\n<\/p><p>The Certification Commission for Healthcare Information Technology (CCHIT), a private nonprofit group, was funded in 2005 by the U.S. Department of Health and Human Services to develop a set of standards for <a href=\"https:\/\/www.limswiki.org\/index.php\/Electronic_health_record\" title=\"Electronic health record\" target=\"_blank\" class=\"wiki-link\" data-key=\"f2e31a73217185bb01389404c1fd5255\">electronic health records<\/a> (EHR) and supporting networks, and certify vendors who meet them. In July, 2006 CCHIT released its first list of 22 certified ambulatory EHR products, in two different announcements.<sup id=\"rdp-ebb-cite_ref-HOISE_46-0\" class=\"reference\"><a href=\"#cite_note-HOISE-46\" rel=\"external_link\">[46]<\/a><\/sup>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"Clinical_informatics\">Clinical informatics<\/span><\/h2>\n<p>While health informatics and clinical informatics are often considered the same, some make a distinction between the two. The American Medical Informatics Association, for example, states clinical informatics is concerned with the use of information in health care by clinicians.<sup id=\"rdp-ebb-cite_ref-AMIACore_47-0\" class=\"reference\"><a href=\"#cite_note-AMIACore-47\" rel=\"external_link\">[47]<\/a><\/sup> By extension, clinical informaticians analyze, design, implement, and evaluate information and communication systems that enhance individual and population health outcomes, improve patient care, and strengthen the clinician-patient relationship.\n<\/p><p>Clinical informaticians use their knowledge of patient care combined with their understanding of informatics concepts, methods, and health informatics tools to:\n<\/p>\n<ul><li> assess information and knowledge needs of health care professionals and patients.<\/li>\n<li> characterize, evaluate, and refine clinical processes.<\/li>\n<li> develop, implement, and refine clinical decision support systems.<\/li>\n<li> lead or participate in the procurement, customization, development, implementation, management, evaluation, and continuous improvement of clinical information systems.<\/li><\/ul>\n<p>Clinicians collaborate with other health care and information technology professionals to develop health informatics tools which promote patient care that is safe, efficient, effective, timely, patient-centered, and equitable.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"Further_reading\">Further reading<\/span><\/h2>\n<ul><li> <span class=\"citation book\">De Moor, Georges J. E. ; McDonald, Clement J.; van Goor, J. M. Noothoven, ed. (1993). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/books.google.com\/books?id=DHzOJaNaOYkC\" target=\"_blank\"><i>Progress in Standardization in Health Care Informatics<\/i><\/a>. IOS Press. pp. 215. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" target=\"_blank\">ISBN<\/a> 9051991142<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/books.google.com\/books?id=DHzOJaNaOYkC\" target=\"_blank\">http:\/\/books.google.com\/books?id=DHzOJaNaOYkC<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Progress+in+Standardization+in+Health+Care+Informatics&rft.date=1993&rft.pages=pp.%26nbsp%3B215&rft.pub=IOS+Press&rft.isbn=9051991142&rft_id=http%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DDHzOJaNaOYkC&rfr_id=info:sid\/en.wikipedia.org:Health_informatics\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li> <span class=\"citation book\">Hovenga, Evelyn J. S., ed. (2010). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/books.google.com\/books?id=eckD3fSrPagC\" target=\"_blank\"><i>Health Informatics: An Overview<\/i><\/a>. IOS Press. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" target=\"_blank\">ISBN<\/a> 1607500922<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/books.google.com\/books?id=eckD3fSrPagC\" target=\"_blank\">http:\/\/books.google.com\/books?id=eckD3fSrPagC<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Health+Informatics%3A+An+Overview&rft.date=2010&rft.pub=IOS+Press&rft.isbn=1607500922&rft_id=http%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DeckD3fSrPagC&rfr_id=info:sid\/en.wikipedia.org:Health_informatics\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li> <span class=\"citation book\">Hoyt, Robert E.; Bailey, Nora; Yoshihashi, Ann, ed. (2012). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/books.google.com\/books?id=6bqruAAACAAJ\" target=\"_blank\"><i>Health Informatics: Practical Guide For Healthcare And Information Technology Professionals<\/i><\/a>. Lulu Enterprises Incorporated. pp. 492. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" target=\"_blank\">ISBN<\/a> 1105437558<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/books.google.com\/books?id=6bqruAAACAAJ\" target=\"_blank\">http:\/\/books.google.com\/books?id=6bqruAAACAAJ<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Health+Informatics%3A+Practical+Guide+For+Healthcare+And+Information+Technology+Professionals&rft.date=2012&rft.pages=pp.%26nbsp%3B492&rft.pub=Lulu+Enterprises+Incorporated&rft.isbn=1105437558&rft_id=http%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3D6bqruAAACAAJ&rfr_id=info:sid\/en.wikipedia.org:Health_informatics\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li> <span class=\"citation book\">Smith, Jack (1999). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/books.google.com\/books?id=8YjlAAAAQBAJ\" target=\"_blank\"><i>Health Management Information Systems: A Handbook for Decision Makers<\/i><\/a> (2nd ed.). McGraw-Hill International. pp. 348. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" target=\"_blank\">ISBN<\/a> 0335205658<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/books.google.com\/books?id=8YjlAAAAQBAJ\" target=\"_blank\">http:\/\/books.google.com\/books?id=8YjlAAAAQBAJ<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Health+Management+Information+Systems%3A+A+Handbook+for+Decision+Makers&rft.aulast=Smith%2C+Jack&rft.au=Smith%2C+Jack&rft.date=1999&rft.pages=pp.%26nbsp%3B348&rft.edition=2nd&rft.pub=McGraw-Hill+International&rft.isbn=0335205658&rft_id=http%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3D8YjlAAAAQBAJ&rfr_id=info:sid\/en.wikipedia.org:Health_informatics\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<h2><span class=\"mw-headline\" id=\"See_also\">See also<\/span><\/h2>\n<ul><li> <a href=\"https:\/\/www.limswiki.org\/index.php\/Informatics_(academic_field)\" title=\"Informatics (academic field)\" target=\"_blank\" class=\"wiki-link\" data-key=\"0391318826a5d9f9a1a1bcc88394739f\">Informatics (academic field)<\/a><\/li>\n<li> <a href=\"https:\/\/www.limswiki.org\/index.php\/Category:Health_informatics\" title=\"Category:Health informatics\" target=\"_blank\" class=\"wiki-link\" data-key=\"6fc2f9ed457bbcb4f0213eb3ba5ed3ed\">Category:Health informatics<\/a><\/li>\n<li> <a href=\"https:\/\/www.limswiki.org\/index.php\/Hospital_information_system\" title=\"Hospital information system\" target=\"_blank\" class=\"wiki-link\" data-key=\"d8385de7b1f39a39d793f8ce349b448d\">Hospital information system<\/a><\/li>\n<li> <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_information_system\" title=\"Laboratory information system\" target=\"_blank\" class=\"wiki-link\" data-key=\"37add65b4d1c678b382a7d4817a9cf64\">Laboratory information system<\/a><\/li><\/ul>\n<h2><span class=\"mw-headline\" id=\"Notes\">Notes<\/span><\/h2>\n<p>Some elements of this article are reused from <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/Health_informatics\" target=\"_blank\">the Wikipedia article<\/a>.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-count references-column-count-3\" style=\"-moz-column-count: 3; -webkit-column-count: 3; column-count: 3; list-style-type: decimal;\">\n<ol class=\"references\">\n<li id=\"cite_note-Hovenga1-1\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-Hovenga1_1-0\" rel=\"external_link\">1.0<\/a><\/sup> <sup><a href=\"#cite_ref-Hovenga1_1-1\" rel=\"external_link\">1.1<\/a><\/sup> <sup><a href=\"#cite_ref-Hovenga1_1-2\" rel=\"external_link\">1.2<\/a><\/sup> <sup><a href=\"#cite_ref-Hovenga1_1-3\" rel=\"external_link\">1.3<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation book\">Hovenga, Evelyn J. S., ed. (2010). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/books.google.com\/books?id=eckD3fSrPagC\" target=\"_blank\">\"Chapter 2: Health Informatics - An Introduction\"<\/a>. <i>Health Informatics: An Overview<\/i>. IOS Press. p. 9\u201315. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" target=\"_blank\">ISBN<\/a> 1607500922<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/books.google.com\/books?id=eckD3fSrPagC\" target=\"_blank\">http:\/\/books.google.com\/books?id=eckD3fSrPagC<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Chapter+2%3A+Health+Informatics+-+An+Introduction&rft.atitle=Health+Informatics%3A+An+Overview&rft.date=2010&rft.pages=p.%26nbsp%3B9%E2%80%9315&rft.pub=IOS+Press&rft.isbn=1607500922&rft_id=http%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DeckD3fSrPagC&rfr_id=info:sid\/en.wikipedia.org:Health_informatics\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-EncyCompSci-2\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-EncyCompSci_2-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Blum, Bruce I.; Kent, Allen (ed.); Williams, James G. (ed.) (1990). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/books.google.com\/books?id=L7NOABDqaMcC\" target=\"_blank\">\"Medical Informatics\"<\/a>. <i>Encyclopedia of Computer Science and Technology<\/i>. <b>22<\/b>. CRC Press. p. 205\u2013224. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" target=\"_blank\">ISBN<\/a> 0824722728<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/books.google.com\/books?id=L7NOABDqaMcC\" target=\"_blank\">http:\/\/books.google.com\/books?id=L7NOABDqaMcC<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Medical+Informatics&rft.atitle=Encyclopedia+of+Computer+Science+and+Technology&rft.aulast=Blum%2C+Bruce+I.%3B+Kent%2C+Allen+%28ed.%29%3B+Williams%2C+James+G.+%28ed.%29&rft.au=Blum%2C+Bruce+I.%3B+Kent%2C+Allen+%28ed.%29%3B+Williams%2C+James+G.+%28ed.%29&rft.date=1990&rft.volume=22&rft.issue=7&rft.pages=p.%26nbsp%3B205%E2%80%93224&rft.pub=CRC+Press&rft.isbn=0824722728&rft_id=http%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DL7NOABDqaMcC&rfr_id=info:sid\/en.wikipedia.org:Health_informatics\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-3rdKnoMan-3\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-3rdKnoMan_3-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Dayyani, Basel; Griffiths, Paul (ed.) (2006). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/books.google.com\/books?id=hD4I12296jYC\" target=\"_blank\">\"Knowledge Informatics: A New Academic Discipline Underpinning Knowledge-based Organisations and Contributing to the Transformation from the Information Age to the Knowledge Age\"<\/a>. <i>Proceedings of the 3rd International Conference on Intellectual Capital and Knowledge Management<\/i>. Academic Conferences Limited. p. 127\u2013138. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" target=\"_blank\">ISBN<\/a> 1905305362<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/books.google.com\/books?id=hD4I12296jYC\" target=\"_blank\">http:\/\/books.google.com\/books?id=hD4I12296jYC<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Knowledge+Informatics%3A+A+New+Academic+Discipline+Underpinning+Knowledge-based+Organisations+and+Contributing+to+the+Transformation+from+the+Information+Age+to+the+Knowledge+Age&rft.atitle=Proceedings+of+the+3rd+International+Conference+on+Intellectual+Capital+and+Knowledge+Management&rft.aulast=Dayyani%2C+Basel%3B+Griffiths%2C+Paul+%28ed.%29&rft.au=Dayyani%2C+Basel%3B+Griffiths%2C+Paul+%28ed.%29&rft.date=2006&rft.pages=p.%26nbsp%3B127%E2%80%93138&rft.pub=Academic+Conferences+Limited&rft.isbn=1905305362&rft_id=http%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DhD4I12296jYC&rfr_id=info:sid\/en.wikipedia.org:Health_informatics\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-univ-4\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-univ_4-0\" rel=\"external_link\">4.0<\/a><\/sup> <sup><a href=\"#cite_ref-univ_4-1\" rel=\"external_link\">4.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/web.archive.org\/web\/20121126102550\/http:\/\/healthinformatics.uic.edu\/history-of-health-informatics\/\" target=\"_blank\">\"The History of Health Informatics\"<\/a>. <i>Health Informatics Guide - The History of Health Informatics<\/i>. University of Illinois at Chicago. Archived from <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/healthinformatics.uic.edu\/history-of-health-informatics\" target=\"_blank\">the original<\/a> on 26 November 2012<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/web.archive.org\/web\/20121126102550\/http:\/\/healthinformatics.uic.edu\/history-of-health-informatics\/\" target=\"_blank\">http:\/\/web.archive.org\/web\/20121126102550\/http:\/\/healthinformatics.uic.edu\/history-of-health-informatics\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 05 January 2015<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=The+History+of+Health+Informatics&rft.atitle=Health+Informatics+Guide+-+The+History+of+Health+Informatics&rft.pub=University+of+Illinois+at+Chicago&rft_id=http%3A%2F%2Fweb.archive.org%2Fweb%2F20121126102550%2Fhttp%3A%2F%2Fhealthinformatics.uic.edu%2Fhistory-of-health-informatics%2F&rfr_id=info:sid\/en.wikipedia.org:Health_informatics\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-nyu-5\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-nyu_5-0\" rel=\"external_link\">5.0<\/a><\/sup> <sup><a href=\"#cite_ref-nyu_5-1\" rel=\"external_link\">5.1<\/a><\/sup> <sup><a href=\"#cite_ref-nyu_5-2\" rel=\"external_link\">5.2<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.nyuinformatics.org\/education\/degree-programs\" target=\"_blank\">\"NYU Graduate Training Program in Biomedical Informatics (BMI): A Brief History of Biomedical Informatics as a Discipline\"<\/a>. <i>www.nyuinformatics.org<\/i>. NYU Langone Medical Center<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.nyuinformatics.org\/education\/degree-programs\" target=\"_blank\">http:\/\/www.nyuinformatics.org\/education\/degree-programs<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 11 November 2010<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=NYU+Graduate+Training+Program+in+Biomedical+Informatics+%28BMI%29%3A+A+Brief+History+of+Biomedical+Informatics+as+a+Discipline&rft.atitle=www.nyuinformatics.org&rft.pub=NYU+Langone+Medical+Center&rft_id=http%3A%2F%2Fwww.nyuinformatics.org%2Feducation%2Fdegree-programs&rfr_id=info:sid\/en.wikipedia.org:Health_informatics\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-Robson_first-6\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-Robson_first_6-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Robson, B.; Baek, O. K. (2009). <i>The engines of Hippocrates: From the Dawn of Medicine to Medical and Pharmaceutical Informatics<\/i>. Hoboken, NJ: John Wiley & Sons. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" target=\"_blank\">ISBN<\/a> 9780470289532.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=The+engines+of+Hippocrates%3A+From+the+Dawn+of+Medicine+to+Medical+and+Pharmaceutical+Informatics&rft.aulast=Robson&rft.aufirst=B.&rft.au=Robson%2C%26%2332%3BB.&rft.au=Baek%2C%26%2332%3BO.+K.&rft.date=2009&rft.place=Hoboken%2C+NJ&rft.pub=John+Wiley+%26+Sons&rft.isbn=9780470289532&rfr_id=info:sid\/en.wikipedia.org:Health_informatics\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-8HIConst-7\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-8HIConst_7-0\" rel=\"external_link\">7.0<\/a><\/sup> <sup><a href=\"#cite_ref-8HIConst_7-1\" rel=\"external_link\">7.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.bcs.org\/upload\/pdf\/mappingupdate.pdf\u200e\" target=\"_blank\">\"UK Council for Health Informatics Professions (UKCHIP): Registration Standards Mapping Update\"<\/a> (PDF). UKCHIP. 12 June 2006<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.bcs.org\/upload\/pdf\/mappingupdate.pdf\u200e\" target=\"_blank\">http:\/\/www.bcs.org\/upload\/pdf\/mappingupdate.pdf\u200e<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 30 October 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=UK+Council+for+Health+Informatics+Professions+%28UKCHIP%29%3A+Registration+Standards+Mapping+Update&rft.atitle=&rft.date=12+June+2006&rft.pub=UKCHIP&rft_id=http%3A%2F%2Fwww.bcs.org%2Fupload%2Fpdf%2Fmappingupdate.pdf%E2%80%8E&rfr_id=info:sid\/en.wikipedia.org:Health_informatics\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-HICF-8\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-HICF_8-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.hicf.org.uk\/AboutHICF.aspx\" target=\"_blank\">\"About the Health Informatics Career Framework (HICF)\"<\/a>. National Health Service<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.hicf.org.uk\/AboutHICF.aspx\" target=\"_blank\">https:\/\/www.hicf.org.uk\/AboutHICF.aspx<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 30 October 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=About+the+Health+Informatics+Career+Framework+%28HICF%29&rft.atitle=&rft.pub=National+Health+Service&rft_id=https%3A%2F%2Fwww.hicf.org.uk%2FAboutHICF.aspx&rfr_id=info:sid\/en.wikipedia.org:Health_informatics\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-HSRIC-9\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-HSRIC_9-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.nlm.nih.gov\/hsrinfo\/informatics.html\" target=\"_blank\">\"HSRIC: Health Informatics\"<\/a>. U.S. National Library of Medicine<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.nlm.nih.gov\/hsrinfo\/informatics.html\" target=\"_blank\">http:\/\/www.nlm.nih.gov\/hsrinfo\/informatics.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 30 October 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=HSRIC%3A+Health+Informatics&rft.atitle=&rft.pub=U.S.+National+Library+of+Medicine&rft_id=http%3A%2F%2Fwww.nlm.nih.gov%2Fhsrinfo%2Finformatics.html&rfr_id=info:sid\/en.wikipedia.org:Health_informatics\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-IMIA_LAC-10\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-IMIA_LAC_10-0\" rel=\"external_link\">10.0<\/a><\/sup> <sup><a href=\"#cite_ref-IMIA_LAC_10-1\" rel=\"external_link\">10.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.imia-medinfo.org\/new2\/node\/159\" target=\"_blank\">\"IMIA LAC: Regional Federation of Health Informatics for Latin America and the Caribbean\"<\/a>. International Medical Informatics Association<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.imia-medinfo.org\/new2\/node\/159\" target=\"_blank\">http:\/\/www.imia-medinfo.org\/new2\/node\/159<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 30 October 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=IMIA+LAC%3A+Regional+Federation+of+Health+Informatics+for+Latin+America+and+the+Caribbean&rft.atitle=&rft.pub=International+Medical+Informatics+Association&rft_id=http%3A%2F%2Fwww.imia-medinfo.org%2Fnew2%2Fnode%2F159&rfr_id=info:sid\/en.wikipedia.org:Health_informatics\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-GIBBA-11\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-GIBBA_11-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.gibba.org.ar\/GIBBAWEB2009\/index.php\" target=\"_blank\">\"Grupo de Inform\u00e1tica Biom\u00e9dica de Buenos Aires - GIBBA\"<\/a>. GIBBA<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.gibba.org.ar\/GIBBAWEB2009\/index.php\" target=\"_blank\">http:\/\/www.gibba.org.ar\/GIBBAWEB2009\/index.php<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 30 October 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Grupo+de+Inform%C3%A1tica+Biom%C3%A9dica+de+Buenos+Aires+-+GIBBA&rft.atitle=&rft.pub=GIBBA&rft_id=http%3A%2F%2Fwww.gibba.org.ar%2FGIBBAWEB2009%2Findex.php&rfr_id=info:sid\/en.wikipedia.org:Health_informatics\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-LatAmerNet-12\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-LatAmerNet_12-0\" rel=\"external_link\">12.0<\/a><\/sup> <sup><a href=\"#cite_ref-LatAmerNet_12-1\" rel=\"external_link\">12.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Sonis, A. (1981). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/7030712\/\" target=\"_blank\">\"The Latin American network of biomedical and health information: experience and future development\"<\/a>. <i>Educaci\u00f3n M\u00e9dica y Salud<\/i> <b>15<\/b> (4): 474\u2013493. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" target=\"_blank\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/7030712\" target=\"_blank\">7030712<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/7030712\/\" target=\"_blank\">http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/7030712\/<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=The+Latin+American+network+of+biomedical+and+health+information%3A+experience+and+future+development&rft.jtitle=Educaci%C3%B3n+M%C3%A9dica+y+Salud&rft.aulast=Sonis%2C+A.&rft.au=Sonis%2C+A.&rft.date=1981&rft.volume=15&rft.issue=4&rft.pages=474%E2%80%93493&rft_id=info:pmid\/7030712&rft_id=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fpubmed%2F7030712%2F&rfr_id=info:sid\/en.wikipedia.org:Health_informatics\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-EnLiInfo43_8-13\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-EnLiInfo43_8_13-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Garcia, Maria L\u00facia Andrade; Kent, Allen (ed.) (1987). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/books.google.com\/books?id=sFqds9V6heMC\" target=\"_blank\">\"Brazil, The Organization Of Scientific and Technological Information In\"<\/a>. <i>Encyclopedia of Library and Information Science<\/i>. <b>43<\/b>. CRC Press. pp. 38\u201347<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/books.google.com\/books?id=sFqds9V6heMC\" target=\"_blank\">http:\/\/books.google.com\/books?id=sFqds9V6heMC<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Brazil%2C+The+Organization+Of+Scientific+and+Technological+Information+In&rft.atitle=Encyclopedia+of+Library+and+Information+Science&rft.aulast=Garcia%2C+Maria+L%C3%BAcia+Andrade%3B+Kent%2C+Allen+%28ed.%29&rft.au=Garcia%2C+Maria+L%C3%BAcia+Andrade%3B+Kent%2C+Allen+%28ed.%29&rft.date=1987&rft.volume=43&rft.issue=8&rft.pages=pp.%26nbsp%3B38%E2%80%9347&rft.pub=CRC+Press&rft_id=http%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DsFqds9V6heMC&rfr_id=info:sid\/en.wikipedia.org:Health_informatics\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-SBISHist-14\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-SBISHist_14-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.sbis.org.br\/site\/site.dll\/view?pagina=5\" target=\"_blank\">\"A Hist\u00f3ria da SBIS\"<\/a>. Sociedade Brasileira de Inform\u00e1tica em Sa\u00fade<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.sbis.org.br\/site\/site.dll\/view?pagina=5\" target=\"_blank\">http:\/\/www.sbis.org.br\/site\/site.dll\/view?pagina=5<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 30 October 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=A+Hist%C3%B3ria+da+SBIS&rft.atitle=&rft.pub=Sociedade+Brasileira+de+Inform%C3%A1tica+em+Sa%C3%BAde&rft_id=http%3A%2F%2Fwww.sbis.org.br%2Fsite%2Fsite.dll%2Fview%3Fpagina%3D5&rfr_id=info:sid\/en.wikipedia.org:Health_informatics\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-CHIReport12-13-15\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CHIReport12-13_15-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.infoway-inforoute.com\/index.php\/resources\/infoway-corporate\/annual-reports\/doc_download\/1876-annual-report-2012-2013\" target=\"_blank\">\"Canada Health Infoway Annual Report 2012\u201313\"<\/a> (PDF). Canada Health Infoway. 26 July 2013<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.infoway-inforoute.com\/index.php\/resources\/infoway-corporate\/annual-reports\/doc_download\/1876-annual-report-2012-2013\" target=\"_blank\">https:\/\/www.infoway-inforoute.com\/index.php\/resources\/infoway-corporate\/annual-reports\/doc_download\/1876-annual-report-2012-2013<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 30 October 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Canada+Health+Infoway+Annual+Report+2012%E2%80%9313&rft.atitle=&rft.date=26+July+2013&rft.pub=Canada+Health+Infoway&rft_id=https%3A%2F%2Fwww.infoway-inforoute.com%2Findex.php%2Fresources%2Finfoway-corporate%2Fannual-reports%2Fdoc_download%2F1876-annual-report-2012-2013&rfr_id=info:sid\/en.wikipedia.org:Health_informatics\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-16\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-16\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation news\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.cbc.ca\/news\/canada\/head-of-ehealth-ontario-is-fired-amid-contracts-scandal-gets-big-package-1.797216\" target=\"_blank\">\"Head of eHealth Ontario is fired amid contracts scandal, gets big package\"<\/a>. <i>CBC News<\/i>. 07 June 2009<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.cbc.ca\/news\/canada\/head-of-ehealth-ontario-is-fired-amid-contracts-scandal-gets-big-package-1.797216\" target=\"_blank\">http:\/\/www.cbc.ca\/news\/canada\/head-of-ehealth-ontario-is-fired-amid-contracts-scandal-gets-big-package-1.797216<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 30 October 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Head+of+eHealth+Ontario+is+fired+amid+contracts+scandal%2C+gets+big+package&rft.jtitle=CBC+News&rft.date=07+June+2009&rft_id=http%3A%2F%2Fwww.cbc.ca%2Fnews%2Fcanada%2Fhead-of-ehealth-ontario-is-fired-amid-contracts-scandal-gets-big-package-1.797216&rfr_id=info:sid\/en.wikipedia.org:Health_informatics\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-NetcareHist-17\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-NetcareHist_17-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.albertanetcare.ca\/History.htm\" target=\"_blank\">\"Alberta Netcare: The History of the EHR\"<\/a>. Government of Alberta<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.albertanetcare.ca\/History.htm\" target=\"_blank\">http:\/\/www.albertanetcare.ca\/History.htm<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 30 October 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Alberta+Netcare%3A+The+History+of+the+EHR&rft.atitle=&rft.pub=Government+of+Alberta&rft_id=http%3A%2F%2Fwww.albertanetcare.ca%2FHistory.htm&rfr_id=info:sid\/en.wikipedia.org:Health_informatics\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-Ledley-18\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-Ledley_18-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Sittig, Dean F.; Ash, Joan S.; Ledley, Robert S. (2006). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC1561796\/\" target=\"_blank\">\"The Story Behind the Development of the First Whole-body Computerized Tomography Scanner as Told by Robert S. Ledley\"<\/a>. <i>Journal of the American Medical Informatics Association<\/i> <b>13<\/b> (5): 465\u20139. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" target=\"_blank\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1197%2Fjamia.M2127\" target=\"_blank\">10.1197\/jamia.M2127<\/a>. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" target=\"_blank\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/1561796\/\" target=\"_blank\">1561796<\/a>. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" target=\"_blank\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/16799115\" target=\"_blank\">16799115<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC1561796\/\" target=\"_blank\">http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC1561796\/<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=The+Story+Behind+the+Development+of+the+First+Whole-body+Computerized+Tomography+Scanner+as+Told+by+Robert+S.+Ledley&rft.jtitle=Journal+of+the+American+Medical+Informatics+Association&rft.aulast=Sittig%2C+Dean+F.%3B+Ash%2C+Joan+S.%3B+Ledley%2C+Robert+S.&rft.au=Sittig%2C+Dean+F.%3B+Ash%2C+Joan+S.%3B+Ledley%2C+Robert+S.&rft.date=2006&rft.volume=13&rft.issue=5&rft.pages=465%E2%80%939&rft_id=info:doi\/10.1197%2Fjamia.M2127&rft_id=info:pmc\/1561796&rft_id=info:pmid\/16799115&rft_id=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fpmc%2Farticles%2FPMC1561796%2F&rfr_id=info:sid\/en.wikipedia.org:Health_informatics\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-MedInfoEd-19\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MedInfoEd_19-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Patton, Gregory A., Gardner, Reed M. (1999). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC61389\/\" target=\"_blank\">\"Medical Informatics Education: The University of Utah Experience\"<\/a>. <i>Journal of the American Medical Informatics Association<\/i> <b>6<\/b> (6): 457\u201365. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" target=\"_blank\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/61389\/\" target=\"_blank\">61389<\/a>. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" target=\"_blank\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/10579604\" target=\"_blank\">10579604<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC61389\/\" target=\"_blank\">http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC61389\/<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Medical+Informatics+Education%3A+The+University+of+Utah+Experience&rft.jtitle=Journal+of+the+American+Medical+Informatics+Association&rft.aulast=Patton%2C+Gregory+A.%2C+Gardner%2C+Reed+M.&rft.au=Patton%2C+Gregory+A.%2C+Gardner%2C+Reed+M.&rft.date=1999&rft.volume=6&rft.issue=6&rft.pages=457%E2%80%9365&rft_id=info:pmc\/61389&rft_id=info:pmid\/10579604&rft_id=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fpmc%2Farticles%2FPMC61389%2F&rfr_id=info:sid\/en.wikipedia.org:Health_informatics\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-APLISReview-20\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-APLISReview_20-0\" rel=\"external_link\">20.0<\/a><\/sup> <sup><a href=\"#cite_ref-APLISReview_20-1\" rel=\"external_link\">20.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Park, Seung Lyung; Pantanowitz, Liron; Sharma, Guarav; Parwani, Anil Vasdev (March 2012). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/ebookbrowse.com\/anatomic-pathology-laboratory-information-systems-a-review-slpark-et-all-adv-anat-pathol-2012-pdf-d344405134\" target=\"_blank\">\"Anatomic Pathology Laboratory Information Systems: A Review\"<\/a>. <i>Advances in Anatomic Pathology<\/i> <b>19<\/b> (2): 81\u201396. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" target=\"_blank\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1097%2FPAP.0b013e318248b787\" target=\"_blank\">10.1097\/PAP.0b013e318248b787<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/ebookbrowse.com\/anatomic-pathology-laboratory-information-systems-a-review-slpark-et-all-adv-anat-pathol-2012-pdf-d344405134\" target=\"_blank\">http:\/\/ebookbrowse.com\/anatomic-pathology-laboratory-information-systems-a-review-slpark-et-all-adv-anat-pathol-2012-pdf-d344405134<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 03 June 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Anatomic+Pathology+Laboratory+Information+Systems%3A+A+Review&rft.jtitle=Advances+in+Anatomic+Pathology&rft.aulast=Park%2C+Seung+Lyung%3B+Pantanowitz%2C+Liron%3B+Sharma%2C+Guarav%3B+Parwani%2C+Anil+Vasdev&rft.au=Park%2C+Seung+Lyung%3B+Pantanowitz%2C+Liron%3B+Sharma%2C+Guarav%3B+Parwani%2C+Anil+Vasdev&rft.date=March+2012&rft.volume=19&rft.issue=2&rft.pages=81%E2%80%9396&rft_id=info:doi\/10.1097%2FPAP.0b013e318248b787&rft_id=http%3A%2F%2Febookbrowse.com%2Fanatomic-pathology-laboratory-information-systems-a-review-slpark-et-all-adv-anat-pathol-2012-pdf-d344405134&rfr_id=info:sid\/en.wikipedia.org:Health_informatics\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-MileCompSci-21\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MileCompSci_21-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Reilly, Edwin D. (2003). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/books.google.com\/books?id=JTYPKxug49IC\" target=\"_blank\"><i>Milestones in Computer Science and Information Technology<\/i><\/a>. Greenwood Publishing Group. pp. 161. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" target=\"_blank\">ISBN<\/a> 9781573565219<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/books.google.com\/books?id=JTYPKxug49IC\" target=\"_blank\">http:\/\/books.google.com\/books?id=JTYPKxug49IC<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Milestones+in+Computer+Science+and+Information+Technology&rft.aulast=Reilly%2C+Edwin+D.&rft.au=Reilly%2C+Edwin+D.&rft.date=2003&rft.pages=pp.%26nbsp%3B161&rft.pub=Greenwood+Publishing+Group&rft.isbn=9781573565219&rft_id=http%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DJTYPKxug49IC&rfr_id=info:sid\/en.wikipedia.org:Health_informatics\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-HistMedInfo-22\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-HistMedInfo_22-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Blum, Bruce I.; Duncan, Karen A. (1990). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/books.google.com\/books\/about\/A_History_of_medical_informatics.html?id=AR5rAAAAMAAJ\" target=\"_blank\"><i>A History of Medical Informatics<\/i><\/a>. ACM Press. pp. 141\u201353. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" target=\"_blank\">ISBN<\/a> 0201501287<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/books.google.com\/books\/about\/A_History_of_medical_informatics.html?id=AR5rAAAAMAAJ\" target=\"_blank\">http:\/\/books.google.com\/books\/about\/A_History_of_medical_informatics.html?id=AR5rAAAAMAAJ<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=A+History+of+Medical+Informatics&rft.aulast=Blum%2C+Bruce+I.%3B+Duncan%2C+Karen+A.&rft.au=Blum%2C+Bruce+I.%3B+Duncan%2C+Karen+A.&rft.date=1990&rft.pages=pp.%26nbsp%3B141%E2%80%9353&rft.pub=ACM+Press&rft.isbn=0201501287&rft_id=http%3A%2F%2Fbooks.google.com%2Fbooks%2Fabout%2FA_History_of_medical_informatics.html%3Fid%3DAR5rAAAAMAAJ&rfr_id=info:sid\/en.wikipedia.org:Health_informatics\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-PractPathInfo-23\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-PractPathInfo_23-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Sinard, John H. (2006). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/books.google.com\/books?id=WerUyK618fcC\" target=\"_blank\"><i>Practical Pathology Informatics: Demstifying Informatics for the Practicing Anatomic Pathologist<\/i><\/a>. Springer. pp. 393. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" target=\"_blank\">ISBN<\/a> 0387280588<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/books.google.com\/books?id=WerUyK618fcC\" target=\"_blank\">http:\/\/books.google.com\/books?id=WerUyK618fcC<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Practical+Pathology+Informatics%3A+Demstifying+Informatics+for+the+Practicing+Anatomic+Pathologist&rft.aulast=Sinard%2C+John+H.&rft.au=Sinard%2C+John+H.&rft.date=2006&rft.pages=pp.%26nbsp%3B393&rft.pub=Springer&rft.isbn=0387280588&rft_id=http%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DWerUyK618fcC&rfr_id=info:sid\/en.wikipedia.org:Health_informatics\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-OverBarEMR-24\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-OverBarEMR_24-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Kumar, Sameer; Aldrich, Krista (December 2010). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/jhi.sagepub.com\/content\/16\/4\/306.abstract\" target=\"_blank\">\"Overcoming barriers to electronic medical record (EMR) implementation in the US healthcare system: A comparative study\"<\/a>. <i>Health Informatics Journal<\/i> <b>16<\/b> (4). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" target=\"_blank\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1177%2F1460458210380523\" target=\"_blank\">10.1177\/1460458210380523<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/jhi.sagepub.com\/content\/16\/4\/306.abstract\" target=\"_blank\">http:\/\/jhi.sagepub.com\/content\/16\/4\/306.abstract<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 03 June 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Overcoming+barriers+to+electronic+medical+record+%28EMR%29+implementation+in+the+US+healthcare+system%3A+A+comparative+study&rft.jtitle=Health+Informatics+Journal&rft.aulast=Kumar%2C+Sameer%3B+Aldrich%2C+Krista&rft.au=Kumar%2C+Sameer%3B+Aldrich%2C+Krista&rft.date=December+2010&rft.volume=16&rft.issue=4&rft_id=info:doi\/10.1177%2F1460458210380523&rft_id=http%3A%2F%2Fjhi.sagepub.com%2Fcontent%2F16%2F4%2F306.abstract&rfr_id=info:sid\/en.wikipedia.org:Health_informatics\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-ResearchIneHealth-25\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-ResearchIneHealth_25-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/ec.europa.eu\/digital-agenda\/en\/research-ehealth\" target=\"_blank\">\"Digital Agenda for Europe: Research in eHealth\"<\/a>. European Commission<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/ec.europa.eu\/digital-agenda\/en\/research-ehealth\" target=\"_blank\">http:\/\/ec.europa.eu\/digital-agenda\/en\/research-ehealth<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 30 October 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Digital+Agenda+for+Europe%3A+Research+in+eHealth&rft.atitle=&rft.pub=European+Commission&rft_id=http%3A%2F%2Fec.europa.eu%2Fdigital-agenda%2Fen%2Fresearch-ehealth&rfr_id=info:sid\/en.wikipedia.org:Health_informatics\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-EHREuro-26\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-EHREuro_26-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.esa.int\/SPECIALS\/Telemedicine_Alliance\/SEMWC7SMD6E_0.html\" target=\"_blank\">\"Electronic Health Records for Europe\"<\/a>. European Space Agency. 30 March 2005<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.esa.int\/SPECIALS\/Telemedicine_Alliance\/SEMWC7SMD6E_0.html\" target=\"_blank\">http:\/\/www.esa.int\/SPECIALS\/Telemedicine_Alliance\/SEMWC7SMD6E_0.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 30 October 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Electronic+Health+Records+for+Europe&rft.atitle=&rft.date=30+March+2005&rft.pub=European+Space+Agency&rft_id=http%3A%2F%2Fwww.esa.int%2FSPECIALS%2FTelemedicine_Alliance%2FSEMWC7SMD6E_0.html&rfr_id=info:sid\/en.wikipedia.org:Health_informatics\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-EuroRecPPT-27\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-EuroRecPPT_27-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Mennerat, Fran\u00e7ois (10 October 2006). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.eurorec.org\/files\/filesPublic\/EuroRec2006_FrancoisMennerat.ppt\u200e\" target=\"_blank\">\"The EuroRec Institute: Its Structure, Activities and New Services\"<\/a> (PPT). EuroRec<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.eurorec.org\/files\/filesPublic\/EuroRec2006_FrancoisMennerat.ppt\u200e\" target=\"_blank\">http:\/\/www.eurorec.org\/files\/filesPublic\/EuroRec2006_FrancoisMennerat.ppt\u200e<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 30 October 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=The+EuroRec+Institute%3A+Its+Structure%2C+Activities+and+New+Services&rft.atitle=&rft.aulast=Mennerat%2C+Fran%C3%A7ois&rft.au=Mennerat%2C+Fran%C3%A7ois&rft.date=10+October+2006&rft.pub=EuroRec&rft_id=http%3A%2F%2Fwww.eurorec.org%2Ffiles%2FfilesPublic%2FEuroRec2006_FrancoisMennerat.ppt%E2%80%8E&rfr_id=info:sid\/en.wikipedia.org:Health_informatics\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-epSOSAbout-28\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-epSOSAbout_28-0\" rel=\"external_link\">28.0<\/a><\/sup> <sup><a href=\"#cite_ref-epSOSAbout_28-1\" rel=\"external_link\">28.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.epsos.eu\/home\/about-epsos.html\" target=\"_blank\">\"About epSOS\"<\/a>. European Commission<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.epsos.eu\/home\/about-epsos.html\" target=\"_blank\">http:\/\/www.epsos.eu\/home\/about-epsos.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 30 October 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=About+epSOS&rft.atitle=&rft.pub=European+Commission&rft_id=http%3A%2F%2Fwww.epsos.eu%2Fhome%2Fabout-epsos.html&rfr_id=info:sid\/en.wikipedia.org:Health_informatics\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-IFIP50Chart-29\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-IFIP50Chart_29-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Zemanek, H.; Brunnstein, K. (31 March 2011). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ifip.org\/50th_anni\/Chart0.htm\" target=\"_blank\">\"Chart 0: IFIP at a Glance\"<\/a>. <i>A Quarter Century of IFIP<\/i>. IFIP<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.ifip.org\/50th_anni\/Chart0.htm\" target=\"_blank\">http:\/\/www.ifip.org\/50th_anni\/Chart0.htm<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 31 October 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Chart+0%3A+IFIP+at+a+Glance&rft.atitle=A+Quarter+Century+of+IFIP&rft.aulast=Zemanek%2C+H.%3B+Brunnstein%2C+K.&rft.au=Zemanek%2C+H.%3B+Brunnstein%2C+K.&rft.date=31+March+2011&rft.pub=IFIP&rft_id=http%3A%2F%2Fwww.ifip.org%2F50th_anni%2FChart0.htm&rfr_id=info:sid\/en.wikipedia.org:Health_informatics\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-IFIPNL2002-30\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-IFIPNL2002_30-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Nedkov, Plamen; Rosenfeld, Jack L. (ed.) (2002). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ifip.org\/newsletters\/News2002\/News_Sep_2002.pdf\u200e\" target=\"_blank\">\"The IFIP Presidents\"<\/a>. <i>IFIP Newsletter<\/i> <b>19<\/b> (1\u20133): 7<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.ifip.org\/newsletters\/News2002\/News_Sep_2002.pdf\u200e\" target=\"_blank\">http:\/\/www.ifip.org\/newsletters\/News2002\/News_Sep_2002.pdf\u200e<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=The+IFIP+Presidents&rft.jtitle=IFIP+Newsletter&rft.aulast=Nedkov%2C+Plamen%3B+Rosenfeld%2C+Jack+L.+%28ed.%29&rft.au=Nedkov%2C+Plamen%3B+Rosenfeld%2C+Jack+L.+%28ed.%29&rft.date=2002&rft.volume=19&rft.issue=1%E2%80%933&rft.pages=7&rft_id=http%3A%2F%2Fwww.ifip.org%2Fnewsletters%2FNews2002%2FNews_Sep_2002.pdf%E2%80%8E&rfr_id=info:sid\/en.wikipedia.org:Health_informatics\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-MIEuro-31\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-MIEuro_31-0\" rel=\"external_link\">31.0<\/a><\/sup> <sup><a href=\"#cite_ref-MIEuro_31-1\" rel=\"external_link\">31.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation book\">Dezelic, Gjuro; Adlassnig, Klaus-Peter (ed.) (2009). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/books.google.com\/books?id=pGHWtG5_xIgC\" target=\"_blank\">\"After Three Decades of Medical Informatics Europe Congresses\"<\/a>. <i>Medical Informatics in a United and Healthy Europe<\/i>. IOS Press. pp. 3\u20137. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" target=\"_blank\">ISBN<\/a> 1607500442<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/books.google.com\/books?id=pGHWtG5_xIgC\" target=\"_blank\">http:\/\/books.google.com\/books?id=pGHWtG5_xIgC<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=After+Three+Decades+of+Medical+Informatics+Europe+Congresses&rft.atitle=Medical+Informatics+in+a+United+and+Healthy+Europe&rft.aulast=Dezelic%2C+Gjuro%3B+Adlassnig%2C+Klaus-Peter+%28ed.%29&rft.au=Dezelic%2C+Gjuro%3B+Adlassnig%2C+Klaus-Peter+%28ed.%29&rft.date=2009&rft.pages=pp.%26nbsp%3B3%E2%80%937&rft.pub=IOS+Press&rft.isbn=1607500442&rft_id=http%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DpGHWtG5_xIgC&rfr_id=info:sid\/en.wikipedia.org:Health_informatics\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-DismantleNPfIT-32\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-DismantleNPfIT_32-0\" rel=\"external_link\">32.0<\/a><\/sup> <sup><a href=\"#cite_ref-DismantleNPfIT_32-1\" rel=\"external_link\">32.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.parliament.uk\/business\/committees\/committees-a-z\/commons-select\/public-accounts-committee\/news\/npfit-report\/\" target=\"_blank\">\"MPs publish report on the dismantled National Programme for IT in the NHS\"<\/a>. U.K. Parliament. 18 September 2013<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.parliament.uk\/business\/committees\/committees-a-z\/commons-select\/public-accounts-committee\/news\/npfit-report\/\" target=\"_blank\">http:\/\/www.parliament.uk\/business\/committees\/committees-a-z\/commons-select\/public-accounts-committee\/news\/npfit-report\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 30 October 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=MPs+publish+report+on+the+dismantled+National+Programme+for+IT+in+the+NHS&rft.atitle=&rft.date=18+September+2013&rft.pub=U.K.+Parliament&rft_id=http%3A%2F%2Fwww.parliament.uk%2Fbusiness%2Fcommittees%2Fcommittees-a-z%2Fcommons-select%2Fpublic-accounts-committee%2Fnews%2Fnpfit-report%2F&rfr_id=info:sid\/en.wikipedia.org:Health_informatics\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-BMAGPASS-33\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-BMAGPASS_33-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/web.bma.org.uk\/pressrel.nsf\/wlu\/GGRT-5AZK3T\" target=\"_blank\">\"Scotland\u2019s doctors welcome review of GPASS\"<\/a>. BMA Scotland. 11 June 2002<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/web.bma.org.uk\/pressrel.nsf\/wlu\/GGRT-5AZK3T\" target=\"_blank\">http:\/\/web.bma.org.uk\/pressrel.nsf\/wlu\/GGRT-5AZK3T<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 01 November 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Scotland%E2%80%99s+doctors+welcome+review+of+GPASS&rft.atitle=&rft.date=11+June+2002&rft.pub=BMA+Scotland&rft_id=http%3A%2F%2Fweb.bma.org.uk%2Fpressrel.nsf%2Fwlu%2FGGRT-5AZK3T&rfr_id=info:sid\/en.wikipedia.org:Health_informatics\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-GPASSNoMo-34\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-GPASSNoMo_34-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Todd, Rebecca (20 August 2012). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ehi.co.uk\/news\/ehi\/8005\/scotland's-gpass-is-no-more\" target=\"_blank\">\"Scotland's GPASS is no more\"<\/a>. <i>EHealth Insider<\/i>. EHealth Media Limited<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.ehi.co.uk\/news\/ehi\/8005\/scotland's-gpass-is-no-more\" target=\"_blank\">http:\/\/www.ehi.co.uk\/news\/ehi\/8005\/scotland's-gpass-is-no-more<\/a><\/span><span class=\"reference-accessdate\">. 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APAMI<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.apami.org\/about.html\" target=\"_blank\">http:\/\/www.apami.org\/about.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 01 November 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=About+Asia+Pacific+Association+of+Medical+Informatics&rft.atitle=&rft.pub=APAMI&rft_id=http%3A%2F%2Fwww.apami.org%2Fabout.html&rfr_id=info:sid\/en.wikipedia.org:Health_informatics\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-ACHI-36\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-ACHI_36-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.achi.org.au\" target=\"_blank\">\"Australasian College of Health Informatics\"<\/a>. ACHI<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.achi.org.au\" target=\"_blank\">http:\/\/www.achi.org.au<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 01 November 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Australasian+College+of+Health+Informatics&rft.atitle=&rft.pub=ACHI&rft_id=http%3A%2F%2Fwww.achi.org.au&rfr_id=info:sid\/en.wikipedia.org:Health_informatics\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-eJSpons-37\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-eJSpons_37-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ejhi.net\/ojs\/index.php\/ejhi\/about\/journalSponsorship\" target=\"_blank\">\"eJHI - Journal Sponsorship\"<\/a>. eJHI<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.ejhi.net\/ojs\/index.php\/ejhi\/about\/journalSponsorship\" target=\"_blank\">http:\/\/www.ejhi.net\/ojs\/index.php\/ejhi\/about\/journalSponsorship<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 01 November 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=eJHI+-+Journal+Sponsorship&rft.atitle=&rft.pub=eJHI&rft_id=http%3A%2F%2Fwww.ejhi.net%2Fojs%2Findex.php%2Fejhi%2Fabout%2FjournalSponsorship&rfr_id=info:sid\/en.wikipedia.org:Health_informatics\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-AHIEC-38\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-AHIEC_38-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ahiec.org.au\/\" target=\"_blank\">\"Australian Health Informatics Education Council\"<\/a>. AHIEC<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.ahiec.org.au\/\" target=\"_blank\">http:\/\/www.ahiec.org.au\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 01 November 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Australian+Health+Informatics+Education+Council&rft.atitle=&rft.pub=AHIEC&rft_id=http%3A%2F%2Fwww.ahiec.org.au%2F&rfr_id=info:sid\/en.wikipedia.org:Health_informatics\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-HISAAbout-39\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-HISAAbout_39-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.hisa.org.au\/?about\" target=\"_blank\">\"About Health Informatics Society of Australia\"<\/a>. 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Retrieved 01 November 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=About+Health+Informatics+Society+of+Australia&rft.atitle=&rft.pub=HISA&rft_id=http%3A%2F%2Fwww.hisa.org.au%2F%3Fabout&rfr_id=info:sid\/en.wikipedia.org:Health_informatics\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-HKHosp-40\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-HKHosp_40-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www3.ha.org.hk\/hi\/Welcome.html\" target=\"_blank\">\"Hong Kong Hospital Authority and Health Informatics Section\"<\/a>. 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Retrieved 01 November 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Hong+Kong+Hospital+Authority+and+Health+Informatics+Section&rft.atitle=&rft.pub=Hong+Kong+Hospital+Authority&rft_id=http%3A%2F%2Fwww3.ha.org.hk%2Fhi%2FWelcome.html&rfr_id=info:sid\/en.wikipedia.org:Health_informatics\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-IPROA-41\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-IPROA_41-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.iproa.org\/index.php\/en-GB\/other-projects\/227-ehealth-consortium.html\" target=\"_blank\">\"eHealth Consortium\"<\/a>. 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Retrieved 01 November 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=eHealth+Consortium&rft.atitle=&rft.pub=IPROA&rft_id=http%3A%2F%2Fwww.iproa.org%2Findex.php%2Fen-GB%2Fother-projects%2F227-ehealth-consortium.html&rfr_id=info:sid\/en.wikipedia.org:Health_informatics\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-HINZRepo-42\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-HINZRepo_42-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Karolyn Kerr; Cullen, Rowena; Duke, Jan; Holt, Alec; Kirk, Ray; Komisarczuk, Peter; Warren, Jim; Wilson, Shona (2006). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/homepages.mcs.vuw.ac.nz\/~peterk\/healthinformatics\/tec-hi-report-06.pdf\" target=\"_blank\">\"Health Informatics Capability Development In New Zealand - A Report to the Tertiary Education Commission\"<\/a> (PDF). National Steering Committee for Health Informatics Education in New Zealand<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/homepages.mcs.vuw.ac.nz\/~peterk\/healthinformatics\/tec-hi-report-06.pdf\" target=\"_blank\">http:\/\/homepages.mcs.vuw.ac.nz\/~peterk\/healthinformatics\/tec-hi-report-06.pdf<\/a><\/span><span class=\"reference-accessdate\">. 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Retrieved 01 November 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=35.240.80%3A+IT+applications+in+health+care+technology&rft.atitle=&rft.pub=ISO&rft_id=http%3A%2F%2Fwww.iso.org%2Fiso%2Fproducts%2Fstandards%2Fcatalogue_ics_browse.htm%3FICS1%3D35%26ICS2%3D240%26ICS3%3D80%26&rfr_id=info:sid\/en.wikipedia.org:Health_informatics\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-isosm-45\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-isosm_45-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Fraser, Ross (06 June 2006). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/sl.infoway-inforoute.ca\/downloads\/Ross_Fraser_-_ISO_27799.pdf\" target=\"_blank\">\"ISO 27799: Security management in health using ISO\/IEC 17799\"<\/a> (PDF). Ross Fraser<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/sl.infoway-inforoute.ca\/downloads\/Ross_Fraser_-_ISO_27799.pdf\" target=\"_blank\">http:\/\/sl.infoway-inforoute.ca\/downloads\/Ross_Fraser_-_ISO_27799.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 01 November 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=ISO+27799%3A+Security+management+in+health+using+ISO%2FIEC+17799&rft.atitle=&rft.aulast=Fraser%2C+Ross&rft.au=Fraser%2C+Ross&rft.date=06+June+2006&rft.pub=Ross+Fraser&rft_id=http%3A%2F%2Fsl.infoway-inforoute.ca%2Fdownloads%2FRoss_Fraser_-_ISO_27799.pdf&rfr_id=info:sid\/en.wikipedia.org:Health_informatics\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-HOISE-46\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-HOISE_46-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Certification Commission for Healthcare Information Technology (18 July 2006). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.hoise.com\/vmw\/06\/articles\/vmw\/LV-VM-08-06-22.html\" target=\"_blank\">\"CCHIT Announces First Certified Electronic Health Record Products\"<\/a>. Virtual Medical Worlds<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.hoise.com\/vmw\/06\/articles\/vmw\/LV-VM-08-06-22.html\" target=\"_blank\">http:\/\/www.hoise.com\/vmw\/06\/articles\/vmw\/LV-VM-08-06-22.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 01 November 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=CCHIT+Announces+First+Certified+Electronic+Health+Record+Products&rft.atitle=&rft.aulast=Certification+Commission+for+Healthcare+Information+Technology&rft.au=Certification+Commission+for+Healthcare+Information+Technology&rft.date=18+July+2006&rft.pub=Virtual+Medical+Worlds&rft_id=http%3A%2F%2Fwww.hoise.com%2Fvmw%2F06%2Farticles%2Fvmw%2FLV-VM-08-06-22.html&rfr_id=info:sid\/en.wikipedia.org:Health_informatics\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-AMIACore-47\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-AMIACore_47-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Gardner, Reed M.; Overhage J. Mark; Steen, Elaine B.; Holmes, John H.; Munger, Benson S.; Williamson, Jeffrey J.; Detmer, Don E. (2009). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC2649328\" target=\"_blank\">\"Core content for the subspecialty of clinical informatics\"<\/a>. <i>Journal of the American Medical Informatics Association<\/i> <b>16<\/b> (2): 153\u20137. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" target=\"_blank\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1197%2Fjamia.M3045\" target=\"_blank\">10.1197\/jamia.M3045<\/a>. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" target=\"_blank\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/2649328\/\" target=\"_blank\">2649328<\/a>. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" target=\"_blank\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/19074296\" target=\"_blank\">19074296<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC2649328\" target=\"_blank\">http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC2649328<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Core+content+for+the+subspecialty+of+clinical+informatics&rft.jtitle=Journal+of+the+American+Medical+Informatics+Association&rft.aulast=Gardner%2C+Reed+M.%3B+Overhage+J.+Mark%3B+Steen%2C+Elaine+B.%3B+Holmes%2C+John+H.%3B+Munger%2C+Benson+S.%3B+Williamson%2C+Jeffrey+J.%3B+Detmer%2C+Don+E.&rft.au=Gardner%2C+Reed+M.%3B+Overhage+J.+Mark%3B+Steen%2C+Elaine+B.%3B+Holmes%2C+John+H.%3B+Munger%2C+Benson+S.%3B+Williamson%2C+Jeffrey+J.%3B+Detmer%2C+Don+E.&rft.date=2009&rft.volume=16&rft.issue=2&rft.pages=153%E2%80%937&rft_id=info:doi\/10.1197%2Fjamia.M3045&rft_id=info:pmc\/2649328&rft_id=info:pmid\/19074296&rft_id=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fpmc%2Farticles%2FPMC2649328&rfr_id=info:sid\/en.wikipedia.org:Health_informatics\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<\/ol><\/div>\n\n<!-- \nNewPP limit report\nCached time: 20181213192743\nCache expiry: 86400\nDynamic content: false\nCPU time usage: 1.097 seconds\nReal time usage: 1.907 seconds\nPreprocessor visited node count: 32836\/1000000\nPreprocessor generated node count: 31742\/1000000\nPost\u2010expand include size: 220228\/2097152 bytes\nTemplate argument size: 82368\/2097152 bytes\nHighest expansion depth: 19\/40\nExpensive parser function count: 2\/100\n-->\n\n<!-- \nTransclusion expansion time report (%,ms,calls,template)\n100.00% 994.977 1 - -total\n 82.00% 815.887 1 - Template:Reflist\n 79.80% 794.019 51 - Template:Citation\/core\n 42.85% 426.381 30 - Template:Cite_web\n 26.25% 261.190 13 - Template:Cite_book\n 14.02% 139.485 7 - Template:Cite_journal\n 4.27% 42.463 61 - Template:Citation\/make_link\n 3.87% 38.530 3 - Template:As_of\n 3.39% 33.752 23 - Template:Citation\/identifier\n 2.42% 24.087 3 - Template:DMCA\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:1613-0!*!0!!en!5!* and timestamp 20181213192741 and revision id 34332\n -->\n<\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Health_informatics\">https:\/\/www.limswiki.org\/index.php\/Health_informatics<\/a><\/div>\n\t\t\t\t\t\t\t\t\t\t<!-- end content -->\n\t\t\t\t\t\t\t\t\t\t<div class=\"visualClear\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t<!-- end of the left (by default at least) column -->\n\t\t<div class=\"visualClear\"><\/div>\n\t\t\t\t\t\n\t\t<\/div>\n\t\t\n\n<\/body>","055eb51f53cfdbacc08ed150b266c9f4_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/0\/0b\/Doctor_review_brain_images.jpg"],"055eb51f53cfdbacc08ed150b266c9f4_timestamp":1544729261,"915c6acf5c1cc4fc5ecfaf557d1c1707_type":"article","915c6acf5c1cc4fc5ecfaf557d1c1707_title":"LII:The Practical Guide to the U.S. Physician Office Laboratory","915c6acf5c1cc4fc5ecfaf557d1c1707_url":"https:\/\/www.limswiki.org\/index.php\/LII:The_Practical_Guide_to_the_U.S._Physician_Office_Laboratory","915c6acf5c1cc4fc5ecfaf557d1c1707_plaintext":"\n\n\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\n\t\t\t\tLII:The Practical Guide to the U.S. Physician Office Laboratory\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\tFrom LIMSWiki\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\tJump to: navigation, search\n\n\t\t\t\t\t\n\t\t\t\t\tThe Practical Guide to the U.S. Physician Office Laboratory \nWritten by: Rebecca A. Fein, M.S.A.H.I., M.B.A.\r\n\nEdited by: Shawn Douglas\n\nContents\n\n1 The Practical Guide to the U.S. Physician Office Laboratory \n2 Introduction \n3 What is a physician office laboratory? \n\n3.1 Types of POLs and their workflow \n3.2 History and market trends of the POL \n\n3.2.1 Early diagnostic testing \n3.2.2 Diagnostic testing in the twentieth century \n\n\n3.3 Why do POLs exist? \n3.4 Advantages and disadvantages of running a POL \n3.5 How the POL integrates with the entire practice \n3.6 POL or reference lab? \n\n\n4 Testing and associated reporting \n\n4.1 Reporting \n\n\n5 Staffing and certification requirements for the POL \n6 Regulatory requirements and considerations \n\n6.1 CLIA \n6.2 HIPAA \n6.3 PPACA \n\n\n7 Economic considerations \n\n7.1 Profitability and sustainability of the POL \n7.2 Insurance reimbursements \n7.3 Billing \n7.4 Return on investment \n\n\n8 Managing data and test results \n\n8.1 Data management systems and test workflow \n8.2 Quality control \n8.3 Integration with instruments and software \n\n\n9 Getting help with your POL \n10 Conclusion \n11 References \n12 Appendix \n13 Addendum \n\n\n\nIntroduction \nThis guide intends to give the reader practical information on the physician office laboratory (POL), assisting the reader with the decision-making processes related to becoming affiliated with a POL. \nThis guide provides a discussion on the history and trends related to the POL market, as well as testing considerations, staffing requirements, regulatory issues, related technology, and economic considerations.\nNo recommendations are made, though appropriate best practices are mentioned.\n\nWhat is a physician office laboratory? \nThe definition of a physician office laboratory varies from state to state. Some states define the POL by the actual number of physicians in the practice, and others do not. When setting up a POL, the proprietor should consult their individual state regulatory body to ensure full compliance.\nFor the purpose of this paper, the definition provided by the State of New York is used, as New York regulations are strict, and using a stringent guideline for the rest of this guide is preferred:\n\nIn order to qualify as a physician office laboratory (POL), individual health care providers must operate the practice or be part of a legally constituted, independently owned, and managed partnership or group practice. Laboratories that are owned, managed and\/or operated by managed care organizations, hospitals or consulting firms do not qualify for the POL exception and should apply for a clinical laboratory permit through the Clinical Laboratory Evaluation Program.[1]\nBased on the New York definition, a POL is thus a laboratory that provides the physician in-office laboratory testing services, thereby allowing the physician to have quicker access to laboratory results. Depending on the rules and regulations in any given state, the lab can be owned and operated either by a single physician practice or by more than one physician practice. In many states, additional regulations prohibit the acceptance of specimens from outside the clinician's practice.\n\nTypes of POLs and their workflow \nPOLs come in many different types. Nearly any practice can operate a POL. However, the most common types include gastroenterology, family practice, internal medicine, obstetrics and gynecology, and hematology and oncology practices. This is likely due to the need for these specialties to get quick results for treatment plan decisions. \nAccording to United Healthcare's Oxford's In-Office Laboratory Testing and Procedures List, the specialists that use an in-office laboratory include[2]:\n\n Primary care physicians and specialists: In some parts of the world, this type of doctor is referred to as a general practitioner. This doctor is the first point of contact for a patient and coordinates referrals to other physicians as necessary (dependent upon the insurance plan a patient has). Often these doctors are family medicine or internal medicine specialists by training. In some cases, these doctors are OB\/GYNs, nephrologists, allergists, pediatricians, or emergency medicine specialists.\n Dermatologists \/ dermatopathologists: A dermatologist is a doctor who specializes in skin conditions. Dermatologists can also board certify as dermatopathologists, which are trained in both dermatology and pathology. A dematopathologist examines tissue samples taken as part of a biopsy, for example.\n Rheumatologists: Rheumatologists deal with issues related to joints, soft tissue, autoimmune diseases, vasculitis, and hereditary connective tissue disorders. \n Urologists: Urologists examine issues related to the male and female urinary tract, as well as the male reproductive tract.\n Pediatricians: Pediatricians are trained to treat medical conditions found in infants, children, and adolescents. Generally, they do not see patients over the age of 18.\n Pulmonologists: Pulmonologists specialize in conditions related to the respiratory tract.\n Hematologists \/ oncologists \/ pediatric hematologists: Hematologists specialize in blood-related conditions, oncologists in cancers, and pediatric hematologists in childhood blood disorders.\n Obstetricians \/ gynecologists: Obstetricians specialize in conditions related to pregnancy. Often they are also gynecologists, specializing in women\u2019s reproductive health conditions.\n Reproductive endocrinologists \/ infertility: This is a sub-branch of the above specialty, addressing both male and female infertility issues.\nOther specialists such as surgeons are not as likely to have a physician office lab. Surgeries often take place in a hospital, and therefore tests would be processed through the hospital lab.\n\r\n \r\n\n\nCommon clinical laboratory workflow:\r\n\n\n\nPOL workflow:\r\n\n\nThe difference in these two workflows mostly comes down to the time spent in transporting the specimen to an outside lab and waiting for the processing. The in-office lab saves time in those parts of the process. \n\nHistory and market trends of the POL \nIn ancient times, patient diagnosis predicated on what the physician could observe during an exam of the patient, and in some cases the samples from the patient.[3]\nBeginning in the Middle Ages and ending during the eighteenth century, bed side medicine was the predominant form of practice. Patients were diagnosed at their bed side, similar to what modern clinicians call point-of-care testing (POCT).[3]\nDuring the eighteenth and nineteenth centuries, with the rise of hospital medicine, laboratory medicine started to play a bigger role in the diagnosis of patients.[3]\nAlthough, instruments such as the stethoscope and thermometer came into use at the end of the nineteenth century, the clinical laboratory did not become a standard part of medical practice until the twentieth century.[4]\n\nEarly diagnostic testing \nDiagnosis of patients via techniques, such as the examination of bodily fluids to predict disease, can be traced back to Hippocrates in ancient Greece. Hippocrates instituted diagnostic criterion that included listening to the patient\u2019s lungs, examining the urine of the patient, and observing the patient\u2019s skin color.[3]\nBlood in urine was linked to kidney failure in 50 AD, followed by another early clinician, Galen, identifying diabetes as \u201cdiarrhea of urine\u201d and noting a normal relationship between fluid intake and urinary output in 180 AD.[3]\nIn 900 AD, Isaac Judaeus established a protocol for using urine in patient diagnoses [3]. By 1300 AD, examination of the urine under a microscope (uroscopy) had become so popular it was nearly universal in Europe.[3]\nThe seventeenth century saw many innovations in diagnostic techniques as a result of the advances in literature related to the structure of the body and the formation of scientific societies.[3] Some of the innovations that came from the seventeenth century include first attempts to use pulse and temperature as indications of illness in a patient; intravenous drug injections; and identification of the sweet taste of urine in patients with diabetes.[3]\nIn the eighteenth century, Dr. William Hewson began to identify ways to measure coagulants in blood tests, an event that set the stage for modern diagnostic laboratory practice. During this time period, the ability to use temperature and blood pressure as diagnostic indicators was refined, allowing James Currie to treat his typhoid fever patients by putting them in a cold bath.[3]\nOther advances out of the eighteenth century include Sir John Floyer\u2019s pulse measuring technique, Tichy\u2019s urine analysis technique, Dobson\u2019s ability to prove the sweetness of both blood and urine in patients with diabetes was caused by sugar, and Home's development of a yeast test for sugar in urine.[3]\nThe nineteenth century is sometimes referred to as the era of public health; during this time independent laboratories started to develop.[3] In the United States, laboratory medicine was viewed with skepticism, as a destructive force related to medical knowledge. As a result of this, many American physicians went to Europe to receive training on laboratory techniques.[3]\nAs older physicians retired from practice and faculty positions, opposition to laboratory practice faded, allowing for bacteriological discoveries like pasteurization.[3] The nineteenth century saw aseptic methodologies produce fewer deaths after surgery, resulting in a greater emphasis on hygienic practices. This is also the period of time when x-ray and microscopy become more important to the practice of medicine.[3]\nAround 1850, the laboratory became popularized, and the first hospital laboratories begin to appear. Prior to this time period, most laboratory tests were performed at the bed side or were performed by the physician in the office laboratory.[3]\n\nDiagnostic testing in the twentieth century \nAlthough the nineteenth century was a time of advancement for clinical laboratory practice, the blossoming of the clinical laboratory did not occur until the twentieth century.[4] In the early twentieth century, laboratories began to stratify into the different types of sub-specialties seen in practice today: public health, forensic, and clinical.[4]\nIn 1928, when Alexander Fleming accidentally discovered penicillin, he ushered in the age of antibiotics, which allowed for new treatment options for infections, especially when combined with Domagk\u2019s discovery that sulphonomides had antibacterial attributes and did not harm humans.[4]\nIn the twentieth century, laboratory medicine personnel needed to be certified and licensed as the movement to ensure quality in medicine came to the laboratory. Organizations were founded to accommodate this, including the American Society for Clinical Pathology (ASCP), founded in 1922 to offer certifications to pathologists.[4]\nBy the end of the 1950s, the clinical laboratory had earned the respect of other medical professionals and the public, ensuring professional legitimacy.[4] This was accomplished by the discoveries made in the clinical laboratory, leading to new treatment options for patients, who would have endured difficult illnesses, or died, without such interventions.[4]\nThe initial creation of Medicare in 1965 was seen as an opportunity for free money by the healthcare industry as a whole. As costs increased, loopholes were found to get more reimbursements; however, these loopholes would be closed, and the resourceful provider would find other ways to continue the practice of charging more to get a higher reimbursement.[5]\nThe government soon discovered the potential for fraud and abuse inherent in Medicare. The need for regulations in order to prevent such abuses became apparent as early as 1967.[5] The Clinical Laboratory Improvement Act came into effect that year as a tool to regulate laboratories practicing across state lines, and it was amended in 1988 to include nearly all laboratories practicing in the United States.[5]\nIn 1989, an estimated 98,400 POLs were operating in the United States. Estimates from the time vary from 20,000 to 200,000 due to the lack of a standard definition for a POL and the need for physicians to self-report the status of their lab.[6] Some of these issues continue to persist today, as states often have different definitions for a POL.\nIn 1989, limited regulatory controls existed for POLs, resulting in wide variations in the complexity of testing among POLs.[6] Kusserow, writing for the HHS Office of Analysis and Inspections, noted the following during this time period:\n\nPhysicians operating office laboratories conduct approximately 25 percent of all laboratory testing in the country. Sixteen States have laws pertaining to them. About $20 billion is spent nationally on laboratory services annually, of which POLs receive $5 billion. Each year Medicare pays POLs over $400 million.[6]\nKusserow also found the average 1985 Medicare Part B payment to POLs was $7 per test, compared to $10 per test for an independent lab, or $19 per test to a lab classified as \"other\".[6] One can see the trend: the POL became a cheaper option when compared to other types of labs.\nSince 1995, with a better understanding and acceptance of regulations on the laboratory and the list of waived tests growing from 8 to 40[7], the number of POLs in the United States increased to a total of 120,399 or 49% of all the laboratories in the United States as of December 2013.[8] Additionally, 60% of the POLs in the United States today are running Clinical Laboratory Improvement Amendments (CLIA) waived tests, and 24% hold provider performed microscopy (PPM) certificates.[9]\nAccording to Bachman, POL growth is expected to increase in the future due to an aging population of baby boomers with money to finance laboratory testing and an increased interest and awareness in healthcare topics. Other factors to watch out for in the future are a softening stance on testing by payors (an example of this is the addition of an initial physical exam given to new Medicare beneficiaries for preventative care) and additions to the list of CLIA waived tests.[7]\n\nWhy do POLs exist? \nHistorically, POLs are a subset of point-of-care testing (POCT), laboratory testing that is done where the patient is located. These laboratories came about initially because as clinical medicine became more complicated to practice and techniques became more sophisticated, physicians still needed to perform tests to diagnose patients.\nPOLs also exist because the industry was looking for a cheaper way to test. Running a POL was found to be an effective way to provide clinician information for treatment plans, while at the same time saving insurers money.\nIn some cases, POLs opened to provide additional revenue streams for a physician\u2019s practice. The reasons for the POL's existence are varied, but the central reason is to provide quality diagnoses, treatment, and care to patients in the healthcare system.\n\nAdvantages and disadvantages of running a POL \nIn the early days of the POL, lack of regulation proved to be a disadvantage; however, over time, regulations have caught up for the better. \nAdvantages include \n\n quicker access to test results for the clinician, leading to more treatment options for the patient; \n greater efficiency of the clinical workflow;\n cheaper testing, though subject to individual test and pricing information; and\n patient comfort and happiness, including time saved by having to go only to one location.\nDisadvantages include: \n\n the physician office being the only point-of-access, with some physicians not willing to release patient information to an outside party (such as a hospital or competing clinician). This disadvantage may be eliminated due to regulatory changes in April of 2014, now allowing patients direct access to their laboratory results;\n patients not feeling comfortable about the physician's office being the central repository of information, and physicians may not see the value in having a lab in their practice; and\n the cost of meeting compliance requirements for local, state, and federal regulations, especially in states with stricter requirements. \nThese lists are of course limited; one could weigh advantages and disadvantages endlessly if the appropriate time was spent to fully evaluate the endeavor. Some of this process would be related to the individual practice in question.\n\nHow the POL integrates with the entire practice \nPOLs can integrate with an entire practice in a variety of ways. First, POLs can store laboratory data in a form more readily exchanged between the laboratory and the patient's broader electronic health record (EHR). A slight disconnect often exists between reference labs and physician offices. By placing a lab in the physician office, tighter integration of patient and testing data is achieved, a benefit for both the patient and the practitioner.\nThe tighter integration may save patients follow-up visits for diagnoses that are able to be done in the office laboratory. For example, in diagnosing a urinary tract infection, the physician office can significantly reduce time spent sending the sample off for testing by doing the testing independently.\nAdditionally, the POL can allow the financial departments of a practice to track costs and revenue by using laboratory data. For example, during flu season the physician can budget more money for gloves if their data indicates they're seeing more patients during this time.\nLaboratory data can also assist with trends related to a population. If a POL notices an unexpected trend in disease among the patient population, the lab data can help the entire organization decide how best to address the related issues through community education or some other outreach program.\n\nPOL or reference lab? \nOn average, most POL testing is simple and basic, falling under what is known as Clinical Laboratory Improvement Amendments (CLIA) waived tests. These tests will be discussed further in the next section, but for now know they are near the patient and simple to perform. As previously discussed, bringing simple laboratory testing to the physician office provides benefits to both the patient and the physician, making the POL more attractive.\nFor some physicians a POL is best because of their location; they may operate in a rural environment and would not have access to laboratory services if they did not do it themselves. For others, the expense of creating such a lab has swayed them towards using a reference lab, which can perform complex tests and, in many cases, has a staff available 24\/7. And while placing a POL in the physician office may integrate patient and lab data better, software-based offerings like Health Gorilla that provide real-time results may be sufficient for physicians that prefer to use a reference lab.\nIn the end, the decision to set up a POL or use a reference lab is based on a review of the advantages and disadvantages, finding a balance of what is best for both the patients' interest and the practice's long-term stability.\n\nTesting and associated reporting \nCLIA lays out seven criteria for determining the complexity of a test, including the origin of the test.[10] For example, if a new test is developed or an existing test is modified, and then it's used at that laboratory, the test is automatically rated a high-complexity test.[10] The complexity of the test determines the requirements the laboratory needs to comply with in order to maintain regulatory compliance. The more complex the test is, the stricter the requirements are.[10]\nTest complexity has three levels: high, moderate, and waived. Waived tests are simple to perform and have a relatively low risk of an incorrect test result.[10] Moderately complex tests include tests like provider performed microscopy (PPM), which requires the use of a microscope during the office visit.[10] Providers that want to perform PPM tests must be qualified to do so under CLIA regulations.[10]\nHigh-complexity tests require the most regulation. These tests are the most complicated and run the highest risk of an inaccurate result, as determined during the FDA pre-market approval process.[10] Tests may come from the manufacturer with their complexity level on them, or one can search the FDA database to determine the complexity of the test.[10] It is important to understand the complexity level of the testing provided in order to ensure full compliance with CLIA.\nCommonly performed tests, according to the United Healthcare guide, include[2]:\n\n urine analysis\n urine pregnancy\n blood occult\n glucose blood\n pathology consultation during surgery\n crystal identification by microscope\n sperm identification and analyses\n bilirubin total\n blood gasses\n complete blood count\n bone marrow smear\n blood bank services\n transfusion medicine\nReimbursement levels for tests are dependent upon the reimbursement guide put out by the individual insurance company. Billing personnel in POL-related offices are ultimately responsible for finding out what the reimbursement is and which tests are permitted for the POL's level of certification.\nAs noted, the predominant form of testing in the POL is waived complexity testing. See Table 1 in the appendix for the complete list of waived tests as of May 2014.\n\nReporting \nJust as POLs manage a set of commonly performed tests, a set of corresponding reports provides the results of those tests. The results will pass through a set of validation and quality control checks (discussed in section 8.2) before being fashioned into a final report for the ordering physician. For example, if a complete blood count is ordered by the physician, a corresponding patient report is produced by the laboratory, often through a laboratory information system (LIS). The patient report contains patient, physician, and sample demographics, as well as the results and whether they are above, below, or within recommended limits. Other types of reports may be generated in the laboratory, including daily summary, test total, and various quality control reports.\n\nStaffing and certification requirements for the POL \nRegulatory requirements regarding laboratory staff vary depending upon the level of testing performed and the state the POL is operating in, and due diligence is required to ensure the POL is meeting those requirements. The previous section noted most POLs perform waived tests, and as such, this section focuses on the requirements for staffing a CLIA waiver-certified laboratory. Typically these labs operate only during office hours, and therefore they do not have 24\/7 staffing.\nThe highest level of laboratory management is typically the person holding the title of laboratory director. Laboratory directors are responsible for the administration and operations of the laboratory, including the hiring of all personnel and ensuring testing procedures are done in the correct manner.[11] For the waiver-certified laboratory, anyone may be a laboratory director; however, the Joint Commission recommends laboratory directors meet the same minimum requirements of those testing in moderately complex laboratories.[12] Some states require the laboratory director of a moderately complex laboratory to be state-licensed and also to be a medical doctor or hold a degree in a laboratory science, such as chemistry.[13]\nIn general, the laboratory staff of a POL may consist of the laboratory director and a mix of laboratory technicians, laboratory technologists, laboratory clinical consultants, and, in some cases, a laboratory manager. The presence of some of these roles may vary, dependent upon if the laboratory is certified for waived, moderately complex, or highly complex testing. Additional educational qualifications and certifications for the laboratory technician, histotechnician, laboratory director, and other staff members may exist based on the lab's complexity level. Directors should check state requirements for the type of lab in question to ensure full compliance.\n\nRegulatory requirements and considerations \nWhen setting up a POL, the proprietor is faced with individual state, local, and federal regulations to ensure full compliance. (This guide is no substitute.) Three key regulations were chosen for discussion in this guide: the Clinical Laboratory Improvement Amendments (CLIA), the Health Insurance Portability and Accountability Act (HIPAA), and the Patient Protection and Affordable Care Act (PPACA). These regulations were chosen because they are the most common \u2014 and most important \u2014 to affect the POL and the physician office.\n\nCLIA \nThe most impactful regulation for the physician office laboratory at the time of this writing was CLIA. The U.S. federal statute was implemented in 1988 to remove obsolete laboratory requirements and include new requirements to improve the quality of a modern clinical laboratory. \nAs previously noted, most POLs are CLIA waiver labs, and therefore much like the previous section, the discussion here is mostly centered on those requirements. Waived tests have a low risk of an incorrect result; this includes the tests the Food and Drug Administration (FDA) has approved for consumers to use in their homes.[10] Tests performed under this provision are done at laboratories that have registered as required by CLIA and obtained a certificate of waiver. These labs are not inspected on a routine basis like labs certified to perform moderate- and high-complexity testing. Laboratories that wish to change their status from waived to one of the other statuses must comply with the CLIA requirements for registration, inspection, and proficiency testing as outlined in the law.[10] Waived laboratory staff, as previously mentioned, does not require proficiency testing, and anyone can be qualified to be the laboratory director.[10]\n\nHIPAA \nPOLs are required to comply with HIPAA and must provide safeguards for the security and privacy of the data collected and maintained in the laboratory. HIPAA passed in 1996 in an attempt to provide better guidance regarding the privacy and security of data, portability of health insurance, and better accountability for violations related to these topics. Laboratories are required to implement measures that prevent the unauthorized disclosure and access to data in the laboratory. \nPrior to 2014, most laboratories were exempt from the HIPAA requirement to provide patients with lab results or other protected health information.[14] However, in February 2014, the Department of Health and Human Services wanted to provide patients the opportunity to become better members of their own care team by giving them more information about their health.[14] This resulted in the amendment of CLIA 1988 to require a laboratory to give a patient, or their designated representative, lab results within 30 days of said individual sending a written request.[14] Laboratories are still required to ensure those accessing this data have authorization to do so, as the original requirements to keep data secure and private remain the same. \nThe annual cost of compliance with this new rule is estimated to be $59 million over the first five years when examining the potential cost to the laboratory industry in general.[15] Laboratories like Quest Diagnostics support the rule because it will allow them to give patients their lab results without prior approval from the patient\u2019s provider.[15]\nAs of this writing, it remains unclear as to how this impacts the POL. Since the POL is located at the physician office, access to results is most likely determined by the provider\u2019s regular procedures for acquiring personal health information (PHI). The POL could provide forms to patients for release of PHI, just as any other lab can, but it is unclear as to how this rule change will impact the POL in the long term.\n\nPPACA \nAs of this writing, the most difficult regulation to assess is the Patient Protection and Affordable Care Act, also known as the ACA. This does not negate the obligations of the laboratory under CLIA and HIPAA. According to the Clinical Laboratory Coalition, laboratory testing informs about 70% of a clinician\u2019s medical decision-making process. However, the laboratory comprises less than two percent of Medicare spending.[16] \n\nThe Patient Protection and Affordable Care Act (PPACA) included a direct cut to the Medicare Clinical Laboratory Fee Schedule of 1.75 percent each year for 5 years. This 9 percent cut is the largest cut among all Part B providers and started in 2011. In PPACA, clinical laboratories also received another cut in the form of a productivity adjustment, resulting in an additional 11 percent cut over 10 years.\r\n \r\n\nThe laboratory-specific cut and the productivity adjustment will already result in a cumulative 20 percent cut over 10 years. Laboratories are also facing up to a 2 percent cut to the fee schedule as a result of sequestration, which begins in January 2013.[16]\nThe laboratory space in general may face challenges from the accountable care organization (ACO) model under the PPACA, due to a decrease in laboratory testing volume.[17] Under the ACO model, unnecessary or redundant testing would be discouraged.[17] This could be a good thing for the POL market, as waived testing would be done in-house, close to the patient. It could also be a problem for the POL market, as physicians may need to recalculate if operating a POL makes economic sense for their practice.\n\nEconomic considerations \nEconomics are very important to any aspect of the medical practice. This is also true for the POL. Four economic considerations should be made regarding the POL: profitability and stability, insurance reimbursements, billing, and return on investment (ROI). For example, at the end of the previous section, the economics surrounding the PPACA were discussed. Other considerations would include things like assessing financial penalties for non-compliance.\n\nProfitability and sustainability of the POL \nMaintaining a profitable and sustainable lab is important. This is why the ROI calculation is provided in section 7.4 for examination. Performing this calculation can help determine how long it will take the lab to become profitable and if it will be sustainable over time. Like most parts of a business, the laboratory becomes profitable by collecting more revenue than it is putting out in expenses. \n\nInsurance reimbursements \nInsurance reimbursements vary by insurance company and plan. Checking with the insurance companies and plans accepted by the POL is advised; these numbers often change, as required by regulations or insurance company needs. It is important to keep current on this subject. Failing to do so can result in less reimbursement than one is expecting. If the reimbursement for a test is cut from $25 to $5, and one fails to keep current with reimbursements from the insurance providers, the shock could ripple through the laboratory or provider practice.\nThe April 2014 passage of the \u201cDoc Fix,\u201d a one-year protection of the Sustainable Growth Rate (SGR) Medicare physician payment formula, saved providers from this type of shock[18], as without this legislation providers were set to experience a 30% reduction in their reimbursement rates.[16] Laboratory personnel, especially billing personnel, would be wise to keep up with trends in this area.\n\nBilling \nBilling requires medical codes such as the International Classification of Disease, Ninth Version, Clinical Modification (ICD-9-CM) codes, soon to be ICD-10-CM codes, as well as procedure codes from either the Current Procedural Terminology (CPT) codes or the Healthcare Common Procedure Coding System (HCPCS). Logical Observation Identifiers Names and Codes (LOINC) may also be used, but mapping to another code set such as CPT is more common. Ordering physician, patient name, medical record number (MRN), and other demographic information may also appear on billing. Laboratory-specific information such as CLIA certification number and modifications indicating whether the test is CLIA-waived are also present.\nLaboratory billing for Medicare went through an important simplification process in 2003, to allow for a more standardized process and to eliminate confusion office staff was experiencing in their attempts to comply with billing rules.[19] The rules changed the billing for 23 laboratory tests that cover nearly two-thirds of all laboratory testing.[19]\n\nReturn on investment \nThe return on investment (ROI) metric is important to the POL. An example of ROI in action is when someone invests in a stock and gets 10% of the money back every year; the 10% would be the ROI from a purely financial standpoint. The formula for an ROI calculation is listed below:\n\nSimple ROI = Financial Gain\/Total Investment\nDiscounted ROI = Net Present Value of Benefits\/Total Present Value of Costs[20]\nThe Simple ROI calculation is primarily used for short-term calculations related to an investment of one year or less, while the Discounted ROI is more accurate for long-term analysis and calculations.[20]\nThe factors included in the ROI calculation will vary, depending on the type of calculation. The Simple ROI, for example, only examines financial gain divided by total investment amount. The person using this formula would say, after gaining $110,000 by investing $100,000, their ROI is 110%.\nBefore performing either calculation, it is important to measure current performance and then measure performance again after the investment.\nThe POL example below uses the IT Economics Corporation ROI calculation formula[20]:\nSimple ROI calculation for Fein and Douglas Associates' POL\nYear 1\n$100,000 benefit to the practice - $100,000 outlay of resources to establish the lab = $0 net savings divided by $100,000 outlay of resources, yielding a Simple ROI of 0%\nYear 2\n$400,000 benefit to the practice - $100,000 outlay of resources to maintain the laboratory = $300,000 net savings divided by $100,000 outlay of resources, yielding a Simple ROI of 300%\nYear 3\n$700,000 benefit to the practice - $100,000 outlay of resources to maintain the laboratory = $600,000 net savings divided by $100,000 outlay of resources, yielding a Simple ROI of 600%.\nThe Simple ROI calculation becomes less accurate as time goes on, because it does not take into account any discounting for the value of money or other assets impacted by time, such as equipment depreciation.\nThe Discounted ROI methodology takes into account a dollar received in 1988 is worth more than one received in 2008. It is more complicated than the Simple ROI, as it requires calculating the present value of costs and benefits, and it also requires knowing the organization discount rate. The organization CFO is typically the best person to contact for that information.\nNote how taking the same laboratory and performing a Discounted ROI calculation shows a more accurate result, as seen below[20]:\nDiscounted ROI calculation for Fein and Douglas Associates' POL\nFor this example, the assumption of an average 6% discount rate was used.\nYear 1\nPresent Value (PV) of Benefits: $100,000 received at the end of year 1 = $94,340\nPV of Costs: $100,000 paid at the end of year 1 = $94,340\n$94,340 PV of benefits to the practice - $94,340 PV of costs to establish the lab = $0 Net PV of benefits divided by $94,340 PV of costs, yielding a Discounted ROI of 0%\nNote how the Simple ROI and the Discounted ROI calculation are the same during the first year due to the cost and benefits all occurring the same year and at the same time.\nYear 2\nPresent Value (PV) of Benefits: $100,000 received at the end of year 1 = $94,340; PV of another $300,000 received at the end of year 2 = $267,000; Net PV of Benefits for year 2 thus = $361,340\nPV of Costs: $100,000 paid at the end of year 2 = $94,340\n$361,340 PV of benefits to the practice - $94,340 PV of costs to maintain the lab = $267,000 Net PV of benefits divided by $94,340 PV of costs, yielding a Discounted ROI of 283%\nNote how the Simple ROI for year 2 was 300%, a full 17% greater than the discounted ROI.\nYear 3\nPresent Value (PV) of Benefits: $100,000 received at the end of year 1 = $94,340; PV of another $300,000 received at the end of year 2 = $267,000; PV of another $300,000 received at the end of year 3 = $251,886; Net PV of Benefits for year 3 thus = $613,226\nPV of Costs: $100,000 paid at the end of year 3 = $94,340\n$613,226 PV of benefits to the practice - $94,340 PV of costs to maintain the lab = $518,886 Net PV of benefits divided by $94,340 PV of costs, yielding a Discounted ROI of 550%\nDiscounted ROI at the end of year 3 is 550%, not the 600% shown by the Simple ROI calculation. In this case the overage is 50% in year 3, as opposed to 17% in year 2. The Simple ROI calculation becomes less accurate as future years increase, which means that by year four, the overage would be greater than 50%.[20]\n\nManaging data and test results \nData management in the physician office laboratory has six important aspects to it:\n\n Overall workflow\n Order entry\n Testing, including associated results and reports\n Quality control\n Integration with instruments and software\n Integration with external reference laboratory results\nIn any modern laboratory, the common way to integrate data and workflow across the enterprise is through a data management system.\n\nData management systems and test workflow \nFrom a basic clinical and research laboratory perspective, there are two common data management systems to choose from: a laboratory information system (LIS) and a laboratory information management system (LIMS). Generally speaking, a LIS will be found more often in a clinical laboratory like the POL, whereas a LIMS will be more common in a research laboratory.[21]\nThe functionality is slightly different between the LIS and LIMS. The LIS tends to be more patient-centric, exhibiting features that focus on subjects and specimens, while the LIMS tends to be more group-centric, focusing on batches and samples. Both of these systems may have the ability to interface with a hospital information system (HIS), electronic health record (EHR), practice management system (PMS), or other types of systems commonly found in healthcare settings.\nOverall, workflow was discussed in a previous section, but just to refresh the reader's mind, here is the chart again:\n\r\n \r\n\n\nPOL workflow:\r\n\n\nNotice the flow starts with the doctor ordering the test and ends with the discussion of options with the patient. POL workflow may vary depending upon specialty, but the steps identified in this guide are the most common. Each part of the workflow is important and dependent upon the other. Without a doctor order, it does not matter if the specimen is collected and sent to the lab. Without a specimen to test, the rest of this workflow is unable to proceed. \nSince the first step is a doctor ordering the test, it is important to understand how the order entry component of a LIS operates. Each vendor will have a slightly different display, but the process is typically the same. The doctor enters the order for the test, often through a drop-down menu of tests in the patient's chart through the provider's EHR system. The LIS integrates to the EHR, allowing the laboratory staff to receive the order to collect the samples, perform the tests, and then transfer the results back into the EHR record for the physician to review, often in the form of a report. If the physician is not using an electronic system, then this process begins with a written or printed order and finishes with a written or printed report of the results for the patient file.\nMany LIS vendors will custom configure the system with tests, including reference ranges for the POL as part of the purchase agreement. These interfaces will often have a drop-down menu as well, so that the person performing the test can select the test and compare the sample result to the reference range for that particular test.\n\nQuality control \nAside from workflow, order entry, testing, and reporting, another important aspect of managing data is quality control (QC), which allows the handler of the data to ensure it still meets the definition of quality data. In healthcare informatics, quality data is defined as data that is clear, complete, relevant, timely, and accurate in presentation.[22]\nPrior to the use of computers, the entire process of informatics involved paper records. In many cases, these records were handwritten, requiring personnel to read the handwriting of others in order to assess the quality of the data provided.[23] Resistance to using a computer for laboratory tasks typically comes from a belief that the old ways are better; however, in most cases the computer can greatly aid in the prevention of errors.[23]\nLIS and LIMS vendors often include a variety of quality control functions in their software. QC tests can be run on specimens, quality control charts and reports can be created, proficiency testing functions can be implemented, and certificates of analysis (COAs) can be produced.[24]\nIt's worth noting, though, the use of computers and information management systems does not completely rule out error. For example, the drop-down menu still allows users to select either the wrong test or a test that looks for the same result but is less effective than another test.[23] These types of errors are more often than not controlled in a system where the laboratory personnel are knowledgeable about testing and are able to educate the ordering physician on such matters.[23]\nOther business processes can benefit from quality control measures, such as the application of Lean Six Sigma \u2014 an approach to reducing waste and limiting defects in a process \u2014 to the laboratory. It is important to examine the needs of the laboratory to ensure appropriate quality control techniques are implemented.\n\nIntegration with instruments and software \nSince workflow is the single most important consideration in the design of the LIS[23], it is important it allows instruments and other software to interface. These interfaces are generally done using standard communication processes and systems, as well as messaging formats, like Health Level 7 (HL7).[23]\nWhile the majority of POLs do waived testing, and those simple tests don't often require advanced equipment, interfacing a data management system may not be a concern. But for those POLs that employ laboratory automation, the ability of the equipment to talk to the LIS is vital, often using HL7.\n\nThe types of information communicated between these systems include process control and status information for each device or analyzer, each specimen, specimen container, and container carrier, information and detailed data related to patients, orders, and results, and information related to specimen flow algorithms and automated decision making.[25]\nA software interface between the LIS and the EHR is often referred to as a result interface, and it typically uses the HL7 messaging protocol and standard communication protocols like TCP\/IP. These interfaces are not turn-key, however, requiring a comprehensive planning and implementation process.[26] After a successful implementation, the interface allows information from a completed test to be reported back to the EHR, where the physician can readily obtain a copy of the patient test report. It can also allow for billing batches and admission\/discharge\/transfer (ADT) reporting. These same interfaces can be used for communicating with other reference laboratories, in addition to the various hospital systems.[23]\n\nGetting help with your POL \nIt is important those involved with the POL know where to get help when issues arise. Often, the first call goes to the vendor of the software, instruments, testing supplies, and other products and services the laboratory utilizes. If the vendor is unable to assist, consultants may prove to be a valuable asset to the POL. Consultants can help staff sort through regulatory compliance, financial planning, systems planning, and laboratory design. Consultants can also assist with filling the gap between a vendor support agreement and the need of the POL, if such a gap exists in the contract.\nAnother route for support with your POL may be a professional organization or trade association. The American College of Physicians, for example, provides numerous printable resources to practices. The American Society for Clinical Laboratory Science offers professional development courses, educational courses, and certification help to its members. \nA directory of consultants, organizations, and other tools is available as an addendum to this guide.\n\nConclusion \nPOLs have existed in various forms since the beginning of medicine. With accountable care organizations (ACO), patient-centered medical homes, direct-to-consumer laboratory testing, and telemedicine, an increased opportunity exists for laboratory medicine to be added to practices. Laboratory medicine influences 70% of all medical decisions, and the POL allows the physician to get results faster than having to send out for testing at a reference laboratory. \nThe decision to operate (or continue operating) a POL is an important one not to be entered into lightly. Owners must consider regulatory compliance, business processes, technology choices, and economic considerations. However, while a daunting task, ultimately choosing to operate a POL may prove to be a rewarding experience.\n\nReferences \n\n\u2191 New York State Department of Health, Wadsworth Center (2014). \"Physician Office Laboratory Evaluation Program (POLEP)\". http:\/\/www.wadsworth.org\/labcert\/polep\/ . Retrieved 14 May 2014 .   \n\n\u2191 2.0 2.1 UnitedHealthcare Oxford (01 July 2012). \"Oxford's in-office laboratory testing and procedures list\" (PDF). https:\/\/www.oxhp.com\/secure\/policy\/oxfords_in_office_laboratory_testing_and_procedures_list.pdf . Retrieved 14 May 2014 .   \n\n\u2191 3.00 3.01 3.02 3.03 3.04 3.05 3.06 3.07 3.08 3.09 3.10 3.11 3.12 3.13 3.14 3.15 Berger, D. (July 1999). \"A brief history of medical diagnosis and the birth of the clinical laboratory: Part 1\u2014Ancient times through the 19th century\" (PDF). Medical Laboratory Observer 31 (7): 28\u201330, 32, 34\u201340. http:\/\/www.academia.dk\/Blog\/wp-content\/uploads\/KlinLab-Hist\/LabHistory1.pdf . Retrieved 14 May 2014 .   \n\n\u2191 4.0 4.1 4.2 4.3 4.4 4.5 4.6 Berger, D. (August 1999). \"A brief history of medical diagnosis and the birth of the clinical laboratory: Part 2\u2014Laboratory science and professional certification in the 20th century\" (PDF). Medical Laboratory Observer 31 (8): 32\u201334, 36, 38. http:\/\/www.academia.dk\/Blog\/wp-content\/uploads\/KlinLab-Hist\/LabHistory2.pdf . Retrieved 14 May 2014 .   \n\n\u2191 5.0 5.1 5.2 Berger, D. (October 1999). \"A brief history of medical diagnosis and the birth of the clinical laboratory: Part 3\u2014Medicare, government regulation and competency certification\" (PDF). Medical Laboratory Observer 31 (10): 40\u201342, 44. http:\/\/www.academia.dk\/Blog\/wp-content\/uploads\/KlinLab-Hist\/LabHistory3.pdf . Retrieved 14 May 2014 .   \n\n\u2191 6.0 6.1 6.2 6.3 Kusserow, R. P. (March 1989). Quality assurance in physician office labs. OAI-0588-00330. U.S. Department of Health and Human Services, Office of Analysis and Inspections. https:\/\/oig.hhs.gov\/oei\/reports\/oai-05-88-00330.pdf . Retrieved 14 May 2014 .   \n\n\u2191 7.0 7.1 Bachman, A. (2004). \"Prosperity in the POL\" (PDF). ADVANCE for Administrators of the Laboratory 13 (12): 66. http:\/\/laboratory-manager.advanceweb.com\/Article\/Prosperity-in-the-POL.aspx . Retrieved 14 May 2014 .   \n\n\u2191 Centers for Medicare and Medicaid Services, Division of Laboratory Services (December 2013). \"Laboratories by type of facility\" (PDF). https:\/\/www.cms.gov\/Regulations-and-Guidance\/Legislation\/CLIA\/downloads\/factype.pdf . Retrieved 14 May 2014 .   \n\n\u2191 Centers for Medicare and Medicaid Services, Division of Laboratory Services (December 2013). \"Enrollment, CLIA exempt states, and certification of accreditation by organization\" (PDF). http:\/\/www.cms.gov\/Regulations-and-Guidance\/Legislation\/CLIA\/Downloads\/statupda.pdf . Retrieved 14 May 2014 .   \n\n\u2191 10.00 10.01 10.02 10.03 10.04 10.05 10.06 10.07 10.08 10.09 10.10 Centers for Disease Control and Prevention (31 May 2013). \"Clinical Laboratory Improvement Amendments (CLIA): Test complexities\". http:\/\/wwwn.cdc.gov\/clia\/Resources\/TestComplexities.aspx . Retrieved 14 May 2014 .   \n\n\u2191 American Academy of Family Physicians (2014). \"Physician office laboratory (POL) director duties\". http:\/\/www.aafp.org\/practice-management\/regulatory\/clia\/pol-director-duties.html . Retrieved 14 May 2014 .   \n\n\u2191 Olea, S. (2012). \"CLIA required personnel qualifications\". http:\/\/www.jointcommission.org\/assets\/1\/18\/CLIA_required_personnel_qualifications.pdf . Retrieved 14 May 2014 .   \n\n\u2191 American Academy of Family Physicians (2014). \"Personnel requirements\". http:\/\/www.aafp.org\/practice-management\/regulatory\/clia\/personnel.html . Retrieved 14 May 2014 .   \n\n\u2191 14.0 14.1 14.2 U.S. Department of Health and Human Services (03 February 2014). \"HHS strengthens patients' right to access lab test reports\". http:\/\/www.hhs.gov\/news\/press\/2014pres\/02\/20140203a.html .   \n\n\u2191 15.0 15.1 Conn, J. (03 February 2014). \"HHS issues rule granting patients direct access to lab test results\". Modern Healthcare. http:\/\/www.modernhealthcare.com\/article\/20140203\/NEWS\/302039958 . Retrieved 14 May 2014 .   \n\n\u2191 16.0 16.1 16.2 Clinical Laboratory Coalition (2012). \"Protect access to laboratory services for Medicare beneficiaries\" (PDF). http:\/\/www.aab.org\/images\/aab\/SGR%20Fix%202012%20Talking%20Points.pdf . Retrieved 14 May 2014 .   \n\n\u2191 17.0 17.1 Hughes, D.; Cammarata, B. (16 January 2014). \"Clinical labs under ACA: Challenge and opportunity\". Law360. http:\/\/www.law360.com\/articles\/500623\/clinical-labs-under-aca-challenge-and-opportunity . Retrieved 14 May 2014 .   \n\n\u2191 HIMSS (01 April 2014). \"After passage by Congress, President signs SGR \"Doc Fix\" & ICD-10 delay\". http:\/\/www.himss.org\/News\/NewsDetail.aspx?ItemNumber=28914 . Retrieved 14 May 2014 .   \n\n\u2191 19.0 19.1 Baker, B.; McKenzie, C. (December 2013). \"Recent CMS lab test standards simplify billing rules\". ACP Observer. http:\/\/www.acpinternist.org\/archives\/2003\/12\/baker.htm . Retrieved 14 May 2014 .   \n\n\u2191 20.0 20.1 20.2 20.3 20.4 IT Economics Corporation (2010). \"Computing the ROI for IT projects and other investments\". http:\/\/iteconcorp.com\/ROICalc.html . Retrieved 14 May 2014 .   \n\n\u2191 Friedman, B. (04 November 2008). \"LIS vs. LIMS: It's time to blend the two types of lab information systems\". Lab Soft News. http:\/\/labsoftnews.typepad.com\/lab_soft_news\/2008\/11\/liss-vs-limss-its-time-to-consider-merging-the-two-types-of-systems.html . Retrieved 14 May 2014 .   \n\n\u2191 World Health Organization, Regional Office for the Western Pacific (2003). \"Data quality: A guide for developing countries\". World Health Organization. http:\/\/www.wpro.who.int\/publications\/docs\/Improving_Data_Quality.pdf . Retrieved 14 May 2014 .   \n\n\u2191 23.0 23.1 23.2 23.3 23.4 23.5 23.6 Sinard, J. (2006). Practical pathology informatics: Demystifying informatics for the practicing anatomic pathologist. Springer Science+Business Media. ISBN 9780387280585. http:\/\/www.springer.com\/medicine\/pathology\/book\/978-0-387-28057-8 .   \n\n\u2191 Hull, C.; Wray, B.; Winslow, F.; Villicich, M. (2011). \"Tracking and controlling everything that affects quality is the key to a quality management system\". Combinatorial Chemistry & High Throughput Screening 14 (9): 772\u2013780. http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/21631414 . Retrieved 14 May 2014 .   \n\n\u2191 Health Level Seven International (2011). \"HL7 version 2.7 standard: Chapter 13 - Clinical laboratory automation\". http:\/\/www.hl7.org\/implement\/standards\/product_brief.cfm?product_id=203 . Retrieved 14 May 2014 .   \n\n\u2191 Kasoff, J. (February 2012). \"Connecting your LIS and EHR\". Medical Laboratory Observer. http:\/\/www.mlo-online.com\/articles\/201202\/connecting-your-lis-and-ehr.php . Retrieved 14 May 2014 .   \n\n\nAppendix \nTable 1. Tests Granted Waived Status under CLIA (This list includes updates from Change Request 8439.)\n\n\n\n\n CPT Code(s)\n\n Test Name\n\n Manufacturer\n\n Use\n\n\n 81002\n\nDipstick or tablet reagent urinalysis \u2013 non-automated for bilirubin, glucose, hemoglobin, ketone, leukocytes, nitrite, pH, protein, specific gravity, and urobilinogen\n\nVarious\n\nScreening of urine to monitor\/diagnose various diseases\/conditions, such as diabetes, the state of the kidney or urinary tract, and urinary tract infections\n\n\n 81025\n\nUrine pregnancy tests by visual color comparison\n\nVarious\n\nDiagnosis of pregnancy\n\n\n 82270\r\n82272\r\n(Contact your Medicare carrier for claims instructions.)\n\nFecal occult blood\n\nVarious\n\nDetection of blood in feces from whatever cause, benign or malignant (colorectal cancer screening)\n\n\n 82962\n\nBlood glucose by glucose monitoring devices cleared by the FDA for home use\n\nVarious\n\nMonitoring of blood glucose levels\n\n\n 83026\n\nHemoglobin by copper sulfate \u2013 non-automated\n\nVarious\n\nMonitors hemoglobin level in blood\n\n\n 84830\n\nOvulation tests by visual color comparison for human luteinizing hormone\n\nVarious\n\nDetection of ovulation (optimal for conception)\n\n\n 85013\n\nBlood count; spun microhematocrit\n\nVarious\n\nScreen for anemia\n\n\n 85651\n\nErythrocyte sedimentation rate \u2013 non-automated\n\nVarious\n\nNonspecific screening test for inflammatory activity, increased for majority of infections, and most cases of carcinoma and leukemia\n\n\n(Recreated from http:\/\/www.cms.gov\/Regulations-and-Guidance\/Legislation\/CLIA\/downloads\/waivetbl.pdf)\n\nAddendum \nAs part of the \"Getting help with your POL\" section, an addendum to this white paper is included, containing information about conferences, consultants, organizations, and published materials that could potentially help those operating and working in a physician office laboratory. \nYou can find that content on this page.\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:The_Practical_Guide_to_the_U.S._Physician_Office_Laboratory\">https:\/\/www.limswiki.org\/index.php\/LII:The_Practical_Guide_to_the_U.S._Physician_Office_Laboratory<\/a>\n\t\t\t\t\tCategory: LII:White papers and other publications\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\n\t\t\n\t\t\tNavigation menu\n\t\t\t\t\t\n\t\t\tViews\n\n\t\t\t\n\t\t\t\t\n\t\t\t\tLII\n\t\t\t\tDiscussion\n\t\t\t\tView source\n\t\t\t\tHistory\n\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\n\t\t\t\t\n\t\t\t\tPersonal tools\n\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\tLog in\n\t\t\t\t\t\t\t\t\t\t\t\t\tRequest account\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\t\t\n\t\tNavigation\n\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tMain page\n\t\t\t\t\t\t\t\t\t\t\tRecent changes\n\t\t\t\t\t\t\t\t\t\t\tRandom page\n\t\t\t\t\t\t\t\t\t\t\tHelp\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\n\t\t\t\n\t\t\tSearch\n\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t \n\t\t\t\t\t\t\n\t\t\t\t\n\n\t\t\t\t\t\t\t\n\t\t\n\t\t\t\n\t\t\tTools\n\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tWhat links here\n\t\t\t\t\t\t\t\t\t\t\tRelated changes\n\t\t\t\t\t\t\t\t\t\t\tSpecial pages\n\t\t\t\t\t\t\t\t\t\t\tPermanent link\n\t\t\t\t\t\t\t\t\t\t\tPage information\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\n\t\t\n\t\tPrint\/export\n\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tCreate a book\n\t\t\t\t\t\t\t\t\t\t\tDownload as PDF\n\t\t\t\t\t\t\t\t\t\t\tDownload as Plain text\n\t\t\t\t\t\t\t\t\t\t\tPrintable version\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\n\t\t\n\t\tSponsors\n\t\t\n\t\t\t \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n \r\n\n\t\n\t\r\n\n \r\n\n\t\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t This page was last modified on 19 June 2015, at 22:24.\n\t\t\t\t\t\t\t\t\tThis page has been accessed 11,321 times.\n\t\t\t\t\t\t\t\t\tContent is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.\n\t\t\t\t\t\t\t\t\tPrivacy policy\n\t\t\t\t\t\t\t\t\tAbout LIMSWiki\n\t\t\t\t\t\t\t\t\tDisclaimers\n\t\t\t\t\t\t\t\n\t\t\n\t\t\n\t\t\n\n","915c6acf5c1cc4fc5ecfaf557d1c1707_html":"<body class=\"mediawiki ltr sitedir-ltr ns-202 ns-subject page-LII_The_Practical_Guide_to_the_U_S_Physician_Office_Laboratory skin-monobook action-view\">\n<div id=\"rdp-ebb-globalWrapper\">\n\t\t<div id=\"rdp-ebb-column-content\">\n\t\t\t<div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\">\n\t\t\t\t<a id=\"rdp-ebb-top\"><\/a>\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">LII:The Practical Guide to the U.S. Physician Office Laboratory<\/h1>\n\t\t\t\t\n\t\t\t\t<div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\">\n\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\n\n\t\t\t\t\t<!-- start content -->\n\t\t\t\t\t<div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><h2><span class=\"mw-headline\" id=\"The_Practical_Guide_to_the_U.S._Physician_Office_Laboratory\"><b>The Practical Guide to the U.S. Physician Office Laboratory<\/b><\/span><\/h2>\n<p><b>Written by<\/b>: Rebecca A. Fein, M.S.A.H.I., M.B.A.<br \/>\n<b>Edited by<\/b>: Shawn Douglas\n<\/p>\n\n\n<h2><span class=\"mw-headline\" id=\"Introduction\">Introduction<\/span><\/h2>\n<p>This guide intends to give the reader practical information on the <a href=\"https:\/\/www.limswiki.org\/index.php\/Physician_office_laboratory\" title=\"Physician office laboratory\" target=\"_blank\" class=\"wiki-link\" data-key=\"0655647b0091e0dd168f162b621a6cef\">physician office laboratory<\/a> (POL), assisting the reader with the decision-making processes related to becoming affiliated with a POL. \n<\/p><p>This guide provides a discussion on the history and trends related to the POL market, as well as testing considerations, staffing requirements, regulatory issues, related technology, and economic considerations.\n<\/p><p>No recommendations are made, though appropriate best practices are mentioned.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"What_is_a_physician_office_laboratory.3F\">What is a physician office laboratory?<\/span><\/h2>\n<p>The definition of a <a href=\"https:\/\/www.limswiki.org\/index.php\/Physician_office_laboratory\" title=\"Physician office laboratory\" target=\"_blank\" class=\"wiki-link\" data-key=\"0655647b0091e0dd168f162b621a6cef\">physician office laboratory<\/a> varies from state to state. Some states define the POL by the actual number of physicians in the practice, and others do not. When setting up a POL, the proprietor should consult their individual state regulatory body to ensure full compliance.\n<\/p><p>For the purpose of this paper, the definition provided by the State of New York is used, as New York regulations are strict, and using a stringent guideline for the rest of this guide is preferred:\n<\/p>\n<blockquote><i>In order to qualify as a physician office laboratory (POL), individual health care providers must operate the practice or be part of a legally constituted, independently owned, and managed partnership or group practice. Laboratories that are owned, managed and\/or operated by managed care organizations, <a href=\"https:\/\/www.limswiki.org\/index.php\/Hospital\" title=\"Hospital\" target=\"_blank\" class=\"wiki-link\" data-key=\"b8f070c66d8123fe91063594befebdff\">hospitals<\/a> or consulting firms do not qualify for the POL exception and should apply for a <a href=\"https:\/\/www.limswiki.org\/index.php\/Clinical_laboratory\" title=\"Clinical laboratory\" target=\"_blank\" class=\"wiki-link\" data-key=\"307bcdf1bdbcd1bb167cee435b7a5463\">clinical laboratory<\/a> permit through the Clinical Laboratory Evaluation Program.<sup id=\"rdp-ebb-cite_ref-NYSPOL_1-0\" class=\"reference\"><a href=\"#cite_note-NYSPOL-1\" rel=\"external_link\">[1]<\/a><\/sup><\/i><\/blockquote>\n<p>Based on the New York definition, a POL is thus a <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory\" title=\"Laboratory\" target=\"_blank\" class=\"wiki-link\" data-key=\"c57fc5aac9e4abf31dccae81df664c33\">laboratory<\/a> that provides the physician in-office laboratory testing services, thereby allowing the physician to have quicker access to laboratory results. Depending on the rules and regulations in any given state, the lab can be owned and operated either by a single physician practice or by more than one physician practice. In many states, additional regulations prohibit the acceptance of specimens from outside the clinician's practice.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Types_of_POLs_and_their_workflow\">Types of POLs and their workflow<\/span><\/h3>\n<p>POLs come in many different types. Nearly any practice can operate a POL. However, the most common types include gastroenterology, family practice, internal medicine, obstetrics and gynecology, and hematology and oncology practices. This is likely due to the need for these specialties to get quick results for treatment plan decisions. \n<\/p><p>According to United Healthcare's Oxford's In-Office Laboratory Testing and Procedures List, the specialists that use an in-office laboratory include<sup id=\"rdp-ebb-cite_ref-UHOxInOffice_2-0\" class=\"reference\"><a href=\"#cite_note-UHOxInOffice-2\" rel=\"external_link\">[2]<\/a><\/sup>:\n<\/p>\n<ul><li> <b>Primary care physicians and specialists<\/b>: In some parts of the world, this type of doctor is referred to as a general practitioner. This doctor is the first point of contact for a patient and coordinates referrals to other physicians as necessary (dependent upon the insurance plan a patient has). Often these doctors are family medicine or internal medicine specialists by training. In some cases, these doctors are OB\/GYNs, nephrologists, allergists, pediatricians, or emergency medicine specialists.<\/li><\/ul>\n<ul><li> <b>Dermatologists \/ dermatopathologists<\/b>: A dermatologist is a doctor who specializes in skin conditions. Dermatologists can also board certify as dermatopathologists, which are trained in both dermatology and pathology. A dematopathologist examines tissue samples taken as part of a biopsy, for example.<\/li><\/ul>\n<ul><li> <b>Rheumatologists<\/b>: Rheumatologists deal with issues related to joints, soft tissue, autoimmune diseases, vasculitis, and hereditary connective tissue disorders. <\/li><\/ul>\n<ul><li> <b>Urologists<\/b>: Urologists examine issues related to the male and female urinary tract, as well as the male reproductive tract.<\/li><\/ul>\n<ul><li> <b>Pediatricians<\/b>: Pediatricians are trained to treat medical conditions found in infants, children, and adolescents. Generally, they do not see patients over the age of 18.<\/li><\/ul>\n<ul><li> <b>Pulmonologists<\/b>: Pulmonologists specialize in conditions related to the respiratory tract.<\/li><\/ul>\n<ul><li> <b>Hematologists \/ oncologists \/ pediatric hematologists<\/b>: Hematologists specialize in blood-related conditions, oncologists in cancers, and pediatric hematologists in childhood blood disorders.<\/li><\/ul>\n<ul><li> <b>Obstetricians \/ gynecologists<\/b>: Obstetricians specialize in conditions related to pregnancy. Often they are also gynecologists, specializing in women\u2019s reproductive health conditions.<\/li><\/ul>\n<ul><li> <b>Reproductive endocrinologists \/ infertility<\/b>: This is a sub-branch of the above specialty, addressing both male and female infertility issues.<\/li><\/ul>\n<p>Other specialists such as surgeons are not as likely to have a physician office lab. Surgeries often take place in a hospital, and therefore tests would be processed through the hospital lab.\n<br \/> <br \/>\n<\/p>\n<dl><dd><b>Common clinical laboratory workflow<\/b>:<br \/><\/dd><\/dl>\n<p><a href=\"https:\/\/www.limswiki.org\/index.php\/File:NormWorkflow.png\" class=\"image wiki-link\" target=\"_blank\" data-key=\"b7253f76c6732f3c13110e6cd31f3fb2\"><img alt=\"NormWorkflow.png\" src=\"https:\/\/www.limswiki.org\/images\/a\/ab\/NormWorkflow.png\" style=\"width: 100%;max-width: 400px;height: auto;\" \/><\/a>\n<\/p>\n<dl><dd><b>POL workflow<\/b>:<br \/><\/dd><\/dl>\n<p><a href=\"https:\/\/www.limswiki.org\/index.php\/File:POLWorkflow.png\" class=\"image wiki-link\" target=\"_blank\" data-key=\"2e8f48b2ca3e3eb8cdcee2c3d559bf69\"><img alt=\"POLWorkflow.png\" src=\"https:\/\/www.limswiki.org\/images\/3\/3d\/POLWorkflow.png\" style=\"width: 100%;max-width: 400px;height: auto;\" \/><\/a>\n<\/p><p>The difference in these two workflows mostly comes down to the time spent in transporting the specimen to an outside lab and waiting for the processing. The in-office lab saves time in those parts of the process. \n<\/p>\n<h3><span class=\"mw-headline\" id=\"History_and_market_trends_of_the_POL\">History and market trends of the POL<\/span><\/h3>\n<p>In ancient times, patient diagnosis predicated on what the physician could observe during an exam of the patient, and in some cases the samples from the patient.<sup id=\"rdp-ebb-cite_ref-BergerP1_3-0\" class=\"reference\"><a href=\"#cite_note-BergerP1-3\" rel=\"external_link\">[3]<\/a><\/sup>\n<\/p><p>Beginning in the Middle Ages and ending during the eighteenth century, bed side medicine was the predominant form of practice. Patients were diagnosed at their bed side, similar to what modern clinicians call point-of-care testing (POCT).<sup id=\"rdp-ebb-cite_ref-BergerP1_3-1\" class=\"reference\"><a href=\"#cite_note-BergerP1-3\" rel=\"external_link\">[3]<\/a><\/sup>\n<\/p><p>During the eighteenth and nineteenth centuries, with the rise of hospital medicine, laboratory medicine started to play a bigger role in the diagnosis of patients.<sup id=\"rdp-ebb-cite_ref-BergerP1_3-2\" class=\"reference\"><a href=\"#cite_note-BergerP1-3\" rel=\"external_link\">[3]<\/a><\/sup>\n<\/p><p>Although, instruments such as the stethoscope and thermometer came into use at the end of the nineteenth century, the clinical laboratory did not become a standard part of medical practice until the twentieth century.<sup id=\"rdp-ebb-cite_ref-BergerP2_4-0\" class=\"reference\"><a href=\"#cite_note-BergerP2-4\" rel=\"external_link\">[4]<\/a><\/sup>\n<\/p>\n<h4><span class=\"mw-headline\" id=\"Early_diagnostic_testing\">Early diagnostic testing<\/span><\/h4>\n<p>Diagnosis of patients via techniques, such as the examination of bodily fluids to predict disease, can be traced back to Hippocrates in ancient Greece. Hippocrates instituted diagnostic criterion that included listening to the patient\u2019s lungs, examining the urine of the patient, and observing the patient\u2019s skin color.<sup id=\"rdp-ebb-cite_ref-BergerP1_3-3\" class=\"reference\"><a href=\"#cite_note-BergerP1-3\" rel=\"external_link\">[3]<\/a><\/sup>\n<\/p><p>Blood in urine was linked to kidney failure in 50 AD, followed by another early clinician, Galen, identifying diabetes as \u201cdiarrhea of urine\u201d and noting a normal relationship between fluid intake and urinary output in 180 AD.<sup id=\"rdp-ebb-cite_ref-BergerP1_3-4\" class=\"reference\"><a href=\"#cite_note-BergerP1-3\" rel=\"external_link\">[3]<\/a><\/sup>\n<\/p><p>In 900 AD, Isaac Judaeus established a protocol for using urine in patient diagnoses <sup id=\"rdp-ebb-cite_ref-BergerP1_3-5\" class=\"reference\"><a href=\"#cite_note-BergerP1-3\" rel=\"external_link\">[3]<\/a><\/sup>. By 1300 AD, examination of the urine under a microscope (uroscopy) had become so popular it was nearly universal in Europe.<sup id=\"rdp-ebb-cite_ref-BergerP1_3-6\" class=\"reference\"><a href=\"#cite_note-BergerP1-3\" rel=\"external_link\">[3]<\/a><\/sup>\n<\/p><p>The seventeenth century saw many innovations in diagnostic techniques as a result of the advances in literature related to the structure of the body and the formation of scientific societies.<sup id=\"rdp-ebb-cite_ref-BergerP1_3-7\" class=\"reference\"><a href=\"#cite_note-BergerP1-3\" rel=\"external_link\">[3]<\/a><\/sup> Some of the innovations that came from the seventeenth century include first attempts to use pulse and temperature as indications of illness in a patient; intravenous drug injections; and identification of the sweet taste of urine in patients with diabetes.<sup id=\"rdp-ebb-cite_ref-BergerP1_3-8\" class=\"reference\"><a href=\"#cite_note-BergerP1-3\" rel=\"external_link\">[3]<\/a><\/sup>\n<\/p><p>In the eighteenth century, Dr. William Hewson began to identify ways to measure coagulants in blood tests, an event that set the stage for modern <a href=\"https:\/\/www.limswiki.org\/index.php\/Diagnostic_laboratory\" title=\"Diagnostic laboratory\" class=\"mw-redirect wiki-link\" target=\"_blank\" data-key=\"4dea9b8dbc15ed897d7aff1b35c381ba\">diagnostic laboratory<\/a> practice. During this time period, the ability to use temperature and blood pressure as diagnostic indicators was refined, allowing James Currie to treat his typhoid fever patients by putting them in a cold bath.<sup id=\"rdp-ebb-cite_ref-BergerP1_3-9\" class=\"reference\"><a href=\"#cite_note-BergerP1-3\" rel=\"external_link\">[3]<\/a><\/sup>\n<\/p><p>Other advances out of the eighteenth century include Sir John Floyer\u2019s pulse measuring technique, Tichy\u2019s urine analysis technique, Dobson\u2019s ability to prove the sweetness of both blood and urine in patients with diabetes was caused by sugar, and Home's development of a yeast test for sugar in urine.<sup id=\"rdp-ebb-cite_ref-BergerP1_3-10\" class=\"reference\"><a href=\"#cite_note-BergerP1-3\" rel=\"external_link\">[3]<\/a><\/sup>\n<\/p><p>The nineteenth century is sometimes referred to as the era of public health; during this time independent laboratories started to develop.<sup id=\"rdp-ebb-cite_ref-BergerP1_3-11\" class=\"reference\"><a href=\"#cite_note-BergerP1-3\" rel=\"external_link\">[3]<\/a><\/sup> In the United States, laboratory medicine was viewed with skepticism, as a destructive force related to medical knowledge. As a result of this, many American physicians went to Europe to receive training on laboratory techniques.<sup id=\"rdp-ebb-cite_ref-BergerP1_3-12\" class=\"reference\"><a href=\"#cite_note-BergerP1-3\" rel=\"external_link\">[3]<\/a><\/sup>\n<\/p><p>As older physicians retired from practice and faculty positions, opposition to laboratory practice faded, allowing for bacteriological discoveries like pasteurization.<sup id=\"rdp-ebb-cite_ref-BergerP1_3-13\" class=\"reference\"><a href=\"#cite_note-BergerP1-3\" rel=\"external_link\">[3]<\/a><\/sup> The nineteenth century saw aseptic methodologies produce fewer deaths after surgery, resulting in a greater emphasis on hygienic practices. This is also the period of time when x-ray and microscopy become more important to the practice of medicine.<sup id=\"rdp-ebb-cite_ref-BergerP1_3-14\" class=\"reference\"><a href=\"#cite_note-BergerP1-3\" rel=\"external_link\">[3]<\/a><\/sup>\n<\/p><p>Around 1850, the laboratory became popularized, and the first hospital laboratories begin to appear. Prior to this time period, most laboratory tests were performed at the bed side or were performed by the physician in the office laboratory.<sup id=\"rdp-ebb-cite_ref-BergerP1_3-15\" class=\"reference\"><a href=\"#cite_note-BergerP1-3\" rel=\"external_link\">[3]<\/a><\/sup>\n<\/p>\n<h4><span class=\"mw-headline\" id=\"Diagnostic_testing_in_the_twentieth_century\">Diagnostic testing in the twentieth century<\/span><\/h4>\n<p>Although the nineteenth century was a time of advancement for clinical laboratory practice, the blossoming of the clinical laboratory did not occur until the twentieth century.<sup id=\"rdp-ebb-cite_ref-BergerP2_4-1\" class=\"reference\"><a href=\"#cite_note-BergerP2-4\" rel=\"external_link\">[4]<\/a><\/sup> In the early twentieth century, laboratories began to stratify into the different types of sub-specialties seen in practice today: <a href=\"https:\/\/www.limswiki.org\/index.php\/Public_health_laboratory\" title=\"Public health laboratory\" target=\"_blank\" class=\"wiki-link\" data-key=\"34ffb658cb79bf322c65efaad95996f5\">public health<\/a>, forensic, and clinical.<sup id=\"rdp-ebb-cite_ref-BergerP2_4-2\" class=\"reference\"><a href=\"#cite_note-BergerP2-4\" rel=\"external_link\">[4]<\/a><\/sup>\n<\/p><p>In 1928, when Alexander Fleming accidentally discovered penicillin, he ushered in the age of antibiotics, which allowed for new treatment options for infections, especially when combined with Domagk\u2019s discovery that sulphonomides had antibacterial attributes and did not harm humans.<sup id=\"rdp-ebb-cite_ref-BergerP2_4-3\" class=\"reference\"><a href=\"#cite_note-BergerP2-4\" rel=\"external_link\">[4]<\/a><\/sup>\n<\/p><p>In the twentieth century, laboratory medicine personnel needed to be certified and licensed as the movement to ensure quality in medicine came to the laboratory. Organizations were founded to accommodate this, including the American Society for Clinical Pathology (ASCP), founded in 1922 to offer certifications to pathologists.<sup id=\"rdp-ebb-cite_ref-BergerP2_4-4\" class=\"reference\"><a href=\"#cite_note-BergerP2-4\" rel=\"external_link\">[4]<\/a><\/sup>\n<\/p><p>By the end of the 1950s, the clinical laboratory had earned the respect of other medical professionals and the public, ensuring professional legitimacy.<sup id=\"rdp-ebb-cite_ref-BergerP2_4-5\" class=\"reference\"><a href=\"#cite_note-BergerP2-4\" rel=\"external_link\">[4]<\/a><\/sup> This was accomplished by the discoveries made in the clinical laboratory, leading to new treatment options for patients, who would have endured difficult illnesses, or died, without such interventions.<sup id=\"rdp-ebb-cite_ref-BergerP2_4-6\" class=\"reference\"><a href=\"#cite_note-BergerP2-4\" rel=\"external_link\">[4]<\/a><\/sup>\n<\/p><p>The initial creation of <a href=\"https:\/\/www.limswiki.org\/index.php\/Centers_for_Medicare_and_Medicaid_Services\" title=\"Centers for Medicare and Medicaid Services\" target=\"_blank\" class=\"wiki-link\" data-key=\"654b4449e4816e190325b420c264df1a\">Medicare<\/a> in 1965 was seen as an opportunity for free money by the healthcare industry as a whole. As costs increased, loopholes were found to get more reimbursements; however, these loopholes would be closed, and the resourceful provider would find other ways to continue the practice of charging more to get a higher reimbursement.<sup id=\"rdp-ebb-cite_ref-BergerP3_5-0\" class=\"reference\"><a href=\"#cite_note-BergerP3-5\" rel=\"external_link\">[5]<\/a><\/sup>\n<\/p><p>The government soon discovered the potential for fraud and abuse inherent in Medicare. The need for regulations in order to prevent such abuses became apparent as early as 1967.<sup id=\"rdp-ebb-cite_ref-BergerP3_5-1\" class=\"reference\"><a href=\"#cite_note-BergerP3-5\" rel=\"external_link\">[5]<\/a><\/sup> The <a href=\"https:\/\/www.limswiki.org\/index.php\/Clinical_Laboratory_Improvement_Amendments\" title=\"Clinical Laboratory Improvement Amendments\" target=\"_blank\" class=\"wiki-link\" data-key=\"64bdae1dc17c40c28e0c560396a6ae35\">Clinical Laboratory Improvement Act<\/a> came into effect that year as a tool to regulate laboratories practicing across state lines, and it was amended in 1988 to include nearly all laboratories practicing in the United States.<sup id=\"rdp-ebb-cite_ref-BergerP3_5-2\" class=\"reference\"><a href=\"#cite_note-BergerP3-5\" rel=\"external_link\">[5]<\/a><\/sup>\n<\/p><p>In 1989, an estimated 98,400 POLs were operating in the United States. Estimates from the time vary from 20,000 to 200,000 due to the lack of a standard definition for a POL and the need for physicians to self-report the status of their lab.<sup id=\"rdp-ebb-cite_ref-HHS89_6-0\" class=\"reference\"><a href=\"#cite_note-HHS89-6\" rel=\"external_link\">[6]<\/a><\/sup> Some of these issues continue to persist today, as states often have different definitions for a POL.\n<\/p><p>In 1989, limited regulatory controls existed for POLs, resulting in wide variations in the complexity of testing among POLs.<sup id=\"rdp-ebb-cite_ref-HHS89_6-1\" class=\"reference\"><a href=\"#cite_note-HHS89-6\" rel=\"external_link\">[6]<\/a><\/sup> Kusserow, writing for the <a href=\"https:\/\/www.limswiki.org\/index.php\/United_States_Department_of_Health_and_Human_Services\" title=\"United States Department of Health and Human Services\" target=\"_blank\" class=\"wiki-link\" data-key=\"efa106bcbb93039b1a6c3c596daedec3\">HHS<\/a> Office of Analysis and Inspections, noted the following during this time period:\n<\/p>\n<blockquote><i>Physicians operating office laboratories conduct approximately 25 percent of all laboratory testing in the country. Sixteen States have laws pertaining to them. About $20 billion is spent nationally on laboratory services annually, of which POLs receive $5 billion. Each year Medicare pays POLs over $400 million.<sup id=\"rdp-ebb-cite_ref-HHS89_6-2\" class=\"reference\"><a href=\"#cite_note-HHS89-6\" rel=\"external_link\">[6]<\/a><\/sup><\/i><\/blockquote>\n<p>Kusserow also found the average 1985 Medicare Part B payment to POLs was $7 per test, compared to $10 per test for an independent lab, or $19 per test to a lab classified as \"other\".<sup id=\"rdp-ebb-cite_ref-HHS89_6-3\" class=\"reference\"><a href=\"#cite_note-HHS89-6\" rel=\"external_link\">[6]<\/a><\/sup> One can see the trend: the POL became a cheaper option when compared to other types of labs.\n<\/p><p>Since 1995, with a better understanding and acceptance of regulations on the laboratory and the list of waived tests growing from 8 to 40<sup id=\"rdp-ebb-cite_ref-Bachman04_7-0\" class=\"reference\"><a href=\"#cite_note-Bachman04-7\" rel=\"external_link\">[7]<\/a><\/sup>, the number of POLs in the United States increased to a total of 120,399 or 49% of all the laboratories in the United States as of December 2013.<sup id=\"rdp-ebb-cite_ref-CMS13LabTypes_8-0\" class=\"reference\"><a href=\"#cite_note-CMS13LabTypes-8\" rel=\"external_link\">[8]<\/a><\/sup> Additionally, 60% of the POLs in the United States today are running <a href=\"https:\/\/www.limswiki.org\/index.php\/Clinical_Laboratory_Improvement_Amendments\" title=\"Clinical Laboratory Improvement Amendments\" target=\"_blank\" class=\"wiki-link\" data-key=\"64bdae1dc17c40c28e0c560396a6ae35\">Clinical Laboratory Improvement Amendments<\/a> (CLIA) waived tests, and 24% hold provider performed microscopy (PPM) certificates.<sup id=\"rdp-ebb-cite_ref-CMS13Enroll_9-0\" class=\"reference\"><a href=\"#cite_note-CMS13Enroll-9\" rel=\"external_link\">[9]<\/a><\/sup>\n<\/p><p>According to Bachman, POL growth is expected to increase in the future due to an aging population of baby boomers with money to finance laboratory testing and an increased interest and awareness in healthcare topics. Other factors to watch out for in the future are a softening stance on testing by payors (an example of this is the addition of an initial physical exam given to new Medicare beneficiaries for preventative care) and additions to the list of CLIA waived tests.<sup id=\"rdp-ebb-cite_ref-Bachman04_7-1\" class=\"reference\"><a href=\"#cite_note-Bachman04-7\" rel=\"external_link\">[7]<\/a><\/sup>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Why_do_POLs_exist.3F\">Why do POLs exist?<\/span><\/h3>\n<p>Historically, POLs are a subset of point-of-care testing (POCT), laboratory testing that is done where the patient is located. These laboratories came about initially because as clinical medicine became more complicated to practice and techniques became more sophisticated, physicians still needed to perform tests to diagnose patients.\n<\/p><p>POLs also exist because the industry was looking for a cheaper way to test. Running a POL was found to be an effective way to provide clinician information for treatment plans, while at the same time saving insurers money.\n<\/p><p>In some cases, POLs opened to provide additional revenue streams for a physician\u2019s practice. The reasons for the POL's existence are varied, but the central reason is to provide quality diagnoses, treatment, and care to patients in the healthcare system.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Advantages_and_disadvantages_of_running_a_POL\">Advantages and disadvantages of running a POL<\/span><\/h3>\n<p>In the early days of the POL, lack of regulation proved to be a disadvantage; however, over time, <a href=\"https:\/\/www.limswiki.org\/index.php\/Category:Regulatory_information\" title=\"Category:Regulatory information\" target=\"_blank\" class=\"wiki-link\" data-key=\"171adcea16c6544d2efab13f36c3dc7d\">regulations<\/a> have caught up for the better. \n<\/p><p>Advantages include \n<\/p>\n<ul><li> quicker access to test results for the clinician, leading to more treatment options for the patient; <\/li>\n<li> greater efficiency of the clinical workflow;<\/li>\n<li> cheaper testing, though subject to individual test and pricing information; and<\/li>\n<li> patient comfort and happiness, including time saved by having to go only to one location.<\/li><\/ul>\n<p>Disadvantages include: \n<\/p>\n<ul><li> the physician office being the only point-of-access, with some physicians not willing to release patient information to an outside party (such as a hospital or competing clinician). This disadvantage may be eliminated due to regulatory changes in April of 2014, now allowing patients direct access to their laboratory results;<\/li>\n<li> patients not feeling comfortable about the physician's office being the central repository of information, and physicians may not see the value in having a lab in their practice; and<\/li>\n<li> the cost of meeting compliance requirements for local, state, and federal regulations, especially in states with stricter requirements. <\/li><\/ul>\n<p>These lists are of course limited; one could weigh advantages and disadvantages endlessly if the appropriate time was spent to fully evaluate the endeavor. Some of this process would be related to the individual practice in question.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"How_the_POL_integrates_with_the_entire_practice\">How the POL integrates with the entire practice<\/span><\/h3>\n<p>POLs can integrate with an entire practice in a variety of ways. First, POLs can store laboratory data in a form more readily exchanged between the laboratory and the patient's broader <a href=\"https:\/\/www.limswiki.org\/index.php\/Electronic_health_record\" title=\"Electronic health record\" target=\"_blank\" class=\"wiki-link\" data-key=\"f2e31a73217185bb01389404c1fd5255\">electronic health record<\/a> (EHR). A slight disconnect often exists between <a href=\"https:\/\/www.limswiki.org\/index.php\/Reference_lab\" title=\"Reference lab\" class=\"mw-redirect wiki-link\" target=\"_blank\" data-key=\"edfcf253b049231e25937d7d35defa85\">reference labs<\/a> and physician offices. By placing a lab in the physician office, tighter integration of patient and testing data is achieved, a benefit for both the patient and the practitioner.\n<\/p><p>The tighter integration may save patients follow-up visits for diagnoses that are able to be done in the office laboratory. For example, in diagnosing a urinary tract infection, the physician office can significantly reduce time spent sending the sample off for testing by doing the testing independently.\n<\/p><p>Additionally, the POL can allow the financial departments of a practice to track costs and revenue by using laboratory data. For example, during flu season the physician can budget more money for gloves if their data indicates they're seeing more patients during this time.\n<\/p><p>Laboratory data can also assist with trends related to a population. If a POL notices an unexpected trend in disease among the patient population, the lab data can help the entire organization decide how best to address the related issues through community education or some other outreach program.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"POL_or_reference_lab.3F\">POL or reference lab?<\/span><\/h3>\n<p>On average, most POL testing is simple and basic, falling under what is known as Clinical Laboratory Improvement Amendments (CLIA) waived tests. These tests will be discussed further in the next section, but for now know they are near the patient and simple to perform. As previously discussed, bringing simple laboratory testing to the physician office provides benefits to both the patient and the physician, making the POL more attractive.\n<\/p><p>For some physicians a POL is best because of their location; they may operate in a rural environment and would not have access to laboratory services if they did not do it themselves. For others, the expense of creating such a lab has swayed them towards using a reference lab, which can perform complex tests and, in many cases, has a staff available 24\/7. And while placing a POL in the physician office may integrate patient and lab data better, software-based offerings like Health Gorilla that provide real-time results may be sufficient for physicians that prefer to use a reference lab.\n<\/p><p>In the end, the decision to set up a POL or use a reference lab is based on a review of the advantages and disadvantages, finding a balance of what is best for both the patients' interest and the practice's long-term stability.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"Testing_and_associated_reporting\">Testing and associated reporting<\/span><\/h2>\n<p>CLIA lays out seven criteria for determining the complexity of a test, including the origin of the test.<sup id=\"rdp-ebb-cite_ref-CDCTestCom_10-0\" class=\"reference\"><a href=\"#cite_note-CDCTestCom-10\" rel=\"external_link\">[10]<\/a><\/sup> For example, if a new test is developed or an existing test is modified, and then it's used at that laboratory, the test is automatically rated a high-complexity test.<sup id=\"rdp-ebb-cite_ref-CDCTestCom_10-1\" class=\"reference\"><a href=\"#cite_note-CDCTestCom-10\" rel=\"external_link\">[10]<\/a><\/sup> The complexity of the test determines the requirements the laboratory needs to comply with in order to maintain regulatory compliance. The more complex the test is, the stricter the requirements are.<sup id=\"rdp-ebb-cite_ref-CDCTestCom_10-2\" class=\"reference\"><a href=\"#cite_note-CDCTestCom-10\" rel=\"external_link\">[10]<\/a><\/sup>\n<\/p><p>Test complexity has three levels: high, moderate, and waived. Waived tests are simple to perform and have a relatively low risk of an incorrect test result.<sup id=\"rdp-ebb-cite_ref-CDCTestCom_10-3\" class=\"reference\"><a href=\"#cite_note-CDCTestCom-10\" rel=\"external_link\">[10]<\/a><\/sup> Moderately complex tests include tests like provider performed microscopy (PPM), which requires the use of a microscope during the office visit.<sup id=\"rdp-ebb-cite_ref-CDCTestCom_10-4\" class=\"reference\"><a href=\"#cite_note-CDCTestCom-10\" rel=\"external_link\">[10]<\/a><\/sup> Providers that want to perform PPM tests must be qualified to do so under CLIA regulations.<sup id=\"rdp-ebb-cite_ref-CDCTestCom_10-5\" class=\"reference\"><a href=\"#cite_note-CDCTestCom-10\" rel=\"external_link\">[10]<\/a><\/sup>\n<\/p><p>High-complexity tests require the most regulation. These tests are the most complicated and run the highest risk of an inaccurate result, as determined during the FDA pre-market approval process.<sup id=\"rdp-ebb-cite_ref-CDCTestCom_10-6\" class=\"reference\"><a href=\"#cite_note-CDCTestCom-10\" rel=\"external_link\">[10]<\/a><\/sup> Tests may come from the manufacturer with their complexity level on them, or one can search the FDA database to determine the complexity of the test.<sup id=\"rdp-ebb-cite_ref-CDCTestCom_10-7\" class=\"reference\"><a href=\"#cite_note-CDCTestCom-10\" rel=\"external_link\">[10]<\/a><\/sup> It is important to understand the complexity level of the testing provided in order to ensure full compliance with CLIA.\n<\/p><p>Commonly performed tests, according to the United Healthcare guide, include<sup id=\"rdp-ebb-cite_ref-UHOxInOffice_2-1\" class=\"reference\"><a href=\"#cite_note-UHOxInOffice-2\" rel=\"external_link\">[2]<\/a><\/sup>:\n<\/p>\n<ul><li> urine analysis<\/li>\n<li> urine pregnancy<\/li>\n<li> blood occult<\/li>\n<li> glucose blood<\/li>\n<li> pathology consultation during surgery<\/li>\n<li> crystal identification by microscope<\/li>\n<li> sperm identification and analyses<\/li>\n<li> bilirubin total<\/li>\n<li> blood gasses<\/li>\n<li> complete blood count<\/li>\n<li> bone marrow smear<\/li>\n<li> blood bank services<\/li>\n<li> transfusion medicine<\/li><\/ul>\n<p>Reimbursement levels for tests are dependent upon the reimbursement guide put out by the individual insurance company. Billing personnel in POL-related offices are ultimately responsible for finding out what the reimbursement is and which tests are permitted for the POL's level of certification.\n<\/p><p>As noted, the predominant form of testing in the POL is waived complexity testing. See Table 1 in <a href=\"#Appendix\" rel=\"external_link\">the appendix<\/a> for the complete list of waived tests as of May 2014.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Reporting\">Reporting<\/span><\/h3>\n<p>Just as POLs manage a set of commonly performed tests, a set of corresponding reports provides the results of those tests. The results will pass through a set of validation and quality control checks (discussed in section 8.2) before being fashioned into a final report for the ordering physician. For example, if a complete blood count is ordered by the physician, a corresponding patient report is produced by the laboratory, often through a <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_information_system\" title=\"Laboratory information system\" target=\"_blank\" class=\"wiki-link\" data-key=\"37add65b4d1c678b382a7d4817a9cf64\">laboratory information system<\/a> (LIS). The patient report contains patient, physician, and sample demographics, as well as the results and whether they are above, below, or within recommended limits. Other types of reports may be generated in the laboratory, including daily summary, test total, and various quality control reports.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"Staffing_and_certification_requirements_for_the_POL\">Staffing and certification requirements for the POL<\/span><\/h2>\n<p>Regulatory requirements regarding laboratory staff vary depending upon the level of testing performed and the state the POL is operating in, and due diligence is required to ensure the POL is meeting those requirements. The previous section noted most POLs perform waived tests, and as such, this section focuses on the requirements for staffing a CLIA waiver-certified laboratory. Typically these labs operate only during office hours, and therefore they do not have 24\/7 staffing.\n<\/p><p>The highest level of laboratory management is typically the person holding the title of laboratory director. Laboratory directors are responsible for the administration and operations of the laboratory, including the hiring of all personnel and ensuring testing procedures are done in the correct manner.<sup id=\"rdp-ebb-cite_ref-AAFPDirDuties_11-0\" class=\"reference\"><a href=\"#cite_note-AAFPDirDuties-11\" rel=\"external_link\">[11]<\/a><\/sup> For the waiver-certified laboratory, anyone may be a laboratory director; however, the Joint Commission recommends laboratory directors meet the same minimum requirements of those testing in moderately complex laboratories.<sup id=\"rdp-ebb-cite_ref-Olea12_12-0\" class=\"reference\"><a href=\"#cite_note-Olea12-12\" rel=\"external_link\">[12]<\/a><\/sup> Some states require the laboratory director of a moderately complex laboratory to be state-licensed and also to be a medical doctor or hold a degree in a laboratory science, such as chemistry.<sup id=\"rdp-ebb-cite_ref-AAFPPersReqs_13-0\" class=\"reference\"><a href=\"#cite_note-AAFPPersReqs-13\" rel=\"external_link\">[13]<\/a><\/sup>\n<\/p><p>In general, the laboratory staff of a POL may consist of the laboratory director and a mix of laboratory technicians, laboratory technologists, laboratory clinical consultants, and, in some cases, a laboratory manager. The presence of some of these roles may vary, dependent upon if the laboratory is certified for waived, moderately complex, or highly complex testing. Additional educational qualifications and certifications for the laboratory technician, histotechnician, laboratory director, and other staff members may exist based on the lab's complexity level. Directors should check state requirements for the type of lab in question to ensure full compliance.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"Regulatory_requirements_and_considerations\">Regulatory requirements and considerations<\/span><\/h2>\n<p>When setting up a POL, the proprietor is faced with individual state, local, and federal regulations to ensure full compliance. (This guide is no substitute.) Three key regulations were chosen for discussion in this guide: the <a href=\"https:\/\/www.limswiki.org\/index.php\/Clinical_Laboratory_Improvement_Amendments\" title=\"Clinical Laboratory Improvement Amendments\" target=\"_blank\" class=\"wiki-link\" data-key=\"64bdae1dc17c40c28e0c560396a6ae35\">Clinical Laboratory Improvement Amendments<\/a> (CLIA), the <a href=\"https:\/\/www.limswiki.org\/index.php\/Health_Insurance_Portability_and_Accountability_Act\" title=\"Health Insurance Portability and Accountability Act\" target=\"_blank\" class=\"wiki-link\" data-key=\"b70673a0117c21576016cb7498867153\">Health Insurance Portability and Accountability Act<\/a> (HIPAA), and the Patient Protection and Affordable Care Act (PPACA). These regulations were chosen because they are the most common \u2014 and most important \u2014 to affect the POL and the physician office.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"CLIA\">CLIA<\/span><\/h3>\n<p>The most impactful regulation for the physician office laboratory at the time of this writing was CLIA. The U.S. federal statute was implemented in 1988 to remove obsolete laboratory requirements and include new requirements to improve the quality of a modern clinical laboratory. \n<\/p><p>As previously noted, most POLs are CLIA waiver labs, and therefore much like the previous section, the discussion here is mostly centered on those requirements. Waived tests have a low risk of an incorrect result; this includes the tests the Food and Drug Administration (FDA) has approved for consumers to use in their homes.<sup id=\"rdp-ebb-cite_ref-CDCTestCom_10-8\" class=\"reference\"><a href=\"#cite_note-CDCTestCom-10\" rel=\"external_link\">[10]<\/a><\/sup> Tests performed under this provision are done at laboratories that have registered as required by CLIA and obtained a certificate of waiver. These labs are not inspected on a routine basis like labs certified to perform moderate- and high-complexity testing. Laboratories that wish to change their status from waived to one of the other statuses must comply with the CLIA requirements for registration, inspection, and proficiency testing as outlined in the law.<sup id=\"rdp-ebb-cite_ref-CDCTestCom_10-9\" class=\"reference\"><a href=\"#cite_note-CDCTestCom-10\" rel=\"external_link\">[10]<\/a><\/sup> Waived laboratory staff, as previously mentioned, does not require proficiency testing, and anyone can be qualified to be the laboratory director.<sup id=\"rdp-ebb-cite_ref-CDCTestCom_10-10\" class=\"reference\"><a href=\"#cite_note-CDCTestCom-10\" rel=\"external_link\">[10]<\/a><\/sup>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"HIPAA\">HIPAA<\/span><\/h3>\n<p>POLs are required to comply with HIPAA and must provide safeguards for the security and privacy of the data collected and maintained in the laboratory. HIPAA passed in 1996 in an attempt to provide better guidance regarding the privacy and security of data, portability of health insurance, and better accountability for violations related to these topics. Laboratories are required to implement measures that prevent the unauthorized disclosure and access to data in the laboratory. \n<\/p><p>Prior to 2014, most laboratories were exempt from the HIPAA requirement to provide patients with lab results or other protected health information.<sup id=\"rdp-ebb-cite_ref-HHS14_14-0\" class=\"reference\"><a href=\"#cite_note-HHS14-14\" rel=\"external_link\">[14]<\/a><\/sup> However, in February 2014, the <a href=\"https:\/\/www.limswiki.org\/index.php\/United_States_Department_of_Health_and_Human_Services\" title=\"United States Department of Health and Human Services\" target=\"_blank\" class=\"wiki-link\" data-key=\"efa106bcbb93039b1a6c3c596daedec3\">Department of Health and Human Services<\/a> wanted to provide patients the opportunity to become better members of their own care team by giving them more information about their health.<sup id=\"rdp-ebb-cite_ref-HHS14_14-1\" class=\"reference\"><a href=\"#cite_note-HHS14-14\" rel=\"external_link\">[14]<\/a><\/sup> This resulted in the amendment of CLIA 1988 to require a laboratory to give a patient, or their designated representative, lab results within 30 days of said individual sending a written request.<sup id=\"rdp-ebb-cite_ref-HHS14_14-2\" class=\"reference\"><a href=\"#cite_note-HHS14-14\" rel=\"external_link\">[14]<\/a><\/sup> Laboratories are still required to ensure those accessing this data have authorization to do so, as the original requirements to keep data secure and private remain the same. \n<\/p><p>The annual cost of compliance with this new rule is estimated to be $59 million over the first five years when examining the potential cost to the laboratory industry in general.<sup id=\"rdp-ebb-cite_ref-Conn14_15-0\" class=\"reference\"><a href=\"#cite_note-Conn14-15\" rel=\"external_link\">[15]<\/a><\/sup> Laboratories like Quest Diagnostics support the rule because it will allow them to give patients their lab results without prior approval from the patient\u2019s provider.<sup id=\"rdp-ebb-cite_ref-Conn14_15-1\" class=\"reference\"><a href=\"#cite_note-Conn14-15\" rel=\"external_link\">[15]<\/a><\/sup>\n<\/p><p>As of this writing, it remains unclear as to how this impacts the POL. Since the POL is located at the physician office, access to results is most likely determined by the provider\u2019s regular procedures for acquiring personal health information (PHI). The POL could provide forms to patients for release of PHI, just as any other lab can, but it is unclear as to how this rule change will impact the POL in the long term.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"PPACA\">PPACA<\/span><\/h3>\n<p>As of this writing, the most difficult regulation to assess is the Patient Protection and Affordable Care Act, also known as the ACA. This does not negate the obligations of the laboratory under CLIA and HIPAA. According to the Clinical Laboratory Coalition, laboratory testing informs about 70% of a clinician\u2019s medical decision-making process. However, the laboratory comprises less than two percent of Medicare spending.<sup id=\"rdp-ebb-cite_ref-CLC12_16-0\" class=\"reference\"><a href=\"#cite_note-CLC12-16\" rel=\"external_link\">[16]<\/a><\/sup> \n<\/p>\n<blockquote><i>The Patient Protection and Affordable Care Act (PPACA) included a direct cut to the Medicare Clinical Laboratory Fee Schedule of 1.75 percent each year for 5 years. This 9 percent cut is the largest cut among all Part B providers and started in 2011. In PPACA, clinical laboratories also received another cut in the form of a productivity adjustment, resulting in an additional 11 percent cut over 10 years.<\/i><br \/> <br \/>\n<i>The laboratory-specific cut and the productivity adjustment will already result in a cumulative 20 percent cut over 10 years. Laboratories are also facing up to a 2 percent cut to the fee schedule as a result of sequestration, which begins in January 2013.<sup id=\"rdp-ebb-cite_ref-CLC12_16-1\" class=\"reference\"><a href=\"#cite_note-CLC12-16\" rel=\"external_link\">[16]<\/a><\/sup><\/i><\/blockquote>\n<p>The laboratory space in general may face challenges from the accountable care organization (ACO) model under the PPACA, due to a decrease in laboratory testing volume.<sup id=\"rdp-ebb-cite_ref-HughesCamm_17-0\" class=\"reference\"><a href=\"#cite_note-HughesCamm-17\" rel=\"external_link\">[17]<\/a><\/sup> Under the ACO model, unnecessary or redundant testing would be discouraged.<sup id=\"rdp-ebb-cite_ref-HughesCamm_17-1\" class=\"reference\"><a href=\"#cite_note-HughesCamm-17\" rel=\"external_link\">[17]<\/a><\/sup> This could be a good thing for the POL market, as waived testing would be done in-house, close to the patient. It could also be a problem for the POL market, as physicians may need to recalculate if operating a POL makes economic sense for their practice.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"Economic_considerations\">Economic considerations<\/span><\/h2>\n<p>Economics are very important to any aspect of the medical practice. This is also true for the POL. Four economic considerations should be made regarding the POL: profitability and stability, insurance reimbursements, billing, and return on investment (ROI). For example, at the end of the previous section, the economics surrounding the PPACA were discussed. Other considerations would include things like assessing financial penalties for non-compliance.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Profitability_and_sustainability_of_the_POL\">Profitability and sustainability of the POL<\/span><\/h3>\n<p>Maintaining a profitable and sustainable lab is important. This is why the ROI calculation is provided in section 7.4 for examination. Performing this calculation can help determine how long it will take the lab to become profitable and if it will be sustainable over time. Like most parts of a business, the laboratory becomes profitable by collecting more revenue than it is putting out in expenses. \n<\/p>\n<h3><span class=\"mw-headline\" id=\"Insurance_reimbursements\">Insurance reimbursements<\/span><\/h3>\n<p>Insurance reimbursements vary by insurance company and plan. Checking with the insurance companies and plans accepted by the POL is advised; these numbers often change, as required by regulations or insurance company needs. It is important to keep current on this subject. Failing to do so can result in less reimbursement than one is expecting. If the reimbursement for a test is cut from $25 to $5, and one fails to keep current with reimbursements from the insurance providers, the shock could ripple through the laboratory or provider practice.\n<\/p><p>The April 2014 passage of the \u201cDoc Fix,\u201d a one-year protection of the Sustainable Growth Rate (SGR) Medicare physician payment formula, saved providers from this type of shock<sup id=\"rdp-ebb-cite_ref-HIMSS14_18-0\" class=\"reference\"><a href=\"#cite_note-HIMSS14-18\" rel=\"external_link\">[18]<\/a><\/sup>, as without this legislation providers were set to experience a 30% reduction in their reimbursement rates.<sup id=\"rdp-ebb-cite_ref-CLC12_16-2\" class=\"reference\"><a href=\"#cite_note-CLC12-16\" rel=\"external_link\">[16]<\/a><\/sup> Laboratory personnel, especially billing personnel, would be wise to keep up with trends in this area.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Billing\">Billing<\/span><\/h3>\n<p>Billing requires medical codes such as the <a href=\"https:\/\/www.limswiki.org\/index.php\/International_Statistical_Classification_of_Diseases_and_Related_Health_Problems\" title=\"International Statistical Classification of Diseases and Related Health Problems\" target=\"_blank\" class=\"wiki-link\" data-key=\"1de9af67005dfe2895e5d8cf6de57d4a\">International Classification of Disease<\/a>, Ninth Version, Clinical Modification (ICD-9-CM) codes, soon to be ICD-10-CM codes, as well as procedure codes from either the Current Procedural Terminology (CPT) codes or the Healthcare Common Procedure Coding System (HCPCS). Logical Observation Identifiers Names and Codes (LOINC) may also be used, but mapping to another code set such as CPT is more common. Ordering physician, patient name, medical record number (MRN), and other demographic information may also appear on billing. Laboratory-specific information such as CLIA certification number and modifications indicating whether the test is CLIA-waived are also present.\n<\/p><p>Laboratory billing for Medicare went through an important simplification process in 2003, to allow for a more standardized process and to eliminate confusion office staff was experiencing in their attempts to comply with billing rules.<sup id=\"rdp-ebb-cite_ref-BakerMcKenzie_19-0\" class=\"reference\"><a href=\"#cite_note-BakerMcKenzie-19\" rel=\"external_link\">[19]<\/a><\/sup> The rules changed the billing for 23 laboratory tests that cover nearly two-thirds of all laboratory testing.<sup id=\"rdp-ebb-cite_ref-BakerMcKenzie_19-1\" class=\"reference\"><a href=\"#cite_note-BakerMcKenzie-19\" rel=\"external_link\">[19]<\/a><\/sup>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Return_on_investment\">Return on investment<\/span><\/h3>\n<p>The return on investment (ROI) metric is important to the POL. An example of ROI in action is when someone invests in a stock and gets 10% of the money back every year; the 10% would be the ROI from a purely financial standpoint. The formula for an ROI calculation is listed below:\n<\/p>\n<dl><dd><i>Simple ROI = Financial Gain\/Total Investment<\/i><\/dd><\/dl>\n<dl><dd><i>Discounted ROI = Net Present Value of Benefits\/Total Present Value of Costs<\/i><sup id=\"rdp-ebb-cite_ref-ITEcoCorp_20-0\" class=\"reference\"><a href=\"#cite_note-ITEcoCorp-20\" rel=\"external_link\">[20]<\/a><\/sup><\/dd><\/dl>\n<p>The Simple ROI calculation is primarily used for short-term calculations related to an investment of one year or less, while the Discounted ROI is more accurate for long-term analysis and calculations.<sup id=\"rdp-ebb-cite_ref-ITEcoCorp_20-1\" class=\"reference\"><a href=\"#cite_note-ITEcoCorp-20\" rel=\"external_link\">[20]<\/a><\/sup>\n<\/p><p>The factors included in the ROI calculation will vary, depending on the type of calculation. The Simple ROI, for example, only examines financial gain divided by total investment amount. The person using this formula would say, after gaining $110,000 by investing $100,000, their ROI is 110%.\n<\/p><p>Before performing either calculation, it is important to measure current performance and then measure performance again after the investment.\n<\/p><p>The POL example below uses the IT Economics Corporation ROI calculation formula<sup id=\"rdp-ebb-cite_ref-ITEcoCorp_20-2\" class=\"reference\"><a href=\"#cite_note-ITEcoCorp-20\" rel=\"external_link\">[20]<\/a><\/sup>:\n<\/p><p><b>Simple ROI calculation for Fein and Douglas Associates' POL<\/b>\n<\/p><p><b>Year 1<\/b>\n<\/p><p><i>$100,000 benefit to the practice - $100,000 outlay of resources to establish the lab = $0 net savings divided by $100,000 outlay of resources, yielding a Simple ROI of 0%<\/i>\n<\/p><p><b>Year 2<\/b>\n<\/p><p><i>$400,000 benefit to the practice - $100,000 outlay of resources to maintain the laboratory = $300,000 net savings divided by $100,000 outlay of resources, yielding a Simple ROI of 300%<\/i>\n<\/p><p><b>Year 3<\/b>\n<\/p><p><i>$700,000 benefit to the practice - $100,000 outlay of resources to maintain the laboratory = $600,000 net savings divided by $100,000 outlay of resources, yielding a Simple ROI of 600%.<\/i>\n<\/p><p>The Simple ROI calculation becomes less accurate as time goes on, because it does not take into account any discounting for the value of money or other assets impacted by time, such as equipment depreciation.\n<\/p><p>The Discounted ROI methodology takes into account a dollar received in 1988 is worth more than one received in 2008. It is more complicated than the Simple ROI, as it requires calculating the present value of costs and benefits, and it also requires knowing the organization discount rate. The organization CFO is typically the best person to contact for that information.\n<\/p><p>Note how taking the same laboratory and performing a Discounted ROI calculation shows a more accurate result, as seen below<sup id=\"rdp-ebb-cite_ref-ITEcoCorp_20-3\" class=\"reference\"><a href=\"#cite_note-ITEcoCorp-20\" rel=\"external_link\">[20]<\/a><\/sup>:\n<\/p><p><b>Discounted ROI calculation for Fein and Douglas Associates' POL<\/b>\n<\/p><p>For this example, the assumption of an average 6% discount rate was used.\n<\/p><p><b>Year 1<\/b>\n<\/p><p>Present Value (PV) of Benefits: $100,000 received at the end of year 1 = $94,340\n<\/p><p>PV of Costs: $100,000 paid at the end of year 1 = $94,340\n<\/p><p><i>$94,340 PV of benefits to the practice - $94,340 PV of costs to establish the lab = $0 Net PV of benefits divided by $94,340 PV of costs, yielding a Discounted ROI of 0%<\/i>\n<\/p><p>Note how the Simple ROI and the Discounted ROI calculation are the same during the first year due to the cost and benefits all occurring the same year and at the same time.\n<\/p><p><b>Year 2<\/b>\n<\/p><p>Present Value (PV) of Benefits: $100,000 received at the end of year 1 = $94,340; PV of another $300,000 received at the end of year 2 = $267,000; Net PV of Benefits for year 2 thus = $361,340\n<\/p><p>PV of Costs: $100,000 paid at the end of year 2 = $94,340\n<\/p><p><i>$361,340 PV of benefits to the practice - $94,340 PV of costs to maintain the lab = $267,000 Net PV of benefits divided by $94,340 PV of costs, yielding a Discounted ROI of 283%<\/i>\n<\/p><p>Note how the Simple ROI for year 2 was 300%, a full 17% greater than the discounted ROI.\n<\/p><p><b>Year 3<\/b>\n<\/p><p>Present Value (PV) of Benefits: $100,000 received at the end of year 1 = $94,340; PV of another $300,000 received at the end of year 2 = $267,000; PV of another $300,000 received at the end of year 3 = $251,886; Net PV of Benefits for year 3 thus = $613,226\n<\/p><p>PV of Costs: $100,000 paid at the end of year 3 = $94,340\n<\/p><p><i>$613,226 PV of benefits to the practice - $94,340 PV of costs to maintain the lab = $518,886 Net PV of benefits divided by $94,340 PV of costs, yielding a Discounted ROI of 550%<\/i>\n<\/p><p>Discounted ROI at the end of year 3 is 550%, not the 600% shown by the Simple ROI calculation. In this case the overage is 50% in year 3, as opposed to 17% in year 2. The Simple ROI calculation becomes less accurate as future years increase, which means that by year four, the overage would be greater than 50%.<sup id=\"rdp-ebb-cite_ref-ITEcoCorp_20-4\" class=\"reference\"><a href=\"#cite_note-ITEcoCorp-20\" rel=\"external_link\">[20]<\/a><\/sup>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"Managing_data_and_test_results\">Managing data and test results<\/span><\/h2>\n<p>Data management in the physician office laboratory has six important aspects to it:\n<\/p>\n<ul><li> Overall workflow<\/li>\n<li> Order entry<\/li>\n<li> Testing, including associated results and reports<\/li>\n<li> Quality control<\/li>\n<li> Integration with instruments and software<\/li>\n<li> Integration with external reference laboratory results<\/li><\/ul>\n<p>In any modern laboratory, the common way to integrate data and workflow across the enterprise is through a data management system.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Data_management_systems_and_test_workflow\">Data management systems and test workflow<\/span><\/h3>\n<p>From a basic clinical and research laboratory perspective, there are two common data management systems to choose from: a <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_information_system\" title=\"Laboratory information system\" target=\"_blank\" class=\"wiki-link\" data-key=\"37add65b4d1c678b382a7d4817a9cf64\">laboratory information system<\/a> (LIS) and a <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_information_management_system\" title=\"Laboratory information management system\" target=\"_blank\" class=\"wiki-link\" data-key=\"8ff56a51d34c9b1806fcebdcde634d00\">laboratory information management system<\/a> (LIMS). Generally speaking, a LIS will be found more often in a clinical laboratory like the POL, whereas a LIMS will be more common in a research laboratory.<sup id=\"rdp-ebb-cite_ref-Friedman08_21-0\" class=\"reference\"><a href=\"#cite_note-Friedman08-21\" rel=\"external_link\">[21]<\/a><\/sup>\n<\/p><p>The functionality is slightly different between the LIS and LIMS. The LIS tends to be more patient-centric, exhibiting features that focus on subjects and specimens, while the LIMS tends to be more group-centric, focusing on batches and samples. Both of these systems may have the ability to interface with a <a href=\"https:\/\/www.limswiki.org\/index.php\/Hospital_information_system\" title=\"Hospital information system\" target=\"_blank\" class=\"wiki-link\" data-key=\"d8385de7b1f39a39d793f8ce349b448d\">hospital information system<\/a> (HIS), <a href=\"https:\/\/www.limswiki.org\/index.php\/Electronic_health_record\" title=\"Electronic health record\" target=\"_blank\" class=\"wiki-link\" data-key=\"f2e31a73217185bb01389404c1fd5255\">electronic health record<\/a> (EHR), <a href=\"https:\/\/www.limswiki.org\/index.php\/Practice_management_system\" title=\"Practice management system\" class=\"mw-redirect wiki-link\" target=\"_blank\" data-key=\"516084c210e06b685bdbf2959ed0a6ae\">practice management system<\/a> (PMS), or other types of systems commonly found in healthcare settings.\n<\/p><p>Overall, workflow was discussed in a previous section, but just to refresh the reader's mind, here is the chart again:\n<br \/> <br \/>\n<\/p>\n<dl><dd><b>POL workflow<\/b>:<br \/><\/dd><\/dl>\n<p><a href=\"https:\/\/www.limswiki.org\/index.php\/File:POLWorkflow.png\" class=\"image wiki-link\" target=\"_blank\" data-key=\"2e8f48b2ca3e3eb8cdcee2c3d559bf69\"><img alt=\"POLWorkflow.png\" src=\"https:\/\/www.limswiki.org\/images\/3\/3d\/POLWorkflow.png\" style=\"width: 100%;max-width: 400px;height: auto;\" \/><\/a>\n<\/p><p>Notice the flow starts with the doctor ordering the test and ends with the discussion of options with the patient. POL workflow may vary depending upon specialty, but the steps identified in this guide are the most common. Each part of the workflow is important and dependent upon the other. Without a doctor order, it does not matter if the specimen is collected and sent to the lab. Without a specimen to test, the rest of this workflow is unable to proceed. \n<\/p><p>Since the first step is a doctor ordering the test, it is important to understand how the order entry component of a LIS operates. Each vendor will have a slightly different display, but the process is typically the same. The doctor enters the order for the test, often through a drop-down menu of tests in the patient's chart through the provider's EHR system. The LIS integrates to the EHR, allowing the laboratory staff to receive the order to collect the samples, perform the tests, and then transfer the results back into the EHR record for the physician to review, often in the form of a <a href=\"https:\/\/www.limswiki.org\/index.php\/LIS_feature#Custom_reporting\" title=\"LIS feature\" target=\"_blank\" class=\"wiki-link\" data-key=\"646d2dfb81e2f917268b05b7a068d39d\">report<\/a>. If the physician is not using an electronic system, then this process begins with a written or printed order and finishes with a written or printed report of the results for the patient file.\n<\/p><p>Many LIS vendors will custom configure the system with tests, including reference ranges for the POL as part of the purchase agreement. These interfaces will often have a drop-down menu as well, so that the person performing the test can select the test and compare the sample result to the reference range for that particular test.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Quality_control\">Quality control<\/span><\/h3>\n<p>Aside from workflow, order entry, testing, and reporting, another important aspect of managing data is <a href=\"https:\/\/www.limswiki.org\/index.php\/LIS_feature#QA.2FQC_functions\" title=\"LIS feature\" target=\"_blank\" class=\"wiki-link\" data-key=\"47bc2def1727b39e330a321323ca99d0\">quality control<\/a> (QC), which allows the handler of the data to ensure it still meets the definition of quality data. In healthcare informatics, quality data is defined as data that is clear, complete, relevant, timely, and accurate in presentation.<sup id=\"rdp-ebb-cite_ref-WHO03_22-0\" class=\"reference\"><a href=\"#cite_note-WHO03-22\" rel=\"external_link\">[22]<\/a><\/sup>\n<\/p><p>Prior to the use of computers, the entire process of <a href=\"https:\/\/www.limswiki.org\/index.php\/Informatics_(academic_field)\" title=\"Informatics (academic field)\" target=\"_blank\" class=\"wiki-link\" data-key=\"0391318826a5d9f9a1a1bcc88394739f\">informatics<\/a> involved paper records. In many cases, these records were handwritten, requiring personnel to read the handwriting of others in order to assess the quality of the data provided.<sup id=\"rdp-ebb-cite_ref-Sinard06_23-0\" class=\"reference\"><a href=\"#cite_note-Sinard06-23\" rel=\"external_link\">[23]<\/a><\/sup> Resistance to using a computer for laboratory tasks typically comes from a belief that the old ways are better; however, in most cases the computer can greatly aid in the prevention of errors.<sup id=\"rdp-ebb-cite_ref-Sinard06_23-1\" class=\"reference\"><a href=\"#cite_note-Sinard06-23\" rel=\"external_link\">[23]<\/a><\/sup>\n<\/p><p>LIS and LIMS vendors often include a variety of quality control functions in their software. QC tests can be run on specimens, quality control charts and reports can be created, proficiency testing functions can be implemented, and certificates of analysis (COAs) can be produced.<sup id=\"rdp-ebb-cite_ref-HullWrayEtAl_24-0\" class=\"reference\"><a href=\"#cite_note-HullWrayEtAl-24\" rel=\"external_link\">[24]<\/a><\/sup>\n<\/p><p>It's worth noting, though, the use of computers and information management systems does not completely rule out error. For example, the drop-down menu still allows users to select either the wrong test or a test that looks for the same result but is less effective than another test.<sup id=\"rdp-ebb-cite_ref-Sinard06_23-2\" class=\"reference\"><a href=\"#cite_note-Sinard06-23\" rel=\"external_link\">[23]<\/a><\/sup> These types of errors are more often than not controlled in a system where the laboratory personnel are knowledgeable about testing and are able to educate the ordering physician on such matters.<sup id=\"rdp-ebb-cite_ref-Sinard06_23-3\" class=\"reference\"><a href=\"#cite_note-Sinard06-23\" rel=\"external_link\">[23]<\/a><\/sup>\n<\/p><p>Other business processes can benefit from quality control measures, such as the application of Lean Six Sigma \u2014 an approach to reducing waste and limiting defects in a process \u2014 to the laboratory. It is important to examine the needs of the laboratory to ensure appropriate quality control techniques are implemented.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Integration_with_instruments_and_software\">Integration with instruments and software<\/span><\/h3>\n<p>Since workflow is the single most important consideration in the design of the LIS<sup id=\"rdp-ebb-cite_ref-Sinard06_23-4\" class=\"reference\"><a href=\"#cite_note-Sinard06-23\" rel=\"external_link\">[23]<\/a><\/sup>, it is important it allows instruments and other software to <a href=\"https:\/\/www.limswiki.org\/index.php\/LIS_feature#Instrument_interfacing_and_management\" title=\"LIS feature\" target=\"_blank\" class=\"wiki-link\" data-key=\"7f2d7a1f94d82fdd1d60f467fb261e9e\">interface<\/a>. These interfaces are generally done using standard communication processes and systems, as well as messaging formats, like <a href=\"https:\/\/www.limswiki.org\/index.php\/Health_Level_7\" title=\"Health Level 7\" target=\"_blank\" class=\"wiki-link\" data-key=\"e0bf845fb58d2bae05a846b47629e86f\">Health Level 7<\/a> (HL7).<sup id=\"rdp-ebb-cite_ref-Sinard06_23-5\" class=\"reference\"><a href=\"#cite_note-Sinard06-23\" rel=\"external_link\">[23]<\/a><\/sup>\n<\/p><p>While the majority of POLs do waived testing, and those simple tests don't often require advanced equipment, interfacing a data management system may not be a concern. But for those POLs that employ <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_automation\" title=\"Laboratory automation\" target=\"_blank\" class=\"wiki-link\" data-key=\"0061880849aeaca05f8aa27ae171f331\">laboratory automation<\/a>, the ability of the equipment to talk to the LIS is vital, often using HL7.\n<\/p>\n<blockquote><i>The types of information communicated between these systems include process control and status information for each device or analyzer, each specimen, specimen container, and container carrier, information and detailed data related to patients, orders, and results, and information related to specimen flow algorithms and automated decision making.<\/i><sup id=\"rdp-ebb-cite_ref-HL711_25-0\" class=\"reference\"><a href=\"#cite_note-HL711-25\" rel=\"external_link\">[25]<\/a><\/sup><\/blockquote>\n<p>A software interface between the LIS and the EHR is often referred to as a result interface, and it typically uses the HL7 messaging protocol and standard communication protocols like TCP\/IP. These interfaces are not turn-key, however, requiring a comprehensive planning and implementation process.<sup id=\"rdp-ebb-cite_ref-Kasoff12_26-0\" class=\"reference\"><a href=\"#cite_note-Kasoff12-26\" rel=\"external_link\">[26]<\/a><\/sup> After a successful implementation, the interface allows information from a completed test to be reported back to the EHR, where the physician can readily obtain a copy of the patient test report. It can also allow for billing batches and admission\/discharge\/transfer (ADT) reporting. These same interfaces can be used for communicating with other reference laboratories, in addition to the various hospital systems.<sup id=\"rdp-ebb-cite_ref-Sinard06_23-6\" class=\"reference\"><a href=\"#cite_note-Sinard06-23\" rel=\"external_link\">[23]<\/a><\/sup>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"Getting_help_with_your_POL\">Getting help with your POL<\/span><\/h2>\n<p>It is important those involved with the POL know where to get help when issues arise. Often, the first call goes to the <a href=\"https:\/\/www.limswiki.org\/index.php\/Category:Vendors\" title=\"Category:Vendors\" target=\"_blank\" class=\"wiki-link\" data-key=\"b8cfb65763011b9bc454f7b22f586995\">vendor<\/a> of the software, instruments, testing supplies, and other products and services the laboratory utilizes. If the vendor is unable to assist, consultants may prove to be a valuable asset to the POL. Consultants can help staff sort through regulatory compliance, financial planning, systems planning, and laboratory design. Consultants can also assist with filling the gap between a vendor support agreement and the need of the POL, if such a gap exists in the contract.\n<\/p><p>Another route for support with your POL may be a professional organization or trade association. The American College of Physicians, for example, provides numerous printable resources to practices. The American Society for Clinical Laboratory Science offers professional development courses, educational courses, and certification help to its members. \n<\/p><p>A directory of consultants, organizations, and other tools is available as an <a href=\"#Addendum\" rel=\"external_link\">addendum<\/a> to this guide.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"Conclusion\">Conclusion<\/span><\/h2>\n<p>POLs have existed in various forms since the beginning of medicine. With accountable care organizations (ACO), patient-centered medical homes, direct-to-consumer laboratory testing, and telemedicine, an increased opportunity exists for laboratory medicine to be added to practices. Laboratory medicine influences 70% of all medical decisions, and the POL allows the physician to get results faster than having to send out for testing at a reference laboratory. \n<\/p><p>The decision to operate (or continue operating) a POL is an important one not to be entered into lightly. Owners must consider regulatory compliance, business processes, technology choices, and economic considerations. However, while a daunting task, ultimately choosing to operate a POL may prove to be a rewarding experience.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<ol class=\"references\">\n<li id=\"cite_note-NYSPOL-1\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-NYSPOL_1-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">New York State Department of Health, Wadsworth Center (2014). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.wadsworth.org\/labcert\/polep\/\" target=\"_blank\">\"Physician Office Laboratory Evaluation Program (POLEP)\"<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.wadsworth.org\/labcert\/polep\/\" target=\"_blank\">http:\/\/www.wadsworth.org\/labcert\/polep\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 May 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Physician+Office+Laboratory+Evaluation+Program+%28POLEP%29&rft.atitle=&rft.aulast=New+York+State+Department+of+Health%2C+Wadsworth+Center&rft.au=New+York+State+Department+of+Health%2C+Wadsworth+Center&rft.date=2014&rft_id=http%3A%2F%2Fwww.wadsworth.org%2Flabcert%2Fpolep%2F&rfr_id=info:sid\/en.wikipedia.org:LII:The_Practical_Guide_to_the_U.S._Physician_Office_Laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-UHOxInOffice-2\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-UHOxInOffice_2-0\" rel=\"external_link\">2.0<\/a><\/sup> <sup><a href=\"#cite_ref-UHOxInOffice_2-1\" rel=\"external_link\">2.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">UnitedHealthcare Oxford (01 July 2012). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oxhp.com\/secure\/policy\/oxfords_in_office_laboratory_testing_and_procedures_list.pdf\" target=\"_blank\">\"Oxford's in-office laboratory testing and procedures list\"<\/a> (PDF)<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.oxhp.com\/secure\/policy\/oxfords_in_office_laboratory_testing_and_procedures_list.pdf\" target=\"_blank\">https:\/\/www.oxhp.com\/secure\/policy\/oxfords_in_office_laboratory_testing_and_procedures_list.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 May 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Oxford%27s+in-office+laboratory+testing+and+procedures+list&rft.atitle=&rft.aulast=UnitedHealthcare+Oxford&rft.au=UnitedHealthcare+Oxford&rft.date=01+July+2012&rft_id=https%3A%2F%2Fwww.oxhp.com%2Fsecure%2Fpolicy%2Foxfords_in_office_laboratory_testing_and_procedures_list.pdf&rfr_id=info:sid\/en.wikipedia.org:LII:The_Practical_Guide_to_the_U.S._Physician_Office_Laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-BergerP1-3\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-BergerP1_3-0\" rel=\"external_link\">3.00<\/a><\/sup> <sup><a href=\"#cite_ref-BergerP1_3-1\" rel=\"external_link\">3.01<\/a><\/sup> <sup><a href=\"#cite_ref-BergerP1_3-2\" rel=\"external_link\">3.02<\/a><\/sup> <sup><a href=\"#cite_ref-BergerP1_3-3\" rel=\"external_link\">3.03<\/a><\/sup> <sup><a href=\"#cite_ref-BergerP1_3-4\" rel=\"external_link\">3.04<\/a><\/sup> <sup><a href=\"#cite_ref-BergerP1_3-5\" rel=\"external_link\">3.05<\/a><\/sup> <sup><a href=\"#cite_ref-BergerP1_3-6\" rel=\"external_link\">3.06<\/a><\/sup> <sup><a href=\"#cite_ref-BergerP1_3-7\" rel=\"external_link\">3.07<\/a><\/sup> <sup><a href=\"#cite_ref-BergerP1_3-8\" rel=\"external_link\">3.08<\/a><\/sup> <sup><a href=\"#cite_ref-BergerP1_3-9\" rel=\"external_link\">3.09<\/a><\/sup> <sup><a href=\"#cite_ref-BergerP1_3-10\" rel=\"external_link\">3.10<\/a><\/sup> <sup><a href=\"#cite_ref-BergerP1_3-11\" rel=\"external_link\">3.11<\/a><\/sup> <sup><a href=\"#cite_ref-BergerP1_3-12\" rel=\"external_link\">3.12<\/a><\/sup> <sup><a href=\"#cite_ref-BergerP1_3-13\" rel=\"external_link\">3.13<\/a><\/sup> <sup><a href=\"#cite_ref-BergerP1_3-14\" rel=\"external_link\">3.14<\/a><\/sup> <sup><a href=\"#cite_ref-BergerP1_3-15\" rel=\"external_link\">3.15<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Berger, D. (July 1999). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.academia.dk\/Blog\/wp-content\/uploads\/KlinLab-Hist\/LabHistory1.pdf\" target=\"_blank\">\"A brief history of medical diagnosis and the birth of the clinical laboratory: Part 1\u2014Ancient times through the 19th century\"<\/a> (PDF). <i>Medical Laboratory Observer<\/i> <b>31<\/b> (7): 28\u201330, 32, 34\u201340<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.academia.dk\/Blog\/wp-content\/uploads\/KlinLab-Hist\/LabHistory1.pdf\" target=\"_blank\">http:\/\/www.academia.dk\/Blog\/wp-content\/uploads\/KlinLab-Hist\/LabHistory1.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 May 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=A+brief+history+of+medical+diagnosis+and+the+birth+of+the+clinical+laboratory%3A+Part+1%E2%80%94Ancient+times+through+the+19th+century&rft.jtitle=Medical+Laboratory+Observer&rft.aulast=Berger%2C+D.&rft.au=Berger%2C+D.&rft.date=July+1999&rft.volume=31&rft.issue=7&rft.pages=28%E2%80%9330%2C+32%2C+34%E2%80%9340&rft_id=http%3A%2F%2Fwww.academia.dk%2FBlog%2Fwp-content%2Fuploads%2FKlinLab-Hist%2FLabHistory1.pdf&rfr_id=info:sid\/en.wikipedia.org:LII:The_Practical_Guide_to_the_U.S._Physician_Office_Laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-BergerP2-4\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-BergerP2_4-0\" rel=\"external_link\">4.0<\/a><\/sup> <sup><a href=\"#cite_ref-BergerP2_4-1\" rel=\"external_link\">4.1<\/a><\/sup> <sup><a href=\"#cite_ref-BergerP2_4-2\" rel=\"external_link\">4.2<\/a><\/sup> <sup><a href=\"#cite_ref-BergerP2_4-3\" rel=\"external_link\">4.3<\/a><\/sup> <sup><a href=\"#cite_ref-BergerP2_4-4\" rel=\"external_link\">4.4<\/a><\/sup> <sup><a href=\"#cite_ref-BergerP2_4-5\" rel=\"external_link\">4.5<\/a><\/sup> <sup><a href=\"#cite_ref-BergerP2_4-6\" rel=\"external_link\">4.6<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Berger, D. (August 1999). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.academia.dk\/Blog\/wp-content\/uploads\/KlinLab-Hist\/LabHistory2.pdf\" target=\"_blank\">\"A brief history of medical diagnosis and the birth of the clinical laboratory: Part 2\u2014Laboratory science and professional certification in the 20th century\"<\/a> (PDF). <i>Medical Laboratory Observer<\/i> <b>31<\/b> (8): 32\u201334, 36, 38<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.academia.dk\/Blog\/wp-content\/uploads\/KlinLab-Hist\/LabHistory2.pdf\" target=\"_blank\">http:\/\/www.academia.dk\/Blog\/wp-content\/uploads\/KlinLab-Hist\/LabHistory2.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 May 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=A+brief+history+of+medical+diagnosis+and+the+birth+of+the+clinical+laboratory%3A+Part+2%E2%80%94Laboratory+science+and+professional+certification+in+the+20th+century&rft.jtitle=Medical+Laboratory+Observer&rft.aulast=Berger%2C+D.&rft.au=Berger%2C+D.&rft.date=August+1999&rft.volume=31&rft.issue=8&rft.pages=32%E2%80%9334%2C+36%2C+38&rft_id=http%3A%2F%2Fwww.academia.dk%2FBlog%2Fwp-content%2Fuploads%2FKlinLab-Hist%2FLabHistory2.pdf&rfr_id=info:sid\/en.wikipedia.org:LII:The_Practical_Guide_to_the_U.S._Physician_Office_Laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-BergerP3-5\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-BergerP3_5-0\" rel=\"external_link\">5.0<\/a><\/sup> <sup><a href=\"#cite_ref-BergerP3_5-1\" rel=\"external_link\">5.1<\/a><\/sup> <sup><a href=\"#cite_ref-BergerP3_5-2\" rel=\"external_link\">5.2<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Berger, D. (October 1999). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.academia.dk\/Blog\/wp-content\/uploads\/KlinLab-Hist\/LabHistory3.pdf\" target=\"_blank\">\"A brief history of medical diagnosis and the birth of the clinical laboratory: Part 3\u2014Medicare, government regulation and competency certification\"<\/a> (PDF). <i>Medical Laboratory Observer<\/i> <b>31<\/b> (10): 40\u201342, 44<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.academia.dk\/Blog\/wp-content\/uploads\/KlinLab-Hist\/LabHistory3.pdf\" target=\"_blank\">http:\/\/www.academia.dk\/Blog\/wp-content\/uploads\/KlinLab-Hist\/LabHistory3.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 May 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=A+brief+history+of+medical+diagnosis+and+the+birth+of+the+clinical+laboratory%3A+Part+3%E2%80%94Medicare%2C+government+regulation+and+competency+certification&rft.jtitle=Medical+Laboratory+Observer&rft.aulast=Berger%2C+D.&rft.au=Berger%2C+D.&rft.date=October+1999&rft.volume=31&rft.issue=10&rft.pages=40%E2%80%9342%2C+44&rft_id=http%3A%2F%2Fwww.academia.dk%2FBlog%2Fwp-content%2Fuploads%2FKlinLab-Hist%2FLabHistory3.pdf&rfr_id=info:sid\/en.wikipedia.org:LII:The_Practical_Guide_to_the_U.S._Physician_Office_Laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-HHS89-6\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-HHS89_6-0\" rel=\"external_link\">6.0<\/a><\/sup> <sup><a href=\"#cite_ref-HHS89_6-1\" rel=\"external_link\">6.1<\/a><\/sup> <sup><a href=\"#cite_ref-HHS89_6-2\" rel=\"external_link\">6.2<\/a><\/sup> <sup><a href=\"#cite_ref-HHS89_6-3\" rel=\"external_link\">6.3<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Kusserow, R. P. (March 1989). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/oig.hhs.gov\/oei\/reports\/oai-05-88-00330.pdf\" target=\"_blank\"><i>Quality assurance in physician office labs<\/i><\/a>. OAI-0588-00330. U.S. Department of Health and Human Services, Office of Analysis and Inspections<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/oig.hhs.gov\/oei\/reports\/oai-05-88-00330.pdf\" target=\"_blank\">https:\/\/oig.hhs.gov\/oei\/reports\/oai-05-88-00330.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 May 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Quality+assurance+in+physician+office+labs&rft.aulast=Kusserow%2C+R.+P.&rft.au=Kusserow%2C+R.+P.&rft.date=March+1989&rft.series=OAI-0588-00330&rft.pub=U.S.+Department+of+Health+and+Human+Services%2C+Office+of+Analysis+and+Inspections&rft_id=https%3A%2F%2Foig.hhs.gov%2Foei%2Freports%2Foai-05-88-00330.pdf&rfr_id=info:sid\/en.wikipedia.org:LII:The_Practical_Guide_to_the_U.S._Physician_Office_Laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-Bachman04-7\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-Bachman04_7-0\" rel=\"external_link\">7.0<\/a><\/sup> <sup><a href=\"#cite_ref-Bachman04_7-1\" rel=\"external_link\">7.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Bachman, A. (2004). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/laboratory-manager.advanceweb.com\/Article\/Prosperity-in-the-POL.aspx\" target=\"_blank\">\"Prosperity in the POL\"<\/a> (PDF). <i>ADVANCE for Administrators of the Laboratory<\/i> <b>13<\/b> (12): 66<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/laboratory-manager.advanceweb.com\/Article\/Prosperity-in-the-POL.aspx\" target=\"_blank\">http:\/\/laboratory-manager.advanceweb.com\/Article\/Prosperity-in-the-POL.aspx<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 May 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Prosperity+in+the+POL&rft.jtitle=ADVANCE+for+Administrators+of+the+Laboratory&rft.aulast=Bachman%2C+A.&rft.au=Bachman%2C+A.&rft.date=2004&rft.volume=13&rft.issue=12&rft.pages=66&rft_id=http%3A%2F%2Flaboratory-manager.advanceweb.com%2FArticle%2FProsperity-in-the-POL.aspx&rfr_id=info:sid\/en.wikipedia.org:LII:The_Practical_Guide_to_the_U.S._Physician_Office_Laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-CMS13LabTypes-8\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CMS13LabTypes_8-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Centers for Medicare and Medicaid Services, Division of Laboratory Services (December 2013). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cms.gov\/Regulations-and-Guidance\/Legislation\/CLIA\/downloads\/factype.pdf\" target=\"_blank\">\"Laboratories by type of facility\"<\/a> (PDF)<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cms.gov\/Regulations-and-Guidance\/Legislation\/CLIA\/downloads\/factype.pdf\" target=\"_blank\">https:\/\/www.cms.gov\/Regulations-and-Guidance\/Legislation\/CLIA\/downloads\/factype.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 May 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Laboratories+by+type+of+facility&rft.atitle=&rft.aulast=Centers+for+Medicare+and+Medicaid+Services%2C+Division+of+Laboratory+Services&rft.au=Centers+for+Medicare+and+Medicaid+Services%2C+Division+of+Laboratory+Services&rft.date=December+2013&rft_id=https%3A%2F%2Fwww.cms.gov%2FRegulations-and-Guidance%2FLegislation%2FCLIA%2Fdownloads%2Ffactype.pdf&rfr_id=info:sid\/en.wikipedia.org:LII:The_Practical_Guide_to_the_U.S._Physician_Office_Laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-CMS13Enroll-9\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CMS13Enroll_9-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Centers for Medicare and Medicaid Services, Division of Laboratory Services (December 2013). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.cms.gov\/Regulations-and-Guidance\/Legislation\/CLIA\/Downloads\/statupda.pdf\" target=\"_blank\">\"Enrollment, CLIA exempt states, and certification of accreditation by organization\"<\/a> (PDF)<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.cms.gov\/Regulations-and-Guidance\/Legislation\/CLIA\/Downloads\/statupda.pdf\" target=\"_blank\">http:\/\/www.cms.gov\/Regulations-and-Guidance\/Legislation\/CLIA\/Downloads\/statupda.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 May 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Enrollment%2C+CLIA+exempt+states%2C+and+certification+of+accreditation+by+organization&rft.atitle=&rft.aulast=Centers+for+Medicare+and+Medicaid+Services%2C+Division+of+Laboratory+Services&rft.au=Centers+for+Medicare+and+Medicaid+Services%2C+Division+of+Laboratory+Services&rft.date=December+2013&rft_id=http%3A%2F%2Fwww.cms.gov%2FRegulations-and-Guidance%2FLegislation%2FCLIA%2FDownloads%2Fstatupda.pdf&rfr_id=info:sid\/en.wikipedia.org:LII:The_Practical_Guide_to_the_U.S._Physician_Office_Laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-CDCTestCom-10\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-CDCTestCom_10-0\" rel=\"external_link\">10.00<\/a><\/sup> <sup><a href=\"#cite_ref-CDCTestCom_10-1\" rel=\"external_link\">10.01<\/a><\/sup> <sup><a href=\"#cite_ref-CDCTestCom_10-2\" rel=\"external_link\">10.02<\/a><\/sup> <sup><a href=\"#cite_ref-CDCTestCom_10-3\" rel=\"external_link\">10.03<\/a><\/sup> <sup><a href=\"#cite_ref-CDCTestCom_10-4\" rel=\"external_link\">10.04<\/a><\/sup> <sup><a href=\"#cite_ref-CDCTestCom_10-5\" rel=\"external_link\">10.05<\/a><\/sup> <sup><a href=\"#cite_ref-CDCTestCom_10-6\" rel=\"external_link\">10.06<\/a><\/sup> <sup><a href=\"#cite_ref-CDCTestCom_10-7\" rel=\"external_link\">10.07<\/a><\/sup> <sup><a href=\"#cite_ref-CDCTestCom_10-8\" rel=\"external_link\">10.08<\/a><\/sup> <sup><a href=\"#cite_ref-CDCTestCom_10-9\" rel=\"external_link\">10.09<\/a><\/sup> <sup><a href=\"#cite_ref-CDCTestCom_10-10\" rel=\"external_link\">10.10<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Centers for Disease Control and Prevention (31 May 2013). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/wwwn.cdc.gov\/clia\/Resources\/TestComplexities.aspx\" target=\"_blank\">\"Clinical Laboratory Improvement Amendments (CLIA): Test complexities\"<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/wwwn.cdc.gov\/clia\/Resources\/TestComplexities.aspx\" target=\"_blank\">http:\/\/wwwn.cdc.gov\/clia\/Resources\/TestComplexities.aspx<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 May 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Clinical+Laboratory+Improvement+Amendments+%28CLIA%29%3A+Test+complexities&rft.atitle=&rft.aulast=Centers+for+Disease+Control+and+Prevention&rft.au=Centers+for+Disease+Control+and+Prevention&rft.date=31+May+2013&rft_id=http%3A%2F%2Fwwwn.cdc.gov%2Fclia%2FResources%2FTestComplexities.aspx&rfr_id=info:sid\/en.wikipedia.org:LII:The_Practical_Guide_to_the_U.S._Physician_Office_Laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-AAFPDirDuties-11\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-AAFPDirDuties_11-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">American Academy of Family Physicians (2014). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.aafp.org\/practice-management\/regulatory\/clia\/pol-director-duties.html\" target=\"_blank\">\"Physician office laboratory (POL) director duties\"<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.aafp.org\/practice-management\/regulatory\/clia\/pol-director-duties.html\" target=\"_blank\">http:\/\/www.aafp.org\/practice-management\/regulatory\/clia\/pol-director-duties.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 May 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Physician+office+laboratory+%28POL%29+director+duties&rft.atitle=&rft.aulast=American+Academy+of+Family+Physicians&rft.au=American+Academy+of+Family+Physicians&rft.date=2014&rft_id=http%3A%2F%2Fwww.aafp.org%2Fpractice-management%2Fregulatory%2Fclia%2Fpol-director-duties.html&rfr_id=info:sid\/en.wikipedia.org:LII:The_Practical_Guide_to_the_U.S._Physician_Office_Laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-Olea12-12\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-Olea12_12-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Olea, S. (2012). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.jointcommission.org\/assets\/1\/18\/CLIA_required_personnel_qualifications.pdf\" target=\"_blank\">\"CLIA required personnel qualifications\"<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.jointcommission.org\/assets\/1\/18\/CLIA_required_personnel_qualifications.pdf\" target=\"_blank\">http:\/\/www.jointcommission.org\/assets\/1\/18\/CLIA_required_personnel_qualifications.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 May 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=CLIA+required+personnel+qualifications&rft.atitle=&rft.aulast=Olea%2C+S.&rft.au=Olea%2C+S.&rft.date=2012&rft_id=http%3A%2F%2Fwww.jointcommission.org%2Fassets%2F1%2F18%2FCLIA_required_personnel_qualifications.pdf&rfr_id=info:sid\/en.wikipedia.org:LII:The_Practical_Guide_to_the_U.S._Physician_Office_Laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-AAFPPersReqs-13\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-AAFPPersReqs_13-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">American Academy of Family Physicians (2014). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.aafp.org\/practice-management\/regulatory\/clia\/personnel.html\" target=\"_blank\">\"Personnel requirements\"<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.aafp.org\/practice-management\/regulatory\/clia\/personnel.html\" target=\"_blank\">http:\/\/www.aafp.org\/practice-management\/regulatory\/clia\/personnel.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 May 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Personnel+requirements&rft.atitle=&rft.aulast=American+Academy+of+Family+Physicians&rft.au=American+Academy+of+Family+Physicians&rft.date=2014&rft_id=http%3A%2F%2Fwww.aafp.org%2Fpractice-management%2Fregulatory%2Fclia%2Fpersonnel.html&rfr_id=info:sid\/en.wikipedia.org:LII:The_Practical_Guide_to_the_U.S._Physician_Office_Laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-HHS14-14\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-HHS14_14-0\" rel=\"external_link\">14.0<\/a><\/sup> <sup><a href=\"#cite_ref-HHS14_14-1\" rel=\"external_link\">14.1<\/a><\/sup> <sup><a href=\"#cite_ref-HHS14_14-2\" rel=\"external_link\">14.2<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">U.S. Department of Health and Human Services (03 February 2014). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.hhs.gov\/news\/press\/2014pres\/02\/20140203a.html\" target=\"_blank\">\"HHS strengthens patients' right to access lab test reports\"<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.hhs.gov\/news\/press\/2014pres\/02\/20140203a.html\" target=\"_blank\">http:\/\/www.hhs.gov\/news\/press\/2014pres\/02\/20140203a.html<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=HHS+strengthens+patients%27+right+to+access+lab+test+reports&rft.atitle=&rft.aulast=U.S.+Department+of+Health+and+Human+Services&rft.au=U.S.+Department+of+Health+and+Human+Services&rft.date=03+February+2014&rft_id=http%3A%2F%2Fwww.hhs.gov%2Fnews%2Fpress%2F2014pres%2F02%2F20140203a.html&rfr_id=info:sid\/en.wikipedia.org:LII:The_Practical_Guide_to_the_U.S._Physician_Office_Laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-Conn14-15\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-Conn14_15-0\" rel=\"external_link\">15.0<\/a><\/sup> <sup><a href=\"#cite_ref-Conn14_15-1\" rel=\"external_link\">15.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Conn, J. (03 February 2014). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.modernhealthcare.com\/article\/20140203\/NEWS\/302039958\" target=\"_blank\">\"HHS issues rule granting patients direct access to lab test results\"<\/a>. Modern Healthcare<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.modernhealthcare.com\/article\/20140203\/NEWS\/302039958\" target=\"_blank\">http:\/\/www.modernhealthcare.com\/article\/20140203\/NEWS\/302039958<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 May 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=HHS+issues+rule+granting+patients+direct+access+to+lab+test+results&rft.atitle=&rft.aulast=Conn%2C+J.&rft.au=Conn%2C+J.&rft.date=03+February+2014&rft.pub=Modern+Healthcare&rft_id=http%3A%2F%2Fwww.modernhealthcare.com%2Farticle%2F20140203%2FNEWS%2F302039958&rfr_id=info:sid\/en.wikipedia.org:LII:The_Practical_Guide_to_the_U.S._Physician_Office_Laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-CLC12-16\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-CLC12_16-0\" rel=\"external_link\">16.0<\/a><\/sup> <sup><a href=\"#cite_ref-CLC12_16-1\" rel=\"external_link\">16.1<\/a><\/sup> <sup><a href=\"#cite_ref-CLC12_16-2\" rel=\"external_link\">16.2<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Clinical Laboratory Coalition (2012). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.aab.org\/images\/aab\/SGR%20Fix%202012%20Talking%20Points.pdf\" target=\"_blank\">\"Protect access to laboratory services for Medicare beneficiaries\"<\/a> (PDF)<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.aab.org\/images\/aab\/SGR%20Fix%202012%20Talking%20Points.pdf\" target=\"_blank\">http:\/\/www.aab.org\/images\/aab\/SGR%20Fix%202012%20Talking%20Points.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 May 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Protect+access+to+laboratory+services+for+Medicare+beneficiaries&rft.atitle=&rft.aulast=Clinical+Laboratory+Coalition&rft.au=Clinical+Laboratory+Coalition&rft.date=2012&rft_id=http%3A%2F%2Fwww.aab.org%2Fimages%2Faab%2FSGR%2520Fix%25202012%2520Talking%2520Points.pdf&rfr_id=info:sid\/en.wikipedia.org:LII:The_Practical_Guide_to_the_U.S._Physician_Office_Laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-HughesCamm-17\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-HughesCamm_17-0\" rel=\"external_link\">17.0<\/a><\/sup> <sup><a href=\"#cite_ref-HughesCamm_17-1\" rel=\"external_link\">17.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Hughes, D.; Cammarata, B. (16 January 2014). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.law360.com\/articles\/500623\/clinical-labs-under-aca-challenge-and-opportunity\" target=\"_blank\">\"Clinical labs under ACA: Challenge and opportunity\"<\/a>. Law360<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.law360.com\/articles\/500623\/clinical-labs-under-aca-challenge-and-opportunity\" target=\"_blank\">http:\/\/www.law360.com\/articles\/500623\/clinical-labs-under-aca-challenge-and-opportunity<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 May 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Clinical+labs+under+ACA%3A+Challenge+and+opportunity&rft.atitle=&rft.aulast=Hughes%2C+D.%3B+Cammarata%2C+B.&rft.au=Hughes%2C+D.%3B+Cammarata%2C+B.&rft.date=16+January+2014&rft.pub=Law360&rft_id=http%3A%2F%2Fwww.law360.com%2Farticles%2F500623%2Fclinical-labs-under-aca-challenge-and-opportunity&rfr_id=info:sid\/en.wikipedia.org:LII:The_Practical_Guide_to_the_U.S._Physician_Office_Laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-HIMSS14-18\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-HIMSS14_18-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">HIMSS (01 April 2014). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.himss.org\/News\/NewsDetail.aspx?ItemNumber=28914\" target=\"_blank\">\"After passage by Congress, President signs SGR \"Doc Fix\" & ICD-10 delay\"<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.himss.org\/News\/NewsDetail.aspx?ItemNumber=28914\" target=\"_blank\">http:\/\/www.himss.org\/News\/NewsDetail.aspx?ItemNumber=28914<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 May 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=After+passage+by+Congress%2C+President+signs+SGR+%22Doc+Fix%22+%26+ICD-10+delay&rft.atitle=&rft.aulast=HIMSS&rft.au=HIMSS&rft.date=01+April+2014&rft_id=http%3A%2F%2Fwww.himss.org%2FNews%2FNewsDetail.aspx%3FItemNumber%3D28914&rfr_id=info:sid\/en.wikipedia.org:LII:The_Practical_Guide_to_the_U.S._Physician_Office_Laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-BakerMcKenzie-19\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-BakerMcKenzie_19-0\" rel=\"external_link\">19.0<\/a><\/sup> <sup><a href=\"#cite_ref-BakerMcKenzie_19-1\" rel=\"external_link\">19.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Baker, B.; McKenzie, C. (December 2013). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.acpinternist.org\/archives\/2003\/12\/baker.htm\" target=\"_blank\">\"Recent CMS lab test standards simplify billing rules\"<\/a>. ACP Observer<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.acpinternist.org\/archives\/2003\/12\/baker.htm\" target=\"_blank\">http:\/\/www.acpinternist.org\/archives\/2003\/12\/baker.htm<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 May 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Recent+CMS+lab+test+standards+simplify+billing+rules&rft.atitle=&rft.aulast=Baker%2C+B.%3B+McKenzie%2C+C.&rft.au=Baker%2C+B.%3B+McKenzie%2C+C.&rft.date=December+2013&rft.pub=ACP+Observer&rft_id=http%3A%2F%2Fwww.acpinternist.org%2Farchives%2F2003%2F12%2Fbaker.htm&rfr_id=info:sid\/en.wikipedia.org:LII:The_Practical_Guide_to_the_U.S._Physician_Office_Laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-ITEcoCorp-20\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-ITEcoCorp_20-0\" rel=\"external_link\">20.0<\/a><\/sup> <sup><a href=\"#cite_ref-ITEcoCorp_20-1\" rel=\"external_link\">20.1<\/a><\/sup> <sup><a href=\"#cite_ref-ITEcoCorp_20-2\" rel=\"external_link\">20.2<\/a><\/sup> <sup><a href=\"#cite_ref-ITEcoCorp_20-3\" rel=\"external_link\">20.3<\/a><\/sup> <sup><a href=\"#cite_ref-ITEcoCorp_20-4\" rel=\"external_link\">20.4<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">IT Economics Corporation (2010). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/iteconcorp.com\/ROICalc.html\" target=\"_blank\">\"Computing the ROI for IT projects and other investments\"<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/iteconcorp.com\/ROICalc.html\" target=\"_blank\">http:\/\/iteconcorp.com\/ROICalc.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 May 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Computing+the+ROI+for+IT+projects+and+other+investments&rft.atitle=&rft.aulast=IT+Economics+Corporation&rft.au=IT+Economics+Corporation&rft.date=2010&rft_id=http%3A%2F%2Fiteconcorp.com%2FROICalc.html&rfr_id=info:sid\/en.wikipedia.org:LII:The_Practical_Guide_to_the_U.S._Physician_Office_Laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-Friedman08-21\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-Friedman08_21-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Friedman, B. (04 November 2008). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/labsoftnews.typepad.com\/lab_soft_news\/2008\/11\/liss-vs-limss-its-time-to-consider-merging-the-two-types-of-systems.html\" target=\"_blank\">\"LIS vs. LIMS: It's time to blend the two types of lab information systems\"<\/a>. Lab Soft News<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/labsoftnews.typepad.com\/lab_soft_news\/2008\/11\/liss-vs-limss-its-time-to-consider-merging-the-two-types-of-systems.html\" target=\"_blank\">http:\/\/labsoftnews.typepad.com\/lab_soft_news\/2008\/11\/liss-vs-limss-its-time-to-consider-merging-the-two-types-of-systems.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 May 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=LIS+vs.+LIMS%3A+It%27s+time+to+blend+the+two+types+of+lab+information+systems&rft.atitle=&rft.aulast=Friedman%2C+B.&rft.au=Friedman%2C+B.&rft.date=04+November+2008&rft.pub=Lab+Soft+News&rft_id=http%3A%2F%2Flabsoftnews.typepad.com%2Flab_soft_news%2F2008%2F11%2Fliss-vs-limss-its-time-to-consider-merging-the-two-types-of-systems.html&rfr_id=info:sid\/en.wikipedia.org:LII:The_Practical_Guide_to_the_U.S._Physician_Office_Laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-WHO03-22\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-WHO03_22-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">World Health Organization, Regional Office for the Western Pacific (2003). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.wpro.who.int\/publications\/docs\/Improving_Data_Quality.pdf\" target=\"_blank\">\"Data quality: A guide for developing countries\"<\/a>. World Health Organization<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.wpro.who.int\/publications\/docs\/Improving_Data_Quality.pdf\" target=\"_blank\">http:\/\/www.wpro.who.int\/publications\/docs\/Improving_Data_Quality.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 May 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Data+quality%3A+A+guide+for+developing+countries&rft.atitle=&rft.aulast=World+Health+Organization%2C+Regional+Office+for+the+Western+Pacific&rft.au=World+Health+Organization%2C+Regional+Office+for+the+Western+Pacific&rft.date=2003&rft.pub=World+Health+Organization&rft_id=http%3A%2F%2Fwww.wpro.who.int%2Fpublications%2Fdocs%2FImproving_Data_Quality.pdf&rfr_id=info:sid\/en.wikipedia.org:LII:The_Practical_Guide_to_the_U.S._Physician_Office_Laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-Sinard06-23\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-Sinard06_23-0\" rel=\"external_link\">23.0<\/a><\/sup> <sup><a href=\"#cite_ref-Sinard06_23-1\" rel=\"external_link\">23.1<\/a><\/sup> <sup><a href=\"#cite_ref-Sinard06_23-2\" rel=\"external_link\">23.2<\/a><\/sup> <sup><a href=\"#cite_ref-Sinard06_23-3\" rel=\"external_link\">23.3<\/a><\/sup> <sup><a href=\"#cite_ref-Sinard06_23-4\" rel=\"external_link\">23.4<\/a><\/sup> <sup><a href=\"#cite_ref-Sinard06_23-5\" rel=\"external_link\">23.5<\/a><\/sup> <sup><a href=\"#cite_ref-Sinard06_23-6\" rel=\"external_link\">23.6<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation book\">Sinard, J. (2006). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.springer.com\/medicine\/pathology\/book\/978-0-387-28057-8\" target=\"_blank\"><i>Practical pathology informatics: Demystifying informatics for the practicing anatomic pathologist<\/i><\/a>. Springer Science+Business Media. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" target=\"_blank\">ISBN<\/a> 9780387280585<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.springer.com\/medicine\/pathology\/book\/978-0-387-28057-8\" target=\"_blank\">http:\/\/www.springer.com\/medicine\/pathology\/book\/978-0-387-28057-8<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Practical+pathology+informatics%3A+Demystifying+informatics+for+the+practicing+anatomic+pathologist&rft.aulast=Sinard%2C+J.&rft.au=Sinard%2C+J.&rft.date=2006&rft.pub=Springer+Science%2BBusiness+Media&rft.isbn=9780387280585&rft_id=http%3A%2F%2Fwww.springer.com%2Fmedicine%2Fpathology%2Fbook%2F978-0-387-28057-8&rfr_id=info:sid\/en.wikipedia.org:LII:The_Practical_Guide_to_the_U.S._Physician_Office_Laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-HullWrayEtAl-24\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-HullWrayEtAl_24-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Hull, C.; Wray, B.; Winslow, F.; Villicich, M. (2011). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/21631414\" target=\"_blank\">\"Tracking and controlling everything that affects quality is the key to a quality management system\"<\/a>. <i>Combinatorial Chemistry & High Throughput Screening<\/i> <b>14<\/b> (9): 772\u2013780<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/21631414\" target=\"_blank\">http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/21631414<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 May 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Tracking+and+controlling+everything+that+affects+quality+is+the+key+to+a+quality+management+system&rft.jtitle=Combinatorial+Chemistry+%26+High+Throughput+Screening&rft.aulast=Hull%2C+C.%3B+Wray%2C+B.%3B+Winslow%2C+F.%3B+Villicich%2C+M.&rft.au=Hull%2C+C.%3B+Wray%2C+B.%3B+Winslow%2C+F.%3B+Villicich%2C+M.&rft.date=2011&rft.volume=14&rft.issue=9&rft.pages=772%E2%80%93780&rft_id=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fpubmed%2F21631414&rfr_id=info:sid\/en.wikipedia.org:LII:The_Practical_Guide_to_the_U.S._Physician_Office_Laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-HL711-25\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-HL711_25-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Health Level Seven International (2011). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.hl7.org\/implement\/standards\/product_brief.cfm?product_id=203\" target=\"_blank\">\"HL7 version 2.7 standard: Chapter 13 - Clinical laboratory automation\"<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.hl7.org\/implement\/standards\/product_brief.cfm?product_id=203\" target=\"_blank\">http:\/\/www.hl7.org\/implement\/standards\/product_brief.cfm?product_id=203<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 May 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=HL7+version+2.7+standard%3A+Chapter+13+-+Clinical+laboratory+automation&rft.atitle=&rft.aulast=Health+Level+Seven+International&rft.au=Health+Level+Seven+International&rft.date=2011&rft_id=http%3A%2F%2Fwww.hl7.org%2Fimplement%2Fstandards%2Fproduct_brief.cfm%3Fproduct_id%3D203&rfr_id=info:sid\/en.wikipedia.org:LII:The_Practical_Guide_to_the_U.S._Physician_Office_Laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-Kasoff12-26\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-Kasoff12_26-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Kasoff, J. (February 2012). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.mlo-online.com\/articles\/201202\/connecting-your-lis-and-ehr.php\" target=\"_blank\">\"Connecting your LIS and EHR\"<\/a>. Medical Laboratory Observer<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.mlo-online.com\/articles\/201202\/connecting-your-lis-and-ehr.php\" target=\"_blank\">http:\/\/www.mlo-online.com\/articles\/201202\/connecting-your-lis-and-ehr.php<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 May 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Connecting+your+LIS+and+EHR&rft.atitle=&rft.aulast=Kasoff%2C+J.&rft.au=Kasoff%2C+J.&rft.date=February+2012&rft.pub=Medical+Laboratory+Observer&rft_id=http%3A%2F%2Fwww.mlo-online.com%2Farticles%2F201202%2Fconnecting-your-lis-and-ehr.php&rfr_id=info:sid\/en.wikipedia.org:LII:The_Practical_Guide_to_the_U.S._Physician_Office_Laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<\/ol>\n<h2><span class=\"mw-headline\" id=\"Appendix\">Appendix<\/span><\/h2>\n<p><b>Table 1.<\/b> Tests Granted Waived Status under CLIA (This list includes updates from Change Request 8439.)\n<\/p>\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"5\" cellspacing=\"0\" style=\"width:50%\">\n\n<tr>\n<th colspan=\"1\" style=\"color:brown; background-color:#ffffee;\"> CPT Code(s)\n<\/th>\n<th colspan=\"1\" style=\"color:brown; background-color:#ffffee;\"> Test Name\n<\/th>\n<th colspan=\"1\" style=\"color:brown; background-color:#ffffee;\"> Manufacturer\n<\/th>\n<th colspan=\"1\" style=\"color:brown; background-color:#ffffee;\"> Use\n<\/th><\/tr>\n<tr>\n<td> <b>81002<\/b>\n<\/td>\n<td style=\"background-color:white;\">Dipstick or tablet reagent urinalysis \u2013 non-automated for bilirubin, glucose, hemoglobin, ketone, leukocytes, nitrite, pH, protein, specific gravity, and urobilinogen\n<\/td>\n<td style=\"background-color:white;\">Various\n<\/td>\n<td style=\"background-color:white;\">Screening of urine to monitor\/diagnose various diseases\/conditions, such as diabetes, the state of the kidney or urinary tract, and urinary tract infections\n<\/td><\/tr>\n<tr>\n<td> <b>81025<\/b>\n<\/td>\n<td style=\"background-color:white;\">Urine pregnancy tests by visual color comparison\n<\/td>\n<td style=\"background-color:white;\">Various\n<\/td>\n<td style=\"background-color:white;\">Diagnosis of pregnancy\n<\/td><\/tr>\n<tr>\n<td> <b>82270<br \/>82272<br \/>(Contact your Medicare carrier for claims instructions.)<\/b>\n<\/td>\n<td style=\"background-color:white;\">Fecal occult blood\n<\/td>\n<td style=\"background-color:white;\">Various\n<\/td>\n<td style=\"background-color:white;\">Detection of blood in feces from whatever cause, benign or malignant (colorectal cancer screening)\n<\/td><\/tr>\n<tr>\n<td> <b>82962<\/b>\n<\/td>\n<td style=\"background-color:white;\">Blood glucose by glucose monitoring devices cleared by the FDA for home use\n<\/td>\n<td style=\"background-color:white;\">Various\n<\/td>\n<td style=\"background-color:white;\">Monitoring of blood glucose levels\n<\/td><\/tr>\n<tr>\n<td> <b>83026<\/b>\n<\/td>\n<td style=\"background-color:white;\">Hemoglobin by copper sulfate \u2013 non-automated\n<\/td>\n<td style=\"background-color:white;\">Various\n<\/td>\n<td style=\"background-color:white;\">Monitors hemoglobin level in blood\n<\/td><\/tr>\n<tr>\n<td> <b>84830<\/b>\n<\/td>\n<td style=\"background-color:white;\">Ovulation tests by visual color comparison for human luteinizing hormone\n<\/td>\n<td style=\"background-color:white;\">Various\n<\/td>\n<td style=\"background-color:white;\">Detection of ovulation (optimal for conception)\n<\/td><\/tr>\n<tr>\n<td> <b>85013<\/b>\n<\/td>\n<td style=\"background-color:white;\">Blood count; spun microhematocrit\n<\/td>\n<td style=\"background-color:white;\">Various\n<\/td>\n<td style=\"background-color:white;\">Screen for anemia\n<\/td><\/tr>\n<tr>\n<td> <b>85651<\/b>\n<\/td>\n<td style=\"background-color:white;\">Erythrocyte sedimentation rate \u2013 non-automated\n<\/td>\n<td style=\"background-color:white;\">Various\n<\/td>\n<td style=\"background-color:white;\">Nonspecific screening test for inflammatory activity, increased for majority of infections, and most cases of carcinoma and leukemia\n<\/td><\/tr>\n<\/table>\n<p>(Recreated from <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.cms.gov\/Regulations-and-Guidance\/Legislation\/CLIA\/downloads\/waivetbl.pdf\" target=\"_blank\">http:\/\/www.cms.gov\/Regulations-and-Guidance\/Legislation\/CLIA\/downloads\/waivetbl.pdf<\/a>)\n<\/p>\n<h2><span class=\"mw-headline\" id=\"Addendum\">Addendum<\/span><\/h2>\n<p>As part of the \"Getting help with your POL\" section, an addendum to this white paper is included, containing information about conferences, consultants, organizations, and published materials that could potentially help those operating and working in a physician office laboratory. \n<\/p><p>You can find that content <a href=\"https:\/\/www.limswiki.org\/index.php\/LII:The_Practical_Guide_to_the_U.S._Physician_Office_Laboratory\/Addendum\" title=\"LII:The Practical Guide to the U.S. Physician Office Laboratory\/Addendum\" target=\"_blank\" class=\"wiki-link\" data-key=\"3014d4b95823af3dfa8474acd66bc62b\">on this page<\/a>.\n<\/p>\n<!-- \nNewPP limit report\nCached time: 20181213192741\nCache expiry: 86400\nDynamic content: false\nCPU time usage: 0.533 seconds\nReal time usage: 0.560 seconds\nPreprocessor visited node count: 16884\/1000000\nPreprocessor generated node count: 25969\/1000000\nPost\u2010expand include size: 112713\/2097152 bytes\nTemplate argument size: 43985\/2097152 bytes\nHighest expansion depth: 13\/40\nExpensive parser function count: 0\/100\n-->\n\n<!-- \nTransclusion expansion time report (%,ms,calls,template)\n100.00% 419.385 1 - -total\n 91.54% 383.904 26 - Template:Citation\/core\n 67.73% 284.038 19 - Template:Cite_web\n 23.64% 99.158 6 - Template:Cite_journal\n 7.76% 32.543 1 - Template:Cite_book\n 4.53% 19.009 26 - Template:Citation\/make_link\n 2.14% 8.957 1 - Template:Citation\/identifier\n 0.52% 2.184 1 - Template:Only_in_print\n 0.52% 2.177 2 - Template:Hide_in_print\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:4994-0!*!0!!en!5!* and timestamp 20181213192741 and revision id 21888\n -->\n<\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:The_Practical_Guide_to_the_U.S._Physician_Office_Laboratory\">https:\/\/www.limswiki.org\/index.php\/LII:The_Practical_Guide_to_the_U.S._Physician_Office_Laboratory<\/a><\/div>\n\t\t\t\t\t\t\t\t\t\t<!-- end content -->\n\t\t\t\t\t\t\t\t\t\t<div class=\"visualClear\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t<!-- end of the left (by default at least) column -->\n\t\t<div class=\"visualClear\"><\/div>\n\t\t\t\t\t\n\t\t<\/div>\n\t\t\n\n<\/body>","915c6acf5c1cc4fc5ecfaf557d1c1707_images":["https:\/\/www.limswiki.org\/images\/a\/ab\/NormWorkflow.png","https:\/\/www.limswiki.org\/images\/3\/3d\/POLWorkflow.png"],"915c6acf5c1cc4fc5ecfaf557d1c1707_timestamp":1544729261,"0655647b0091e0dd168f162b621a6cef_type":"article","0655647b0091e0dd168f162b621a6cef_title":"Physician office laboratory","0655647b0091e0dd168f162b621a6cef_url":"https:\/\/www.limswiki.org\/index.php\/Physician_office_laboratory","0655647b0091e0dd168f162b621a6cef_plaintext":"\n\n\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\n\t\t\t\tPhysician office laboratory\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\tFrom LIMSWiki\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\tJump to: navigation, search\n\n\t\t\t\t\t\n\t\t\t\t\t The early physician's laboratory was certainly more modest than the 21st-century POL.\nA physician office laboratory (POL) is a physician-, partnership-, or group-maintained laboratory that performs diagnostic tests or examines specimens in order to diagnose, prevent, and\/or treat a disease or impairment in a patient as part of the physician practice.[1][2] The POL shows up in primary care physician offices as well as the offices of specialists like urologists, hematologists, gynecologists, and endocrinologists. In many countries like the United States, the physician office laboratory is considered a clinical laboratory and is thus regulated by federal, state, and\/or local laws affecting such laboratories.[2][3]\n\nContents\n\n1 POL workflow \n2 Advantages and disadvantages of the POL \n3 POLs in the United States \n\n3.1 History \n\n3.1.1 1800s \n3.1.2 1900 to 1979 \n3.1.3 1980 to present \n\n\n3.2 Regulatory considerations \n\n3.2.1 CLIA \n3.2.2 HIPAA \n3.2.3 PPACA \n\n\n3.3 Testing and reporting \n\n\n4 POLs in other parts of the world \n5 Further reading \n6 References \n\n\n\nPOL workflow \nTypically, clinical laboratory workflow roughly works as such:\n\n The physician orders a lab test for a patient.\n A specimen is collected from the patient.\n The specimen is packaged and processed according to specifications.\n The specimen is delivered to a reference laboratory for testing.\n Tests are performed on the specimen as ordered.\n Results and analysis are reported back to the physician, who reviews them.\n The physician discusses the results and options with the patient.\nIf the workflow bypasses the reference lab in favor of an in-office physician laboratory:\n\n The physician orders a lab test for a patient.\n A specimen is collected from the patient.\n The specimen is sent over to the in-office laboratory.\n Tests are performed on the specimen as ordered.\n Results and analysis are reported back to the physician, who reviews them.\n The physician discusses the results and options with the patient.\nThe difference in these two workflows mostly comes down to the time spent in transporting the specimen to an outside lab and waiting for the processing. The in-office lab saves time in those parts of the process. This can be advantageous, as seen in the next section.\n\nAdvantages and disadvantages of the POL \nAdvantages include[4][5]: \n\n quicker access to test results for the clinician, leading to more treatment options for the patient; \n greater efficiency of the clinical workflow;\n cheaper testing, though subject to individual test and pricing information; and\n patient comfort and happiness, including time saved by having to go only to one location.\nDisadvantages include[4][5]: \n\n the physician office being the only point-of-access, with some physicians not willing to release patient information to an outside party (such as a hospital or competing clinician). This disadvantage may be eliminated due to regulatory changes in April of 2014, now allowing patients direct access to their laboratory results[6];\n patients not feeling comfortable about the physician's office being the central repository of information, and physicians may not see the value in having a lab in their practice; and\n the cost of meeting compliance requirements for local, state, and federal regulations, especially in states with stricter requirements. \nPOLs in the United States \nHistory \n1800s \n The urinalysis was commonly performed not only at the bedside but also in the physician office laboratory during the nineteenth century.\nThroughout the mid- to late 1800s, both the university and hospital laboratory played an important role in helping physicians diagnose disease[7][8][9], followed by the bedside care and analysis of the physician. However, the physician office laboratory also contributed to diagnoses, especially in the latter decades of the century.[9][10][11]\nWhether at the hospital lab, the bedside, or the physician office, the urinalysis was a common and important test utilized in diagnosing illness.[12] For the POL in particular, however, the 1890s brought more accessible tests like water examination, poisonous metals analysis, and tests for hypersecretion of hydrochloric acid in the stomach.[10][11][13] Equipment like a water incubating oven, microtome, sterilizer, pipettes, reagents, evaporating dish, centrifuge, and microscope were also more readily available to the physician running their own laboratory.[13][14][15][16]\n\n1900 to 1979 \nThe promotion and success of the physician office laboratory continued on into the first decade of the twentieth century, with most urban physicians able to perform analysis of urine, blood, sputum, and feces.[17][18] Yet the first two decades of the 1900s also saw the slow rise of the \"commercial laboratory,\" a privately- or group-held clinical pathology, chemical, or radiological lab that processed laboratory tests or chemical compounds ordered by a referring physician.[19][20] (Though the same idea, the term \"referral lab\" didn't begin to appear in medical literature regularly until the early 1950s and \"independent laboratory\" until the mid-1960s.[21][22][23] ) While some physicians \u2014 especially those in thriving urban areas \u2014 had a large enough clientele to invest in laboratory equipment and supplies for their own office, others in rural areas were less likely to be able to afford such luxuries. In the latter case, physicians were not able to as effectively provide a clinical diagnosis to their patients. These physicians had to either hope for connections at community regional hospitals to utilize the hospital laboratory (if they were even in reasonable distance or had the testing tools) or find some other means of sample testing.[24] Practitioners and businesspeople alike saw an opportunity for the commercial laboratory to fill those gaps.\nHowever, around the early 1920s, the push for or against the increasingly popular commercial laboratory became more noticeably vocal. Some physicians, specialists, and dentists complained heavily of the lack of quality standards, regulations, and ethics inherent in for-profit clinical, chemical, and radiological laboratories.[25][26][27][28] An alternative was at times proposed in the form of a state or local diagnostic lab or a referral-only \"clinic\" that could be well-equipped with professional tools, staff, and procedures, critical for rural areas and usable for more than just public health care diagnoses.[19][29] However, other medical professionals, while recognizing the need for more professional laboratory environments and more ethical advertising, dismissed those declaring the commercial laboratory as \"evil,\"[30] content to state those types of labs were needed and then fully entrenched in the health care environment.[19][27]\nThe for-profit clinical laboratory, however, would only garner minor prominence until the '70s and '80s. In the meantime, organizations like the American Society of Clinical Pathologists' (ASCP's) Board of Registry (1928) and the American Society of Medical Technologists (1932) began appearing to help promote higher standards in clinical laboratory standards, whether it be in the commercial laboratory, the hospital laboratory, or the physician's office.[31] [32] And with the ever-increasing variety of tests and associated equipment (as well as the demand for it), clinical laboratory practice continued to move out of the physicians office and into the hospital laboratory.[33][34][35][36] \nOn December 5, 1967, the U.S. enacted Public Law 90-174, which included in Section 5 the \"Clinical Laboratories Improvement Act of 1967.\" CLIA '67 set regulations on the licensing of clinical laboratories and the movement of samples in and out of them across state lines. Laboratories would be eligible for a full, partial, or exempt CLIA-67 license, depending on the laboratory's conducted tests.[37] However, CLIA '67 wasn't thorough, and only about 12,000 of nearly 200,000 U.S. laboratories were regulated. Physician office laboratories in particular were unaffected by the regulations.[38] Another attempt was made to place more clinical labs into the regulation net, with proposed but unsuccessful legislation in 1976 and 1977 that would have extended federal licensure to all hospital and independent laboratories. POLs again would have been exempted, requiring only participation in a federal proficiency testing program.[39]\nThe U.S. National Center for Health Statistics (NCHS) reported in its 1965 publication of Health Resources Statistics the following statistics for laboratories[40]:\n\n In 1958, around 6,500 to 7,000 hospitals labs employed roughly 45,000 to 50,000 personnel.\n In 1962, physician office laboratories employed roughly 25,000 to 30,000 personnel.[41]\n In 1962, around 2,000 independent\/commercial labs employed roughly 10,000 personnel.\nThe publication didn't mention the number of POLs in 1962. One could arguably assume hospital labs still outnumbered POLs that year. In the last year of its publication of Health Resources Statistics (1976\u20131977), the NCHS reported \"[t]he largest number of clinical laboratories are in the offices of private physicians, and the next largest number are in hospitals,[42]\" indicating a potential flip-flop in lab numbers over a period of nearly 15 years. The increase in POLs during the 1970s has been largely attributed to the technological development of small, affordable analyzers; more affordable office laboratory equipment; and the convenience associated with in-office testing.[43] \nThe 1976\u20131977 report is also notable for its focus on the \"independent clinical laboratory\" (the commercial clinical laboratory) as defined by Medicare, indicating an increase from 2,355 such labs in 1967 to 3,024 on January 1976.[42]\n\n1980 to present \nBetween 1983 and 1984 physician office testing increased by an estimated 11 percent, while the volume of physician-referred diagnostic tests to third-party labs declined 2 percent[44], likely buoyed by relatively inexpensive in-office laboratory equipment and more efficient drug monitoring capabilities.[45] The Deficit Reduction Act of 1984 further helped to increase the number of physician office laboratories by eliminating physicians' ability to mark up tests sent out to referral labs. Additional changes to Medicare reimbursement meant the laboratory that performed the tests got paid, while physicians were suddenly limited to a $3 payment per patient visit for collecting and distributing specimens. As physician laboratories were at that point still not regulated, physicians and equipment vendors alike saw an opportunity to expand physician office laboratory functions.[44] By the end of 1985, 10 percent of group practices with one to five physicians and 40 percent of those with six to 25 physicians were operating POLs.[46] In 1989, an estimated 98,400 POLs were operating in the United States, conducting roughly 25 percent of all laboratory testing in the country. Estimates from the time vary from 20,000 to 200,000 due to the lack of a standard definition for a POL and the need for physicians to self-report the status of their lab.[47] Some of these issues continue to persist today, as states often have different definitions for a POL.\nOn January 1, 1987, the Health Care Financing Administration ruled physicians must accept assignment for performed in-office Medicare lab testing, significantly cutting physician revenues. This, combined with plans from third-party to reduce POL payments and increased pressure on Congress to regulate POLs like other clinical laboratories, led to suggestions of physicians banding together into limited partnerships to start their own reference labs.[46] That pressure on Congress led to the signing into effect of the Clinical Laboratory Improvement Amendments (CLIA) on October 31, 1988.[48] Regulations for implementing CLIA continued to be developed afterwards, with the Department of Health and Human Services considering thousands of comments to the proposed regulations. The final regulations were published February 28, 1992, set to be effective on September 1 of the same year. The new CLIA regulations put into place regulations concerning test complexity, certification, proficiency testing, patient test management, personnel requirements, quality assurance, and other processes in the clinical laboratory, including physician office laboratories.[49] Additional controls were placed on POLs that year by the Stark Amendment, which sought to prohibit physician referrals of designated health services for Medicare and Medicaid patients if the physician or an immediate family member had a financial relationship with that entity.[50] \nBy 1993, some physicians running POLs were already protesting CLIA, stating the legislation imposed too many rules, regulations, and fees on physicians who perform any kind of in-office testing.[51][52] A mix of public commentary and internal consideration caused the effective date of CLIA for labs to be extended on several occasions afterwards: on December 6, 1994 in the Federal Register (59 FR 62606), May 12, 1997 in the Federal Register (62 FR 25855), October 14, 1998 in the Federal Register (63 FR 55031), and December 29, 2000 in the Federal Register (65 FR 82941).[53]\n\n\"The extensions allowed previously unregulated laboratories time to understand and implement these requirements. The extensions also provided the Department of Health and Human Services (HHS) additional time to issue revised QC requirements, review board certification program requests for approval, and ensure that laboratory directors with a doctoral degree had sufficient time to successfully complete the requirements for board certification.\"[53]\nSurveys conducted by Mathematica Policy Research in 1991 and again in 1995 provided data that suggested \"that CLIA '88 was primarily responsible for the reduction of in-office laboratory testing between 1991 and 1995. While more than 70% of practices surveyed have reduced or eliminated testing during this period, we found that a vast majority of those surveyed (64%) cited CLIA '88 as the force driving this change.\"[54] Yet by 2000, some physicians were still espousing the benefits of the POL despite the implementation of CLIA, stating that CLIA fees, proficiency testing fees, inspection fees, and staff time account for only roughly about three to four percent of overall lab costs.[4] However, a 2003 report from the College of American Pathologists found \"a small, slow drop-off in the POL market as some laboratories close or move to waived testing.[55]\" \nIn early 2011, researchers estimated the worldwide market for in vitro diagnostic (IVD) company sales from over 100 companies to POLs was valued at around $2.3 billion U.S.[56]\nIn July 2015, the Centers for Medicare and Medicaid Services (CMS) reported nearly half of all CLIA-certified laboratories in the United States (122,189) were physician office laboratories.[57] Additionally, 61.3% of the POLs in the United States today are running Clinical Laboratory Improvement Amendments (CLIA) waived tests, and 22.7% hold provider performed microscopy (PPM) certificates.[58] However, in late 2010 POLs were estimated to be processing only about eight percent of all clinical laboratory tests.[59] That number went up to nine percent in late 2014.[60]\n\nRegulatory considerations \nOperators of POLs in the United States face individual state, local, and federal regulations to ensure full compliance of their operations. The following are the three regulations most likely to affect the POL and the physician office.\n\nCLIA \nThe Clinical Laboratory Improvement Amendments (CLIA) arguably have the largest effect on the physician office laboratory. The U.S. federal statute was implemented in 1988 to remove obsolete laboratory requirements and include new requirements to improve the quality of a modern clinical laboratory. Most POLs operate as CLIA waiver labs. Waived tests have a low risk of an incorrect result; this includes the tests the Food and Drug Administration (FDA) has approved for consumers to use in their homes.[61] Tests performed under this provision are done at laboratories that have registered as required by CLIA and obtained a certificate of waiver. These labs are not inspected on a routine basis like labs certified to perform moderate- and high-complexity testing. Laboratories that wish to change their status from waived to one of the other statuses must comply with the CLIA requirements for registration, inspection, and proficiency testing as outlined in the law. Waived laboratory staff, as previously mentioned, does not require proficiency testing, and anyone can be qualified to be the laboratory director.[61]\n\nHIPAA \nPOLs in the U.S. are also required to comply with the Health Insurance Portability and Accountability Act (HIPAA) and must provide safeguards for the security and privacy of the data collected and maintained in the laboratory. HIPAA passed in 1996 in an attempt to provide better guidance regarding the privacy and security of data, portability of health insurance, and better accountability for violations related to these topics. Laboratories are required to implement measures that prevent the unauthorized disclosure and access to data in the laboratory. \nPrior to 2014, most laboratories were exempt from the HIPAA requirement to provide patients with lab results or other protected health information.[6] However, in February 2014, the Department of Health and Human Services wanted to provide patients the opportunity to become better members of their own care team by giving them more information about their health. This resulted in the amendment of CLIA 1988 to require a laboratory to give a patient, or their designated representative, lab results within 30 days of said individual sending a written request.[6] Laboratories are still required to ensure those accessing this data have authorization to do so, as the original requirements to keep data secure and private remain the same. \nAs of July 2014[update], it remains unclear as to how this impacts the POL. Since the POL is located at the physician office, access to results is most likely determined by the provider\u2019s regular procedures for acquiring personal health information (PHI). The POL could provide forms to patients for release of PHI, just as any other lab can, but it is unclear as to how this rule change will impact the POL in the long term.\n\nPPACA \nThe most difficult regulation to assess in correlation to the POL is the Patient Protection and Affordable Care Act, also known as the ACA. This does not negate the obligations of the laboratory under CLIA and HIPAA. According to the Clinical Laboratory Coalition, laboratory testing informs about 70% of a clinician\u2019s medical decision-making process. However, the laboratory comprises less than two percent of Medicare spending.[62] \n\nThe Patient Protection and Affordable Care Act (PPACA) included a direct cut to the Medicare Clinical Laboratory Fee Schedule of 1.75 percent each year for 5 years. This 9 percent cut is the largest cut among all Part B providers and started in 2011. In PPACA, clinical laboratories also received another cut in the form of a productivity adjustment, resulting in an additional 11 percent cut over 10 years.\r\n \r\n\nThe laboratory-specific cut and the productivity adjustment will already result in a cumulative 20 percent cut over 10 years. Laboratories are also facing up to a 2 percent cut to the fee schedule as a result of sequestration, which begins in January 2013.[62]\nThe laboratory space in general may face challenges from the accountable care organization (ACO) model under the PPACA, due to a decrease in laboratory testing volume.[63] Under the ACO model, unnecessary or redundant testing would be discouraged.[63]\n\nTesting and reporting \n The complete blood count, typically done with an automated analyzer, is a common test performed in the POL today.\nIn the United States, CLIA lays out seven criteria for determining the complexity of a test, including the origin of the test.[61] For example, if a new test is developed or an existing test is modified, and then it's used at that laboratory, the test is automatically rated a high-complexity test. The complexity of the test determines the requirements the laboratory needs to comply with in order to maintain regulatory compliance. The more complex the test is, the stricter the requirements are.[61]\nTest complexity has three levels: high, moderate, and waived.[61] Waived tests are simple to perform and have a relatively low risk of an incorrect test result. Moderately complex tests include tests like provider performed microscopy (PPM), which requires the use of a microscope during the office visit. Providers that want to perform PPM tests must be qualified to do so under CLIA regulations.[61]\nHigh-complexity tests require the most regulation. These tests are the most complicated and run the highest risk of an inaccurate result, as determined during the FDA pre-market approval process. Tests may come from the manufacturer with their complexity level on them, or one can search the FDA database to determine the complexity of the test.[61] It is important to understand the complexity level of the testing provided in order to ensure full compliance with CLIA.\nCommonly performed tests include[64]:\n\n urine analysis\n urine pregnancy\n blood occult\n glucose blood\n pathology consultation during surgery\n crystal identification by microscope\n sperm identification and analyses\n bilirubin total\n blood gasses\n complete blood count\n bone marrow smear\n blood bank services\n transfusion medicine\nJust as POLs manage a set of commonly performed tests, a set of corresponding reports provides the results of those tests. The results will pass through a set of validation and quality control checks before being fashioned into a final report for the ordering physician. For example, if a complete blood count is ordered by the physician, a corresponding patient report is produced by the laboratory, often through a laboratory information system (LIS). The patient report contains patient, physician, and sample demographics, as well as the results and whether they are above, below, or within recommended limits. Other types of reports may be generated in the laboratory, including daily summary, test total, and various quality control reports.\n\nPOLs in other parts of the world \nLittle in the way of public information (in English) is available concerning the practices, regulations, and markets involving physician office laboratories in other parts of the world. Market research companies like Kalorama Information and Transparency Market Research have conducted research into the marketing and regulatory environments of POLs around the world[65][66], but that research has generally not been freely available to the public. \nIn November 2014, however, Kalorama did make public a few statistics about POLs outside the United States, including the following[60]:\n\n Non-U.S. POL markets \"are defined by the strong stance of regulators and payers who have effectively both crafted and blocked POL diagnostics market development.\"\n While Germany leads European countries in IVD market size, several factors have contributed to stunted POL growth there, including \"cuts to clinical testing or pathology payments under the public insurance program GKV,\" the growth of POL alternatives such as the local physician-supported lab or Laborgemeinschaften, and limitations on allowed POL procedures.\n Japan's POLs are largely focused on rapid flu testing, while other point-of-care tests and devices have been slow to move from hospitals and emergency care centers to the POL environment.\n \"In India, rapid growth in out-of-pocket and private insurance payments has encouraged the build-out of private clinics and primary healthcare centers. Many such businesses perform in-office tests such as CBCs, ESR, glucose, chemistry panels, lipid panels, and urinalysis.\"\n The remaining \"middle-income and developing countries outside of Europe, North America and Japan [represent] only 5% of the global POL market.\"\n The rise of \"diabetes, hypertension, heart disease, and obesity\" have led to a generally increased demand globally for IVD, POL-friendly tests \"such as lipid panels, HbA1c, and cardiac markers.\"\nFurther reading \n Camac, C. N. B.; Cattell, Henry W. (ed.) (1901). \"The Clinical Laboratory in Private Practice and in the Physician's Office\". International Clinics: A Quarterly of Clinical Lectures. 3. J.B. Lippincott Company. pp. 289\u2013299. https:\/\/books.google.com\/books?id=TigSAAAAYAAJ&pg=PA289 .   \n Dolan, Thomas (June 2003). \"What lies in wait for office labs?\". CAP Today. College of American Pathologists. http:\/\/www.cap.org\/apps\/portlets\/contentViewer\/show.do?printFriendly=true&contentReference=cap_today%2Ffeature_stories%2Foffice_labs.html .   \n Kotlarz, V. R. (January\u2013February 1998). \"Tracing our roots: origins of clinical laboratory science\". Clinical Laboratory Science 11 (1): 5\u20137. PMID 10177215. http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/10177215 .   \n Welch, William Henry (1920). \"The Evolution of Modern Scientific Laboratories\". Papers and Addresses by William Henry Welch. 3. The Johns Hopkins Press. pp. 200\u2013211. http:\/\/books.google.com\/books?id=utc0AQAAMAAJ&pg=200 .   \nReferences \n\n\n\u2191 \"Chapter 16 - Laboratory Services\" (PDF). Medicare Claims Processing Manual. Centers for Medicare and Medicaid Services. 20 June 2013. http:\/\/www.cms.gov\/Regulations-and-Guidance\/Guidance\/Manuals\/downloads\/clm104c16.pdf . Retrieved 3 April 2014 .   \n\n\u2191 2.0 2.1 \"Physician Office Laboratory Evaluation Program (POLEP)\". Wadsworth Center New York State Department of Health. http:\/\/www.wadsworth.org\/labcert\/polep\/ . Retrieved 3 April 2014 .   \n\n\u2191 \"Physician Office Laboratories or Clinics - Frequently Asked Questions about Clinical Laboratory Licensing and Registration\" (PDF). California Department of Public Health. May 2008. http:\/\/www.cdph.ca.gov\/programs\/lfs\/Documents\/POL-FAQ.pdf . Retrieved 3 April 2014 .   \n\n\u2191 4.0 4.1 4.2 Walpert, Bryan (February 2000). \"How an office lab can help patients\u2014and your income\". ACP Internist. American College of Physicians. http:\/\/www.acpinternist.org\/archives\/2000\/02\/officelab.htm . Retrieved 29 July 2014 .   \n\n\u2191 5.0 5.1 Garrels, Marti (2014). \"Chapter 1: Introduction to the Laboratory and Safety Training\". Laboratory Testing for Ambulatory Settings (2nd ed.). Elsevier Health Sciences. pp. 1\u201331. ISBN 9780323292375. http:\/\/books.google.com\/books?id=O7bwAwAAQBAJ&pg=PA1 . Retrieved 29 July 2014 .   \n\n\u2191 6.0 6.1 6.2 U.S. Department of Health and Human Services (29 July 2014). \"HHS strengthens patients' right to access lab test reports\". http:\/\/www.hhs.gov\/news\/press\/2014pres\/02\/20140203a.html .   \n\n\u2191 Trustees of the Vermont Asylum for the Insane (October 1837). First Annual Report of the Trustees of the Vermont Asylum for the Insane. E. P. Walton and Son. http:\/\/books.google.com\/books?id=EWAxAQAAMAAJ&pg=PA261 . Retrieved 14 April 2014 .   \n\n\u2191 Trustees of the Massachusetts General Hospital (1898). Eighty-Fourth Annual Report of the Trustees of the Massachusetts General Hospital. The Barta Press. http:\/\/books.google.com\/books?id=dLk4AAAAYAAJ&pg=RA1-PA123 . Retrieved 14 April 2014 .   \n\n\u2191 9.0 9.1 Welch, William Henry (1920). \"The Evolution of Modern Scientific Laboratories\". Papers and Addresses by William Henry Welch. 3. The Johns Hopkins Press. pp. 200\u2013211. http:\/\/books.google.com\/books?id=utc0AQAAMAAJ&pg=200 . Retrieved 14 April 2014 .   \n\n\u2191 10.0 10.1 Simon, Charles E. (9 May 1896). \"The Importance of Laboratory Methods in Diagnosis\". Maryland Medical Journal 35 (4): 55\u201357. http:\/\/books.google.com\/books?id=dooRAAAAYAAJ&pg=PA55 . Retrieved 14 April 2014 .   \n\n\u2191 11.0 11.1 Shoemaker, John V. (ed.) (November 1884). \"Chemical Department at Jefferson Medical College\". The Medical Bulletin: A Monthly Journal of Medicine and Surgery 6 (11): 277\u2013278. http:\/\/books.google.com\/books?id=DmQWAAAAYAAJ&pg=PA277 . Retrieved 14 April 2014 .   \n\n\u2191 Wellcome, Henry S. (1911). \"Chapter VI: The Advent of Scientific Urine Analysis\". The Evolution of Urine Analysis: An Historical Sketch of the Clinical Examination of Urine. Burroughs Wellcome & Co.. http:\/\/catalog.hathitrust.org\/Record\/007935440 . Retrieved 14 April 2014 .   \n\n\u2191 13.0 13.1 Andrews, J. W. (1897). \"Some of the Minor Ailments of the Stomach and Their Remedies\". Northwestern Lancet 17: 291\u2013294. http:\/\/books.google.com\/books?id=ZhcTAAAAYAAJ&pg=PA291 . Retrieved 14 April 2014 .   \n\n\u2191 Elliott, L. B. (March 1898). \"Editorial\". Journal of Applied Microscopy 1 (3): 57\u201358. http:\/\/books.google.com\/books?id=bcjRAAAAMAAJ&pg=PA57 . Retrieved 14 April 2014 .   \n\n\u2191 Koplik, Henry (01 August 1896). \"The Rapid and Bacteriological and Clinical Diagnosis of Diphtheria\". The New York Medical Journal 64: 147\u2013151. http:\/\/books.google.com\/books?id=M1s5AQAAMAAJ&pg=PA147 . Retrieved 14 April 2014 .   \n\n\u2191 Bartley, Elias H. (1899). Manual of Clinical Chemistry. P. Blakiston's Son & Co. p. 53. http:\/\/books.google.com\/books?id=FqPVAAAAMAAJ&pg=PA53 . Retrieved 14 April 2014 .   \n\n\u2191 Harrower, Henry R. (July 1909). \"The Physician's Office Laboratory\". 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U.S. Department of Health and Human Services, Office of Analysis and Inspections. https:\/\/oig.hhs.gov\/oei\/reports\/oai-05-88-00330.pdf . Retrieved 14 May 2014 .   \n\n\u2191 \"Public Law 100-578\" (PDF). United States Statutes at Large, Volume 102. 1988. http:\/\/www.gpo.gov\/fdsys\/pkg\/STATUTE-102\/pdf\/STATUTE-102-Pg2903.pdf . Retrieved 24 March 2014 .   \n\n\u2191 \"Regulations for Implementing the Clinical Laboratory Improvement Amendments of 1988: A Summary\". Morbidity and Mortality Weekly Report 41 (RR-2): 1\u201317. 28 February 1992. PMID 1538689. http:\/\/www.cdc.gov\/mmwr\/preview\/mmwrhtml\/00016177.htm . Retrieved 24 March 2014 .   \n\n\u2191 Roberts, Rebecca; Valiant, Carrie (May\u2013June 1992). \"1992 brings significant regulation for physician office laboratories\". Physician Executive 18 (3): 60. http:\/\/www.thefreelibrary.com\/1992+brings+significant+regulation+for+physician+office+laboratories.-a012224764 . Retrieved 4 April 2014 .   \n\n\u2191 Markle, George B. (8 March 1993). \"Dear HCFA: don't handcuff us with these lab regs\". Medical Economics 70 (5): 151. http:\/\/business.highbeam.com\/62468\/article-1G1-13564202\/dear-hcfa-dont-handcuff-us-these-lab-regs . Retrieved 4 April 2014 .   \n\n\u2191 Carpi, John (15 July 1993). \"AMA battle cry: get off our backs; in a broadside swipe at federal legislation, angry delegates reject CLIA, databank\". Medical World News 34 (7): 28. http:\/\/trove.nla.gov.au\/work\/42776413?q=Off+our+backs&c=picture&versionId=55658033 . Retrieved 4 April 2014 .   \n\n\u2191 53.0 53.1 \"Medicare, Medicaid, and CLIA Programs; Laboratory Requirements Relating to Quality Systems and Certain Personnel Qualifications; Final Rule\". Federal Register 68 (16): 3639\u20133714. 24 January 2003. PMID 12545998. http:\/\/www.gpo.gov\/fdsys\/pkg\/FR-2003-01-24\/html\/03-1230.htm . Retrieved 24 March 2014 .   \n\n\u2191 Born, Patricia H.; Thran, Sara L. (April 1998). \"The influence of CLIA '88 on physician office laboratories\". Journal of Family Practice 46 (4): 319\u2013327. PMID 9564374. http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/9564374 . Retrieved 17 April 2014 .   \n\n\u2191 Dolan, Thomas (June 2003). \"What lies in wait for office labs?\". CAP Today. College of American Pathologists. http:\/\/www.cap.org\/apps\/portlets\/contentViewer\/show.do?printFriendly=true&contentReference=cap_today%2Ffeature_stories%2Foffice_labs.html . Retrieved 14 April 2014 .   \n\n\u2191 \"Healthcare Cost Worries Boost Physician Office Lab Market\". Thomson Reuters. 10 February 2011. http:\/\/www.reuters.com\/article\/2011\/02\/10\/idUS249575+10-Feb-2011+MW20110210 . Retrieved 3 April 2014 .   \n\n\u2191 \"Laboratories by Type of Facility\" (PDF). Centers for Medicare and Medicaid Services. July 2015. https:\/\/www.cms.gov\/Regulations-and-Guidance\/Legislation\/CLIA\/downloads\/factype.pdf . Retrieved 02 December 2015 .   \n\n\u2191 Centers for Medicare and Medicaid Services, Division of Laboratory Services (July 2015). \"Enrollment, CLIA exempt states, and certification of accreditation by organization\" (PDF). http:\/\/www.cms.gov\/Regulations-and-Guidance\/Legislation\/CLIA\/Downloads\/statupda.pdf . Retrieved 02 December 2015 .   \n\n\u2191 Carlson, Bruce (1 December 2010). \"Physician Office Lab Diagnostic Market\". GEN. Genetic Engineering & Biotechnology News. http:\/\/www.genengnews.com\/gen-articles\/physician-office-lab-diagnostic-market\/3493\/ . Retrieved 3 April 2014 .   \n\n\u2191 60.0 60.1 \"How and Where IVD Will Find Growth in the Global POL Market \u2013 Part 2\". Kalorama Information. November 2014. Archived from the original on 17 April 2015. https:\/\/web.archive.org\/web\/20150417204832\/http:\/\/www.kaloramainformation.com\/article\/2014-11\/How-and-Where-IVD-Will-Find-Growth-Global-POL-Market-%E2%80%93-Part-2 . Retrieved 02 December 2015 .   \n\n\u2191 61.0 61.1 61.2 61.3 61.4 61.5 61.6 Centers for Disease Control and Prevention (31 May 2013). \"Clinical Laboratory Improvement Amendments (CLIA): Test complexities\". http:\/\/wwwn.cdc.gov\/clia\/Resources\/TestComplexities.aspx . Retrieved 14 May 2014 .   \n\n\u2191 62.0 62.1 Clinical Laboratory Coalition (2012). \"Protect access to laboratory services for Medicare beneficiaries\" (PDF). http:\/\/www.aab.org\/images\/aab\/SGR%20Fix%202012%20Talking%20Points.pdf . Retrieved 14 May 2014 .   \n\n\u2191 63.0 63.1 Hughes, D.; Cammarata, B. (16 January 2014). \"Clinical labs under ACA: Challenge and opportunity\". Law360. http:\/\/www.law360.com\/articles\/500623\/clinical-labs-under-aca-challenge-and-opportunity . Retrieved 14 May 2014 .   \n\n\u2191 UnitedHealthcare Oxford (01 July 2012). \"Oxford's in-office laboratory testing and procedures list\" (PDF). https:\/\/www.oxhp.com\/secure\/policy\/oxfords_in_office_laboratory_testing_and_procedures_list.pdf . Retrieved 14 May 2014 .   \n\n\u2191 \"Physician Office Laboratory (POL) Testing Markets Worldwide: Status Quo and Future Trends\". Kalorama Information. 01 November 2010. http:\/\/www.kaloramainformation.com\/Physician-Office-Laboratory-2807838\/ . Retrieved 29 July 2014 .   \n\n\u2191 \"Physician Office Laboratory (POL) Testing Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast, 2013 - 2019\". Transparency Market Research. http:\/\/www.transparencymarketresearch.com\/pol-testing-market.html . Retrieved 29 July 2014 .   \n\n\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Physician_office_laboratory\">https:\/\/www.limswiki.org\/index.php\/Physician_office_laboratory<\/a>\n\t\t\t\t\tCategories: Articles containing potentially dated statements from July 2014Articles with invalid date parameter in templateAll articles containing potentially dated statementsLaboratory types\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\n\t\t\n\t\t\tNavigation menu\n\t\t\t\t\t\n\t\t\tViews\n\n\t\t\t\n\t\t\t\t\n\t\t\t\tPage\n\t\t\t\tDiscussion\n\t\t\t\tView source\n\t\t\t\tHistory\n\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\n\t\t\t\t\n\t\t\t\tPersonal tools\n\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\tLog in\n\t\t\t\t\t\t\t\t\t\t\t\t\tRequest account\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\t\t\n\t\tNavigation\n\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tMain page\n\t\t\t\t\t\t\t\t\t\t\tRecent changes\n\t\t\t\t\t\t\t\t\t\t\tRandom page\n\t\t\t\t\t\t\t\t\t\t\tHelp\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\n\t\t\t\n\t\t\tSearch\n\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t \n\t\t\t\t\t\t\n\t\t\t\t\n\n\t\t\t\t\t\t\t\n\t\t\n\t\t\t\n\t\t\tTools\n\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tWhat links here\n\t\t\t\t\t\t\t\t\t\t\tRelated changes\n\t\t\t\t\t\t\t\t\t\t\tSpecial pages\n\t\t\t\t\t\t\t\t\t\t\tPermanent link\n\t\t\t\t\t\t\t\t\t\t\tPage information\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\n\t\t\n\t\tPrint\/export\n\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tCreate a book\n\t\t\t\t\t\t\t\t\t\t\tDownload as PDF\n\t\t\t\t\t\t\t\t\t\t\tDownload as Plain text\n\t\t\t\t\t\t\t\t\t\t\tPrintable version\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\n\t\t\n\t\tSponsors\n\t\t\n\t\t\t \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n \r\n\n\t\n\t\r\n\n \r\n\n\t\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\t\t\n\t\t\n\t\t\t\n\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t This page was last modified on 23 June 2017, at 16:46.\n\t\t\t\t\t\t\t\t\tThis page has been accessed 25,710 times.\n\t\t\t\t\t\t\t\t\tContent is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.\n\t\t\t\t\t\t\t\t\tPrivacy policy\n\t\t\t\t\t\t\t\t\tAbout LIMSWiki\n\t\t\t\t\t\t\t\t\tDisclaimers\n\t\t\t\t\t\t\t\n\t\t\n\t\t\n\t\t\n\n","0655647b0091e0dd168f162b621a6cef_html":"<body class=\"mediawiki ltr sitedir-ltr ns-0 ns-subject page-Physician_office_laboratory skin-monobook action-view\">\n<div id=\"rdp-ebb-globalWrapper\">\n\t\t<div id=\"rdp-ebb-column-content\">\n\t\t\t<div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\">\n\t\t\t\t<a id=\"rdp-ebb-top\"><\/a>\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Physician office laboratory<\/h1>\n\t\t\t\t\n\t\t\t\t<div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\">\n\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\n\n\t\t\t\t\t<!-- start content -->\n\t\t\t\t\t<div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"thumb tright\"><div class=\"thumbinner\" style=\"width:282px;\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Johannes_Cordua_Arzt_in_seinem_Studierzimmer.jpg\" class=\"image wiki-link\" target=\"_blank\" data-key=\"387f4890ddda384ed47a830c48366b4a\"><img alt=\"\" src=\"https:\/\/www.limswiki.org\/images\/9\/9f\/Johannes_Cordua_Arzt_in_seinem_Studierzimmer.jpg\" width=\"280\" height=\"339\" class=\"thumbimage\" \/><\/a> <div class=\"thumbcaption\"><div class=\"magnify\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Johannes_Cordua_Arzt_in_seinem_Studierzimmer.jpg\" class=\"internal wiki-link\" title=\"Enlarge\" target=\"_blank\" data-key=\"387f4890ddda384ed47a830c48366b4a\"><\/a><\/div>The early physician's laboratory was certainly more modest than the 21st-century POL.<\/div><\/div><\/div>\n<p>A <b>physician office laboratory<\/b> (<b>POL<\/b>) is a physician-, partnership-, or group-maintained <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory\" title=\"Laboratory\" target=\"_blank\" class=\"wiki-link\" data-key=\"c57fc5aac9e4abf31dccae81df664c33\">laboratory<\/a> that performs diagnostic tests or examines specimens in order to diagnose, prevent, and\/or treat a disease or impairment in a patient as part of the physician practice.<sup id=\"rdp-ebb-cite_ref-CMSPOLDef_1-0\" class=\"reference\"><a href=\"#cite_note-CMSPOLDef-1\" rel=\"external_link\">[1]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-WasPOLEP_2-0\" class=\"reference\"><a href=\"#cite_note-WasPOLEP-2\" rel=\"external_link\">[2]<\/a><\/sup> The POL shows up in primary care physician offices as well as the offices of specialists like urologists, hematologists, gynecologists, and endocrinologists. In many countries like the United States, the physician office laboratory is considered a <a href=\"https:\/\/www.limswiki.org\/index.php\/Clinical_laboratory\" title=\"Clinical laboratory\" target=\"_blank\" class=\"wiki-link\" data-key=\"307bcdf1bdbcd1bb167cee435b7a5463\">clinical laboratory<\/a> and is thus regulated by federal, state, and\/or local laws affecting such laboratories.<sup id=\"rdp-ebb-cite_ref-WasPOLEP_2-1\" class=\"reference\"><a href=\"#cite_note-WasPOLEP-2\" rel=\"external_link\">[2]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-CDPHLabs_3-0\" class=\"reference\"><a href=\"#cite_note-CDPHLabs-3\" rel=\"external_link\">[3]<\/a><\/sup>\n<\/p>\n\n\n<h2><span class=\"mw-headline\" id=\"POL_workflow\">POL workflow<\/span><\/h2>\n<p>Typically, clinical laboratory workflow roughly works as such:\n<\/p>\n<ol><li> The physician orders a lab test for a patient.<\/li>\n<li> A specimen is collected from the patient.<\/li>\n<li> The specimen is packaged and processed according to specifications.<\/li>\n<li> The specimen is delivered to a <a href=\"https:\/\/www.limswiki.org\/index.php\/Reference_laboratory#Referral_and_diagnostic\" title=\"Reference laboratory\" target=\"_blank\" class=\"wiki-link\" data-key=\"01bb83c904a4c3b7fdb1d31b2dc4fd78\">reference laboratory<\/a> for testing.<\/li>\n<li> Tests are performed on the specimen as ordered.<\/li>\n<li> Results and analysis are reported back to the physician, who reviews them.<\/li>\n<li> The physician discusses the results and options with the patient.<\/li><\/ol>\n<p>If the workflow bypasses the reference lab in favor of an in-office physician laboratory:\n<\/p>\n<ol><li> The physician orders a lab test for a patient.<\/li>\n<li> A specimen is collected from the patient.<\/li>\n<li> The specimen is sent over to the in-office laboratory.<\/li>\n<li> Tests are performed on the specimen as ordered.<\/li>\n<li> Results and analysis are reported back to the physician, who reviews them.<\/li>\n<li> The physician discusses the results and options with the patient.<\/li><\/ol>\n<p>The difference in these two workflows mostly comes down to the time spent in transporting the specimen to an outside lab and waiting for the processing. The in-office lab saves time in those parts of the process. This can be advantageous, as seen in the next section.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"Advantages_and_disadvantages_of_the_POL\">Advantages and disadvantages of the POL<\/span><\/h2>\n<p>Advantages include<sup id=\"rdp-ebb-cite_ref-WalpertHow_4-0\" class=\"reference\"><a href=\"#cite_note-WalpertHow-4\" rel=\"external_link\">[4]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-GarrelsLabTest_5-0\" class=\"reference\"><a href=\"#cite_note-GarrelsLabTest-5\" rel=\"external_link\">[5]<\/a><\/sup>: \n<\/p>\n<ul><li> quicker access to test results for the clinician, leading to more treatment options for the patient; <\/li>\n<li> greater efficiency of the clinical workflow;<\/li>\n<li> cheaper testing, though subject to individual test and pricing information; and<\/li>\n<li> patient comfort and happiness, including time saved by having to go only to one location.<\/li><\/ul>\n<p>Disadvantages include<sup id=\"rdp-ebb-cite_ref-WalpertHow_4-1\" class=\"reference\"><a href=\"#cite_note-WalpertHow-4\" rel=\"external_link\">[4]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-GarrelsLabTest_5-1\" class=\"reference\"><a href=\"#cite_note-GarrelsLabTest-5\" rel=\"external_link\">[5]<\/a><\/sup>: \n<\/p>\n<ul><li> the physician office being the only point-of-access, with some physicians not willing to release patient information to an outside party (such as a hospital or competing clinician). This disadvantage may be eliminated due to regulatory changes in April of 2014, now allowing patients direct access to their laboratory results<sup id=\"rdp-ebb-cite_ref-HHS14_6-0\" class=\"reference\"><a href=\"#cite_note-HHS14-6\" rel=\"external_link\">[6]<\/a><\/sup>;<\/li>\n<li> patients not feeling comfortable about the physician's office being the central repository of information, and physicians may not see the value in having a lab in their practice; and<\/li>\n<li> the cost of meeting compliance requirements for local, state, and federal regulations, especially in states with stricter requirements. <\/li><\/ul>\n<h2><span class=\"mw-headline\" id=\"POLs_in_the_United_States\">POLs in the United States<\/span><\/h2>\n<h3><span class=\"mw-headline\" id=\"History\">History<\/span><\/h3>\n<h4><span class=\"mw-headline\" id=\"1800s\">1800s<\/span><\/h4>\n<div class=\"thumb tright\"><div class=\"thumbinner\" style=\"width:322px;\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Urinalysis_evolution_90.jpg\" class=\"image wiki-link\" target=\"_blank\" data-key=\"3cea1c29a2d3647ec5a957da13bc337f\"><img alt=\"\" src=\"https:\/\/www.limswiki.org\/images\/a\/a4\/Urinalysis_evolution_90.jpg\" class=\"thumbimage\" style=\"width: 100%;max-width: 400px;height: auto;\" \/><\/a> <div class=\"thumbcaption\"><div class=\"magnify\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Urinalysis_evolution_90.jpg\" class=\"internal wiki-link\" title=\"Enlarge\" target=\"_blank\" data-key=\"3cea1c29a2d3647ec5a957da13bc337f\"><\/a><\/div>The urinalysis was commonly performed not only at the bedside but also in the physician office laboratory during the nineteenth century.<\/div><\/div><\/div>\n<p>Throughout the mid- to late 1800s, both the university and hospital laboratory played an important role in helping physicians diagnose disease<sup id=\"rdp-ebb-cite_ref-VAI1837_7-0\" class=\"reference\"><a href=\"#cite_note-VAI1837-7\" rel=\"external_link\">[7]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MGH1898_8-0\" class=\"reference\"><a href=\"#cite_note-MGH1898-8\" rel=\"external_link\">[8]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-PapAddWelch_9-0\" class=\"reference\"><a href=\"#cite_note-PapAddWelch-9\" rel=\"external_link\">[9]<\/a><\/sup>, followed by the bedside care and analysis of the physician. However, the physician office laboratory also contributed to diagnoses, especially in the latter decades of the century.<sup id=\"rdp-ebb-cite_ref-PapAddWelch_9-1\" class=\"reference\"><a href=\"#cite_note-PapAddWelch-9\" rel=\"external_link\">[9]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MMJSimon_10-0\" class=\"reference\"><a href=\"#cite_note-MMJSimon-10\" rel=\"external_link\">[10]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MedBullShoe_11-0\" class=\"reference\"><a href=\"#cite_note-MedBullShoe-11\" rel=\"external_link\">[11]<\/a><\/sup>\n<\/p><p>Whether at the hospital lab, the bedside, or the physician office, the urinalysis was a common and important test utilized in diagnosing illness.<sup id=\"rdp-ebb-cite_ref-EvoWellcome_12-0\" class=\"reference\"><a href=\"#cite_note-EvoWellcome-12\" rel=\"external_link\">[12]<\/a><\/sup> For the POL in particular, however, the 1890s brought more accessible tests like water examination, poisonous metals analysis, and tests for hypersecretion of hydrochloric acid in the stomach.<sup id=\"rdp-ebb-cite_ref-MMJSimon_10-1\" class=\"reference\"><a href=\"#cite_note-MMJSimon-10\" rel=\"external_link\">[10]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MedBullShoe_11-1\" class=\"reference\"><a href=\"#cite_note-MedBullShoe-11\" rel=\"external_link\">[11]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-SomeAndrews_13-0\" class=\"reference\"><a href=\"#cite_note-SomeAndrews-13\" rel=\"external_link\">[13]<\/a><\/sup> Equipment like a water incubating oven, <a href=\"https:\/\/www.limswiki.org\/index.php\/Microtome\" title=\"Microtome\" target=\"_blank\" class=\"wiki-link\" data-key=\"d2f6053708b8e33d1f2097526d56c248\">microtome<\/a>, sterilizer, pipettes, reagents, evaporating dish, centrifuge, and microscope were also more readily available to the physician running their own laboratory.<sup id=\"rdp-ebb-cite_ref-SomeAndrews_13-1\" class=\"reference\"><a href=\"#cite_note-SomeAndrews-13\" rel=\"external_link\">[13]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-EditorialElliott_14-0\" class=\"reference\"><a href=\"#cite_note-EditorialElliott-14\" rel=\"external_link\">[14]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-NYMJKoplik_15-0\" class=\"reference\"><a href=\"#cite_note-NYMJKoplik-15\" rel=\"external_link\">[15]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MCCBartley_16-0\" class=\"reference\"><a href=\"#cite_note-MCCBartley-16\" rel=\"external_link\">[16]<\/a><\/sup>\n<\/p>\n<h4><span class=\"mw-headline\" id=\"1900_to_1979\">1900 to 1979<\/span><\/h4>\n<p>The promotion and success of the physician office laboratory continued on into the first decade of the twentieth century, with most urban physicians able to perform analysis of urine, blood, sputum, and feces.<sup id=\"rdp-ebb-cite_ref-POLHarrower_17-0\" class=\"reference\"><a href=\"#cite_note-POLHarrower-17\" rel=\"external_link\">[17]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-IC1901_18-0\" class=\"reference\"><a href=\"#cite_note-IC1901-18\" rel=\"external_link\">[18]<\/a><\/sup> Yet the first two decades of the 1900s also saw the slow rise of the \"commercial laboratory,\" a privately- or group-held clinical pathology, chemical, or radiological lab that processed laboratory tests or chemical compounds ordered by a referring physician.<sup id=\"rdp-ebb-cite_ref-TNHJan1921_19-0\" class=\"reference\"><a href=\"#cite_note-TNHJan1921-19\" rel=\"external_link\">[19]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-PSMar1908_20-0\" class=\"reference\"><a href=\"#cite_note-PSMar1908-20\" rel=\"external_link\">[20]<\/a><\/sup> (Though the same idea, the term \"<a href=\"https:\/\/www.limswiki.org\/index.php\/Reference_laboratory\" title=\"Reference laboratory\" target=\"_blank\" class=\"wiki-link\" data-key=\"f719f408e1660f86b53857eef2f13f32\">referral lab<\/a>\" didn't begin to appear in medical literature regularly until the early 1950s and \"independent laboratory\" until the mid-1960s.<sup id=\"rdp-ebb-cite_ref-TXTSep1952_21-0\" class=\"reference\"><a href=\"#cite_note-TXTSep1952-21\" rel=\"external_link\">[21]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-NYDH1953_22-0\" class=\"reference\"><a href=\"#cite_note-NYDH1953-22\" rel=\"external_link\">[22]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-CodeLawsUS_23-0\" class=\"reference\"><a href=\"#cite_note-CodeLawsUS-23\" rel=\"external_link\">[23]<\/a><\/sup> ) While some physicians \u2014 especially those in thriving urban areas \u2014 had a large enough clientele to invest in laboratory equipment and supplies for their own office, others in rural areas were less likely to be able to afford such luxuries. In the latter case, physicians were not able to as effectively provide a clinical diagnosis to their patients. These physicians had to either hope for connections at community regional hospitals to utilize the hospital laboratory (if they were even in reasonable distance or had the testing tools) or find some other means of sample testing.<sup id=\"rdp-ebb-cite_ref-MHSept1921_24-0\" class=\"reference\"><a href=\"#cite_note-MHSept1921-24\" rel=\"external_link\">[24]<\/a><\/sup> Practitioners and businesspeople alike saw an opportunity for the commercial laboratory to fill those gaps.\n<\/p><p>However, around the early 1920s, the push for or against the increasingly popular commercial laboratory became more noticeably vocal. Some physicians, specialists, and dentists complained heavily of the lack of quality standards, regulations, and ethics inherent in for-profit clinical, chemical, and radiological laboratories.<sup id=\"rdp-ebb-cite_ref-TSJMOct1920_25-0\" class=\"reference\"><a href=\"#cite_note-TSJMOct1920-25\" rel=\"external_link\">[25]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-NYSJMOct1921_26-0\" class=\"reference\"><a href=\"#cite_note-NYSJMOct1921-26\" rel=\"external_link\">[26]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-KMJAug1922_27-0\" class=\"reference\"><a href=\"#cite_note-KMJAug1922-27\" rel=\"external_link\">[27]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-BMSJMar1922_28-0\" class=\"reference\"><a href=\"#cite_note-BMSJMar1922-28\" rel=\"external_link\">[28]<\/a><\/sup> An alternative was at times proposed in the form of a state or local diagnostic lab or a referral-only \"clinic\" that could be well-equipped with professional tools, staff, and procedures, critical for rural areas and usable for more than just public health care diagnoses.<sup id=\"rdp-ebb-cite_ref-TNHJan1921_19-1\" class=\"reference\"><a href=\"#cite_note-TNHJan1921-19\" rel=\"external_link\">[19]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-KMJDec1922_29-0\" class=\"reference\"><a href=\"#cite_note-KMJDec1922-29\" rel=\"external_link\">[29]<\/a><\/sup> However, other medical professionals, while recognizing the need for more professional laboratory environments and more ethical advertising, dismissed those declaring the commercial laboratory as \"evil,\"<sup id=\"rdp-ebb-cite_ref-JNDAVol81921_30-0\" class=\"reference\"><a href=\"#cite_note-JNDAVol81921-30\" rel=\"external_link\">[30]<\/a><\/sup> content to state those types of labs were needed and then fully entrenched in the health care environment.<sup id=\"rdp-ebb-cite_ref-TNHJan1921_19-2\" class=\"reference\"><a href=\"#cite_note-TNHJan1921-19\" rel=\"external_link\">[19]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-KMJAug1922_27-1\" class=\"reference\"><a href=\"#cite_note-KMJAug1922-27\" rel=\"external_link\">[27]<\/a><\/sup>\n<\/p><p>The for-profit clinical laboratory, however, would only garner minor prominence until the '70s and '80s. In the meantime, organizations like the American Society of Clinical Pathologists' (ASCP's) Board of Registry (1928) and the American Society of Medical Technologists (1932) began appearing to help promote higher standards in clinical laboratory standards, whether it be in the commercial laboratory, the hospital laboratory, or the physician's office.<sup id=\"rdp-ebb-cite_ref-SciTechSocs_31-0\" class=\"reference\"><a href=\"#cite_note-SciTechSocs-31\" rel=\"external_link\">[31]<\/a><\/sup> <sup id=\"rdp-ebb-cite_ref-KotlarzRoots_32-0\" class=\"reference\"><a href=\"#cite_note-KotlarzRoots-32\" rel=\"external_link\">[32]<\/a><\/sup> And with the ever-increasing variety of tests and associated equipment (as well as the demand for it), clinical laboratory practice continued to move out of the physicians office and into the hospital laboratory.<sup id=\"rdp-ebb-cite_ref-100Med_33-0\" class=\"reference\"><a href=\"#cite_note-100Med-33\" rel=\"external_link\">[33]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-IntroExpMed_34-0\" class=\"reference\"><a href=\"#cite_note-IntroExpMed-34\" rel=\"external_link\">[34]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-LIFEMedTech_35-0\" class=\"reference\"><a href=\"#cite_note-LIFEMedTech-35\" rel=\"external_link\">[35]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-NewSciMedTech_36-0\" class=\"reference\"><a href=\"#cite_note-NewSciMedTech-36\" rel=\"external_link\">[36]<\/a><\/sup> \n<\/p><p>On December 5, 1967, the U.S. enacted Public Law 90-174, which included in Section 5 the \"Clinical Laboratories Improvement Act of 1967.\" CLIA '67 set regulations on the licensing of clinical laboratories and the movement of samples in and out of them across state lines. Laboratories would be eligible for a full, partial, or exempt CLIA-67 license, depending on the laboratory's conducted tests.<sup id=\"rdp-ebb-cite_ref-CLIA67Doc_37-0\" class=\"reference\"><a href=\"#cite_note-CLIA67Doc-37\" rel=\"external_link\">[37]<\/a><\/sup> However, CLIA '67 wasn't thorough, and only about 12,000 of nearly 200,000 U.S. laboratories were regulated. Physician office laboratories in particular were unaffected by the regulations.<sup id=\"rdp-ebb-cite_ref-LiesekeEss_38-0\" class=\"reference\"><a href=\"#cite_note-LiesekeEss-38\" rel=\"external_link\">[38]<\/a><\/sup> Another attempt was made to place more clinical labs into the regulation net, with proposed but unsuccessful legislation in 1976 and 1977 that would have extended federal licensure to all hospital and independent laboratories. POLs again would have been exempted, requiring only participation in a federal proficiency testing program.<sup id=\"rdp-ebb-cite_ref-PeddClinLab_39-0\" class=\"reference\"><a href=\"#cite_note-PeddClinLab-39\" rel=\"external_link\">[39]<\/a><\/sup>\n<\/p><p>The U.S. National Center for Health Statistics (NCHS) reported in its 1965 publication of <i>Health Resources Statistics<\/i> the following statistics for laboratories<sup id=\"rdp-ebb-cite_ref-HRS65_40-0\" class=\"reference\"><a href=\"#cite_note-HRS65-40\" rel=\"external_link\">[40]<\/a><\/sup>:\n<\/p>\n<ul><li> In 1958, around 6,500 to 7,000 hospitals labs employed roughly 45,000 to 50,000 personnel.<\/li>\n<li> In 1962, physician office laboratories employed roughly 25,000 to 30,000 personnel.<sup id=\"rdp-ebb-cite_ref-C.26EN63_41-0\" class=\"reference\"><a href=\"#cite_note-C.26EN63-41\" rel=\"external_link\">[41]<\/a><\/sup><\/li>\n<li> In 1962, around 2,000 independent\/commercial labs employed roughly 10,000 personnel.<\/li><\/ul>\n<p>The publication didn't mention the number of POLs in 1962. One could arguably assume hospital labs still outnumbered POLs that year. In the last year of its publication of <i>Health Resources Statistics<\/i> (1976\u20131977), the NCHS reported \"[t]he largest number of clinical laboratories are in the offices of private physicians, and the next largest number are in hospitals,<sup id=\"rdp-ebb-cite_ref-HRS76-77_42-0\" class=\"reference\"><a href=\"#cite_note-HRS76-77-42\" rel=\"external_link\">[42]<\/a><\/sup>\" indicating a potential flip-flop in lab numbers over a period of nearly 15 years. The increase in POLs during the 1970s has been largely attributed to the technological development of small, affordable analyzers; more affordable office laboratory equipment; and the convenience associated with in-office testing.<sup id=\"rdp-ebb-cite_ref-StJohnImprove_43-0\" class=\"reference\"><a href=\"#cite_note-StJohnImprove-43\" rel=\"external_link\">[43]<\/a><\/sup> \n<\/p><p>The 1976\u20131977 report is also notable for its focus on the \"independent clinical laboratory\" (the commercial clinical laboratory) as defined by Medicare, indicating an increase from 2,355 such labs in 1967 to 3,024 on January 1976.<sup id=\"rdp-ebb-cite_ref-HRS76-77_42-1\" class=\"reference\"><a href=\"#cite_note-HRS76-77-42\" rel=\"external_link\">[42]<\/a><\/sup>\n<\/p>\n<h4><span class=\"mw-headline\" id=\"1980_to_present\">1980 to present<\/span><\/h4>\n<p>Between 1983 and 1984 physician office testing increased by an estimated 11 percent, while the volume of physician-referred diagnostic tests to third-party labs declined 2 percent<sup id=\"rdp-ebb-cite_ref-GallivanPhys_44-0\" class=\"reference\"><a href=\"#cite_note-GallivanPhys-44\" rel=\"external_link\">[44]<\/a><\/sup>, likely buoyed by relatively inexpensive in-office laboratory equipment and more efficient drug monitoring capabilities.<sup id=\"rdp-ebb-cite_ref-CuminsInOff_45-0\" class=\"reference\"><a href=\"#cite_note-CuminsInOff-45\" rel=\"external_link\">[45]<\/a><\/sup> The Deficit Reduction Act of 1984 further helped to increase the number of physician office laboratories by eliminating physicians' ability to mark up tests sent out to referral labs. Additional changes to Medicare reimbursement meant the laboratory that performed the tests got paid, while physicians were suddenly limited to a $3 payment per patient visit for collecting and distributing specimens. As physician laboratories were at that point still not regulated, physicians and equipment vendors alike saw an opportunity to expand physician office laboratory functions.<sup id=\"rdp-ebb-cite_ref-GallivanPhys_44-1\" class=\"reference\"><a href=\"#cite_note-GallivanPhys-44\" rel=\"external_link\">[44]<\/a><\/sup> By the end of 1985, 10 percent of group practices with one to five physicians and 40 percent of those with six to 25 physicians were operating POLs.<sup id=\"rdp-ebb-cite_ref-WilkinsonAre_46-0\" class=\"reference\"><a href=\"#cite_note-WilkinsonAre-46\" rel=\"external_link\">[46]<\/a><\/sup> In 1989, an estimated 98,400 POLs were operating in the United States, conducting roughly 25 percent of all laboratory testing in the country. Estimates from the time vary from 20,000 to 200,000 due to the lack of a standard definition for a POL and the need for physicians to self-report the status of their lab.<sup id=\"rdp-ebb-cite_ref-HHS89_47-0\" class=\"reference\"><a href=\"#cite_note-HHS89-47\" rel=\"external_link\">[47]<\/a><\/sup> Some of these issues continue to persist today, as states often have different definitions for a POL.\n<\/p><p>On January 1, 1987, the <a href=\"https:\/\/www.limswiki.org\/index.php\/Centers_for_Medicare_and_Medicaid_Services\" title=\"Centers for Medicare and Medicaid Services\" target=\"_blank\" class=\"wiki-link\" data-key=\"654b4449e4816e190325b420c264df1a\">Health Care Financing Administration<\/a> ruled physicians must accept assignment for performed in-office Medicare lab testing, significantly cutting physician revenues. This, combined with plans from third-party to reduce POL payments and increased pressure on Congress to regulate POLs like other clinical laboratories, led to suggestions of physicians banding together into limited partnerships to start their own <a href=\"https:\/\/www.limswiki.org\/index.php\/Reference_lab\" title=\"Reference lab\" class=\"mw-redirect wiki-link\" target=\"_blank\" data-key=\"edfcf253b049231e25937d7d35defa85\">reference labs<\/a>.<sup id=\"rdp-ebb-cite_ref-WilkinsonAre_46-1\" class=\"reference\"><a href=\"#cite_note-WilkinsonAre-46\" rel=\"external_link\">[46]<\/a><\/sup> That pressure on Congress led to the signing into effect of the <a href=\"https:\/\/www.limswiki.org\/index.php\/Clinical_Laboratory_Improvement_Amendments\" title=\"Clinical Laboratory Improvement Amendments\" target=\"_blank\" class=\"wiki-link\" data-key=\"64bdae1dc17c40c28e0c560396a6ae35\">Clinical Laboratory Improvement Amendments<\/a> (CLIA) on October 31, 1988.<sup id=\"rdp-ebb-cite_ref-CLIA88Doc_48-0\" class=\"reference\"><a href=\"#cite_note-CLIA88Doc-48\" rel=\"external_link\">[48]<\/a><\/sup> Regulations for implementing CLIA continued to be developed afterwards, with the <a href=\"https:\/\/www.limswiki.org\/index.php\/United_States_Department_of_Health_and_Human_Services\" title=\"United States Department of Health and Human Services\" target=\"_blank\" class=\"wiki-link\" data-key=\"efa106bcbb93039b1a6c3c596daedec3\">Department of Health and Human Services<\/a> considering thousands of comments to the proposed regulations. The final regulations were published February 28, 1992, set to be effective on September 1 of the same year. The new CLIA regulations put into place regulations concerning test complexity, certification, proficiency testing, patient test management, personnel requirements, quality assurance, and other processes in the clinical laboratory, including physician office laboratories.<sup id=\"rdp-ebb-cite_ref-MMERFeb2892_49-0\" class=\"reference\"><a href=\"#cite_note-MMERFeb2892-49\" rel=\"external_link\">[49]<\/a><\/sup> Additional controls were placed on POLs that year by the Stark Amendment, which sought to prohibit physician referrals of designated health services for Medicare and Medicaid patients if the physician or an immediate family member had a financial relationship with that entity.<sup id=\"rdp-ebb-cite_ref-Roberts1992_50-0\" class=\"reference\"><a href=\"#cite_note-Roberts1992-50\" rel=\"external_link\">[50]<\/a><\/sup> \n<\/p><p>By 1993, some physicians running POLs were already protesting CLIA, stating the legislation imposed too many rules, regulations, and fees on physicians who perform any kind of in-office testing.<sup id=\"rdp-ebb-cite_ref-MarkleDear_51-0\" class=\"reference\"><a href=\"#cite_note-MarkleDear-51\" rel=\"external_link\">[51]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-CarpiAMA_52-0\" class=\"reference\"><a href=\"#cite_note-CarpiAMA-52\" rel=\"external_link\">[52]<\/a><\/sup> A mix of public commentary and internal consideration caused the effective date of CLIA for labs to be extended on several occasions afterwards: on December 6, 1994 in the Federal Register (59 FR 62606), May 12, 1997 in the Federal Register (62 FR 25855), October 14, 1998 in the Federal Register (63 FR 55031), and December 29, 2000 in the Federal Register (65 FR 82941).<sup id=\"rdp-ebb-cite_ref-68FR3639_53-0\" class=\"reference\"><a href=\"#cite_note-68FR3639-53\" rel=\"external_link\">[53]<\/a><\/sup>\n<\/p>\n<blockquote>\"The extensions allowed previously unregulated laboratories time to understand and implement these requirements. The extensions also provided the Department of Health and Human Services (HHS) additional time to issue revised QC requirements, review board certification program requests for approval, and ensure that laboratory directors with a doctoral degree had sufficient time to successfully complete the requirements for board certification.\"<sup id=\"rdp-ebb-cite_ref-68FR3639_53-1\" class=\"reference\"><a href=\"#cite_note-68FR3639-53\" rel=\"external_link\">[53]<\/a><\/sup><\/blockquote>\n<p>Surveys conducted by Mathematica Policy Research in 1991 and again in 1995 provided data that suggested \"that CLIA '88 was primarily responsible for the reduction of in-office laboratory testing between 1991 and 1995. While more than 70% of practices surveyed have reduced or eliminated testing during this period, we found that a vast majority of those surveyed (64%) cited CLIA '88 as the force driving this change.\"<sup id=\"rdp-ebb-cite_ref-BornInfluence_54-0\" class=\"reference\"><a href=\"#cite_note-BornInfluence-54\" rel=\"external_link\">[54]<\/a><\/sup> Yet by 2000, some physicians were still espousing the benefits of the POL despite the implementation of CLIA, stating that CLIA fees, proficiency testing fees, inspection fees, and staff time account for only roughly about three to four percent of overall lab costs.<sup id=\"rdp-ebb-cite_ref-WalpertHow_4-2\" class=\"reference\"><a href=\"#cite_note-WalpertHow-4\" rel=\"external_link\">[4]<\/a><\/sup> However, a 2003 report from the College of American Pathologists found \"a small, slow drop-off in the POL market as some laboratories close or move to waived testing.<sup id=\"rdp-ebb-cite_ref-CAP03POL_55-0\" class=\"reference\"><a href=\"#cite_note-CAP03POL-55\" rel=\"external_link\">[55]<\/a><\/sup>\" \n<\/p><p>In early 2011, researchers estimated the worldwide market for <i>in vitro<\/i> diagnostic (IVD) company sales from over 100 companies to POLs was valued at around $2.3 billion U.S.<sup id=\"rdp-ebb-cite_ref-ReutHealthcareCosts_56-0\" class=\"reference\"><a href=\"#cite_note-ReutHealthcareCosts-56\" rel=\"external_link\">[56]<\/a><\/sup>\n<\/p><p>In July 2015, the <a href=\"https:\/\/www.limswiki.org\/index.php\/Centers_for_Medicare_and_Medicaid_Services\" title=\"Centers for Medicare and Medicaid Services\" target=\"_blank\" class=\"wiki-link\" data-key=\"654b4449e4816e190325b420c264df1a\">Centers for Medicare and Medicaid Services<\/a> (CMS) reported nearly half of all <a href=\"https:\/\/www.limswiki.org\/index.php\/Clinical_Laboratory_Improvement_Amendments\" title=\"Clinical Laboratory Improvement Amendments\" target=\"_blank\" class=\"wiki-link\" data-key=\"64bdae1dc17c40c28e0c560396a6ae35\">CLIA<\/a>-certified laboratories in the United States (122,189) were physician office laboratories.<sup id=\"rdp-ebb-cite_ref-CMSDec13Count_57-0\" class=\"reference\"><a href=\"#cite_note-CMSDec13Count-57\" rel=\"external_link\">[57]<\/a><\/sup> Additionally, 61.3% of the POLs in the United States today are running <a href=\"https:\/\/www.limswiki.org\/index.php\/Clinical_Laboratory_Improvement_Amendments\" title=\"Clinical Laboratory Improvement Amendments\" target=\"_blank\" class=\"wiki-link\" data-key=\"64bdae1dc17c40c28e0c560396a6ae35\">Clinical Laboratory Improvement Amendments<\/a> (CLIA) waived tests, and 22.7% hold provider performed microscopy (PPM) certificates.<sup id=\"rdp-ebb-cite_ref-CMS13Enroll_58-0\" class=\"reference\"><a href=\"#cite_note-CMS13Enroll-58\" rel=\"external_link\">[58]<\/a><\/sup> However, in late 2010 POLs were estimated to be processing only about eight percent of all clinical laboratory tests.<sup id=\"rdp-ebb-cite_ref-CarlsonPhys_59-0\" class=\"reference\"><a href=\"#cite_note-CarlsonPhys-59\" rel=\"external_link\">[59]<\/a><\/sup> That number went up to nine percent in late 2014.<sup id=\"rdp-ebb-cite_ref-KalHow14Arch_60-0\" class=\"reference\"><a href=\"#cite_note-KalHow14Arch-60\" rel=\"external_link\">[60]<\/a><\/sup>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Regulatory_considerations\">Regulatory considerations<\/span><\/h3>\n<p>Operators of POLs in the United States face individual state, local, and federal regulations to ensure full compliance of their operations. The following are the three regulations most likely to affect the POL and the physician office.\n<\/p>\n<h4><span class=\"mw-headline\" id=\"CLIA\">CLIA<\/span><\/h4>\n<p>The <a href=\"https:\/\/www.limswiki.org\/index.php\/Clinical_Laboratory_Improvement_Amendments\" title=\"Clinical Laboratory Improvement Amendments\" target=\"_blank\" class=\"wiki-link\" data-key=\"64bdae1dc17c40c28e0c560396a6ae35\">Clinical Laboratory Improvement Amendments<\/a> (CLIA) arguably have the largest effect on the physician office laboratory. The U.S. federal statute was implemented in 1988 to remove obsolete laboratory requirements and include new requirements to improve the quality of a modern clinical laboratory. Most POLs operate as CLIA waiver labs. Waived tests have a low risk of an incorrect result; this includes the tests the Food and Drug Administration (FDA) has approved for consumers to use in their homes.<sup id=\"rdp-ebb-cite_ref-CDCTestCom_61-0\" class=\"reference\"><a href=\"#cite_note-CDCTestCom-61\" rel=\"external_link\">[61]<\/a><\/sup> Tests performed under this provision are done at laboratories that have registered as required by CLIA and obtained a certificate of waiver. These labs are not inspected on a routine basis like labs certified to perform moderate- and high-complexity testing. Laboratories that wish to change their status from waived to one of the other statuses must comply with the CLIA requirements for registration, inspection, and proficiency testing as outlined in the law. Waived laboratory staff, as previously mentioned, does not require proficiency testing, and anyone can be qualified to be the laboratory director.<sup id=\"rdp-ebb-cite_ref-CDCTestCom_61-1\" class=\"reference\"><a href=\"#cite_note-CDCTestCom-61\" rel=\"external_link\">[61]<\/a><\/sup>\n<\/p>\n<h4><span class=\"mw-headline\" id=\"HIPAA\">HIPAA<\/span><\/h4>\n<p>POLs in the U.S. are also required to comply with the <a href=\"https:\/\/www.limswiki.org\/index.php\/Health_Insurance_Portability_and_Accountability_Act\" title=\"Health Insurance Portability and Accountability Act\" target=\"_blank\" class=\"wiki-link\" data-key=\"b70673a0117c21576016cb7498867153\">Health Insurance Portability and Accountability Act<\/a> (HIPAA) and must provide safeguards for the security and privacy of the data collected and maintained in the laboratory. HIPAA passed in 1996 in an attempt to provide better guidance regarding the privacy and security of data, portability of health insurance, and better accountability for violations related to these topics. Laboratories are required to implement measures that prevent the unauthorized disclosure and access to data in the laboratory. \n<\/p><p>Prior to 2014, most laboratories were exempt from the HIPAA requirement to provide patients with lab results or other protected health information.<sup id=\"rdp-ebb-cite_ref-HHS14_6-1\" class=\"reference\"><a href=\"#cite_note-HHS14-6\" rel=\"external_link\">[6]<\/a><\/sup> However, in February 2014, the <a href=\"https:\/\/www.limswiki.org\/index.php\/United_States_Department_of_Health_and_Human_Services\" title=\"United States Department of Health and Human Services\" target=\"_blank\" class=\"wiki-link\" data-key=\"efa106bcbb93039b1a6c3c596daedec3\">Department of Health and Human Services<\/a> wanted to provide patients the opportunity to become better members of their own care team by giving them more information about their health. This resulted in the amendment of CLIA 1988 to require a laboratory to give a patient, or their designated representative, lab results within 30 days of said individual sending a written request.<sup id=\"rdp-ebb-cite_ref-HHS14_6-2\" class=\"reference\"><a href=\"#cite_note-HHS14-6\" rel=\"external_link\">[6]<\/a><\/sup> Laboratories are still required to ensure those accessing this data have authorization to do so, as the original requirements to keep data secure and private remain the same. \n<\/p><p>As of July 2014<sup class=\"plainlinks noprint asof-tag update\" style=\"display:none;\"><\/sup>, it remains unclear as to how this impacts the POL. Since the POL is located at the physician office, access to results is most likely determined by the provider\u2019s regular procedures for acquiring personal health information (PHI). The POL could provide forms to patients for release of PHI, just as any other lab can, but it is unclear as to how this rule change will impact the POL in the long term.\n<\/p>\n<h4><span class=\"mw-headline\" id=\"PPACA\">PPACA<\/span><\/h4>\n<p>The most difficult regulation to assess in correlation to the POL is the Patient Protection and Affordable Care Act, also known as the ACA. This does not negate the obligations of the laboratory under CLIA and HIPAA. According to the Clinical Laboratory Coalition, laboratory testing informs about 70% of a clinician\u2019s medical decision-making process. However, the laboratory comprises less than two percent of Medicare spending.<sup id=\"rdp-ebb-cite_ref-CLC12_62-0\" class=\"reference\"><a href=\"#cite_note-CLC12-62\" rel=\"external_link\">[62]<\/a><\/sup> \n<\/p>\n<blockquote><i>The Patient Protection and Affordable Care Act (PPACA) included a direct cut to the Medicare Clinical Laboratory Fee Schedule of 1.75 percent each year for 5 years. This 9 percent cut is the largest cut among all Part B providers and started in 2011. In PPACA, clinical laboratories also received another cut in the form of a productivity adjustment, resulting in an additional 11 percent cut over 10 years.<\/i><br \/> <br \/>\n<i>The laboratory-specific cut and the productivity adjustment will already result in a cumulative 20 percent cut over 10 years. Laboratories are also facing up to a 2 percent cut to the fee schedule as a result of sequestration, which begins in January 2013.<sup id=\"rdp-ebb-cite_ref-CLC12_62-1\" class=\"reference\"><a href=\"#cite_note-CLC12-62\" rel=\"external_link\">[62]<\/a><\/sup><\/i><\/blockquote>\n<p>The laboratory space in general may face challenges from the accountable care organization (ACO) model under the PPACA, due to a decrease in laboratory testing volume.<sup id=\"rdp-ebb-cite_ref-HughesCamm_63-0\" class=\"reference\"><a href=\"#cite_note-HughesCamm-63\" rel=\"external_link\">[63]<\/a><\/sup> Under the ACO model, unnecessary or redundant testing would be discouraged.<sup id=\"rdp-ebb-cite_ref-HughesCamm_63-1\" class=\"reference\"><a href=\"#cite_note-HughesCamm-63\" rel=\"external_link\">[63]<\/a><\/sup>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Testing_and_reporting\">Testing and reporting<\/span><\/h3>\n<div class=\"thumb tright\"><div class=\"thumbinner\" style=\"width:282px;\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:CBC_report.JPG\" class=\"image wiki-link\" target=\"_blank\" data-key=\"107b05d79b68e6755489f250c2de3cd3\"><img alt=\"\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/1\/1d\/CBC_report.JPG\" width=\"280\" height=\"210\" class=\"thumbimage\" \/><\/a> <div class=\"thumbcaption\"><div class=\"magnify\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:CBC_report.JPG\" class=\"internal wiki-link\" title=\"Enlarge\" target=\"_blank\" data-key=\"107b05d79b68e6755489f250c2de3cd3\"><\/a><\/div>The complete blood count, typically done with an automated analyzer, is a common test performed in the POL today.<\/div><\/div><\/div>\n<p>In the United States, CLIA lays out seven criteria for determining the complexity of a test, including the origin of the test.<sup id=\"rdp-ebb-cite_ref-CDCTestCom_61-2\" class=\"reference\"><a href=\"#cite_note-CDCTestCom-61\" rel=\"external_link\">[61]<\/a><\/sup> For example, if a new test is developed or an existing test is modified, and then it's used at that laboratory, the test is automatically rated a high-complexity test. The complexity of the test determines the requirements the laboratory needs to comply with in order to maintain regulatory compliance. The more complex the test is, the stricter the requirements are.<sup id=\"rdp-ebb-cite_ref-CDCTestCom_61-3\" class=\"reference\"><a href=\"#cite_note-CDCTestCom-61\" rel=\"external_link\">[61]<\/a><\/sup>\n<\/p><p>Test complexity has three levels: high, moderate, and waived.<sup id=\"rdp-ebb-cite_ref-CDCTestCom_61-4\" class=\"reference\"><a href=\"#cite_note-CDCTestCom-61\" rel=\"external_link\">[61]<\/a><\/sup> Waived tests are simple to perform and have a relatively low risk of an incorrect test result. Moderately complex tests include tests like provider performed microscopy (PPM), which requires the use of a microscope during the office visit. Providers that want to perform PPM tests must be qualified to do so under CLIA regulations.<sup id=\"rdp-ebb-cite_ref-CDCTestCom_61-5\" class=\"reference\"><a href=\"#cite_note-CDCTestCom-61\" rel=\"external_link\">[61]<\/a><\/sup>\n<\/p><p>High-complexity tests require the most regulation. These tests are the most complicated and run the highest risk of an inaccurate result, as determined during the FDA pre-market approval process. Tests may come from the manufacturer with their complexity level on them, or one can search the FDA database to determine the complexity of the test.<sup id=\"rdp-ebb-cite_ref-CDCTestCom_61-6\" class=\"reference\"><a href=\"#cite_note-CDCTestCom-61\" rel=\"external_link\">[61]<\/a><\/sup> It is important to understand the complexity level of the testing provided in order to ensure full compliance with CLIA.\n<\/p><p>Commonly performed tests include<sup id=\"rdp-ebb-cite_ref-UHOxInOffice_64-0\" class=\"reference\"><a href=\"#cite_note-UHOxInOffice-64\" rel=\"external_link\">[64]<\/a><\/sup>:\n<\/p>\n<ul><li> urine analysis<\/li>\n<li> urine pregnancy<\/li>\n<li> blood occult<\/li>\n<li> glucose blood<\/li>\n<li> pathology consultation during surgery<\/li>\n<li> crystal identification by microscope<\/li>\n<li> sperm identification and analyses<\/li>\n<li> bilirubin total<\/li>\n<li> blood gasses<\/li>\n<li> complete blood count<\/li>\n<li> bone marrow smear<\/li>\n<li> blood bank services<\/li>\n<li> transfusion medicine<\/li><\/ul>\n<p>Just as POLs manage a set of commonly performed tests, a set of corresponding reports provides the results of those tests. The results will pass through a set of validation and quality control checks before being fashioned into a final report for the ordering physician. For example, if a complete blood count is ordered by the physician, a corresponding patient report is produced by the laboratory, often through a <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_information_system\" title=\"Laboratory information system\" target=\"_blank\" class=\"wiki-link\" data-key=\"37add65b4d1c678b382a7d4817a9cf64\">laboratory information system<\/a> (LIS). The patient report contains patient, physician, and sample demographics, as well as the results and whether they are above, below, or within recommended limits. Other types of reports may be generated in the laboratory, including daily summary, test total, and various quality control reports.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"POLs_in_other_parts_of_the_world\">POLs in other parts of the world<\/span><\/h2>\n<p>Little in the way of public information (in English) is available concerning the practices, regulations, and markets involving physician office laboratories in other parts of the world. Market research companies like Kalorama Information and Transparency Market Research have conducted research into the marketing and regulatory environments of POLs around the world<sup id=\"rdp-ebb-cite_ref-KaloPOL_65-0\" class=\"reference\"><a href=\"#cite_note-KaloPOL-65\" rel=\"external_link\">[65]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-TransparencyPOL_66-0\" class=\"reference\"><a href=\"#cite_note-TransparencyPOL-66\" rel=\"external_link\">[66]<\/a><\/sup>, but that research has generally not been freely available to the public. \n<\/p><p>In November 2014, however, Kalorama did make public a few statistics about POLs outside the United States, including the following<sup id=\"rdp-ebb-cite_ref-KalHow14Arch_60-1\" class=\"reference\"><a href=\"#cite_note-KalHow14Arch-60\" rel=\"external_link\">[60]<\/a><\/sup>:\n<\/p>\n<ul><li> Non-U.S. POL markets \"are defined by the strong stance of regulators and payers who have effectively both crafted and blocked POL diagnostics market development.\"<\/li><\/ul>\n<ul><li> While Germany leads European countries in IVD market size, several factors have contributed to stunted POL growth there, including \"cuts to clinical testing or pathology payments under the public insurance program GKV,\" the growth of POL alternatives such as the local physician-supported lab or <i>Laborgemeinschaften<\/i>, and limitations on allowed POL procedures.<\/li><\/ul>\n<ul><li> Japan's POLs are largely focused on rapid flu testing, while other point-of-care tests and devices have been slow to move from hospitals and emergency care centers to the POL environment.<\/li><\/ul>\n<ul><li> \"In India, rapid growth in out-of-pocket and private insurance payments has encouraged the build-out of private clinics and primary healthcare centers. Many such businesses perform in-office tests such as CBCs, ESR, glucose, chemistry panels, lipid panels, and urinalysis.\"<\/li><\/ul>\n<ul><li> The remaining \"middle-income and developing countries outside of Europe, North America and Japan [represent] only 5% of the global POL market.\"<\/li><\/ul>\n<ul><li> The rise of \"diabetes, hypertension, heart disease, and obesity\" have led to a generally increased demand globally for IVD, POL-friendly tests \"such as lipid panels, HbA1c, and cardiac markers.\"<\/li><\/ul>\n<h2><span class=\"mw-headline\" id=\"Further_reading\">Further reading<\/span><\/h2>\n<ul><li> <span class=\"citation book\">Camac, C. N. B.; Cattell, Henry W. (ed.) (1901). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=TigSAAAAYAAJ&pg=PA289\" target=\"_blank\">\"The Clinical Laboratory in Private Practice and in the Physician's Office\"<\/a>. <i>International Clinics: A Quarterly of Clinical Lectures<\/i>. <b>3<\/b>. J.B. Lippincott Company. pp. 289\u2013299<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=TigSAAAAYAAJ&pg=PA289\" target=\"_blank\">https:\/\/books.google.com\/books?id=TigSAAAAYAAJ&pg=PA289<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=The+Clinical+Laboratory+in+Private+Practice+and+in+the+Physician%27s+Office&rft.atitle=International+Clinics%3A+A+Quarterly+of+Clinical+Lectures&rft.aulast=Camac%2C+C.+N.+B.%3B+Cattell%2C+Henry+W.+%28ed.%29&rft.au=Camac%2C+C.+N.+B.%3B+Cattell%2C+Henry+W.+%28ed.%29&rft.date=1901&rft.volume=3&rft.issue=11&rft.pages=pp.%26nbsp%3B289%E2%80%93299&rft.pub=J.B.+Lippincott+Company&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DTigSAAAAYAAJ%26pg%3DPA289&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/li>\n<li> <span class=\"citation web\">Dolan, Thomas (June 2003). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.cap.org\/apps\/portlets\/contentViewer\/show.do?printFriendly=true&contentReference=cap_today%2Ffeature_stories%2Foffice_labs.html\" target=\"_blank\">\"What lies in wait for office labs?\"<\/a>. <i>CAP Today<\/i>. College of American Pathologists<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.cap.org\/apps\/portlets\/contentViewer\/show.do?printFriendly=true&contentReference=cap_today%2Ffeature_stories%2Foffice_labs.html\" target=\"_blank\">http:\/\/www.cap.org\/apps\/portlets\/contentViewer\/show.do?printFriendly=true&contentReference=cap_today%2Ffeature_stories%2Foffice_labs.html<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=What+lies+in+wait+for+office+labs%3F&rft.atitle=CAP+Today&rft.aulast=Dolan%2C+Thomas&rft.au=Dolan%2C+Thomas&rft.date=June+2003&rft.pub=College+of+American+Pathologists&rft_id=http%3A%2F%2Fwww.cap.org%2Fapps%2Fportlets%2FcontentViewer%2Fshow.do%3FprintFriendly%3Dtrue%26contentReference%3Dcap_today%252Ffeature_stories%252Foffice_labs.html&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/li>\n<li> <span class=\"citation Journal\">Kotlarz, V. R. (January\u2013February 1998). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/10177215\" target=\"_blank\">\"Tracing our roots: origins of clinical laboratory science\"<\/a>. <i>Clinical Laboratory Science<\/i> <b>11<\/b> (1): 5\u20137. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" target=\"_blank\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/10177215\" target=\"_blank\">10177215<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/10177215\" target=\"_blank\">http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/10177215<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Tracing+our+roots%3A+origins+of+clinical+laboratory+science&rft.jtitle=Clinical+Laboratory+Science&rft.aulast=Kotlarz%2C+V.+R.&rft.au=Kotlarz%2C+V.+R.&rft.date=January%E2%80%93February+1998&rft.volume=11&rft.issue=1&rft.pages=5%E2%80%937&rft_id=info:pmid\/10177215&rft_id=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fpubmed%2F10177215&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/li>\n<li> <span class=\"citation book\">Welch, William Henry (1920). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/books.google.com\/books?id=utc0AQAAMAAJ&pg=200\" target=\"_blank\">\"The Evolution of Modern Scientific Laboratories\"<\/a>. <i>Papers and Addresses by William Henry Welch<\/i>. <b>3<\/b>. The Johns Hopkins Press. pp. 200\u2013211<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/books.google.com\/books?id=utc0AQAAMAAJ&pg=200\" target=\"_blank\">http:\/\/books.google.com\/books?id=utc0AQAAMAAJ&pg=200<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=The+Evolution+of+Modern+Scientific+Laboratories&rft.atitle=Papers+and+Addresses+by+William+Henry+Welch&rft.aulast=Welch%2C+William+Henry&rft.au=Welch%2C+William+Henry&rft.date=1920&rft.volume=3&rft.pages=pp.%26nbsp%3B200%E2%80%93211&rft.pub=The+Johns+Hopkins+Press&rft_id=http%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3Dutc0AQAAMAAJ%26pg%3D200&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-count references-column-count-3\" style=\"-moz-column-count: 3; -webkit-column-count: 3; column-count: 3; list-style-type: decimal;\">\n<ol class=\"references\">\n<li id=\"cite_note-CMSPOLDef-1\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CMSPOLDef_1-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.cms.gov\/Regulations-and-Guidance\/Guidance\/Manuals\/downloads\/clm104c16.pdf\" target=\"_blank\">\"Chapter 16 - Laboratory Services\"<\/a> (PDF). <i>Medicare Claims Processing Manual<\/i>. Centers for Medicare and Medicaid Services. 20 June 2013<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.cms.gov\/Regulations-and-Guidance\/Guidance\/Manuals\/downloads\/clm104c16.pdf\" target=\"_blank\">http:\/\/www.cms.gov\/Regulations-and-Guidance\/Guidance\/Manuals\/downloads\/clm104c16.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 3 April 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Chapter+16+-+Laboratory+Services&rft.atitle=Medicare+Claims+Processing+Manual&rft.date=20+June+2013&rft.pub=Centers+for+Medicare+and+Medicaid+Services&rft_id=http%3A%2F%2Fwww.cms.gov%2FRegulations-and-Guidance%2FGuidance%2FManuals%2Fdownloads%2Fclm104c16.pdf&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-WasPOLEP-2\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-WasPOLEP_2-0\" rel=\"external_link\">2.0<\/a><\/sup> <sup><a href=\"#cite_ref-WasPOLEP_2-1\" rel=\"external_link\">2.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.wadsworth.org\/labcert\/polep\/\" target=\"_blank\">\"Physician Office Laboratory Evaluation Program (POLEP)\"<\/a>. Wadsworth Center New York State Department of Health<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.wadsworth.org\/labcert\/polep\/\" target=\"_blank\">http:\/\/www.wadsworth.org\/labcert\/polep\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 3 April 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Physician+Office+Laboratory+Evaluation+Program+%28POLEP%29&rft.atitle=&rft.pub=Wadsworth+Center+New+York+State+Department+of+Health&rft_id=http%3A%2F%2Fwww.wadsworth.org%2Flabcert%2Fpolep%2F&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-CDPHLabs-3\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CDPHLabs_3-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.cdph.ca.gov\/programs\/lfs\/Documents\/POL-FAQ.pdf\" target=\"_blank\">\"Physician Office Laboratories or Clinics - Frequently Asked Questions about Clinical Laboratory Licensing and Registration\"<\/a> (PDF). California Department of Public Health. May 2008<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.cdph.ca.gov\/programs\/lfs\/Documents\/POL-FAQ.pdf\" target=\"_blank\">http:\/\/www.cdph.ca.gov\/programs\/lfs\/Documents\/POL-FAQ.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 3 April 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Physician+Office+Laboratories+or+Clinics+-+Frequently+Asked+Questions+about+Clinical+Laboratory+Licensing+and+Registration&rft.atitle=&rft.date=May+2008&rft.pub=California+Department+of+Public+Health&rft_id=http%3A%2F%2Fwww.cdph.ca.gov%2Fprograms%2Flfs%2FDocuments%2FPOL-FAQ.pdf&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-WalpertHow-4\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-WalpertHow_4-0\" rel=\"external_link\">4.0<\/a><\/sup> <sup><a href=\"#cite_ref-WalpertHow_4-1\" rel=\"external_link\">4.1<\/a><\/sup> <sup><a href=\"#cite_ref-WalpertHow_4-2\" rel=\"external_link\">4.2<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Walpert, Bryan (February 2000). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.acpinternist.org\/archives\/2000\/02\/officelab.htm\" target=\"_blank\">\"How an office lab can help patients\u2014and your income\"<\/a>. <i>ACP Internist<\/i>. American College of Physicians<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.acpinternist.org\/archives\/2000\/02\/officelab.htm\" target=\"_blank\">http:\/\/www.acpinternist.org\/archives\/2000\/02\/officelab.htm<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 29 July 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=How+an+office+lab+can+help+patients%E2%80%94and+your+income&rft.atitle=ACP+Internist&rft.aulast=Walpert%2C+Bryan&rft.au=Walpert%2C+Bryan&rft.date=February+2000&rft.pub=American+College+of+Physicians&rft_id=http%3A%2F%2Fwww.acpinternist.org%2Farchives%2F2000%2F02%2Fofficelab.htm&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-GarrelsLabTest-5\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-GarrelsLabTest_5-0\" rel=\"external_link\">5.0<\/a><\/sup> <sup><a href=\"#cite_ref-GarrelsLabTest_5-1\" rel=\"external_link\">5.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation book\">Garrels, Marti (2014). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/books.google.com\/books?id=O7bwAwAAQBAJ&pg=PA1\" target=\"_blank\">\"Chapter 1: Introduction to the Laboratory and Safety Training\"<\/a>. <i>Laboratory Testing for Ambulatory Settings<\/i> (2nd ed.). Elsevier Health Sciences. pp. 1\u201331. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" target=\"_blank\">ISBN<\/a> 9780323292375<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/books.google.com\/books?id=O7bwAwAAQBAJ&pg=PA1\" target=\"_blank\">http:\/\/books.google.com\/books?id=O7bwAwAAQBAJ&pg=PA1<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 29 July 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Chapter+1%3A+Introduction+to+the+Laboratory+and+Safety+Training&rft.atitle=Laboratory+Testing+for+Ambulatory+Settings&rft.aulast=Garrels%2C+Marti&rft.au=Garrels%2C+Marti&rft.date=2014&rft.pages=pp.%26nbsp%3B1%E2%80%9331&rft.edition=2nd&rft.pub=Elsevier+Health+Sciences&rft.isbn=9780323292375&rft_id=http%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DO7bwAwAAQBAJ%26pg%3DPA1&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-HHS14-6\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-HHS14_6-0\" rel=\"external_link\">6.0<\/a><\/sup> <sup><a href=\"#cite_ref-HHS14_6-1\" rel=\"external_link\">6.1<\/a><\/sup> <sup><a href=\"#cite_ref-HHS14_6-2\" rel=\"external_link\">6.2<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">U.S. Department of Health and Human Services (29 July 2014). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.hhs.gov\/news\/press\/2014pres\/02\/20140203a.html\" target=\"_blank\">\"HHS strengthens patients' right to access lab test reports\"<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.hhs.gov\/news\/press\/2014pres\/02\/20140203a.html\" target=\"_blank\">http:\/\/www.hhs.gov\/news\/press\/2014pres\/02\/20140203a.html<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=HHS+strengthens+patients%27+right+to+access+lab+test+reports&rft.atitle=&rft.aulast=U.S.+Department+of+Health+and+Human+Services&rft.au=U.S.+Department+of+Health+and+Human+Services&rft.date=29+July+2014&rft_id=http%3A%2F%2Fwww.hhs.gov%2Fnews%2Fpress%2F2014pres%2F02%2F20140203a.html&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-VAI1837-7\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-VAI1837_7-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Trustees of the Vermont Asylum for the Insane (October 1837). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/books.google.com\/books?id=EWAxAQAAMAAJ&pg=PA261\" target=\"_blank\"><i>First Annual Report of the Trustees of the Vermont Asylum for the Insane<\/i><\/a>. E. P. Walton and Son<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/books.google.com\/books?id=EWAxAQAAMAAJ&pg=PA261\" target=\"_blank\">http:\/\/books.google.com\/books?id=EWAxAQAAMAAJ&pg=PA261<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 April 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=First+Annual+Report+of+the+Trustees+of+the+Vermont+Asylum+for+the+Insane&rft.aulast=Trustees+of+the+Vermont+Asylum+for+the+Insane&rft.au=Trustees+of+the+Vermont+Asylum+for+the+Insane&rft.date=October+1837&rft.pub=E.+P.+Walton+and+Son&rft_id=http%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DEWAxAQAAMAAJ%26pg%3DPA261&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-MGH1898-8\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MGH1898_8-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Trustees of the Massachusetts General Hospital (1898). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/books.google.com\/books?id=dLk4AAAAYAAJ&pg=RA1-PA123\" target=\"_blank\"><i>Eighty-Fourth Annual Report of the Trustees of the Massachusetts General Hospital<\/i><\/a>. The Barta Press<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/books.google.com\/books?id=dLk4AAAAYAAJ&pg=RA1-PA123\" target=\"_blank\">http:\/\/books.google.com\/books?id=dLk4AAAAYAAJ&pg=RA1-PA123<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 April 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Eighty-Fourth+Annual+Report+of+the+Trustees+of+the+Massachusetts+General+Hospital&rft.aulast=Trustees+of+the+Massachusetts+General+Hospital&rft.au=Trustees+of+the+Massachusetts+General+Hospital&rft.date=1898&rft.pub=The+Barta+Press&rft_id=http%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DdLk4AAAAYAAJ%26pg%3DRA1-PA123&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-PapAddWelch-9\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-PapAddWelch_9-0\" rel=\"external_link\">9.0<\/a><\/sup> <sup><a href=\"#cite_ref-PapAddWelch_9-1\" rel=\"external_link\">9.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation book\">Welch, William Henry (1920). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/books.google.com\/books?id=utc0AQAAMAAJ&pg=200\" target=\"_blank\">\"The Evolution of Modern Scientific Laboratories\"<\/a>. <i>Papers and Addresses by William Henry Welch<\/i>. <b>3<\/b>. The Johns Hopkins Press. pp. 200\u2013211<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/books.google.com\/books?id=utc0AQAAMAAJ&pg=200\" target=\"_blank\">http:\/\/books.google.com\/books?id=utc0AQAAMAAJ&pg=200<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 April 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=The+Evolution+of+Modern+Scientific+Laboratories&rft.atitle=Papers+and+Addresses+by+William+Henry+Welch&rft.aulast=Welch%2C+William+Henry&rft.au=Welch%2C+William+Henry&rft.date=1920&rft.volume=3&rft.pages=pp.%26nbsp%3B200%E2%80%93211&rft.pub=The+Johns+Hopkins+Press&rft_id=http%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3Dutc0AQAAMAAJ%26pg%3D200&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-MMJSimon-10\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-MMJSimon_10-0\" rel=\"external_link\">10.0<\/a><\/sup> <sup><a href=\"#cite_ref-MMJSimon_10-1\" rel=\"external_link\">10.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Simon, Charles E. (9 May 1896). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/books.google.com\/books?id=dooRAAAAYAAJ&pg=PA55\" target=\"_blank\">\"The Importance of Laboratory Methods in Diagnosis\"<\/a>. <i>Maryland Medical Journal<\/i> <b>35<\/b> (4): 55\u201357<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/books.google.com\/books?id=dooRAAAAYAAJ&pg=PA55\" target=\"_blank\">http:\/\/books.google.com\/books?id=dooRAAAAYAAJ&pg=PA55<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 April 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=The+Importance+of+Laboratory+Methods+in+Diagnosis&rft.jtitle=Maryland+Medical+Journal&rft.aulast=Simon%2C+Charles+E.&rft.au=Simon%2C+Charles+E.&rft.date=9+May+1896&rft.volume=35&rft.issue=4&rft.pages=55%E2%80%9357&rft_id=http%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DdooRAAAAYAAJ%26pg%3DPA55&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-MedBullShoe-11\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-MedBullShoe_11-0\" rel=\"external_link\">11.0<\/a><\/sup> <sup><a href=\"#cite_ref-MedBullShoe_11-1\" rel=\"external_link\">11.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Shoemaker, John V. (ed.) (November 1884). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/books.google.com\/books?id=DmQWAAAAYAAJ&pg=PA277\" target=\"_blank\">\"Chemical Department at Jefferson Medical College\"<\/a>. <i>The Medical Bulletin: A Monthly Journal of Medicine and Surgery<\/i> <b>6<\/b> (11): 277\u2013278<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/books.google.com\/books?id=DmQWAAAAYAAJ&pg=PA277\" target=\"_blank\">http:\/\/books.google.com\/books?id=DmQWAAAAYAAJ&pg=PA277<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 April 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Chemical+Department+at+Jefferson+Medical+College&rft.jtitle=The+Medical+Bulletin%3A+A+Monthly+Journal+of+Medicine+and+Surgery&rft.aulast=Shoemaker%2C+John+V.+%28ed.%29&rft.au=Shoemaker%2C+John+V.+%28ed.%29&rft.date=November+1884&rft.volume=6&rft.issue=11&rft.pages=277%E2%80%93278&rft_id=http%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DDmQWAAAAYAAJ%26pg%3DPA277&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-EvoWellcome-12\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-EvoWellcome_12-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Wellcome, Henry S. (1911). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/catalog.hathitrust.org\/Record\/007935440\" target=\"_blank\">\"Chapter VI: The Advent of Scientific Urine Analysis\"<\/a>. <i>The Evolution of Urine Analysis: An Historical Sketch of the Clinical Examination of Urine<\/i>. Burroughs Wellcome & Co.<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/catalog.hathitrust.org\/Record\/007935440\" target=\"_blank\">http:\/\/catalog.hathitrust.org\/Record\/007935440<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 April 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Chapter+VI%3A+The+Advent+of+Scientific+Urine+Analysis&rft.atitle=The+Evolution+of+Urine+Analysis%3A+An+Historical+Sketch+of+the+Clinical+Examination+of+Urine&rft.aulast=Wellcome%2C+Henry+S.&rft.au=Wellcome%2C+Henry+S.&rft.date=1911&rft.pub=Burroughs+Wellcome+%26+Co.&rft_id=http%3A%2F%2Fcatalog.hathitrust.org%2FRecord%2F007935440&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-SomeAndrews-13\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-SomeAndrews_13-0\" rel=\"external_link\">13.0<\/a><\/sup> <sup><a href=\"#cite_ref-SomeAndrews_13-1\" rel=\"external_link\">13.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Andrews, J. W. (1897). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/books.google.com\/books?id=ZhcTAAAAYAAJ&pg=PA291\" target=\"_blank\">\"Some of the Minor Ailments of the Stomach and Their Remedies\"<\/a>. <i>Northwestern Lancet<\/i> <b>17<\/b>: 291\u2013294<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/books.google.com\/books?id=ZhcTAAAAYAAJ&pg=PA291\" target=\"_blank\">http:\/\/books.google.com\/books?id=ZhcTAAAAYAAJ&pg=PA291<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 April 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Some+of+the+Minor+Ailments+of+the+Stomach+and+Their+Remedies&rft.jtitle=Northwestern+Lancet&rft.aulast=Andrews%2C+J.+W.&rft.au=Andrews%2C+J.+W.&rft.date=1897&rft.volume=17&rft.pages=291%E2%80%93294&rft_id=http%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DZhcTAAAAYAAJ%26pg%3DPA291&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-EditorialElliott-14\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-EditorialElliott_14-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Elliott, L. B. (March 1898). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/books.google.com\/books?id=bcjRAAAAMAAJ&pg=PA57\" target=\"_blank\">\"Editorial\"<\/a>. <i>Journal of Applied Microscopy<\/i> <b>1<\/b> (3): 57\u201358<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/books.google.com\/books?id=bcjRAAAAMAAJ&pg=PA57\" target=\"_blank\">http:\/\/books.google.com\/books?id=bcjRAAAAMAAJ&pg=PA57<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 April 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Editorial&rft.jtitle=Journal+of+Applied+Microscopy&rft.aulast=Elliott%2C+L.+B.&rft.au=Elliott%2C+L.+B.&rft.date=March+1898&rft.volume=1&rft.issue=3&rft.pages=57%E2%80%9358&rft_id=http%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DbcjRAAAAMAAJ%26pg%3DPA57&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-NYMJKoplik-15\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-NYMJKoplik_15-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Koplik, Henry (01 August 1896). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/books.google.com\/books?id=M1s5AQAAMAAJ&pg=PA147\" target=\"_blank\">\"The Rapid and Bacteriological and Clinical Diagnosis of Diphtheria\"<\/a>. <i>The New York Medical Journal<\/i> <b>64<\/b>: 147\u2013151<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/books.google.com\/books?id=M1s5AQAAMAAJ&pg=PA147\" target=\"_blank\">http:\/\/books.google.com\/books?id=M1s5AQAAMAAJ&pg=PA147<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 April 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=The+Rapid+and+Bacteriological+and+Clinical+Diagnosis+of+Diphtheria&rft.jtitle=The+New+York+Medical+Journal&rft.aulast=Koplik%2C+Henry&rft.au=Koplik%2C+Henry&rft.date=01+August+1896&rft.volume=64&rft.pages=147%E2%80%93151&rft_id=http%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DM1s5AQAAMAAJ%26pg%3DPA147&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-MCCBartley-16\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MCCBartley_16-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Bartley, Elias H. (1899). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/books.google.com\/books?id=FqPVAAAAMAAJ&pg=PA53\" target=\"_blank\"><i>Manual of Clinical Chemistry<\/i><\/a>. P. Blakiston's Son & Co. p. 53<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/books.google.com\/books?id=FqPVAAAAMAAJ&pg=PA53\" target=\"_blank\">http:\/\/books.google.com\/books?id=FqPVAAAAMAAJ&pg=PA53<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 April 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Manual+of+Clinical+Chemistry&rft.aulast=Bartley%2C+Elias+H.&rft.au=Bartley%2C+Elias+H.&rft.date=1899&rft.pages=p.%26nbsp%3B53&rft.pub=P.+Blakiston%27s+Son+%26+Co&rft_id=http%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DFqPVAAAAMAAJ%26pg%3DPA53&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-POLHarrower-17\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-POLHarrower_17-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Harrower, Henry R. (July 1909). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/books.google.com\/books?id=CxIxAQAAMAAJ&pg=PA7\" target=\"_blank\">\"The Physician's Office Laboratory\"<\/a>. <i>Practical Therapeutics<\/i> <b>23<\/b> (1): 7\u201310<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/books.google.com\/books?id=CxIxAQAAMAAJ&pg=PA7\" target=\"_blank\">http:\/\/books.google.com\/books?id=CxIxAQAAMAAJ&pg=PA7<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 April 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=The+Physician%27s+Office+Laboratory&rft.jtitle=Practical+Therapeutics&rft.aulast=Harrower%2C+Henry+R.&rft.au=Harrower%2C+Henry+R.&rft.date=July+1909&rft.volume=23&rft.issue=1&rft.pages=7%E2%80%9310&rft_id=http%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DCxIxAQAAMAAJ%26pg%3DPA7&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-IC1901-18\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-IC1901_18-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Camac, C. N. B.; Cattell, Henry W. (ed.) (1901). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=TigSAAAAYAAJ&pg=PA289\" target=\"_blank\">\"The Clinical Laboratory in Private Practice and in the Physician's Office\"<\/a>. <i>International Clinics: A Quarterly of Clinical Lectures<\/i>. <b>3<\/b>. J.B. Lippincott Company. pp. 289\u2013299<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=TigSAAAAYAAJ&pg=PA289\" target=\"_blank\">https:\/\/books.google.com\/books?id=TigSAAAAYAAJ&pg=PA289<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 23 June 2017<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=The+Clinical+Laboratory+in+Private+Practice+and+in+the+Physician%27s+Office&rft.atitle=International+Clinics%3A+A+Quarterly+of+Clinical+Lectures&rft.aulast=Camac%2C+C.+N.+B.%3B+Cattell%2C+Henry+W.+%28ed.%29&rft.au=Camac%2C+C.+N.+B.%3B+Cattell%2C+Henry+W.+%28ed.%29&rft.date=1901&rft.volume=3&rft.issue=11&rft.pages=pp.%26nbsp%3B289%E2%80%93299&rft.pub=J.B.+Lippincott+Company&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DTigSAAAAYAAJ%26pg%3DPA289&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-TNHJan1921-19\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-TNHJan1921_19-0\" rel=\"external_link\">19.0<\/a><\/sup> <sup><a href=\"#cite_ref-TNHJan1921_19-1\" rel=\"external_link\">19.1<\/a><\/sup> <sup><a href=\"#cite_ref-TNHJan1921_19-2\" rel=\"external_link\">19.2<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">American Medical Association (5 November 1921). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/books.google.com\/books?id=dzMKAQAAMAAJ&pg=PA1498\" target=\"_blank\">\"Clinical Laboratory Service for Physicians\"<\/a>. <i>Journal of the American Medical Association<\/i> <b>77<\/b> (19): 1498\u20131499<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/books.google.com\/books?id=dzMKAQAAMAAJ&pg=PA1498\" target=\"_blank\">http:\/\/books.google.com\/books?id=dzMKAQAAMAAJ&pg=PA1498<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 5 April 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Clinical+Laboratory+Service+for+Physicians&rft.jtitle=Journal+of+the+American+Medical+Association&rft.aulast=American+Medical+Association&rft.au=American+Medical+Association&rft.date=5+November+1921&rft.volume=77&rft.issue=19&rft.pages=1498%E2%80%931499&rft_id=http%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DdzMKAQAAMAAJ%26pg%3DPA1498&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-PSMar1908-20\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-PSMar1908_20-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Saint Paul Medical Journal (March 1908). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/books.google.com\/books?id=E741AQAAMAAJ&pg=PA442\" target=\"_blank\">\"What We Owe to the Manufacturing Pharmacist and the Commercial Scientific Laboratory\"<\/a>. <i>The Physician and Surgeon<\/i> <b>30<\/b> (3): 130\u2013131<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/books.google.com\/books?id=E741AQAAMAAJ&pg=PA442\" target=\"_blank\">http:\/\/books.google.com\/books?id=E741AQAAMAAJ&pg=PA442<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 5 April 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=What+We+Owe+to+the+Manufacturing+Pharmacist+and+the+Commercial+Scientific+Laboratory&rft.jtitle=The+Physician+and+Surgeon&rft.aulast=Saint+Paul+Medical+Journal&rft.au=Saint+Paul+Medical+Journal&rft.date=March+1908&rft.volume=30&rft.issue=3&rft.pages=130%E2%80%93131&rft_id=http%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DE741AQAAMAAJ%26pg%3DPA442&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-TXTSep1952-21\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-TXTSep1952_21-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">The American Society of X-Ray Technicians (September 1952). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/books.google.com\/books?id=pMwvAQAAMAAJ\" target=\"_blank\">\"Unknown\"<\/a>. <i>The X-Ray Technician \/ Radiologic Technology<\/i> <b>24<\/b> (3): 251<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/books.google.com\/books?id=pMwvAQAAMAAJ\" target=\"_blank\">http:\/\/books.google.com\/books?id=pMwvAQAAMAAJ<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 5 April 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Unknown&rft.jtitle=The+X-Ray+Technician+%2F+Radiologic+Technology&rft.aulast=The+American+Society+of+X-Ray+Technicians&rft.au=The+American+Society+of+X-Ray+Technicians&rft.date=September+1952&rft.volume=24&rft.issue=3&rft.pages=251&rft_id=http%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DpMwvAQAAMAAJ&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-NYDH1953-22\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-NYDH1953_22-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">New York Dept. of Health (1953). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/books.google.com\/books?id=-5E4AAAAIAAJ\" target=\"_blank\">\"Annual Report of the Dept. of Health of the City of New York\"<\/a>. p. 72<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/books.google.com\/books?id=-5E4AAAAIAAJ\" target=\"_blank\">http:\/\/books.google.com\/books?id=-5E4AAAAIAAJ<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 5 April 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Annual+Report+of+the+Dept.+of+Health+of+the+City+of+New+York&rft.atitle=&rft.aulast=New+York+Dept.+of+Health&rft.au=New+York+Dept.+of+Health&rft.date=1953&rft.pages=p.+72&rft_id=http%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3D-5E4AAAAIAAJ&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-CodeLawsUS-23\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CodeLawsUS_23-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/books.google.com\/books?id=W-I5AAAAIAAJ&pg=PA533\" target=\"_blank\">\"US Code of Federal Regulations, Title 20, Part 405, Subpart M, Sections 1301\u20131316\"<\/a>. Office of the Federal Register. 01 January 1972<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/books.google.com\/books?id=W-I5AAAAIAAJ&pg=PA533\" target=\"_blank\">http:\/\/books.google.com\/books?id=W-I5AAAAIAAJ&pg=PA533<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 April 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=US+Code+of+Federal+Regulations%2C+Title+20%2C+Part+405%2C+Subpart+M%2C+Sections+1301%E2%80%931316&rft.atitle=&rft.date=01+January+1972&rft.pub=Office+of+the+Federal+Register&rft_id=http%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DW-I5AAAAIAAJ%26pg%3DPA533&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-MHSept1921-24\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MHSept1921_24-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Pettit, Roswell T. (September 1921). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/books.google.com\/books?id=tcsyAQAAMAAJ&pg=PA196\" target=\"_blank\">\"The Diagnostic Hospital of a Small Community\"<\/a>. <i>The Modern Hospital<\/i> <b>17<\/b> (3): 195\u2013199<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/books.google.com\/books?id=tcsyAQAAMAAJ&pg=PA196\" target=\"_blank\">http:\/\/books.google.com\/books?id=tcsyAQAAMAAJ&pg=PA196<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 5 April 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=The+Diagnostic+Hospital+of+a+Small+Community&rft.jtitle=The+Modern+Hospital&rft.aulast=Pettit%2C+Roswell+T.&rft.au=Pettit%2C+Roswell+T.&rft.date=September+1921&rft.volume=17&rft.issue=3&rft.pages=195%E2%80%93199&rft_id=http%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DtcsyAQAAMAAJ%26pg%3DPA196&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-TSJMOct1920-25\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-TSJMOct1920_25-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Taylor, Holman (ed.) (October 1920). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/books.google.com\/books?id=LbEDAAAAYAAJ&pg=PA229\" target=\"_blank\">\"Advertising Medical Laboratories (Encore)\"<\/a>. <i>Texas State Journal of Medicine<\/i> <b>16<\/b> (6): 229\u2013230<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/books.google.com\/books?id=LbEDAAAAYAAJ&pg=PA229\" target=\"_blank\">http:\/\/books.google.com\/books?id=LbEDAAAAYAAJ&pg=PA229<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 5 April 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Advertising+Medical+Laboratories+%28Encore%29&rft.jtitle=Texas+State+Journal+of+Medicine&rft.aulast=Taylor%2C+Holman+%28ed.%29&rft.au=Taylor%2C+Holman+%28ed.%29&rft.date=October+1920&rft.volume=16&rft.issue=6&rft.pages=229%E2%80%93230&rft_id=http%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DLbEDAAAAYAAJ%26pg%3DPA229&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-NYSJMOct1921-26\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-NYSJMOct1921_26-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Sondern, Frederic E. (ed.) (October 1921). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/books.google.com\/books?id=j7hYAAAAYAAJ&pg=PA390\" target=\"_blank\">\"Commercial Laboratories\"<\/a>. <i>New York State Journal of Medicine<\/i> <b>21<\/b> (10): 390<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/books.google.com\/books?id=j7hYAAAAYAAJ&pg=PA390\" target=\"_blank\">http:\/\/books.google.com\/books?id=j7hYAAAAYAAJ&pg=PA390<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 5 April 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Commercial+Laboratories&rft.jtitle=New+York+State+Journal+of+Medicine&rft.aulast=Sondern%2C+Frederic+E.+%28ed.%29&rft.au=Sondern%2C+Frederic+E.+%28ed.%29&rft.date=October+1921&rft.volume=21&rft.issue=10&rft.pages=390&rft_id=http%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3Dj7hYAAAAYAAJ%26pg%3DPA390&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-KMJAug1922-27\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-KMJAug1922_27-0\" rel=\"external_link\">27.0<\/a><\/sup> <sup><a href=\"#cite_ref-KMJAug1922_27-1\" rel=\"external_link\">27.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">White, Courtland Y. (August 1922). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/books.google.com\/books?id=OTMTAAAAYAAJ&pg=PA755\" target=\"_blank\">\"The Role of the Nonmedical Graduate in the Medical Laboratory\"<\/a>. <i>Kentucky Medical Journal<\/i> <b>25<\/b> (11): 755\u2013760<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/books.google.com\/books?id=OTMTAAAAYAAJ&pg=PA755\" target=\"_blank\">http:\/\/books.google.com\/books?id=OTMTAAAAYAAJ&pg=PA755<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 5 April 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=The+Role+of+the+Nonmedical+Graduate+in+the+Medical+Laboratory&rft.jtitle=Kentucky+Medical+Journal&rft.aulast=White%2C+Courtland+Y.&rft.au=White%2C+Courtland+Y.&rft.date=August+1922&rft.volume=25&rft.issue=11&rft.pages=755%E2%80%93760&rft_id=http%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DOTMTAAAAYAAJ%26pg%3DPA755&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-BMSJMar1922-28\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-BMSJMar1922_28-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Sundelof, E. M. (30 March 1922). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/books.google.com\/books?id=E741AQAAMAAJ&pg=PA442\" target=\"_blank\">\"The Business Side of X-ray Diagnosis and Treatment\"<\/a>. <i>The Boston Medical and Surgical Journal<\/i> <b>186<\/b> (13): 442\u2013444<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/books.google.com\/books?id=E741AQAAMAAJ&pg=PA442\" target=\"_blank\">http:\/\/books.google.com\/books?id=E741AQAAMAAJ&pg=PA442<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 5 April 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=The+Business+Side+of+X-ray+Diagnosis+and+Treatment&rft.jtitle=The+Boston+Medical+and+Surgical+Journal&rft.aulast=Sundelof%2C+E.+M.&rft.au=Sundelof%2C+E.+M.&rft.date=30+March+1922&rft.volume=186&rft.issue=13&rft.pages=442%E2%80%93444&rft_id=http%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DE741AQAAMAAJ%26pg%3DPA442&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-KMJDec1922-29\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-KMJDec1922_29-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Jones, Vernon R. (December 1922). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/books.google.com\/books?id=WOcvAQAAMAAJ&pg=PA839\" target=\"_blank\">\"The County and Community Diagnostic Laboratory\"<\/a>. <i>Kentucky Medical Journal<\/i> <b>20<\/b> (12): 836\u2013841<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/books.google.com\/books?id=WOcvAQAAMAAJ&pg=PA839\" target=\"_blank\">http:\/\/books.google.com\/books?id=WOcvAQAAMAAJ&pg=PA839<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 5 April 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=The+County+and+Community+Diagnostic+Laboratory&rft.jtitle=Kentucky+Medical+Journal&rft.aulast=Jones%2C+Vernon+R.&rft.au=Jones%2C+Vernon+R.&rft.date=December+1922&rft.volume=20&rft.issue=12&rft.pages=836%E2%80%93841&rft_id=http%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DWOcvAQAAMAAJ%26pg%3DPA839&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-JNDAVol81921-30\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-JNDAVol81921_30-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Sears, Victor H. (January 1921). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/books.google.com\/books?id=vcoyAQAAMAAJ&pg=PA68\" target=\"_blank\">\"Need and Means of Educating Laboratory Assistants\"<\/a>. <i>The Journal of the National Dental Association<\/i> <b>8<\/b> (1): 65\u201368<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/books.google.com\/books?id=vcoyAQAAMAAJ&pg=PA68\" target=\"_blank\">http:\/\/books.google.com\/books?id=vcoyAQAAMAAJ&pg=PA68<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 5 April 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Need+and+Means+of+Educating+Laboratory+Assistants&rft.jtitle=The+Journal+of+the+National+Dental+Association&rft.aulast=Sears%2C+Victor+H.&rft.au=Sears%2C+Victor+H.&rft.date=January+1921&rft.volume=8&rft.issue=1&rft.pages=65%E2%80%9368&rft_id=http%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DvcoyAQAAMAAJ%26pg%3DPA68&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-SciTechSocs-31\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-SciTechSocs_31-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">National Academy of Sciences, National Research Council - Canada (1955). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/books.google.com\/books?id=3lIZAAAAYAAJ&pg=PA100\" target=\"_blank\"><i>Scientific and Technical Societies of the United States and Canada<\/i><\/a>. National Academies. pp. 100\u2013101<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/books.google.com\/books?id=3lIZAAAAYAAJ&pg=PA100\" target=\"_blank\">http:\/\/books.google.com\/books?id=3lIZAAAAYAAJ&pg=PA100<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 9 April 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Scientific+and+Technical+Societies+of+the+United+States+and+Canada&rft.aulast=National+Academy+of+Sciences%2C+National+Research+Council+-+Canada&rft.au=National+Academy+of+Sciences%2C+National+Research+Council+-+Canada&rft.date=1955&rft.pages=pp.%26nbsp%3B100%E2%80%93101&rft.pub=National+Academies&rft_id=http%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3D3lIZAAAAYAAJ%26pg%3DPA100&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-KotlarzRoots-32\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-KotlarzRoots_32-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Kotlarz, V. R. (January\u2013February 1998). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/10177215\" target=\"_blank\">\"Tracing our roots: origins of clinical laboratory science\"<\/a>. <i>Clinical Laboratory Science<\/i> <b>11<\/b> (1): 5\u20137. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" target=\"_blank\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/10177215\" target=\"_blank\">10177215<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/10177215\" target=\"_blank\">http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/10177215<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 10 April 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Tracing+our+roots%3A+origins+of+clinical+laboratory+science&rft.jtitle=Clinical+Laboratory+Science&rft.aulast=Kotlarz%2C+V.+R.&rft.au=Kotlarz%2C+V.+R.&rft.date=January%E2%80%93February+1998&rft.volume=11&rft.issue=1&rft.pages=5%E2%80%937&rft_id=info:pmid\/10177215&rft_id=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fpubmed%2F10177215&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-100Med-33\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-100Med_33-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Haagensen, Cushman Davis; Lloyd, Wyndham Edward Buckley (1943). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/books.google.com\/books?id=c_wze-n-y2oC&pg=PA375\" target=\"_blank\">\"Chapter 37: The Doctors' Dilemma\"<\/a>. <i>A Hundred Years of Medicine<\/i>. Beard Books. pp. 375\u2013412. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" target=\"_blank\">ISBN<\/a> 9781587980879<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/books.google.com\/books?id=c_wze-n-y2oC&pg=PA375\" target=\"_blank\">http:\/\/books.google.com\/books?id=c_wze-n-y2oC&pg=PA375<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 9 April 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Chapter+37%3A+The+Doctors%27+Dilemma&rft.atitle=A+Hundred+Years+of+Medicine&rft.aulast=Haagensen%2C+Cushman+Davis%3B+Lloyd%2C+Wyndham+Edward+Buckley&rft.au=Haagensen%2C+Cushman+Davis%3B+Lloyd%2C+Wyndham+Edward+Buckley&rft.date=1943&rft.pages=pp.%26nbsp%3B375%E2%80%93412&rft.pub=Beard+Books&rft.isbn=9781587980879&rft_id=http%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3Dc_wze-n-y2oC%26pg%3DPA375&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-IntroExpMed-34\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-IntroExpMed_34-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Bernard, Claude (1957). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/books.google.com\/books?id=MIx8D61JlboC&pg=PA140\" target=\"_blank\">\"Part Two, Chapter X: The Physiologist's Laboratory and Various Methods Necessary to the Study of Experimental Medicine\"<\/a>. <i>An Introduction to the Study of Experimental Medicine<\/i>. Courier Dover Publications. pp. 140\u2013150. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" target=\"_blank\">ISBN<\/a> 9780486204000<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/books.google.com\/books?id=MIx8D61JlboC&pg=PA140\" target=\"_blank\">http:\/\/books.google.com\/books?id=MIx8D61JlboC&pg=PA140<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 9 April 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Part+Two%2C+Chapter+X%3A+The+Physiologist%27s+Laboratory+and+Various+Methods+Necessary+to+the+Study+of+Experimental+Medicine&rft.atitle=An+Introduction+to+the+Study+of+Experimental+Medicine&rft.aulast=Bernard%2C+Claude&rft.au=Bernard%2C+Claude&rft.date=1957&rft.pages=pp.%26nbsp%3B140%E2%80%93150&rft.pub=Courier+Dover+Publications&rft.isbn=9780486204000&rft_id=http%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DMIx8D61JlboC%26pg%3DPA140&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-LIFEMedTech-35\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-LIFEMedTech_35-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Street, Charlotte (21 October 1957). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/books.google.com\/books?id=QFYEAAAAMBAJ&pg=PA60\" target=\"_blank\">\"Should your child be a Medical Technologist?\"<\/a>. <i>LIFE<\/i> <b>43<\/b> (17): 60\u201361<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/books.google.com\/books?id=QFYEAAAAMBAJ&pg=PA60\" target=\"_blank\">http:\/\/books.google.com\/books?id=QFYEAAAAMBAJ&pg=PA60<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 9 April 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Should+your+child+be+a+Medical+Technologist%3F&rft.jtitle=LIFE&rft.aulast=Street%2C+Charlotte&rft.au=Street%2C+Charlotte&rft.date=21+October+1957&rft.volume=43&rft.issue=17&rft.pages=60%E2%80%9361&rft_id=http%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DQFYEAAAAMBAJ%26pg%3DPA60&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-NewSciMedTech-36\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-NewSciMedTech_36-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Lavington, R. J. (23 January 1958). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/books.google.com\/books?id=AIAjKi5RaBQC&pg=PA37\" target=\"_blank\">\"A Guide to Careers: No. 61 - Medical laboratory technology\"<\/a>. <i>The New Scientist<\/i> <b>3<\/b> (62): 37<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/books.google.com\/books?id=AIAjKi5RaBQC&pg=PA37\" target=\"_blank\">http:\/\/books.google.com\/books?id=AIAjKi5RaBQC&pg=PA37<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 9 April 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=A+Guide+to+Careers%3A+No.+61+-+Medical+laboratory+technology&rft.jtitle=The+New+Scientist&rft.aulast=Lavington%2C+R.+J.&rft.au=Lavington%2C+R.+J.&rft.date=23+January+1958&rft.volume=3&rft.issue=62&rft.pages=37&rft_id=http%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DAIAjKi5RaBQC%26pg%3DPA37&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-CLIA67Doc-37\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CLIA67Doc_37-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.gpo.gov\/fdsys\/pkg\/STATUTE-81\/pdf\/STATUTE-81-Pg533.pdf\" target=\"_blank\">\"Public Law 90-174\"<\/a> (PDF). <i>United States Statutes at Large, Volume 81<\/i>. 1967<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.gpo.gov\/fdsys\/pkg\/STATUTE-81\/pdf\/STATUTE-81-Pg533.pdf\" target=\"_blank\">http:\/\/www.gpo.gov\/fdsys\/pkg\/STATUTE-81\/pdf\/STATUTE-81-Pg533.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 24 March 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Public+Law+90-174&rft.atitle=United+States+Statutes+at+Large%2C+Volume+81&rft.date=1967&rft_id=http%3A%2F%2Fwww.gpo.gov%2Ffdsys%2Fpkg%2FSTATUTE-81%2Fpdf%2FSTATUTE-81-Pg533.pdf&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-LiesekeEss-38\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-LiesekeEss_38-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Lieseke, Constance L.; Zeibig, Elizabeth A. (2012). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/books.google.com\/books?id=IX_2AAAAQBAJ&pg=PA29\" target=\"_blank\"><i>Essentials Of Medical Laboratory Practice<\/i><\/a>. F. A. Davis. p. 29. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" target=\"_blank\">ISBN<\/a> 9780803630352<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/books.google.com\/books?id=IX_2AAAAQBAJ&pg=PA29\" target=\"_blank\">http:\/\/books.google.com\/books?id=IX_2AAAAQBAJ&pg=PA29<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 10 April 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Essentials+Of+Medical+Laboratory+Practice&rft.aulast=Lieseke%2C+Constance+L.%3B+Zeibig%2C+Elizabeth+A.&rft.au=Lieseke%2C+Constance+L.%3B+Zeibig%2C+Elizabeth+A.&rft.date=2012&rft.pages=p.%26nbsp%3B29&rft.pub=F.+A.+Davis&rft.isbn=9780803630352&rft_id=http%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DIX_2AAAAQBAJ%26pg%3DPA29&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-PeddClinLab-39\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-PeddClinLab_39-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Peddecord, K. Michael; Hammond, Herbert C. (December 1990). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.clinchem.org\/content\/36\/12\/2027.full.pdf\" target=\"_blank\">\"Clinical Laboratory Regulation under the Clinical Laboratory Improvement Amendments of 1988: Can It Be Done?\"<\/a> (PDF). <i>Clinical Chemistry<\/i> <b>36<\/b> (12): 2027\u20132035. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" target=\"_blank\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/2253342\" target=\"_blank\">2253342<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.clinchem.org\/content\/36\/12\/2027.full.pdf\" target=\"_blank\">http:\/\/www.clinchem.org\/content\/36\/12\/2027.full.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 10 April 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Clinical+Laboratory+Regulation+under+the+Clinical+Laboratory+Improvement+Amendments+of+1988%3A+Can+It+Be+Done%3F&rft.jtitle=Clinical+Chemistry&rft.aulast=Peddecord%2C+K.+Michael%3B+Hammond%2C+Herbert+C.&rft.au=Peddecord%2C+K.+Michael%3B+Hammond%2C+Herbert+C.&rft.date=December+1990&rft.volume=36&rft.issue=12&rft.pages=2027%E2%80%932035&rft_id=info:pmid\/2253342&rft_id=http%3A%2F%2Fwww.clinchem.org%2Fcontent%2F36%2F12%2F2027.full.pdf&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-HRS65-40\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-HRS65_40-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">National Center for Health Statistics (1965). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/babel.hathitrust.org\/cgi\/pt?id=mdp.39015068164634;view=1up;seq=44\" target=\"_blank\"><i>Health Resources Statistics<\/i><\/a>. U.S. Dept. of Health, Education, and Welfare; Public Health Service. p. 38<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/babel.hathitrust.org\/cgi\/pt?id=mdp.39015068164634;view=1up;seq=44\" target=\"_blank\">http:\/\/babel.hathitrust.org\/cgi\/pt?id=mdp.39015068164634;view=1up;seq=44<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 April 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Health+Resources+Statistics&rft.aulast=National+Center+for+Health+Statistics&rft.au=National+Center+for+Health+Statistics&rft.date=1965&rft.pages=p.%26nbsp%3B38&rft.pub=U.S.+Dept.+of+Health%2C+Education%2C+and+Welfare%3B+Public+Health+Service&rft_id=http%3A%2F%2Fbabel.hathitrust.org%2Fcgi%2Fpt%3Fid%3Dmdp.39015068164634%3Bview%3D1up%3Bseq%3D44&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-C.26EN63-41\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-C.26EN63_41-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Chemical & Engineering News (15 July 1963). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/pubs.acs.org\/doi\/abs\/10.1021\/cen-v041n028.p102\" target=\"_blank\">\"The Chemist in the Clinical Lab\"<\/a>. <i>Chemical & Engineering News<\/i> <b>41<\/b> (28): 102\u2013118. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" target=\"_blank\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1021%2Fcen-v041n028.p102\" target=\"_blank\">10.1021\/cen-v041n028.p102<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/pubs.acs.org\/doi\/abs\/10.1021\/cen-v041n028.p102\" target=\"_blank\">http:\/\/pubs.acs.org\/doi\/abs\/10.1021\/cen-v041n028.p102<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=The+Chemist+in+the+Clinical+Lab&rft.jtitle=Chemical+%26+Engineering+News&rft.aulast=Chemical+%26+Engineering+News&rft.au=Chemical+%26+Engineering+News&rft.date=15+July+1963&rft.volume=41&rft.issue=28&rft.pages=102%E2%80%93118&rft_id=info:doi\/10.1021%2Fcen-v041n028.p102&rft_id=http%3A%2F%2Fpubs.acs.org%2Fdoi%2Fabs%2F10.1021%2Fcen-v041n028.p102&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-HRS76-77-42\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-HRS76-77_42-0\" rel=\"external_link\">42.0<\/a><\/sup> <sup><a href=\"#cite_ref-HRS76-77_42-1\" rel=\"external_link\">42.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation book\">National Center for Health Statistics (1976\u201377). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/babel.hathitrust.org\/cgi\/pt?id=mdp.39015068164634;view=1up;seq=44\" target=\"_blank\"><i>Health Resources Statistics<\/i><\/a>. U.S. Dept. of Health, Education, and Welfare; Public Health Service. p. 49; 359\u2013361<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/babel.hathitrust.org\/cgi\/pt?id=mdp.39015068164634;view=1up;seq=44\" target=\"_blank\">http:\/\/babel.hathitrust.org\/cgi\/pt?id=mdp.39015068164634;view=1up;seq=44<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 April 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Health+Resources+Statistics&rft.aulast=National+Center+for+Health+Statistics&rft.au=National+Center+for+Health+Statistics&rft.date=1976%E2%80%9377&rft.pages=p.%26nbsp%3B49%3B+359%E2%80%93361&rft.pub=U.S.+Dept.+of+Health%2C+Education%2C+and+Welfare%3B+Public+Health+Service&rft_id=http%3A%2F%2Fbabel.hathitrust.org%2Fcgi%2Fpt%3Fid%3Dmdp.39015068164634%3Bview%3D1up%3Bseq%3D44&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-StJohnImprove-43\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-StJohnImprove_43-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">St. John, Tina M.; Lipman, Harvey B.; Krolak, John M.; Hearn, Thomas L. (2000). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.archivesofpathology.org\/doi\/full\/10.1043\/0003-9985%282000%29124%3C1066:IIPSOL%3E2.0.CO;2\" target=\"_blank\">\"Improvement in Physician's Office Laboratory Practices, 1989\u20131994\"<\/a>. <i>Archives of Pathology & Laboratory Medicine<\/i> <b>124<\/b> (7): 1066\u20131073. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" target=\"_blank\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/10888785\" target=\"_blank\">10888785<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.archivesofpathology.org\/doi\/full\/10.1043\/0003-9985%282000%29124%3C1066:IIPSOL%3E2.0.CO;2\" target=\"_blank\">http:\/\/www.archivesofpathology.org\/doi\/full\/10.1043\/0003-9985%282000%29124%3C1066:IIPSOL%3E2.0.CO;2<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 17 April 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Improvement+in+Physician%27s+Office+Laboratory+Practices%2C+1989%E2%80%931994&rft.jtitle=Archives+of+Pathology+%26+Laboratory+Medicine&rft.aulast=St.+John%2C+Tina+M.%3B+Lipman%2C+Harvey+B.%3B+Krolak%2C+John+M.%3B+Hearn%2C+Thomas+L.&rft.au=St.+John%2C+Tina+M.%3B+Lipman%2C+Harvey+B.%3B+Krolak%2C+John+M.%3B+Hearn%2C+Thomas+L.&rft.date=2000&rft.volume=124&rft.issue=7&rft.pages=1066%E2%80%931073&rft_id=info:pmid\/10888785&rft_id=http%3A%2F%2Fwww.archivesofpathology.org%2Fdoi%2Ffull%2F10.1043%2F0003-9985%25282000%2529124%253C1066%3AIIPSOL%253E2.0.CO%3B2&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-GallivanPhys-44\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-GallivanPhys_44-0\" rel=\"external_link\">44.0<\/a><\/sup> <sup><a href=\"#cite_ref-GallivanPhys_44-1\" rel=\"external_link\">44.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Gallivan, Mary (16 October 1985). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/3899902\" target=\"_blank\">\"Physician offices invade clinical laboratory market\"<\/a>. <i>Hospitals<\/i> <b>59<\/b> (20): 84, 89, 92\u20134. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" target=\"_blank\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/3899902\" target=\"_blank\">3899902<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/3899902\" target=\"_blank\">http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/3899902<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 4 April 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Physician+offices+invade+clinical+laboratory+market&rft.jtitle=Hospitals&rft.aulast=Gallivan%2C+Mary&rft.au=Gallivan%2C+Mary&rft.date=16+October+1985&rft.volume=59&rft.issue=20&rft.pages=84%2C+89%2C+92%E2%80%934&rft_id=info:pmid\/3899902&rft_id=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fpubmed%2F3899902&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-CuminsInOff-45\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CuminsInOff_45-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Cumins, L. (September 1984). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/10267706\" target=\"_blank\">\"The In-Office Laboratory: Benefits for You and Your Patients\"<\/a>. <i>Computers in Healthcare<\/i> <b>5<\/b> (9): 60\u20132. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" target=\"_blank\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/10267706\" target=\"_blank\">10267706<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/10267706\" target=\"_blank\">http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/10267706<\/a><\/span><span class=\"reference-accessdate\">. 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Retrieved 4 April 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Are+physician+labs+a+competitive+threat%3F&rft.jtitle=Hospitals&rft.aulast=Wilkinson%2C+Richard&rft.au=Wilkinson%2C+Richard&rft.date=20+April+1987&rft.volume=61&rft.issue=8&rft.pages=96%2C+98&rft_id=info:pmid\/3557409&rft_id=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fpubmed%2F3557409&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-HHS89-47\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-HHS89_47-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Kusserow, R. P. (March 1989). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/oig.hhs.gov\/oei\/reports\/oai-05-88-00330.pdf\" target=\"_blank\"><i>Quality assurance in physician office labs<\/i><\/a>. OAI-0588-00330. U.S. Department of Health and Human Services, Office of Analysis and Inspections<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/oig.hhs.gov\/oei\/reports\/oai-05-88-00330.pdf\" target=\"_blank\">https:\/\/oig.hhs.gov\/oei\/reports\/oai-05-88-00330.pdf<\/a><\/span><span class=\"reference-accessdate\">. 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Retrieved 29 July 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Physician+Office+Laboratory+%28POL%29+Testing+Markets+Worldwide%3A+Status+Quo+and+Future+Trends&rft.atitle=&rft.date=01+November+2010&rft.pub=Kalorama+Information&rft_id=http%3A%2F%2Fwww.kaloramainformation.com%2FPhysician-Office-Laboratory-2807838%2F&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-TransparencyPOL-66\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-TransparencyPOL_66-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.transparencymarketresearch.com\/pol-testing-market.html\" target=\"_blank\">\"Physician Office Laboratory (POL) Testing Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast, 2013 - 2019\"<\/a>. Transparency Market Research<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.transparencymarketresearch.com\/pol-testing-market.html\" target=\"_blank\">http:\/\/www.transparencymarketresearch.com\/pol-testing-market.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 29 July 2014<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Physician+Office+Laboratory+%28POL%29+Testing+Market+-+Global+Industry+Analysis%2C+Size%2C+Share%2C+Growth%2C+Trends+and+Forecast%2C+2013+-+2019&rft.atitle=&rft.pub=Transparency+Market+Research&rft_id=http%3A%2F%2Fwww.transparencymarketresearch.com%2Fpol-testing-market.html&rfr_id=info:sid\/en.wikipedia.org:Physician_office_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<\/ol><\/div>\n\n<!-- \nNewPP limit report\nCached time: 20181213192740\nCache expiry: 86400\nDynamic content: false\nCPU time usage: 1.401 seconds\nReal time usage: 2.304 seconds\nPreprocessor visited node count: 46727\/1000000\nPreprocessor generated node count: 33939\/1000000\nPost\u2010expand include size: 327563\/2097152 bytes\nTemplate argument size: 122121\/2097152 bytes\nHighest expansion depth: 14\/40\nExpensive parser function count: 1\/100\n-->\n\n<!-- \nTransclusion expansion time report (%,ms,calls,template)\n100.00% 1295.501 1 - -total\n 89.54% 1160.050 1 - Template:Reflist\n 85.13% 1102.843 70 - Template:Citation\/core\n 43.73% 566.513 33 - Template:Cite_journal\n 25.37% 328.731 22 - Template:Cite_web\n 20.77% 269.120 15 - Template:Cite_book\n 4.60% 59.581 86 - Template:Citation\/make_link\n 1.89% 24.455 15 - Template:Citation\/identifier\n 1.46% 18.950 1 - Template:As_of\n 1.12% 14.482 1 - Template:DMCA\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:4935-0!*!0!!en!5!* and timestamp 20181213192738 and revision id 30818\n -->\n<\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Physician_office_laboratory\">https:\/\/www.limswiki.org\/index.php\/Physician_office_laboratory<\/a><\/div>\n\t\t\t\t\t\t\t\t\t\t<!-- end content -->\n\t\t\t\t\t\t\t\t\t\t<div class=\"visualClear\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t<!-- end of the left (by default at least) column -->\n\t\t<div class=\"visualClear\"><\/div>\n\t\t\t\t\t\n\t\t<\/div>\n\t\t\n\n<\/body>","0655647b0091e0dd168f162b621a6cef_images":["https:\/\/www.limswiki.org\/images\/9\/9f\/Johannes_Cordua_Arzt_in_seinem_Studierzimmer.jpg","https:\/\/www.limswiki.org\/images\/a\/a4\/Urinalysis_evolution_90.jpg","https:\/\/upload.wikimedia.org\/wikipedia\/commons\/1\/1d\/CBC_report.JPG"],"0655647b0091e0dd168f162b621a6cef_timestamp":1544729258,"307bcdf1bdbcd1bb167cee435b7a5463_type":"article","307bcdf1bdbcd1bb167cee435b7a5463_title":"Clinical laboratory","307bcdf1bdbcd1bb167cee435b7a5463_url":"https:\/\/www.limswiki.org\/index.php\/Clinical_laboratory","307bcdf1bdbcd1bb167cee435b7a5463_plaintext":"\n\n\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\n\t\t\t\tClinical laboratory\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\tFrom LIMSWiki\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\tJump to: navigation, search\n\n\t\t\t\t\t\n\t\t\t\t\t The clinical\/medical laboratory plays a vital role in the diagnosis of disease in the human and animal population.\nA clinical laboratory (sometimes referred to as a medical laboratory) is a laboratory where tests are done on clinical specimens in order to get information about the health of a patient as pertaining to the diagnosis, treatment, and prevention of disease.[1] The Clinical Laboratory Improvement Amendments (CLIA) program defines a clinical (medical) laboratory as \"a facility that performs testing on materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or assessment of the health of, human beings.\"[2]\n\nContents\n\n1 Basics of operations \n2 Government regulatory bodies \n\n2.1 Other certifying bodies \n\n\n3 Classification of tests performed by clinical laboratories \n\n3.1 FDA-approved \n3.2 Laboratory-developed \n\n\n4 HIPAA regulations \n5 Medicare regulations (CLIA) \n6 Laboratory information systems \n7 Further reading \n8 Notes \n9 References \n\n\n\nBasics of operations \nThe clinical laboratory at one level, whether chemistry or pathology, operates like many other testing laboratories. However, there are a number of operational differences between the clinical laboratory and the many other laboratories. One of these differences is the need to have a specific unidirectional workflow. This is intended to both minimize the risk of biohazard contamination, and to establish assurance that samples cross contamination is minimized.[3][4] Another difference, addressed below, concerns the regulations governing the management of patient data. This creates a significant challenge not generally experienced by other types of laboratories.\n\nGovernment regulatory bodies \nIn the United States, clinical laboratories are primarily regulated by the Department of Health and Human Services. Inside that infrastructure are sub-entities like the Centers for Disease Control and Prevention (CDC) and the Centers for Medicare and Medicaid Services (CMS) to apply standards and regulations through their respective Laboratory Quality Assurance and Standardization Programs and Clinical Laboratory Improvement Amendments (CLIA).[5][6][7] Although generally not as strict as the regulations regarding pharmaceutical and diagnostic manufacturers, they nonetheless establish a significant hurdle to managing the overall operations of the laboratory, from acquiring customers to acquiring samples, to testing, reporting results, and handling billing for the completed tests.\nInternationally, regulatory bodies vary from country to country. However, organizations like the not-for-profit Clinical and Laboratory Standards Institute (CLSI)[8] and associations like the Research Quality Association (RQA)[9] exist to promote a more global approach to regulations and guidance affecting clinical laboratories. Additionally, a set of Good Clinical Laboratory Practice standards \u2014 originally developed in 2002 and since adopted by the World Health Organisation (WHO), non-governmental organisations (NGOs), and research institutions worldwide \u2014 provide guidance on implementing laboratory practices that are critical for laboratory operations around the world.[10][11]\n\nOther certifying bodies \nFor certifications and guidelines that affect laboratory safety, please see the standards and guidance section of the laboratory entry.\nMany laboratories, especially pathology laboratories, will seek accreditation from the College of American Pathologists. This organization has a more extensive set of laboratory certification requirements than those contained within the CLIA regulations.\n\nClassification of tests performed by clinical laboratories \nClinical laboratories perform basically two classes of tests: FDA-approved and laboratory-developed. \n\nFDA-approved \nThe U.S. Food and Drug Administration (FDA) regulates the \"reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.\" This type of test equipment is referred to by the FDA as an in vitro diagnostic product (IVD), \"intended for use in the collection, preparation, and examination of specimens taken from the human body.\"[12] These testing products are classified into three different levels: Class I, II, and III. These classifications reflect the risk associated with erroneous results as well as the complexity of the test. Class I tests are frequently exempt from FDA review and approval, while Class II and III tests are not. Class III tests tend to require extensive review and approval, including extensive evaluation of clinical data associated with the test.[12][13]\n\nLaboratory-developed \nLaboratory-developed tests are not generally marketed; they are usually performed by only a small number of laboratories. While these developed tests don't currently require FDA review and approval, there is increasing pressure on the FDA to maintain oversight of these tests. In addition, laboratory-developed tests may not be covered by insurance programs such as Medicare, and thus they may have more limited market penetration compared to an FDA-approved test.[13]\n\nHIPAA regulations \nThe Health Insurance Portability and Accountability Act was passed in 1996, with the initial objective to address problems associated with benefits upon retirement, as well as other legal issues around the delivery of healthcare. In 2003, the privacy rule came into effect. The privacy rule has become the best known provision of HIPAA, and has significant impact on the operations of the clinical laboratory, in particular the data handling\/records management aspect of the laboratory operations.\nThe general principal that the HIPAA privacy regulations establish is that personal data needs to be protected. The general requirement is that data that can be used to identify an individual has to be handled in such a way that it is only connected with healthcare related information for the minimum necessary number of individuals required to execute the required healthcare related activities for the patient.[14]\n\nMedicare regulations (CLIA) \nIn 1988, in response to fatalities due to improper reading of PAP smears, Congress passed the Clinical Laboratory Improvement Amendments, which established quality standards for clinical laboratories. Although the faulty PAP smears were performed by Federal laboratories, the new law applied to all clinical laboratories, though interestingly enough, one major part of Federal laboratories, the Veteran's Administration, received an exemption from the new CLIA regulations.[15]\nThe CLIA regulations are not particularly complex, largely focusing on proficiency verification requirements for individuals performing tests, and the classification of tests according to complexity. It is this classification which, in turn, affects the licensing requirements of laboratories and individuals performing those tests.[7][16]\n\nLaboratory information systems \nA significant component of most clinical laboratories is their laboratory information system (LIS). These systems vary significantly in complexity, with systems for anatomical pathology laboratories often requiring significant customization, while smaller systems for supporting basic clinical chemistry laboratories acting as an \"out of the box\" solution.[17][18][19]\n\nFurther reading \n Sood, Ramnik (2006). \"Chapter 1: Laboratory\". Textbook of Medical Laboratory Technology. Jaypee Brothers Publishers. pp. 01\u201328. ISBN 818061591X. http:\/\/books.google.com\/books?id=NJNYKeftqYQC .   \n Ezzelle, J; Rodriguez-Chavez, IR; Darden, JM; Stirewalt, M; Kunwar, N; Hitchcock, R; Walter, T; D'Souza, MP (2008). \"Guidelines on Good Clinical Laboratory Practice - Bridging Operations between Research and Clinical Research Laboratories\". Journal of Pharmaceutical and Biomedical Analysis 46 (1): 18\u201329. doi:10.1016\/j.jpba.2007.10.010. http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC2213906\/ .   \nNotes \nAn element or two of this article is reused from the Wikipedia article.\n\nReferences \n\n\u2191 Sood, Ramnik (2006). \"Chapter 1: Laboratory\". Textbook of Medical Laboratory Technology. Jaypee Brothers Publishers. pp. 01\u201328. ISBN 818061591X. http:\/\/books.google.com\/books?id=NJNYKeftqYQC .   \n\n\u2191 \"CLIA - How to Obtain a CLIA Certificate of Waiver\" (PDF). Centers for Disease Control and Prevention. March 2006. http:\/\/wwwn.cdc.gov\/cliac\/pdf\/Addenda\/cliac0210\/Addendum%20F.pdf\u200e . Retrieved 10 September 2013 .   \n\n\u2191 Chen, Bin; Gagnon, MariBeth; Shahangian, Shahram; Anderson, Nancy L.; Howerton, Devery A., Boone, D. Joe (12 June 2009). \"Good Laboratory Practices for Molecular Genetic Testing for Heritable Diseases and Conditions\". Morbidity and Mortality Weekly Report 58 (RR06): 1\u201329. http:\/\/www.cdc.gov\/mmwr\/preview\/mmwrhtml\/rr5806a1.htm . Retrieved 11 September 2013 .   \n\n\u2191 Viana, Raquel V.; Wallis, Carole L.; Isin, Akyar (ed.) (2011). \"Chapter 3: Good Clinical Laboratory Practice (GCLP) for Molecular Based Tests Used in Diagnostic Laboratories\" (PDF). Wide Spectra of Quality Control. InTech. pp. 29\u201352. ISBN 9789533076836. http:\/\/www.intechopen.com\/download\/pdf\/23728 .   \n\n\u2191 \"HHS Organizational Chart\". U.S. Department of Health & Human Services. http:\/\/www.hhs.gov\/about\/orgchart\/ . Retrieved 11 September 2013 .   \n\n\u2191 \"Laboratory Quality Assurance and Standardization Programs\". Centers for Disease Control and Prevention. http:\/\/www.cdc.gov\/labstandards\/ . Retrieved 11 September 2013 .   \n\n\u2191 7.0 7.1 \"Clinical Laboratory Improvement Amendments (CLIA)\". Centers for Medicare and Medicaid Services. http:\/\/www.cms.gov\/Regulations-and-Guidance\/Legislation\/CLIA\/index.html . Retrieved 11 September 2013 .   \n\n\u2191 \"About CLSI\". Clinical and Laboratory Standards Institute. http:\/\/www.clsi.org\/about-clsi\/ . Retrieved 11 September 2013 .   \n\n\u2191 \"What is RQA?\". Research Quality Association. http:\/\/www.therqa.com\/about-us\/ . Retrieved 11 September 2013 .   \n\n\u2191 \"Good Clinical Laboratory Practice (GCLP) Version 2\". Research Quality Association. http:\/\/www.therqa.com\/publications\/booklets\/gclp\/ . Retrieved 11 September 2013 .   \n\n\u2191 Ezzelle, J; Rodriguez-Chavez, IR; Darden, JM; Stirewalt, M; Kunwar, N; Hitchcock, R; Walter, T; D'Souza, MP (2008). \"Guidelines on Good Clinical Laboratory Practice - Bridging Operations between Research and Clinical Research Laboratories\". Journal of Pharmaceutical and Biomedical Analysis 46 (1): 18\u201329. doi:10.1016\/j.jpba.2007.10.010. http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC2213906\/ . Retrieved 11 September 2013 .   \n\n\u2191 12.0 12.1 \"IVD Regulatory Assistance - Overview of IVD Regulation\". Food and Drug Administration. 03 September 2010. http:\/\/www.fda.gov\/MedicalDevices\/DeviceRegulationandGuidance\/IVDRegulatoryAssistance\/ucm123682.htm . Retrieved 13 September 2013 .   \n\n\u2191 13.0 13.1 Kazon, Peter M.; Danzis, Scott D. (ed.); Flannery, Ellen J. (ed.) (2010). \"Chapter 6: Laboratory Developed Tests\". In Vitro Diagnostics: The Complete Regulatory Guide. Food and Drug Law Institute. pp. 115\u2013127. ISBN 193506522X. http:\/\/www.fdli.org\/resources\/resources-order-box-detail-view\/in-vitro-diagnostics-the-complete-regulatory-guide .   \n\n\u2191 \"Overview HIPAA - General Information\". Centers for Medicare and Medicaid Services. http:\/\/www.cms.gov\/HIPAAGenInfo\/ . Retrieved 11 September 2013 .   \n\n\u2191 \"Clinical Laboratory Improvement Act (CLIA)\". Association of American Physicians and Surgeons, Inc. http:\/\/www.aapsonline.org\/msas\/clia.php . Retrieved 11 September 2013 .   \n\n\u2191 \"VD Regulatory Assistance - CLIA Categorization Criteria\". Food and Drug Administration. http:\/\/www.fda.gov\/MedicalDevices\/DeviceRegulationandGuidance\/IVDRegulatoryAssistance\/ucm124208.htm . Retrieved 13 September 2013 .   \n\n\u2191 Pantanowitz, Liron; Henricks, Walter H.; Beckwith, Bruce A. (December 2007). \"Medical Laboratory Informatics\". Clinics in Laboratory Medicine 27 (4): 823\u201343. doi:10.1016\/j.cll.2007.07.011. http:\/\/www.sciencedirect.com\/science\/article\/pii\/S0272271207000893 . Retrieved 11 September 2013 .   \n\n\u2191 \"Medical laboratory informatics\". ClinfoWiki. 19 November 2011. http:\/\/clinfowiki.org\/wiki\/index.php\/Medical_laboratory_informatics . Retrieved 11 September 2013 .   \n\n\u2191 Henricks, Walter H. (09 October 2012). \"LIS Basics: CP and AP LIS Design and Operations\" (PDF). Pathology Informatics 2012. Walter H. Henricks, MD. http:\/\/www.pathinformatics.pitt.edu\/sites\/default\/files\/2012Powerpoints\/01HenricksTues.pdf . 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id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Clinical laboratory<\/h1>\n\t\t\t\t\n\t\t\t\t<div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\">\n\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\n\n\t\t\t\t\t<!-- start content -->\n\t\t\t\t\t<div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"thumb tright\"><div class=\"thumbinner\" style=\"width:402px;\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Medical_Laboratory_Scientist_US_NIH.jpg\" class=\"image wiki-link\" target=\"_blank\" data-key=\"3f511b16db27b5fe7e44c5ba90684100\"><img alt=\"\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/e\/e3\/Medical_Laboratory_Scientist_US_NIH.jpg\" class=\"thumbimage\" style=\"width: 100%;max-width: 400px;height: auto;\" \/><\/a> <div class=\"thumbcaption\"><div class=\"magnify\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Medical_Laboratory_Scientist_US_NIH.jpg\" class=\"internal wiki-link\" title=\"Enlarge\" target=\"_blank\" data-key=\"3f511b16db27b5fe7e44c5ba90684100\"><\/a><\/div>The clinical\/medical laboratory plays a vital role in the diagnosis of disease in the human and animal population.<\/div><\/div><\/div>\n<p>A <b>clinical laboratory<\/b> (sometimes referred to as a <b>medical laboratory<\/b>) is a <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory\" title=\"Laboratory\" target=\"_blank\" class=\"wiki-link\" data-key=\"c57fc5aac9e4abf31dccae81df664c33\">laboratory<\/a> where tests are done on clinical specimens in order to get information about the health of a patient as pertaining to the diagnosis, treatment, and prevention of disease.<sup id=\"rdp-ebb-cite_ref-MedLabTech_1-0\" class=\"reference\"><a href=\"#cite_note-MedLabTech-1\" rel=\"external_link\">[1]<\/a><\/sup> The <a href=\"https:\/\/www.limswiki.org\/index.php\/Clinical_Laboratory_Improvement_Amendments\" title=\"Clinical Laboratory Improvement Amendments\" target=\"_blank\" class=\"wiki-link\" data-key=\"64bdae1dc17c40c28e0c560396a6ae35\">Clinical Laboratory Improvement Amendments<\/a> (CLIA) program defines a clinical (medical) laboratory as \"a facility that performs testing on materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or assessment of the health of, human beings.\"<sup id=\"rdp-ebb-cite_ref-CLIACDCLab_2-0\" class=\"reference\"><a href=\"#cite_note-CLIACDCLab-2\" rel=\"external_link\">[2]<\/a><\/sup>\n<\/p>\n\n\n<h2><span class=\"mw-headline\" id=\"Basics_of_operations\">Basics of operations<\/span><\/h2>\n<p>The clinical laboratory at one level, whether chemistry or pathology, operates like many other testing laboratories. However, there are a number of operational differences between the clinical laboratory and the many other laboratories. One of these differences is the need to have a specific unidirectional workflow. This is intended to both minimize the risk of biohazard contamination, and to establish assurance that samples cross contamination is minimized.<sup id=\"rdp-ebb-cite_ref-MMWR1_3-0\" class=\"reference\"><a href=\"#cite_note-MMWR1-3\" rel=\"external_link\">[3]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-GCLP_4-0\" class=\"reference\"><a href=\"#cite_note-GCLP-4\" rel=\"external_link\">[4]<\/a><\/sup> Another difference, addressed below, concerns the regulations governing the management of patient data. This creates a significant challenge not generally experienced by other types of laboratories.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"Government_regulatory_bodies\">Government regulatory bodies<\/span><\/h2>\n<p>In the United States, clinical laboratories are primarily regulated by the <a href=\"https:\/\/www.limswiki.org\/index.php\/United_States_Department_of_Health_and_Human_Services\" title=\"United States Department of Health and Human Services\" target=\"_blank\" class=\"wiki-link\" data-key=\"efa106bcbb93039b1a6c3c596daedec3\">Department of Health and Human Services<\/a>. Inside that infrastructure are sub-entities like the <a href=\"https:\/\/www.limswiki.org\/index.php\/Centers_for_Disease_Control_and_Prevention\" title=\"Centers for Disease Control and Prevention\" target=\"_blank\" class=\"wiki-link\" data-key=\"176aa9c9513251c328d864d1e724e814\">Centers for Disease Control and Prevention<\/a> (CDC) and the <a href=\"https:\/\/www.limswiki.org\/index.php\/Centers_for_Medicare_and_Medicaid_Services\" title=\"Centers for Medicare and Medicaid Services\" target=\"_blank\" class=\"wiki-link\" data-key=\"654b4449e4816e190325b420c264df1a\">Centers for Medicare and Medicaid Services<\/a> (CMS) to apply standards and regulations through their respective Laboratory Quality Assurance and Standardization Programs and <a href=\"https:\/\/www.limswiki.org\/index.php\/Clinical_Laboratory_Improvement_Amendments\" title=\"Clinical Laboratory Improvement Amendments\" target=\"_blank\" class=\"wiki-link\" data-key=\"64bdae1dc17c40c28e0c560396a6ae35\">Clinical Laboratory Improvement Amendments<\/a> (CLIA).<sup id=\"rdp-ebb-cite_ref-DHHS_5-0\" class=\"reference\"><a href=\"#cite_note-DHHS-5\" rel=\"external_link\">[5]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-CDCProgs_6-0\" class=\"reference\"><a href=\"#cite_note-CDCProgs-6\" rel=\"external_link\">[6]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-CLIA_7-0\" class=\"reference\"><a href=\"#cite_note-CLIA-7\" rel=\"external_link\">[7]<\/a><\/sup> Although generally not as strict as the regulations regarding pharmaceutical and diagnostic manufacturers, they nonetheless establish a significant hurdle to managing the overall operations of the laboratory, from acquiring customers to acquiring samples, to testing, reporting results, and handling billing for the completed tests.\n<\/p><p>Internationally, regulatory bodies vary from country to country. However, organizations like the not-for-profit Clinical and Laboratory Standards Institute (CLSI)<sup id=\"rdp-ebb-cite_ref-CLSIAbout_8-0\" class=\"reference\"><a href=\"#cite_note-CLSIAbout-8\" rel=\"external_link\">[8]<\/a><\/sup> and associations like the Research Quality Association (RQA)<sup id=\"rdp-ebb-cite_ref-RQAAbout_9-0\" class=\"reference\"><a href=\"#cite_note-RQAAbout-9\" rel=\"external_link\">[9]<\/a><\/sup> exist to promote a more global approach to regulations and guidance affecting clinical laboratories. Additionally, a set of Good Clinical Laboratory Practice standards \u2014 originally developed in 2002 and since adopted by the World Health Organisation (WHO), non-governmental organisations (NGOs), and research institutions worldwide \u2014 provide guidance on implementing laboratory practices that are critical for laboratory operations around the world.<sup id=\"rdp-ebb-cite_ref-RQAGCLP_10-0\" class=\"reference\"><a href=\"#cite_note-RQAGCLP-10\" rel=\"external_link\">[10]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-GCLPEzzelle_11-0\" class=\"reference\"><a href=\"#cite_note-GCLPEzzelle-11\" rel=\"external_link\">[11]<\/a><\/sup>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Other_certifying_bodies\">Other certifying bodies<\/span><\/h3>\n<p><i>For certifications and guidelines that affect laboratory safety, please see the <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory#Standards_and_guidance\" title=\"Laboratory\" target=\"_blank\" class=\"wiki-link\" data-key=\"18090e6986b16c618e1367e037688460\">standards and guidance<\/a> section of the <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory\" title=\"Laboratory\" target=\"_blank\" class=\"wiki-link\" data-key=\"c57fc5aac9e4abf31dccae81df664c33\">laboratory<\/a> entry.<\/i>\n<\/p><p>Many laboratories, especially pathology laboratories, will seek accreditation from the College of American Pathologists. This organization has a more extensive set of laboratory certification requirements than those contained within the CLIA regulations.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"Classification_of_tests_performed_by_clinical_laboratories\">Classification of tests performed by clinical laboratories<\/span><\/h2>\n<p>Clinical laboratories perform basically two classes of tests: FDA-approved and laboratory-developed. \n<\/p>\n<h3><span class=\"mw-headline\" id=\"FDA-approved\">FDA-approved<\/span><\/h3>\n<p>The U.S. Food and Drug Administration (FDA) regulates the \"reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.\" This type of test equipment is referred to by the FDA as an in vitro diagnostic product (IVD), \"intended for use in the collection, preparation, and examination of specimens taken from the human body.\"<sup id=\"rdp-ebb-cite_ref-FDAIVD_12-0\" class=\"reference\"><a href=\"#cite_note-FDAIVD-12\" rel=\"external_link\">[12]<\/a><\/sup> These testing products are classified into three different levels: Class I, II, and III. These classifications reflect the risk associated with erroneous results as well as the complexity of the test. Class I tests are frequently exempt from FDA review and approval, while Class II and III tests are not. Class III tests tend to require extensive review and approval, including extensive evaluation of clinical data associated with the test.<sup id=\"rdp-ebb-cite_ref-FDAIVD_12-1\" class=\"reference\"><a href=\"#cite_note-FDAIVD-12\" rel=\"external_link\">[12]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-IVDGuide_13-0\" class=\"reference\"><a href=\"#cite_note-IVDGuide-13\" rel=\"external_link\">[13]<\/a><\/sup>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"Laboratory-developed\">Laboratory-developed<\/span><\/h3>\n<p>Laboratory-developed tests are not generally marketed; they are usually performed by only a small number of laboratories. While these developed tests don't currently require FDA review and approval, there is increasing pressure on the FDA to maintain oversight of these tests. In addition, laboratory-developed tests may not be covered by insurance programs such as Medicare, and thus they may have more limited market penetration compared to an FDA-approved test.<sup id=\"rdp-ebb-cite_ref-IVDGuide_13-1\" class=\"reference\"><a href=\"#cite_note-IVDGuide-13\" rel=\"external_link\">[13]<\/a><\/sup>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"HIPAA_regulations\">HIPAA regulations<\/span><\/h2>\n<p>The <a href=\"https:\/\/www.limswiki.org\/index.php\/Health_Insurance_Portability_and_Accountability_Act\" title=\"Health Insurance Portability and Accountability Act\" target=\"_blank\" class=\"wiki-link\" data-key=\"b70673a0117c21576016cb7498867153\">Health Insurance Portability and Accountability Act<\/a> was passed in 1996, with the initial objective to address problems associated with benefits upon retirement, as well as other legal issues around the delivery of healthcare. In 2003, the privacy rule came into effect. The privacy rule has become the best known provision of HIPAA, and has significant impact on the operations of the clinical laboratory, in particular the data handling\/records management aspect of the laboratory operations.\n<\/p><p>The general principal that the HIPAA privacy regulations establish is that personal data needs to be protected. The general requirement is that data that can be used to identify an individual has to be handled in such a way that it is only connected with healthcare related information for the minimum necessary number of individuals required to execute the required healthcare related activities for the patient.<sup id=\"rdp-ebb-cite_ref-HIPAAInfo_14-0\" class=\"reference\"><a href=\"#cite_note-HIPAAInfo-14\" rel=\"external_link\">[14]<\/a><\/sup>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"Medicare_regulations_.28CLIA.29\">Medicare regulations (CLIA)<\/span><\/h2>\n<p>In 1988, in response to fatalities due to improper reading of PAP smears, Congress passed the Clinical Laboratory Improvement Amendments, which established quality standards for clinical laboratories. Although the faulty PAP smears were performed by Federal laboratories, the new law applied to all clinical laboratories, though interestingly enough, one major part of Federal laboratories, the Veteran's Administration, received an exemption from the new CLIA regulations.<sup id=\"rdp-ebb-cite_ref-CLIAHist_15-0\" class=\"reference\"><a href=\"#cite_note-CLIAHist-15\" rel=\"external_link\">[15]<\/a><\/sup>\n<\/p><p>The CLIA regulations are not particularly complex, largely focusing on proficiency verification requirements for individuals performing tests, and the classification of tests according to complexity. It is this classification which, in turn, affects the licensing requirements of laboratories and individuals performing those tests.<sup id=\"rdp-ebb-cite_ref-CLIA_7-1\" class=\"reference\"><a href=\"#cite_note-CLIA-7\" rel=\"external_link\">[7]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-CLIAIVD_16-0\" class=\"reference\"><a href=\"#cite_note-CLIAIVD-16\" rel=\"external_link\">[16]<\/a><\/sup>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"Laboratory_information_systems\">Laboratory information systems<\/span><\/h2>\n<p>A significant component of most clinical laboratories is their <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_information_system\" title=\"Laboratory information system\" target=\"_blank\" class=\"wiki-link\" data-key=\"37add65b4d1c678b382a7d4817a9cf64\">laboratory information system<\/a> (LIS). These systems vary significantly in complexity, with systems for anatomical pathology laboratories often requiring significant customization, while smaller systems for supporting basic <a href=\"https:\/\/www.limswiki.org\/index.php\/Clinical_chemistry\" title=\"Clinical chemistry\" target=\"_blank\" class=\"wiki-link\" data-key=\"184d3433dd1f9dba149f42bc82234b8d\">clinical chemistry<\/a> laboratories acting as an \"out of the box\" solution.<sup id=\"rdp-ebb-cite_ref-MedLabInfoPaper_17-0\" class=\"reference\"><a href=\"#cite_note-MedLabInfoPaper-17\" rel=\"external_link\">[17]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MedLabInfoDesc_18-0\" class=\"reference\"><a href=\"#cite_note-MedLabInfoDesc-18\" rel=\"external_link\">[18]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-CPAPLISDiffs_19-0\" class=\"reference\"><a href=\"#cite_note-CPAPLISDiffs-19\" rel=\"external_link\">[19]<\/a><\/sup>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"Further_reading\">Further reading<\/span><\/h2>\n<ul><li> <span class=\"citation book\">Sood, Ramnik (2006). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/books.google.com\/books?id=NJNYKeftqYQC\" target=\"_blank\">\"Chapter 1: Laboratory\"<\/a>. <i>Textbook of Medical Laboratory Technology<\/i>. Jaypee Brothers Publishers. pp. 01\u201328. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" target=\"_blank\">ISBN<\/a> 818061591X<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/books.google.com\/books?id=NJNYKeftqYQC\" target=\"_blank\">http:\/\/books.google.com\/books?id=NJNYKeftqYQC<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Chapter+1%3A+Laboratory&rft.atitle=Textbook+of+Medical+Laboratory+Technology&rft.aulast=Sood%2C+Ramnik&rft.au=Sood%2C+Ramnik&rft.date=2006&rft.pages=pp.%26nbsp%3B01%E2%80%9328&rft.pub=Jaypee+Brothers+Publishers&rft.isbn=818061591X&rft_id=http%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DNJNYKeftqYQC&rfr_id=info:sid\/en.wikipedia.org:Clinical_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/li>\n<li> <span class=\"citation Journal\">Ezzelle, J; Rodriguez-Chavez, IR; Darden, JM; Stirewalt, M; Kunwar, N; Hitchcock, R; Walter, T; D'Souza, MP (2008). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC2213906\/\" target=\"_blank\">\"Guidelines on Good Clinical Laboratory Practice - Bridging Operations between Research and Clinical Research Laboratories\"<\/a>. <i>Journal of Pharmaceutical and Biomedical Analysis<\/i> <b>46<\/b> (1): 18\u201329. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" target=\"_blank\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1016%2Fj.jpba.2007.10.010\" target=\"_blank\">10.1016\/j.jpba.2007.10.010<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC2213906\/\" target=\"_blank\">http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC2213906\/<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Guidelines+on+Good+Clinical+Laboratory+Practice+-+Bridging+Operations+between+Research+and+Clinical+Research+Laboratories&rft.jtitle=Journal+of+Pharmaceutical+and+Biomedical+Analysis&rft.aulast=Ezzelle%2C+J%3B+Rodriguez-Chavez%2C+IR%3B+Darden%2C+JM%3B+Stirewalt%2C+M%3B+Kunwar%2C+N%3B+Hitchcock%2C+R%3B+Walter%2C+T%3B+D%27Souza%2C+MP&rft.au=Ezzelle%2C+J%3B+Rodriguez-Chavez%2C+IR%3B+Darden%2C+JM%3B+Stirewalt%2C+M%3B+Kunwar%2C+N%3B+Hitchcock%2C+R%3B+Walter%2C+T%3B+D%27Souza%2C+MP&rft.date=2008&rft.volume=46&rft.issue=1&rft.pages=18%E2%80%9329&rft_id=info:doi\/10.1016%2Fj.jpba.2007.10.010&rft_id=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fpmc%2Farticles%2FPMC2213906%2F&rfr_id=info:sid\/en.wikipedia.org:Clinical_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<h2><span class=\"mw-headline\" id=\"Notes\">Notes<\/span><\/h2>\n<p>An element or two of this article is reused from <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/Clinical_laboratory\" target=\"_blank\">the Wikipedia article<\/a>.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<ol class=\"references\">\n<li id=\"cite_note-MedLabTech-1\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MedLabTech_1-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Sood, Ramnik (2006). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/books.google.com\/books?id=NJNYKeftqYQC\" target=\"_blank\">\"Chapter 1: Laboratory\"<\/a>. <i>Textbook of Medical Laboratory Technology<\/i>. Jaypee Brothers Publishers. pp. 01\u201328. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" target=\"_blank\">ISBN<\/a> 818061591X<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/books.google.com\/books?id=NJNYKeftqYQC\" target=\"_blank\">http:\/\/books.google.com\/books?id=NJNYKeftqYQC<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Chapter+1%3A+Laboratory&rft.atitle=Textbook+of+Medical+Laboratory+Technology&rft.aulast=Sood%2C+Ramnik&rft.au=Sood%2C+Ramnik&rft.date=2006&rft.pages=pp.%26nbsp%3B01%E2%80%9328&rft.pub=Jaypee+Brothers+Publishers&rft.isbn=818061591X&rft_id=http%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DNJNYKeftqYQC&rfr_id=info:sid\/en.wikipedia.org:Clinical_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-CLIACDCLab-2\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CLIACDCLab_2-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/wwwn.cdc.gov\/cliac\/pdf\/Addenda\/cliac0210\/Addendum%20F.pdf\u200e\" target=\"_blank\">\"CLIA - How to Obtain a CLIA Certificate of Waiver\"<\/a> (PDF). Centers for Disease Control and Prevention. March 2006<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/wwwn.cdc.gov\/cliac\/pdf\/Addenda\/cliac0210\/Addendum%20F.pdf\u200e\" target=\"_blank\">http:\/\/wwwn.cdc.gov\/cliac\/pdf\/Addenda\/cliac0210\/Addendum%20F.pdf\u200e<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 10 September 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=CLIA+-+How+to+Obtain+a+CLIA+Certificate+of+Waiver&rft.atitle=&rft.date=March+2006&rft.pub=Centers+for+Disease+Control+and+Prevention&rft_id=http%3A%2F%2Fwwwn.cdc.gov%2Fcliac%2Fpdf%2FAddenda%2Fcliac0210%2FAddendum%2520F.pdf%E2%80%8E&rfr_id=info:sid\/en.wikipedia.org:Clinical_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-MMWR1-3\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MMWR1_3-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Chen, Bin; Gagnon, MariBeth; Shahangian, Shahram; Anderson, Nancy L.; Howerton, Devery A., Boone, D. Joe (12 June 2009). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.cdc.gov\/mmwr\/preview\/mmwrhtml\/rr5806a1.htm\" target=\"_blank\">\"Good Laboratory Practices for Molecular Genetic Testing for Heritable Diseases and Conditions\"<\/a>. <i>Morbidity and Mortality Weekly Report<\/i> <b>58<\/b> (RR06): 1\u201329<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.cdc.gov\/mmwr\/preview\/mmwrhtml\/rr5806a1.htm\" target=\"_blank\">http:\/\/www.cdc.gov\/mmwr\/preview\/mmwrhtml\/rr5806a1.htm<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 11 September 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Good+Laboratory+Practices+for+Molecular+Genetic+Testing+for+Heritable+Diseases+and+Conditions&rft.jtitle=Morbidity+and+Mortality+Weekly+Report&rft.aulast=Chen%2C+Bin%3B+Gagnon%2C+MariBeth%3B+Shahangian%2C+Shahram%3B+Anderson%2C+Nancy+L.%3B+Howerton%2C+Devery+A.%2C+Boone%2C+D.+Joe&rft.au=Chen%2C+Bin%3B+Gagnon%2C+MariBeth%3B+Shahangian%2C+Shahram%3B+Anderson%2C+Nancy+L.%3B+Howerton%2C+Devery+A.%2C+Boone%2C+D.+Joe&rft.date=12+June+2009&rft.volume=58&rft.issue=RR06&rft.pages=1%E2%80%9329&rft_id=http%3A%2F%2Fwww.cdc.gov%2Fmmwr%2Fpreview%2Fmmwrhtml%2Frr5806a1.htm&rfr_id=info:sid\/en.wikipedia.org:Clinical_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-GCLP-4\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-GCLP_4-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Viana, Raquel V.; Wallis, Carole L.; Isin, Akyar (ed.) (2011). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.intechopen.com\/download\/pdf\/23728\" target=\"_blank\">\"Chapter 3: Good Clinical Laboratory Practice (GCLP) for Molecular Based Tests Used in Diagnostic Laboratories\"<\/a> (PDF). <i>Wide Spectra of Quality Control<\/i>. InTech. pp. 29\u201352. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" target=\"_blank\">ISBN<\/a> 9789533076836<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.intechopen.com\/download\/pdf\/23728\" target=\"_blank\">http:\/\/www.intechopen.com\/download\/pdf\/23728<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Chapter+3%3A+Good+Clinical+Laboratory+Practice+%28GCLP%29+for+Molecular+Based+Tests+Used+in+Diagnostic+Laboratories&rft.atitle=Wide+Spectra+of+Quality+Control&rft.aulast=Viana%2C+Raquel+V.%3B+Wallis%2C+Carole+L.%3B+Isin%2C+Akyar+%28ed.%29&rft.au=Viana%2C+Raquel+V.%3B+Wallis%2C+Carole+L.%3B+Isin%2C+Akyar+%28ed.%29&rft.date=2011&rft.pages=pp.%26nbsp%3B29%E2%80%9352&rft.pub=InTech&rft.isbn=9789533076836&rft_id=http%3A%2F%2Fwww.intechopen.com%2Fdownload%2Fpdf%2F23728&rfr_id=info:sid\/en.wikipedia.org:Clinical_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-DHHS-5\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-DHHS_5-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.hhs.gov\/about\/orgchart\/\" target=\"_blank\">\"HHS Organizational Chart\"<\/a>. U.S. Department of Health & Human Services<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.hhs.gov\/about\/orgchart\/\" target=\"_blank\">http:\/\/www.hhs.gov\/about\/orgchart\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 11 September 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=HHS+Organizational+Chart&rft.atitle=&rft.pub=U.S.+Department+of+Health+%26+Human+Services&rft_id=http%3A%2F%2Fwww.hhs.gov%2Fabout%2Forgchart%2F&rfr_id=info:sid\/en.wikipedia.org:Clinical_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-CDCProgs-6\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CDCProgs_6-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.cdc.gov\/labstandards\/\" target=\"_blank\">\"Laboratory Quality Assurance and Standardization Programs\"<\/a>. Centers for Disease Control and Prevention<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.cdc.gov\/labstandards\/\" target=\"_blank\">http:\/\/www.cdc.gov\/labstandards\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 11 September 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Laboratory+Quality+Assurance+and+Standardization+Programs&rft.atitle=&rft.pub=Centers+for+Disease+Control+and+Prevention&rft_id=http%3A%2F%2Fwww.cdc.gov%2Flabstandards%2F&rfr_id=info:sid\/en.wikipedia.org:Clinical_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-CLIA-7\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-CLIA_7-0\" rel=\"external_link\">7.0<\/a><\/sup> <sup><a href=\"#cite_ref-CLIA_7-1\" rel=\"external_link\">7.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.cms.gov\/Regulations-and-Guidance\/Legislation\/CLIA\/index.html\" target=\"_blank\">\"Clinical Laboratory Improvement Amendments (CLIA)\"<\/a>. Centers for Medicare and Medicaid Services<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.cms.gov\/Regulations-and-Guidance\/Legislation\/CLIA\/index.html\" target=\"_blank\">http:\/\/www.cms.gov\/Regulations-and-Guidance\/Legislation\/CLIA\/index.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 11 September 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Clinical+Laboratory+Improvement+Amendments+%28CLIA%29&rft.atitle=&rft.pub=Centers+for+Medicare+and+Medicaid+Services&rft_id=http%3A%2F%2Fwww.cms.gov%2FRegulations-and-Guidance%2FLegislation%2FCLIA%2Findex.html&rfr_id=info:sid\/en.wikipedia.org:Clinical_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-CLSIAbout-8\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CLSIAbout_8-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.clsi.org\/about-clsi\/\" target=\"_blank\">\"About CLSI\"<\/a>. 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Retrieved 11 September 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=About+CLSI&rft.atitle=&rft.pub=Clinical+and+Laboratory+Standards+Institute&rft_id=http%3A%2F%2Fwww.clsi.org%2Fabout-clsi%2F&rfr_id=info:sid\/en.wikipedia.org:Clinical_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-RQAAbout-9\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-RQAAbout_9-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.therqa.com\/about-us\/\" target=\"_blank\">\"What is RQA?\"<\/a>. 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Retrieved 11 September 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=What+is+RQA%3F&rft.atitle=&rft.pub=Research+Quality+Association&rft_id=http%3A%2F%2Fwww.therqa.com%2Fabout-us%2F&rfr_id=info:sid\/en.wikipedia.org:Clinical_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-RQAGCLP-10\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-RQAGCLP_10-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.therqa.com\/publications\/booklets\/gclp\/\" target=\"_blank\">\"Good Clinical Laboratory Practice (GCLP) Version 2\"<\/a>. 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Retrieved 11 September 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Guidelines+on+Good+Clinical+Laboratory+Practice+-+Bridging+Operations+between+Research+and+Clinical+Research+Laboratories&rft.jtitle=Journal+of+Pharmaceutical+and+Biomedical+Analysis&rft.aulast=Ezzelle%2C+J%3B+Rodriguez-Chavez%2C+IR%3B+Darden%2C+JM%3B+Stirewalt%2C+M%3B+Kunwar%2C+N%3B+Hitchcock%2C+R%3B+Walter%2C+T%3B+D%27Souza%2C+MP&rft.au=Ezzelle%2C+J%3B+Rodriguez-Chavez%2C+IR%3B+Darden%2C+JM%3B+Stirewalt%2C+M%3B+Kunwar%2C+N%3B+Hitchcock%2C+R%3B+Walter%2C+T%3B+D%27Souza%2C+MP&rft.date=2008&rft.volume=46&rft.issue=1&rft.pages=18%E2%80%9329&rft_id=info:doi\/10.1016%2Fj.jpba.2007.10.010&rft_id=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fpmc%2Farticles%2FPMC2213906%2F&rfr_id=info:sid\/en.wikipedia.org:Clinical_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-FDAIVD-12\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-FDAIVD_12-0\" rel=\"external_link\">12.0<\/a><\/sup> <sup><a href=\"#cite_ref-FDAIVD_12-1\" rel=\"external_link\">12.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.fda.gov\/MedicalDevices\/DeviceRegulationandGuidance\/IVDRegulatoryAssistance\/ucm123682.htm\" target=\"_blank\">\"IVD Regulatory Assistance - Overview of IVD Regulation\"<\/a>. 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(2010). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.fdli.org\/resources\/resources-order-box-detail-view\/in-vitro-diagnostics-the-complete-regulatory-guide\" target=\"_blank\">\"Chapter 6: Laboratory Developed Tests\"<\/a>. <i>In Vitro Diagnostics: The Complete Regulatory Guide<\/i>. Food and Drug Law Institute. pp. 115\u2013127. <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" target=\"_blank\">ISBN<\/a> 193506522X<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.fdli.org\/resources\/resources-order-box-detail-view\/in-vitro-diagnostics-the-complete-regulatory-guide\" target=\"_blank\">http:\/\/www.fdli.org\/resources\/resources-order-box-detail-view\/in-vitro-diagnostics-the-complete-regulatory-guide<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Chapter+6%3A+Laboratory+Developed+Tests&rft.atitle=In+Vitro+Diagnostics%3A+The+Complete+Regulatory+Guide&rft.aulast=Kazon%2C+Peter+M.%3B+Danzis%2C+Scott+D.+%28ed.%29%3B+Flannery%2C+Ellen+J.+%28ed.%29&rft.au=Kazon%2C+Peter+M.%3B+Danzis%2C+Scott+D.+%28ed.%29%3B+Flannery%2C+Ellen+J.+%28ed.%29&rft.date=2010&rft.pages=pp.%26nbsp%3B115%E2%80%93127&rft.pub=Food+and+Drug+Law+Institute&rft.isbn=193506522X&rft_id=http%3A%2F%2Fwww.fdli.org%2Fresources%2Fresources-order-box-detail-view%2Fin-vitro-diagnostics-the-complete-regulatory-guide&rfr_id=info:sid\/en.wikipedia.org:Clinical_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-HIPAAInfo-14\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-HIPAAInfo_14-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.cms.gov\/HIPAAGenInfo\/\" target=\"_blank\">\"Overview HIPAA - General Information\"<\/a>. 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Retrieved 11 September 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Medical+laboratory+informatics&rft.atitle=&rft.date=19+November+2011&rft.pub=ClinfoWiki&rft_id=http%3A%2F%2Fclinfowiki.org%2Fwiki%2Findex.php%2FMedical_laboratory_informatics&rfr_id=info:sid\/en.wikipedia.org:Clinical_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<li id=\"cite_note-CPAPLISDiffs-19\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CPAPLISDiffs_19-0\" rel=\"external_link\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Henricks, Walter H. (09 October 2012). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pathinformatics.pitt.edu\/sites\/default\/files\/2012Powerpoints\/01HenricksTues.pdf\" target=\"_blank\">\"LIS Basics: CP and AP LIS Design and Operations\"<\/a> (PDF). <i>Pathology Informatics 2012<\/i>. Walter H. Henricks, MD<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pathinformatics.pitt.edu\/sites\/default\/files\/2012Powerpoints\/01HenricksTues.pdf\" target=\"_blank\">http:\/\/www.pathinformatics.pitt.edu\/sites\/default\/files\/2012Powerpoints\/01HenricksTues.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 11 September 2013<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=LIS+Basics%3A+CP+and+AP+LIS+Design+and+Operations&rft.atitle=Pathology+Informatics+2012&rft.aulast=Henricks%2C+Walter+H.&rft.au=Henricks%2C+Walter+H.&rft.date=09+October+2012&rft.pub=Walter+H.+Henricks%2C+MD&rft_id=http%3A%2F%2Fwww.pathinformatics.pitt.edu%2Fsites%2Fdefault%2Ffiles%2F2012Powerpoints%2F01HenricksTues.pdf&rfr_id=info:sid\/en.wikipedia.org:Clinical_laboratory\"><span style=\"display: none;\"> <\/span><\/span><\/span>\n<\/li>\n<\/ol>\n\n<!-- \nNewPP limit report\nCached time: 20181213192738\nCache expiry: 86400\nDynamic content: false\nCPU time usage: 0.484 seconds\nReal time usage: 1.438 seconds\nPreprocessor visited node count: 13106\/1000000\nPreprocessor generated node count: 21833\/1000000\nPost\u2010expand include size: 90506\/2097152 bytes\nTemplate argument size: 35446\/2097152 bytes\nHighest expansion depth: 13\/40\nExpensive parser function count: 0\/100\n-->\n\n<!-- \nTransclusion expansion time report (%,ms,calls,template)\n100.00% 384.119 1 - -total\n 89.76% 344.770 21 - Template:Citation\/core\n 49.20% 188.981 13 - Template:Cite_web\n 27.37% 105.145 4 - Template:Cite_book\n 20.95% 80.490 4 - Template:Cite_journal\n 5.27% 20.249 26 - Template:Citation\/make_link\n 4.19% 16.083 7 - Template:Citation\/identifier\n 1.31% 5.031 14 - Template:Hide_in_print\n 1.06% 4.056 7 - Template:Only_in_print\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:2897-0!*!0!!en!5!* and timestamp 20181213192736 and revision id 14994\n -->\n<\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Clinical_laboratory\">https:\/\/www.limswiki.org\/index.php\/Clinical_laboratory<\/a><\/div>\n\t\t\t\t\t\t\t\t\t\t<!-- end content -->\n\t\t\t\t\t\t\t\t\t\t<div class=\"visualClear\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t<!-- end of the left (by default at least) column -->\n\t\t<div class=\"visualClear\"><\/div>\n\t\t\t\t\t\n\t\t<\/div>\n\t\t\n\n<\/body>","307bcdf1bdbcd1bb167cee435b7a5463_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/e\/e3\/Medical_Laboratory_Scientist_US_NIH.jpg"],"307bcdf1bdbcd1bb167cee435b7a5463_timestamp":1544729256,"03f67a6ae65a3dda39217d716f662a6e":{"type":"chapter","title":"1. 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