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The 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]
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.[2]
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 and 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]
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.[3]
On 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]
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 '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]
On 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]
In the fall of 2019, the Centers for Disease Control and Prevention's Director of Laboratory Systems Reynolds Salerno requested comments from its Clinical Laboratory Improvement Advisory Committee (CLIAC), as well as from the public, in regards to how CLIA regulations should be revised. “It’s a dramatic step for the government to ask the laboratory community how to revise the CLIA regulations,” Salerno told Dark Daily.[9] During the November CLIAC meeting, attendees reviewed CLIAC's 23 recommendations it had made prior (April 2019) in regards to updates to CLIA, grouped into CLIA personnel requirement changes, nontraditional test workflow (big data- and machine learning-driven) changes, and changes related to next-generation sequencing testing, workflows, and best practices.[10][11]
The 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:
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, 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.[12]
The seven criteria for categorization are:
The 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.
The CLIA Program is funded by user fees collected from over 317,000 laboratories[13], most located in the United States.[14]
Under CLIA, tests and test systems that meet risk, error, and complexity requirements are issued a CLIA certificate of waiver.[15][14] In its 2017 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."[16]
While 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[15]:
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.
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.[17]
A list of tests categorized by the FDA as waived since 2000 can be found at the FDA website. As of January 2022, the list includes slightly more than 4,600 unique approved CLIA-waived test devices.
A couple elements of this article are reused from the Wikipedia article.
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