The Clinical Laboratory Improvement Amendments (CLIA) passed by the U.S. government establishes a program to regulate laboratories that test patient specimens, to ensure the labs produce accurate and reliable test results.
Congress passed CLIA in 1988 to establish quality standards for all non-research laboratory testing:
- Performed on specimens derived from humans; and
- For providing information for the diagnosis, prevention, and treatment of disease or impairment, or assessment of health. CLIA mandates that virtually all laboratories, including physician office laboratories, meet applicable Federal requirements and have a CLIA certificate to operate.
CLIA requires the U.S. Department of Health & Human Services (HHS) to certify laboratories performing non-research testing. The Centers for Medicare & Medicaid Services (CMS) administers the CLIA certification program for HHS along with the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Fees from the regulated facilities cover all costs of administering the program, including certificate and survey costs.
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.
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.
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.
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.
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." 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.
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. 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).
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.
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. 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.
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:
- diagnosis, prevention, or treatment of disease or impairment.
- health assessments.
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.
The seven criteria for categorization are:
- Training and experience
- Reagents and materials preparation
- Characteristics of operational steps
- Calibration, quality control, and proficiency testing materials
- Test system troubleshooting and equipment maintenance
- Interpretation and judgment
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.
CLIA waived tests
Under CLIA, tests and test systems that meet risk, error, and complexity requirements are issued a CLIA certificate of waiver. 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."
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:
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.
List of tests
A list of tests categorized by the FDA as waived since 2000 can be found at the FDA website. As of April 2020, the list includes slightly more than 2,000 unique approved CLIA-waived test devices.
- 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): 328–336. PMID 3542302. http://www.clinchem.org/content/33/2/328.full.pdf.
- 42 CFR 493 at the U.S. Government Printing Office
- CLIA Law & Regulations at CDC
- Chronology of CLIA Related Documents in the Federal Register & Code of Federal Regulations
A couple elements of this article are reused from the Wikipedia article.
- "Clinical Laboratory Improvement Amendments (CLIA)". Centers for Medicare and Medicaid Services. 26 March 2020. https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index. Retrieved 15 April 2020.
- "Public Law 90-174" (PDF). United States Statutes at Large, Volume 81. 1967. https://www.govinfo.gov/content/pkg/STATUTE-81/pdf/STATUTE-81-Pg533.pdf. Retrieved 15 April 2020.
- Kenney, M.L. (1987). "Quality Assurance in Changing Times: Proposals for Reform and Research in the Clinical Laboratory Field". Clinical Chemistry 33 (2): 328–36. doi:10.1093/clinchem/33.2.328. PMID 3542302.
- 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. 273–402. ISBN 9780824787844. http://books.google.ca/books?id=tTm3hfom96sC&pg=PA273&lpg=PA273.
- "Public Law 100-578" (PDF). United States Statutes at Large, Volume 102. 1988. https://www.govinfo.gov/content/pkg/STATUTE-102/pdf/STATUTE-102-Pg2903.pdf. Retrieved 15 April 2020.
- "Regulations for Implementing the Clinical Laboratory Improvement Amendments of 1988: A Summary". Morbidity and Mortality Weekly Report 41 (RR-2): 1–17. 28 February 1992. PMID 1538689. https://www.cdc.gov/mmwr/preview/mmwrhtml/00016177.htm. Retrieved 15 April 2020.
- "Medicare, Medicaid, and CLIA Programs; Laboratory Requirements Relating to Quality Systems and Certain Personnel Qualifications; Final Rule". Federal Register 68 (16): 3639–3714. 24 January 2003. PMID 12545998. https://www.govinfo.gov/content/pkg/FR-2003-01-24/html/03-1230.htm. Retrieved 15 April 2020.
- "Clinical Laboratory Improvement Act (CLIA) - Legislative History". New Mexico Department of Health. Archived from the original on 09 March 2014. https://web.archive.org/web/20140309070758/http://dhi.health.state.nm.us/CLIA/clia_history.php. Retrieved 15 April 2020.
- Burns, J. (16 October 2019). "Federal Advisory Committee Seeks Public Comments on Revising CLIA Regulations, says Keynote Speaker at 13th Annual Lab Quality Confab in Atlanta". Dark Daily. https://www.darkdaily.com/federal-advisory-committee-seeks-public-comments-on-revising-clia-regulations-says-keynote-speaker-at-13th-annual-lab-quality-confab-in-atlanta/. Retrieved 15 April 2020.
- Clinical Laboratory Improvement Advisory Committee (07 November 2019). "CLIAC Summary Report November 6–7, 2019, Atlanta, Georgia" (PDF). Centers for Disease Control and Prevention. https://www.cdc.gov/cliac/docs/summary/cliac0919_summary.pdf. Retrieved 15 April 2020.
- Clinical Laboratory Improvement Advisory Committee (01 October 2019). "Clinical Laboratory Improvement Advisory Committee (CLIAC) Recommendations Table" (PDF). Centers for Disease Control and Prevention. https://www.cdc.gov/cliac/docs/CLIAC_RecommendationsTable_10012019.pdf. Retrieved 15 April 2020.
- "CLIA Categorizations". U.S. Food and Drug Administration. 25 February 2020. https://www.fda.gov/medical-devices/ivd-regulatory-assistance/clia-categorizations. Retrieved 15 April 2020.
- "CLIA Update – October 2019 - Laboratories by Type of Facility" (PDF). Centers for Medicare and Medicaid Services. October 2019. https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/factype.pdf. Retrieved 15 April 2020.
- "CLIA Program and Medicare Laboratory Services" (PDF). Centers for Medicare and Medicaid Services. October 2018. https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/CLIABrochure.pdf. Retrieved 15 April 2020.
- "Waived Tests". Centers for Disease Control and Prevention. 16 December 2019. https://www.cdc.gov/labquality/waived-tests.html. Retrieved 15 April 2020.
- "Administrative Procedures for CLIA Categorization - Guidance for Industry and Food and Drug Administration Staff". U.S. Food and Drug Administration. October 2017. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/administrative-procedures-clia-categorization. Retrieved 15 April 2020.
- "IVD Regulatory Assistance - CLIA Waivers". U.S. Food and Drug Administration. 19 June 2009. Archived from the original on 02 February 2020. https://web.archive.org/web/20120202233933/http://www.fda.gov/medicaldevices/deviceregulationandguidance/ivdregulatoryassistance/ucm124202.htm. Retrieved 15 April 2020.