Difference between revisions of "Clinical Laboratory Improvement Amendments"

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The '''Clinical Laboratory Improvement Amendments''' ('''CLIA''') program of 1988 is a United States federal regulatory standards program that applies to all [[clinical laboratory]] testing performed on humans in the United States, except clinical trials and basic research.<ref name="CMSAboutCLIA">{{cite web |url=http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html |title=Clinical Laboratory Improvement Amendments (CLIA) |publisher=Centers for Medicare and Medicaid Services |accessdate=23 March 2014}}</ref>
The '''Clinical Laboratory Improvement Amendments''' ('''CLIA''') program of 1988 is a United States federal regulatory standards program that applies to all [[clinical laboratory]] testing performed on humans in the United States, except clinical trials and basic research.<ref name="CMSAboutCLIA">{{cite web |url=http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html |title=Clinical Laboratory Improvement Amendments (CLIA) |publisher=Centers for Medicare and Medicaid Services |accessdate=23 March 2014}}</ref>
==History==
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. Laboratories would be eligible for a full, partial, or exempt CLIA-67 license, depending on the laboratory's conducted tests.<ref name="CLIA67Doc">{{cite web |url=http://www.gpo.gov/fdsys/pkg/STATUTE-81/pdf/STATUTE-81-Pg533.pdf |format=PDF |title=Public Law 90-174 |work=United States Statutes at Large, Volume 81 |date=1967 |accessdate=24 March 2014}}</ref>
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.<ref name="KenneyQACLIA">{{cite journal |url=http://www.clinchem.org/content/33/2/328.full.pdf |format=PDF |journal=Clinical Chemistry |volume=33 |issue=2 |year=February 1987 |pages=328–336 |title=Quality Assurance in Changing Times: Proposals for Reform and Research in the Clinical Laboratory Field |author=Kenney, Michael L. |pmid=3542302}}</ref>
<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 receMng 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 (c clinical laboratory regulations should be based upon objective data to the maximum extent possible.<ref name="KenneyQACLIA" /></blockquote>


==CLIA program==
==CLIA program==

Revision as of 17:07, 24 March 2014

The Clinical Laboratory Improvement Amendments (CLIA) program of 1988 is a United States federal regulatory standards program that applies to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research.[1]

History

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. 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 receMng 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 (c clinical laboratory regulations should be based upon objective data to the maximum extent possible.[3]


CLIA program

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.[4]

The seven criteria for categorization are:

  1. Knowledge
  2. Training and experience
  3. Reagents and materials preparation
  4. Characteristics of operational steps
  5. Calibration, quality control, and proficiency testing materials
  6. Test system troubleshooting and equipment maintenance
  7. 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.

The CLIA Program is funded by user fees collected from over 244,000 laboratories[5], most located in the United States.[6]

CLIA waived tests

Under CLIA, tests and test systems that meet risk, error, and complexity requirements are issued a CLIA certificate of waiver.[7][6] 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[8]

See also

References

  1. ↑ "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. 
  2. ↑ "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. 
  3. ↑ 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): 328–336. PMID 3542302. http://www.clinchem.org/content/33/2/328.full.pdf. 
  4. ↑ "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. 
  5. ↑ "CLIA Update – 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. 
  6. ↑ 6.0 6.1 "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. 
  7. ↑ "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. 
  8. ↑ "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. 
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