Clinical Laboratory Improvement Amendments
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]
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.[2]
The seven criteria for categorization are:
- Knowledge
- 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.
The CLIA Program is funded by user fees collected from over 244,000 laboratories[3], most located in the United States.[4]
CLIA Waived Tests
Under CLIA, tests and test systems that meet risk, error, and complexity requirements are issued a CLIA certificate of waiver.[5][4] 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[6]
See also
References
- ↑ "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.
- ↑ "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.
- ↑ "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.
- ↑ 4.0 4.1 "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.
- ↑ "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.
- ↑ "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.
