Clinical Laboratories
Guidance for Medicare clinical laboratories regarding the Clinical Laboratory Improvement Amendments (CLIA) establishing quality standards for all laboratories testing to ensure the accuracy, reliability, and timeliness of patient test results, regardless of where the test was performed.
Final
Issued by: Centers for Medicare & Medicaid Services (CMS)
Issue Date: March 05, 2012
Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988 establishing quality standards for all laboratories testing to ensure the accuracy, reliability, and timeliness of patient test results, regardless of where the test was performed. The CLIA regulations are based on the complexity of the test method; thus, the more complicated the test, the more stringent the requirements.
State Survey Agencies, under agreements between the State and the Secretary, carry out the Medicare certification process. The State Survey Agency is also authorized to set and enforce standards for CLIA and Medicaid. (The State Survey Agency may partially re-delegate the functions to local agencies.)
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