![]() The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. The Clinical Laboratory Improvement Amendments (CLIA) were passed by Congress in 1988 establishing quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed.Ī laboratory under CLIA is defined as any facility which performs laboratory testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention, treatment of disease, or impairment of, or assessment of health. Clinical Laboratory (CLIA) Licensing and Certification Program Program Overview
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