Transcription of MLN006270 – CLIA Program & Medicare Lab Services
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MLN006270 – CLIA Program & Medicare Lab Services
Page 1 of 8 CLIA Program AND Medicare LABORATORY SERVICESICN MLN006270 May 2020 PRINT-FRIENDLY VERSIONThe Hyperlink Table, at the end of this document, gives the complete URL for each Clinical Laboratory Improvement Amendments (CLIA) Program regulates laboratories that test human specimens and ensures they give accurate, reliable, and timely patient test results regardless of where the test is about these laboratory Services topics: CLIA Program overview Getting CLIA certification Types of laboratory certificates CLIA Proficiency Testing (PT) Test categorization Medicare laboratory Services ResourcesCLIA Program OVERVIEWThe Centers for Medicare & Medicaid Services (CMS) oversees all laboratory testing (except research) done on humans in the through CLIA. Congress passed CLIA in 1988 to establish quality standards, strengthen Federal oversight of clinical laboratories, and ensure the accuracy and reliability of patient test Fact SheetCLIA Program and Medicare Laboratory ServicesICN MLN006270 May 2020 Page 2 of 8 CLIA RESEARCHCLIA regulates research testing when patient-specific results are returned.
Certificate of Compliance (CoC) A lab gets a CoC after an on-site survey finds it meets all applicable CLIA regulations. Surveys : happen every 2 years at CoC labs doing moderate and high complexity testing. The surveys:
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