Clinical Laboratory Improvement Amendments (CLIA) Certificates
Summary
There are four Clinical Laboratory Improvement Amendments (CLIA) certificates that laboratories can apply for: Certificate of Waiver; Certificate for Provider-Performed Microscopy (PPM) Procedures; Certificate of Compliance (COC); Certificate of Accreditation (COA). Single locations (e.g., same building, same suite) are allowed to house multiple laboratories each possessing a separate CLIA certificate, provided they demonstrate that each laboratory operates as a distinct entity. Laboratories that participate in Medicare may also have their approval to receive Medicare payments cancelled, suspended for all tests, or suspended for some tests. When a laboratory is deemed noncompliant, Centers for Medicare and Medicaid Services will provide written notification to the laboratory. For situations where noncompliance is deemed to pose immediate jeopardy to patient care, notification should be provided at least 5 days before the sanctions are effective. Nonwaived CLIA certificates may also be suspended or limited for failure to participate successfully in proficiency testing.