US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) 1773: Permit CMS or its agent to inspect, revisit and investigate complaints: allow testing of samples including PT samples, interviews of all personnel, observation of every phase of testing, access to all specimen, storage, testing and reporting areas, copies of all records and data, keep records accessible and retrievable within a reasonable time during the inspection, and provide all information needed to determine compliance; refusal leads to loss of Medicare and Medicaid participation and action against the certificate

What does 1773 require?

A laboratory issued a CLIA certificate must permit CMS or a CMS agent (usually the State survey agency) to inspect it to assess compliance with Part 493, and a CLIA-exempt or accredited laboratory must permit validation and complaint inspections. During an inspection CMS may require the laboratory to test samples including PT samples or perform procedures, permit interviews of all personnel about compliance, permit observation of personnel performing all phases of the total testing process, give access to all areas under the certificate including specimen procurement and processing areas, storage for specimens, reagents, supplies, records and reports, and testing and reporting areas, and provide copies or exact duplicates of all records and data required. All records and data must be accessible and retrievable within a reasonable time during the inspection, and the laboratory must provide on request all information and data CMS needs to determine compliance. CMS may reinspect at any time to evaluate the laboratory's ability to give accurate and reliable results and may inspect on a complaint alleging noncompliance. Failure to permit an inspection or reinspection results in suspension or cancellation of Medicare and Medicaid participation and suspension, limitation or revocation of the CLIA certificate under Subpart R.