What does CLIA require of a site that holds a Certificate of Waiver?

A site that holds a Certificate of Waiver under the Clinical Laboratory Improvement Amendments (CLIA) is required to keep its CLIA certificate current. This means the facility must ensure that its certificate does not expire and that it meets the regulatory requirements that govern the laboratory's operations. Maintaining an active certificate signifies compliance with standard practices and ongoing eligibility to perform waived tests.

While following manufacturers' instructions and only performing specific tests are important practices, they are not specifically mandated as requirements for maintaining a Certificate of Waiver. Similarly, while patient record maintenance is essential for best practices in healthcare, it is not a direct requirement tied to the status of the CLIA waiver itself. Thus, the requirement to keep the CLIA certificate current emphasizes the importance of compliance and quality assurance in point-of-care testing environments.