Laboratories Performing Limited Public Health Testing

6010.2 - Laboratories Performing Limited Public Health Testing (Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) Exception (b)(2): Not-for-profit or Federal, State, or local government laboratories that engage in limited (not more than a combination of 15 moderately complex or waived tests per certificate) public health testing may file a single application. (42 CFR 493.35(b)(2), 493.43(b)(2), or 493.55(b)(2)). • The facility must either be Not-for-profit, or a Federal, State or local government facility (e.g., Women, Infants and Children (WIC) clinics). o Not-for-profit status is a legal designation. • Limited public health testing is not defined in the regulation. • The testing is limited to 15 or fewer tests, and those fifteen tests must be listed on the license application. Those fifteen tests may be solely comprised of moderate complexity tests, solely comprised of waived tests, or comprised of a combination of moderate and waived tests. • A Certificate of Waiver laboratory is eligible if it only performs 15 or fewer waived tests. • The various sites under this certificate may only perform tests within the 15 tests listed on the certificate application. • An entity performing any high complexity testing cannot use this exception for a multi- site certificate. • The multi-sites cannot perform tests that are outside of those listed for the CLIA certificate they are operating under. The name of the tests must be shown on the CLIA application for this exception. (Although certificates are currently issued by specialty/subspecialty, the tests must be verified and shown on the CLIA application Form CMS-116.) • The location designated as the primary site on the CLIA application/certificate must perform testing and hold the certificate. • The primary site must also identify the type of testing performed at each site. If any of the multi-site laboratories is located in more than one State, the State Agency (SA) contacts the Regional Office to determine which State conducts the inspection.