US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) 35-63: Hold the CLIA certificate that matches the complexity of testing performed, apply and renew on the HHS form, and notify CMS within 30 days of any change of ownership, name, location or director and before adding tests or specialties outside the current certificate

What does 35-63 require?

A laboratory performing only waived tests applies for a certificate of waiver; a laboratory performing moderate or high complexity testing applies for a registration certificate and then a certificate of compliance (after a successful inspection) or a certificate of accreditation (on evidence of accreditation by a CMS-approved organisation); a laboratory confined to PPM procedures applies for the PPM certificate. Applications and renewals are made on the HHS form, state the testing performed with its specialties and subspecialties, name the director, and are accompanied by the Subpart F fee; a registration certificate is issued for up to two years pending inspection, and certificates of compliance and accreditation run for two years. Every certificate holder must notify HHS or its designee within 30 days of a change in ownership, name, location or director, and must notify before performing and reporting any test outside the scope of its certificate (for example a waived laboratory adding a nonwaived test, a PPM laboratory adding moderate complexity tests, or an accredited laboratory adding a specialty) so that the certificate is amended first. During a declared public health emergency, laboratories performing SARS-CoV-2 tests report results to the Secretary as prescribed.