CMS Proposes CLIA Updates on Virtual Access, Cytology Testing
CMS has issued a proposed rule amending Clinical Laboratory Improvement Amendments (CLIA) regulations to permit virtual access under the CLIA certificate of the primary testing laboratory, with an exception for the cytology subspecialty, and to allow digital images for gynecologic cytology proficiency testing. The rule also proposes changes to personnel qualification requirements, SARS-CoV-2 reporting requirements, certificate requirements, test reporting requirements, enforcement requirements, and public consultation processes, along with editorial and technical updates. Clinical laboratories, pathologists, and testing personnel nationwide would be affected by the revised oversight and workforce requirements. CMS states the changes aim to modernize federal laboratory oversight while addressing workforce shortages and reflecting current technological capabilities.