ASCLS has submitted comments in response to a wide-ranging Request for Information from the Centers for Medicare and Medicaid Services that will shape future regulations of clinical laboratories under CLIA. The voluminous document covers many topics, including breath testing, specimen preparation personnel, handling of suboptimal specimens, remote competency assessment, and cybersecurity.
Subject matter expertise was supplied by members of the Society’s Government Affairs Committee, in particular, Jesse Day, Elissa Passiment, Brandy Gunsolus, and Judy Davis.
To date, CMS has posted 374 comments received, with all clinical laboratory groups weighing in with their own perspectives.