April 19, 2023
In response to recent questions from AABB-accredited facilities about several Clinical Laboratory Improvement Amendments (CLIA) regulations involving laboratory directors and general supervisors, AABB obtained clarification from Centers for Medicare and Medicaid Services (CMS).
CMS has clarified that the laboratory director at each site “has the overall responsibility for reviewing and evaluating the overall quality of the analytic system and documenting all analytic systems quality activities in that laboratory” (including equipment and storage devices) and that the laboratory director at each site “must approve the operating procedures at that location.”
In addition, the general supervisor for high complexity testing is responsible for monitoring test analyses and specimen examinations to ensure that acceptable levels of analytic performance are maintained. This extends to equipment – including testing platforms – and storage devices.
AABB recently added a new resource to its “CLIA Corner” web page, outlining the clarification. The resource also includes a chart depicting how the various CLIA regulations are addressed in AABB Standards.