AHA to CMS: Proposed rule risks weakening CLIA’s high regulatory standards

The AHA, in a letter today to the Centers for Medicare & Medicaid Services, cautioned against softening standards designed to maintain the safety and quality of laboratory testing in the U.S., including those regulating the professionals who staff the nation’s Clinical Laboratory Improvement Amendments-certified labs. CMS in July proposed adding nursing degrees as a means for qualifying to become high-complexity testing personnel. “We are concerned that this would weaken CLIA’s regulatory structure and its ability to continue to ensure the highest quality of laboratory testing,” AHA wrote. 

AHA did express support for a separate CMS proposal that would make permanent COVID-19-era waivers that expanded the agency’s ability to deploy alternative sanctions for non-compliance in certificate of waiver laboratories; such flexibility is already provided for CLIA-certified labs, but not for certificate of waiver labs.