CLIA final rule addresses Certificate of Waiver sanctions, personnel qualifications

The Centers for Medicare & Medicaid Services and the Centers for Disease Control and Prevention Dec. 28 released a final rule updating Clinical Laboratory Improvement Amendments fees and clarifying CLIA regulations. Within the final rule, CMS amends provisions governing alternative sanctions (including civil money penalties, a directed plan of correction, a directed portion of a plan of correction and onsite state monitoring) to allow for the imposition of such sanctions against non-compliant laboratories operating under Certificates of Waiver, rather than being limited only to imposing principal sanctions of revocation, suspension or limitation of a laboratory’s CLIA certificate. AHA last August commented on the rule as proposed, urging CMS to avoid changes that would weaken the program’s high regulatory standards and so is pleased that the agency has removed the proposed addition of a nursing degree qualification for high complexity testing personnel. AHA is reviewing the policy and will update members with further information as appropriate.