New AABB Resources Summarize Upcoming Changes to CLIA Regulations

December 18, 2024

AABB released two resources this week to help facilities understand upcoming changes to the Clinical Laboratory Improvement Amendments (CLIA) by the Centers for Medicare and Medicaid Services (CMS).

AABB provided a summary of updates to CLIA laboratory regulations on personnel qualifications. These changes were announced in Final Rule 3226-F, issued on Dec. 28, 2023, that also addressed CLIA fees, histocompatibility and alternative sanctions for Certificate of Waiver laboratories. These changes will take effect Dec. 28, 2024. 

AABB also released a summary of changes to CLIA regulations surrounding Final Rule 3355, which addresses proficiency testing for analytes and acceptable performance. These changes will take effect Jan. 1, 2025. 

Accredited facilities may contact AABB Accreditation via email with questions.