AABB Calls for Risk-Based Approach to CLIA Modernization

AABB urged the Centers for Medicare and Medicaid Services (CMS) to take a risk-based, technology-neutral and nonduplicative approach to modernizing the Clinical Laboratory Improvement Amendments (CLIA) regulations in comments on a July 16 request for information. In a letter to CMS Administrator Mehmet Oz, MD, the Association said updates should reflect advances in laboratory practice while preserving flexibility and avoiding unnecessary burden.

In response to CMS questions on specimen preparation staff, AABB cautioned against new prescriptive educational or credentialing requirements for laboratory personnel. Such mandates could add to existing workforce challenges without improving quality or patient care, the Association said, and it supported continued use of competency-based qualification systems.

The comments stressed that existing quality systems and accreditation programs already cover many areas raised in the request, including validation of tests that are not FDA-cleared or approved. AABB recommended a technology-neutral framework for software algorithms and artificial intelligence (AI) focused on validation, performance and qualified human review. It also warned that prescriptive approaches could quickly become outdated and that AI-specific requirements could unintentionally capture long-established laboratory software. Any AI-generated results should be reviewed and confirmed by a qualified laboratory professional, the letter noted.

AABB said current CLIA language does not fully reflect modern immunohematology practice, such as molecular blood group genotyping and electronic crossmatching. It asked CMS and the Centers for Disease Control and Prevention (CDC) to harmonize CLIA with FDA regulations rather than add requirements. The letter also addressed suboptimal specimens, remote competency assessment, emergency preparedness, biosafety, cybersecurity and specialty testing categories.

AABB looks forward to continuing to work with CMS and CDC as they evaluate potential changes to CLIA.