The Centers for Medicare & Medicaid Services (CMS) recently sought feedback from the public to help with the upcoming update of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations. The Association for Diagnostics & Laboratory Medicine (ADLM) shared their suggestions.

CMS published their request for information (RFI) in the Federal Register on July 16, with a deadline of September 14 for comments regarding:

• Breath testing
• Laboratory processes and procedures
• Emergency preparedness
• Biosafety and biosecurity
• Cybersecurity
• Specialty testing areas

ADLM’s comment letter contained several suggestions, including recommendations for ethical artificial intelligence (AI) use. They said, “AI tools should remain subject to the same professional expertise, quality systems, validation requirements, and monitoring standards that apply to traditional laboratory testing.” Some of ADLM’s recommendations are:

• CLIA should include targeted updates, reflecting new challenges that come with AI, like errors and safety concerns.
• Federal oversight for AI-based tools should be established by CMS and CDC aimed at avoiding unnecessary duplication between agencies.
• Performance differences between traditional software and learned models should be taken into account when evaluating them.
• A risk-based, technology-appropriate approach to AI oversight was suggested that sets clear quality expectations and allows laboratory directors and qualified laboratory professionals to decide how to meet those expectations.
• CLIA oversight was recommended for facilities that independently analyze patient-specific laboratory data or provide specialized laboratory interpretations that contribute to test results for clinical use.

Additional recommendations from the public can be viewed on the Federal Regulations website.