The Association for Pathology Informatics (API) would like to make members aware of an important opportunity to provide input on potential updates to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations.
The Centers for Medicare & Medicaid Services (CMS), in coordination with the Centers for Disease Control and Prevention (CDC), has issued a Request for Information (RFI) seeking feedback from the clinical laboratory community. Comments are due September 14, 2026.
The RFI addresses a broad range of issues relevant to clinical laboratories and laboratory medicine, including:
  • Use of artificial intelligence (AI)
  • Cybersecurity
  • Laboratory personnel qualifications, including personnel involved in pre-analytic processes
  • Testing involving suboptimal specimens
  • Validation requirements
  • Emergency preparedness and biosafety
  • Blood culture contamination reduction and monitoring
  • Other areas in which existing CLIA requirements may warrant modernization or clarification
This is an opportunity for laboratories, institutions, organizations, and individuals within the pathology and laboratory medicine community to provide CMS and CDC with perspectives based on their own experiences and operational needs.
View the full RFI:
https://www.federalregister.gov/documents/2026/07/16/2026-14358/request-for-information-clinical-laboratory-improvement-amendments-of-1988-clia-regulations
Submit comments by September 14, 2026:
https://www.regulations.gov/commenton/CMS-2026-2345-0001
Responses may be entered directly through Regulations.gov or submitted as an attached PDF.
View comments already submitted:
https://www.regulations.gov/document/CMS-2026-2345-0001/comment
We encourage API members and their institutions to review the RFI, particularly the questions related to AI, validation, cybersecurity, and other areas relevant to pathology informatics, and to consider submitting comments where you have expertise or experience to share.