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Request for Information (RFI); Clinical Laboratory Improvement Amendments of 1988 (CLIA), CMS-3485-NC
Important: Your Input Needed on Possible Updates to CLIA!
The Centers for Medicare & Medicaid Services (CMS) is asking for public comments to help update the Clinical Laboratory Improvement Amendments (CLIA) regulations from 1988. The request for information (RFI) includes the following topics: 1) breath testing; 2) laboratory processes and procedures; 3) emergency preparedness, biosafety and biosecurity, and cybersecurity; and 4) specialty testing areas. The RFI was published on July 16, 2026, in the Federal Register.
The RFI requests input on the following topics:
- Breath Testing
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Laboratory Processes and Procedures
- Pathology Specimen Block Retention
- Specimen Preparation Activities and Personnel
- Suboptimal Specimens
- Establishment and Verification of Performance Specifications
- Calibration Verification
- Postanalytic Interpretation and Use of Artificial Intelligence (AI)
- Data‑Only Facilities
- Remote Direct Observation Competency Assessment
- Emergency Preparedness, Biosafety and Biosecurity, and Cybersecurity
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Specialty Testing Areas
- General Considerations
- Clinical Cytogenetics, Immunohematology, and Microbiology
To read the RFI, go to the Federal Register, and submit your comments.
Important Deadline:
Comments must be received no later than September 14, 2026.
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