Proposed Rule to the Clinical Laboratory Improvement Amendments of 1988 (CLIA); Virtual Access, Gynecologic Cytology Proficiency Testing (PT), Personnel Qualifications, and Other Changes

Published: 10/09/2026

Sources:
  • Centers for Medicare and Medicaid Services,
  • Centers for Disease Control and Prevention
Relevant To:
  • All Healthcare Organizations

CMS and CDC published a proposed rule on October 8, 2026 that would materially update CLIA requirements for laboratories.

This proposed rule would amend the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to allow for virtual access under the CLIA certificate of the primary testing laboratory that generated the data, with the exception of the subspecialty of cytology, and the use of digital images for gynecologic cytology proficiency testing.

This proposed rule also i…

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