Federal Register #2026-20613

CMS and CDC proposed updates to CLIA rules for virtual laboratory access, cytology proficiency testing, and personnel qualifications

CMS and CDC propose changes to federal laboratory regulations; this is a regulatory action, not a purchase opportunity. - Government agencies: U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC). - Scope: Proposed amendments to regulations implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA); no products or services are requested. - Proposed changes: - Permit secure virtual access to laboratory data and results under a primary testing laboratory’s CLIA certificate, with an exception for the cytology subspecialty. - Allow digital images in gynecologic cytology proficiency testing. - Revise personnel qualification requirements and requirements for SARS-CoV-2 reporting, certificates, test reporting, enforcement, public consultation, and record retention. - Notable requirements: Virtual access would require secure connections and confidential environments. Applicable digital laboratory data and images would need to be retained, and systems would be needed to monitor proficiency-testing integrity. - OEMs and vendors: None identified; no manufacturers, vendors, or purchase quantities are specified.

Description

This proposed rule would amend the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations. It proposes to allow virtual access under the CLIA certificate of the primary testing laboratory, except for cytology, and to permit digital images for gynecologic cytology proficiency testing. It also proposes changes to personnel qualifications and requirements concerning SARS-CoV-2 reporting, certificates, test reporting, enforcement, public consultation, and editorial and technical updates. Comments must be received by December 7, 2026.

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