CLIA proposal would permit specified virtual access and digital cytology proficiency testing

What happened

The October 8 CMS/CDC proposed rule CMS-3478-P would treat qualified personnel's secure remote review of laboratory data, results, live imaging, and digital images as activity under the primary testing laboratory's CLIA certificate. The virtual-access definition excludes cytology, and the proposed compliance-certificate provision excludes provider-performed microscopy certificates. The primary director would remain responsible for testing, including virtual work, and the laboratory would supply CMS with its virtual-access staff list on request. The proposal describes codifying and updating prior enforcement-discretion arrangements; it does not by itself change an existing certificate or authorize a new practice.

A separate proposal would allow digital images of slides in gynecologic cytology proficiency testing so testing can align with the laboratory's primary methodology. Approved programs would need systems to monitor testing integrity. Other proposed changes address personnel qualifications, digital record preservation, reporting, certificate administration, and enforcement; the document presents these as proposals rather than completed regulatory changes. The Federal Register notice requests comments by December 7, 2026 using CMS-3478-P. That comment date is a participation deadline, not a laboratory compliance date or a general permission for remote cytology screening.

Why it matters

Personnel qualifications, reporting, certification and enforcement provisions also appear in the proposal. Proposed flexibility does not authorize a laboratory to change its current certificate or testing practice.

Sources

• CLIA proposed rule CMS-3478-POfficial · CMS and CDC · 2026-10-08 · Source review 2026-10-11