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

Open for public comment until Dec. 7, 2026. Comment on Regulations.gov

What it does

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 includes proposed changes to personnel qualification requirements and other proposed changes pertaining to SARS-CoV-2 reporting requirements, certificate requirements, test reporting requirements, enforcement requirements, public consultation requirements, and editorial and technical updates. These proposed updates aim to strengthen the Federal oversight of clinical laboratories and ensure accurate and reliable patient test results while adapting to modern technological capabilities and industry needs, including workforce shortages.

The Centers for Medicare & Medicaid Services's summary, as published in the Federal Register.

What it would change

1 part of Title 42 of the Code of Federal Regulations:

42 CFR 493

Before this

No earlier Federal Register document under regulation identifier 0938-AV89 since Jan. 1, 2025.

What happens next and when

To be assured consideration, comments must be received at one of the addresses provided below, by December 7, 2026.

The agency's dates, word for word.

Check it yourself

• The document in the Federal Register
• Docket CMS-2026-3235 on Regulations.gov
• Title 42 on eCFR

The record as published

Source: the Federal Register (public domain). The document in the Federal Register