Data / Federal rules / 2026-20613
Clinical Laboratory Improvement Amendments of 1988 (CLIA); Virtual Access, Gynecologic Cytology Proficiency Testing (PT), Personnel Qualifications, and Other Changes
The Centers for Medicare & Medicaid Services published this proposed rule in the Federal Register on October 8, 2026. Comments are due by December 7, 2026.
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What the agency says
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.
Key facts
- Document number
- 2026-20613
- Type
- Proposed rule
- Action
- Proposed rule
- Agency
- Health and Human Services Department; Centers for Medicare & Medicaid Services
- Published
- October 8, 2026
- Comments due
- December 7, 2026
- Dates
- To be assured consideration, comments must be received at one of the addresses provided below, by December 7, 2026.
- Docket
- CMS-3478-P
- Regulation ID (RIN)
- 0938-AV89
- Code of Federal Regulations
- 42 CFR 493
- Topics
- Administrative practice and procedure; Grant programs-health; Health facilities; Laboratories; Medicaid; Medicare; Penalties; Reporting and recordkeeping requirements
- Pages
- 51
Other documents from the Centers for Medicare & Medicaid Services
Everything from the Centers for Medicare & Medicaid Services · Rules on administrative practice and procedure · Rules on grant programs-health · Rules on health facilities · Published in October 2026
Read from the Federal Register API, last updated 2026-10-23. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.