CMS proposes CLIA updates for digital access, personnel qualifications
Proposed changes by CMS aim to improve clinical laboratory operations by allowing remote digital data access, updating proficiency testing for gynecologic cytology, and addressing staff shortages through revised eligibility criteria, seeking stakeholder feedback.
The Centers for Medicare & Medicaid Services (CMS) proposed a rule on October 8 regarding virtual access, gynecologic cytology proficiency testing, personnel qualifications, plus other changes.
The proposed rule, if finalized, would update federal oversight of clinical laboratories to include:
Remote access of digital laboratory testing data for qualified personnel under the lab that generated the data’s CLIA certificate, except cytology
Digital images for gynecologic cytology proficiency testing
Changes to eligibility requirements for certain roles to combat staff shortages
Changes to outdated SARS-CoV-2 reporting requirements
Modernizing the wording of current regulations
Requirements for email address changes
Updates to test reporting, how regulations are enforced, and protocol for seeking public comments
CMS is seeking feedback on the proposed changes. Interested parties must submit comments by December 7, 2026, electronically, or by mail at Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-3478-P, P.O. Box 8016, Baltimore, MD 21244-8016.
