Labs Get Virtual Access, Digital Pap Smears in New Rules
Published Date: 10/8/2026
Proposed Rule
Summary
This proposed rule updates lab rules to let primary labs use virtual access (except for cytology), and allows digital images for gynecologic cytology testing. It also changes who can work in labs and updates COVID-19 reporting, certificates, and test rules to keep labs accurate and modern. Labs and workers should get ready for these changes, with comments due by December 7, 2026.
Analyzed Economic Effects
5 provisions identified: 4 benefits, 1 costs, 0 mixed.
Remote 'Virtual Access' Allowed (Except Cytology)
If you run or work for a clinical laboratory, the rule would let qualified staff review digital lab data, results, live imaging, and digital images remotely under the CLIA certificate of the primary testing laboratory that generated the data. Virtual access must use a secure connection, is not allowed for the subspecialty of cytology, and the primary laboratory director remains responsible for testing performed via virtual access.
Personnel Qualification Flexibilities Restored
The rule proposes revising personnel qualification requirements (including some finalized in the December 28, 2023 rule that took effect December 28, 2024) to restore flexibilities, remove certain 'human-only' limitations, and add qualifications for histopathology gross tissue exam personnel and Mohs dermatology laboratory directors. CMS states the proposed changes are generally more permissive than the 2023 CLIA final rule and would restore pre-December 28, 2024 flexibilities.
Digital Images and Data Must Be Retained
The rule would require laboratories to retain digital images and digital data under existing record-retention rules. Existing retention time frames remain (for example, cytology slide preparations are retained at least 5 years and histopathology slides at least 10 years) and the rule adds digital images/data to the items that must be preserved.
Digital Images Allowed for Gynecologic PT
If you take gynecologic cytology proficiency testing, the rule would let HHS-approved PT programs use digital images of glass slides for the required 10- or 20-slide test sets. PT programs using digital images must have a system to monitor the integrity of the testing so individual results accurately reflect performance.
SARS‑CoV‑2 Reporting Requirements Removed
The rule would remove SARS‑CoV‑2 (COVID-19) reporting requirements from the CLIA regulations. Laboratories that previously had reporting obligations under CLIA would no longer have those specific SARS‑CoV‑2 reporting rules in CLIA.
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Key Dates
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