CMS proposes to let labs read results remotely and digitise cytology proficiency tests

The agencies that oversee the United States' clinical laboratories have proposed the most substantial update to the rules governing them in years, moving to write pandemic-era flexibilities into permanent regulation and to modernise how laboratories are staffed and tested. A proposed rule published in the Federal Register on 8 October 2026, issued jointly by the Centers for Medicare & Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC), would amend the regulations that implement the Clinical Laboratory Improvement Amendments of 1988 [s1].

CLIA was enacted on 31 October 1988 and is codified at 42 U.S.C. 263a; its implementing regulations at 42 CFR part 493 set the conditions every laboratory must meet to be certified to test human specimens [s1]. Those rules, the agencies note, were written before much of today's digital laboratory technology existed. The proposed rule, CMS-3478-P, would update them across four areas while, the agencies say, maintaining laboratory quality and safety standards [s1].

Reading results from somewhere else

The central change concerns what the rule calls virtual access. Existing CLIA rules generally require a laboratory to hold a separate certificate for each physical location, and were built on the assumption that work happens on the premises [s1]. During the COVID-19 public health emergency, CMS used enforcement discretion to let pathologists review digital data, results and pathology images remotely, and interested parties urged it to keep that flexibility afterward; on 11 May 2023, when the emergency ended, the agency issued a memo continuing the practice [s1].

The proposed rule would codify that flexibility, allowing pathologists and laboratory personnel to review digital laboratory data, digital results, live imaging and digital images remotely under the CLIA certificate of the primary testing laboratory that generated the data [s1]. One subspecialty is carved out: cytology. Federal law and the regulation at 42 CFR 493.1274(a) require cytology slide screening and preparation to be done on the premises of a laboratory certified for that subspecialty, and the rule leaves that requirement in place [s1].

Digital Pap-test proficiency testing

The second area addresses that cytology exception from a different angle. Gynaecologic cytology — the microscopic reading of cervical-screening slides — is subject to mandatory proficiency testing, in which screeners are periodically tested on known slides. The proposed rule would allow digital images of glass slides to be used in that proficiency testing, which the agencies say would align the programme with FDA-authorised digital cytology screening systems now entering use [s1]. It is a technical change with a practical point: as laboratories adopt digital cytology, the exam that checks their competence has to be able to use the same digital images. Cervical screening is one of the areas where accurate reading most directly affects patients, so the proficiency programme that polices it cannot lag behind the technology laboratories are deploying.

Staffing, COVID reporting and housekeeping

The third area is personnel qualifications. The rule would address concerns about the burden of qualification requirements that took effect on 28 December 2024, including by removing limitations that recognised only human-only laboratory science degrees and by adding qualification routes for histopathology gross-tissue examination personnel and for Mohs dermatology laboratory directors [s1]. The agencies frame these changes partly as a response to laboratory workforce shortages [s1].

The fourth area is a set of other changes. The rule would remove the requirement that laboratories report SARS-CoV-2 results — a reporting obligation that originated in the pandemic — and would update certificate requirements, test-report requirements, enforcement provisions, public-consultation rules and the regulatory text establishing the Clinical Laboratory Improvement Advisory Committee, along with editorial and technical corrections [s1].

What happens next

This is a proposal, not a final rule, and none of it takes effect yet. CMS is accepting public comment through 7 December 2026, after which it must consider the comments before issuing any final rule [s1]. The significance lies in the direction: the agencies are trying to reconcile a 1988 oversight framework with remote digital review, digital pathology and a strained laboratory workforce, while holding on to the on-premises rule for cytology that CLIA's statute still mandates [s1]. Whether the balance they have drawn survives comment — particularly the scope of remote review and the eased staffing rules — is the open question the comment period is meant to answer.

Sources

• [s1] Clinical Laboratory Improvement Amendments of 1988 (CLIA); Virtual Access, Gynecologic Cytology Proficiency Testing (PT), Personnel Qualifications, and Other Changes — Centers for Medicare & Medicaid Services / Centers for Disease Control and Prevention (Federal Register), 8 October 2026.