CMS and CDC have proposed changes to CLIA regulations that would significantly revise laboratory director qualifications, personnel standards, and laboratory oversight. Among the most consequential changes are eliminating mandatory board certification for qualifying doctoral directors and removing prescribed on-site director visits. CMS describes the changes as reducing regulatory burdens, but their implications for professional preparation and oversight deserve careful scrutiny.
ADLM has long supported board certification as an important measure of doctoral laboratory directors’ qualifications. The association’s whitepaper describes certification as a means of establishing a standardized knowledge base alongside formal training and experience. Removing this independent assessment is a major area of concern.
Key changes to qualifications and oversight
- Removing scheduled on-site director visits: Moderate- and high-complexity directors would no longer be required to visit at least once every six months, with at least four months between the two required visits. Directors would remain responsible and accessible as needed. Eliminating this minimum raises questions about how directors would identify workflow problems, evaluate working conditions, and maintain effective supervision remotely.
- Eliminating mandatory doctoral board certification: Qualifying doctoral high-complexity directors would retain specified education prerequisites but could qualify through either one year directing or supervising high-complexity testing or 20 continuing-education (CE) credit hours covering director responsibilities. The CE option would not require supervisory experience. This would remove independent specialty assessment from federal requirements, leaving uncertainty about how clinical and supervisory readiness would be demonstrated.
- Reducing moderate-complexity experience requirements: Qualifying doctoral directors could use one year directing or supervising nonwaived testing or 20 CE credit hours, without mandatory board certification. Eligible master’s- and bachelor’s-level candidates could use one year of supervisory experience in nonwaived testing or 20 CE credit hours, with separate laboratory-experience requirements removed. Education prerequisites remain, but these changes could allow directors to qualify without practical supervisory experience.
- Recognizing animal-related education and experience: The proposal would include specified animal and veterinary science degrees and remove definitions restricting qualifying laboratory experience to clinical settings. Certain thesis and research-project requirements would also lose their human-testing limitation. Animal research can inform human medicine, but familiarity with similar instruments itself does not demonstrate readiness to oversee human diagnostic testing. How relevant clinical competencies are established warrants clarification.
- Removing specified microscopy competency duties: The proposal would rescind director duties to evaluate and document competency for provider-performed microscopy, including first-year semiannual and subsequent annual assessments. This raises questions about identifying performance problems. It would not eliminate competency assessment throughout CLIA.
Specified physician pathways would also change, including experience, CE, or residency/fellowship laboratory-training alternatives. A dermatopathology-specific route would recognize specified physician certifications. Existing targeted personnel enforcement discretion does not waive doctoral board certification.
Virtual access and cytology
Qualified personnel could securely review digital information under the originating laboratory’s certificate. Remote workflows would retain director accountability and require confidentiality and documentation controls; effective oversight across locations remains important. Provider-performed microscopy certificates are excluded.
Cytology would remain excluded from virtual access. Current guidance requires appropriate separate certification for remote cytology review locations following the March 23, 2026 end of the temporary exception. Digital images would separately be permitted in gynecologic proficiency testing, without authorizing remote cytology practice under the primary certificate.
Scientific consultation and other operations
ADLM has publicly supported reinstating CLIAC. Changing its regulatory establishment requirement from mandatory to discretionary would remove the commitment to this dedicated scientific forum. Statutory consultation would remain required, but sustained expert participation deserves attention.
Other proposals address digital-image retention, laboratory identifiers on reports, email-change notifications, same-campus certification, gross tissue examination, blood-gas personnel, and reinstatement after proficiency-testing failures.
Members can submit comments through the CMS docket by December 7, 2026.