Summary
The Centers for Medicare and Medicaid Services announced changes to personnel requirements in response to feedback on the CLIA final rule. The CAP Checklists Committee revised the checklists to reflect these changes, making requirements more flexible. Notable changes include easing the 20 CE credit hour requirement for laboratory directors and clarifying the definition of “continuous employment.”
Valerie Neff Newitt
March 2026—More flexibility and less burden sum up the personnel requirement changes in the accreditation program checklists released in December last year.
The revisions to the CAP checklists stem from changes that the Centers for Medicare and Medicaid Services announced on June 23, 2025 in response to feedback the CMS had received about what it required in the CLIA final rule implemented on Dec. 28, 2024. The announcements were in CMS memorandum QSO-25-21-CLIA (CLIA Enforcement Discretion and Clarification on Personnel Regulations) and QSO-25-10-CLIA Revised (Revisions to State Operations Manual, Appendix C–Advance Copy).
“People felt that what they came out with in December [2024] wasn’t as practical as it maybe should have been, and the June changes were fine-tuning efforts by CMS. Then we had to fine-tune our checklists,” says Greg Gagnon, MD, vice chair of the CAP Checklists Committee.
The result: “The requirements have become more flexible,” says Amer Mahmoud, MD, chair of the CAP Checklists Committee and clinical associate professor of pathology at the University of New Mexico.
In the director assessment checklist, for example, DRA.10100 on laboratory director qualifications was revised to remove the requirement for 20 CE credit hours in laboratory practice that cover director responsibilities; the 20 hours had been added based on the CLIA final rule.
“It seems that CMS received negative feedback about the 20 CE credit hours,” says Dr. Mahmoud, who is with Pathology Associates of Albuquerque and Presbyterian Hospital’s Department of Hematopathology and Molecular Genetic Pathology, and is CLIA medical director, TriCore Laboratories.
The CMS 20-hour requirement had applied to non-pathologist physicians and doctoral degree directors. While directors in roles as of Dec. 28, 2024 were allowed to continue in their roles without obtaining the 20 CE credit hours, it had an impact on new directors and existing directors with breaks in service that exceeded six months. The required two years of experience are now sufficient for directors of high-complexity testing laboratories.
For moderate-complexity testing, Dr. Gagnon says, the CMS did it differently. “They took away the 20 CE credit hours for the moderate-complexity lab directors with a doctoral degree,” and returned to allowing one year of experience or the 20 CE credit hours for lab directors of moderate-complexity labs with an MD, DO, or DPM, as was required prior to the CLIA final rule.
The 20-hour requirement was eased also for clinical consultants and is now reflected in GEN.53650 Clinical Consultant Qualifications/Responsibilities.
In another CMS change, now seen in DRA.10100, dermatologists are allowed to direct Mohs laboratories, as they were before December 2024.