A new proposed rule from the Centers for Medicare and Medicaid Services (CMS) would reduce the minimum qualifications needed for directors of laboratories that perform the most advanced and essential laboratory testing. According to CMS, changes would provide flexibility, reduce regulatory burden, and help with workforce shortages. But several provisions would remove independent safeguards that determine whether laboratory directors have the knowledge and competence required to oversee complex testing that millions of patients depend on every day.
The rule, CMS-3478-P, would not only update personnel provisions but also would recommend broad changes to the Clinical Laboratory Improvement Amendments (CLIA). For example, the rule would generally allow qualified laboratory personnel to remotely review digital data, results, live imaging, and digital images under the certificate of the primary testing laboratory, except in cytology. It also would allow digital images to be used in gynecologic cytology proficiency testing.
While the remote review allowance may provide needed flexibility in an era of remote work, the personnel provisions themselves raise serious concerns for laboratory professionals and the patients we serve. Specifically, CMS proposes eliminating the requirement that doctoral scientists directing high-complexity laboratories hold a Department of Health and Human Services (HHS)-approved board certification. Under current regulations, these directors must hold certification, have 2 years of relevant experience, and complete 20 continuing education (CE) credit hours. Under the proposal, a doctoral scientist could qualify with either 1 year of experience directing or supervising high-complexity testing or 20 CE hours covering laboratory director responsibilities.
CMS also proposes alternatives for physicians who are not pathologists. The board-certification requirements for pathologists would not change.
Board certification is about more than experience
CMS notes that approved doctoral boards require at least 1 year of supervisory experience. This seems to be the agency’s rationale for accepting certification as documentation of experience while no longer requiring certification itself.
However, board certification for laboratory directors documents much more than the fact that someone has spent time in a supervisory position. Importantly, it provides an independent assessment of specialized knowledge and competence across laboratory medicine. Experience remains important, but it does not, in itself, show that a candidate has mastered the breadth of knowledge required to direct a high-complexity laboratory. Nor do 20 CE hours provide the same independent assessment as an examination administered by a recognized certification board.
CMS itself made a similar distinction when it preserved board certification in a 2003 rule. CMS concluded then that high-complexity clinical laboratory procedures require broad knowledge and the highest skills needed to fulfill director responsibilities and ensure quality testing, and that these qualifications could best be demonstrated through board certification.
Laboratory medicine has become more complex since that decision. Technologies such as next-generation sequencing, mass spectrometry, and flow cytometry increasingly require laboratories to integrate specialized technical expertise with quality management, clinical interpretation, and regulatory oversight. That complexity strengthens the case for preserving an independently assessed baseline of knowledge for laboratory directors.
The laboratory director’s role cannot be reduced to management
CMS says laboratory director responsibilities center on administrative and supervisory duties and not specialized expertise in each subspecialty, noting that laboratories must also employ technical consultants or technical supervisors with relevant specialty experience.
Technical expertise can and should be distributed among qualified laboratory professionals; however, assigning specific duties to technical personnel does not make the laboratory director’s role administrative.
Laboratory directors need broad knowledge of laboratory theory and practice, analytical science, quality management, troubleshooting, and clinical interpretation. Directors also must be able to evaluate problems that cross technical, operational, and clinical boundaries.
The proposal would also remove the specific requirement for directors to visit the moderate- and high-complexity laboratories they oversee at least twice each year. Instead, directors would have to be accessible to the laboratory as needed. The value and feasibility of onsite work can vary among laboratories, but reducing director qualifications while also removing a defined onsite requirement warrants scrutiny.
Laboratory innovation requires strong professional oversight
Laboratory directors’ expertise is especially important as medicine is transformed by artificial intelligence (AI). ADLM has urged policymakers to ensure that emerging AI tools remain subject to the same professional expertise, quality systems, validation, and monitoring standards that apply to laboratory testing. Effective oversight requires qualified laboratory professionals who understand laboratory methods, data, validation, and sources of error. As AI becomes more deeply integrated into laboratory medicine, maintaining that expertise becomes more important.
In addition, clinical laboratories face real workforce pressures, but available evidence does not establish a significant nationwide shortage specifically of qualified laboratory directors.
ADLM supports practical pathways that allow qualified professionals from different educational backgrounds to enter laboratory leadership. However, regulatory flexibility should be evidence-based: Expanding pathways does not require eliminating trusted, independent measures of competence.
CMS should retain the HHS-approved board-certification requirement for doctoral high-complexity laboratory directors and reconsider the proposed experience and CE alternatives. Modernizing CLIA should strengthen the law’s ability to protect patients as laboratory medicine changes: It should not undermine standards for those entrusted to lead its most complex work.