Background
On October 8, 2026, the Centers for Medicare & Medicaid Services (CMS) and Centers for Disease Control and Prevention (CDC) published a proposed rule to update regulations under the Clinical Laboratory Improvement Amendments (CLIA). The proposal includes significant changes to laboratory personnel qualifications, laboratory director responsibilities, remote access to laboratory data, proficiency testing, and federal laboratory oversight.
Of particular concern is the proposed elimination of mandatory board certification for doctoral scientists directing high-complexity laboratories. The proposal would also reduce certain laboratory experience requirements and allow qualifying doctoral scientists to meet additional director qualification requirements through either one year of experience directing or supervising high-complexity testing or a one-time completion of 20 hours of continuing education covering laboratory director responsibilities.
ADLM opposes eliminating mandatory board certification for doctoral high-complexity laboratory directors and the proposed reductions in laboratory experience requirements. ADLM is concerned that these changes would negatively impact patient safety by weakening important safeguards that help ensure accurate and reliable laboratory testing. Because laboratory results inform diagnosis and treatment, lapses in laboratory oversight can have direct consequences for patient care.
Importance of board certification
High-complexity laboratory directors oversee the clinical, scientific, and operational aspects of laboratory testing. Their responsibilities include evaluating and validating test methods, monitoring test performance, overseeing quality management, interpreting complex results, consulting with healthcare providers, and investigating laboratory errors. Board-certified doctoral laboratory directors are trained to serve as clinical counterparts to treating physicians, advising on appropriate test selection and interpretation, helping identify potential testing errors, and promoting patient safety.
Board certification provides an independent assessment of the specialized scientific and clinical knowledge required to fulfill these responsibilities. Unlike continuing education or experience alone, certification requires candidates to demonstrate their knowledge through an established examination process.
Impact of the proposed changes
Eliminating board certification would remove an independent competency assessment from the federal qualification requirements for doctoral high-complexity laboratory directors. Although the proposal would retain degree requirements and other laboratory quality standards, it would permit certain individuals to qualify without completing a recognized specialty board examination. These changes would reduce qualification requirements while leaving laboratory directors responsible for the same clinical and scientific duties, including ensuring testing quality and providing clinical consultation.
The proposed rule also includes several other significant changes:
Laboratory director oversight: Eliminates the requirement for moderate- and high-complexity laboratory directors to visit their laboratories at least once every six months, while retaining the requirement that directors remain accessible.
Personnel qualifications: Revises educational and experience requirements for several laboratory positions, including moderate-complexity laboratory directors, and expands recognition of certain animal-science and veterinary-related educational backgrounds.
Virtual access: Allows qualified personnel to securely review digital laboratory data, images, and results remotely under a primary laboratory's CLIA certificate, with an exception for cytology.
Digital cytology: Permits digital images for gynecologic cytology proficiency testing and expands certain digital record-retention requirements.
Scientific oversight: Changes the requirement that HHS establish the Clinical Laboratory Improvement Advisory Committee (CLIAC) from mandatory to discretionary.
Talking points
Board certification is an essential measure of laboratory director competency. High-complexity laboratory directors must possess specialized scientific and clinical expertise to oversee sophisticated diagnostic testing. Independent board certification provides an established means of assessing this knowledge and competency. ADLM is concerned that eliminating this safeguard would put patient safety at risk.
One-time continuing education and laboratory experience are not equivalent to independent board certification. The proposed alternative qualifications of 20 continuing education hours or one year of supervisory experience do not include the same independent assessment of specialized knowledge provided by board certification. The proposal would remove CLIA's requirement to maintain board certification and meet applicable board-specific continuing-education obligations throughout a director's career.
Workforce shortages among testing personnel should not be conflated with the availability of qualified high-complexity laboratory directors. Laboratories face documented recruitment and retention challenges among medical laboratory scientists and technicians. However, those workforce data do not establish a comparable national shortage of qualified doctoral high-complexity laboratory directors. CMS should provide director-specific workforce evidence before relying on workforce concerns to justify reducing director qualification standards.
Modernizing CLIA should not weaken laboratory director qualification standards. ADLM supports expanding opportunities for qualified scientists from diverse educational and professional backgrounds. However, recognizing different educational pathways should not come at the expense of rigorous scientific and clinical competency requirements.
Laboratory directors are clinical counterparts to physicians, not just administrators. Directors must exercise independent scientific judgment when evaluating test performance, implementing new technologies, reviewing quality concerns, investigating laboratory errors, and consulting with healthcare providers on test selection and interpretation. These responsibilities require expertise that extends beyond general laboratory management and plays an important role in protecting patient safety.
Technical supervisors and laboratory directors have fundamentally different responsibilities. Technical supervisors oversee the technical aspects of laboratory testing, while laboratory directors have broader responsibilities for laboratory quality, scientific oversight, and clinical consultation. Experience as a technical supervisor does not, by itself, provide the specialized clinical and scientific expertise required to direct a high-complexity laboratory.
Animal-related education and research must demonstrate relevance to human clinical testing. The proposal would recognize certain animal-science and veterinary-related educational backgrounds and remove human-testing-specific language from some research requirements. Although animal-based research and training can provide valuable scientific experience, they do not necessarily demonstrate the clinical expertise required to oversee diagnostic testing on human patients. Qualification standards must continue to ensure appropriate competency in human clinical laboratory testing.
Changes to director oversight requirements should maintain accountability for laboratory quality. Removing mandatory semiannual on-site visits could provide additional flexibility, but laboratories must maintain effective mechanisms for supervision, quality assurance, communication, and oversight.
CLIA modernization should support technological innovation while maintaining laboratory quality. Secure virtual access and digital laboratory technologies can facilitate modern laboratory workflows. Requirements governing these technologies should be clear, practical, and consistent with maintaining reliable testing and protecting patient information.
Scientific expertise must remain central to federal laboratory oversight. CLIAC has historically provided scientific and technical recommendations on laboratory quality, personnel qualifications, and testing standards. Maintaining a consistent mechanism for expert consultation is important as laboratory technologies and practices evolve.
Ask
ADLM urges its members to submit comments to CMS addressing these issues prior to the December 7, 2026 deadline.
Comments may be submitted through Regulations.gov using docket CMS-2026-3235 and referencing CMS-3478-P.
Learn more about this issue and about writing effective comments.
Additional Resources