ADLM opposes CMS proposal to eliminate board certification for high-complexity laboratory directors

WASHINGTON, Oct. 19, 2026 /PRNewswire/ -- The following statement is attributable to Stanley F. Lo, PhD, DABCC, FADLM, president of the Association for Diagnostics & Laboratory Medicine (ADLM):

"The Association for Diagnostics & Laboratory Medicine strongly opposes a proposed rule from the Centers for Medicare & Medicaid Services (CMS) that would eliminate the requirement for doctoral scientists who direct high-complexity clinical laboratories to hold board certification approved by the Department of Health and Human Services (HHS).

"High-complexity laboratories perform sophisticated testing that physicians depend on every day to diagnose disease and guide treatment for patients. Directors of these laboratories oversee all clinical, scientific, and operational aspects of the laboratory. They must have the scientific and clinical expertise to evaluate test methods, validate and monitor test performance in their patient populations, oversee laboratory personnel, advise physicians on appropriate test ordering and interpretation, and investigate errors. Board certification is a critical independent assessment of the specialized knowledge and competence required to provide today's advanced clinical laboratory testing.

"Under the proposed rule, qualifying doctoral scientists could meet federal requirements through 1 year of experience directing or supervising high-complexity testing or 20 hours of continuing education about laboratory director responsibilities. Neither of these alternative measures is equivalent to the independent assessment of specialized knowledge that board certification provides.

"ADLM supports modernizing CLIA and expanding opportunities for qualified scientists from different educational and professional backgrounds. However, expanding these opportunities need not come at the expense of rigorous standards. Laboratory directors must be able to exercise independent scientific judgment, even when they rely on other qualified professionals for specialized technical expertise.

"CMS should retain the HHS-approved board certification requirement for doctoral scientists directing high-complexity laboratories and reconsider the proposed reductions in experience requirements. Patients deserve high-quality care backed by laboratory directors whose qualifications have been independently demonstrated."

About the Association for Diagnostics & Laboratory Medicine (ADLM)
Dedicated to achieving better health for all through laboratory medicine, ADLM unites more than 70,000 clinical laboratory professionals, physicians, research scientists, and business leaders from 110 countries around the world. Our community is at the forefront of laboratory medicine's diverse subdisciplines, including clinical chemistry, molecular diagnostics, mass spectrometry, clinical microbiology, and data science, and is comprised of individuals holding the spectrum of lab-related professional degrees, certifications, and credentials. Since 1948, ADLM has championed the advancement of laboratory medicine by fostering scientific collaboration, knowledge sharing, and the development of innovative solutions that enhance health outcomes. For more information, visit www.myadlm.org.

Christine DeLong
ADLM
Director, Editorial and Media Relations
(p) 202.835.8722
[email protected]

Bill Malone
ADLM
Senior Director, Strategic Communications
(p) 202.835.8756
[email protected]

SOURCE Association for Diagnostics & Laboratory Medicine (ADLM)