The Association for Diagnostics and Laboratory Medicine firmly rejects a suggested regulation issued by the Centers for Medicare and Medicaid Services that would drop the need for doctoral scientists directing high-complexity clinical laboratories to hold board certification approved by the Department of Health and Human Services.

High-complexity laboratories carry out advanced testing that physicians count on daily to identify disease and direct patient care. Directors of these labs supervise all clinical, scientific, and operational functions. They need strong scientific and clinical skills to review test methods, confirm and track performance in their patient groups, manage staff, counsel physicians on proper test selection and result interpretation, and examine errors. Board certification offers a vital independent check of the specialized expertise required to deliver today's sophisticated clinical laboratory services.

Under the suggested rule, qualifying doctoral scientists could satisfy federal standards with one year of experience directing or supervising high-complexity testing or twenty hours of continuing education on laboratory director duties. Neither option matches the independent review of specialized knowledge that board certification supplies.

ADLM backs efforts to update CLIA and broaden paths for qualified scientists from varied educational and professional routes. Yet expanding access should not reduce rigorous standards. Laboratory directors must retain the ability to apply independent scientific judgment, even when drawing on other qualified experts for technical tasks.

CMS should keep the HHS-approved board certification requirement for doctoral scientists who direct high-complexity laboratories and revisit the proposed cuts in experience standards. Patients deserve high-quality care supported by laboratory directors whose qualifications have been independently verified.

About the Association for Diagnostics and Laboratory Medicine
Committed to better health for everyone through laboratory medicine, ADLM connects more than 70,000 clinical laboratory professionals, physicians, research scientists, and business leaders from 110 countries. Its members lead in fields such as clinical chemistry, molecular diagnostics, mass spectrometry, clinical microbiology, and data science, and hold a wide range of lab-related degrees and credentials. Since 1948, ADLM has advanced laboratory medicine by encouraging scientific collaboration, knowledge exchange, and innovative solutions that improve health results. For details, see the ADLM website.

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 and Laboratory Medicine