Lab Director Qualifications Change Dec. 28
Oct. 24, 2024, News Staff — Family physicians who have a moderate-complexity lab in their practices will want to be aware of upcoming CMS rule changes about qualifications for lab directors that take effect late this year, although current lab directors will be exempt from the changes as long as they stay at their existing locations.
To qualify as a new lab director of a moderate-complexity lab beginning Dec. 28, physicians must
pass a 20-hour course in laboratory practice and
have one year of experience directing or supervising non-waived testing.
The current requirements call for either the course or the experience, but both will be required under the new rule.
Physicians who are lab directors at moderate-complexity labs can continue serving in that role at their existing location but will have to meet the new requirements if they establish a new lab or move to a different medical practice.
Members who plan to register for the laboratory practice course can take advantage of a 10% discount on courses offered at COLA Academy.
Practices that are subject to the new requirements might instead choose to hire a local pathologist or a qualified clinical laboratory scientist. Other educational pathways for those who do not meet the new physician qualifications are
board-certified pathologist;
board-certified Ph.D. in biology, chemistry or clinical lab science with the same 20-hour course and one year of directing or supervising experience;
master’s degree in biology, chemistry or clinical lab science with the same 20-hour course and one year of directing or supervising experience, as well as one year of training or experience; or
bachelor’s degree in biology, chemistry or clinical lab science with the same 20-hour course, two years of directing or supervising experience and two years of training or experience.
The AAFP offers more information about Clinical Laboratory Improvement Amendments (CLIA) and office labs, including how to obtain a CLIA certificate, information about education and more.