At the end of 2024, CMS updated their requirements for laboratory directors. This update was part of the final rule which also included changes to other laboratory personnel requirements, histocompatibility requirements and fees. The new requirements became effective December 28, 2024. One of the most significant was an augmentation of the required qualifications for physician directors of moderate complexity laboratories. Effective December 28, 2024, the new rule required BOTH 1 year of experience directing or supervising nonwaived laboratory testing AND 20 continuing education (CE) credit hours relating to laboratory director responsibilities. Then, at the end of June 2025, CMS announced enforcement discretion regarding the new personnel requirements. Under this enforcement discretion, physician directors of moderate complexity laboratories require EITHER 1 year experience directing a laboratory OR completion of a 20 CE/CME hour laboratory director course (instead of both). These changes made me think about my own experience as a laboratory director.
CMS states that a “laboratory director is responsible for the overall operation and administration of the entire laboratory, which includes employing qualified personnel who are competent to perform their duties.” As laboratory directors, we are “responsible for the laboratory and must ensure it meets all applicable CLIA regulations,” and we are “responsible for developing and applying a quality system approach to laboratory testing that provides accurate and reliable patient test results.” (CMS. May 2025. Laboratory Director Responsibilities. [Laboratory Director Brochure]
As an AP/CP trained pathologist, I learned about many of these concepts in residency. And while I may understand the regulatory responsibilities of a laboratory director, it’s valuable to think about what makes an effective laboratory director. In my residency program at George Washington University, I was fortunate to have excellent mentorship in hematology, microbiology and blood bank. Each of these professors taught me about what being a good director of these divisions meant to them. From my microbiology professor, Dr. Kaiser, I learned about the importance of going to look at plates and smears directly and about the importance of talking to the medical laboratory scientists who know so much more than the residents. From the blood bank director, Dr. Lee, I learned the importance of attention to detail and the importance of reviewing patient charts and figuring out the clinical significance of blood product requests. From our hematopathologists, Dr. Karcher and Dr. DePalma, I learned the importance of morphology and clinical history when reviewing peripheral smears and aspirates. Dr. Karcher, who was also the hospital laboratory director, really modeled the importance of open communication and seeing to problems personally.
The burden of understanding the responsibilities of a laboratory director and determining what makes a director effective can seem overwhelming. Cost concerns, proficiency testing requirements, test volume, staffing requirements and adhering to CLIA standards are just a few of the things laboratory directors need to manage. That’s where COLA’s laboratory director track program comes in. COLA typically offers two different laboratory director programs: an in-person program held during the Laboratory Enrichment Forum (COLA’s annual national meeting) in May and a second online program that you can complete at your own pace. As I mentioned in my previous blog, this course covers the basics of quality control and quality assessment, but will also discuss utilization, competency and even molecular diagnostics. I will be presenting lectures along with COLA Board Member Verlin Janzen, MD, FAAFP and some of COLA’s expert surveyors during this year’s Laboratory Enrichment Forum (LEF), in Nashville, TN. This course is targeted at all current or aspiring laboratory directors regardless of training or experience. Medical laboratory scientists, non-pathologist physicians, PhDs and pathologists are all welcome and will all find something useful in the course.