If you’re working in the clinical lab space, there are some key updates from CMS regarding laboratory director qualifications to be aware of. These changes, which take effect on Dec. 28, 2024, are broken down below so labs and aspiring directors understand what’s required moving forward and ensure they maintain regulatory compliance.
Note: These changes apply to CLIA-Certified Laboratory Directors of moderate- and high-complexity laboratories. Administrative lab directors and other non-CLIA-certified lab management positions are not impacted by this update.
The Basics of Qualification: Who’s Eligible?
Under the updated rules, the path to becoming a lab director depends on an individual’s education and professional background. Here’s a snapshot of what’s changing:
- Doctoral Degrees (PhD/DCLS): If they’ve earned a doctoral degree in fields like chemistry, biology, clinical laboratory science, medical laboratory science (MLS), or medical technology (MT), the individual qualifies as long as they meet the following criteria:
- Board certification from an HHS-approved body.
- At least one year of experience supervising or directing non-waived lab testing.
- 20 continuing education (CE) credits related to laboratory director duties.
- Finally, those without a relevant doctoral degree must also have completed 16 semester hours of doctoral-level coursework in biology, chemistry, medical technology, or related fields.
- MDs/DOs: For medical doctors (MDs) and doctors of osteopathy (DOs), things are getting streamlined. If they’re board-certified in pathology (ABP) or by the American Osteopathic Board of Pathology (AOBP), with recognized equivalency qualifications now removed as a qualification. If they don’t have that certification but have experience directing or supervising high-complexity testing for two years, plus 20 CE credits, they can still qualify.
- Master’s and Bachelor’s Degree Holders: For those working in moderate-complexity labs, they can qualify as a lab director with a master’s or bachelor’s degree, provided they have relevant experience and training, and they’ve completed 20 CE credits.
Experience Counts — But Only If It’s Specific
For MD, DO, or Doctor of Podiatric Medicine (DPM) degree holders who do not hold board certification, CMS is tightening the experience requirements. Lab Directors now need to have at least one year of training or experience directing or supervising non-waived lab testing to qualify. For high-complexity labs, that requirement jumps to two years.
Patty Hess, Senior Account Manager
But it’s not just about time spent in the role. Labs and directors also need to make sure they’re keeping up with the latest in laboratory practices by completing 20 CE credits focused on the duties of a lab director.
Patty Hess, Senior Account Manager with the Lighthouse Lab Director Program, says the CE requirement is among the most significant changes in her eyes.
“Lab Directors will need to provide proof they have completed those,” Hess notes, adding that the definition of directing/supervising experience is another key item of importance.
Changes to On-Site Requirements
Another update is the on-site visit requirement. Starting next year, laboratory directors will need to visit their labs at least twice every six months, with at least four months between those visits. Each visit must be documented, showing that necessary responsibilities are being fulfilled.
Grandfather Clause: A Silver Lining
If you have a lab director in place before Dec. 28, 2024, that individual will be covered by a grandfather clause, meaning they can continue in the role even if they don’t meet all new qualifications. If you’re looking to hire a new director, now is the time to make sure any candidates you consider will meet existing or new requirements based on the timing of your hire.
Lighthouse Lab Services is a leading source of qualified lab director candidates and has a knowledgeable recruiting team ready to help labs navigate these changes and ensure you remain compliant. We also assist lab directors seeking new positions through our candidate placement services.
Final Thoughts
These CMS updates reflect a broader push for higher standards and accountability in laboratory testing. If you’re seeking a new lab director or aspiring to become one, now is the time to review these new requirements and ensure you’re prepared when changes take effect at the end of 2024.
Contact Lighthouse today for a complimentary consultation with questions or to learn more about our Lab Director Services!
Could you please add verbiage that these changes apply to those serving in the medical laboratory director’s role, normally held by a pathologist? People who are not familiar with laboratory terminology that are unfortunately in hiring manager roles in private companies are trying to apply this to those in clinical/administrative director (lab management) positions.
Thanks for raising that point of clarification, Amanda. We’ll add a note to the article that reiterates this is for CLIA Lab Directors, not administrative LDs.
Recommend adding a source (s) for the 20 CEUs laboratory director duties training.
Thanks for the feedback. We’ll look to add some good options once we consult with our LD team.
“Master’s and Bachelor’s degree” provided they have relevant experience and training, and they’ve completed 20 CE credits. Any specific field of study?
Thanks for reaching out for clarification. There is no specific field of study required if you meet the experience and CE requirements. I’ve reached out to our Lab Director team for further clarification and will get back to you with any additional info!
20 CE total, or is this 20 CE per year? There is no frequency mentioned here. Also must these CE’s be specifically FOR Lab Directors?
Thanks for clarifying. We’ve reached out to our consulting team and will be back soon with a response. Some team members are on vacation, but we should have a response within the week!
CB, we’re still looking to confirm the frequency requirement. That said, here is some clarification from our team on the CE specifications: “Directors must have at least 20 CE credit hours in laboratory practice that cover the director’s responsibilities.”