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 took 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 changed:
- 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 has tightened 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. Now, laboratory directors must visit their labs at least once 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 had 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 meet these new heightened requirements.
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 your lab is compliant.
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.”
Question about “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.”
I have looked into it and so far I didn’t find any university or college that allows students not enrolled in doctoral program to take doctoral level classes.
How is a candidate expected to complete 16 semester hours?
Hi Cristina,
We reached out to our Lab Director Team for clarification, and here was their response: The term “relevant doctoral degree” refers to doctoral degrees in fields such as chemical, biological, clinical, or medical laboratory science, or medical technology. The requirement of completing 16 semester hours of doctoral-level coursework in biology, chemistry, medical technology, or related fields applies to individuals holding a doctoral degree in a non-science discipline, allowing them to qualify for high-complexity testing.
Let us know if you still have questions or need further help!
According to ABB (American Board of Bioanalysis) my doctorate in Food Biotechnology does not satisfy the requirement of PhD in the fields of either chemical, biological, clinical, or medical laboratory science, or medical technology.
Therefore, I would like to take additional courses (16 doctoral level semester units), but as I mentioned above, looks like universities don’t allows students not enrolled in doctoral program to take doctoral level classes.
Any suggestion on how to satisfy the requirement?
I really appreciate your help.
I’ve followed up with our LD Team and will let you know if they have additional details. Thanks again for reaching out to us for clarification.
Correction in my previous e- mail:
Question: What are the states that will not follow the new CMS rule regarding lab director’s onsite visit to the lab at least twice a year?
Thanks for reaching out to us. We’re checking with our Lab Director team on whether there are any states with exemptions or differing rules. We’ll let you know if there are!
From what I understand, every state can have its own lab program, but it must be at least as stringent as CLIA, meaning, they must follow at least the basics of CLIA, so the quarterly rule still applies.
Thanks for this clarification!
Hi , does this 20 hours credit apply for NEW directors only? Or for directors already in functions?
Thanks for reaching out to us. In most instances, this applies only to lab directors who weren’t already in place prior to Dec. 28. If you want to clarify with us further, feel free to reach out to our team directly!
What documentation is required for an MD with the 20 CME to show the necessary experience as a lab supervisor to be qualified as a Lab Director of a Moderate Complexity lab? Documentation in their CV?
Hi Matt,
Thanks for reaching out for clarification. We’re consulting with our LD Team and will let you know when they have a response.
Here’s the answer from our Recruiting Team: “Documentation on the CV is sufficient, however if will be necessary to ensure that this CV is on-file for review by an inspector and up to date.”
Disagree. There is language on CLIA guidance memos that CVs, resumes or any documents written by candidate are not acceptable ss evidence of experience. The expectation is to produce records produced by the employer related to that supervusor experience e.g. job description, competency assessment, personnel roster etc. listing prrsonnel role.
Agree with Joseph. A CV might be accepted by some inspectors doing a cursory examination, but there needs to be 3rd party verification of experience. It must also be a lab testing human samples (not vet) and of a certain complexity, i.e moderate or high, based on the complexity of the lab the person is applying to direct. So directing waived testing for 2 years, for example, would not qualify as “experience” to direct a high complexity lab.
Thanks for the feedback. We agree and are working to update the article with better guidance on this area.
Does the grandfather clause mean that CLIA lab directors are not required to take the 20 CEUs directly related to Lab Director duties?
Hi Earl, thanks for reaching out to us. We’re checking with our team and will let you know when they get back with an answer.
Here’s the answer from Joe Kessler, Director of our Recruiting Team: “The grandfather clause means that if you are already an LD at a moderate or high complexity lab, you can continue to serve in that role without the 20 hour course. However, if you sign on as LD with a new lab or move to a different practice, you will need to meet the full requirements which includes 20 hours of instruction and one year of experience directing or supervising non-waived testing. Experience for high complexity LDs MDs without a board certification and PhD need to show 2 years of experience directing or supervising high-complexity testing. “
Hi there! Thanks for this. In your update per the new CMS requirement, does this mean that LD visits continue to be optional for CLIA-waived only labs (on a federal level)? Looking into getting a director for California but now having second thoughts
Hi, thanks for checking. This update doesn’t impact CLIA-waived labs, so no changes are taking place with regard to their visit requirements.
For CLIA Waived Laboratories: What are the requirements for Laboratory Director?
There are no federal standards. Here’s more from the Joint Commission: “For waived testing, there are no federally defined qualifications for the Laboratory Director in the Clinical Laboratory Improvement Amendments (CLIA). The individual should have the technical knowledge and experience required to oversee the specific laboratory testing performed.
The Joint Commission further recommends that the individual at least meet the minimum qualification route otherwise defined in the CLIA regulations for moderate complexity testing personnel [42 CFR 493, Subpart M]. Individual states may also have applicable regulations and licensure requirements for the Laboratory Director. Note that the Laboratory Director is legally responsible for all testing performed under the CLIA certificate. Non-physicians serving as Laboratory Director should seek professional advice regarding the necessity of additional professional liability insurance.”
Source: https://www.jointcommission.org/standards/standard-faqs/home-care/waived-testing-wt/000001789/
Am I interpreting this correctly that as long as the Medical Director is board certified in Anatomic or Clinical Pathology the 20 hours of continuing education is not required?
Hi Mike, I’ll reach out to our Lab Director Team to double check and will get back to you soon with a response.