The Clinical Laboratory Improvement Amendments (CLIA) regulations specify the requirements for becoming a lab director. Rigorous standards ensure labs have qualified directors for high- and moderate-complexity testing.
The lab director ensures CLIA compliance in the pre-analytic, analytic, and post-analytic testing phases. Let’s learn more about what a CLIA lab director is and what their requirements are.
CLIA Lab Director Duties
A CLIA lab director meets CLIA requirements regarding experience, education, and training. They’re also responsible for the lab meeting CLIA regulatory requirements, staffing the lab with qualified experts, and assisting the laboratory staff as needed. Even when a director delegates a task, the director remains responsible for how the job is performed and whether it adheres to CLIA standards.
CLIA Categorizations
A CLIA lab director’s duties and the requirements for attaining the job depend on the lab’s testing complexity. The FDA categorizes diagnostic tests into three levels of complexity: waived tests, moderate-complexity tests, and high-complexity tests. The complexity rating is based on seven criteria.
- Knowledge
- Training and experience
- Reagents and materials preparation
- Characteristics of operational steps
- Calibration, quality control, and proficiency testing materials
- Test system troubleshooting and equipment maintenance
- Interpretation and judgment
The FDA adds the scores of all seven criteria to get a test’s total score. A test with a score of 12 or less has a CLIA categorization of moderate complexity, and a score of 13 or more is high complexity.
Moderate Complexity Testing Requirements
Four pathways exist for a lab director to meet the requirements for supervising a moderate complexity lab:
- Be a Doctor of Medicine (MD), Osteopathy (DO), or Podiatry (DPM) and
- Certified in anatomic or clinical pathology or
- Have lab training or experience of one year directing or supervising non-waived tests or
- Have earned at least 20 CME credits in lab practice or training equivalent to 20 CME credits earned during medical residency
- Hold a doctoral degree in laboratory science and
- Be certified by an HHS-approved board or
- Have one year of experience directing or supervising non-waived tests
- Hold a master’s degree in lab science and one year lab training or experience and one year experience supervising non-waived tests.
- Hold a bachelor’s degree in lab science and two years lab training or experience and two years’ experience supervising non-waived testing.
High Complexity Testing Requirements
There are two ways a lab director can meet the requirements for supervising and running a high-complexity testing lab.
- Be a licensed MD/DO/DPM and
- Be certified in clinical pathology or
- Have one year of lab training during medical residency or
- Have two years of experience directing or supervising high-complexity testing
- Hold a doctoral degree in chemical, physical, biological, or laboratory science and be able to prove all the following:
- Be certified by an HHS-approved board
- Have two years of lab training or experience
- Have two years of experience supervising or directing high-complexity testing
Use lab management services by Lighthouse Lab Services to meet and maintain CLIA standards. Whether you want to fill a part-time or full-time lab director position, we can connect you with qualified professionals. Contact us today for a free consultation.
I have a question regarding becoming a supervisor of a lab and certification. Can you please contact me when you can.
Absolutely, we’ll have someone reach out to you shortly. Is aniskaramsay@hotmail.com the best address to use?
Hello I am Nichole Jennings, I completed a LD application, I relized now that was the wrong one, it should of been for a Lab Tech / Supervisor, what is the next step?
Hi Nichole! Was this an application you completed through us? If so, I can reach out to our recruiting team and let them know to consider you for a different position instead.
I am not a doctor but I have managed/supervised a highly complexed lab for 23 years. Would I be eligible to become the director of this highly complex lab?
Hi India! We’d need to know more about your qualifications and the lab in question before we could accurately answer your question. Feel free to reach out to info@lighthouselabservices.com if you’d like to speak with our Lab Director team.
Hello,
I have a PhD degree and would like to understand how one get to “Be certified by an HHS-approved board”?
Hi Gabriela, thanks for your question. There are a number of boards approved by HHS for providing various certification exams to qualify as a lab director. Reach out to us directly at info@lighthouselabservices.com and we’d be happy to walk you through the process!
Greetings, I hold a PhD in Molecular Biology and possess clinical experience both prior to and following the completion of my doctorate (Total of 8 years). I am currently seeking guidance on the path to becoming a lab director. I kindly request your assistance in providing me with direction in this endeavor.
Hi! We’d love to help you secure a lab director position that meets your qualifications. Could you please reach out to us with a CV/resume at info@lighthouselabservices.com so we can get someone on our team assigned to assist you?
If the test is a simple dipstick urine test and you have a waiver, what is the Lab Director education requirements?
Hi! Thanks for your question. We’ve reached out to our Lab Director team and will get back to you soon with a response.
Here’s what our VP of Lab Director Services, Tara Luellen, had to say: It depends on the state. Some states have specific qualification requirements for LDs of waived testing; states that simply follow CLIA regulations for personnel (which is most states) don’t mandate specific qualifications, but you do still need to list someone as the LD. In those instances, anyone can be listed, regardless of their education or experience, but the listed LD will be the responsible party for ensuring compliance.
Hello,
I am a medical doctor (MD) and have helped supervise a high complexity lab for 1.5 years while our PhD has been the full lab director. We are thinking of downgrading to a moderate complexity lab rather than high complexity.
– since I have been under the PhD for high complexity lab for last 1.5 years can I serve as the lab director for the moderate complexity lab now (“Have lab training or experience of one year directing or supervising non-waived tests”) or would I still need to do an additional 20 hours of CME?
Hi Lee, thanks for your question! I’ve reached out to our Lab Director Services team and will get back to you soon with a response. Some members are on vacation this week, so apologies if we take a few days to get back to you.
Here’s what our LD Team had to say in response to your question: The qualifications for moderate complexity are as follows; ” Licensed MD/DO/DPM, AND certified in anatomic or clinical pathology, OR lab training or experience consisting of 1 year directing or supervising non-waived tests.” The 20 hours of CME are only applicable if the MD is not board-certified, nor do they have 1 year of directing or supervising non-waived tests. Since this person has experience supervising non-waived tests, they are qualified as a moderate-complexity lab director in most states.
However, there are some states that do not recognize moderate-complexity and require all lab directors to meet high-complexity requirements. For example, California, Connecticut, and New Jersey are states in which this statement is true. So, depending on the state, this person would be qualified as a moderate complexity lab director.
Can a technical supervisor sign out high complexity test?
Hi Samuel, thanks for your question! We’ve reached out to our consulting team and will get back to you soon with a response!
Here’s the response from our team: “This is a hard one to answer, as it really depends on the type of test. Some tests require review and sign-out by someone qualified as a CLIA LD, and some can be signed out by a TS. We would need more info about their specific tests, the lab’s location, and the qualifications/experience of the TS to accurately answer this question!”
If you’d like to follow up for a free consultation, send us an email at info@lighthouselabservices.com.
I am a medical doctor from India (MBBS) with a specialization in microbiology. I have gotten my Microbiology degree evaluated by IEE and the report was given as a US equivalent of PHD. I have also worked as a lab director for a national lab in India for more than 2 years. Based on this background, what is my best route to becoming a high complexity lab director in the US ?
Hi Mohammed,
Thanks for reaching out to us with your question. I’ve forwarded it to our Lab Director Team and will follow up with their response here soon!
Hello!
I was wondering if the MD I am looking to put as the LD (who meets all of the qualifications) has to hold a license to practice in the state in which the clinic resides. He oversees all of our research that is sent to him, but he is not physically present in the state this clinic is in. Am I able to put him as the LD on a CLIA (waived testing only), or does it have to a provider in the clinic that holds a license in that state? Thank you!
Thanks for your question. We’ve reached out to our Lab Director team with this and will get back to you here soon!
Here’s the response from our Lab Director team. We’ll need more info to probably answer the question, so feel free to reach out to us at info@lighthouselabservices.com for a free consultation!
Response: It depends on the state; some states have specific qualification requirements for LDs of waived testing to include licensure in that state if they are an MD (CA, for example). However, most other states don’t have specific qualification requirements for an LD of waived testing.
In the state of CO and in the state of NM, does a LD who is a MD have to be licensed in that specific state to be listed as the LD for a CLIA Waived testing only?
Hi Michelle, thanks for your question! I’ve reached out to our Lab Director team with this and will get back to you soon with a response.
Here’s the feedback from our regulatory experts: Colorado and New Mexico do not have specific qualifications or educational requirements for a Director of Waived testing. The lab must list someone in the Director’s role on the application for Waiver, but there are no specific qualifications required. As a result, anyone affiliated with the lab can serve as the Director and the lab must always have someone fulfilling this role to be compliant. Whomever is listed as the Lab Director will be responsible for ensuring the lab runs compliantly.
That said, if the laboratory names an MD to be the Lab Director, it is recommended that he/she holds licensure in that state to avoid any red flags from the respective CLIA offices.
Can a PhD in Health Services with an MLS (ASCP) and more than 5 years in the filed be able to be a Lab Director?
Hi Sheila, thanks for your question! If you let us know what state you’re in (or where you’d like to work), I will forward the question to our Lab Director team for more info. A lot of rules are state-specific, so that information will be helpful for us.
Colorado
Is there a limit on the # of High complexity labs a Director can be over?
It varies by state, but most states allow lab directors to oversee up to five laboratories!
Hello
Can a lab hire an external consultant/individual (not permanent staff) who already holds High Complexity Clinical Director qualification in order to fulfill the CLIA requirements
Hi, thanks for this question! The lab can hire a part-time director who holds high complexity qualification in order to fulfill CLIA requirements if they don’t require a director on site full-time. If this is something you’re interested in exploring, it can be a huge cost savings! We assist with placing part-time directors and would be happy to tell you more about your options if you’d like to reach out to recruiting@lighthouselabservives.com.