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Industry Insights

Why Understanding Lab Director State Requirements is Crucial for Clinical Labs

It’s no secret clinical laboratories and pathology groups are currently experiencing a shortage of qualified candidates to staff their facilities and maintain business as usual.

While this environment can be attributed to a multitude of factors ranging from the Great Resignation to the lack of new programs dedicated to advancing the careers of medical laboratory professionals, the issue only further exacerbates the difficulties lab owners face when trying to hire CLIA Lab Directors or other designated roles to maintain compliance with CMS.

Tara Luellen, VP of Lab Director Services, LLS

Tara Luellen, VP of Lab Director Services, LLS

“There are a lot of nuances involved in determining the qualifications necessary for personnel to fulfill specific CLIA designated roles in the laboratory, and these can change rapidly without advance notice by state regulating bodies, especially in response to something like the COVID-19 pandemic,” says Tara Luellen, Vice President of Lab Director Services for Lighthouse Lab Services. “I have been recruiting for Lab Directors and Pathologists for six years, and I still learn new things every day because the industry and regulations are constantly changing, not to mention candidate outlooks on opportunities.”

Just a few of these variables include: state requirements for experience and/or licensure, federal CLIA guidelines, accrediting bodies’ additional requirements, specialties and subspecialties performed in-house, and what roles are being fulfilled, among others. Ensuring your lab or group has a strong understanding of these guidelines is crucial to your ability to maintain regulatory compliance and efficient operations.

MORE: Check out our new Lab Personnel FAQ page


Why Lab Director State Requirements are Especially Stringent

While most states explicitly follow CLIA regulations for Lab Director qualifications required for the level of testing and complexity they perform in-house, 15 states and the District of Columbia have some unique differences, as outlined below:

  • A doctoral degree and board certification are the minimum requirements to qualify as a high complexity Medical Laboratory Director, as per CLIA regulations. However, the following states have additional requirements for licensure, experience, and/or credentials: AL, CA, FL, HI, LA, NV, NJ, NY, ND, TN, and Washington D.C.
  • Moderate Complexity qualified Medical Lab Directors must possess at least a bachelor’s degree coupled with experience, but the following states have additional requirements in order to qualify to direct moderate complexity testing: AL, CA, FL, KY, LA, NV, NJ, NY, ND, TN, and Washington D.C.
  • Most states do not have specific requirements for the qualifications of Lab Directors overseeing Waived testing; however, CA, HI, IL, MD, MA, NV, NJ, NY, PA, and TN do require the CLIA Director of Waived testing to possess certain credentials, and these state qualification standards range from an Associate’s Degree to being qualified to direct high complexity testing (minimum of a doctoral degree and board certification).

Additionally, CLIA mandates all Lab Directors as responsible for ensuring personnel in their labs have the appropriate education and experience for their particular role and duties prior to testing patient specimens, receive adequate and on-going training as needed, and be able to demonstrate that they can perform all testing operations reliably to report accurate results. Working to both hire and maintain a sufficient number of lab personnel who meet these qualifications can make a Lab Director’s duties particularly difficult in states that also have heightened personnel requirements for other positions.

For example, here is a list of states that have additional requirements for Technical Supervisors for high complexity testing and Technical Consultants for moderate complexity testing: AL, CA, FL, GA, IL, KS, KY, LA, MD, MA, NJ, NY, ND, PA, TN, and WV.

Finally, the following states also have requirements beyond the CLIA regulations for General Supervisors and Testing Personnel: CA, FL, NV, NY, TN, HI, LA, MT, ND, RI, and WV.


The Benefits of Working with an Industry Recruiter

Many Lighthouse clients are located in the states noted above as having more stringent personnel requirements due to the difficulty of navigating said additional qualifications. Fortunately, due to our experience working exclusively in the clinical lab and pathology industry, we can advise labs in any state, regardless of type of testing and complexity level, as to what they need in terms of personnel.

“Someone who does not work explicitly within your industry cannot possibly stay abreast of these changes and how they may affect your business and hiring needs,” Luellen stresses. “Working with an expert who is well-versed in these nuances will greatly increase labs’ success rate in terms of filling the roles required by CLIA compliantly so that there are not unforeseen deficiencies related to personnel qualifications during inspection.”

If you need assistance navigating state personnel requirements for Lab Directors, other lab positions, or are seeking a recruiter to assist with staffing for any clinical laboratory or pathology role, don’t hesitate to contact us for a free consultation.


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