By: Tara Luellen, Vice President of Lab Director Services, LLS

After connecting with COLA’s Director of Accreditation and COO last week, we’d like to provide additional clarity:

COLA firmly follows CLIA regulations for personnel, including the Clinical Consultant role; this means that someone with a doctoral degree (MD, DO, DPM, or PhD in an approved science) who is certified by any HHS-approved board will meet the requirements to fulfill this role, although MDs, Dos, and DPMs are additionally required to possess a valid medical license in the state where the lab is located.

Tara Luellen, VP of Lab Director Services, LLS

The confusion that stricter qualifications for the Clinical Consultant were required seems to have stemmed from their published manual, which noted that board certification in the specialty/subspecialty of service was required for those with PhDs in approved sciences; if this were correct, then this would, indeed, be a more stringent requirement than what CLIA regulations set forth.

However, in discussion with COLA’s Director of Accreditation, Eamon Tiffany, our Vice President of Laboratory Director Services Tara Luellen was able to confirm that COLA has always followed CLIA guidelines for personnel requirements and will continue to do so. A revision to their next manual was promised in order to eliminate conflicting information, surveyors will continue to be trained to follow CLIA regulations for personnel requirements, and COLA is investigating any deficiencies clinical labs have encountered as a result of this erroneous enforcement of an unclear guideline from their manual; at least one lab, in particular, has had its deficiency regarding the Clinical Consultant role expunged.

In following up, Kathy Nucifora, Chief Operating Officer of COLA, pointed to the federal CLIA regulations and stressed that COLA follows these to a tee: “For both CLIA and COLA, to serve as Clinical Consultant at §493.1405 (b) (3)i for moderate complexity laboratories or at §493.1443 (b) (3)i for high complexity laboratories, a doctoral degree in a chemical, biological, physical or clinical laboratory science AND an HHS-approved board certification is required. COLA does not require a specific board certification, as long as the board is HHS-approved, as listed in the CLIA regulations.”

COLA is committed to assisting laboratories in meeting the highest compliance standards, and Lighthouse continues to work closely with them and recommend their accreditation to appropriate client facilities.

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ORIGINAL BLOG BELOW:

If you operate a moderate or high-complexity CLIA diagnostic testing laboratory, you are probably familiar with the Clinical Consultant role; it is one of the required roles that must be fulfilled at all times while testing is being performed. This role’s main responsibility is to provide consultation to a laboratory’s clients about diagnosis, treatment, and management of patient care.

You must possess a doctoral degree (PhD, MD, DO, or DPM) in order to qualify for this role; the doctoral degree you possess then affects what additional qualifications you will need to be approved for this role. An MD, DO, or DPM must possess a currently valid medical license in the state where the lab is located, while a PhD needs to be certified by an HHS-approved board.

• You can find a comprehensive list of these boards here: https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Certification_Boards_Laboratory_Directors

Both CLIA and COLA guidelines for the Clinical Consultant role have always indicated that PhDs’ board certifications need to be in the specialty or subspecialty of service, i.e. the testing specialty(ies) performed in-house. Previously, in our experience, having a PhD Clinical Consultant who is board certified in the main specialty of the lab (for example, a board-certified toxicologist for a lab that primarily offers toxicology but may also run hematology samples as well), has been acceptable. However, we now understand COLA is placing stricter emphasis on labs obtaining more broadly trained Clinical Consultants.

New emphasis being placed on broader training

Recent COLA surveys of some clients who are COLA accredited have led us to understand that this will no longer satisfy their regulatory requirements. Instead, labs that offer multiple specialties in-house have been tasked with either securing a more broadly trained Clinical Consultant (i.e. a licensed physician – MD, DO, or DPM, or someone who is a PhD and ABB certified, as this exam tests for a variety of testing specialty knowledge in lieu of one specific specialty) or engaging a PhD with board certifications in all of the specialties performed in-house.

Unfortunately, the latter option is not always achievable; many PhDs hold only one board certification given the requirements to achieve those qualifications in various specialties. Additionally, by referencing the above link of accepted board certifications for PhDs, you may notice that there is no certification for the hematology specialty, for example. Currently approved board certifications for PhDs include these specialties: microbiology, chemistry, toxicology, immunology, genetics/genomics, and histocompatibility/immunogenetics; the ABCC has a molecular diagnostics specific certification, too.

As a result, labs that offer hematology testing in-house can only meet the more stringently interpreted guidelines for the Clinical Consultant role by employing a more broadly trained Clinical Consultant (a licensed physician or ABB-certified PhD, as mentioned above). This can create a hurdle for, particularly for independent reference labs, as there are only so many ABB-certified PhDs and reference labs are not always affiliated with physician practices to have access to licensed physicians. This places a strain on the laboratory to find a way to meet compliance guidelines set by CLIA and COLA in an economically feasible way for their business.

Our Clinical Consultant network

Here at Lighthouse, we have more than 20,000 qualified Clinical Consultants in our network, most of whom are licensed Pathologists who, with a Clinical Pathology board certification, are qualified to both Direct and serve as Clinical Consultant for nearly all types of testing. While this excludes Anatomic Pathology, which requires board certification in that specific specialty, we also have these folks in our network to assist our AP labs, as well!

We can provide a part-time a COLA-qualified Clinical Consultant to your lab or hospital at a cost-effective price to allow you to achieve regulatory compliance without the worrying whether your personnel will be deemed compliant during your next inspection. Reach out to us directly to connect with our Vice President of Laboratory Director Services Tara Luellen, who also oversees the management of our part-time Clinical Consultant services, to learn more!