New Guidelines for CLIA Laboratory Testing Personnel

The U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services (CMS) recently published its final rule updating the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The updates include changes regarding laboratory personnel requirements, which went into effect on January 27, 2024. So, what do these changes mean for staffing and recruitment in CLIA labs? Here are the key staffing related updates to take note of in the “Testing Personnel Qualifications” section of the final rule:

Changes: High-level overview

• The grandfather clause. This is important for existing laboratories. Individuals who are already employed in the CLIA role of laboratory testing personnel but who will no longer qualify under the changes will be grandfathered in, assuming they continuously fulfill their testing personnel position. Essentially, if you have staff members serving as testing personnel who qualified under previous CLIA regulations but don’t under the changes recently imposed, so long as the testing personnel are continuously employed in that role at your facility, they will remain grandfathered in and can continue serving your lab compliantly in this role.

• Clarification of training and experience requirements. CMS codifies that training and experience must occur in a laboratory setting that meets 42 CFR 493.2, i.e. a facility that provides diagnostic reporting of the human specimens tested.

• Physical science degrees no longer qualify. Consistent with concurrent changes to other clinical lab personnel requirements, CMS has chosen to remove physical science as qualifying education for the testing personnel role for all non-waived laboratories.

• Respiratory therapist and pulmonary technologist clinical rotations. After receiving several comments asking for clarification, CMS ruled that the 18 months of clinical rotation respiratory therapists and pulmonary technologists complete as part of their training would, indeed, count toward the total of two years of experience required for moderate complexity technical consultants.

• Nursing degrees qualify for moderate complexity testing. CMS finalized a rule that allows nurses to qualify as moderate complexity testing personnel by creating such a path: nursing degrees now meet the educational requirements for that role.

What’s all this discussion about nurses in labs?

In their originally drafted suggestions in July 2022, CMS proposed that nursing degrees be deemed qualifying education for testing personnel for all non-waived tests, essentially equivocating them with biological or chemical science degrees. A majority of commenters disagreed that these degrees are equivalent based on the little laboratory science coursework included in nursing degree programs, and, after reconsidering based on the comments, CMS ultimately agreed to change the proposal. However, CMS noted that their stance since 2016 has been that nursing degrees are equivalent to biological science degrees, as, in their experience since 2016, nurses who have received appropriate training and demonstrated competency have shown capability to perform moderately complex tests accurately and reliably.

As a result, CMS offered the finalized rule that reflects a compromise between their stance on nursing degree equivalency and commenters’ disagreement with such: nursing degrees will now be accepted as qualifying education for the role of testing personnel in moderately complex laboratories. It is important to note, however, that nursing degrees will not qualify individuals as high complexity laboratory testing personnel—this was removed from the original proposal.

What these changes mean when recruiting testing personnel for your lab

Given the grandfather clause, your current testing personnel staff are safe; no need to panic if your current staff qualified previously but will not qualify as testing personnel under the changed rules. For example, let’s say you have a testing personnel employee who has an associate’s degree in physical science; although CMS is removing physical science as a qualifying degree for CLIA personnel roles, so long as the individual remains continuously employed in their current testing personnel position in your lab, they will continue to be approved as such.

However, should you need to add or replace testing personnel in your facility, all new staff will need to qualify under the new rules. That means that no one with a physical science degree as the qualifying education will be permitted as new staff personnel, nurses will only be allowed in the role of point-of-care testing and/or moderately complex testing personnel, and everyone will need to demonstrate that their qualifying training and experience was gained in CLIA licensed laboratories, essentially. Additionally, individuals with respiratory therapy degrees who completed 18 months of clinical rotations and have gained an additional six months of diagnostic laboratory testing experience (in a CLIA licensed facility, of course) will now qualify as a moderate complexity technical consultant for the subspecialties in which they’ve gained experience.

Overall, there aren’t many big changes to navigate with regard to CLIA testing personnel for laboratories. These new requirements for CLIA lab staff, updating 42 CFR 493.1423, appear to be largely an effort to ensure flexibility during future public health emergencies (PHE), given the hurdles experienced as a result of the COVID-19 pandemic.

Allowing for grandfathered-in individuals to remain in their CLIA roles, nurses to qualify with point-of-care testing and as moderate complexity testing personnel, and clinical rotations from respiratory and pulmonary technologist training programs to count toward the experience required for moderately complex technical consultants may allow for more individuals to qualify as CLIA personnel. The one major thing to avoid now that these changes have been enacted is the hiring of individuals with physical science degrees who have no other educational means of qualifying for CLIA designated roles, as these individuals will no longer be approved as qualified by CLIA representatives and inspectors.

What might these changes mean for patient care?

Given the current shortage of qualified laboratory personnel, understaffing in many laboratories and hospital systems, and the fact that this shortage is only projected to get worse due to staff leaving the industry and insufficient numbers of new graduates to replace them, many laboratory advocates agree clearer pathways to personnel approval are good for patient care.

One positive impact to patient care is that moving toward regulations that eliminate more general training (such as physical science education) and require more specialized training and experience will likely yield more qualified laboratory professionals providing that care.

References:

1. 1. https://www.federalregister.gov/documents/2023/12/28/2023-28170/clinical-laboratory-improvement-amendments-of-1988-clia-fees-histocompatibility-personnel-and

1. 1. https://public-inspection.federalregister.gov/2022-15300.pdf