To maintain the highest standards in diagnostic medicine, the CAP opposed several changes to the Centers for Medicare & Medicaid Services (CMS) staffing qualifications recommendations in a proposed 2023 CLIA regulation. These adverse changes included the qualifications for doctorate level scientists, the consideration of the doctor of clinical laboratory scientist (DCLS), the expansion of other degree types eligible to be laboratory directors, and technical supervisor qualifications for immunohematology qualifications.

Overall, the CAP was supportive of many of the regulatory changes proposed by the CMS. However, there were areas of concern. In an August 29 letter to the CMS, the CAP outlined its opposition to the updated CMS qualifications for laboratory directors. The CAP firmly opposed the inclusion of a DCLS degree and the expansions of other types of degrees, such as a master’s degree, as qualifications to lead laboratory teams. In the letter, the CAP said, “While the CAP supports the agency effort to clarify doctorate-level degrees within CLIA, we strongly oppose the inclusion of the DCLS degree as a qualifying degree under CLIA.”

Additionally, the CAP opposed lowering the standards to include other degrees to qualify for Technical Supervisor Qualifications for Immunohematology. The CAP also disagreed with the CMS’s proposal for nurses as high-complexity personnel.

The CAP said it believed a nursing degree is not equivalent to a bachelor’s degree necessary to perform high-complexity testing, and therefore it should be a separate qualifying degree. Nurses perform laboratory-related functions such as point-of-care testing (POCT), specimen collection, and test ordering, which are not their primary job functions, but rather secondary tasks performed outside of the central laboratory. Unlike laboratorians in the central laboratory, nurses often have minimal time to reflect on the total testing process. In addition, nurses may have the understanding in terms of clinical knowledge but not in the laboratory medicine practice, which we believe a separate qualifying degree will better provide the skills, experience, and training necessary to perform these limited laboratory-related functions.

Nevertheless, the CAP was supportive of many of the regulatory changes proposed by the CMS. For instance, the CAP supports the CLIA proposals that address practice and technology changes, such as the updates to the Histocompatibility regulations, especially the recognition of virtual crossmatching; the creation of qualification algorithms for testing personnel instead of specific degrees; allowance of respiratory therapists with an associate degree to qualify as a technical consultant; the removal of the physical science degree; and, allowing military trained individuals to qualify as testing personnel once they move to the private sector.

CMS Allows Additional Time for Public Comment

Last week, the CMS extended the comment period for the proposed CLIA regulation to September 26 to give stakeholder more time to offer input. The CAP had joined an effort led by the American Society for Clinical Pathology (ASCP) to successfully urge the agency to move the deadline.