Special Advocacy Update

• CMS Finalizes DCLS Proposal in CLIA Regulation Opposed by CAP

Despite strong opposition from the CAP, the Centers for Medicare & Medicaid Services (CMS) finalized a regulatory proposal to allow individuals with a Doctor of Clinical Laboratory Science (DCLS) degree to qualify for high-complexity laboratory director positions. The CMS finalized the provision in a regulation released December 22 concerning CLIA fees: histocompatibility, personnel, and alternative sanctions for certificate of waiver laboratories.

While the CAP had supported the CMS’ effort to clarify doctorate-level degrees within CLIA, the CAP strongly opposed the inclusion of the DCLS degree as a qualifying degree under CLIA to direct laboratories. The CAP has stated that the DCLS degree will cause confusion among the public about the distinctions between a clinical pathologist and those with a DCLS. The CAP had detailed its opposition in an August 29, 2022 letter to the CMS.

The CAP opposed the addition of this professional category to CLIA since these individuals do not receive the clinical training to consult clinicians with laboratory testing. Further, the CAP has said it is inappropriate to include a professional designation as a qualifying educational category for CLIA.

While the CMS regulation will allow DCLS degrees to qualify as high-complexity laboratory directors, the CMS does not consider DCLS the same as a physician with an MD or DO. DCLS degree holders as other individuals with nonmedical doctoral degrees must qualify under the doctoral degree requirements.

A clinical pathologist is a physician who is trained to render diagnoses, interpret laboratory tests, and provide clinical consultations in the field of laboratory medicine to other physicians. The professional activities of clinical pathologists constitute the practice of medicine.

Nurses Qualify for Point-of-Care Testing

The final regulation also created a pathway for nurses to qualify as testing personnel in laboratories performing moderate complexity testing. Nurses will only be able to qualify for personnel positions for point-of-care-testing and are no longer eligible to qualify as laboratory directors. The CAP supported the creation of a pathway for nurses since they perform most of the point-of-care testing within health care systems.