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- ICYMI: 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 has detailed its opposition in an August 29, 2022 letter to the CMS.
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.