In late December, the Centers for Medicare & Medicare Services (CMS) finalized a regulation adopting a new fee structure and CLIA updates proposals concerning histocompatibility, personnel, and alternative sanctions for certificate of waiver laboratories. In total, CLIA covers about 320,000 laboratories, and the CLIA program's objective is to ensure quality laboratory testing. These are the first significant updates to the CLIA regulations since its inception in 1992.

Some changes within the rule are meant to provide more flexibility for clinical testing under CLIA. The rule also clarifies confusing provisions and removes grandfathered and other obsolete personnel degrees along with practices.

Key Provisions within the Final Rule

Fees: Created a new fee structure that would consider travel and inspection cost.

Personnel: Defined the doctorate-level degree by providing an educational requirement of three years

• Accepted Doctorate of Clinical Laboratory Services (DCLS) as a qualifying degree for high-complexity laboratory directors.
  • The CMS does not consider DCLS the same as a MD or DO, therefore, DCLS degree holders as other individuals with nonmedical doctoral degrees must qualify under the doctoral degree requirements.
• Allowed non-scientific degree individuals to qualify for roles within CLIA if they meet a qualification algorithm. (This applies to the roles of technical supervision, testing personnel, and moderate-complexity laboratory director).
• Created a new category for nurses to qualify as testing personnel in moderate complexity testing labs and Point of Care testing in hospitals, and for respiratory therapists as Technical Supervisor to oversee blood gas labs.
• Updated Laboratory Director responsibilities, including requirements for in-person visits. Laboratory Director’s must make an in-person visit to the laboratory at least once every 6 months, with at least 4 months between visits, but can come more often than that if they choose to.

Histology: Updated the histocompatibility requirements to reflect current day practices especially related to crossmatching.

Certificate of Waiver (COW Laboratories Sanctions): Allowed alternative sanctions for waived laboratories (including civil monetary penalties, a directed plan of correction and onsite monitoring).

Although the CAP supported many of the changes in the final rule, particularly around the creation of a pathway for nurses to qualify as testing personnel, flexibility for nonscientific degrees and clarification of doctorate-level degrees within CLIA, the CAP strongly opposes allowing individuals with the DCLS degree to qualify for high-complexity laboratory director positions under CLIA. 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.

Most of these regulations were made effective January 27, 2024, however, personnel changes will be made effective December 28, 2024. Questions about the CLIA program should be submitted to LabExcellence@cms.hhs.gov.