CMS Enacts New CLIA Regulations Effective January 2025 | Baker Donelson

Revisions to Definitions Pertinent to Personnel

In addition to the updated education and training requirements discussed further below, CMS has revised or introduced several definitions related to personnel qualifications under CLIA. This effort aims to clarify prior ambiguities regarding the applicable education and training requirements for clinical lab personnel and to establish clear standards for the future. These updates include the following:

1. CMS is updating the definition of “midlevel practitioner” for purposes of CLIA to explicitly include nurse anesthetists and clinical nurse specialists.
2. CMS is adding a definition for “continuing education (CE) credit hours” that includes both “continuing medical education” hours and “continuing education” hours to encompass physician and nonphysician education requirements.
3. CMS is adding a definition for “doctoral degree” to distinguish it from MD, DO, and DPM programs. The definition would include earned post-baccalaureate degrees with at least three years of graduate-level study that includes research related to clinical lab testing or medical technology but would not encompass a Doctor of Veterinary Medicine.
4. CMS is adding a definition for “laboratory training or experience,” which means training or experience obtained in a facility subject to and meeting CLIA standards (i.e., conducting nonwaived lab tests). CMS generally intended to ensure that all individuals performing nonwaived lab tests have proper training on the pre-analytic, analytic, and post-analytic phases of testing.
5. CMS is adding a definition for “experience directing or supervising” to clarify that this means experience obtained in a facility subject to and meeting CLIA standards (i.e., conducting nonwaived lab tests).

Personnel Requirements

The new education and training requirements are categorized according to the clinical lab position and the complexity of the lab test. For references to doctoral, master’s, and bachelor’s degrees, CMS has updated the permitted degrees to include only chemical, biological, clinical or medical lab science, or medical technology degrees across all positions (including those not addressed further below). This change removes “physical science” as a permitted degree. Additionally, the following represents a high-level summary of the Final Rule’s updates to requirements related to personnel qualifications and duties:

Given the broad-sweeping nature of the Final Rule’s changes, a number of actions are recommended to promote and maintain compliance. Because the Final Rule became effective in January 2025, such actions should be implemented promptly. Recommended actions include but are not limited to:

1. Assessing and monitoring personnel requirements.

While the Final Rule generally includes a grandfathering clause for the changes to personnel qualification requirements, such grandfathering is limited to individuals who were in their role as of December 28, 2024, and maintain continuous employment. These grandfathered individuals should be monitored so that any lapse in employment is flagged. Additionally, hiring policies and job criteria should be updated to reflect the requirements summarized above.

2. Update policies and procedures.

As noted above, the Final Rule requires laboratory directors to now visit the lab in person at least once per six months with at least four months between such visits. These onsite visits should be planned and documented, including evidence of performing activities that are part of the lab director’s responsibilities. These and other changes in the Final Rule necessitate various changes to existing procedures, and such changes should be reflected in written policies and procedures and communicated to relevant individuals to promote and maintain compliance with CLIA.

3. Budget for additional costs.

The Final Rule’s changes to personnel requirements and proficiency testing for certain clinical lab personnel will necessitate several costs as a result of the necessary updates to policies and procedures, additional training requirements, and travel and implementation of increased lab director visits. Additionally, the Final Rule incorporates some increased fees and provides a pathway allowing for alternative sanctions rather than being limited to principal sanctions.

The resulting implementation costs from this Final Rule are contemplated to be borne by clinical labs, accrediting organizations, and states that are exempt from CLIA certification and are therefore obligated to ensure their programs implement the updated requirements. Additional costs could also emerge as certain clinical lab personnel are required to acquire further certification or education and seek to pass this cost on to their respective employing labs.