CMS issues enforcement discretion on CLIA personnel requirements

On July 2, the Centers for Medicare & Medicaid Services (CMS) released memo QSO-25-21-CLIA, announcing targeted enforcement discretion for select CLIA personnel requirements. This policy change responds directly to concerns raised by ADLM and other stakeholders regarding the December 2024 final rule, which significantly tightened qualification standards for laboratory personnel.

Effective immediately, CMS will exercise enforcement discretion in the following areas:

• Laboratory directors may now qualify with either one year of experience directing or supervising nonwaived testing or 20 continuing education (CE) credit hours in laboratory director responsibilities—rather than being required to meet both.
• Previously qualified clinical consultants and high-complexity laboratory directors will not be required to complete additional CE hours to retain their existing credentials.

These updates reflect a meaningful response to advocacy efforts by ADLM and the broader laboratory community, which emphasized the potential for unintended disruptions to lab operations and staffing pipelines if the stricter December 2024 standards were fully enforced.

The association will continue to engage CMS in discussions around the modernization of CLIA personnel standards to ensure they remain science-based, flexible, and achievable—without compromising quality or patient safety.