Attn: CLIA Laboratories
CMS announces enforcement discretion and clarification of personnel regulations.
As part of the Division’s commitment to Teach, Learn, and Collaborate, the Division of Quality Assurance (DQA) is providing you with the following important message from CMS.
On June 23, 2025, Centers for Medicare & Medicaid Services (CMS) issued QSO-25-21-CLIA. The following summary was provided by CMS.
Enforcement discretion of personnel regulations
The new personnel qualification regulations found in CMS-3326-F went into effect on December 28, 2024. Since the effective date, CMS has received stakeholder feedback that some of the new personnel qualification regulations are burdensome and unclear. Based on the significant concerns raised by stakeholders, CMS will be exercising enforcement discretion in the following limited circumstances stated in the memo with respect to certain personnel qualification requirements and plans to address these changes in future notice-and-comment rulemaking.
Clarification of personnel regulations
CMS is further clarifying and plans to address in future notice-and-comment rulemaking that “an approved thesis or research project related to laboratory testing for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings,” does not need to be on human subjects, as most research is performed on animal models. In addition, CMS would like to make clear that the requirements under §493.1443(b)(3)(iii) for high complexity laboratory directors to require a total of two, not four, years of laboratory training or experience and laboratory experience directing or supervising high complexity testing.
Questions
For questions or concerns relating to QSO-25-21-CLIA, please contact LabExcellence@cms.hhs.gov.
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