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- CMS eases lab personnel rules with new guidance
The Centers for Medicare and Medicaid Services (CMS) issued guidance clarifying regulatory changes from the 2023 CLIA Personnel Rule, which took effect in December 2024. The updates outline how the agency will apply enforcement discretion and new flexibility in qualification requirements.
This guidance affects laboratory directors, clinical consultants, and technical supervisors.
Clarifications:
- Moderate complexity laboratory directors can qualify with either one year of supervision experience or 20 CE credit hours—both are not needed. We advocated for this change in our deregulatory relief recommendations.
- Clinical consultants who were previously qualified can continue in that role without needing additional CE credits.
- Technical supervisors qualify as high-complexity laboratory directors for dermatopathology testing.
- High-complexity lab directors with a doctoral degree need only two years (down from four years) of training or experience.
What's next: CMS intends to formalize these updates in future notice-and-comment rulemaking, during which the CAP can provide feedback.
Dive in: Read the full memo.