1. Medtech Insight

New CLIA Rule Updates Personnel Policies

 
• By Elizabeth Orr

A new set of clinical lab regulations, which came into effect in January, include higher fees, an expanded set of possible consequences for labs that are not in compliance, and revised employee standards.

Female scientist working in research lab
(Gorodenkoff/Shutterstock)

Diagnostics firms that operate facilities regulated under the Clinical Laboratory Improvement Amendments (CLIA) may need to check their personnel policies to stay in compliance after recent revisions to the rule.

A new CLIA final rule, issued in December 2023, came into effect in January 2025

Key Takeaways
  • While new CLIA rules imposed by CMS in January have been overshadowed by the FDA's LDT final rule, they remain significant for regulated laboratories.
  • The new rules increase fees, expand the variety of sanctions that CMS can impose for noncompliance, and revise criteria for employment in CLIA-certified labs

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