Expanding Test Menus: A Compliance Roadmap for FDA-Regulated Labs
Two OIG advisory opinions guide laboratories that want to work with pharma or medical device companies on expanded testing
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Reporting Noncompliance in Clinical Labs Requires the Right Channels and Culture
A lawyer advises medical laboratories on how to improve their avenues for reporting unethical behavior
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Audits, the False Claims Act and Clinical Lab Enforcement: 2025 Trends and Compliance Tips
Original Air Date: Wednesday July 11, 2025 1:00 PM ET Register now to View On-Demand! Significant cases decided in 2024 and 2025 are shaping the landscape of enforcement for clinical laboratories. Government regulators continue to focus on medical necessity and...
Further Details to Note about Updated Clinical Lab Director Qualifications
Put into place late last year, the new rules place more emphasis on formal and continuing education requirements
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Updates to CLIA Personnel Requirements May Lengthen Hiring Times
Changes ‘have had a significant impact on the recruitment process for laboratory directors and technical supervisors,’ recruiter says
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