Enduring Leveraging Lessons from the Past Webinar: What's New in Quality & Regulatory? (2025)

Course overview

This webinar will provide an overview of recent regulatory changes impacting clinical laboratories. This will include the latest updates to Clinical Laboratory Improvement Amendments (CLIA) memos and brochures, the termination of Clinical Laboratory Improvement Advisory Committee (CLIAC) and its impact to clinical laboratories, a summary of the FDA LDT final rule regulatory journey, and a discussion of the shift to announced inspections. Objectives: 1. Describe the current situation with the Clinical Laboratory Improvement Advisory Committee (CLIAC) and implications to clinical laboratories. 2. Determine the operational impact of recent updates to CLIA brochures and memos. 3. Summarize the regulatory journey of the FDA's LDT final rule. 4. Describe the shift from unannounced to announced inspections by CAP and AABB.