Enduring Leveraging Lessons from the Past Webinar: What's New in Quality & Regulatory? (2024)

Course overview

This webinar will provide an overview of recent operational updates to the Clinical Laboratory Improvement Amendments (CLIA) and administrative process changes in the Centers for Medicare & Medicaid Services (CMS). The presenters will review new proficiency testing rules, which haven't been updated in many years. Finally, expect a recap of activities and news surrounding the FDA's new regulations for laboratory-developed tests (LDTs). Learning Objectives: 1. Evaluate current operations to determine if impacted by recent CMS/CLIA operational updates. 2. Paraphrase updates to CLIA regulations impacting CLIA fees, histocompatability, personnel, and alternative sanctions. 3. Identify new proficiency testing (PT) regulations. 4. Assess potential compliance gaps for FDA LDT regulations.