Key Updates on Today’s Regulatory Landscape for Outreach Laboratories

In this episode of the “Leveraging the Laboratory” podcast, Jane Hermansen, outreach manager at Mayo Clinic Laboratories, welcomes Chelsea Conn, Mayo Clinic Laboratories’ director of regulatory affairs. Together, they break down the latest regulatory changes and share actionable strategies to help outreach programs stay informed and prepared. Key topics include:

• FDA rule for lab-developed tests (01:36): What the recent rescinding of the FDA rule means for labs.
• New Clinical Laboratory Improvement Act (CLIA) regulations (04:36): Clarifications on lab director qualification updates from late 2024.
• College of American Pathologists (CAP) accreditation (07:52): New checklist requirements for reporting and submitting to public health authorities.
• Protecting Access to Medicare Act (PAMA) reform (11:40): The latest developments on new approaches to reimbursement for laboratory tests.
• Recommended resources (17:32): How to stay up to date on regulations affecting the laboratory industry.