25EL-500 On-Demand eCast: Countdown to Compliance: Preparing for Stage 1 Phaseout - Implementation of the FDA's Final Rule on Laboratory Developed Tests (LDTs)

CABP CE Eligible

Live Program Date: Wednesday, January 15, 2025
Program Number: 25EL-505

Educational Track: Quality Education
Topics: Blood Donation & Collection, Patient Transfusion
Intended Audience: Facilities that perform molecular testing, Hospital Blood Banks, Hospitals, Immunohematology Reference Labs (IRL’s), Laboratory Staff, Managers/Supervisors, Medical Directors, Physicians, Residents/Fellows, Students (MD, MT, SBB), Technologists
Teaching Level: Advanced, Basic, Intermediate

Faculty
(titles and affiliations at the time of the live program)
Directors/Moderator: Leah Mendelsohn Stone, JD, Vice President, Public Policy and Advocacy, AABB, Bethesda, MD
Speakers: Meghan Delaney, DO, MPH, Chief, Division of Pathology & Laboratory Medicine, Children's National Hospital; Professor of Pathology & Pediatrics, George Washington University School of Medicine and Health Sciences, Washington, DC; Karen Palmer, MT(ASCP), CQA(ASQ), Director, Regulatory Affairs, AABB, Bethesda, MD; Leah Mendelsohn Stone, JD, Vice President, Public Policy and Advocacy, AABB, Bethesda, MD

Program Description
The FDA's Final Rule on Laboratory Developed Tests (LDTs) marks a significant shift in the regulatory landscape for many laboratories, with implementation of the Stage 1 phaseout of FDA’s enforcement discretion set to take effect on May 6, 2025. This eCast is designed to equip AABB members with the knowledge and tools needed to navigate this regulatory change. Attendees will gain a comprehensive understanding of Stage 1 requirements, including new medical device reporting requirements, corrections and removals reporting requirements, and quality system requirements. The program will also highlight the broader implications of these regulations on laboratory workflows, quality systems, and patient care.

This program will help participants develop effective strategies for compliance while minimizing operational disruptions. Attendees will learn to evaluate their current tests, identify gaps, and implement necessary changes to align with FDA regulations. Additionally, the eCast will provide access to valuable resources and will describe the continuously evolving landscape related to the regulation of LDTs.

Learning Objectives
After participating in this educational activity, participants should be able to:

• Discuss the key regulatory requirements that will apply to laboratory developed tests (LDTs) beginning on May 6, 2025.
• Prepare and implement changes to meet the May 6, 2025 compliance deadline.
• Access and utilize available FDA guidance, AABB toolkits, and other resources to support compliance activities.
• Anticipate obstacles to the Stage I phaseout of FDA’s enforcement discretion.
• Discuss the continuously evolving landscape related to the regulation of LDTs.

How to Claim Continuing Education Credit

• Single Viewers: if you registered as a single viewer, complete the evaluation found on the "CE Information" tab after watching the video. By submitting the evaluation, you are attesting to watching the presentation in its entirety.

• Group Viewers: This is applicable for groups/facilities that purchased Group Viewing access for this program (registration will be verified prior to processing a group viewing attendance log). Group Viewing Coordinators should submit the attendance log to eLearning@aabb.org within 72 hours of the completion/viewing date. Once AABB receives an attendance log, each participant on the attendance log will be granted access as a single viewer to this program and will be required to complete the evaluation in order to claim continuing education credit. Each participant will be required to have an AABB account in order to access this program/platform. If a participant does not have an account, he/she can create one using the same email address provided on the attendance log.