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

Please note: AABB reserves the right to make updates to this program.

• Educational Track: Technical/Clinical
• 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

• Director/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.

  Registration

  Registration includes access to both the live and on-demand version of this eCast.

  If you are a facility interested in participating in this eCast, simply complete the Group Viewing registration form and AABB will provide detailed instructions to share with your team approximately one week prior to the live program (each team member to register for the program utilizing a promocode). For single viewers, simply click on the Register button below to register.

  Please note: registration for the live eCast will close 1 hour prior to the eCast start time. If you register after this time, you will receive access to the on-demand eCast when it is available.

  Single Viewer	Register
  Group Viewing	Register

  Continuing Education Credit

  This activity is eligible for one and one quarter (1.25) continuing education credit/contact hour for Physicians, Nurses (including California-based nursing professionals through CBRN), California Lab Personnel, Florida Lab Personnel and General Participation credit. AABB reserves the right to reduce or increase the number of credits granted based on the final activity duration. For more information on each credit type please visit our Continuing Education Credits webpage.

  There is no financial support for this activity.

  

  In support of improving patient care, this activity has been planned and implemented by the Association for the Advancement of Blood & Biotherapies (AABB) and CME Outfitters, LLC. CME Outfitters LLC. is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

  Physicians (ACCME): CME Outfitters, LLC, designates this live activity for a maximum of one and one quarter (1.25) AMA PRA Category 1 Credit^TM. CME Outfitters, LLC, designates this enduring activity for a maximum of one and one quarter (1.25) AMA PRA Category 1 Credit^TM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

  Claiming Credit
  Live Activity - Upon completion of the live activity, you will receive instructions to complete your evaluation, which is necessary to claim credit and receive your certificate of attendance/completion (credit must be claimed by the date provided in the instructions). The evaluation can be found by logging into the AABB Education Platform.

  Enduring Activity - Once the enduring (on-demand) program is available, you will receive instructions to access the AABB Education Platform. Upon completion of viewing the enduring activity, you will need to complete the evaluation, which is necessary to claim credit and receive your certificate of completion (credit must be claimed by the date provided in the AABB Education Platform).

  Program & Credit Expiration Dates:

  • Live Activity Program Date: January 15, 2025; Credit Expiration Date: February 15, 2025
  • Enduring Activity Program Dates: January 15, 2025 – January 14, 2028; Credit Expiration Date: January 14, 2028

  Disclosure Declaration

  It is the policy of CME Outfitters, LLC, and the Association for the Advancement of Blood & Biotherapies to ensure independence, balance, objectivity, and scientific rigor and integrity in all of their CE activities. Faculty must disclose to the participants any relationships with commercial companies whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients. CME Outfitters, LLC, has evaluated, identified, and mitigated any potential conflicts of interest through a rigorous content validation procedure, use of evidence-based data/research, and a multidisciplinary peer review process. The following information is for participant information only. It is not assumed that the presence of such relationships will have a negative impact on the presentations.

  Disclosures for the planners of this event can be found here. Disclosures for the program faculty, peer reviewers, and CME Outfitters, LLC. personnel are provided at the beginning of the program.

  Faculty Biographies

  Dr. Meghan Delaney is the Chief of the Division of Pathology & Laboratory Medicine (CLIA) and the Director of Transfusion Medicine at Children’s National Hospital and she is Professor of Pathology and Pediatrics and the George Washington University in Washington, DC. At Children’s National, Dr. Delaney is the President of the Medical Staff. Dr Delaney serves as President of the Board of Directors for AABB. She has over 120 peer reviewed publications and lectures nationally and internationally on transfusion medicine, laboratory medicine, global health and advocacy. Dr. Delaney is a member of AABB’s Public Policy Strategy Committee and the College of American Pathologists’ Political Action Committee Board.

  
  

  Leah Mendelsohn Stone, JD is Vice President of Public Policy and Advocacy at AABB. She leads the strategic development and implementation of the association’s efforts to advance policies that promote access to safe blood, transfusion medicine, and biotherapies. Leah uses her extensive subject matter expertise in health policy to inform AABB’s positions and generate innovative policy solutions. Prior to joining AABB, Leah spent a decade in private practice as a healthcare policy and advocacy attorney. In that capacity, she provided legislative, regulatory, and policy counsel to a wide variety of healthcare organizations. Before entering private practice, Leah was the Research Regulations Specialist at the Johns Hopkins Bloomberg School of Public Health.

  
  

  Karen Palmer, MT(ASCP), CQA(ASQ) is the director of Regulatory Affairs with the AABB where she is responsible for providing regulatory analysis for key regulatory issues affecting transfusion medicine and related biotherapies for the Board of Directors and senior management, preparing AABB positions on proposed rules, guidance documents and items for regulatory advisory committee discussions and maintaining surveillance of regulatory publications and actions and advise on proactive courses of action. Ms. Palmer provides regulatory support and advice to Standards Program Units, Accreditation department, and Consulting Services, including real time response to assessors. Ms. Palmer has over 40 years of experience in blood and biotherapies including transfusion medicine, blood collection, research and quality.