Vaccination and Blood Donation Policies Protect Blood Safety (24EL-498)

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

• Educational Track: Quality Education
• Topics: Blood Donation & Collection, Public Policy, Regulatory & Compliance
• Intended Audience: CEOs, COOs, Directors, Government Affairs Professionals, Health Care Association Members, Hospitals, Managers/Supervisors, Medical Directors, Medical Staff, Nurses, Physicians, Policy Professionals, Residents/Fellows, Scientists
• Teaching Level: Basic, Intermediate

• Registration

  This on-demand eCast is complimentary to all to view via the AABB YouTube channel.

  Program Description

  The Association for the Advancement of Blood & Biotherapies (AABB) invites healthcare professionals to participate in a one-hour educational program designed to address challenges to critical blood donation safety policies. This timely program focuses on potential policy proposals that would mandate labeling “mRNA-free donations” based on testing that that is not available for use with donated blood and does not comply with FDA requirements, or requirements for patient consent requirements for blood transfusions donated by individuals vaccinated with mRNA or self-amplifying RNA vaccines.

  By dispelling misconceptions and emphasizing evidence-based practices, this program demonstrates the integrity of the blood supply, shows how needless, unproven testing for the presence of mRNA is not available for blood donations and could threaten continued availability of blood for patients in need. Participants will learn about the scientific evidence supporting the safety of blood donations from vaccinated individuals, the negligible risk posed by vaccine components in transfusions, and the unintended, far-reaching consequences of unnecessarily restrictive policies on the blood supply. Additionally, participants will learn about FDA regulations related to false claims of “vaccine-free” or “mRNA-free” donations and will gain the tools and knowledge to engage with policymakers effectively, fostering informed dialogue that counters unnecessary and potentially harmful policies.

  Learning Objectives

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

  • Explain the scientific evidence demonstrating the safety of blood donations and the biological basis for the negligible risk of vaccine components in blood transfusions.
  • Explain relevant FDA requirements addressing donor testing and blood labeled in a manner that is false or misleading are misbranded, in violation of section 502(a) of the Federal Food, Drug, and Cosmetic Act.
  • Identify examples of policy proposals targeting vaccinated blood donors and assess their potential impact on public health.
  • Utilize educational and advocacy tools, such as fact sheets and messaging strategies, to engage policymakers and stakeholders effectively to prevent the adoption of unnecessary measures that could compromise the availability and accessibility of the blood supply.
  • Support evidence-based policymaking that prioritizes public health and preserves a reliable and equitable blood donation system that meets the needs of all patients.

  Faculty

  Director/Moderator: Susan N. Leppke, MPH, Senior Director, Public Policy & Strategic Partnerships, AABB, Bethesda, MD
  Speakers:

  • Claudia Cohn, MD, PhD, Chief Medical Officer, AABB, Bethesda, MD
  • Cliff Numark, Senior Vice President, Donor Services, Chief of Marketing, Vitalant, Scottsdale, AZ
  • Susan N. Leppke, MPH, Senior Director, Public Policy & Strategic Partnerships, AABB, Bethesda, MD

  Panelist: Karen Palmer, MT(ASCP) CQA(ASQ), Director, Regulatory Affairs, AABB

  Continuing Education Credit

  Continuing education credit is not available for this program.

  Faculty Biographies

  Claudia Cohn, MD, PhD is the chief medical officer at the Association for Blood & Biotherapies (AABB) and is the medical director of the blood bank laboratory and associate director of laboratories at the University of Minnesota. She earned her PhD in Immunology and Infectious Diseases from Johns Hopkins University and subsequently earned her MD at Louisiana State University. After finishing her Transfusion Medicine fellowship at University of California, San Francisco, Dr. Cohn joined the faculty at the University of Minnesota, in Minneapolis, where she is Medical Director of the Blood Bank, Associate Medical Director of the HLA lab and Associate Head of Laboratories. Dr. Cohn’s major interests include platelet support for stem cell transplant patients, hemovigilance and appropriate use of blood components. She is Editor-in-Chief of the AABB Technical Manual (20th edition), and Associate Editor of the International Society of Blood Transfusion (ISBT) Science Series, which is dedicated to publishing manuscripts on transfusion/blood banking in resource-limited countries. Dr. Cohn has served on the AABB Clinical Transfusion Medicine committee, Transfusion Standards committee and the Transfusion Transmitted Disease committee.

  
  

  Susan N. Leppke, MPH is the senior director of public policy and strategic partnerships for the Association for the Advancement of Blood & Biotherapies (AABB) where she is responsible for advancing advocacy and driving public policy initiatives on improving access to transfusion medicine and biotherapies. Ms. Leppke has over 15 years of experience in health care management, reimbursement, access-to-care policy and analysis, and stakeholder engagement. Prior to her role at AABB, Ms. Leppke served as the Director of Public and Payer Policy at the National Marrow Donor Program where she led multi-stakeholder teams to successfully pass federal and state policies to protect access to cellular therapies for patients with blood cancer and other blood diseases and disorders. Prior to that, Ms. Leppke managed and led efforts in organ transplant policy where she provided strategic leadership and direction on organ allocation policy, transplant research, and payment analysis, strategically engaging with external stakeholders. Her experience includes leading government affairs and policy teams to drive change in the federal, state, and local legislative and regulatory settings. Ms. Leppke has her master’s degree in public health administration and policy from the University of Minnesota.

  
  

  Cliff Numark is the Chief of Marketing and Senior Vice President for Vitalant, one of the nation’s largest nonprofit blood and biotherapies healthcare organizations. Vitalant supplies blood to 900 hospitals across 28 states through 115 donation centers, 60,000 blood drives, and 1.5 million blood donations annually. In his role, Cliff oversees public affairs, marketing, communications, blood donor recruitment, and operations, leading 2,200 team members. Before joining Vitalant, Cliff spent over 16 years at the American Red Cross, where he led marketing, communications, and blood operations in local, regional, and national roles, ultimately overseeing recruitment for 5 million blood donations annually. Cliff began his career in public affairs as a journalist and legislative aide at the federal and state levels. Since 2008, he has served as a local elected official, first as a City Councilman and then as a Community College Trustee. Cliff received a Bachelor of Arts, magna cum laude, in Chemistry and Public Policy from Pomona College, a Master of Science from the University of Sussex in the United Kingdom, a Master in Public Affairs from Princeton University, and a Juris Doctor from UC Berkeley.