Options for Improved Platelet Safety Under the NEW DRAFT Guidance

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

Live Program Date: Wednesday, March 13, 2019 - On-Demand Available

Master Program Number: 18EL-385 (see program format numbers below under Registration)

Educational Track: Technical/Clinical
Topic: Transfusion Medicine
Intended Audience: CEOs, Director, Hospitals, Hospital Blood Banks, Managers/Supervisors, Medical Director, Physicians, Resident/Fellow, Scientist, Students (MD, MT, SBB), Transfusion Safety Officer
Teaching Level: Intermediate to Advanced

Director: Eric A. Gehrie, MD, Assistant Professor, Pathology, Johns Hopkins University, Baltimore, MD
Moderator: Kelly Meyer, Webcast Specialist, AABB, Bethesda, MD
Speakers: Deborah A. Sesok-Pizzini, MD, Medical Director, Blood Bank and Transfusion Medicine, Children’s Hospital of Philadelphia, Philadelphia, PA; Sarah Rutter, MD, Transfusion Medicine Fellow, Yale-New Haven Hospital, New Haven, CT; Eric A. Gehrie, MD, Medical Director, Blood Bank, Johns Hopkins Medical Institutions, Baltimore, MD (Dr. Sesok-Pizzini presented Dr. Gehrie’s presentation as he was unable to attend)

Learning Objectives

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

  • Discuss the risks posed to patients by bacteria in platelet components.
  • Appreciate the various technologies that can mitigate bacterial contamination of platelet concentrates.
  • Identify draft regulatory guidance regarding the implementation of technologies intended to limit the exposure of transfusion recipients to platelets contaminated with bacteria.
  • Have an action plan for compliance with regulatory requirements.

Program Description

For many years, bacterial contamination of platelets has been a major medical and regulatory concern. With the development of several different platforms (FDA-approved pathogen reduction technology, FDA-approved point of release bacterial testing, and introduction of supplementary bacterial cultures performed by a transfusion service) that could be used to detect and/or limit exposure of patients to bacteria via platelets, the transfusion community is anticipating additional regulatory action/requirements from the FDA. This eCast will describe a number of approaches taken by hospitals to comply with the Draft FDA Guidance published in December 2018. Please note: AABB plans to offer an eCast on Implementing the Final Guidance on Enhancing PLT Safety after the final guidance is released (final guidance expected late 2019; eCast expected in 2020).

Registration

   Program #
Single Viewer: On-Demand Register18EL-385-4035
Group Viewing: On-Demand Register18EL-385-8035

Continuing Education Credit

AABB designates both the live and on-demand version of this eCast each to be eligible for 1.0 continuing education credits/contact hours for Physicians, California Nurse, California Lab Personnel, Florida Lab Personnel and General Participation credit. The number and type of credits awarded for this program (both live and on-demand) was determined by the program duration. For more information on each credit type please visit our Continuing Education Credits webpage.

Disclosures for the planners of this event can be found here. Disclosures for the program faculty are provided at the beginning of the program.

Speaker Biographies

Dr. Eric Gehrie is an assistant professor of pathology and surgery at The Johns Hopkins University School of Medicine and serves as medical director of the blood bank, co-director of the patient blood management program, and associate director of the pathology residency program at The Johns Hopkins Hospital. He has been an investigator on both the Phase IV trial of psoralen and UV-A light treated platelets as well as the Phase III trial of riboflavin and UV-light treated platelets, and oversees a hospital based secondary culture program for platelet concentrates at Johns Hopkins.

Dr. Sara Rutter is currently a transfusion medicine fellow at the Yale-New Haven Hospital, where she previously completed the AP/CP residency program. She has a strong interest in transfusion medicine and apheresis and has worked extensively with Dr. Edward Snyder, medical director of the blood bank, in developing and implementing a comprehensive platelet safety program at Yale.

Dr. Sesok-Pizzini is Professor of Clinical Pathology and Laboratory Medicine at the Perelman School of Medicine at the University of Pennsylvania. She serves as the vice-chief of the department of pathology and laboratory medicine; the chief of the division of transfusion medicine; the patient safety officer; and the medical director of the blood bank at The Children’s Hospital of Philadelphia, where she also attends on the apheresis service.