HOT TOPIC: FDA DRAFT Guidance on Bacterial Risk Control Strategies to Enhance Safety and Availability of Platelets: Pros and Cons of the Various Options

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

Live Program Date: Wednesday, September 5, 2018 - On-Demand Available

Master Program Number: 18EL-347 (see program format numbers below under Registration)

Educational Track: Technical/Clinical
Topic: Transfusion Medicine
Intended Audience: Physicians, Scientists, Technologists, Laboratory Staff, Medical Directors, Hospital Blood Banks
Teaching Level: Intermediate/Advanced

Director/Moderator: Erin Meyer, DO, MPH, Medical Director of Apheresis, Associate Medical Director of Transfusion Services, Nationwide Children’s Hospital, Columbus, OH
Speakers: Ralph Vassallo, MD, FACP, EVP / Chief Medical & Scientific Officer, Blood Systems, Inc., Scottsdale, AZ; Sarah Harm, MD, MS, Medical Director, Transfusion Service, The University of Vermont Medical Center, Burlington, VT; Paul Ness, MD, Director, Transfusion Medicine, Johns Hopkins University, Baltimore, MD

Learning Objectives

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

  • Summarize the background for the FDA Draft Guidance.
  • Discuss the utility of delayed large volume sampling in a blood center setting.
  • Recognize the functionality of rapid bacterial testing for a hospital transfusion service.
  • Analyze the impact of second culture testing on a hospital-based transfusion service.

Program Description

In March of 2016, the FDA released a second draft guidance on bacterial risk control strategies to enhance the safety and availability of platelets for transfusion. This guidance outlined the use of either pathogen reduction technology or bacterial testing of platelets intended for transfusion. The ability to implement these processes to ensure platelet safety while maintaining adequate inventory is potentially challenging.

The AABB in conjunction with American Red Cross and America’s Blood Centers issued a response to the draft guidance in May of 2016 warning of issues not only with platelet inventory but also expense of implementation at the transfusion service level. In November 2017, the FDA BPAC agreed that 5-day storage of apheresis platelets is possible without secondary testing if they are cultured no sooner than 24-36 hours post collection with a sample volume of 3.8% of the collection volume. In addition, the committee supported extending apheresis platelet outdate to day 7 if on day 4 there is repeat culturing using at least 16 mL per apheresis platelet split. Also, the BPAC agreed that platelet bacterial testing should include both aerobic and anaerobic cultures.

This program will examine how a blood center and two academic transfusion services have been able to apply the current draft guidance to their platelet inventories. Dr. Vassallo is the Executive Vice President, Chief Medical & Scientific Officer of Blood Systems and will discuss delayed large volume sampling. Dr. Harm, the Medical Director of the Blood Bank at the University of Vermont Medical Center, will describe how her service implemented rapid testing in a hospital-based transfusion service. Alternatively, Dr. Ness as the Medical Director of the Transfusion Service at Johns Hopkins Hospital is going to explain how his services employed the second culture method. Each speaker will discuss the pros and cons of their chosen method as well as operational and inventory management roadblocks. By critically examining three methods of FDA guidance implementation, your transfusion service will be better equipped to choose and apply the method that best serves you once the final guidance is published.


   Program #
Single Viewer: On-Demand Register18EL-347-4035
Group Viewing: On-Demand Register18EL-347-8035

Continuing Education Credit

AABB designates the live eCast eligible for 1.5 continuing education credits/contact hours for Physicians, General Participation, California Nurse, California Lab Personnel and Florida Lab Personnel. The number and type of credits awarded for this program was determined by the program duration.

AABB designates the on-demand version of this eCast each eligible for 1.25 continuing education credits/contact hours for Physicians, General Participation, California Nurse, California Lab Personnel and Florida Lab Personnel. 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. Ralph Vassallo oversees medical direction in the areas of donor suitability and donor care, the clinical services and consultation we provide to hospitals, and initiatives at Blood Systems Research Institute. Previously, Dr. Vassallo was the Chief Medical Officer of the American Red Cross Blood Services’ East Division, having served in various Red Cross medical leadership roles for 12 years.

Dr. Sarah Harm is the Medical Director of the Blood Bank at University of Vermont Medical Center and Assistant Professor at the Larner College of Medicine at University of Vermont.

Dr. Paul Ness is the director of transfusion medicine and professor of pathology, medicine and oncology at Johns Hopkins University in Baltimore, is also an editorial board member for HemOnc Today, as well as editor for Transfusion, the leading blood transfusion publication.