Final Guidance on Enhancing Platelet Safety and the Role of Rapid Testing

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

Tuesday, September 29, 2020
2:00 – 3:00 PM (ET) 7:00 – 8:00 PM (GMT)
Master Program Number: 20EL-579


Verax BiomedicalThis eCast is provided complimentary to AABB members through the generous support of Verax Biomedical; nonmembers to pay a reduced fee of $59. Registration is required. After registering, immediate access is granted via the AABB Education Platform (after logging in using your AABB username and password simply click on “My Learning Programs” and then “On-Demand eCasts”). Please note: if you registered for the live eCast you do not need to register for this on-demand eCast (access to the on-demand eCast was included with the live eCast registration). If you would like to receive this program for free as well as other great benefits consider joining AABB today.

  • Educational Track: Quality Education
  • Topics: FDA, Infectious Diseases, Outcomes, Patient Blood Management, Patient Transfusion, Regulatory & Compliance, Transfusion Safety
  • Intended Audience: Hospital Blood Banks, Hospital Laboratory Administration, Hospitals, Laboratory Staff, Managers/Supervisors, Medical Directors, Physicians, Technologists, Transfusion Safety Officers
  • Teaching Level: Advanced, Intermediate
  • Director/Moderator: Paul D. Mintz, MD, Senior VP and Chief Medical Officer, Verax Biomedical Inc., Marlborough, MA
    Speakers: Michael R. Jacobs, MD, PhD, FRCPath, D(ABMM), F(AAM), Professor Emeritus, Department of Pathology, Director Emeritus, Clinical Microbiology, Case Western Reserve University and University Hospitals Cleveland Medical Center, Cleveland, OH; Arthur W. Bracey, Jr., MD, Chief, Clinical Pathology, Baylor St. Luke’s Medical Center, Professor, Pathology & Immunology, Baylor College of Medicine, Houston, TX
  • Learning Objectives

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

    • Discuss the risks posed to patients by bacteria in platelet components.
    • Describe new regulatory guidance, effective April 2021, regarding the implementation of technologies intended to further limit the exposure of transfusion recipients to platelets contaminated with bacteria.
    • Explain the primary approaches to satisfying the new guidance and the differences between these.
    • Discuss the role of rapid testing as an approach to complying with guidance.
    • Develop an action plan for compliance with the new regulatory requirements.

    Program Description

    For many years, bacterial contamination of platelets has been a major medical and regulatory concern. With the FDA approval and clearance of several different platforms (Rapid Testing, Pathogen Reduction, LVDS primary culture) that could be used to detect and/or limit exposure of patients to platelets contaminated with bacteria, the transfusion community has been anticipating regulatory action/requirements. As the final regulatory action is effective April 2021, this eCast will seek to explain the significance of the action and review and contrast the different approaches for hospital transfusion services to comply with a specific emphasis on the role of rapid testing.

    Continuing Education Credit

    AABB designates both the live and on-demand version of this eCast each eligible for 1 continuing education credits/contact hours for General Participation, 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. Please note this program is not eligible for continuing education credit for physicians or California Nurses. For more information on each credit type please visit our Continuing Education Credits webpage.

    Disclosures for the program faculty are provided at the beginning of the program.

    Speaker Biographies

    Dr. Michael R. Jacobs is board certified in Medical Microbiology and was Director of Clinical Microbiology at University Hospitals Cleveland Medical Center, Cleveland, Ohio, 1979-2019. He was also Professor of Pathology at Case Western Reserve University and is now Emeritus. Dr. Jacobs received his medical degree and doctorate in Medical Microbiology from the University of the Witwatersrand in Johannesburg, South Africa. He completed Internships in Surgery and Internal Medicine at the Johannesburg Hospital, and a Residency in Medical Microbiology at the School of Pathology of the South African Institute for Medical Research and the University of the Witwatersrand in Johannesburg. Dr. Jacobs' research interests include epidemiology, antimicrobial susceptibility and mechanisms of resistance of antibiotic-resistant Streptococcus pneumoniae, the microbiology and antimicrobial susceptibility of otitis media pathogens, clinical study design, application of pharmacokinetic and pharmacodynamic principles to respiratory tract and other infections, bacterial contamination of platelet and stem cell products, mycobacterial infections and evaluation of new diagnostic products. In collaboration with his Transfusion Medicine colleagues, he has authored several seminal papers on the epidemiology and clinical consequences of bacterial contamination of platelets. He has published over 500 papers in peer-reviewed journals and as well as several book chapters.

    Dr. Arthur Bracey graduated with distinction from the University of Pennsylvania in 1972 with a BA in Biochemistry. He obtained his MD from Georgetown University Medical School in 1976. Post-graduate training includes: Intern - Internal Medicine – Georgetown, Resident - Anatomic Pathology – Georgetown, Resident - Clinical Pathology - NIH Clinical Center. He is Professor of Pathology & Immunology at Baylor College of Medicine from 2017. He is Chief of Clinical Pathology at Baylor St. Luke’s Medical Center. Board and professional organization service includes: Medical Advisory Committee - American Red Cross - member, Annual Meeting Education Program Unit American Association of Blood Banks - chair, Transfusion Medicine Resource Committee College of American Pathologists - chair, American Association of Blood Banks - board, National Marrow Donor Program - board Gulf Coast Regional Blood Center – board, HRSA Advisory Council on Blood Stem Cell Transplantation – member, and HHS Advisory Committee on Blood Safety and Availability - chair.