Fifty-third ACBTSA Meeting: August 17-18, 2021

August 17, 2021 - August 18, 2021

Meeting Materials

The Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) convened on August 17-18, 2021 to conduct the fifty-third meeting.

Agenda

August 17, 2021

TIME AGENDA ITEM SPEAKER
Committee Business
9:30 Doors Open (committee members to join 15-30 minutes prior)
All timings listed are in ET
10:00 Welcome Jackie Fredrick, MT (ASCP) SBB, MBA, Hon DB/DPH, Chair ACBTSA
10:05 Roll call James Berger, MS, MT (ASCP) SBB, Designated Federal Officer, ACBTSA
10:10 Call to Order James Berger, MS, MT (ASCP) SBB
10:15 Purpose of the Meeting and Questions for the Committee Jackie Fredrick, MT (ASCP) SBB, MBA, Hon DB/DPH
10:30 Welcome and Comments Rachel L. Levine, MD, Assistant Secretary of Health
10:45 Review Recommendations in the HHS Adequacy of the National Blood Supply: Report to Congress, 2020 and ACBTSA Recommendations to the ASH, September 2020 Jackie Fredrick, MT (ASCP) SBB, MBA, Hon DB/DPH
11:00 Public Comments James Berger, MS, MT (ASCP) SBB
Supply Chain to Produce Blood Products, Recommendation 3
11:30 Common Definition of Supply Chain Sally Caglioti, MS, MT (ASCP), President & CEO, Creative Testing Solutions
11:45 Lessons Learned from the COVID-19 Pandemic
  • Inside a Pandemic: An Academic Medical Center’s Response
  • BCA’s COVID-19 Experience
  • The Canadian Experience
 Jackie Fredrick, MT (ASCP) SBB, MBA, Hon DB/DPH to serve as Moderator
  • Eric L. Conley, Executive Vice President, Froedtert Health, President, Froedtert Hospital
  • Bill Block, CEO and President, Blood Centers of America, Inc.
  • Dr. Graham Sher, MD PhD, Chief Executive Officer, Canadian Blood Services
12:45 Q&A/Discussion Jackie Fredrick, MT (ASCP) SBB, MBA, Hon DB/DPH to serve as Moderator
1:15 Lunch
1:45 Identification and Prioritization of Key Risk Drivers for the Dutch Blood Supply David Perez, Board Member, Retired President & CEO of Terumo BCT to serve as Moderator
  • Mart P. Janssen, PhD, Principal Investigator Transfusion Technology Assessment, Sanquin Research Amsterdam, The Netherlands
  • Syeldy Langi Sasongko, MSc, PhD student, Transfusion Technology Assessment, Sanquin Research Amsterdam, The Netherlands
2:30 Q&A/Discussion David Perez, Board Member, Retired President & CEO of Terumo BCT to serve as Moderator
2:45 Break
3:00 Risk Management: Impact of the COVID-19 Pandemic Sally Caglioti, MS, MT (ASCP) and David Perez to serve as Moderators
  • Sally Caglioti, MT (ASCP) SBB
  • Bill Block, CEO and President, Blood Centers of America, Inc.
  • David R. Green, President/CEO, Vitalant
  • Eric Santiago-Justiniano, MBA, Vice President Operations, Fresenius Kabi Puerto Rico; Chief Financial Officer, Fenwal International, Inc.; Vice President Operations, Fresenius Kabi Puerto Rico
  • Michael P. Angelastro, Director, Division of Pharmaceutical Countermeasures Infrastructure, Biomedical Advanced Research & Development Authority, Assistant Secretary for Preparedness & Response, U.S. Department of Health & Human Services
  • Claudia S. Cohn, MD, PhD, Professor of Laboratory Medicine and Pathology, University of Minnesota, Chief Medical Officer, AABB
  • Steven M. Frank, MD, Professor, Department of Anesthesiology/Critical Care Medicine, Director, Johns Hopkins Health System Blood Management Program, Director, Center for Bloodless Medicine and Surgery Johns Hopkins Medical Institutions
5:00 Committee Discussion and Recommendation Formulation Sally Caglioti, MS, MT (ASCP) and David Perez
6:00 Committee Recommendations Summary and Vote Jackie Fredrick, MT (ASCP) SBB, MBA, Hon DB/DPH
6:15 Wrap-up and Adjournment Jackie Fredrick, MT (ASCP) SBB, MBA, Hon DB/DPH and James Berger, MS, MT (ASCP) SBB

August 18, 2021

TIME AGENDA ITEM SPEAKER
Committee Business
9:30 Doors Open (committee members to join 15-30 minutes prior)
All timings listed are in ET
10:00 Roll Call James Berger, MS, MT (ASCP) SBB
10:05 Call to Order James Berger, MS, MT (ASCP) SBB
Data Infrastructure Solutions, Recommendation 5
10:10 Introduction and Outline the Goal Claudia Cohn, MD, PhD
10:40 Revision of the EU Blood Legislation – Lessons from COVID Deirdre Fehily, PhD, Policy Officer, Substances of Human Origin, DG Santé, European Commission
11:00 Blood Donors as a Sentinel Population Christian Erikstrup, MD, PhD, Chair Professor, Consultant, Department of Clinical Immunology, Aarhus University Hospital, Department of Clinical Medicine, Aarhus University
11:25 Q&A/Discussion Matthew J. Kuehnert, MD to serve as Moderator
11:55 Lunch
12:25 AABB Interorganizational Task Force – US Perspective on Blood Supply and Inventory Data Leo DeBandi, Vice President, Analytics, Production and Inventory Planning, American Red Cross
12:55 National Data Warehouse for Blood Martin Grable, Executive Vice President, Chief Financial and Administrative Officer,
OneBlood John Mass, Vice President Biomedical Services Business Systems, American Red Cross
1:25 Q&A/Discussion (for US Network and Blood Center Networks) Matthew J. Kuehnert, MD to serve as Moderator
1:55 Recipient Hemovigilance – How to Enable and/or Encourage Hospitals to Provide Data Chester Andrzejewski, PhD, MD, FCAP, Director of System Blood Banking and Transfusion/Apheresis Medicine Services, Baystate Health, Assistant Professor, Department of Pathology, University of Massachusetts Medical School-Baystate Melissa Cumming, MS, CIC, Senior Epidemiologist, Healthcare-Associated Infections and Antibiotic Resistance Program Lead, Bureau of Infectious Disease and Laboratory Sciences,
Massachusetts Department of Public Health
2:40 Q&A/Discussion Matthew J. Kuehnert, MD to serve as Moderator
2:55 Break
3:10 Focus on Comparative Blood Utilization David Levine, MD, FACEP, Group Senior Vice President, Advanced Analytics and Data Science, Vizient, Inc. Saloni Kapur Jain, PharmD, MPA, Vice President, Advanced Analytics and Informatics, Vizient, Inc.
3:55 Q&A/Discussion Matthew J. Kuehnert, MD, to serve as Moderator
4:10 Donor Data for Public Health Brian Custer, PhD, MPH, Director, Epidemiology and Health Policy Science
Vice President, Research and Scientific Programs, Vitalant Research Institute,
Adjunct Professor, Laboratory Medicine, UCSF
4:55 Q&A/Discussion Matthew J. Kuehnert, MD, to serve as Moderator
5:10 Committee Discussion and Recommendation Formulation Matthew J. Kuehnert, MD, and Claudia Cohn, MD, PhD
Discussion and Process for Formulation of Recommendations
6:15 Committee Recommendation Summary and Vote Jackie Fredrick, MT (ASCP) SBB, MBA, Hon DB/DPH
6:30 Adjournment James Berger, MS, MT (ASCP) SBB

The fifty-third ACBTSA meeting was held on August 17-18, 2021.

During this meeting, the committee discussed recommendations related to supply chain resiliency and data infrastructure to support the blood and plasma industries. The Committee elected to deliberate potential recommendations to submit to the Assistant Secretary for Health among work groups and reconvene to vote on such recommendations during fifty-fourth meeting, scheduled for September 23, 2021.

Meeting Summary

Federal Register Notice

View the Meeting Recording

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