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 | |
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Committee Business | |||
9:30 | Doors Open (committee members to join 15-30 minutes prior) All timings listed are in ET |
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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
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Jackie Fredrick, MT (ASCP) SBB, MBA, Hon DB/DPH to serve as Moderator
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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
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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
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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 |
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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 |
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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 |
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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 |
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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.