Fifty-Ninth ACBTSA Meeting

September 4, 2024 - September 5, 2024

Tissue Biovigilance Gap Analysis Report

Federal Register Notice

Subcommittee Recommendations to be Considered

Meeting Summary

Agenda

September 4th, 2024

Fifty-Ninth ACBTSA Meeting Agenda
TimeAgenda ItemSpeaker
9:00 am – 9:10 amOpening Remarks & Swearing in CeremonyADM Rachel Levine, MD
Assistant Secretary for Health
B. Kaye Hayes, MPA
Deputy Assistant Secretary and Director, Office of Infectious Disease and HIV/AIDS Policy
9:10 am – 9:15 amRoll CallJames Berger, MS, MT (ASCP) SBB
Designated Federal Officer
9:15 am – 9:20 amCall to OrderJames Berger, MS, MT (ASCP) SBB
9:20 am – 9:30 amPurpose of the MeetingClaudia Cohn, MD, PhD
Committee Chair
Diane Wilson, MSN/MHA
Committee Chair
Presentations and Committee Business
9:30 am – 9:40 amIntroductory RemarksMichael Bell, MD
Acting Director, Centers for Disease Control and Prevention (CDC) Division of Healthcare Quality Promotion
9:40 am – 11:10 amTissue transmitted infections and traceability challenges: the CDC experienceCDR Sridhar Basavaraju, MD
Director, Office of Blood, Organ, and Other Tissue Safety (BOOTS), CDC
11:10 am – 11:40 amRegulatory oversight of tissue establishments and HCT/PsScott Brubaker
Senior Advisor
Office of Cellular Therapy and Human Tissue, Office of Therapeutic Products
Center for Biologics Evaluation and Research (CBER)
U.S. Food and Drug Administration (FDA)
11:40 am – 12:40 pmLunch 
12:40 pm – 1:10 pmPractical experience of tissue traceability challenges in a healthcare facilityKristen Marshall, PhD, MPH
Epidemiologist, CDC Epidemiology Field Officer Program
Colorado Department of Public Health and Environment
1:10 pm – 1:30 pmBlood product lookback, traceability, and adverse event reporting requirementsAnne Eder, MD, PhD
Director, Office of Blood Research and Review, Center for Biologics Evaluation and Research (CBER), FDA
1:30 pm – 1:40 pmBreak 
1:40 pm – 2:25 pmSolid organ transplant lookback, traceability, and transmitted infections/malignancy reporting requirements and practicesStephanie Pouch, MD, MS, FAST, FIDSA
Chair, Disease Transmission Advisory Committee (DTAC)
Organ Procurement and Transplantation Network (OPTN)
2:25 pm – 2:55 pmCMS regulatory oversight over healthcare facilities, infection control requirements: opportunities for enhancing tissue safetyDiane Corning, RN, JD
Health Insurance Specialist, Office of Clinical Standards and Quality, Clinical Standards Group,
Centers for Medicare & Medicaid Services (CMS)
2:55 pm – 3:55 pmHow do tissue establishments conduct product tracking?Melissa Greenwald, MD, FAST
Chief Medical Officer, American Association of Tissue Banks (AATB)
3:55 pm – 4:00 pmWrap-up and AdjournmentClaudia Cohn, MD, PhD
Diane Wilson, MSN/MHA
James Berger, MS, MT (ASCP) SBB

September 5th, 2024

Fifty-Ninth ACBTSA Meeting Agenda
TimeAgenda ItemSpeaker
9:00 am – 9:05 amRoll CallJames Berger, MS, MT (ASCP) SBB
Designated Federal Officer
9:05 am – 9:10 amCall to OrderJames Berger, MS, MT (ASCP) SBB
Presentations and Committee Business
9:10 am – 9:20 amWorking Group 1: Overview of Tissue Source Gaps and RecommendationsScott Brubaker
FDA
Timothy Pruett, MD
University of Minnesota
9:20 am – 10:05 amDiscussion and Vote on Tissue Source Gaps and RecommendationsScott Brubaker
FDA
Timothy Pruett, MD
University of Minnesota
10:05 am – 10:10 amBreak 
10:10 am – 10:20 amWorking Group 2: Overview of Tissue Processing Gaps and RecommendationsScott Brubaker
FDA
Timothy Pruett, MD
University of Minnesota
10:20 am – 11:05 amDiscussion and Vote on Tissue Processing Gaps and RecommendationsScott Brubaker
FDA
Timothy Pruett, MD
University of Minnesota
11:05 am – 11:15 amBreak 
11:15 am – 11:25 amWorking Group 3: Overview of Tissue End-User/Consignee Receipt and Use Gaps and RecommendationsScott Brubaker
FDA
Timothy Pruett, MD
University of Minnesota
11:25 am – 12:10 pmDiscussion and Vote on Tissue End-User/Consignee Receipt and Use Gaps and RecommendationsScott Brubaker
FDA
Timothy Pruett, MD
University of Minnesota
12:10 pm – 1:40 pmLunch 
1:40 pm – 1:50 pmWorking Group 4: Overview of Tissue Recipient Adverse Events/Reactions Gaps and RecommendationsScott Brubaker
FDA
Timothy Pruett, MD
University of Minnesota
1:50 pm – 2:35 pmDiscussion and Vote on Tissue Recipient Adverse Events/Reactions Gaps and RecommendationsScott Brubaker
FDA
Timothy Pruett, MD
University of Minnesota
2:35 pm – 2:40 pmWrap-up and AdjournmentClaudia Cohn, MD, PhD
Diane Wilson, MSN/MHA
James Berger, MS, MT (ASCP) SBB

*Agenda is subject to change

View the Meeting Record

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