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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 4^th, 2024

Fifty-Ninth ACBTSA Meeting Agenda
Time	Agenda Item	Speaker
9:00 am – 9:10 am	Opening Remarks & Swearing in Ceremony	ADM 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 am	Roll Call	James Berger, MS, MT (ASCP) SBB Designated Federal Officer
9:15 am – 9:20 am	Call to Order	James Berger, MS, MT (ASCP) SBB
9:20 am – 9:30 am	Purpose of the Meeting	Claudia Cohn, MD, PhD Committee Chair Diane Wilson, MSN/MHA Committee Chair
Presentations and Committee Business
9:30 am – 9:40 am	Introductory Remarks	Michael Bell, MD Acting Director, Centers for Disease Control and Prevention (CDC) Division of Healthcare Quality Promotion
9:40 am – 11:10 am	Tissue transmitted infections and traceability challenges: the CDC experience	CDR Sridhar Basavaraju, MD Director, Office of Blood, Organ, and Other Tissue Safety (BOOTS), CDC
11:10 am – 11:40 am	Regulatory oversight of tissue establishments and HCT/Ps	Scott 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 pm	Lunch
12:40 pm – 1:10 pm	Practical experience of tissue traceability challenges in a healthcare facility	Kristen Marshall, PhD, MPH Epidemiologist, CDC Epidemiology Field Officer Program Colorado Department of Public Health and Environment
1:10 pm – 1:30 pm	Blood product lookback, traceability, and adverse event reporting requirements	Anne Eder, MD, PhD Director, Office of Blood Research and Review, Center for Biologics Evaluation and Research (CBER), FDA
1:30 pm – 1:40 pm	Break
1:40 pm – 2:25 pm	Solid organ transplant lookback, traceability, and transmitted infections/malignancy reporting requirements and practices	Stephanie Pouch, MD, MS, FAST, FIDSA Chair, Disease Transmission Advisory Committee (DTAC) Organ Procurement and Transplantation Network (OPTN)
2:25 pm – 2:55 pm	CMS regulatory oversight over healthcare facilities, infection control requirements: opportunities for enhancing tissue safety	Diane 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 pm	How do tissue establishments conduct product tracking?	Melissa Greenwald, MD, FAST Chief Medical Officer, American Association of Tissue Banks (AATB)
3:55 pm – 4:00 pm	Wrap-up and Adjournment	Claudia Cohn, MD, PhD Diane Wilson, MSN/MHA James Berger, MS, MT (ASCP) SBB

September 5^th, 2024

Fifty-Ninth ACBTSA Meeting Agenda
Time	Agenda Item	Speaker
9:00 am – 9:05 am	Roll Call	James Berger, MS, MT (ASCP) SBB Designated Federal Officer
9:05 am – 9:10 am	Call to Order	James Berger, MS, MT (ASCP) SBB
Presentations and Committee Business
9:10 am – 9:20 am	Working Group 1: Overview of Tissue Source Gaps and Recommendations	Scott Brubaker FDA Timothy Pruett, MD University of Minnesota
9:20 am – 10:05 am	Discussion and Vote on Tissue Source Gaps and Recommendations	Scott Brubaker FDA Timothy Pruett, MD University of Minnesota
10:05 am – 10:10 am	Break
10:10 am – 10:20 am	Working Group 2: Overview of Tissue Processing Gaps and Recommendations	Scott Brubaker FDA Timothy Pruett, MD University of Minnesota
10:20 am – 11:05 am	Discussion and Vote on Tissue Processing Gaps and Recommendations	Scott Brubaker FDA Timothy Pruett, MD University of Minnesota
11:05 am – 11:15 am	Break
11:15 am – 11:25 am	Working Group 3: Overview of Tissue End-User/Consignee Receipt and Use Gaps and Recommendations	Scott Brubaker FDA Timothy Pruett, MD University of Minnesota
11:25 am – 12:10 pm	Discussion and Vote on Tissue End-User/Consignee Receipt and Use Gaps and Recommendations	Scott Brubaker FDA Timothy Pruett, MD University of Minnesota
12:10 pm – 1:40 pm	Lunch
1:40 pm – 1:50 pm	Working Group 4: Overview of Tissue Recipient Adverse Events/Reactions Gaps and Recommendations	Scott Brubaker FDA Timothy Pruett, MD University of Minnesota
1:50 pm – 2:35 pm	Discussion and Vote on Tissue Recipient Adverse Events/Reactions Gaps and Recommendations	Scott Brubaker FDA Timothy Pruett, MD University of Minnesota
2:35 pm – 2:40 pm	Wrap-up and Adjournment	Claudia Cohn, MD, PhD Diane Wilson, MSN/MHA James Berger, MS, MT (ASCP) SBB

*Agenda is subject to change

View the Meeting Record

Content last reviewed November 15, 2024