December 4, 2013 - December 5, 2013
NIH Conference Room
5635 Fisher’s Lane, Terrace Level
Rockville, MD 20852
Meeting Materials
- Live December 4-5 webcasts
- Recommendations
Wednesday, December 4, 2013
| Time | Agenda Item | Presenter |
|---|---|---|
| 07:30 (30 min) |
Doors Open | Open to the Public |
| 08:00 (10 min) |
Call to Order | Jay Menitove, MD Committee Chair |
| 08:10 (5 min) |
Roll Call | James Berger Executive Secretary |
Committee Business
| Time | Agenda Item | Presenter |
|---|---|---|
| 08:15 (30 min) |
Assistant Secretary for Health’s Charge to the Committee | Howard K. Koh, MD, MPH HHS Assistant Secretary for Health |
Advisory Committee Updates-I
| Time | Agenda Item | Presenter |
|---|---|---|
| 08:45 (30 min) |
Disease Transmission Advisory Committee
|
Michael Green, MD, MPH Chair, OPTN/UNOS ad hoc Disease Transmission Advisory Committee Professor of Pediatrics, Surgery & Clinical and Translational Science University of Pittsburgh School of Medicine Division of Infectious Diseases Children’s Hospital of Pittsburgh |
Reports on WHO Products of Human Origin (MPHO) Initiativeand an HHS Innovation Project
| Time | Agenda Item | Presenter |
|---|---|---|
| 09:15 (40 min) |
WHO initiative on fostering consensus on global requirements for Medical Products of Human Origin (MPHO) | Luc Noel, MD, Msc Patient Safety Special Adviser Initiative for MPHO World Health Organization |
| 09:55 (40 min) |
HHS Innovation Project on Organ Electronic Tracking and Transport | Chris McLaughlin Chief, Organ Transplantation Branch Division of Transplantation HRSA David Cartier HHS Entrepreneur Division of Transplantation HRSA |
Advisory Committee Updates-II
| Time | Agenda Item | Presenter |
|---|---|---|
| 10:35 (10 min) |
Blood Products Advisory Committee (BPAC) Update
|
Pradip Akolkar, PhD FDA/CBER/OBRR |
| 10:45 (10 min) |
Advisory Committee on Organ Transplantation (ACOT) Update
|
Mark Barr, MD Chair, Advisory Committee on Organ Transplantation, HHS / HRSA |
| 10:55 | Break • 10 min |
ACBTSA Subcommittee Reports
| Time | Agenda Item | Presenter |
|---|---|---|
| 11:05 (40 min) |
Subcommittee Update: Tissue Safety and Availability in Emergencies | Tim Pruett, MD Chief, Division of Transplantation University of Minnesota |
| 11:45 (40 min) |
Subcommittee Update: Blood Safety and Availability in Emergencies | Aryeh Shander, MD Chief, Department of Anesthesiology, Critical Care Medicine, Hyperbaric Medicine & Pain Management Englewood Hospital & Medical Center Clinical Professor of Anesthesiology, Medicine & Surgery Mount Sinai School of Medicine |
| 12:25 (5 min) |
Subcommittee Update: Informed Consent in Transfusions and Transplantation | Debbie Seem, RN, MPH Advisor for Tissue Safety and Availability HHS/OASH/OHAIDP |
| 12:30 | Lunch Break • 45 min | |
| 01:15 (30 min) |
Open Public Hearing (all sessions/considerations) | |
| 01:45 (1.5 hrs) |
Committee Questions, Discussion, and Recommendations | |
| 03:15 | Adjournment | Jay Menitove, MD Committee Chair |
Thursday, December 5, 2013
| Time | Agenda Item | Presenter |
|---|---|---|
| 07:30 (30 min) |
Doors Open | Open to the Public |
| 08:00 (5 min) |
Call to Order | Jay Menitove, MD Committee Chair |
| 08:05 (10 min) |
Roll Call | James Berger Executive Secretary |
Optimal Blood Service Delivery in the Current Era of Health Care Reform
| Time | Agenda Item | Presenter |
|---|---|---|
| 08:15 (40 min) |
Cost Recovery System of Blood Centers | Miriam Markowitz Chief Executive Officer AABB |
| 08:55 (40 min) |
Capacity for Product and Service Innovation within the Blood Industry | Raymond Goodrich, PhD Vice President Scientific and Clinical Affairs; Chief Science Officer Blood Bank Technologies Terumo BCT |
| 09:35 (40 min) |
Promotion of Risk-Based Decision Making from Donor to Recipient | Judie Leach Bennett Director Centre for Innovation Canadian Blood Services |
| 10:15 | Break • 10 min |
Update on Blood Donor Policy for Men who have Sex with Men
| Time | Agenda Item | Presenter |
|---|---|---|
| 10:25 (15 min) |
Review of ACBSA’s 2010 Decision and Progress Since | James Berger Executive Secretary |
| 10:40 (40 min) |
Results from the Uniform Donor History Questionnaire | Kristen Miller, PhD, BCBA-D CDC/OSELS/NCHS Stephanie Willson, PhD CDC/OSELS/NCHS |
| 11:20 (20 min) |
Review of the Goals and Work Product of the Quarantine Release Error Task Force | M. Allene Carr-Greer, MT(ASCP) SBB Director Regulatory Affairs AABB |
| 11:40 (5 min) |
Update on the Recipient Epidemiology and Donor Evaluation Study – III (REDS-III) Blood Donation Rules Opinion Study (Blood DROPS) | Brian Custer, PhD, MPH Associate Investigator Epidemiology and Health Research Policy Blood Systems Research Institute |
| 11:45 (15 min) |
Open Public Hearing (all sessions/considerations) | |
| 12:00 | Lunch Break • 45 min | |
| 12:45 (20 min) |
REDS-II: Feasibility of Constructing a Multicenter Blood Donation Database for Surveillance Purposes in the United States | Edward Notari, MPH Project Manager III American Red Cross |
| 01:05 (20 min) |
REDS-II: Risk Factor Analysis for a Blood Surveillance Program | Brian Custer, PhD, MPH Associate Investigator Epidemiology and Health Research Policy Blood Systems Research Institute |
| 01:25 (30 min) |
Establishing a U.S. Donor Transfusion-Transmissible Infection Monitoring System—Next Steps | Simone Glynn, MD, MPH Branch Chief Transfusion Medicine and Cellular Therapeutics National Heart, Blood, and Lung Institute |
| 01:55 (1.5 hrs) |
Committee Questions, Discussion, and Recommendations | |
| 03:30 | Adjournment | Jay Menitove, MD Committee Chair |
