Skip Navigation
  • Text Size: A A A
  • Print
  • Email
  • Facebook
  • Tweet
  • Share
  • Print
  • Email
  • Facebook
  • Tweet
  • Share

Advisory Committee on Blood & Tissue Safety & Availability (ACBTSA) 

U.S. Department of Health & Human Services 
Forty-Fourth Meeting, December 4 & 5, 2013

NIH Conference Room 
5635 Fisher’s Lane, Terrace Level 
Rockville, MD 20852 

Wednesday, December 4, 2013

07:30
(30 min)
Doors Open  Open to the Public
08:00
(10 min)
Call to OrderJay Menitove, MD
Committee Chair
08:10
(5 min)
Roll CallJames Berger
Executive Secretary
Committee Business
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
08:45
(30 min)
Disease Transmission Advisory Committee
  • Progress in implementing new PHS Guideline for Reducing Transmission of HIV, HBV, and HCV through Organ Transplantation
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) Initiative 
and an HHS Innovation Project
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
10:35
(10 min)
Blood Products Advisory Committee (BPAC) Update
  1. November meeting on interpretive criteria for MP Diagnostics HTLV Blot 2.4
Pradip Akolkar, PhD
FDA/CBER/OBRR  
10:45
(10 min)
Advisory Committee on Organ Transplantation (ACOT) Update
  1. New definition of human organ
Mark Barr, MD
Chair, Advisory Committee on Organ Transplantation, HHS / HRSA
10:55  Break 10 min)
 
ACBTSA Subcommittee Reports
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 EmergenciesAryeh 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  
12:30Lunch Break  (45 min)  
01:15
(30 min)  
Open Public Hearing (all sessions/considerations)
01:45 (1.5 hrs)  Committee Questions, Discussion, and Recommendations
03:15AdjournmentJay Menitove, MD
Committee Chair  

Thursday, December 5, 2013

07:30
(30 min)
Doors OpenOpen to the Public
08:00
(5 min)
Call to OrderJay 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
08:15
(40 min)
Cost Recovery System of Blood CentersMiriam 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  
10:15Break (10 min)
Update on Blood Donor Policy for Men who have Sex with Men  
10:25
(15 min)
Review of ACBSA’s 2010 Decision and Progress SinceJames Berger
Executive Secretary  
10:40
(40 min)
Results from the Uniform Donor History QuestionnaireKristen 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)
12:00Lunch Break  (45 min)  
12:45
(20 min)
REDS-II: Feasibility of Constructing a Multicenter Blood Donation Database for Surveillance Purposes in the United StatesEdward Notari, MPH
Project Manager III American Red Cross
01:05
(20 min)
REDS-II: Risk Factor Analysis for a Blood Surveillance ProgramBrian 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 StepsSimone 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
03:30AdjournmentJay Menitove, MD
Committee Chair