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

Agenda

Forty-Third Meeting, June  5-6, 2013

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


 

Wednesday, June 5, 2013

Doors Open


Open to the Public


Call to Order


Jay Menitove, MD
Committee Chair


Roll Call


James Berger
Executive Secretary


Committee Business

08:15
(10 min)


New Members Welcome


Howard K. Koh, MD, MPH
HHS Assistant Secretary for Health


08:25
(20 min)


Assistant Secretary for Health’s Charge to the Committee


Howard K. Koh, MD, MPH
HHS Assistant Secretary for Health


Committee, Subcommittee & Workshop Updates

08:45
(10 min)


Advisory Committee on Organ Transplantation (ACOT) Update


Mark Barr, MD
Chair, Advisory Committee on Organ Transplantation, HHS / HRSA


08:55
(10 min)


Transmissible Spongiform Encephalopathies Advisory Committee (TSEAC) Update

  • FDA risk assessment of vCJD risk for transfusions of Red Blood Cells in the U.S.

Hong Yang, PhD
HHS/ FDA/CBER/OBE


09:05
(10 min)


Blood Products Advisory Committee (BPAC) Update

  • December Meeting, Organ donor infectious disease screening

Laura St. Martin, MD, MPH
HHS/FDA/CBER/OCTGT


09:15 (10 min)


FDA Workshop on Advances in Nucleic Acid and Protein Bases Multiplex Detection Methods to Improve Transfusion Safety


Sanjai Kumar, PhD
HHS/FDA/CBER/OBRR


09:25
(5 min)


MSM Study Update and Timeline


James Berger
Executive Secretary


09:30
(5 min)


Public Health Service Guidelines Update

  • 2013 Public Health Service (PHS) Guideline for Reducing Transmission of HIV, HBV, and HCV through Solid Organ Transplantation

Matthew Kuehnert, MD
Director, Office of Blood, Organ, & Other Tissues Safety
HHS / CDC / OID / NCEZID


09:35
(10 min)


Subcommittee Update: Informed Consent in Transfusions and Transplantation


Jim Bowman, MD
Medical Director
Division of Transplantation
HHS/HRSA


09:45
(15 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


10:00
(15 min)


Subcommittee Update: Tissue Safety and Availability in Emergencies


Tim Pruett, MD
Chief, Division of Transplantation University of Minnesota


10:15


Break  (10 min)


Committee Topic: Is the Current Blood Center System in the U.S. Designed
for Optimal Service Delivery in the Era of Health Care Reform

10:25
(40 min)


Trends in Blood Collection and Utilization: Results from the 2011 National Blood Collection & Utilization Survey


Barbee Whitaker, PhD
Director, Center for Data and Special Programs
AABB


11:05
(40 min)


Perspectives from AABB


Karen Shoos, JD
Principal Investigator,
International Technical Assistance
AABB


11:45
(40 min)


Perspectives from America’s Blood Centers


David Green, MSA
CEO, Mississippi Valley Regional Blood Center
ABC President


12:25


Lunch Break (45 min)


01:10
(40 min)


Perspectives from the Plasma Protein Therapeutics Association


Bill Speir, JD
PPTA Director, State Affairs


01:50
(40 min)


Insuring a Successful Future for America’s Blood Centers


Mark Popovsky, MD
Vice President and Chief Medical Officer Haemonetics


02:30


Break (10 min)


02:40
(40 min)


Pathway to the Future – Pluralistic and Innovative Models for Blood Centers


Jackie Fredrick
President & CEO,
Centers for Transfusion and Transplant Medicine,
Blood Center of Wisconsin I


03:20
(25 min)


Potential Impact of Pathogen Inactivation: A Hospital and Clinician Perspective


S. Gerald Sandler, MD, FACP, FCAP
Georgetown University Hospital


03:45
(40 min)


Perspectives from a Blood and Tissue Center


Linda Myers
CEO South Texas Blood & Tissue Center
President/COO of QualTex Laboratories


04:25


Adjournment


Committee Chair



 

Thursday, June 6, 2013

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


08:15
(40 min)


Blood Center Sustainability: Knowing the Customer


Jim AuBuchon, MD
President & CEO
Puget Sound Blood Center


08:55
(30 min)


Hospital Perspective


Joe Rutledge, MD
Medical Director, Laboratories
Seattle Children’s Hospital


09:25
(40 min)


Changes in Transfusion Demand


Richard Benjamin, MD, PhD, FRCPath
Chief Medical Officer, Biomedical Services
American Red Cross


10:05


Break (10 min)


10:15
(40 min)


Perspectives from the American Red Cross


Chris Hrouda
Executive Vice President
American Red Cross


10:55
(40 min)


Interpreting the Affordable Care Acts impact on the Blood Community


Theresa Weigmann, JD
Director, Public Policy and Special Counsel
AABB


11:35
(35 min)


Thoughts on Present and Future Drivers of the Demand for Blood Products in a Reforming U.S. Health Care System


David O. Meltzer, MD, PhD
Chief, Section of Hospital Medicine;
Associated Faculty Member, the Harris School and the Department of Economics,
the University of Chicago


12:10


Lunch Break  (45 min)


12:55
(15 min)


Open Public Hearing (all sessions/considerations)


01:10
(2 hr)


Committee Discussion for Committee Questions & Recommendations


03:10


Adjournment


Jay Menitove, MD
Committee Chair