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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

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

 

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 SurveyBarbee 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 OpenOpen 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

03:10Adjournment

Jay Menitove, MD
Committee Chair