Department of Health and Human Services
Office of the Assistant Secretary for Health (ASH)
Advisory Committee on Blood Safety
and Availability (ACBSA)
Update
James J. Berger
Acting Director, Blood Safety and Availability
Executive Secretary, ACBSA
December 2011
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ACBSA Description of Duties
ACBSA shall provide advise to the Secretary
through the OASH on a range of policy issues to
include:
1) Definition of public health parameters around safety &
availability of the blood supply & blood products
2) Broad public health, ethical & legal issues related to
transfusion & transplantation safety
3) The implications for safety & the availability of various
economic factors affecting product cost & safety
ACBSA Membership
The Committee consists of 20 voting members; 14
public members, including the chair, who are
selected from:
• State & local organizations, advocacy groups,
provider organizations, academic researchers,
ethicists, private physicians, scientists, consumer
advocates, legal organizations, & from among
communities of persons who are frequent
recipients of blood or blood products.
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Dr. Michael Ison – Chair
Dr. John Arnold
Mr. Edward Burke
Ms. Alissa Cofer
ACBSA Membership - Cont
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Dr. Scott Halpern
Dr. Andra James
Dr. Ileana Lopex-Plaza
Dr. Greg Pomper
Dr. Tim Pruett
Dr. Karen Quillen
Dr. Sally Campbell-Lee
Dr. Ravindra Sarode
Dr. Aryeh Shander
Mr. Richard Vogel
Dr. Roslyn Yomtovian
ACBSA Representative Membership
6 members designated as official representative
members of the blood & blood products industry
or professional organizations:
• AABB
• Plasma protein fraction community
• 1 of the 2 major distributors of blood (rotating)
• A trade organization or manufacturer of blood,
plasma, infectious disease screening assays or
other tissue test kits or equipment
• A major health care organization that purchases
blood and blood products
ACBSA Representative Membership
Representative Members (Voting)
─ Dr. Laurence Corash – Cerus Manufacturing
─ Mr. Klaus Nether – TJC
─ Ms. Mary Gustafson – PPTA
─ Dr. Frederick Axelrod – ABC
─ Dr. Jay Menitove - AABB
ACBSA Non-Voting Ex-Officio Membership
Ex-Officio Member
─ Dr. Matt Kuehnert – CDC
─ Dr. Jay Epstein – FDA/OBRR
─ Dr. Harvey Klein – NIH
─ Dr. Monique Hollis-Perry – DoD
─ Ms. Diane Corning – CMS
─ Dr. Jim Bowman – HRSA
─ Dr. Laura St. Martin – FDA/OCTGT
Informed Consent for Recipients of Blood,
Organs and Tissues Discussion
• the informed consent process, including the
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content of those discussions and how complex
medical information can be presented in a manner
that improves patient comprehension;
what data about noninfectious and infectious risks
are currently available to clinicians for use in
informed consent discussions;
ways in which available data are accessible to
clinicians; and
what research is needed to better understand both
the noninfectious and infectious risks involved in
blood transfusion, organ transplantation, and
tissue transplantation
Recommendation
Whereas the Committee believes that:
• All patients are entitled to be informed that they are
receiving a substance of human origin, such as blood,
organs, cells, and tissues
•
A robust process of informed consent for recipients
of transfusion and transplantation is an ethical
imperative
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Recommendation
1.
Practices of informed consent for transfusion &
transplantation are highly variable
2. Practices of informed consent in many instances
appear to be inadequate to properly engage patients
in shared decision making
3. Gaps exist in:
a. Data on the risks of transfusion & transplantation
and their alternatives
b. Current knowledge and communication of risks,
benefits, and options by persons obtaining
informed consent for transfusion
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Recommendation
GAPS Continued:
c. Current knowledge and communication of
donor
derived disease transmission risks by
persons
obtaining informed consent for organ
transplantation
d. Knowledge of informed consent practices for
the wide spectrum of tissues for
transplantation.
4. Training (e.g., physician and other health
professional) in the need for, and processes
to achieve appropriate patient informed
Recommendation
5. CMS requires patient informed consent for organ
transplantation, and does not require specific
patient informed consent for transfusion and
tissue transplantation
6. Disclosures of risk are generally inadequate
including
a. The most common transfusion related risks
including administration of the incorrect
unit, TRALI, TACO, and alloimmunization
b. Infectious and non-infectious risks of
tissues
7. Unnecessary transfusions contribute to the risk of
transfusion
Recommendation
The Committee recommends that the Secretary:
1) Direct CMS to establish requirements for patient
informed consent for transfusion and tissue
transplantation
2) Establish a working group to cooperate with
stakeholders to identify opportunities and strategies
for improvement in informed consent for recipients
of transfusion and transplantation to include:
a. A focus on shared decision making involving the
clinicians and patients
b. Assessment of the patient’s needs and competencies
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Recommendation
• The Committee recommends that the Secretary:
c. Qualitative and quantitative communication of the
relative and absolute risks of therapy options and
inaction in the specific setting
d. Clarification of the elements of informed consent and
the accountability of the primary care provider
e. Two-stage process of education where time permits
(once at time the need is identified and again when the
procedure is imminent)
f. Standardized documentation of the patient agreement
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Recommendation
The Committee recommends that the Secretary:
3. Support research on optimization of patient
informed consent for transfusion and
transplantation including:
a. Metrics for patient assessment including
comprehension
b. Utility of decision aids and media alternatives
c. Medical education and tools for implementing
informed consent
d. Public education
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Recommendation
The Committee recommends that the Secretary:
4. Provide funds to address identified gaps, including
a. Defining risks associated with blood transfusion and
tissue transplantation
b. Defining risks associated with donor-derived
disease transmission through organ
transplantation
c. The deficiencies in the informed consent process
5. Enhance funding for NHSN, SRTR, and the OPTN to
support Biovigilance efforts (donor and recipient)
6. Promote best practices in patient blood management
including CPOE to reduce unnecessary transfusions
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Questions
• Next meeting – June 15 and 16, 2012
• www.hhs.gov/bloodsafety
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