Department of Health and Human ServicesOffice of the Assistant Secretary for Health (ASH)

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James J. Berger

Acting Director, Blood Safety and Availability

Executive Secretary, ACBSA

December 2011

Advisory Committee on Blood Safety and Availability (ACBSA)

Update

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.

─ Dr. Michael Ison – Chair─ Dr. John Arnold─ Mr. Edward Burke─ Ms. Alissa Cofer

ACBSA Membership - Cont

─ 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 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 consent is inconsistent and generally inadequate

Recommendation5. 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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