Department of Health and Human Services Office of the Assistant Secretary for Health (ASH) 0 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 8

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 9

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

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 12

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 13

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 14

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 15

Questions Next meeting – June 15 and 16,