The partnership would identify risks and strategies for ensuring the safety of the U.S. supply of blood and blood components.

HHS Exploring Biovigilance Partnership

Its aim would be to ensure the safety of the U.S. supply of blood and blood components, tissues, cells, and organs.

The U.S. Department of Health and Human Services is asking stakeholders to help as it considers forming a public-private partnership to identify risks and strategies for ensuring the safety of the U.S. supply of blood and blood components, tissues, cells, and organs. HHS published a notice seeking comments from public or private entities with an interest in biovigilance and entities with experience and capabilities managing public-private partnerships in the biological sciences and public health.

Responses are due by 4 p.m. EDT June 9, 2011, and should be e-mailed to [email protected] (attention Dr. Jerry Holmberg). They should be no more than 10 pages. Holmberg is senior advisor for blood safety in the Office of the Assistant Secretary for Health in HHS Secretary Kathleen Sebelius' office.

A 2009 report assessed the current state of U.S. biovigilance, which was defined as "a comprehensive and integrated national patient safety program to collect, analyze, and report on the outcomes of collection and transfusion and/or transplantation of blood components and derivatives, tissues, cells, and organs." The definition excludes vaccines, allergenic products, and most recombinant human proteins.

The "Biovigilance: Efforts to Bridge a Critical Gap in Patient Safety and Donor Health" report recommended that HHS develop an action plan to support a national biovigilance program, integration of systems within government and private sectors, and steps to enhance mechanisms for surveillance. The assistant secretary for health has charged a biovigilance working group, with members from the HHS operating divisions, to define the operating framework for a National Biovigilance Program within HHS and for a partnership.

The notice says biovigilance is an area of growing importance, with a potential role in these areas:

  • Identifying strategies for protecting recipients and living donor health
  • Identifying processes that reduce medical errors and improve donor/patient outcomes in blood transfusions and tissue and organ transplants
  • Reporting and analyzing adverse events, including medical "near misses" and patient adverse reactions
  • Identifying emerging infectious disease prevalence and incidence in donors and recipients, both quickly and effectively
  • Informing public health and regulatory policy, and reimbursement decisions
  • Contributing to and collaborating on research studies, including research that provides a basic understanding of recipient outcomes so as to inform future surveillance activities

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