HHS Seeks Comments on Creation of National Biovigilance Program

Date: May 9, 2011

The U.S. Department of Health and Human Services (HHS) is seeking comments from public or private entities with an interest in biovigilance on how to identify risks and strategies for ensuring the safety of the U.S. supply of blood and blood components, tissues, cells and organs.

The sought-out comments are in response to a 2009 report titled “Biovigilance: Efforts to Bridge a Critical Gap in Patient Safety and Donor Health,” which recommended that HHS develop an action plan to support a national biovigilance program, including integration of systems within government and private sectors and steps to enhance mechanisms for surveillance.

The report defined the current state of U.S. biovigilance 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.” However, this definition excludes vaccines, allergenic products and most recombinant human proteins. And, because biovigilance is an area of growing importance, its role should be expanded to:

• dentifying strategies for protecting recipients and living donor health
• identifying processes that reduce medical errors and improve donor/patient outcomes in blood transfusions and tissues and organ transplants
• reporting and analyzing adverse events, including medical “near misses” and patient adverse reactions.
• identifying emerging infectious disease prevalence and incidence of donors and recipients, both quickly and efficiently
• 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

Those interested in submitting comments should email them by June 9, 2011, at 4 p.m. EDT to biovigilance@hhs.gov (attention Dr. Jerry Holmberg). Comments should be limited to 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.