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Biovigilance Update - Spring 2009 

A Message from Mike Strong, PhD, Chair of AABB's Interorganizational Task Force on Biovigilance

Welcome to the first issue of the U.S. Biovigilance Network’s e-newsletter, Biovigilance Update.

Our goal in creating this newsletter is to keep you informed about what is going on with the network in the most efficient and economical way possible. To that end, Biovigilance Update will provide the latest information on the recipient and donor systems, new resources available to data contributors, funding milestones, and what the task force is doing to continue to raise awareness of the vital nature of this program with key stakeholders, among other priorities.

We hope you will find this new communication vehicle useful in learning how the U.S. Biovigilance Network is working toward improving patient safety and protecting donor health while reducing overall health care costs. If you have any thoughts about how Biovigilance Update can better meet those needs, please contact us with your suggestions.


D. Michael Strong, PhD, MT(ASCP)

 Visit aabb.org/biovigilance




Recipient Hemovigilance System Pilot Launches May 7

A pilot of the recipient hemovigilance portion of the U.S. Biovigilance Network was launched May 7, with nine hospitals participating. This system — part of the Centers for Disease Control and Prevention’s National Healthcare Safety Network, a secure, voluntary, Internet-based surveillance system — will collect and analyze data on the blood transfusion process to identify trends and recommend best practices to reduce adverse reactions and incidents. The pilot will take place for a minimum of three months, during which time the CDC and AABB will collect feedback from the participants on the protocol, definitions and structured reports. The protocol and definitions were developed by the AABB Hemovigilance System Working Group and CDC to be consistent with those developed by ISBT and used within the MERS-TM and Canadian hemovigilance systems and to facilitate reliable reporting. The recipient hemovigilance system is expected to expand nationwide in the fall.

New Audioconference to Offer Training for Recipient Hemovigilance System

A new biovigilance-focused audioconference has been added to the 2009 schedule and is being offered for free to the first 100 AABB institutional members that register. On May 27, “Adverse Transfusion Reactions: Common Definitions and Reporting into the National Biovigilance System” will be presented by Beth Shaz, MD, a director at Grady Memorial Hospital Blood Bank and Emory University School of Medicine, and Mark Fung, MD, PhD, medical director of the blood bank and HLA laboratory at Fletcher Allen Health Care at the University of Vermont. The audioconference will review case studies and identify blood transfusion recipient adverse reactions, including transfusion-related acute lung injury, transfusion-associated circulatory overload, transfusion-associated graft-versus-host disease, hemolytic reactions, allergic reactions, and infections, as defined by the recipient hemovigilance system protocol.


Data Testing Begins for Donor Hemovigilance System

Mock data are being uploaded into the donor hemovigilance system, a component of the U.S. Biovigilance Network, as part of the testing phase for the system. Members of the Donor Hemovigilance System Working Group are leading this effort and working within their own blood centers to ensure that the system functions properly.

AABB already has published a document outlining how developers of blood donor software systems can develop interface files that will allow data to be uploaded directly to the donor hemovigilance system. The interface control document details the types of data and formats that the network will use and that should be contained in the CSV interface file. It also contains definitions for each of the fields in the file, including standard definitions for donor-related adverse reactions. These standards — developed by the working group — will facilitate the smooth exchange of data with the national system.

The donor hemovigilance system will collect data on blood donors with the goal of identifying trends, recommending best practices and designing interventions to reduce adverse reactions associated with blood donation.

AABB Listed as Patient Safety Organization to Protect and Ensure Data Confidentiality

AABB’s Patient and Donor Safety Center — developed to house data collected from hospitals and blood centers as a part of the larger U.S. Biovigilance Network — has been officially listed as a patient safety organization by the secretary of the U.S. Department of Health and Human Services. The recognition, which became effective in December, ensures confidentiality for patient safety data needed for analysis and quality improvements to encourage clinicians and health care organizations to voluntarily report and share such data without fear of legal discovery. Patient safety organizations were authorized under The Patient Safety and Quality Improvement Act of 2005, which is administered by the Agency for Healthcare Quality and Research, to reduce the incidence of events that adversely affect patients.


AABB Advocates for Public Funding of U.S. Biovigilance Network

As the nation begins discussions about health care reform, AABB is taking the opportunity to advocate for funding of the U.S. Biovigilance Network as a tool to help improve patient safety and protect donor health while reducing overall costs of the system.

In its outreach to the U.S. Congress, AABB members and staff have met with the offices of representatives from the House and Senate appropriations subcommittees that are responsible for allocating funding to the Centers for Disease Control and Prevention, including Sen. Tom Harkin (D-Iowa) and Rep. David Obey (D-Wis.), chairmen of the Senate and House Labor, Health and Human Services, Education and Related Agencies appropriations subcommittees. These meetings have focused on educating lawmakers about the network and garnering support for long-term federal funding. The association is requesting funding for CDC in the fiscal year 2010 budget, which will be critical to sustaining ongoing operating costs of the network.

AABB also has been working with key staff in federal agencies to evaluate potential funding available through stimulus legislation, the American Recovery and Reinvestment Act of 2009, or fiscal year 2009 and 2010 appropriations. The association has advocated for funding to be directed toward the network from CDC and the U.S. Department of Health and Human Services’ health information technology initiative. Other avenues explored include grant opportunities through the National Heart, Lung and Blood Institute for future hypotheses-driven research on the data collected in the network.

FAQs for the U.S. Biovigilance Network Now Available

A set of frequently asked questions about the U.S. Biovigilance Network is now available. The answers to these questions will help those interested in the network learn more about the initiative. The FAQs describe the basics of the network and hemovigilance, and give an overview of why it is needed, who developed it and how facilities can become involved. Additional technical FAQs provide details on data entry within the donor biovigilance and recipient hemovigilance systems, current interfacing software systems, and data ownership and confidentiality.

Biovigilance Recruitment Meetings Extend Coast to Coast

A series of regional recruitment meetings designed to discuss the U.S. Biovigilance Network kicked off in March with stops in San Francisco, Los Angeles, San Diego and New York City. Participants in the meetings expressed concern about data entry and verification as well as the need to interpret the data accurately. Other suggestions included integrating the network with the Center for Medicare and Medicaid Services, the Food and Drug Administration, and The Joint Commission; tracking and benchmarking blood utilization requirements to be competitive; creating tools for physicians and nurses to promote recognition of adverse reactions; and paying close attention to how the network will interface with laboratory systems. Outreach efforts will continue this spring, with meetings planned for the greater Baltimore/Washington, D.C., area. Facilities interested in hosting a meeting can contact AABB’s Center for Data and Special Programs.


U.S. Biovigilance Network Attracts Media Attention from Leading U.S. Newspapers

The U.S. Biovigilance Network has attracted media attention from leading newspapers in the United States, increasing public awareness of the project. Late last year, The Wall Street Journal published an article on the efforts by the Centers for Disease Control and Prevention to establish a national biovigilance network. The article explains that the network will use Web-based reporting systems to gather data on disease transmission and other complications caused by blood transfusion and transplants. It also notes that AABB is collaborating with CDC for the development of the recipient hemovigilance portion that will collect data on adverse events and incidents associated with recipients of blood transfusions. A profile of the recipient hemovigilance system, which was included in the April 19 edition of the Baltimore Sun, indicated that John Hopkins Hospital will be participating in the pilot of the system along with eight other facilities across the United States. Paul Ness, MD, the hospital’s director of transfusion medicine, was quoted in the article, saying the U.S. has fallen behind efforts in the rest of the world to establish a system, and without one, the community is unable to accurately estimate the incidence of potential risks associated with receiving a blood transfusion.

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