First Ever National Biovigilance Network in the U.S. Reaches $1 Million in Funding, Prepares for Fall Pilot Launch

Network Data and Analysis Will Greatly Enhance Patient Safety and Reduce Healthcare Costs

Bethesda, Md. – The U.S. Biovigilance Network, the nation’s first and only nationwide data collection program for the transfusion and biological therapy communities, is preparing for a fall 2008 launch of its pilot. The Network has raised more than $1 million in private donations, including an $84,000 contribution by Fenwal Inc., one of the community’s medical technology leaders. It has also secured support from hospitals and blood centers across the country.

The Network is a unique public/private collaboration with shared responsibilities for program development, operation and management, and funding. The federal government, through the Department of Health and Human Services, including the Centers for Disease Control and Prevention, has provided the platform for initial surveillance efforts through its National Healthcare Safety Network. The U.S. Biovigilance Network has raised $1 million in private contributions to fund the initial expenses and is seeking $2 million in additional support to complete development and implement the program.

“To ensure the safety of America’s blood supply, it is vital that we create a centralized and standardized process for reporting adverse events,” said Barbee Whitaker, Ph.D., AABB’s Director of Data and Special Programs. “With data from the U.S. Biovigilance Network, we will be able to create a quality system that benefits patients, donors and the public health of the U.S.”

The U.S. Biovigilance Network will, for the first time on a nationwide basis, collect and analyze data to identify trends and recommend best practices to reduce adverse reactions and incidents associated with blood transfusion and related biological therapies. Ultimately, the analyses of these data will enhance patient safety, make better use of blood and biological therapies, and reduce healthcare costs.

“This has the potential to be a significant advancement, benefiting both patients and donors,” said Ron K. Labrum, President and CEO of Fenwal Inc. “By standardizing and validating comprehensive information on the safety of transfusion medicine, biovigilance can provide a critical early-warning system that benefits patients and helps focus health-care innovators on those issues most critical to improving health-care outcomes.”

The first stage of the pilot phase will be implemented with nine hospitals across the country. This phase will allow for fine-tuning of the surveillance system and analysis of initial data collected. Additional organizations are voluntarily registering to contribute data, with full participation and system launch anticipated in 2009.

The U.S. is the only developed nation that does not have a national system to track and monitor the safety of blood collection and transfusion. To date, the U.S. has relied on information from hemovigilance systems in other countries and on tracking by individual hospitals, transfusing organizations and blood centers. The challenge is that these results are not widely shared and common conclusions cannot be drawn. This results in the loss of an opportunity to learn from adverse events that may happen in more than one place and reduces the likelihood that the events can be prevented elsewhere. By contrast, those countries with surveillance systems have lower morbidity and mortality rates for patients and donors.

Hospitals, blood centers and other facilities will use the U.S. Biovigilance Network to report adverse events and unexpected reactions and incidents related to transfusion medicine. Analysis of this data will lead to process improvements which may lead to new standards of quality and safety for the collection, testing, processing, storage, distribution and transfusion of blood and use of related biological therapies. It will also allow for the design of interventions that can be adopted nationally.

“The U.S. Biovigilance Network is one of the most important initiatives to advance patient safety and reduce costs within our community,” said Karen Shoos Lipton, AABB’s CEO. “The financial support we have received is a powerful endorsement of the Network’s value and of the community’s commitment to its patients and to the public health of our country. We thank our supporters for their contributions and hope others will follow the example set by their leadership.”

Private sector organizations that have pledged their financial support of the U.S. Biovigilance Network include:

“The quality gurus say ‘If you can't measure it, you can't improve it’,” stated Dr. James AuBuchon, Chair of Pathology, Dartmouth-Hitchcock Medical Center. “The U.S. Biovigilance Network will allow us to see what's happening in transfusion and transplantation, use experts to analyze the situation, and recommend improvements in the system leading to augmented patient safety.”

In addition, the U.S. Biovigilance Network has commitments to participate from facilities that account for approximately 20 percent of the transfusion activity in the U.S. Organizations that have agreed to contribute data to the Network include:

The U.S. Biovigilance Network must build on its current momentum for its success in the long-term. The transfusion and biological therapies communities’ help is needed to provide the critical data that will fuel the U.S. Biovigilance Network, to provide the startup capital, and to advocate for its development and sustained operation. For more information, please visit www.aabb.org/biovigilance.

About AABB

Established in 1947, AABB (formerly known as the American Association of Blood Banks) is an international, not-for-profit association dedicated to the advancement of science and the practice of transfusion medicine and related biological therapies. The association is committed to improving health by developing and delivering standards, accreditation and educational programs and services to optimize patient and donor care and safety. AABB membership consists of approximately 1,800 institutions and 8,000 individuals, including physicians, scientists, administrators, medical technologists, nurses, researchers, blood donor recruiters and public relations personnel. Members are located in all 50 states and 80 countries.

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