Participation by both hospitals and blood collection facilities is voluntary and non-punitive. Data contributed by participants and held in the Network systems will be protected from disclosure under existing law.
Using the recipient- and donor-based systems the process will begin at the local level with hospitals and/or blood collection facilities. These facilities will be asked to identify adverse reactions and incidents and enter data describing these events into the appropriate module.
The facilities will receive training and support to ensure that adverse incidents are appropriately recognized and data is entered and captured efficiently and accurately. Data entry can be done at the convenience of the staff in each facility and is anticipated to take no more than a few minutes per event once the facility has completed its investigation. Task Force work groups are carefully addressing issues and listening to concerns to be sure that staff effort in hospitals and blood centers is optimized to identify and enter data. Every effort is being made to identify limited and common data elements to avoid the need for unnecessary investigation and tracking. Where possible, electronic interfaces will be developed to take advantage of data already contributed to existing systems. In the long run, as this program develops, a single-portal data entry concept is envisioned and expected to be a considerable time saver for participating facilities.
Once data is entered into the system, the U.S. Biovigilance Network will:
· Aggregate nationwide data from all reported adverse reactions, and incidents, including near-miss events.
· Evaluate and analyze data using qualified experts.
· Make aggregate adverse reaction and incident-related reports available to the medical and public health communities in a systematic manner.
· Make recommendations for improvements leading to changes in practice designed to eliminate the identified adverse reactions or incidents.
Facilities That Have Agreed to Contribute Data to the U.S. Biovigilance Network
Altru Health System/ DAK-Minn Blood Bank
American Red Cross
Aurora St. Luke’s Medical Center
Baystate Medical Center
Beth Israel Deaconess Medical Center
Blood Centers of the Pacific
Blood Center of Wisconsin
Central Florida Regional Hospital
Children's Healthcare of Atlanta
Children’s Hospital (Los Angeles)
Children’s Hospital (Dallas)
Children’s National Medical Center
Cleveland Clinic
Columbia University Hospital
Community Blood Center (Dayton)
Danbury Hospital
Dartmouth Hitchcock Medical Center
Doctors Community Hospital
Emory Crawford Long Hospital
Emory University Hospital
Euclid Hospital
Fairview Hospital
Fairview Southdale Hospital
Fletcher Allen Health Care
Florida Hospital
Froedtert & the Medical College of Wisconsin
Genesis Medical Center
Grady Memorial Hospital
Hahnemann University Hospital
Hennepin County Medical Center
Henry Ford Hospital/Henry Ford Health System
Hillcrest Hospital
Holy Cross Hospital (Chicago)
Hoxworth Blood Center
The Johns Hopkins Hospital and Health System
Lakewood Hospital
Lutheran Hospital
Maimonides Medical Center
Marymount Hospital
M. D. Anderson Cancer Center
Mayo Clinic (Rochester)
Mayo Clinic (Scottsdale)
Mercy Memorial Hospital System
New York Presbyterian Hospital
Northshore University HealthSystem
Ochsner Health System Blood Bank
Puget Sound Blood Center
Rhode Island Blood Center
Shands Hospital at the University of Florida
Somerset Medical Center
South Pointe Hospital
Southern Maryland Hospital Center
St. Luke’s Episcopal Hospital
St. Mary’s Regional Blood Center
Stevens Hospital
Stormont-Vail HealthCare
Temple University Hospital
UCLA Health System
Underwood Memorial Hospital
University Hospital Case Medical Center
University of Texas Medical Branch
VA Connecticut Healthcare System
Whidbey General Hospital
Yale-New Haven Hospita
Testimonials
“A nationwide biovigilance network is absolutely critical for patient safety, public health and adoption of best practices. That’s why Blood Systems has committed $350,000 in support of the Network, helping ensure the safety of America’s blood and tissue services.”
— J. Daniel Connor, President and CEO, Blood Systems Inc., and President, AABB Board of Directors
“The quality gurus say, ‘If you can't measure it, you can’t improve it.’ The 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.”
— James AuBuchon, MD, Chair, Department of Pathology, Dartmouth-Hitchcock Medical Center
“The Department of Health and Human Services and the Centers for Disease Control and Prevention initial funding of this project is a powerful endorsement of the Network’s value to patients and the public health. This is precisely the kind of leadership that will ultimately enhance patient safety and reduce costs— we hope the private sector will continue to fully step up to the plate.”
— Karen Shoos Lipton, CEO, AABB
View the U.S. Biovigilance Network launch press release