Most of the world’s industrialized nations have a comprehensive, national level biovigilance system that tracks events relating to blood transfusions and cell, tissue, and organ transplants, significantly improving the safety of these procedures. The U.S., however, currently lacks such a biovigilance system to track and analyze routine blood and blood product related procedures. In addition, in light of the current emphasis on national security, there is a critical need to analyze, in real-time, incidents of disease or safety issues to determine key performance metrics and trends, and to determine if the presence of these trends signal random events, possible outbreaks, or terrorist acts.
The Department of Health and Human Services (DHHS) is addressing the absence of a biovigilance system by piloting a nation-wide system focused on hemovigilance and donor safety issues. KBSI has been tasked with designing and developing this system by leveraging the web-based data capture, reporting, and analysis framework of the Blood Reserve Availability Assessment, Tracking, and Management System (BRAMS™) developed in an earlier effort. The BRAMS™ initiative, now in Phase III, supplements the Joint Medical Asset Repository (JMAR) by allowing users to manually enter data via a Web-based system. The BRAMS™ technology provides data integrity and access control mechanisms to ensure that the data entered is valid, clean, and not duplicated in other data sources.
The BRAMS™ technology also provides predictive logistics and forecasting, agent-based alerts and notifications, emergency response management, and transportation optimization. This functionality enables program and preparedness managers to use data mining and analytics to detect problems, analyze the underlying drivers for system behavior, evaluate alternate solutions, and optimize the supply chain.
The Biovigilance system captures and analyzes reaction information from the nation’s blood centers, focusing on hemovigilance: monitoring, analyzing, and researching the risks involved for a donor at the time of blood donation or following the donation event. The Biovigilance system includes the following innovative approaches:
- Gather the information related to donor reactions that have occurred during blood donation using Web-based data capture methods;
- Monitor the key metrics related to the occurrence of reactions, and track them across facilities and regions nationally;
- Use the collected information for data mining and GIS-based visualization to analyze changes in trend differences in patterns and identify the underlying causalities;
- Apply pattern analysis for generating reports related to the early warning of safety issues, application of evidence for practice improvements, and the promotion of educational activities.
The Biovigilance technology will establish a comprehensive system for collecting, analyzing, and reporting the outcomes of blood components and derivatives, cells, tissues, and organ collections. The system will also provide early warning detection for adverse events and support the continuous improvement of donor and recipient safety in the U.S. This capability will form a critical component of the nation’s medical safety and security infrastructure.