Biovigilance initiatives
Authors: Strong D. M. , AuBuchon J. , Whitaker B. , Kuehnert M. J. 
Published: April 2008

Background  Haemovigilance systems have been in existence for over 10 years, having been established after recognition of the impact from the AIDS epidemic, and other potential risks, on the safety of blood transfusion. Haemovigilance systems now have been implemented globally in most developed countries, with some exceptions including the USA, to monitor the adverse events and incidents associated with blood donations and transfusions. ‘Biovigilance’ extends this term beyond blood to incorporate monitoring of events associated with tissue, organs and cellular components. In the USA, with the absence of either national haemovigilance or broader biovigilance systems, there has been growing interest in development of a national biovigilance programme.

Methods  The AABB has established a multiorganizational task force, made up of both public and private organizations, to help build a biovigilance network with three separate components addressing safety for transfusion recipients, blood donors and organ/tissue. These systems are being developed through various public–private partnerships with funding from both government and private sectors. The Transfusion Recipient System is being developed by AABB in collaboration with the Centers for Disease Control and Prevention (CDC), as a module in CDC's National Healthcare Safety Network (NHSN). The blood donor system is a collaborative effort with the Department of Health and Human Services, Office of Public Health and Safety and AABB member blood donor programmes. Under a cooperative agreement with the CDC, the United Network for Organ Sharing and other partners are developing a system to increase recognition of adverse events associated with organ and tissues, the Transplantation Transmission Sentinel Network (TTSN).

Results  These systems have many features in common. They are designed to be voluntary, non‐punitive and confidential in order to encourage participation, and are expected to generate data in order to prompt policy changes, standards and procedural interventions to improve patient safety and outcomes. However, the systems also are slightly different in configuration and source of development. For example, for a sentinel network such as TTSN, the additional intention is to improve communications between organ and tissue agencies and to notify healthcare providers when there is a risk associated with a particular donor.

Conclusions  These biovigilance initiatives are being developed simultaneously through a unique public–private partnership. Furthest along in development are the transfusion recipient NHSN module and the TTSN; both are targeted for pilot testing by the spring of 2008. The blood donor system is still in the concept stage. Although global haemovigilance efforts are more advanced in comparison to the USA, the extent of progress in biovigilance efforts is varied. The safety of solid organs is almost universally not being addressed. However, efforts are currently underway to establish systems to ensure that the safety and quality of blood, tissues and cells are monitored and information shared.