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In the Swedish Guide for Transfusion Medicine, Haemovigilance (blood monitoring) is defined as standardized data collection and assessment of information about deviations in the collection, testing, production, storage and distribution of blood and blood components and the adverse and unexpected effects of the performed blood transfusions.
A Haemovigilance system should lead to improvement of the quality and safety in transfusion medicine. To assure the quality of all transfusion-associated operations, a broad haemovigilance system is required covering the whole chain  "from vein to vein" - which should be complementary to the existing deviation reporting system in each blood bank.
BIS, the blood monitoring system in Sweden, and other national deviation reporting systems stand for a haemovigilance which is broader than the EU Directive and The National Board of Health and Welfare requirements. Experiences from haemovigilance systems worldwide show that a good blood monitoring system should be constructed as follows:

  • not being punitive
  • being confidential
  • being independent
  • having access to the experts for assessment of the deviations
  • being systems-oriented, i.e. being focused on the changes needed to be done in the system
  • showing responsibility, i.e. implementing the recommendations when is needed
  • being easy to report to the system

The Swedish Association for Transfusion Medicine established a working group for hemovigilance in September 2002. The group consists of specialists in transfusion medicine from each Swedish regional blood center. During the second half of 2003 a trial reporting system was started, and since 2004, the hemovigilance system is fully in operation. Reporting to the Swedish Haemovigilance System (BIS) is voluntary and the organization is not a governmental authority in Sweden.