Eight years with haemovigilance in Norway. What have we learnt?

ABSTRACT

The purpose of a haemovigilance system is to identify complications related to transfusion or blood donation, analyze them and learn in order to avoid complications in the future. The Norwegian Haemovigilance System (Troll) started as a voluntary, professionally led reporting system in 2004. In 2007 haemovigilance became an authority task, according to the EU blood directive, and reporting of serious adverse reactions and serious adverse events became mandatory. The Norwegian Directorate of Health became responsible for the system and asked The Norwegian Knowledge Centre for the Health Services to run it. Results from the first eight years of reporting are presented. A total of 2607 transfusion complications or incorrect blood component transfused (IBCT) have been reported (127 per 100,000 transfusions). Most transfusion reactions are mild. The most frequently reported are febrile non-hemolytic and mild allergic reactions. Serious adverse reactions such as anaphylaxis, TRALI and hemolytic transfusion reactions occur, but are rare. One incident of bacterial transmission and four incidents of viral transmission have been reported, among them one case of HCV transmission. No incidents of transmission of HIV or hepatitis B have been reported. IBCT was reported 168 times. Our data are comparable with data from other countries. Recommendations from the haemovigilance system are included in local and national guidelines. Increased knowledge of haemovigilance among physicians and nurses can lead to improved transfusion safety. It is safe to receive blood in Norway, but serious adverse reactions do occur. Our reporting system seems to be well accepted. We have not yet been able to document any change of practice that has lead to a reduction in the number of complications.