The Quebec hemovigilance system: description and results from the first two years.

Following federal and provincial reviews of the blood system, the Canadian province of Quebec passed a series of legislative and administrative measures to improve blood safety, including the establishment of a hemovigilance system, and made infrastructure and human resource investments to support their implementation. The Quebec hemovigilance system was inspired by the French system using similar data elements and case definitions, grading of severity and determination of likelihood of association with transfusion for adverse transfusion events (ATE). The Quebec system also monitors transfusion incidents without adverse consequences such as "incorrect blood component transfused" (IBCT) and near-miss events. Accurate rate estimates are possible through the collection of denominator data on the number of blood products transfused. This paper describes the Quebec hemovigilance system and reports on ATE (including IBCT but excluding near-miss events) associated with blood components notified in 2000 and 2001, the first two years of implementation. The Quebec hemovigilance system is voluntary, but hospital participation in 2000 and 2001 represented 80% and 82% of transfused products, respectively. Notified ATE (including IBCT) increased 78% between 2000 and 2001 primarily because of better reporting of minor adverse reactions. In 2001, the overall ATE rate was 3.5 per 1000 blood components transfused. Despite an overall increase in reported ATE, rates for some serious ATE decreased in the second year, including ABO-incompatible transfusions, acute hemolytic reactions and bacterial contamination.