Serious adverse reactions related to the quality and safety of transfusion products occurring in recipients must be reported by the clinical units where the transfusion therapies are carried out to the reference TS, which in turn must report the event to the competent regional authority.
The Italian national haemovigilance system, in compliance with the European directive, classifies adverse effects as follows:
- serious symptomatic adverse reactions, i.e. characterised by the appearance of recognisable clinical signs and symptoms, occurring during or shortly after the transfusion
- serious asymptomatic adverse effects or those with delayed symptomatology, which include transfusion-transmitted viral infections
- avoided transfusion errors or near misses
The constant monitoring of serious adverse effects of transfusion therapy on recipients and transfusion errors, even if avoided, makes it possible to keep track of mistakes that can occur even in the best transfusion practices. It also makes it possible to introduce targeted corrective and preventive measures, and provides evidence that can re-address national policies in terms of improving blood component production and transfusion-associated care practices.
