Every step in blood component production and transfusion must be registered and monitored by the blood establishment and qualified healthcare professionals in order to establish a safe and qualitative product on output; the so-called "vein-to-vein" path. The system is therefore called the haemovigilance system. Blood Establishments as well as the Hospital Blood Banks are obliged to register every deficiency or unintended donor reaction that occurred during production or transfusion of the blood component. According to the Blood Act the State Agency of Medicines has to be notified of any serious adverse events and/or reactions.
Serious Adverse Event (SAE) means any untoward occurrence associated with the collection, testing, processing, storage and distribution, of blood and/or blood components that might lead to death or life-threatening, disabling or incapacitating conditions for patients or which results in, or prolongs, hospitalisation or morbidity.
Serious Adverse Reaction (SAR) means an unintended response in donor or in patient associated with the collection or transfusion of blood or blood components that is fatal, life-threatening, disabling, incapacitating, or which results in, or prolongs, hospitalisation or morbidity.
On the basis of the SAE/SAR investigational reports the State Agency of Medicines is obliged to compile annual reports and inspection schedules. Annual reports are to be distributed to all Blood Establishments, the Ministry of Social Affairs and the European Commission.