Subsection 1: General provisions.

The aim of transfusion safety is to identify hazards that have caused, are causing or are likely to cause incidents or adverse reactions that have threatened, are threatening or may threaten the health of donors or recipients, in order to eliminate or reduce the associated risks. Haemovigilance is a component of transfusion safety. It involves, for any donation of blood or blood components and for any labile blood product: 1°…

For the purposes of this section, the following definitions shall apply 1° Adverse reaction: a harmful reaction in donors associated or possibly associated with the collection of blood or in recipients associated or possibly associated with the administration of a labile blood product; 2° Serious adverse reaction: an adverse reaction resulting in death or life-threatening, disabling or incapacitating, or causing or prolonging hospitalisation or any other morbid condition; 3° Incident…