Subsection 6: Role of blood transfusion establishments.

I.-Each blood establishment is required to collect and keep, for each unit of labile blood product which it prepares, the following information: 1° The identification of the donation of blood or blood components from which the unit was obtained and the identification of the donor ; 2° The results of the biological analyses and screening tests carried out on the donation; 3° The identification of the blood establishment to which…

At the request of the Agence nationale de sécurité du médicament et des produits de santé, the blood establishment shall collect and keep all the information necessary for haemovigilance and transfusion safety to which it has access and which relates to : 1° Scheduled autologous transfusions in which the establishment has participated ; 2° Pre-transfusion and, where appropriate, post-transfusion examinations carried out on the patient; 3° The storage, for subsequent…

Health establishments send their referring blood establishment the information mentioned in II of article R. 1221-36 and in 2° of article R. 1221-37. Decisions by the Director General of the Agence nationale de sécurité du médicament et des produits de santé (French Agency for the Safety of Medicines and Health Products) taken after consultation with the Etablissement français du sang (French Blood Establishment) and the Armed Forces Blood Transfusion Centre…

In each blood establishment, a haemovigilance and transfusion safety correspondent is responsible for ensuring, under the authority of the person in charge: 1° Collecting and keeping the information mentioned in articles R. 1221-36 to R. 1221-38 , ensuring its quality and reliability; 2° Reporting, under the conditions and in accordance with the procedures set out in articles R. 1221-49 to R. 1221-49-4, any serious adverse reaction occurring in a blood…