Book II: Donation and use of human body parts and products

Each public or private healthcare establishment is required to collect and keep the following information for each unit of labile blood product distributed or issued to it for a hospitalised patient: 1° The identification number of the unit prepared in accordance with the national coding system approved by the Agence nationale de sécurité du médicament et des produits de santé ; 2° Identification of the product code in accordance with…

At the request of the Agence nationale de sécurité du médicament et des produits de santé, the establishments mentioned in the first paragraph of Article R. 1221-40 shall collect and keep all the information relating to haemovigilance and transfusion safety to which they have access and which concerns : 1° Scheduled autologous transfusions ; 2° Pre-transfusion and, where appropriate, post-transfusion examinations carried out on the patient; 3° The administration, as…

The referring blood establishment sends the establishments mentioned in the first paragraph of article R. 1221-40, the information relating to 1° and 2° of the same article and, where applicable, 2° of article R. 1221-41. 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…

I.-In each of the establishments mentioned in the first paragraph of article R. 1221-40, a haemovigilance and transfusion safety correspondent is responsible for ensuring : 1° Reporting, under the conditions and according to the procedures set out in articles R. 1221-49 and R. 1221-49-2, any adverse reaction occurring in a recipient of labile blood products, as well as any serious incident ; 2° Collecting and storing the information mentioned in…

I. – The haemovigilance and transfusion safety correspondent is appointed, in public health establishments and health cooperation groups set up as public health establishments, by the director. This appointment is made after consultation with the chairman of the establishment’s medical committee. II. – The haemovigilance and transfusion safety correspondent is appointed, in private health establishments, by the legal representative of the establishment, and in health cooperation groups set up as…

I.- The mission of the institutional medical committees in public health establishments and the institutional medical conferences in private health establishments is, in particular, to contribute through their studies and proposals to improving the safety of patients transfused in the health establishments in which they are set up. These bodies ensure the implementation of the haemovigilance and transfusion safety rules and procedures provided for in this section and in particular…

When the agenda concerns transfusion safety and haemovigilance, the following are present as of right at meetings of the institutional medical committee in public health establishments or the institutional medical conference in private health establishments: 1° The regional haemovigilance and transfusion safety coordinator ; 2° The haemovigilance and transfusion safety correspondent of the referring blood establishment; 3° The haemovigilance and transfusion safety correspondent for the health establishment; 4° The head…

The regional haemovigilance and transfusion safety coordinator receives the minutes, reports and other documents relating to transfusion safety and haemovigilance drawn up by the hospital medical committee or hospital medical conference. It informs the Agence Nationale de Sécurité du Médicament et des Produits de Santé, the Director General of the Regional Health Agency and the Central Director of the Armed Forces Health Service, as necessary.

I. – The health care organisation’s medical committee or medical conference may refer any matter relating to the implementation of haemovigilance rules in the health care organisation to the regional haemovigilance and transfusion safety coordinator and the Agence nationale de sécurité du médicament et des produits de santé. II. – In public health establishments and health cooperation groups set up as public health establishments, the director, when approached by the…