Subsection 1: Activities of establishments

The collection of blood and its components, their biological qualification, the preparation, processing, distribution and issue of labile blood products are carried out in compliance with the good practices defined by decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé, taken in application of article L. 1222-12. For each of these activities and on each of the sites where they are…

All blood establishments have the means to ensure the quality control of their products. However, the blood establishment may entrust quality control, under an agreement, either to another blood establishment or to an external laboratory authorised to carry out the corresponding activity; it may also enter into an agreement for the irradiation of the products it prepares with another blood establishment or, where appropriate, with a health establishment.

Each team carrying out whole blood sampling at a fixed or mobile site includes, in addition to the presence of a person mentioned in II of Article R. 1222-17: a) A person authorised to carry out the sampling and meeting the conditions laid down in Article R. 1222-18; b) A nurse if the team consists of more than three people; In the absence of a doctor, a means of communication…

The blood establishment’s biological qualification laboratory for donations, which is placed under the responsibility of a doctor or pharmacist, must have at least two technicians with the required qualifications as set out in article L. 1222-10 at each site assigned to this activity.

All blood establishments must ensure the continuity of the public transfusion service. When applying for accreditation, and at the request of the inspector from the Agence nationale de sécurité du médicament et des produits de santé, it must provide evidence of compliance with this obligation. For the activities of supply, transfusion advice and, where appropriate, immuno-haematology, the blood establishment must be on call 24 hours a day, in accordance with…