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

The health cooperation groupings mentioned in articles L. 1221-10 and L. 6133-1 may be authorised to manage a blood bank. The authorisation for a blood depot is issued by the Director General of the Regional Health Agency for the needs of several health establishments that are members of the group, in compliance with the following cumulative conditions: 1° The time taken to supply or transfer labile blood products from the…

Blood depot authorisations are granted under one of the following categories: 1° Dispensing depot: a depot which stores labile blood products distributed by the referring blood establishment and dispenses them for a patient hospitalised in the health establishment; 2° Emergency depot: depot which stores group O red blood cell concentrates and, if necessary, group AB plasma or lyophilised plasma distributed by the referring blood establishment and issues them in a…

To be authorised, a blood depot must meet the following conditions: 1° Have an organisation and resources enabling it to carry out its activities in accordance with the procedures defined by order of the Minister for Health, ensuring the supply of labile blood products, the safety of these products and their traceability; 2° It must have a doctor or pharmacist with the qualifications mentioned in article R. 1222-23 and at…

The authorisation to manage a blood depot referred to in article L. 1221-10 is granted by the regional health agency with territorial jurisdiction, after obtaining the opinion of the Etablissement français du sang for the health establishments and health cooperation groups referred to in article L. 6133-1. When a health establishment or a health cooperation group applies for authorisation to manage a blood depot, it first signs an agreement with…

I.-The application for an initial authorisation to manage a blood establishment is sent by the director of the health establishment or by the administrator of the grouping to the regional health agency, by any means enabling receipt of the application to be dated with certainty. The order of the Minister for Health provided for in article R. 1221-20-1 defines the content of the application for authorisation, which includes in particular…

Non-substantial modifications must be declared to the regional health agency. A copy is sent to the Etablissement français du sang or, where applicable, to the Centre de transfusion sanguine des armées. Non-substantial modifications are modifications that are not listed in article R. 1221-20-3 and in particular: 1° The appointment of a new depot manager; 2° The change of equipment appearing on the list of health depot equipment determined by order…

I.-The refusal of authorisation to manage a blood establishment, its renewal or the substantial modification of one of its elements is notified to the director of the health establishment or to the administrator of the consortium by the director general of the regional health agency. A copy of this decision is sent to the regional haemovigilance and transfusion safety coordinator and to the Etablissement Français du Sang or, where applicable,…

Blood banks are subject to at least one inspection by the regional health agency during the period of validity of the authorisation.

For the application of this section, the Minister of Defence shall exercise the powers conferred on the competent regional health agency for army hospitals, whose technical opinion he may seek if necessary.

Blood establishments, health establishments and health cooperation groups authorised to store labile blood products intended for therapeutic use must have a procedure for withdrawing any unit of such products from the circuit. An order by the Minister for Health sets the conditions under which health establishments may store in their departments labile blood products issued, with a view to a transfusion procedure, by their referral blood establishment or by the…