French Public Health Code
In forceI. - The local biovigilance correspondent is responsible for :
1° Ensuring that surveillance of incidents and adverse reactions is set up by healthcare professionals involved in the activities mentioned in 2° of I of article R. 1211-29;
2° Collecting, storing and making accessible the information communicated to it relating to incidents and adverse reactions;
3° Identifying and declaring serious incidents and unexpected adverse reactions to the Agence de la biomédecine without delay;
4° Informing, where appropriate, the other local biovigilance correspondents;
5° Informing other vigilance correspondents if other vigilance systems are involved;
6° Investigating or coordinating the investigation of serious incidents and unexpected adverse reactions reported to it and ensuring that the healthcare professional concerned implements corrective measures where necessary;
7° Informing the Agence de la biomédecine of the results of these investigations and any corrective measures put in place;
8° Notifying the Agence de la biomédecine of any difficulties likely to compromise the smooth operation of the system;
9° Transmitting an annual report to the Agence de la biomédecine by 31 March each year, summarising all incidents and adverse reactions and the frequency with which they occur in relation to the activities. The model for the report is set by the Director General of the Agence de la biomédecine.
II. - In addition to the tasks mentioned in I of this article, the local biovigilance correspondent who carries out his tasks in an establishment or organisation mentioned in a or c of 3° of article R. 1211-32, is responsible for :
1° Ensuring that the professionals involved in these activities put in place procedures for collecting and storing any information useful for the traceability of these elements or products so as to enable a link to be established between donors and recipients and to establish any link between the elements or products which have been used for therapeutic purposes and the products which have come into contact with them;
2° Ensure the quality and reliability of the information mentioned in 1°;
3° Collaborate, within the framework of its missions, with the removal or transplantation teams of the health establishment or the structure to which it is attached, as well as, where applicable, with the hospital coordination structure for removal.
III. - During investigations into serious incidents or unexpected adverse reactions, the local biovigilance correspondents of the establishments or organisations mentioned in a and c of 3° of Article R. 1211-32 provide the local biovigilance correspondents of the establishments or organisations mentioned in b of 3° of the same article with:
1° The data required to ensure the traceability of these elements or products as well as that of the products coming into contact with them;
2° Biological samples used to carry out tests for biological markers of infection on the donor or on the element removed for subsequent analysis.
