Section 3: Local experimental protocols

I.-Healthcare professionals practising in a public or private health institution or within a regional hospital grouping referred to in article L. 6132-1 may, on their own initiative, draw up and implement local cooperation protocols, by decision of the director of the institution and, in public health institutions, after receiving the assent of the institution's medical committee or, where applicable, the group medical committee and the nursing, rehabilitation and medico-technical care committee. In private health establishments, the assent is given by the bodies mentioned in articles L. 6161-2 and L. 6161-2-1.

These protocols are only valid within the promoting establishment or hospital grouping. The director of the institution shall declare the implementation of these protocols to the director general of the regional health agency with territorial jurisdiction. The latter will forward these protocols to the Haute Autorité de Santé (French National Authority for Health) for information, as well as to the Comité National des Coopérations Interprofessionnelles (National Committee for Interprofessional Cooperation) referred to in Article L. 4011-3.

Local protocols must meet the essential quality and safety requirements referred to in Article L. 4011-2.

II.-The director of the health care organisation will forward data relating to protocol monitoring indicators to the Director General of the Regional Health Agency on an annual basis. He shall inform him without delay of any undesirable events relating to its application.

In the event of non-compliance with the provisions of a protocol or a serious undesirable event, the director of the establishment may suspend the implementation of this protocol.

When he finds that the essential quality and safety requirements mentioned in Article L. 4011-2 are not guaranteed or that the provisions of the protocol are not being complied with, the Director General of the regional health agency with territorial jurisdiction may suspend the implementation or terminate a local cooperation protocol.

III. - At the request of one or more of the regional health agencies, the Director General of the establishment may suspend the implementation or terminate the local cooperation protocol.At the request of one or more healthcare establishments, or on its own initiative, the National Committee for Interprofessional Cooperation may propose the deployment of a local protocol throughout France. This deployment is authorised by order of the ministers responsible for health and social security, after obtaining the opinion of the Haute Autorité de santé.

IV - A decree sets out the conditions for the application of this article and in particular:

1° The provisions of section 2 of this chapter which apply to the deployment of a local protocol throughout the national territory in application of III of this article;

2° The nature of the indicators mentioned in II which include monitoring of the quality of care.