French Public Health Code
In forceI.-The declaration provided for in article R. 6122-37 is sent to the Director General of the Regional Health Agency by registered letter with acknowledgement of receipt, or by any means providing equivalent guarantees of receipt on a date certain. The holder of the authorisation undertakes to ensure that the healthcare activity or the installation of the heavy equipment complies with the conditions of the authorisation. All documents attesting to the fact that the holder has obtained a positive result in the technical inspections applicable to its installations, where applicable, are attached to this letter. The holder may begin to carry out the activity or use the heavy equipment and provide care reimbursable by social security from the day following this dispatch.
Within the six-month period provided for in article L. 6122-4, a compliance visit may be carried out by the Regional Health Agency and scheduled by agreement between the Agency and the holder. If the visit follows the commencement of activity, its principle is notified by the Director General of the Regional Health Agency within one month of receipt of the declaration of commencement of activity. If the holder fails to carry out a visit within this period, the Director General of the Regional Health Agency may suspend the authorisation under the conditions laid down in II of Article L. 6122-13.
The visit is carried out by at least two persons appointed by the Director General of the Regional Health Agency from among the persons mentioned in Articles L. 1421-1 and L. 1435-7 and the consultant practitioners of the basic health insurance schemes. The Director General of the Regional Health Agency may arrange for them to be assisted by persons, in particular representatives of government departments or national bodies, with specific knowledge of the healthcare activity or facilities concerned.
The visit will focus on the holder's compliance with the location conditions laid down in Article L. 6123-1 and the technical operating conditions laid down in Article L. 6124-1, applicable to the facilities visited, and, where applicable, on compliance with the special conditions or commitments attached to the authorisation or to which it is subject under Article L. 6122-7. It also looks at the implementation of the elements presented in the authorisation application, particularly those relating to premises, staff and agreements with other establishments or healthcare professionals. Finally, it ensures that the holder implements the other regulatory provisions applicable, where applicable, to the performance of the healthcare activity or the use of the heavy equipment.
If the result of the visit is positive, a statement of observations and reasoned conclusions is sent to the authorisation holder within one month.
Where the facilities or operation do not comply with the criteria on the basis of which the authorisation was granted or with the conditions to which it is subject, the Director General of the Regional Health Agency, on the basis of the report drawn up by the persons who carried out the visit, informs the authorisation holder without delay of the observations made and the changes or improvements to be made to ensure compliance. The provisions of article L. 6122-13 will then be applied.
In the case of heavy equipment authorised for mobile use, for each site of use mentioned in the authorisation, the compliance visit is, where appropriate, decided and carried out by the regional health agency with territorial jurisdiction, which sends the report to the director of the regional health agency which issued the authorisation.
When renewal of the authorisation is granted under the conditions set out in the last paragraph of Article L. 6122-10, the Director General of the Regional Health Agency may decide that a compliance visit will be carried out within six months of the start of the period of validity of the renewal; this visit will be carried out in accordance with the provisions set out in the previous six paragraphs.
II - When the holder of the authorisation intends to modify the premises or the conditions under which the authorisation for a health care activity or heavy equipment is granted, it must inform the Director General of the Regional Health Agency and send it the documents relating to the project. Where the Director General of the Regional Health Agency establishes that the modification does not require a new authorisation decision requiring an application to be submitted, he gives his agreement to the project, indicating that once it has been carried out, a check may be made to ensure that the elements of the healthcare activity or the use of the heavy equipment affected by this operation remain compliant. This verification is carried out in accordance with the procedure set out in I, after the authorisation holder has declared the completion of the operation to the Director General of the Regional Health Agency.
