When, on the date of entry into force of this regulation, a medical-biological laboratory was established in more than three health areas or in non-border health areas that do not meet the conditions prescribed first paragraph of article L. 6222-5 of the law on public healththe general director of the regional health agency informs about this situation in violation of the law of the legal representative of the laboratory in question within three months after the entry into force of this regulation.
The legal representative of the laboratory submits to the director general of the competent regional health agency a request for exceptional maintenance of the location(s) in question, within six months after receiving the notice specified in the previous paragraph, accompanied by documentation that explains the general organization of the laboratory and the activities carried out at each location.
The director general of the agency may authorize the maintenance, on a temporary or permanent basis, of the place(s) in question, in accordance with the third paragraph of Article L. 6222-5, as long as the plan of the regional care organization ensures this in one of the following cases:
1° Or the exam offer has a highly specialized character, based especially on highly technical equipment, processes or necessary skills, and does not require a local organization to ensure the quality and security of answers;
2° The needs of the population defined by the spatial plan would no longer be met if this or these locations were not maintained.
The general director of the regional health agency notifies his reasoned decision within four months of the request.