Chapter II: Opening and operating conditions

The opening of a medical biology laboratory is subject to the prior filing, by its legal representative, of a declaration with the regional health agency, within a period set by regulation. The content of this declaration is also laid down by regulation. Where the laboratory’s sites are located in regions under the jurisdiction of different regional health agencies, the declaration must be filed with each of the regional health agencies….

The Director General of the Regional Health Agency may object to the opening of a medical biology laboratory or a site of a medical biology laboratory, where this would have the effect of increasing the supply of medical biology examinations in the area determined in application of b of 2° of Article L. 1434-9 in question to a level 25% higher than the needs of the population as defined by…

The Director General of the Regional Health Agency may object, on grounds relating to the risk of jeopardising the continuity of medical biology services, to the acquisition of a medical biology laboratory or a medical biology laboratory site, to the purchase of all or part of the assets of a company operating a medical biology laboratory or to a merger of medical biology laboratories, including the transfer of all assets…

A health establishment may only manage one medical biology laboratory. However, the public health establishments mentioned in the first paragraph of Article L. 6147-1 may be authorised by the Director General of the Regional Health Agency to have several medical biology laboratories under conditions laid down by regulation. A medical biology laboratory may be shared by several health establishments.

The sites of the medical biology laboratory are located either in the same area determined in application of b of 2° of Article L. 1434-9, or in a maximum of three of these adjoining areas, unless an exemption is granted by the Director General of the Regional Health Agency under conditions determined by decree in the Council of State and provided for in the regional health plan. When a medical…

At each site, a laboratory biologist must be able to respond to the needs of the site and, if necessary, to intervene within timescales compatible with patient safety requirements. To ensure compliance with this obligation, the laboratory must have a number of biologists at least equal to the number of sites it has created. The biologist responsible for the site must be identifiable at all times.

The medical biology laboratory informs patients of its accreditation, its organisational and operational procedures and the identity of the biologist in charge, by means of posters in the premises where the public is received.

Any form of direct or indirect advertising or promotion of a medical biology laboratory is prohibited. However, scientific information for the medical and pharmaceutical professions and information relating to the existence and location of the medical laboratory published at the time of the opening of the laboratory or its sites and mention of the laboratory’s accreditation do not constitute advertising or promotion within the meaning of this article.