Subsection 4: Tasks and procedures for designating reference medical biology laboratories

Without prejudice to the provisions of Articles L. 1413-3 and L. 1413-8, a reference medical biology laboratory for specific medical biology tests or for specific pathologies, within the meaning of paragraph III of Article L. 6211-19, is a medical biology laboratory which, designated under the conditions defined in Article D. 6211-19, meets the following conditions: 1° Demonstrates a high level of competence in the three pre-analytical, analytical and post-analytical phases…

I.-Reference medical biology laboratories are designated for a period of five years. For the designation of reference medical biology laboratories, a call for applications is launched by the Minister for Health at least eight months before the expected date of publication of the order establishing the list of reference medical biology laboratories provided for inArticle L. 6211-19 of the Public Health Code. This call for applications is made on the…

A medical biology laboratory may decide to terminate its functions as a reference medical biology laboratory, subject to nine months’ notice. Failure to comply with this time limit exposes the medical biology laboratory or the legal structure to which it belongs to the penalties provided for in 7° of Article L. 6241-1.

A reference medical biology laboratory that ceases to fulfil the conditions for operating a medical biology laboratory provided for in Book II of Part Six or that does not apply the obligations of its specifications may be removed from the list of reference medical biology laboratories. After receiving the opinion of the selection committee referred to in Article D. 6211-19, the Minister responsible for health shall notify the manager of…

The reference medical biology laboratory draws up an annual report on its activities. This report includes an assessment of the changes observed and those that are desirable. It includes a list of publications or recommendations made by the reference laboratory during the past year and its work prospects for the coming year. The annual report is sent by 31 March of the following year, by the biologist in charge, to…

A medical biology laboratory attached to a national reference centre for the control of transmissible diseases as referred to in Article L. 1413-3 is automatically included on the list referred to in the first paragraph of Article D. 6211-19. It is not subject to the designation procedures of this sub-section.