French Public Health Code
In forceWithout prejudice to the provisions of Articles
L. 1413-3and
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 for specified medical biology tests or for medical biology tests relating to specified pathologies. This competence is assessed on the basis of the specifications provided for in Article D. 6211-19;
2° To meet a public health need;
3° To provide the following public health services for these examinations, in accordance with Article L. 6212-3:
a) High-level expertise for specific medical biology examinations or for medical biology examinations relating to specific pathologies. This mission concerns assistance with screening, prevention, diagnosis, evaluation of the occurrence of pathological conditions and therapeutic management. In particular, this expertise contributes to the development and evaluation of new analytical methods for diagnosing the disease(s) in question and to participating in their dissemination. This mission is carried out in all cases where a sample is sent to the reference medical biology laboratory or where it is asked to provide a biological interpretation based on the clinical situation;
b) A mission to collect the data received in the appropriate public databases, for the purposes of epidemiological surveillance, research and the development of knowledge for the individual or collective management of patients. This mission also contributes to the knowledge and improvement of the pre-analytical conditions for carrying out medical biology examinations, the reference analytical methods for these examinations and the interpretation of the results obtained;
c) A mission to alert the health authorities in the event of the emergence of signs suggestive of major public health problems of which the reference medical biology laboratory is aware. This task is carried out, where applicable, in compliance with the rules governing it, in particular for reactovigilance and health monitoring. In the absence of a specific rule, the alert is sent to the regional health agencies;
d) To provide information, recommendations or training, by participating in university teaching or other types of training on the reference activity;
e) To coordinate a network with other medical biology laboratories working in the fields for which qualification as a reference medical biology laboratory is requested.
