Section 2: Terms and conditions

The medical biology laboratory is managed by a medical biologist known as the biologist-in-charge. The medical biologist benefits from the rules of professional independence recognised for doctors and pharmacists in the code of ethics applicable to them. The biologist in charge manages the laboratory in compliance with these rules.

When a public health establishment, or a private not-for-profit health establishment, has a medical biology laboratory organised in the form of an activity centre or a university hospital centre, the biologist in charge is the head of this centre and is responsible for its functions. The organisation of the laboratory is, depending on the case, either that of the activity centre or that of the university hospital centre. When a…

With the exception of not-for-profit laboratories, private medical laboratories are managed by a biologist in charge who is the legal representative. When the legal structure of a medical biology laboratory allows for the existence of several legal representatives, these representatives are called co-responsible biologists. Medical specialists qualified in pathological anatomy and cytology may be designated as co-responsible biologists. The biologist-co-responsible and the medical specialists qualified in pathological anatomy and cytology…

The biologist-responsible, the biologists-co-responsible and the qualified medical specialists in anatomy and pathological cytology who are co-responsible may only perform this function in a single medical biology laboratory.

A decree sets the conditions under which, by way of derogation from Articles L. 6213-1 and L. 6213-2, medical biologists may be temporarily replaced.

When decisions taken by the natural or legal person operating the medical biology laboratory appear to the biologist in charge to be of such a nature as to jeopardise the health of patients and public health or the operating rules of the laboratory as provided for in this Book, the biologist in charge shall inform the Director General of the Regional Health Agency who shall take the appropriate measures.

The orders and decisions mentioned in articles L. 6211-3, L. 6211-22, L. 6211-23, L. 6213-2 and L. 6213-3 are made after consultation with a commission, including professionals, whose composition, conditions of consultation and powers are set by decree in the Conseil d’Etat.