Section 2: Terms and conditions of implementation

A medical biology examination is carried out by a medical biologist or, for certain phases, under his or her responsibility.

A medical biology examination is carried out on the basis of a prescription containing the relevant clinical elements. When he considers it appropriate, the medical biologist carries out, in accordance with the recommendations of good practice mentioned inarticle L. 161-37 of the Social Security Code when they exist and in compliance with the nomenclature of medical biology procedures established in application of article L. 162-1-7 of the same code, medical…

I. – Medical biology examinations, including in emergency situations, are carried out within timescales compatible with the state of the art, in accordance with the information available to the biologist on the patient’s state of health. The regional health agencies take these situations into account in the territorial organisation of healthcare. II. – The list of examinations deemed to be urgent, together with the conditions under which they must be…

A medical biology examination may also be carried out at the patient’s request, under the conditions of reimbursement and information set out inarticle L. 162-13-2 of the Social Security Code.

The biologist in charge of the medical biology laboratory to which the patient has referred retains responsibility for all phases of the medical biology examination, including when one of them, in the cases provided for in this Title, is performed, in whole or in part, by a medical biology laboratory other than the one in which he or she practises, or outside a medical biology laboratory.

When the patient’s care pathway includes tests, collection and processing of biological signals for which a prescription has been issued and which require a measuring device, the medical biologist shall ensure, at the time of an examination, under conditions set by decree, that the data from the medical device or in vitro diagnostic medical device is consistent with the result of the medical biology examination that he carries out.

When the sampling for a medical biology examination cannot be carried out in the medical biology laboratory within a timeframe compatible with the patient’s state of health, it may be carried out in a health establishment, in an army hospital, at the patient’s home or in places where this is possible, by an authorised health professional in accordance with procedures determined with the biologist in charge of the laboratory referred…

When the test is not taken in a medical biology laboratory or a healthcare establishment, an agreement signed between the legal representative of the laboratory and the healthcare professional or, where applicable, between the legal representative of the laboratory and the legal representative of the structure in which the healthcare professional works, sets out the applicable procedures.

When the test sample is taken outside the laboratory and in a health establishment to which the laboratory belongs, and the health professional who takes the sample does not belong to the laboratory but works in the health establishment, the applicable procedures are determined by the biologist in charge of the medical biology laboratory. The director of the establishment ensures that they are applied.

A biological sample must be taken in one of the areas determined in application of b of 2° of Article L. 1434-9 where the medical biology laboratory is located, unless an exception is made for public health reasons and under conditions determined by decree in the Conseil d’Etat.