French Public Health Code
In forceI. - When the analytical phase of a medical biology examination cannot be carried out in a medical biology laboratory within a timeframe compatible with the patient's state of health, it may be carried out :
1° Either in a health establishment or an element of the armed forces health service within the meaning of Article L. 6147-7 ;
2° Or, for reasons related to the patient's state of health, in categories of premises that meet the conditions determined by order of the Minister for Health, after receiving the opinion of the Haute Autorité de santé.
The conditions laid down in the first paragraph of this 2° guarantee the quality of the analytical phase of the examination and take into account the local supply of medical biology laboratories. The Director General of the Regional Health Agency shall draw up a list of places that meet these conditions.
The reading of the results required for the therapeutic decision is then carried out by the doctor. However, the medical biologist remains responsible for validating the results obtained.
The list of tests and the categories of healthcare professionals authorised to carry out the analytical phase outside a medical biology laboratory are set by order of the Minister for Health and, where applicable, the Minister for the Armed Forces.
II - When the analytical phase of the examination is not carried out either in a medical biology laboratory or in the health establishment to which this laboratory belongs, an agreement signed between the legal representative of the laboratory and the health professional or, where applicable, between the legal representative of the laboratory and the legal representative of the structure in which this health professional works sets out the applicable procedures.
When the analytical phase of the examination is carried out outside the laboratory and in a healthcare establishment to which the laboratory belongs and the healthcare professional who carries out this examination does not belong to the laboratory but works within the healthcare establishment, the places where the examination is carried out and 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.
