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.
The provisions of Articles L. 6211-14 to L. 6211-16 do not apply to samples taken within the armed forces health service when the analytical phase of the medical biology examination is carried out in a medical biology laboratory under the authority of the Minister of Defence. When the test sample is taken within the armed forces health service outside a laboratory under the authority of the Minister of Defence by…
For medical biology laboratories under the authority of the Minister for Defence, the provisions of Articles L. 6211-10, L. 6211-19 and L. 6212-3 are applicable only to laboratories on the list provided for in II of Article L. 6147-7. The authorisation provided for in the third paragraph of I of Article L. 6211-19 is granted, for laboratories under the authority of the Minister for Defence: 1° By decision of this…
For medical biology laboratories under the authority of the Minister for Defence, the information provided for in Article L. 6213-11 shall be sent to this Minister, who shall take the appropriate measures. For laboratories on the list provided for in Article L. 6147-7, the Minister for Defence shall inform the Director of the Regional Health Agency of the reports made and the measures taken.
A medical biology laboratory may not carry out medical biology examinations without accreditation. Accreditation shall cover all the medical biology activities carried out by the laboratory, taking into account the three phases of the examination defined in Article L. 6211-2, and in accordance with the procedures laid down by order of the Minister for Health. Accreditation also covers, where the laboratory carries out these activities: 1° Biological activities relating to…
I. – The accreditation of a medical biology laboratory is granted, at its request, by the national accreditation body provided for in I of Article 137 of Law No. 2008-776 of 4 August 2008 on the modernisation of the economy, when it meets the criteria defined by the harmonised standards in force applicable to medical biology laboratories, the references of which are set by an order of the ministers responsible…
A medical biology laboratory established in another Member State of the European Union or party to the Agreement on the European Economic Area may open a site in France if : 1° The laboratory is accredited by the competent body of the Member State in which it is established; 2° Or the activity linked to this site is covered by an accreditation issued under the conditions mentioned in Article L….
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