Chapter I: Accreditation and quality control

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….

A medical biology laboratory established in another Member State of the European Union or party to the Agreement on the European Economic Area may carry out the analytical phase of a medical biology examination begun in France, for insured persons covered by a French social security scheme, under the following conditions : 1° Where the laboratory is established in a Member State or Party whose accreditation conditions have previously been…

When carrying out accreditation tasks on behalf of the national accreditation body, a doctor, pharmacist or other health professional may only be brought before the disciplinary court of the association to which he belongs by the Minister for Health, the public prosecutor or the director general of the regional health agency.

The national accreditation body immediately sends the Haute Autorité de santé, the Agence nationale de sécurité du médicament et des produits de santé, the Agence de la biomédecine and the regional health agency any decisions to accredit, suspend or withdraw the accreditation of medical biology laboratories.

Without prejudice to the provisions of Articles L. 1221-13, L. 5212-1, L. 5222-3 and L. 5232-4, the biologist in charge of the medical biology laboratory shall immediately declare to the bodies mentioned in Article L. 6221-6 any event affecting its operation and likely to result in a major risk to patients’ health.

In response to emergency situations or a serious shortage of local supply, the Director General of the Regional Health Agency may authorise the medical biology laboratory to continue certain activities for which its accreditation has been suspended or withdrawn, for a maximum period of three months, renewable once. Its decision shall state the reasons on which it is based. The medical biology laboratory shall inform patients and medical biology laboratories…

A medical biology laboratory shall have the quality of the results of the medical biology examinations it carries out checked by external quality assessment bodies. The external quality assessment bodies send the French National Agency for the Safety of Medicines and Health Products an annual report, the content of which is determined by order of the Minister for Health, issued on a proposal from the Director General of the French…

The Agence Française de Sécurité Sanitaire des Produits de Santé (French Health Products Safety Agency) carries out national quality control of medical biology test results, the procedures for which are laid down by decree, which in particular determines the categories of medical biology tests subject to this control.