Book II: Medical biology

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the medical biology laboratory to continue certain activities for which its accreditation has been suspended or withdrawn, for a maximum period of three months, renewable once.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.

Without prejudice to Articles L. 1223-2 and L. 5313-1, the structures of the Etablissement Français du Sang which ensure the biological qualification of donations are subject to the provisions of this chapter in respect of activities likely to give rise to medical biology examinations.