Section 2: Quality control

I.-Medical biology laboratories shall submit each analytical system they use to an external quality assessment. II.-Each external quality assessment body for medical biology examinations mentioned in Article L. 6221-9 carries out an inter-laboratory comparison of the results obtained and a comparison of results between groups of laboratories using the same techniques. The body also periodically compares the results of each medical biology laboratory with the result obtained by the reference…

I.-The external quality assessment bodies referred to in article L. 6221-9 must meet the following criteria: 1° Competence, in terms of qualifications and experience, to organise quality control campaigns; 2° Independence from manufacturers of in vitro diagnostic medical devices and medical biology laboratories. The conditions of this independence are defined by order of the Minister for Health, after obtaining the opinion of the Director General of the Agence nationale de…

External quality assessment bodies use a coding system to identify the techniques used in the analytical phase of each examination. Where quality control of a medical biology examination is carried out by more than one body, these bodies use a common coding system. The Agence nationale de sécurité du médicament et des produits de santé coordinates the production and updating of this coding. An order of the Minister for Health…

I.-The Director General of the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products) determines an annual programme of controls carried out by the Agency, in the light of the annual reports referred to in Article L. 6221-9 which are sent to it by the external quality assessment bodies. This programme is communicated to the Minister for…