L'accréditation des laboratoires d'ACP : pourquoi est-ce incontournable ?

The activity of pathology laboratories has been changed these last few years due to the evolution of clinical practices and improvement of different therapies. The onset of target therapies and immunotherapies has changed radically the management of tissue and cytological samples as well as those of the blood samples for diagnosis, prognosis and theragnosis to new molecules. In this context it is pivotal to optimize good practices in pathology laboratories in order to ensure high level of quality of care in close collaboration with the physicians. Since a couple of years, most of the industrial countries have implemented different accreditation initiatives in their pathology laboratories. However it is noteworthy that in France a very few pathology laboratories are currently accredited. The applicable standard to get an accreditation for a medical laboratory in France is the ISO 15189 norm. In France, this accreditation is issued by a notified body called the COFRAC according to the results of an audit. However if this norm is well appropriate to the practices of biology laboratories, it is more challenging for the practices of pathology laboratories. Yet it is essential for a pathology laboratory in France to be engaged in an accreditation process in order to meet the new standards of the clinical and molecular pathology and to remain competitive in Europe. The purpose of this review is to describe the main current and future challenges of the accreditation process for the pathology laboratories in France. The main constraints and potential weaknesses of the ISO 15189 norm for the accreditation of pathology laboratories will be addressed.