title: [Accreditation of the activity of molecular pathology according to ISO 15189: key steps to follow and the main potential pitfalls].
abstract: The quick emerging of the several targeted therapies and the concept of personnalized medicine underlie the necessity to develop and to well organize a molecular biology (or molecular pathology) unit of high quality, dedicated to clinical care, in order to look for tissular and cellular theragnosis biomarkers. This new and sudden area of activity for a clinical pathologist is strongly linked to the knowledge of a new medical speciality in health care institutions. Thus, the molecular pathology (or molecular biology made from cellular or tissular samples) can nicely be implemented in a clinical pathology laboratory. This new mission for a pathologist has to be done in respect with a great quality assurance which should allow obtaining in a short-term an ISO 15189 accreditation to keep going to perform this activity. The present work aims to describe the main steps to be set up in the order to get an ISO 15189 accreditation in molecular pathology. The different chapters of this norm will not be described in their exhaustivity, but in their large lines. Finally, we will describe the potential difficulties and pitfalls to be avoided before getting this accreditation.
authors.affiliation: Laboratoire de pathologie clinique et expérimentale (LPCE), hôpital Pasteur, CHU, BP 69, 06002 Nice, France.
authors.forename: Elodie
authors.initials: E
authors.lastname: Long
authors.forename: Véronique
authors.initials: V
authors.lastname: Hofman
authors.forename: Marius
authors.initials: M
authors.lastname: Ilie
authors.forename: Kevin
authors.initials: K
authors.lastname: Washetine
authors.forename: Virgine
authors.initials: V
authors.lastname: Lespinet
authors.forename: Christelle
authors.initials: C
authors.lastname: Bonnetaud
authors.forename: Olivier
authors.initials: O
authors.lastname: Bordone
authors.forename: Virginie
authors.initials: V
authors.lastname: Gavric-Tanga
authors.forename: Marie Clotilde
authors.initials: MC
authors.lastname: Gaziello
authors.forename: Sandra
authors.initials: S
authors.lastname: Lassalle
authors.forename: Eric
authors.initials: E
authors.lastname: Selva
authors.forename: Katia
authors.initials: K
authors.lastname: Zahaf
authors.forename: Aude
authors.initials: A
authors.lastname: Lamy
authors.forename: Jean-Christophe
authors.initials: JC
authors.lastname: Sabourin
authors.forename: Paul
authors.initials: P
authors.lastname: Hofman
mesh_terms: D000068:Accreditation / Q000592:standards*; D005602:France; D017408:Guidelines as Topic; D006801:Humans; D057089:Pathology, Molecular / Q000592:standards*