title: [The accreditation of a surgical pathology and somatic genetic laboratory (LPCE, CHU of Nice) according to the ISO 15189 norm: Sharing of experience].
abstract: Accreditation is going to be vital and unavoidable in the medium term for medical biology laboratories in France. This accreditation will certainly condition the authorization to conduct biological testing in the health care system. All the biological specialities are now affected by this procedure, including the somatic genetics. The anatomo-pathology, which is a medical speciality in France, may be also concerned by the accreditation. However, the nature and the practices of this specialty increase the complexity of this approach to be implemented according to the standard requested by the authorities, i.e. the ISO 15189 normative standard (standard on "specific requirements for quality and competence for medical biology analysis laboratories"). The present article recounts the experience of a hospital laboratory (LPCE, Nice University Hospital) composed of a surgical pathology and a somatic genetics unit: (1) in the accreditation process according to the ISO 15189 standard, (2) at the time of the audit made by the team of "COFRAC" evaluators, and, (3) in evaluating the strategy implemented following the audit.
authors: Laboratoire de pathologie clinique et expérimentale (LPCE), hôpital Pasteur, CHU, BP 69, 06002 Nice, France; Tumorothèque, centre de ressources biologiques, hôpital Pasteur, 06002 Nice, France.
authors: Kevin
authors: K
authors: Washetine
authors: Laboratoire de pathologie clinique et expérimentale (LPCE), hôpital Pasteur, CHU, BP 69, 06002 Nice, France.
authors: Elodie
authors: E
authors: Long
authors: Laboratoire de pathologie clinique et expérimentale (LPCE), hôpital Pasteur, CHU, BP 69, 06002 Nice, France; Tumorothèque, centre de ressources biologiques, hôpital Pasteur, 06002 Nice, France.
authors: Véronique
authors: V
authors: Hofman
authors: Laboratoire de pathologie clinique et expérimentale (LPCE), hôpital Pasteur, CHU, BP 69, 06002 Nice, France.
authors: Sandra
authors: S
authors: Lassalle
authors: Laboratoire de pathologie clinique et expérimentale (LPCE), hôpital Pasteur, CHU, BP 69, 06002 Nice, France.
authors: Marius
authors: M
authors: Ilie
authors: Laboratoire de pathologie clinique et expérimentale (LPCE), hôpital Pasteur, CHU, BP 69, 06002 Nice, France.
authors: Virgine
authors: V
authors: Lespinet
authors: Tumorothèque, centre de ressources biologiques, hôpital Pasteur, 06002 Nice, France.
authors: Christelle
authors: C
authors: Bonnetaud
authors: Tumorothèque, centre de ressources biologiques, hôpital Pasteur, 06002 Nice, France.
authors: Olivier
authors: O
authors: Bordone
authors: Tumorothèque, centre de ressources biologiques, hôpital Pasteur, 06002 Nice, France.
authors: Virginie
authors: V
authors: Gavric-Tanga
authors: Tumorothèque, centre de ressources biologiques, hôpital Pasteur, 06002 Nice, France.
authors: Eric
authors: E
authors: Selva
authors: Laboratoire de pathologie clinique et expérimentale (LPCE), hôpital Pasteur, CHU, BP 69, 06002 Nice, France.
authors: Julie
authors: J
authors: Reverso-Meinietti
authors: Laboratoire de pathologie clinique et expérimentale (LPCE), hôpital Pasteur, CHU, BP 69, 06002 Nice, France.
authors: Dominique
authors: D
authors: Sadoulet
authors: Laboratoire de pathologie clinique et expérimentale (LPCE), hôpital Pasteur, CHU, BP 69, 06002 Nice, France.
authors: Laurence
authors: L
authors: Lacour
authors: Laboratoire de pathologie clinique et expérimentale (LPCE), hôpital Pasteur, CHU, BP 69, 06002 Nice, France.
authors: Yvonne
authors: Y
authors: Bille
authors: Laboratoire de pathologie clinique et expérimentale (LPCE), hôpital Pasteur, CHU, BP 69, 06002 Nice, France.
authors: Richard
authors: R
authors: Lavagna
authors: Laboratoire de pathologie clinique et expérimentale (LPCE), hôpital Pasteur, CHU, BP 69, 06002 Nice, France.
authors: Pascal
authors: P
authors: Grier
authors: Laboratoire de pathologie clinique et expérimentale (LPCE), hôpital Pasteur, CHU, BP 69, 06002 Nice, France.
authors: Katia
authors: K
authors: Zahaf
authors: Laboratoire de pathologie clinique et expérimentale (LPCE), hôpital Pasteur, CHU, BP 69, 06002 Nice, France.
authors: Mireille
authors: M
authors: Mari
authors: Laboratoire de pathologie clinique et expérimentale (LPCE), hôpital Pasteur, CHU, BP 69, 06002 Nice, France; Tumorothèque, centre de ressources biologiques, hôpital Pasteur, 06002 Nice, France. Electronic address: hofman.p@chu-nice.fr.
authors: Paul
authors: P
authors: Hofman
mesh_terms: D000068:Accreditation / Q000331:legislation & jurisprudence / Q000458:organization & administration*; D057189:Checklist; D005602:France; D005826:Genetics, Medical / Q000458:organization & administration / Q000592:standards*; D006785:Hospitals, University / Q000458:organization & administration / Q000592:standards; D007755:Laboratories, Hospital / Q000592:standards*; D008485:Medical Audit; D010340:Pathology, Surgical / Q000458:organization & administration / Q000592:standards*; D058996:Quality Improvement
keywords: Accreditation; Accréditation; Anatomo-pathologie; COFRAC; Génétique somatique; ISO 15189 norm; Norme NF EN ISO 15189; Pathology; Somatic genetics