title: Accreditation of flow cytometry in Europe.
abstract: ISO 15189 has been introduced to enable any clinical laboratory, irrespective of geographic location, to be accredited against internationally recognized standards and therefore facilitate direct international comparison of laboratories. Together with increasing use of ISO 15189 for standardization and competition purposes, often triggered by demands of patients and clinicians, clinical flow cytometry laboratories are becoming increasingly challenged to introduce compliant quality management systems. Whilst in most countries, ISO 15189 accreditation is not yet compulsory, there is increasing evidence to suggest that the implementation of this standard is growing. As a result, the European Society of Clinical Cell Analysis (ESCCA) has analysed the impact of accreditation in clinical flow cytometry laboratories. It found, through a discussion forum, that staff qualification, adaptation of multicolour antibody panels, and implementation of a comprehensive quality system (including quality assessment) have been identified as major challenges.
authors.affiliation: Universität Leipzig, Medizinische Fakultät, Institut für Klinische Immunologie, Johannisallee 30, Leipzig 04103, Germany. sack@uni-leipzig.de
authors.forename: Ulrich
authors.initials: U
authors.lastname: Sack
authors.forename: David
authors.initials: D
authors.lastname: Barnett
authors.forename: Gulderen Yanikkaya
authors.initials: GY
authors.lastname: Demirel
authors.forename: Chantal
authors.initials: C
authors.lastname: Fossat
authors.forename: Stephan
authors.initials: S
authors.lastname: Fricke
authors.forename: Nikolitsa
authors.initials: N
authors.lastname: Kafassi
authors.forename: Thomas
authors.initials: T
authors.lastname: Nebe
authors.forename: Katherina
authors.initials: K
authors.lastname: Psarra
authors.forename: Jörg
authors.initials: J
authors.lastname: Steinmann
authors.forename: Claude
authors.initials: C
authors.lastname: Lambert
mesh_terms: D000068:Accreditation; D005060:Europe; D005434:Flow Cytometry / Q000592:standards*; D006801:Humans; D007755:Laboratories, Hospital / Q000592:standards*; D011786:Quality Control