title: Interest and limits of the six sigma methodology in medical laboratory.
abstract: The mandatory accreditation of clinical laboratories in France provides an incentive to develop real tools to measure performance management methods and to optimize the management of internal quality controls. Six sigma methodology is an approach commonly applied to software quality management and discussed in numerous publications. This paper discusses the primary factors that influence the sigma index (the choice of the total allowable error, the approach used to address bias) and compares the performance of different analyzers on the basis of the sigma index. Six sigma strategy can be applied to the policy management of internal quality control in a laboratory and demonstrates through a comparison of four analyzers that there is no single superior analyzer in clinical chemistry. Similar sigma results are obtained using approaches toward bias based on the EQAS or the IQC. The main difficulty in using the six sigma methodology lies in the absence of official guidelines for the definition of the total error acceptable. Despite this drawback, our comparison study suggests that difficulties with defined analytes do not vary with the analyzer used.
authors.affiliation: LBM BioRhone, Roussillon, France ; ProBioQual, Lyon, France.
authors.forename: Florian
authors.initials: F
authors.lastname: Scherrer
authors.affiliation: LBM LXBIO, Rodez, France.
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Bouilloux
authors.affiliation: LBM Canarelli Colonna Fernandez, Ajaccio, France.
authors.forename: Ors'Anton
authors.initials: O
authors.lastname: Calendini
authors.affiliation: LBM Isibio, Meximieux, France.
authors.forename: Didier
authors.initials: D
authors.lastname: Chamard
authors.affiliation: LBM Biomnis, Lyon, France.
authors.forename: François
authors.initials: F
authors.lastname: Cornu
mesh_terms: D000068:Accreditation / Q000379:methods*; D064790:Clinical Laboratory Services / Q000592:standards*; D005602:France; D019983:Guideline Adherence; D006757:Hospital Units; D006801:Humans; D007753:Laboratories / Q000592:standards*; D059021:Laboratory Proficiency Testing / Q000379:methods / Q000592:standards; D011785:Quality Assurance, Health Care / Q000379:methods*; D011786:Quality Control; D017749:Total Quality Management
keywords: accreditation; internal quality control; six sigma