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Quality specifications for evaluation and comparison of performance among external quality assessment schemes in occupational and environmental laboratory medicine
Authors:Andrew Taylor  Jurgen Angerer  Josiane Arnaud  Françoise Claeys  Robert L. Jones  Olav Mazarrasa  Eric Mairiaux  Antonio Menditto  Patrick J. Parsons  Marina Patriarca  Alain Pineau  Sinikka Valkonen  Jean-Philippe Weber  Cas Weykamp
Affiliation:(1) Centre for Clinical Science and Measurement, School of Biomedical and Molecular Sciences, University of Surrey, Guildford, GU2 7XH, UK;(2) Institute of Occupational, Social and Environmental Medicine, University of Erlangen-Nuernberg, 91054 Erlangen, Germany;(3) Département de Biologie Intégrée (DBI)-CHU de Grenoble, BP 217 38043, Grenoble Cedex 9, France;(4) Unit of Epidemiology, Scientific Institute of Public Health, 1050 Brussels, Belgium;(5) Nutritional Biochemistry, Division of Laboratory Sciences, National Center for Environmental Health, CDC, Atlanta, GA 30341-3724, USA;(6) Laboratorio de Higiene Industrial, Centro de Seguridad y Salud en el Trabajo, Gobierno de Cantabria, 39012 Santander, Spain;(7) Department of Food Safety and Veterinary Public Health, Istituto Superiore di Sanità, 00161 Rome, Italy;(8) New York State Department of Health, Wadsworth Center Laboratories, PO Box 509, Albany, NY 12201-0509, USA;(9) Laboratoire de Toxicologie, UFR de Pharmacie, Université de Nantes, 44035 Nantes, France;(10) Biomonitoring Laboratory, Department of Toxicology and Industrial Hygiene, Finnish Institute of Occupational Health, 00250 Helsinki, Finland;(11) Centre de Toxicologie, Institut National de Santé Publique du Québec, 945 Wolfe Avenue, Québec, Canada, G1V 5B3;(12) MCA Laboratory, Queen Beatrix Hospital, 7101 BN, Winterswijk, The Netherlands
Abstract:Quality specifications (QS) are proposed for lead in blood and for aluminium, copper, selenium and zinc in serum as part of the aim to set standards of performance for laboratories so that results can be demonstrated to be fit for the purpose to which they are applied. The QS were established taking account of the analytical state-of-the-art, physiological variations in the concentrations of the analyte and the clinical purpose for which the assay is to be used. A procedure was devised that uses these QS to give equivalence of assessment among external quality assessment schemes (EQAS), thus avoiding conflicting information which has been demonstrated in the past. Advantages of this procedure are: to provide direct comparison of performance of laboratories taking part in different schemes, to provide equivalence of assessment of laboratory performance necessary to establish mutual recognition agreements, and to demonstrate the fitness for purpose of results from participants.Presented at the Eurachem PT Workshop September 2005, Portorož, Slovenia
Keywords:Quality specifications  Occupational and environmental laboratory medicine  Z-score  Equivalence of performance assessment  Fitness-for-purpose
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