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Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Ed. by Gillery, Philippe / Greaves, Ronda / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter


IMPACT FACTOR 2018: 3.638

CiteScore 2018: 2.44

SCImago Journal Rank (SJR) 2018: 1.191
Source Normalized Impact per Paper (SNIP) 2018: 1.205

Online
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1437-4331
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Volume 45, Issue 2

Issues

Accreditation of medical laboratories in the European Union

Wim Huisman / A. Rita Horvath / David Burnett / Victor Blaton / Rózsa Czikkely / Rob T.P. Jansen / Anders Kallner / Desmond Kenny
  • Department of Clinical Biochemistry, Our Lady's Hospital for Sick Children, Crumlin, Dublin, Ireland
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Pika Mesko
  • Department of Clinical Chemistry, University Clinic of Respiratory Diseases and Allergy, Golnik, Slovenia
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Mario Plebani / José Queralto / Gerhard Schumann / Luděk Šprongl / Dalius Vitkus
  • Department of Clinical Chemistry, University Hospital, Santariskiu Clinics, Vilnius, Lithuania
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Hans Wallinder / Simone Zerah

Abstract

Background: Using a questionnaire, the EC4 (European Communities Confederation of Clinical Chemistry and Laboratory Medicine) has collated an inventory of the accreditation procedures for medical laboratories in the EU.

Results and discussion: Accreditation of medical laboratories in the countries of the EU is mostly carried out in cooperation with national accreditation bodies. These national accreditation bodies work together in a regional cooperation, the European Cooperation for Accreditation (EA). Professionals are trained to become assessors and play a prominent role in the accreditation process. The extent of the training is diverse, but assessors are kept informed and up-to-date by annual meetings. The frequency of assessments and surveillance visits differs from country to country and ranges from 1 to 4 years. More harmonisation is needed in this respect, based on a frequency that can be pragmatically handled by laboratory professionals. In the majority of EA bodies, accreditation is carried out on a test-by-test basis. Many professionals would prefer accreditation of the entire service provided within the actual field of testing (i.e., haematology, immunology, etc.), with accreditation granted if the majority of tests offered within a service field fulfil the requirements of the ISO 15189 standard. The scope of accreditation is a major point of discussions between the EC4 Working Group on Accreditation and representatives of accreditation bodies in the EA Medical Laboratory Committee.

Clin Chem Lab Med 2007;45:268–75.

Keywords: accreditation; ISO standards; medical laboratory; quality

About the article

Corresponding author: Wim Huisman, Clinical Laboratory Medisch Centrum Haaglanden, Westeinde, P.O. Box 432, 2501 CK The Hague, The Netherlands Fax: +31-70-3303072


Published in Print: 2007-02-01


Citation Information: Clinical Chemical Laboratory Medicine, Volume 45, Issue 2, Pages 268–275, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/CCLM.2007.037.

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