Abstract
Accreditation of medical laboratories in Europe is primarily according to ISO15189. The percentage of accredited laboratories is still small. The time spent on an assessment is quite different between countries. More important is the way the assessment process is carried out. Harmonisation in accrediting medical laboratories is the main task of the Health Care Committee within EA (European cooperation of Accreditation). The EFCC Working Group on Accreditation strongly contributes as the representative of laboratory professionals. An important item is the use of flexible scope. The intention is that all tests within a medical discipline are offered for accreditation. This is not yet normal practice. Other items concern accreditation of point-of-care testing (POCT) – reliability of the pre-analytical phase, when the phlebotomy is not done by the laboratory, and practical use of uncertainty and verification. Also the diversity in time spent for an assessment is discussed. The added value of accreditation is strongly dependent upon the assessors who have an important task. Their training and calibration needs continuous input. The medical laboratory professionals should participate in all aspects concerning the quality system, starting with the standard, working on the guidelines, the assessment itself, and input in the accreditation bodies.
About the author
Wim Huisman received his PhD in Biochemistry in 1974 and was registered as a Clinical Biochemist in 1982. He has worked in the laboratory of Clinical Chemistry and Hematology of the Medical Centre Haaglanden in The Hague, The Netherlands since 1982 and has been head from 1997 to 2011. He served his society as secretary from 1987 to 1993 and as chair of their Quality Committee from 1989 to 2002. He is a member of the WG on Accreditation of EC4 later EFCC since 1993 and has chaired it since 2002. He is a technical assessor for ISO15189 and a member of the Accreditation Committee of RvA (Netherland Accreditation Body) and a member of the Health Care Committee of EA. He is a member of the Subcommittee on Quality Management of CLSI and a member of WG 1 of ISO TC212.
©2012 by Walter de Gruyter Berlin Boston
