European medical laboratory accreditation. Present situation and steps to harmonisation

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.