Rtp. Jansen et al., ADDITIONAL ESSENTIAL CRITERIA FOR QUALITY SYSTEMS OF MEDICAL LABORATORIES, CLINICAL CHEMISTRY AND LABORATORY MEDICINE, 36(4), 1998, pp. 249-252
Essential Criteria for Quality Systems of Medical Laboratories have be
en published recently by the European Community Confederation of Clini
cal Chemistry (EC4) Working Group on Harmonisation of Quality Systems
and Accreditation. The Essential Criteria address the majority of crit
ical aspects of quality management in the medical laboratory. They hav
e been accepted by the EC4 General Assembly and are endorsed by the Fo
rum of European Societies for Clinical Chemistry (FESCC). However, a s
upplement to the Essential Criteria was necessary, addressing two aspe
cts, which are only partly covered by the Essential Criteria: the mana
gement of resources and point of care testing. Thus, the EC4 Working G
roup on Harmonisation of Quality Systems and Accreditation has decided
to formulate Additional Essential Criteria for Quality Systems of Med
ical Laboratories, directed at the issues of management of resources a
nd point of care testing. Criteria on management of resources address
financial aspects, information logistics and acceptance by clients. Cr
iteria on point of care testing address responsibilities, education of
non-laboratory staff and operational aspects. The Additional Criteria
are supplementary to the previously published Essential Criteria and
should be read as an integral part of these.