Abstract
Quality in health care is an increasingly important issue. There will be a growing demand for demonstrable quality. In laboratory medicine this issue has been recognised and the subject of accreditation has become a main topic in medical laboratories.
The development of the European Union reinforces the need for harmonisation of services in general and health services in particular. Also the harmonisation of medical laboratory service is important in this respect. The European Communities Confederation of Clinical Chemistry (EC4) tries to co-ordinate this process via harmonisation of the profession and harmonisation of laboratory service. Harmonisation of the profession is reached via the European Register of Clinical Chemists, which harmonises training and postgraduate education of applicants.
Harmonisation of laboratory services is aimed at by defining criteria for quality systems and accreditation. Therefore EC4 has defined Essential Criteria for Quality Systems of Medical Laboratories.
The ISO and CEN standards for accreditation of testing and calibration laboratories (ISO guide 25 and EN 45000), and for certification of companies in general (ISO 9000), are considered insufficient and not adequate for medical laboratories.
Particularly criteria for the pre- and post-analytical process, for consultation, management of resources and for point of care testing are not addressed in these ISO and CEN documents. Such criteria are extensively formulated in the EC4 Essential Criteria. It is important that there is influence from the profession in the development of international standards. The EC4 Essential Criteria have had a major influence on the development of a new Draft International Standard ISO/CD 15189 “Quality Management in the Medical Laboratory”. This standard is adequate for medical laboratories. However, since it is difficult to read, the EC4 Essential Criteria may serve as a guideline to the standard. Many European countries are setting up accreditation systems for medical laboratories. (
Accreditation in the European Union
In the view of EC4 such systems should bear a strong impuls from the profession and also cooperate with a European co-operation for accreditation (EA) related notified body. The influence of the profession is important also for the selection of the right criteria used for accreditation and the set up of the quality systems. Standards and criteria that are or will be used in operating systems are summarized in
Standards used in accreditation of medical laboratories
Medical laboratories that have implemented a quality system according to the new ISO standard and/or the Essential Criteria, are ready for accreditation. EC4 tries to facilitate the installation of an European Committee on Accreditation of Medical Laboratories, preferably within the European cooperation for Accreditation (EA). This EA committee should use ISO 15189 as Standard, while guidelines should be made by the professions, nationally and internationally, like the EC4 Criteria. For an adequate harmonisation process, European bodies of medical laboratory specialists should work together more closely than is the case now.