Accreditation of medical laboratories in the European Union.
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.


CONCLUSIONS
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.
Huisman
Wim
W
Department of Clinical Chemistry, Medisch Centrum Haaglanden, The Hague, The Netherlands. w.huisman@mchaaglanden.nl
Horvath
A Rita
AR
Burnett
David
D
Blaton
Victor
V
Czikkely
Rózsa
R
Jansen
Rob T P
RT
Kallner
Anders
A
Kenny
Desmond
D
Mesko
Pika
P
Plebani
Mario
M
Queralto
José
J
Schumann
Gerhard
G
Sprongl
Ludek
L
Vitkus
Dalius
D
Wallinder
Hans
H
Zerah
Simone
S
D000068:Accreditation / Q000592:standards*; D005060:Europe; D007755:Laboratories, Hospital / Q000592:standards*; D011795:Surveys and Questionnaires