Avtor/Urednik     Huisman, Wim; Horvath, A Rita; Burnett, David; Blaton, Victor; Czikkely, Rózsa; Jansen, Rob T P; Kallner, Anders; Kenny, Desmond; Meško, Pika; Plebani, Mario; Queralto, José; Schumann, Gerhard; Sprongl, Ludek; Vitkus, Dalius; Wallinder, Hans; Zerah, Simone
Naslov     Accreditation of medical laboratories in the European Union
Tip     članek
Vir     Clin Chem Lab Med
Vol. in št.     Letnik 45, št. 2
Leto izdaje     2007
Obseg     str. 268-75
Jezik     eng
Abstrakt     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. Results and discussion: 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. Clin Chem Lab Med 2007;45:268-75.
Deskriptorji     ACCREDITATION
QUALITY CONTROL
LABORATORIES, HOSPITAL
EUROPE