Huisman Wim, Horvath A Rita, Burnett David, Blaton Victor, Czikkely Rózsa, Jansen Rob T P, Kallner Anders, Kenny Desmond, Mesko Pika, Plebani Mario, Queralto José, Schumann Gerhard, Sprongl Ludek, Vitkus Dalius, Wallinder Hans, Zerah Simone
Department of Clinical Chemistry, Medisch Centrum Haaglanden, The Hague, The Netherlands.
Clin Chem Lab Med. 2007;45(2):268-75. doi: 10.1515/CCLM.2007.037.
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.
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.
欧洲临床化学与检验医学共同体联盟（EC4）通过问卷调查，整理了欧盟医学实验室认可程序的清单。
欧盟国家的医学实验室认可大多是与国家认可机构合作进行的。这些国家认可机构在区域合作——欧洲认可合作组织（EA）中共同协作。专业人员接受培训成为评审员，并在认可过程中发挥重要作用。培训程度各不相同，但评审员通过年度会议了解最新信息。评估和监督访问的频率因国家而异，从1年到4年不等。基于实验室专业人员能够切实应对的频率，在这方面需要更多的协调统一。在大多数EA机构中，认可是逐测试进行的。许多专业人员更倾向于对实际检测领域内提供的整个服务进行认可（即血液学、免疫学等），如果一个服务领域内提供的大多数检测符合ISO 15189标准的要求，就给予认可。认可范围是EC4认可工作组与EA医学实验室委员会认可机构代表之间讨论的一个主要议题。
