Boursier Guilaine, Vukasovic Ines, Brguljan Pika Mesko, Lohmander Maria, Ghita Irina, Bernabeu Andreu Francisco A, Barrett Edward, Brugnoni Duilio, Kroupis Christos, Sprongl Ludek, Thelen Marc H M, Vanstapel Florent, Vodnik Tatjana, Huisman Willem, Vaubourdolle Michel
Clin Chem Lab Med. 2016 Apr;54(4):545-51. doi: 10.1515/cclm-2015-0780.
Accreditation is a valuable resource for medical laboratories. The development of quality systems based on ISO 15189 has taken place in many laboratories in the European countries but data about accreditation remain scarce. The EFLM Working Group "Accreditation and ISO/CEN standards" conducted a survey that reviews the current state of the accreditation process in European countries.
An on-line questionnaire was addressed to delegates of 39 EFLM scientific societies in March 2014. One answer by country was taken into account. The survey was dealing with mandatory status, number of accredited medical laboratories in each country, possibility of flexible scope and concerned medical fields. The status of point-of-care testing (POCT) in each country was also studied.
Twenty-nine responses (74%) were registered. All the assessed countries (100%) have begun an accreditation process in various ways. All the national accreditation bodies (NAB) offer or are working to offer an ISO 15189 accreditation. The accreditation process most often concerns all phases of the examination and various medical fields. Medical laboratories are responsible for POCT in 20 (69%) countries. The accreditation process for POCT, according to ISO 15189 and ISO 22870, is also developing.
While there are several variations in the approaches to accreditation of medical laboratories in the European countries, the ISO 15189 accreditation project has been widely accepted. The use of a unique standard and the cooperation among countries due to scientific societies, EFLM, accreditation bodies and EA enable laboratory professionals to move toward uniform implementation of the accreditation concept.
认可对医学实验室而言是一项宝贵资源。欧洲许多国家的众多实验室已基于ISO 15189制定了质量体系，但有关认可的数据仍然匮乏。欧洲临床实验室医学联合会（EFLM）“认可与ISO/CEN标准”工作组开展了一项调查，以审视欧洲国家认可程序的现状。
2014年3月向39个EFLM科学学会的代表发放了在线调查问卷。每个国家仅考虑一份回复。该调查涉及强制状态、各国认可的医学实验室数量、灵活范围的可能性以及相关医学领域。还研究了每个国家即时检验（POCT）的状况。
共收到29份回复（74%）。所有评估国家（100%）均已通过各种方式启动了认可程序。所有国家认可机构（NAB）均提供或正在努力提供ISO 15189认可。认可程序最常涉及检验的各个阶段及各种医学领域。20个国家（69%）的医学实验室负责POCT。按照ISO 15189和ISO 22870的POCT认可程序也在发展。
尽管欧洲国家医学实验室认可方法存在若干差异，但ISO 15189认可项目已被广泛接受。由于科学学会、EFLM、认可机构和欧洲认可合作组织（EA）的存在，采用统一标准以及各国之间的合作使实验室专业人员能够朝着认可概念的统一实施迈进。
