Medical Centre Haaglanden, Department of Clinical Chemistry, Den Haag, The Netherlands.
Clin Chem Lab Med. 2012 Jul;50(7):1147-52. doi: 10.1515/cclm-2011-0586.
Accreditation of medical laboratories in Europe is primarily according to ISO15189. The percentage of accredited laboratories is still small. The time spent on an assessment is quite different between countries. More important is the way the assessment process is carried out. Harmonisation in accrediting medical laboratories is the main task of the Health Care Committee within EA (European cooperation of Accreditation). The EFCC Working Group on Accreditation strongly contributes as the representative of laboratory professionals. An important item is the use of flexible scope. The intention is that all tests within a medical discipline are offered for accreditation. This is not yet normal practice. Other items concern accreditation of point-of-care testing (POCT) - reliability of the pre-analytical phase, when the phlebotomy is not done by the laboratory, and practical use of uncertainty and verification. Also the diversity in time spent for an assessment is discussed. The added value of accreditation is strongly dependent upon the assessors who have an important task. Their training and calibration needs continuous input. The medical laboratory professionals should participate in all aspects concerning the quality system, starting with the standard, working on the guidelines, the assessment itself, and input in the accreditation bodies.
欧洲的医学实验室认可主要依据 ISO15189。认可实验室的比例仍然很小。评估所花费的时间在不同国家之间有很大差异。更重要的是评估过程的执行方式。在医疗保健委员会内，协调医学实验室的认可工作是 EA（欧洲认可合作组织）的主要任务。EFCC 认证工作组作为实验室专业人员的代表做出了重要贡献。一个重要项目是使用灵活的范围。目的是为所有医学学科的所有测试提供认证。但这还不是常规做法。其他项目还涉及即时护理检测 (POCT) 的认证——分析前阶段的可靠性，当采血不是由实验室进行时，以及对不确定性和验证的实际使用。还讨论了评估所花费时间的多样性。认证的附加值在很大程度上取决于评估员，他们承担着重要的任务。他们的培训和校准需要不断的投入。医学实验室专业人员应参与与质量体系有关的所有方面，从标准开始，遵循指南，进行评估本身，并为认证机构提供投入。
