Okada Ken, Itoshima Kouichi, Watanabe Toshiyuki, Koide Norio
Division of Medical Support, Okayama University Hospital, Okayama 700-8558, Japan.
Rinsho Byori. 2009 Oct;57(10):971-7.
The evaluation of medical laboratories by a third person has recently become popular in Japan. Establishing a quality management system, putting it into practice, and maintaining and improving it are considered to achieve the standardization, efficacy improvement, and safety management of laboratory activities. The Departments of Clinical Laboratory and Blood Transfusion, Okayama University Hospital was awarded ISO15189 accreditation on July 6, 2007. In this paper, we describe the process of ISO15189 accreditation in our institute. As an outcome of ISO accreditation, the frequency of laboratory incidents was reduced through seeking the causes of incidents and performing continual improvement according to ISO 15189: "Plan, Do, Check, Action". Additionally the motivation and competence of laboratory staff concerned have also improved, consequently leading to a favorable influence on other laboratory staff members. Therefore, we conclude that ISO15189 is an effective tool for medical laboratory management.
最近，由第三方对医学实验室进行评估在日本开始流行起来。建立质量管理体系、付诸实践并维持和改进该体系，被认为能够实现实验室活动的标准化、效能提升以及安全管理。冈山大学医院临床检验与输血科于2007年7月6日获得了ISO15189认可。在本文中，我们描述了我院获得ISO15189认可的过程。作为ISO认可的成果，通过查找事故原因并依据ISO 15189：“计划、执行、检查、行动”进行持续改进，实验室事故的发生率降低了。此外，相关实验室工作人员的积极性和能力也有所提高，从而对其他实验室工作人员产生了积极影响。因此，我们得出结论，ISO15189是医学实验室管理的有效工具。
