Kayamori Yuzo, Takagi Yasushi
Department of Clinical Chemistry and Laboratory Medicine, Kyushu University Hospital, Fukuoka 812-8582, Japan.
Rinsho Byori. 2012 Jul;60(7):650-2.
Recently, transparency of the organization administration and patient-centered medical care such as patient service and satisfaction have been demanded in the medical field. The role of the clinical laboratory, one of the organizations in the medical field, is to provide quality laboratory data to improve diagnosis and treatment. Other than clinical laboratory facilities, education and the ability of staff to use it, the management of the organization must be appropriate to produce high quality laboratory data. International guidance on how to manage a laboratory is shown in ISO 15189. Clinical laboratories with ISO accreditation in Europe, Australia and Asia are increasing. On the other hand, only 60 institutions (10 national university hospitals, 4 public private university hospitals, 12 private hospitals and 34 referral laboratories) are accredited in Japan. Six speakers spoke at this symposium about the accreditation system of ISO 15189, the experiences of the acquiring institution and the effect of acquisition, as well as the future prospects of ISO 15189. This was a good opportunity to become informed about the current situation of ISO 15189 in Japan and internationally.
最近，医疗领域对组织管理的透明度以及以患者为中心的医疗服务（如患者服务和满意度）提出了要求。临床实验室作为医疗领域的机构之一，其作用是提供高质量的实验室数据以改善诊断和治疗。除了临床实验室设施、教育以及工作人员使用这些设施的能力之外，组织的管理必须得当，才能产生高质量的实验室数据。ISO 15189展示了关于如何管理实验室的国际指南。在欧洲、澳大利亚和亚洲，获得ISO认证的临床实验室正在增加。另一方面，在日本，只有60家机构（10所国立大学医院、4所公立私立大学医院、12所私立医院和34所转诊实验室）获得了认证。六位演讲者在本次研讨会上谈到了ISO 15189的认证体系、获证机构的经验和获证效果，以及ISO 15189的未来前景。这是一个了解ISO 15189在日本和国际上现状的好机会。
