Yoshiko Kenichi
Department of Clinical Laboratory, Nagoya University Hospital, Nagoya 466-8560, Japan.
Rinsho Byori. 2012 Jul;60(7):667-73.
The Department of Clinical Laboratory, Nagoya University Hospital acquired ISO 15189 accreditation in November, 2009. The operation of our Quality Management System (QMS) was first surveyed in October, 2010. In this paper, we reported the activity for the preparation and operation of our QMS and the effects of ISO 15189 accreditation. We investigated the changes in the number and content on nonconformities, incident reports and complaints before and after accreditation as indicators to evaluate the effect of ISO 15189 accreditation. Post accreditation, the number of nonconformities and incident reports decreased, seeming to show an improvement of quality of the laboratory activity; however, the number of complaints increased. We identified the increase of complaints at the phlebotomy station. There had been some problems with blood sampling in the past, but it seemed that staff had a high level of concern regarding these problems at the phlebotomy station and took appropriate measures to resolve the complaints. We confirmed that the ISO 15189 accreditation was instrumental in the improvements of the safety and efficiency on laboratory works. However there was a problem that increase of overtime works to operate the QMS. We deal with development of a laboratory management system using IT recourses to solve the problem.
名古屋大学医院临床检验部于2009年11月获得了ISO 15189认可。我们质量管理体系（QMS）的运行于2010年10月首次接受审查。在本文中，我们报告了QMS的准备和运行活动以及ISO 15189认可的效果。我们调查了认可前后不符合项、事件报告和投诉的数量及内容变化，以此作为评估ISO 15189认可效果的指标。认可后，不符合项和事件报告的数量减少，似乎表明实验室活动质量有所提高；然而，投诉数量增加了。我们确定采血站的投诉有所增加。过去在采血方面存在一些问题，但似乎采血站的工作人员对这些问题高度关注，并采取了适当措施来解决投诉。我们确认ISO 15189认可有助于提高实验室工作的安全性和效率。然而，存在一个问题，即运行QMS导致加班工作增加。我们正在利用信息技术资源开发实验室管理系统来解决这个问题。
