Kayamori Yuzo, Fujishima Akiyoshi, Noda Nozomi, Kurihara Masako, Tsutsui Toshiharu, Mochimaru Tomomi, Ikematsu Yohko, Monji Nobuhisa, Ishigaki Takuya, Aoki Kanae, Ushinohama Sayaka, Nishioka Shoko, Egashira Sadaomi, Kang Dongchon
Department of Clinical Laboratory and Laboratory Medicine, Kyushu University Hospital, Fukuoka 812-8582, Japan.
Rinsho Byori. 2010 Aug;58(8):839-46.
With the increasing need for medical laboratory data, the importance of the medical laboratory in medical care has grown exponentially. Therefore, it is necessary that the medical laboratory provide the doctor and the patient receiving medical care with accurate, precise, and reliable medical laboratory data. Quality assurance and safety management in the medical laboratory are necessary to prevent medical test malpractice, which would lead to a medical accident, and to manage the overall processes required to provide high quality medical laboratory data. ISO 15189 is an international standard known as an organizational management tool for medical laboratories. Our medical laboratory acquired this ISO in March 2005 and we utilized PDCA cycle as required by the international standard in order to establish appropriate safety management and crisis control. We introduced practices for quality improvement and prevention of medical test malpractice proposed by the ISO committee of our medical laboratory and describe these practices in this report.
随着对医学检验数据需求的不断增加，医学实验室在医疗保健中的重要性呈指数级增长。因此，医学实验室有必要为医生和接受医疗护理的患者提供准确、精确和可靠的医学检验数据。医学实验室的质量保证和安全管理对于防止可能导致医疗事故的医学检验失误以及管理提供高质量医学检验数据所需的整体流程是必要的。ISO 15189是一项作为医学实验室组织管理工具的国际标准。我们的医学实验室于2005年3月获得了该ISO认证，并且我们按照国际标准的要求采用PDCA循环，以建立适当的安全管理和危机控制。我们引入了医学实验室ISO委员会提出的质量改进和预防医学检验失误的做法，并在本报告中对这些做法进行描述。
