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Rinsho Byori. 2010 Aug;58(8):839-46.

[Approach for prevention of medical test malpractice using ISO 15189].

[Article in Japanese]

Author information

  • 1Department of Clinical Laboratory and Laboratory Medicine, Kyushu University Hospital, Fukuoka 812-8582, Japan.


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.

[PubMed - indexed for MEDLINE]
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