title: [Approach for prevention of medical test malpractice using ISO 15189].
abstract: 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.
authors.affiliation: Department of Clinical Laboratory and Laboratory Medicine, Kyushu University Hospital, Fukuoka 812-8582, Japan. kayamori@cclm.med.kyushu-u.ac.jp
authors.forename: Yuzo
authors.initials: Y
authors.lastname: Kayamori
authors.forename: Akiyoshi
authors.initials: A
authors.lastname: Fujishima
authors.forename: Nozomi
authors.initials: N
authors.lastname: Noda
authors.forename: Masako
authors.initials: M
authors.lastname: Kurihara
authors.forename: Toshiharu
authors.initials: T
authors.lastname: Tsutsui
authors.forename: Tomomi
authors.initials: T
authors.lastname: Mochimaru
authors.forename: Yohko
authors.initials: Y
authors.lastname: Ikematsu
authors.forename: Nobuhisa
authors.initials: N
authors.lastname: Monji
authors.forename: Takuya
authors.initials: T
authors.lastname: Ishigaki
authors.forename: Kanae
authors.initials: K
authors.lastname: Aoki
authors.forename: Sayaka
authors.initials: S
authors.lastname: Ushinohama
authors.forename: Shoko
authors.initials: S
authors.lastname: Nishioka
authors.forename: Sadaomi
authors.initials: S
authors.lastname: Egashira
authors.forename: Dongchon
authors.initials: D
authors.lastname: Kang
mesh_terms: D019411:Clinical Laboratory Techniques / Q000592:standards*; D006801:Humans; D019300:Medical Errors / Q000517:prevention & control*; D013677:Medical Laboratory Science / Q000592:standards*; D011785:Quality Assurance, Health Care; D011787:Quality of Health Care / Q000592:standards; D012308:Risk Management; D017751:Safety Management / Q000458:organization & administration / Q000592:standards*