title: [Medical safety management in the setting of a clinical reference laboratory--risk management efforts in clinical testing].
abstract: As a result of recurring medical accidents, risk management in the medical setting has been given much attention. The announcement in August, 2000 by the Ministry of Health committee for formulating a standard manual for risk management, of a "Risk management manual formulation guideline" has since been accompanied by the efforts of numerous medical testing facilities to develop such documents. In 2008, ISO/TS 22367:2008 on "Medical laboratories-Reduction of error through risk management and continual improvement" was published. However, at present, risk management within a medical testing facility stresses the implementation of provisional actions in response to a problem after it has occurred. Risk management is basically a planned process and includes "corrective actions" as well as "preventive actions." A corrective action is defined as identifying the root cause of the problem and removing it, and is conducted to prevent the problem from recurring. A preventive action is defined as identifying of the any potential problem and removing it, and is conducted to prevent a problem before it occurs. Presently, I shall report on the experiences of our laboratory regarding corrective and preventive actions taken in response to accidents and incidents, respectively.
authors.affiliation: Health Sciences Research Institute, Inc., Yokohama 240-0008, Japan. seki@hkk.co.jp
authors.forename: Akira
authors.initials: A
authors.lastname: Seki
authors.forename: Tetsumasa
authors.initials: T
authors.lastname: Miya
mesh_terms: D019411:Clinical Laboratory Techniques; D006801:Humans; D010338:Pathology, Clinical; D012308:Risk Management; D017751:Safety Management