title: [Quality Management System in Pathological Laboratory].
abstract: Even compared to other clinical laboratories, the pathological laboratory conducts troublesome work, and many of the work processes are also manual. Therefore, the introduction of the systematic management of administration is necessary. It will be a shortcut to use existing standards such as ISO 15189 for this purpose. There is no standard specialized for the pathological laboratory, but it is considered to be important to a pathological laboratory in particular. 1. Safety nianagement of the personnel and environmental conditions. Comply with laws and regulations concerning the handling of hazardous materials. 2. Pre-examination processes. The laboratory shall have documented procedures for the proper collection and handling of primary samples. Developed and documented criteria for acceptance or rejection of samples are applied. 3. Examination processes. Selection, verification, and validation of the examination procedures. Devise a system that can constantly monitor the traceability of the sample. 4. Post-examination processes. Storage, retention, and disposal of clinical samples. 5. Release of results. When examination results fall within established alert or critical intervals, immediately notify the physicians. The important point is to recognize the needs of the client and be aware that pathological diagnoses are always "the final diagnoses".
authors.forename: Junichi
authors.initials: J
authors.lastname: Koyatsu
authors.forename: Yoshihiko
authors.initials: Y
authors.lastname: Ueda
mesh_terms: D064790:Clinical Laboratory Services; D006801:Humans; D007753:Laboratories / Q000592:standards*; D010338:Pathology, Clinical / Q000592:standards*; D010808:Physical Examination / Q000592:standards*; D011786:Quality Control; D012449:Safety / Q000592:standards