title: [Development of Standards for Baseline Quality in Quality Management of Molecular-Diagnostic Testing].
abstract: As molecular-diagnostic testing is expanding in clinical use, the demand for its quality assurance is increasing. To this end, efforts towards quality management have been made regionally and globally. An entire testing procedure needs to be properly performed from the preanalytic, analytic, and postanalytic processes. Particularly, the preanalytic process largely affects the measurement and, thus, the result. The Japanese Committee for Clinical Laboratory and Standard developed the standard documents, such as that for the quality management of clinical specimens and best-practice guideline for quality assurance of molecular-genetic testing. These standard documents would provide not only the requirements as the best practice for testing, but also the basis of baseline quality and reliability. They can be used as the basis for assessment of the quality of practice in reimbursement coverage by payers and in certification or accreditation by a third party.
authors.forename: Hayato
authors.initials: H
authors.lastname: Miyachi
mesh_terms: D000818:Animals; D002568:Certification / Q000592:standards; D064790:Clinical Laboratory Services / Q000592:standards*; D006301:Health Services Needs and Demand / Q000592:standards*; D006801:Humans; D007564:Japan; D025202:Molecular Diagnostic Techniques / Q000592:standards*; D011786:Quality Control; D015203:Reproducibility of Results