title: [Standardization of clinical laboratory data in Japan by the JAMT and JCCLS].
abstract: For clinical laboratory data to be utilized in the diagnosis and prevention of diseases, their reliability must be verified. However, the results of many external quality assessments show that the reliabilities of measurement values are not always satisfactory. Thus, the Japanese Association of Medical Technologists (JAMT) and the Japanese Committee for Clinical Laboratory Standards (JCCLS) have been making joint efforts to promote the standardization of clinical laboratory tests in order to obtain highly reliable test results whenever and wherever tests are conducted. So far, the patchwork method has been used to accomplish this, by which standardization activities in regional units are connected by a network to achieve wide-area standardization. The network for sharing clinical laboratory data was reconstructed under the leadership of the JAMT, to usher in a new system aimed at nationwide standardization for 32 blood constituents. The new network encompassed 43 of 47 prefectural Associations of Medical Technologists, and 147 core laboratories that play a central role in regional standardization are promoting the activities to ensure the reliability of laboratory data in cooperation with the JAMT. To ensure the reliability of routine test data in all laboratories across Japan, it is necessary for the clinical laboratory data to be consistent with the traceability chain for each constituent, and the values be transferred from that measurement system appropriately. To achieve this system-based consistency, each core laboratory should verify the accuracy of test data using JCCLS-certified reference materials, and carry out calibration as necessary. The clinical laboratories in that region verify the accuracy of test data using pooled sera, which are inexpensive, with minimal matrix effects, and are easy to handle, by the transfer of data between that laboratory and the core laboratory, with verified accuracy. The measurement values standardized using reference materials and pooled sera are used to guarantee long-term reliability. The nationwide standardization of measurement data by the utilization of reference materials will enable us to ensure the widespread and long-term reliability of clinical laboratory data, and contribute to health care policy aimed at the prevention of lifestyle-related diseases by targeting metabolic syndrome.
authors.affiliation: Kagawa Prefectural College of Health Sciences, Takamatsu 761-0123, Japan. hosogaya@chs.pref.kagawa.jp
authors.forename: Shigemi
authors.initials: S
authors.lastname: Hosogaya
mesh_terms: D026683:Advisory Committees; D019411:Clinical Laboratory Techniques / Q000592:standards*; D007564:Japan; D015588:Observer Variation; D010338:Pathology, Clinical / Q000458:organization & administration* / Q000592:standards*; D012015:Reference Standards; D015203:Reproducibility of Results; D012958:Societies, Scientific / Q000458:organization & administration*