[Standardization of clinical laboratory testing in Japan]

In Japan, we have been engaged in the standardization of clinical laboratory testing for more than 30 years for the purposes of (1) development of reference materials, (2) development of external quality control system and validation. As a result, we have been able to control % CV of enzyme measurements such as AST, ALT, CK, LDH to less than 5-10% nationwide during the last 10 years. To streamline the standardization activities, we established a new standardization project in the Japanese Committee for Clinical Laboratory Standards (JCCLS) in 2004. The project consists of three subprojects as follows: (1) Working group 1 (WG1) for reference materials; (2) Working group 2 (WG2) for harmonization of nationwide laboratory data; (3) Working group 3 (WG3) for the database project for diagnoses. Through the JCCLS Standardization project, we expect to collaborate with the Joint Committee on Traceability in Laboratory Medicine (JCTLM) worldwide and achieve optimum standardization of laboratory testing in our nation.