[Japanese sentinel project and contribution of laboratory medicine]

Ordinary passive surveillance (generally spontaneous reporting) of adverse effects of medical products is not enough to manage medical risks/safety. The Japanese government, following the "sentinel initiative" by the US government, started the "Japanese sentinel project" as an active surveillance of medical products with the Pharmaceuticals and Medical Devices Agency(PMDA). Using entire prescription data in the hospital information system, data on laboratory examinations, diagnosis, and therapy specific to an adverse effect are checked by detecting differences between before and after prescription of a specific medical product to extract adverse effects and calculate their correct frequency in the surveillance. The project uses standard masters and protocols to analyze data among medial institutes by installation of the SS-MIX standard storage system. Ten hospitals were selected in 2011 to join the project, and the entire system and network will be implemented in those hospitals and PMDA until 2013 fiscal year. JLAC10 is used in the project as the laboratory examination code of the Japanese Society of Laboratory Medicine. Many incorrect coding and ambiguous coding rules were found by voluntary surveillance of 6 of the 10 hospitals in the project. Thus, the Council on Standardized Master Operation of Clinical Laboratory Examinations will launch in 2013 to improve and maintain JLAC10, which is essential not only for the Japanese sentinel project but also for data utilization by many other projects.