2018 Volume 45 Issue 5 Pages 618-625
The quality management survey by the Japan Society of Health Evaluation and Promotion currently has approximately 360 registered facilities. A majority of the data has been assessed without any issues. However, on blood analysis, differences in quality control samples (quality control blood cells) have severely deterred the equal assessment of manufacturers and devices. Consequently, it has become necessary to use different quality control blood cells for each manufacturer. To resolve this issue, in conformance with the 3rd survey in 2016 and 2017, we requested all registered facilities to conduct measurements on a pilot basis, using novel quality control blood cells to demonstrate both a normal range and an abnormal range. Greater than 97% of registered facilities participated in both pilot trials. Some items for some manufacturers demonstrated a matrix effect, believed to have resulted from the measurement modality. Excluding these data and data suspected to have been input incorrectly, the coefficient of variance in all surveys of eight blood-cell related items was <10%, indicating that the data are accurate.