Comparison of Six Sigma theory applied to two biochemical detection systems
SONG Yuyin1 XU Hua1 CHEN Jia2
1. Department of Laboratory, Panjin Liaoyou Gem Flower Hospital, Liaoning Province, Panjin 124010, China
2. Department of General Medicine, Panjin Liaoyou Gem Flower Hospital, Liaoning Province, Panjin 124010, China
Abstract：Objective To explore the application of Six Sigma (6σ) theory for comparison of two biochemical detection systems. Methods The indoor quality control test results of 32 items on the biochemical analyzer in the Department of Laboratory, Panjin Liaoyou Gem Flower Hospital from July 1 to December 31, 2022 were collected. The Sigma (σ) value and bias of each item were calculated from the internal quality control data of two instruments, and the bias of each item was calculated by the traditional comparison method. The Pearson correlation analysis between the σ value and bias calculated from the internal quality control data and the bias of the traditional method was carried out by using SPSS 26.0 statistical software. Results Among the 32 items, 15 items had a σ value ≥6 and did not need to be improved. 17 items were improved by calculating the results of quality goal index (QGI), among which, 15 items needed to improve the precision, and 2 items needed to improve the precision and accuracy. The calculated coefficient of variation (CV) of 17 items needed to be improved was compared with the allowable CV in the laboratory. The results showed that both were less than the allowable CV. According to the comparison of the two instruments, for the traditional method, the bias of the two instruments was also within the standard range. There was no significant correlation between the σ values of the two quality control levels and the bias of the traditional method (P=0.754, 0.779), but there was a positive correlation between the bias of the two quality control levels and the bias of the traditional method (P=0.041, 0.029). Conclusion Application of quality control data to calculate σ value and QGI for comparison between different detection systems is a relatively convenient and operable method, which can monitor the comparability between different detection systems in the laboratory at any time, and complement the traditional comparison method.
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