Application of 6σ quality management method in quality improvement of clinical biochemical tests
Objective:To evaluate the clinical biochemical test items by applying the Sigma quality management method,establish a scientific and reasonable personalized quality control program,and guide the improvement.Methods:The cumulative data of two-level internal quality control of 25 items of clinical biochemistry in Department of Medical Laboratory of Nanyang Central Hospital were collected,and the average bias of each item was calculated from National Health Commission EQA data three times per year,The Sigma value was calculated according to the allowable total errors of health industry standards,national standards,and external quality assessment standards.The standardized Sigma performance verification chart was drawn and the quality objective index was calculated.Results:The results of 2019 showed that,4 items with σ≥6,account for 16%;1 item with 5≤σ<6,account for4%;4 items with 4≤σ<5,account for 16%;9 items with 3≤σ<4,account for 36%;6 items with 3≤σ<2,account for 24%;1 items with σ<2,account for 4%.According to the quality objective index,20 items need to be improved in precision priority,and 1 item needs to be improved in precision plus accuracy priority.After improvement,the number of unacceptable items is zero.7 items had improved in good condition.Conclusion:Sigma's quality management method can effectively improve the performance of clinical biochemical tests,and can guide continuous quality improvement.