Application of Six Sigma methodology in the development and implementation of a POCT blood glucose quality management system

WANG Cui; TAN Jing; SHAO Yang; WANG Huihui; HE Yue; WANG Yongqiang

doi:10.3969/j.issn.2096-501X.2025.05.010

Abstract：Objective To evaluate the performance level of point-of-care testing(POCT)blood glucose by Six Sigma quality management and guide quality improvement.Methods External quality assessment(EQA)was conducted according to National Center for Clinical Laboratories(NCCL)POCT blood glucose instrument results,and internal quality control(IQC)data were assessed from surgical departments in June 2022.Bias and coefficient of variation(CV)values were detected with EQA and IQC.According to the total allowable error(TEa=20%)of the POCT blood glucose instrument,Sigma(σ)and QGI were calculated with the standardized σ performance charts and the causes of suboptimal performance were analyzed.A structured quality management system was then implemented to verify the effectiveness of corrective measures in one surgical department.Results The σ values were all less than 6 and the QGI values were all less than 0.8 in seven surgical departments.Fishbone and Pareto analyses indicated that inadequate precision was mainly attributable to deviations from standard operating procedures(SOPs),limited knowledge of quality control among nurses,and repeated use of opened control materials.After implementing corrective measures,the GLU1 bias was reduced to 2.17%,the total CV value was 3.22%,the σ value was 4.23,and the QGI was 0.75,reflecting an improvement compared with baseline.Conclusions The Six Sigma quality management system is an important management tool for the quality of POCT blood glucose,which can effectively analyze the causes of quality issues and guide quality improvement,and has strong potential for broader clinical application.