Abstract:

Objective To evaluate the quality of c16000 automatic biochemical analysis system by 6 sigma（σ） metrics. Methods External quality assessment（EQA） and internal quality control（IQC） data of 42 clinical chemistry assay items were collected in 2018. The biases（Bias） were calculated by EQA data,and the coefficients of variation（CV） were got by IQC data. Allowable total errors（TEa） were from Chinese health industry standard WS/T403—2012. σ scale was obtained,and the quality of growth indexes（QGI） were calculated. The clinical chemistry assay items were evaluated by σ performance verification diagram. Results In the 42 clinical chemistry assay items,13（31%） items were ≥6σ,3（7%） items were 5σ-6σ,7（17%） items were 4σ-5σ,8（19%） items were 3σ-4σ,7（17%） items were 2σ-3σ,4（9%） items were <2σ. In the items of <6σ,2 items were needed to improve accuracy firstly,21 items were needed to improve precision firstly,and 6 items were needed to improve both accuracy and precision. Conclusions 6σ quality management is an effective method for the quality control of clinical chemical assay items. It can point out the quality improvement aspect and improve the analysis level.

Key words: Six sigma, Quality control, Clinical chemistry assay