摘要
目的 :应用六西格玛(6σ)理论分析临床干化学检验项目质量控制数据,评价其分析性能,设计质量控制规则,并指导其质量改进。方法:收集2014年度临床干化学18个检验项目室内质量控制及室间质量评价的数据,按照生物学变异的质量规范(allowable total error,TEa)标准,使用Bio-Rad公司的Unity Real Time软件进行操作,计算σ值并绘制操作过程规范(OPSpecs)图和西格玛度量图,评价检验项目分析性能,设计质量控制方案;计算检验项目的质量目标指数(quality goal index,QGI),查找导致性能不佳的主要原因,提出优先改进方法。结果:18个临床干化学检验项目中,以生物学变异质量规范TEa取期望值为例,6个(33%)项目的性能大于6σ,1个(6%)大于4σ,11个(61%)小于3σ。所有项目的平均σ值4.23。在总分析性能未达到6σ的检验项目中,8个项目(QGI<0.8)需优先改进精密度,占67%;3个项目(0.8≤QGI<1.2)需同时改进精密度和准确度,占25%;1个项目(QGI>1.2)需优先改进准确度,占8%。18个干化学项目最终质控方案是为,1个项目选择了最佳水平的生物学变异的质量规范,6个项目选择了期望水平,5个项目选择了最低水平。本实验室目前钠、氯、钙、碱性磷酸酶和白蛋白、总蛋白水平检测的性能不能满足最低水平生物学变异质量规范的要求,可降低质控目标的设置等级。结论:6σ质量管理方法可有效评价临床干化学检测性能,设计个性化的质量控制方案可更有效地控制测检质量,有助于不断提高临床实验室生化检验项目质量水平。
Objective： To analyze the quality control data from dry chemistry in clinical laboratory and evaluate performance of dry chemistry tests with Six Sigma（6σ） quality management method for improving the design rules of quality control. Methods： Data of internal quality control and external quality control from 18 dry chemistry analysis items in clinical laboratory were collected. According to the quality specification based on biological variation, Bio-Rad Unity Real Time was used to calculate σ, generating statistical graphics, evaluating analytical performance and design quality control rules. The quality goal index was also calculated for finding out the reason of poor performance. Results： In 18 analysis items, desirable quality specification based on biological variation was taken as an example; quality in 6（33）%was above 6σ, 1（6%） were above 4σ and 11（61%） were less than 3σ, while the average of all items was 4.23σ. For analysis of items less than 6σ, precision needed to be improved in 8（67%）, accuracy in 1（8%） and both in 3（25%）. The final selection of optimum, desirable and minimum quality specifications based on biological variation were 1, 6 and 5,respectively. The current performance of Na, Cl, Ca, TP, ALP and Alb cannot meet the minimum quality specification. The specifications of them were selected according to CLIA′88 and Spanish, Minimum Consensus, respectively. Conclusions：Six Sigma quality management method can be applied effectively in performance evaluation of clinical dry chemistry,personalizing quality control rule design, and is helpful for improving the quality in clinical laboratory.
出处
《诊断学理论与实践》
2014年第5期495-500,共6页
Journal of Diagnostics Concepts & Practice
关键词
六西格玛
质量规范
质控规则
Six Sigma
Quality specification
Quality control rules
