6σ管理在电解质检测性能持续改进中的应用
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摘要
目的运用六西格玛(6σ)管理理论评价电解质分析项目中阶段的检测性能、发现问题、指导实验室质量的持续改进,并对改进效果加以验证。方法(1)将两个水平室内质控在控数据的累积变异系数(CV)合成,并将合成后的CV作为不精密度的估计值,将2017年度卫生部临床检验中心电解质正确度验证计划中两个批号偏倚的绝对值的平均值作为检测的偏倚估计值,以卫生行业标准WS/T403-2012中电解质项目的允许总误差作为质量规范,计算电解质项目的西格玛(σ)值,未达到6σ水平的检测项目,计算质量目标指数(QGI)值,查找导致性能不佳的主要原因,并进行质量改进;(2)2018年卫生部临床检验中心电解质正确度验证计划结果反馈后,用同样的方法计算各项目的σ度量值,并比较改进前后σ度量值的差异,验证质量改进的效果。结果经过将近1年的持续改进,各项目的改进效果明显,σ水平大幅提升,具体如下:钾由3.07提高到6.07,钠由2.15提高到4.27,钙由1.70提高到3.03,镁由3.13提高到3.62。结论6σ管理理论可以量化电解质项目的检测性能,并能帮助实验室发现自身问题,在实验室质量持续改进中具有重要应用价值。
Objective To apply six sigma(6σ)management theory to evaluate the detection performance of the phase of the analysis of the electrolyte items,to identify the problems,so to guide the continuous improvement of the quality of the laboratory and to verify the effect of the improvement.Methods(1)The two levels of indoor quality control were synthesized in the cumulative coefficient of variation(CV)of the controlled data,and the synthesized CV was used as an inaccurate estimation value,and the average value of the absolute value of the two batch number bias in the electrolyte correctness verification program of the Ministry of health in 2017 year was taken as the bias estimation value,and the total allowable error of the electrolytes in the health professional standard WS/T 403-2012 was taken as the quality specification to calculate the sigma(σ)value of the electrolyte items and items not reaching the level of 6 Sigma,so to calculate the quality goal index(QGI)value,and to find the main cause of the poor performance and to improve the quality.(2)The verification plan was developed for the electrolyte correctness of the Ministry of health in 2018.After obtaining the feedbacks,the Sigma(σ)values of each item were calculated by the same method,and the difference of the sigma values before and after the improvement were compared to verify the effect of quality improvement.Results After nearly a year of continuous improvement,the improvement effect of each item was obvious,the level of the sigma was greatly improved.Specifically,potassium increased from 3.07 to6.07,sodium increased from 2.15 to 4.27,calcium increased from 1.70 to 3.03,and magnesium was increased from 3.13 to 3.62.Conclusion The six sigma management theory can quantify the detection performance of the electrolyte items and help the laboratory to find out its own problems.It has an important application value in the continuous improvement of the quality of the laboratory.
Objective To apply six sigma(6σ)management theory to evaluate the detection performance of the phase of the analysis of the electrolyte items,to identify the problems,so to guide the continuous improvement of the quality of the laboratory and to verify the effect of the improvement.Methods(1)The two levels of indoor quality control were synthesized in the cumulative coefficient of variation(CV)of the controlled data,and the synthesized CV was used as an inaccurate estimation value,and the average value of the absolute value of the two batch number bias in the electrolyte correctness verification program of the Ministry of health in 2017 year was taken as the bias estimation value,and the total allowable error of the electrolytes in the health professional standard WS/T 403-2012 was taken as the quality specification to calculate the sigma(σ)value of the electrolyte items and items not reaching the level of 6 Sigma,so to calculate the quality goal index(QGI)value,and to find the main cause of the poor performance and to improve the quality.(2)The verification plan was developed for the electrolyte correctness of the Ministry of health in 2018.After obtaining the feedbacks,the Sigma(σ)values of each item were calculated by the same method,and the difference of the sigma values before and after the improvement were compared to verify the effect of quality improvement.Results After nearly a year of continuous improvement,the improvement effect of each item was obvious,the level of the sigma was greatly improved.Specifically,potassium increased from 3.07 to6.07,sodium increased from 2.15 to 4.27,calcium increased from 1.70 to 3.03,and magnesium was increased from 3.13 to 3.62.Conclusion The six sigma management theory can quantify the detection performance of the electrolyte items and help the laboratory to find out its own problems.It has an important application value in the continuous improvement of the quality of the laboratory.
引文
[1]康凤凤,张传宝,王薇,等.正确度验证计划在六西格玛性能评价中的应用[J].临床检验杂志,2014,32(2):130-132.
[2]肖亚玲,王薇,赵海建,等.用西格玛性能验证图评价中国血糖检测项目[J].临床检验杂志,2015,33(3):223-225.
[3]章晓燕,王薇,赵海建,等.全国糖化血红蛋白正确度验证室间质评不同检测系统的结果分析[J].中华检验医学杂志,2015,38(11):742-745.
[4]赵海建,张传宝,周伟燕,等.应用六西格玛管理方法评价脂类检验项目质量水平[J].中华检验医学杂志,2014,37(4):311-314.
[5]WS/T403-2012.临床生物化学检验指标分析质量指标[S].中华人民共和国卫生部,2012.
[6]王治国.临床检验6σ质量设计与控制[M].北京:人民卫生出版社,2012:42-43.
[7]AFRIFA J,GYEKYE S A,OWIREDU W K,et al.Application of sigma metrics for the assessment of quality control in clinical chemistry laboratory in Ghana:A pilot study[J].Niger Med J,2015,56(1):54-58.
[8]李园园,李萍,宋昊岚,等.应用6σ理论评价临床实验室各阶段性能及设计质控方案[J].中华检验医学杂志,2007,30(12):1408-1412.
[9]王治国.临床检验6σ质量设计与控制[M].北京:人民卫生出版社,2012:154-160.
[10]章小燕,王薇,王治国.临床检验正确度控制品-评估偏倚[J].现代检验医学杂志,2016,31(5):147-149.
[11]袁勇,孔凡斌,吴晓明,等.六西格玛理论在4种胱抑素C试剂性能评价中的应用[J].国际检验医学杂志,2018,39(5):591-594.
[12]KUMAR B V,MOHAN T.Sigma metrics as a tool for evaluating the performance of internal quality control in a clinical chemistry laboratory[J].J Lab Physicians,2018,10(2):194-199.
[13]NEVALAINEN D,BERTE L,KRAFT C,et al.Evaluating laboratory performance on quality indicators with the six sigma scale[J].Arch Pathol Lab Med,2000,124(4):516-519.
[14]冯品宁,林文彬,姚真荣,等.不同正确度验证方法来源的偏移对实验室σ水平的影响[J].检验医学,2017,32(2):158-160.
[15]张路,王薇,王治国.国内两种允许总误差标准在评估临床化学检测项目分析质量及选择质控程序中的应用比较[J].现代检验医学杂志,2015,30(3):162-168.
[16]王治国.临床检验6σ质量设计与控制[M].北京:人民卫生出版社,2012:97-120.
[17]赵霞,汪萍,张广慧,等.应用六西格玛理论评价和设计临床干化学检验室内质控规则[J].诊断学理论与实践,2014,13(5):495-500.
[18]陈涛.Westgard-西格玛规则在血细胞分析室内质控规则选择上的应用[J].实验与检验医学,2018,36(3):348-350.
[2]肖亚玲,王薇,赵海建,等.用西格玛性能验证图评价中国血糖检测项目[J].临床检验杂志,2015,33(3):223-225.
[3]章晓燕,王薇,赵海建,等.全国糖化血红蛋白正确度验证室间质评不同检测系统的结果分析[J].中华检验医学杂志,2015,38(11):742-745.
[4]赵海建,张传宝,周伟燕,等.应用六西格玛管理方法评价脂类检验项目质量水平[J].中华检验医学杂志,2014,37(4):311-314.
[5]WS/T403-2012.临床生物化学检验指标分析质量指标[S].中华人民共和国卫生部,2012.
[6]王治国.临床检验6σ质量设计与控制[M].北京:人民卫生出版社,2012:42-43.
[7]AFRIFA J,GYEKYE S A,OWIREDU W K,et al.Application of sigma metrics for the assessment of quality control in clinical chemistry laboratory in Ghana:A pilot study[J].Niger Med J,2015,56(1):54-58.
[8]李园园,李萍,宋昊岚,等.应用6σ理论评价临床实验室各阶段性能及设计质控方案[J].中华检验医学杂志,2007,30(12):1408-1412.
[9]王治国.临床检验6σ质量设计与控制[M].北京:人民卫生出版社,2012:154-160.
[10]章小燕,王薇,王治国.临床检验正确度控制品-评估偏倚[J].现代检验医学杂志,2016,31(5):147-149.
[11]袁勇,孔凡斌,吴晓明,等.六西格玛理论在4种胱抑素C试剂性能评价中的应用[J].国际检验医学杂志,2018,39(5):591-594.
[12]KUMAR B V,MOHAN T.Sigma metrics as a tool for evaluating the performance of internal quality control in a clinical chemistry laboratory[J].J Lab Physicians,2018,10(2):194-199.
[13]NEVALAINEN D,BERTE L,KRAFT C,et al.Evaluating laboratory performance on quality indicators with the six sigma scale[J].Arch Pathol Lab Med,2000,124(4):516-519.
[14]冯品宁,林文彬,姚真荣,等.不同正确度验证方法来源的偏移对实验室σ水平的影响[J].检验医学,2017,32(2):158-160.
[15]张路,王薇,王治国.国内两种允许总误差标准在评估临床化学检测项目分析质量及选择质控程序中的应用比较[J].现代检验医学杂志,2015,30(3):162-168.
[16]王治国.临床检验6σ质量设计与控制[M].北京:人民卫生出版社,2012:97-120.
[17]赵霞,汪萍,张广慧,等.应用六西格玛理论评价和设计临床干化学检验室内质控规则[J].诊断学理论与实践,2014,13(5):495-500.
[18]陈涛.Westgard-西格玛规则在血细胞分析室内质控规则选择上的应用[J].实验与检验医学,2018,36(3):348-350.