六西格玛质量管理在临床生化检验中的应用

Application of six sigma quality management in clinical biochemical testing

目的探索六西格玛质量管理在临床生化检验中应用的效果,指导临床生化检验中的质量管理办法和改进。方法在我院检验科2018年1月至2019年12月的室内质控数据以及参与卫生部临床检验中心室间质评数据,计算不精密度变异系数(CV)、不正确度偏移(Bias),然后计算西格玛值(σ),对于未达到5σ的项目,计算质量目标指数(QGI)。结果2018—2019年的23个生化检验项目均达到6σ值的为:P、CK、Mg、AST、DBIL、LDH、AMY、TG、CRE、UN;连续2年均未达到3σ值的项目为:Na、ALB;2018年达到6σ值的项目占52.17%,未达到3σ值的项目占17.39%;2019年达到6σ值的项目占56.52%,未达到3σ值的项目占17.39%。未达到5σ值的项目:2018年为8个,2019年为7个,计算QGI值,其中QGI值<0.8的2018年为4个,2019年为3个,需优先改进精密度;QGI值>1.2的2018年为3个,2019年为2个,需优先改进准确度;QGI值在0.8~1.2之间的2018年为1个,2019年为2个,准确度和精密度均需改进。结论在临床生化检验中采用六西格玛质量管理法检验各个检验项目的性能,从而有利于设计出个体化的质控管理方案,更好的指导生化检验工作中的质量改进,保证检验结果的准确性。

Objective To explore the effect of six sigma quality management in clinical biochemical testing and to guide the quality management methods and improvements in clinical biochemical testing.Methods For the indoor quality control data in the laboratory of our hospital and the data from the inter-laboratory quality evaluation of the clinical laboratory center of the Ministry of Health from January 2018 to December 2019,the coefficient of variation(CV)of the imprecision and the deviation of the inaccuracy(Bias)were calculated.And then the sigma value(σ)was calculated.For items that did not reach 5σ,the quality objective index(QGI)was calculated.Results From 2018 to 2019,23 biochemical test items reached 6σvalue,including P,CK,Mg,AST,DBIL,LDH,AMY,TG,CRE,UN.Items that did not reach 3σvalue for 2 consecutive years included Na,ALB.In 2018,52.17%of projects reached 6σvalue,and projects that did not reach 3σvalue accounted for 17.39%.Projects that reached 6σvalue in 2019 accounted for 56.52%,and projects that did not reach 3σvalue accounted for 17.39%.Projects that did not reach the 5σvalue were 8 in 2018 and 7 in 2019.The QGI value was calculated.Among them,there were 4 in 2018 and 3 in 2019 for QGI value<0.8.Priority should be given to improving the precision.There were 3 in 2018 and 2 in 2019 for QGI value>1.2.Priority was needed to improve the accuracy.There was 1 in 2018 and 2 in 2019 for the QGI between 0.8 and 1.2.Both accuracy and precision need to be improved.Conclusion The six sigma quality management method is used to test the performance of each test item in the clinical biochemical test,which is conducive to designing an individualized quality control management plan,better guiding the quality improvement in the biochemical test work,and ensuring the accuracy of the test results.