张佳夫

[关键词] 生化检验;六西格玛;质量控制;σ值;QGI值;质量改进

[中图分类号] R446.1          [文献标识码] C          [文章编号] 1673-9701（2021）23-0158-03

Application of six sigma quality management in clinical biochemical testing

ZHANG Jiafu

Department of Laboratory Medicine， Jiamusi Maternal and Child Health Hospital of Hei Longjiang Province， Jiamusi   154004， China

[Abstract] 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 6σ value，including P，CK，Mg，AST，DBIL，LDH，AMY，TG，CRE，UN.Items that did not reach 3σ value for 2 consecutive years included Na，ALB.In 2018，52.17% of projects reached 6σ value，and projects that did not reach 3σ value accounted for 17.39%. Projects that reached 6σ value in 2019 accounted for 56.52%，and projects that did not reach 3σ value accounted for 17.39%.Projects that did not reach the 5σ value 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.

[Key words] Biochemical testing; Six sigma; Quality control; σ value; QGI value; Quality improvement

生化檢验是检验科的主要检验项目，在多科疾病的诊疗中发挥着重要作用。加强对临床生化检验的质量控制，有利于保证检验结果的准确性[1-3]。传统的临床生化检验方法性能评价方法有较多，如精密度试验、回收试验、方法对比试验等，评价结果可通过数据和图表来表示，虽然这些评价方法具有一定价值，但各有缺陷，往往一张图表只能显示一个检验项目的评价结果，而项目间的比较则相比较为麻烦，无法从整体上了解全部项目的性能状况[4-5]。而六西格玛质量管理是近年来国际上发展起来的一种质量管理模式，其以数据为基础，以顾客为中心，追求质量的零缺陷，能极大提高产品的质量和管理水平[6-7]。我院检验科应用六西格玛质量管理办法进行生化检验项目的质控，指导生化检验工作中的质量管理，现报道如下。

1 资料与方法

1.1 评估项目

选取我院检验科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资料，其中生化检验项目如下：钾（K）、钠（Na）、氯（Cl）、钙（Ca）、磷（P）、镁（Mg）、谷丙转氨酶（ALT）、天门冬氨基转移酶（AST）、γ-谷氨酰转肽酶（γ-GGT）、总胆红素（TBIL）、直接胆红素（DBIL）、乳酸脱氢酶（LDH）、碱性磷酸酶（ALP）、肌酸激酶（CK）、淀粉酶（AMY）、尿酸（UA）、葡萄糖（GLU）、总胆固醇（CHOL）、三酰甘油（TG）、总蛋白（TP）、白蛋白（ALB）、肌酐（CRE）、尿素（UN），共23项。

1.2 仪器与试剂

①仪器。本研究中采用Roche Modular DP生化分析仪以及Johnson VITRO 350干式生化分析仪。②试剂。生化检验项目中所使用的试剂为Roche公司生产的原装试剂、配套罗氏校准物以及强生公司生产的原装试剂、配套强生校准物。……