基于患者数据的质控与传统质控方法比对研究

doi:10.3969/j.issn.1006-7795.2021.05.003

摘要/Abstract

摘要： 目的研究基于患者数据的质控方法(patient-based quality control,PBQC)在某些生化项目检测中与传统质控方法的比对,增加常规质控数据与临床患者数据之间的互通性及相关性,提高检测结果的准确性。方法连续收集25 d来自18~55周岁体检人群正常参考范围内的血糖(blood glucose,Glu)、糖化白蛋白(glycosylated albumin,GA)、糖化血红蛋白(glycated hemoglobin,HbA1c)、三酰甘油(triglyceride,TG)、总胆固醇(total cholesterol,TC)、同型半胱氨酸(homocysteine,HCY)检测数据,获得每日均值和中位数。同时收集上述生化检测项目在相同时期内的常规质量控制数据,计算总均值、中位数和标准差,采用六西格玛(σ)质量管理方法评价基于患者数据的移动均值法、移动中位数法与常规质控法的性能,绘制质控图,对比趋势。另外收集20 d患者数据,引入5%的正偏差,与前25 d的数据进行比较,绘制质控图,根据Westgard质控规则判断是否在控。结果常规质量控制方法中,Glu、GA、HbA1c、TG、TC、HCY的σ值分别为2.85、0.89、3.64、15.03、5.14、2.83,性能评价为中、差、良、优、优、中。基于患者数据的移动均值法和中位数法,Glu、GA、HbA1c、TG、TC、HCY的σ值分别为3.05,2.90;2.63,1.58;4.49,0.84;3.38,2.45; 4.39,3.59;1.61,0.93;性能评价为良,中;中,差;优,差;良,中;优,良;差,差。PBQC法能检测出除TG外的其他检测项目引入5%误差后的失控。结论 PBQC的移动均值法与常规质量控制方法在6σ质量管理方法综合评价下性能相当,可为互补。Glu、GA和HbA1c项目PBQC的移动均值法表现更优;TG和HCY项目常规质控方法更优。PBQC的移动均值法可作为一种有效的质量控制方法辅助常规质量控制。

关键词: 基于患者数据的质量控制, 常规质量控制, 实验室管理, 移动均值法

Abstract: Objective To compare the patient-based quality control(PBQC)with the traditional quality control method in some biochemical items detection, increase the interoperability and correlation between routine quality control data and clinical patient data, and improve the accuracy of detection results. Methods The data of blood glucose (Glu), glycosylated albumin (GA), glycosylated hemoglobin (HbA1c), triglyceride (TG), total cholesterol (TC), and blood homocysteine (HCY) within the normal reference range from 18 to 55 years old were collected continuously for 25 days to obtain the daily mean and median. The routine quality control data of the above biochemical test items in the same period were collected. The total mean, median and standard deviation were calculated with 6σ the quality management methods to evaluate the performance of moving average method, moving median method and conventional quality control method based on patient data. The patient data for another 20 days were collected, with a positive deviation of 5%, and compared with the data of the previous 25 days. Whether the patient was in control or not was judged according to the Westgard quality control rules. Results In the routine quality control methods, Glu, GA, HbA1c, TG, TC, and HCY were the most important, with the σ values 2.85, 0.89, 3.64, 15.03, 5.14 and 2.83 respectively, corresponding to the performance evaluation medium, poor, good, excellent, excellent, and medium. Based on the moving mean method and median method of patient data, the changes of Glu, GA, HbA1c, TG, TC and HCY were analyzed, with the σ values 3.05, 2.90; 2.63,1.58; 4.49,0.84; 3.38,2.45; 4.39,3.59; and 1.61,0.93; respectively, corresponding to the performance evaluation good, medium; medium, poor; excellent, poor; good, medium; excellent, good; and poor, poor. The out of control of other detection items except triglyceride could be detected by PBQC method with 5% error. Conclusion Under the comprehensive evaluation of 6 σ quality management, the moving average method of PBQC and the conventional quality control method was compared with each other, and their performance was equivalent and complementary. The moving average method of PBQC on Glu, GA and HbA1c projects performed better, whilst routine quality control method on TG and HCY project was better. The moving average method of PBQC could be used as an effective quality control method to assist conventional quality control.

Key words: patient-based quality control, routine quality control, laboratory management, moving average method

中图分类号:

R446.1

刘瑜, 张顺利, 岳育红, 张瑞. 基于患者数据的质控与传统质控方法比对研究[J]. 首都医科大学学报, 2021, 42(5): 706-714.

Liu Yu, Zhang Shunli, Yue Yuhong, Zhang Rui. Comparative study of patient-based quality control (PBQC) and traditional quality control methods[J]. Journal of Capital Medical University, 2021, 42(5): 706-714.

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