摘要
目的探讨患者数据移动均值法在临床生化检验无质控品项目间接胆红素、锌和批间室内质控中的应用价值。方法收集病人血清标本间接胆红素、锌及总蛋白参考范围内和医学决定水平处的检测数据,采用移动均值法处理数据绘制L-J质控图。同时检测锌、总蛋白质控品,间胆数据通过总胆红素质控品结果减去直接胆红素质控品结果获得,按常规质控品质控方法处理数据绘制L-J质控图。采用Westgard多规则中的1-3s,2-2s规则判断质控结果是否在控。采用6σ质量管理理论评价两种质控方法的性能。结果两种质控方法所得质控图上的每一个质控值均在控。经6σ质量管理理论性能评价,常规质控法中,间胆、锌及总蛋白σ分别为6.5、1.7、2.1,性能评价为优、差、差。移动均值法中,检测浓度在参考范围内间胆、锌及总蛋白σ分别为3.5、2.2、3.3,性能评价为良、中、良,检测浓度在医学决定水平处σ分别为0.3、1.3、1.1,性能评价均为差。结论患者数据移动均值法应用于间接胆红素、锌及总蛋白室内质控中,检测浓度在参考范围内6σ质量管理评价优于常规质控法,可作为一种有效的辅助质控方法,应用于无质控品、自制质控品项目的质控中。检测浓度在医学决定水平处,患者数据移动均值法尚不能有较好的质量性能。常规质控品法和患者数据移动均值法联合使用可有效监控开机、分析中因素导致失控。
Objective To discuss the application values of the patient data moving average method applied to indoor quality control of no quality product project indirect bilirubin,zinc and batch quality control in analytical phase of clinical biochemistry. Methods Collecting detection data of indirect bilirubin,zinc and total protein,which are in reference range,and higher or lower than concentration in medical decision level,of patient samples. Usingdata moving average method to process and draw L- J quality control chart. At the same time detecting control serum of zinc,total protein,and collecting detection data of indirect bilirubin data obtained through the total bilirubin QC results minus direct bilirubin results,quality control data process by conventional quality control method and draw L- J quality control chart. Finally using the 1- 3s,2- 2s rules in Westgard multiple rules determine whether in control. Evaluate performance of the two quality control methods by using 6 Sigma quality management and evaluation theory. Results Two quality control methods for each control value are in the control. In the conventional control method,indirect bilirubin,zinc and total protein respectivelyσ is 6. 5,1. 7,2. 1,performance evaluation is better,poor,poor. However,in moving average method,detection of concentration in reference range indirect bilirubin,zinc and total protein respectivelyσ is 3. 6,2. 2,3. 3 performance evaluation is good,medium,good,Moreover,detection of concentration in medical decision level indirect bilirubin,zinc and total protein respectivelyσ is 0. 3,1. 3,1. 1 and performance evaluation is poor in all. Conclusion Moving average method is better than conventional quality control in detection of concentration in reference range of6σ quality management evaluation. Patients data moving average method has some value in indoor quality control of indirect bilirubin,zinc and total protein,which can be used as an effective auxiliary method of quality control applied to indoor quality control of no quality serum items,self- made quality control serum items. Moving average method could not have good quality performance on detection of concentration in medical decision level.Moving average method and conventional quality control together are applied can monitoring out of control in the initial and analytical phase.
出处
《合肥医学院学报》
2015年第4期412-416,共5页
Journal of Zunyi Medical University
基金
贵州省卫生计生委科学技术基金项目(NO:gzwjkj2014-2-2174)
关键词
移动均值法
质控品
L-J质控图
6σ
data moving average method
indoor quality control
6 sigma