Westgard室内质量控制频率在线计算工具在常规化学室内质量控制中的应用

Application of Westgard internal quality control frequency on-line calculator in general chemistry internal quality control

目的用室内质量控制频率在线计算工具为北京同仁医院常规化学检验项目选择质量控制程序及合适的批长度。方法收集北京同仁医院检验科10个常规化学项目连续19个月累积在控变异系数,作为各项目不精密度。采用实验室参加2018年常规化学全国临床检验室间质量评价(EQA)计划中,10个项目全年共计15个批号质控结果与靶值百分差值绝对值的平均值,估计各项目偏倚(Bias)。使用2018年国家卫生健康委临床检验中心EQA靶值的允许范围,估计各项目允许总误差(TEa)。将数据录入Westgard室内质量控制频率计算工具,在线计算出包括单规则和多规则,质控浓度水平(或试验项目)个数从1到4在内的10种不同候选统计质量控制(SQC)程序和相应批长度。结合实验室实际情况选择质控规则相对简单、批长度长的SQC程序。结果ALP和CR项目可以采用1_(3s),N=3或1_(3s),N=2规则,对应批长度均为1000;TBIL和ALT项目可采用1_(3s),N=3或13s,N=2规则及其对应批长度;UA、CHO、AST和AMY项目可以采用1_(3s)/2_(2s)/R_(4s)/41s,N=4或1_(3s)/2of3_(2s)/R_(4s)/3_(1s) N=3两个多规则及其对应批长度;GGT项目可以采用1_(3s)/2_(2s)/R4s/4_(1s),N=4规则(批长度50);LDH计算出的10种候选质控规则对应批长度过短,应优先提高其检测性能,暂不推荐质控规则和对应批长度。结论Westgard室内质量控制频率在线计算工具操作简单易行,可为实验室选择SQC程序和合适的批长度。实验室根据实际情况调整SQC方案。

Objective An on-line calculator for calculating the frequency of internal quality control is recommended to select quality control procedures and appropriate run lengths for general chemistry in Beijing Tongren Hospital.Methods The cumulative controlled coefficient of variations of 10 general chemical tests in the laboratory department of Beijing Tongren Hospital for 19 consecutive months were used as the imprecision.The mean value of absolute percentage difference between the quality control results and the target value of 15 batches of 10 tests in the external quality assessment(EQA)general chemistry in 2018 was used to estimate the Bias of each test.Use the allowable range of EQA target value of the National Center for Clinical Laboratories in 2018 to estimate the total allowable error(TEa)of each test.The data were input into the Westgard internal quality control frequency calculator,and 10 different candidate statistical quality control(SQC)procedures and corresponding run lengths were calculated online,including single rule and multiple rule,number of quality control concentration levels(or test projects)ranging from 1 to 4.The SQC program with relatively simple quality control rules and long run length was selected according to the actual situation of the laboratory.Results The 1_(3s),N=3 or 1_(3s),N=2 rule could be adopted for ALP and CR,and the corresponding run length was 1000.TBIL and ALT projects can adopt 1_(3s),N=3 or 1_(3s),N=2 rule and its corresponding run length;UA can use multiple rules 1_(3S)/2_(2S)/R_(4s)/4_(1s),N=4(run length 395)or 13S/(2of3)2S/R4s/31s N=3(run length 259);CHO,AST and AMY can adopt two multiple rules 13S/22S/R4s/41s,N=4 or 13S/(2of3)2S/R4s/31s,N=3 and their corresponding run length.GGT project can adopt 1_(3S)/2_(2S)/R_(4s)/4_(1S),N=4 rule(run length 50);The run length of 10 candidate quality control rules calculated by LDH was too short,the detection performance should be improved preferentially,and the quality control rules and corresponding run length were not recommended for the time being.Conclusion The Westgard internal quality control frequency online calculator is easy to operate.Clinical laboratories can use this calculator to select SQC program and appropriate run length.It is recommended that laboratories adjust SQC program according to the current actual situation.