常规化学项目个性化σ质控规则的应用探讨

Discussion on the application of personalizedσquality control rules in routine chemical projects

目的根据常规化学项目的西格玛(σ)值,制订个性化质控规则并实践于室内质控,评价应用效果。方法收集伯乐常规化学室内质控数据,应用伯乐unityTM质控软件计算σ值及推荐个性化质控规则,并将其应用于室内质控6个月,评价各项目σ值、误差检出率、假失控率应用前和应用后的变化。总误差选用参考《临床生物化学检验常规项目分析质量指标:WS/T 403-2012》,变异系数来源于6个月室内质控数据,偏倚来源于Bio-Rad常规化学质控全球实验室对等组比对数据,测定项目包括淀粉酶(AMYL)、总胆固醇(TC)、肌酸激酶(CK)、乳酸脱氢酶(LDH)、钾(K)、钠(Na)、丙氨酸氨基转移酶(ALT)、天门冬氨酸氨基转移酶(AST)。结果应用13s/22s(N=2)质控规则,统计6个月数据,室内质控水平1各项目σ值分别为AMYL 9.37,TC 4.64,CK 7.32,LDH 4.85,K 7.28,Na 4.83,ALT 3.93,AST 3.28;室内质控水平2各项目σ值分别为AMYL 10.47,TC 3.57,CK 7.32,LDH 4.87,K 7.92,Na 3.27,ALT 9.75,AST 6.73。应用个性化质控规则后室内质控水平1各项目σ值分别为AMYL 8.65,TC 7.16,CK 7.24,LDH 4.96,K 6.29;室内质控水平2各项目σ值分别为AMYL 7.35,TC 4.86,CK 7.58,LDH 5.39,K 6.97。结论AMYL、TC、CK、LDH、K应用效果良好,个性化质控规则应用后,保证误差检出率>90%情况下,假失控率明显降低。Na、ALT、AST个性化质控规则应用值得探讨,需强大的实验室信息管理系统支持。

Objective According to the Sigma(σ)value of routine chemical items,individualized quality control rules are formulated and applied to indoor quality control to evaluate the application effect.Methods The data of routine chemical indoor quality control of Bole were collected,theσvalue was calculated by Bole unitytm quality control software and the personalized quality control rules were recommended.Theσvalue,error detection rate and false out of control rate of each item were evaluated before and after application.The total error was determined by the quality index WS/T 403-2012,coefficient of variation was derived from the six-month indoor quality control data,bias was derived from the global peer group comparison data of Bio-Rad routine chemical quality control.The determination items included amylase(AMYL),total cholesterol(TC),creatine kinase(CK),lactate dehydrogenase(LDH),potassium(K),sodium(Na),alanine aminotransferase(ALT),aspartate aminotransferase(AST).Results According to the 13s/22s(N=2)quality control rules,the six-month data were statistically analyzed.Theσvalues of each item in the indoor quality control level 1 were AMYL 9.37,TC 4.64,CK 7.32,LDH 4.85,K 7.28,Na 4.83,ALT 3.93,AST 3.28;theσvalues of each item in the indoor quality control level 2 were AMYL 10.47,TC 3.57,CK 7.32,LDH 4.87,K 7.92,Na 3.27,ALT 9.75,AST 6.73.After the application of personalized quality control rules,theσvalues of each item in indoor quality control level 1 were AMYL 8.65,TC 7.16,CK 7.24,LDH 4.96,and K 6.29;theσvalues of each item in indoor quality control level 2 were AMYL 7.35,TC 4.86,CK 7.58,LDH 5.39,and K 6.97.Conclusion The application effect of AMYL,TC,CK,LDH and K is good.After the application of personalized quality control rules,the false out of control rate will be significantly reduced when the error detection rate is more than 90%.The application of Na,ALT and AST personalized quality control rules is worth exploring and needs the support of a strong laboratory information management system.