临床常规生化项目室内质控方法的设计  

Indoor Quality Control Rules for Routine Clinical Biochemical Tests

作　　者：郑强[1] 

机构地区：[1]沈阳市骨科医院输血科,沈阳110044

出　　处：《解放军医药杂志》2015年第2期89-93,共5页Medical & Pharmaceutical Journal of Chinese People’s Liberation Army

摘　　要：目的探讨保证临床质量要求的常规生化项目室内质控规则的设计。方法收集2012年7—12月碱性磷酸酶(ALKP)、钾、钙的质控数据,以室内质控的累积变异系数(CV)作为项目的不精密度,应用卫生部临床检验中心室间质评结果计算偏倚,选择美国临床实验室改进修正法规88能力比对检验评价限为总允许误差,借助操作过程规范图设计符合本实验室切实可行的室内质控方法,从而提高误差检出概率(Ped),降低假失控概率(Pfr)。结果ALKP、钾每天测定质控品个数为2,选择1-3 s单质控规则即可满足Ped>90%,Pfr<5%;钙每天测定质控品个数为4,选择1-3 s/2-2 s/R-4 s/4-1 s/12-X作为质控规则,满足Ped>90%,Pfr<5%。结论不同生化分析项目应根据分析方法性能特征的不同,选择满足临床质量要求的控制方法。Objective To study the indoor quality control rules for routine clinical biochemical tests. Methods Quality control indexes of Alkaline phosphatase（ ALKP）,potassium（ K） and calcium（ Ca） from July to December 2012 were collected. The accumulative coefficient of variation（ CA） of indoor quality control was used as imprecision degree; bias was calculated using external quality assessment of Clinical Laboratory Center of Chinese Ministry of Public Health; total error allowance was evaluated using proficiency testing in American Clinical Laboratory Improvement Amendments 88（ CLIA＇88）. The feasible indoor quality control methods were made based on operational process of specification chart so as to improve the probability for error detection（ Ped） and reduce the probability for false rejection（ Pfr）. Results The measured value of each batch control number was 2,and ALKP and K were chosen for 1-3 s as quality control rule in order to achieve Ped above 90%and Pfr below 5%; however,the measured value of each batch control number was 4,and Ca was chosen for 1-3 s /2-2 s / R-4 s /4-1 s /12-X as quality control rule in order to achieve Ped above 90% and Pfr below 5%. Conclusion Different biochemical analysis projects should select different control rules based on the different performance characteristics of analytical methods.

关 键 词：血液化学分析 质量控制 误差检出概率 假失控概率 操作过程规范图 

分 类 号：R446.112[医药卫生—诊断学]