应用操作过程规范图设计血液分析仪室内质量控制方法

Design of internal quality control procedures for multichannel hematology analyzers using operational process specifications (OPSpecs) charts

目的 对血液分析仪试验项目选择质控方法即质控规则和质控测定值个数 ,以了解他们满足临床或医学实用性质量要求的情况。方法 1.对每项试验以“允许总误差”形式规定质量要求 ;2 .确定每项测定方法稳定操作下的不精密度或标准差 (s)和不准确度或偏倚 (bias) ;3.查找操作过程规范 (OPSpecs)图 ;4 .画出操作点 ;5 .评价候选质控方法的误差检出概率 (Ped)和假失控概率 (Pfr) ;6 .选择质控规则和质控测定结果个数。结果 血红蛋白、白细胞、MCV、MCH使用 13 .5s质控规则 (N =1) ,红细胞、MCHC使用 13s质控规则 (N =1) ,红细胞压积使用 12 .5s质控规则 (N =1) ,血小板使用Westgard多规则 (13s/ 2 2s/R4s/ 4 1s/ 10 x) (N =2 )均可达到 90 %的Ped。结论 对所有血液分析仪试验项目均能采用类似方式进行质控方法的选择和设计。

Objective Quality control(QC) procedure (control rules and numbers of control measurements per run) have been selected for individual tests of multichannel hematology analyzer, to see that clinical or medical usefulnessrequirements for quality are met. Methods 1.defining requirements for quality in form of the “total allowable analytical error” for each test; 2.determining the imprecision and inaccuracy of each measurement procedure; 3.looking up OPSpecs charts; 4.plotting the operating point; 5.assessing the probabilities for error detection and false rejection for candidate control procedure; 6.selecting control procedures and the number of control measurements.Results In applying this approach to the multichannel hematology analyzer, a design objective of 90%( or greater) detection of systematic errors was met for most tests (hemoglobin, WBC, MCV, MCH) by use of 3.5 s control limits with one control measurements per run (N=1). For RBC, MCHC requirement for 1 3.0 S control rule with N=1. For Hct requirement for 1 2.5 s control rule with N=1. For Plt requirement for Westgard multi rules (1 3s /2 2s /R 4s /4 1s/10) with two control measurements per run.Conclusions The general design approach is applicable in all instrument systems.