用过程能力指标结合功效函数图设计血气分析指标的个性化质量控制方案

Design of individual quality control scheme for blood gas analysis by process capability index combined with power function graph

目的通过过程能力指标结合功效函数图,对血气分析指标筛选既经济又高效的质控方案。方法通过实验室信息管理系统(LIS)收集华西第二医院检验科2014年1至6月酸性、中性以及碱性3个质控水平的质控品室内质控数据,导入Excel的公式后计算出各个过程能力指标,结合功效函数图评价候选质控方法的误差检出率和假失控率。结果过程能力的评价标准分为5级,p H、K和Ca 3个质控水平均达到Ⅰ级,二氧化碳分压(PCO_2)的中性、碱性质控水平以及乳酸(Lac)的中性质控水平同样也达到Ⅰ级。PO_2和Lac的碱性质控水平达到Ⅱ级。Na 3个质控水平均为Ⅲ级,氧分压(PO_2)的中性质控水平也为Ⅲ级。Glu 3个质控水平均为Ⅳ级,PCO_2、PO_2和Lac的酸性质控水平也为Ⅳ级。没有试验指标为Ⅴ级。p H、K和Ca的3个质控水平,中性质控水平的PCO_2和Lac,碱性质控水平的PCO_2用1_(3s)质控规则(N=1)就能使Ped达到90%以上。碱性质控水平的PO_2和Lac用12.5s质控规则(N=1)就能使Ped达到90%以上。Na的碱性质控水平,用1_(3s)/2_(2s)/R_(4s)/4_(1s)/10x珋质控规则(N=2)就能使Ped达到90%以上。3个质控水平的Glu,酸性质控水平的PCO_2、PO_2、Na和Lac,中性质控水平的PO_2和Na,用1_(3s)/2_(2s)/R_(4s)/4_(1s)/10x珋质控规则(N=4)可使Ped接近90%。结论用过程能力指标结合功效函数图对血气分析指标筛选了既经济又高效的个性化质控方案。

Objective To screen the economic and high efficient quality control scheme for blood gas analysis by process capability index combined with power function graph. Methods The data of internal quality control materials with acidic,neutral and alkaline levels from Department of Laboratory Medicine,West China Second Hospital during January to June of 2014 were collected by the laboratory information system（ LIS）,and imported into the Excel. Then,the process capability indexes were calculated,and the probability for error detection（ Ped） and the probability for false rejection（ Pfr） were evaluated combining with power function graph. Results Evaluation criterion of process capability is divided into five grades. The quality control levels for three levels of p H,K and Ca,neutral and alkaline levels of PCO2,and neutral level of Lac reached at grade Ⅰ. The quality control levels for alkaline levels of PO2 and Lac reached at grade Ⅱ. The quality control levels for three levels of Na and neutral level of PO2 just reached at grade Ⅲ. The quality control levels for three levels of Glu and acidic levels of PCO2,PO2 and Lac belonged to grade Ⅳ,and there was no any blood gas marker at Grade Ⅴ. The Pedfor three levels of PH,K and Ca,neutral levels of PCO2 and Lac,and alkaline level of PCO2 could reach to above 90% when the 13 squality control rules（ N = 1） were used. The Pedfor alkaline levels of PO2 and Lac using the 12. 5squality control（ N = 1）,and for alkaline level of Na using the 13s/22s/ R4s/41s/10x珋quality control rules（ N = 2） could also reach to above 90%.The Ped for three levels of Glu,acidic levels of PCO2,PO2,Na and Lac,and neutral levels of PO2 and Na using the 13s/22s/ R4s/41s/10x珋quality control rules（ N = 4） were close to 90%. Conclusion Process capability index combined with power function graph may screen the economic and high efficient individual quality control scheme for blood gas analysis.