The Establishment Of Quality Control Scheme For Clinical Chemical Quantitative Project Based On Risk Assessment

ObjectiveAccording to Total allowable error(TEa)from five different sources,quality control data related to routine chemical quantitative projects in clinical laboratory and the number of patient sample between two quality control(NB),we calculate the risk size of each test item in the quantitative test project.Moreover,according to the laboratory's risk quality objectives to determine the best level gradient,frequency and out-of-control rules of quality control,and to optimize the relationship between quality and cost.Methods1.Based on the theory of risk assessment and software designed from risk assessment formula,choose nineteen projects to evaluate and debug the risk assessment software,making the software satisfy the needs of the clinical routine biochemical quantitative project comprehensive evaluation.2.Selected 87 routine clinical chemical quantitative test items(140tests)from the laboratory biochemistry group of Guangdong provincial hospital,and to statistic testing data of six months(number of quality level,frequency,mean,standard deviation,out of control rules,and analysis of batch size etc),Use risk assessment software to calculate the size of the risk(E(Nu))in each project by five different sources of TEa(standards designed by Chinese clinical testing center,CLIA '88,clinical laboratory of Guangdong provincial hospital,BV Des bias/Des imprecision and BV Min bias/Min imprecision).3.Collective and analyze the six mouth testing data,including the number of quality level,frequency,mean,standard deviation,out of control rules,analysis of batch size and etc,from 87 routine clinical chemical quantitativetest items(140 tests)in the laboratory biochemistry group of Guangdong provincial hospital.Then use risk assessment software to calculate the size of the risk(E(Nu))in each project by five different sources of TEa,including standards designed by Chinese clinical testing center,CLIA '88,clinical laboratory of Guangdong provincial hospital,BV Des bias/Des imprecision and BV Min bias/Min imprecision.4.Calculated the best level,frequency and out-of-control rules of internal quality control for each project and developed personalized quality control strategy for quantitative projects by analyzing the laboratory risk quality objectives,the number of patients between two quality control(NB),the number of patients tested on this test system every day(NPD),the number of the largest unreliable patient reports that the lab can tolerate and the highest quality control frequency in the laboratory etc.Results1.The optimized risk assessment software can meet the requirements of quantitative project evaluation.2.According to analysis of the quality control scheme in this laboratory,most quantitative items obtained a low risk value(E(Nuf)< 1),while a small part of projects have higher risk in different TEa.What's more,the TEa designed by clinical laboratory of Guangdong provincial hospital given the most number of risk projects and the highest risk value.3.In high-risk projects,the value of E(Nuf)can be reduced by changing the quality control frequency and out-of-control rules,and the adjustment of out-of-control rules are more influential on the value of E(Nuf)than the change of quality control frequency.4.Depending on the difference of the risk objectives in different test project,laboratory can develop a personalized quality control scheme for different test items.ConclusionThe quantitative risk assessment of the detection project is conducive to the real-time control of the risk in the lab.Minimization of the risk of issuing false patient tests could obtain by quantitative risk management lab quality control and the design of personalized quality control scheme based on the sample size.