The Computer Simulation Study And Application Of The External Quality Assessment For Quantitative Tests In Clinical Laboratory

ObjectiveTo study and develop a kind of software, and through it establish the quantitative relationship between actual intralaboratory characteristics (coefficient of variation and bias) and external quality assessment for providing a timeliness and effective information to improve the test quality. Through this way, we can provide with objective and scientific evidence for the improvement of test quality.MethodsBasing on the theory of using a computer modeling with Monte Carlo simulation approach by random number generator to produce random number according with the Gaussian distribution, we study the quantitative relationship between the characteristics of intralaboratory (CV & Bias) and external quality assessment. The utility of this simulation procedure is illustrated in an example. CV is from the internal quality control data, and the bias is computed by averaging the multi-bias in external quality assessment program.ResultsA laboratory can predict the probability of passing external quality assessment based on its internal imprecision (CV) and bias. After analyzing the tables and figures that can describe the probability which the laboratory can pass in external quality assessment programs under different total allowable errors, we conclude that a laboratory that operates with methods that has internal CV≤30% and bias≤30% of the total error criteria will have a >95% chance of passing external quality assessment. Under the same condition, the bias has the greater effect on the probability of pass the external quality assessment program. The more the test analytes what the laboratory produces, the less probability that the laboratory passes external quality assessment. The probability that the laboratory can pass for different tests in external quality assessment programs is 100% except for chlorine and glucose.Conclusions Medical laboratories must provide high quality service to clinicians by producing accurate, precise, relevant and comprehensive data that can be applied to the diagnostics and treatment of diseases. Internal quality control and external quality assessment are very important ways to assure the test quality. We establish the quantitative relationship in two respects. In the future, by the computer model we can set the allowable total error in our country according to the practice condition.