Using patient risk in analysis of quality control strategy for lab results

摘要

#$%^&*AU2016202692A120161117.pdf#####ABSTRACT OF THE DISCLOSURE Methods, apparatuses, and systems are disclosed for analyzing quality control (QC) strategies that are applied to testing processes an analyte in order to meet an acceptable level of probability of patient harm that could result from incorrect test results. The measure of patient harm takes into account severity of patient harm, as well as its occurrence. Methods include calculating, based on the parameters of the QC strategies and the test apparatus, an expected number of incorrect final results E(Nuf ) due to a test system failure. The value of E(Nuf) can be used as part of a calculation of a predicted level of probability patient harm. The ratio of the acceptable level of probability of patient harm to the predicted level of probability patient harm can determine the adequacy of the QC strategies. 68422694V.1 7676912 1 (GHMatters) P102980.AUObtain non-failure probability of error and average number of reported 910 results between failures Obtain Quality Control strategy 920 information Calculate expected number of 930 unreliable final results due to test system failure Obtain a probability that an unreliable 940 final result leads to patient harm Calculate a predicted probability of 950 patient harm Provide assessment of Quality 960 Control strategy using predicted probability of patient harm and allowable probability of patient harm FIG. 9