Abstract
Change limits, more commonly called delta check, are those in which a change in a patient's measured result in relation to their corresponding preceding measurement is suspected of being erroneous and should be considered as a doubtful result. The aim of this study was to provide change limits for some biochemical and haematological quantities to detect doubtful measured results and to assess its effectiveness to detect erroneous results for their application in and the standardization of the plausibility control. Change limits have been estimated for 13 biochemical and 6 haematological quantities. For each quantity, relative differences (D), expressed as a percentage between the two consecutive measured results from the same patient (from scheduled laboratory requests), were calculated. From these differences (D), the p5 and p95 percentiles of the data distribution were calculated. To assess the effectiveness of the change limits to detect laboratory errors, 43 erroneous laboratory reports, containing different biochemical and haematological quantities, were obtained from the standard laboratory plausibility control procedure. From the 43 erroneous laboratory reports, 31 (72%) were due to endovenous administration errors and 12 (28%) were due to mislabeling errors. All erroneous laboratory reports were detected when the change limits of the quantities were combined and applied together. The best combination of quantities, which detect all the erroneous reports in the same specimen were: potassium, albumin, creatinine, glucose and haemoglobin.
Highlights
Plausibility control, commonly called “autoverification”, is defined as the set of procedures used to determine whether a patient’s measured result is valid according to previously-established clinical and biological criteria [1,2,3,4,5]
Plausibility control includes some tools that can be used to detect doubtful measured results, including alert limits [11], change limits [11] and prediction limits [12]
Both tables describe the quantities according to the International Union of Pure and Applied Chemistry (IUPAC) and the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) recommended syntax [23], and express them using the International System of Units
Summary
Plausibility control, commonly called “autoverification”, is defined as the set of procedures used to determine whether a patient’s measured result is valid according to previously-established clinical and biological criteria [1,2,3,4,5]. This is the last process in the postanalytical phase and is carried out to assure the quality of a clinical laboratory report before it is released to the requester. These actions include to check information about the specimen, about the diagnosis, repeating measurement, requesting a new sample... [13]
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