B-108 Delta Check Performance Assessment by Using Real-WorldData at the Temple University Health System​
Authors: Ulas M , Yin J 
Published: October 2024

Background

Delta check is a post-analytic tool focusing on pre-analytical, analytical and post-analytical errors. It can be sensitive in detecting isolated errors affecting a single patient, as opposed to moving patient averages, which is another QC tool for detecting errors that affect a cohort/population of patients. As a computer-based system on selected tests, delta checks are to detect excessive changes from prior value in the patient test result and to detect possible specimen errors such as misidentified or compromised samples before results are reported. It may also play a role in detecting examination(analytical) issues and clinically significant results. If delta checks exceed established limits, the result is flagged. There is a common agreement that measurands with low indices of individuality (&lt;0.6) make good candidates for the identification of cases of sample misidentification than higher indices of individuality (&gt;1.4). CLSI EP33 Use of Delta Checks in the Medical Laboratory guidelines recommends that laboratories assess the validity of current delta check parameters by reviewing retrospective data on flagged results to determine if errors are being identified efficiently. At Temple University Health System, delta check limits were established historically by using published data, however, its performance characteristics have not been verified previously. Verification of clinical performance of predefined delta check limits can be performed either through mathematical calculations or via clinical audits.  Clinical audits are achieved by documenting the follow-up actions and outcomes of the samples flagged by a delta check rule(s). It has been suggested that this should be performed using a protocolized follow-up procedure to ensure uniformity in the investigation and management. Corey M. et al. shared an excel template, a mathematical model that can be adopted easily by replacing the example data with retrospectively extracted data and modifying the parameters to suit their laboratory’s requirements.

Methods

We collected up to 30,000 data points for each 12 measurand in the clinical chemistry lab retrospectively. By using the excel template, clinical sensitivity and clinical specificity has been calculated. Furthermore, we created ROC curves and evaluated them using the (YI) Youden Index and AUC (Area Under the Curve).

Results

In general, YI values were found to be very low, less than 0.6. Highest YI was used to establish new delta check limits for each analyte; only the current creatinine delta check limit was found as effective, and no change required. 11 out of 12 measurand were required a revision of delta check limits and were proposed to replace with lower delta checks. AUC values were found between 0.56-0.794. Na showed the highest AUC, which correlates its low individuality index (0.5) and its effects on effectiveness of the delta check system.

Conclusions

It is of vital importance to establish a solid follow-up evaluation for delta check alerts and distinguish between integrity issues and clinically significant changes. Conclusively, this endeavor can develop into extensive information for the application, evaluation, and follow-up of delta checks whilst improving diagnostic accuracy and quality assurance.