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B-135 Evaluation of Verification Decision Limits (VDL) for Routine Coagulation Post-Analytical Review: A Preliminary Analysis

A major challenge faced by medical laboratories is to meet the demand for high-throughput laboratory analysis while maintaining the quality and accuracy of the results. Manual validation remains an obstacle,… Click to show full abstract

A major challenge faced by medical laboratories is to meet the demand for high-throughput laboratory analysis while maintaining the quality and accuracy of the results. Manual validation remains an obstacle, with increased workloads for medical technologists leading to delayed results. The purpose of the study is to evaluate and implement VDL for routine coagulation automated post-analytical review system. The study was conducted in the Division of Laboratory Medicine, King Chulalongkorn Memorial Hospital, Thailand. Our coagulation assay consists of activated partial thromboplastin time (APTT), and prothrombin time (PT). The VDL was a population-based percentile calculation, excluding the outlier using the Tukey method and incorporated with reference values. The decision range was implemented in the post-analytical review of the LIS system. The evaluation was carried out by using simulation analysis and post-implementation data collection to estimate the passing rate, sensitivity, and specificity. A total of 70,865 historical routine coagulation data were obtained from January 2021 to January 2022 to create VDL. The passing rate was assessed by simulation analysis using 21,277 coagulation results over 3 months(Table 1). In the initial implementation using VDL (5th, 95th percentiles combined with reference value) to the LIS in October 2023, a total of 9,792 cases were collected. The VDL identified 258 cases of aPTT and 115 cases of PT for review, while 9,534 cases of aPTT and 9,677 cases of PT were automatically released. This VDL showed a sensitivity of 99.6% and a specificity of 52.3%. Three error cases were found in partial clot specimens that the analyzer could not detect but were within the reference range. This study evaluated the use of verification decision limits in an automated post-analytical review for routine coagulation tests which has the potential to improve the efficiency of the result reporting system.

Keywords: post analytical; analysis; coagulation; routine coagulation; analytical review

Journal Title: Clinical Chemistry
Year Published: 2024

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