Development and assessment of autoverification system for routine coagulation assays in inpatient and outpatient settings of tertiary care hospital: algorithm performance and impact on laboratory efficiency.

IF 2 Q2 MEDICINE, GENERAL & INTERNAL
Diagnosis Pub Date : 2025-03-03 eCollection Date: 2025-08-01 DOI:10.1515/dx-2025-0004
Orakan Limpornpugdee, Surapat Tanticharoenkarn, Tapakorn Thepnarin, Manissara Yeekaday, Pitchayaporn Riyagoon, Waroonkarn Laiklang, Piyapat Limprapassorn, Eakachai Prompetchara
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引用次数: 0

Abstract

Objectives: This study aimed to develop and implement autoverification (AV) system for routine coagulation assays, specifically prothrombin time (PT) and activated partial thromboplastin time (APTT), in tertiary care hospital. The efficiency, accuracy, and impact on turnaround time (TAT) were evaluated.

Methods: AV rules were developed using historical data from 70,865 coagulation test results. The rules included pre-analytical, analytical, and post-analytical checks. The system underwent validation through data simulations, pilot phase, go-live implementation. Performance metrics included sensitivity, specificity, predictive values, passing rates, error rates, TAT.

Results: The AV system achieved 63.3 % overall passing rate (analyzed from 159,183 data), with outpatient settings showing higher rate (69.2 %) than inpatient settings (56.3 %). Final performance evaluation showed sensitivity, specificity, PPV, and NPV of 93.0 , 65.0, 59.7, and 94.4 %, respectively. Manual verification was required for 36 % of cases, mainly due to defective sample volumes (21.5 %). False negatives, primarily from partial clots, occurred in 0.1 % of cases. Integrating CBC clot alerts into AV rules halved the errors. The system increased tests completed within guaranteed TAT of 90 min by 2.4 %, from 89.7 to 92.1 % and reduced median TAT by 5 min. Outpatient TAT improved significantly, with a reduction over 19 min.

Conclusions: The AV system for APTT and PT tests was successfully implemented, reducing manual verification, improving TAT, particularly in outpatient settings. This study highlights AV systems' potential to enhance laboratory performance for routine coagulation panels, which rely only on APTT and PT assays. Ongoing rule refinement and monitoring remain crucial for enhancing system accuracy and effectiveness.

三级医院住院和门诊常规凝血检测自动验证系统的开发和评估:算法性能和对实验室效率的影响。
目的:本研究旨在开发和实施自动验证(AV)系统的常规凝血测定,特别是凝血酶原时间(PT)和活化部分凝血活素时间(APTT),在三级医院。评估了效率、准确性和对周转时间(TAT)的影响。方法:根据70,865例凝血试验结果的历史数据制定AV规则。这些规则包括分析前、分析后和分析后的检查。该系统通过数据模拟、试验阶段和投入使用进行了验证。性能指标包括灵敏度、特异性、预测值、通过率、错误率、TAT。结果:AV系统的总通过率达到63.3 %(从159,183个数据中分析),门诊的通过率(69.2 %)高于住院的(56.3% %)。最终性能评价显示,敏感性、特异性、PPV和NPV分别为93.0 、65.0、59.7%和94.4 %。36% %的病例需要人工验证,主要是由于有缺陷的样品量(21.5% %)。假阴性,主要来自部分血块,发生在0.1% %的病例。将CBC血块警报整合到AV规则中使错误减少了一半。该系统将保证TAT为90 min的测试完成率提高了2.4 %,从89.7%提高到92.1 %,并将中位TAT降低了5 min。门诊TAT显著改善,降低了19 min以上。结论:用于APTT和PT测试的AV系统成功实施,减少了人工验证,提高了TAT,特别是在门诊环境中。这项研究强调了AV系统的潜力,以提高常规凝血板的实验室性能,这只依赖于APTT和PT分析。持续的规则细化和监控对于提高系统的准确性和有效性仍然至关重要。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Diagnosis
Diagnosis MEDICINE, GENERAL & INTERNAL-
CiteScore
7.20
自引率
5.70%
发文量
41
期刊介绍: Diagnosis focuses on how diagnosis can be advanced, how it is taught, and how and why it can fail, leading to diagnostic errors. The journal welcomes both fundamental and applied works, improvement initiatives, opinions, and debates to encourage new thinking on improving this critical aspect of healthcare quality.  Topics: -Factors that promote diagnostic quality and safety -Clinical reasoning -Diagnostic errors in medicine -The factors that contribute to diagnostic error: human factors, cognitive issues, and system-related breakdowns -Improving the value of diagnosis – eliminating waste and unnecessary testing -How culture and removing blame promote awareness of diagnostic errors -Training and education related to clinical reasoning and diagnostic skills -Advances in laboratory testing and imaging that improve diagnostic capability -Local, national and international initiatives to reduce diagnostic error
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