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常规凝血/止血检测的自动验证与异常检测结果的反射测试。

Auto-validation of Routine Coagulation/Hemostasis Assays with Reflex Testing of Abnormal Test Results.

机构信息

School of Medical Sciences, Faculty of Medicine and Health University of Sydney, Westmead Hospital, Westmead, NSW, Australia.

School of Dentistry and Medical Sciences, Faculty of Science and Health, Charles Sturt University, Wagga, Wagga, NSW, Australia.

出版信息

Methods Mol Biol. 2023;2663:93-109. doi: 10.1007/978-1-0716-3175-1_6.

DOI:10.1007/978-1-0716-3175-1_6
PMID:37204706
Abstract

Hemostasis laboratories play a crucial role in the diagnosis and treatment of individuals with bleeding or thrombotic disorders. Routine coagulation assays, including the prothrombin time (PT)/international normalized ratio (INR), and activated partial thromboplastin time (APTT), are used for various purposes. These include as a screen of hemostasis function/dysfunction (e.g., possible factor deficiency) and for monitoring of anticoagulant therapy, such as vitamin K antagonists (PT/INR) and unfractionated heparin (APTT). Clinical laboratories are also under increasing pressure to improve services, especially response (test turnaround) times. There is also a need for laboratories to try to reduce error rates and for laboratory networks to standardize/harmonize processes and policies. Accordingly, we describe our experience with the development and implementation of automated processes for reflex testing and validation of routine coagulation test results. This has been implemented in a large pathology network compromising 27 laboratories and is under consideration for expansion to our larger network (of 60 laboratories). These rules have been custom-built within our laboratory information system (LIS), perform reflex testing of abnormal results, and fully automate the process of routine test validation for appropriate results. These rules also permit adherence to standardized pre-analytical (sample integrity) checks, automate reflex decisions, automate verification, and provide an overall alignment of network practices in a large network of 27 laboratories. In addition, the rules enable clinically significant results to be quickly referred to hematopathologists for review. We also documented an improvement in test turnaround times, with savings in operator time and thus operating costs. Finally, the process was generally well received and determined to be beneficial for most laboratories in our network, in part identified by improved test turnaround times.

摘要

止血实验室在诊断和治疗出血或血栓形成障碍患者方面发挥着至关重要的作用。常规凝血检测,包括凝血酶原时间(PT)/国际标准化比值(INR)和活化部分凝血活酶时间(APTT),用于各种目的。这些目的包括作为止血功能/障碍的筛选(例如,可能的因子缺乏)和监测抗凝治疗,如维生素 K 拮抗剂(PT/INR)和未分级肝素(APTT)。临床实验室也面临着提高服务质量的压力,特别是响应(测试周转)时间。实验室还需要努力降低错误率,并使实验室网络标准化/协调流程和政策。因此,我们描述了我们在开发和实施常规凝血测试结果自动反射测试和验证的自动化流程方面的经验。这在一个由 27 个实验室组成的大型病理网络中得到了实施,并正在考虑将其扩展到我们更大的网络(60 个实验室)。这些规则是在我们的实验室信息系统(LIS)中定制的,对异常结果进行反射测试,并对适当的结果进行常规测试验证的全过程自动化。这些规则还允许遵守标准化的分析前(样本完整性)检查,自动反射决策,自动验证,并在一个由 27 个实验室组成的大型网络中实现网络实践的总体一致性。此外,这些规则使具有临床意义的结果能够快速提交给血液病理学家进行审查。我们还记录了测试周转时间的改善,节省了操作人员的时间,从而降低了运营成本。最后,该过程得到了广泛的认可,并被确定为我们网络中大多数实验室都有益,部分原因是测试周转时间的改善。

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