Discipline of Laboratory Medicine, Faculty of Medicine, Memorial University, St. John's, NL A1B 3V6, Canada.
Gayrettepe Florence Nightingale Hospital, Department of Core Laboratory Medicine, Istanbul 34349, Turkey.
Clin Biochem. 2019 Nov;73:11-25. doi: 10.1016/j.clinbiochem.2019.08.002. Epub 2019 Aug 3.
Verification of laboratory test results represents the last opportunity to identify errors before they become part of the electronic medical record. Manual verification of test results places significant reliance on the experience and attentiveness of individual observers to identify errors and is vulnerable to errors through omission and neglect. Peer-reviewed publications have documented gains in process efficiency and quality improvement by use of middleware or laboratory information systems to autoverify test results based on pre-defined acceptability criteria. This review evaluates the acceptability of autoverification (AV) as a safe and reliable alternative to total manual review of laboratory test results. AV schemes developed in accordance with international guidelines and standards are applied throughout the laboratory. Careful design of AV systems involves using multidisciplinary teams to develop test-specific decision algorithms, to assist with programming, to verify programming, and validate programmed algorithms prior to use in evaluation of patient test result profiles. Development of test specific decision algorithms makes use of criteria based on instrument messages and flags, quality control status, result limit checks, delta checks, critical values, consistency checks, and patient-related clinical information. Monitoring of the performance of AV parameters, and regular audits of the AV system integrity is recommended in both the literature and guidelines. The potential for gains to process efficiency, error detection and patient safety, through adoption of AV as part of a laboratories quality assurance tool-case, is well supported in published literature.
实验室检验结果的验证是在其成为电子病历的一部分之前识别错误的最后机会。检验结果的人工验证高度依赖于个体观察者的经验和注意力，以识别错误，并且容易因疏忽而出现错误。经过同行评审的出版物记录了使用中间件或实验室信息系统根据预定义的可接受性标准自动验证检验结果，在提高流程效率和质量改进方面的收益。本综述评估了自动验证（AV）作为替代实验室检验结果的完全人工审核的安全可靠方法的可行性。符合国际指南和标准的 AV 方案在整个实验室中得到应用。AV 系统的精心设计涉及使用多学科团队来开发特定于检验的决策算法，以协助编程、验证编程，并在评估患者检验结果概况之前验证编程算法。特定于检验的决策算法的开发利用基于仪器信息和标记、质量控制状态、结果限值检查、差值检查、临界值、一致性检查和与患者相关的临床信息的标准。建议在文献和指南中监测 AV 参数的性能，并定期审核 AV 系统的完整性。在发表的文献中，通过采用 AV 作为实验室质量保证工具的一部分来提高流程效率、错误检测和患者安全性的潜力得到了充分支持。
