Metabolic Laboratory, Genetics and Molecular Pathology Directorate, SA Pathology, Women's and Children's Hospital Site, Adelaide, Australia.
Engineering Cluster, Singapore Institute of Technology, Singapore, Singapore.
Crit Rev Clin Lab Sci. 2021 Jan;58(1):49-59. doi: 10.1080/10408363.2020.1800585. Epub 2020 Aug 14.
Delta checks are a post-analytical verification tool that compare the difference in sequential laboratory results belonging to the same patient against a predefined limit. This unique quality tool highlights a potential error at the individual patient level. A difference in sequential laboratory results that exceeds the predefined limit is considered likely to contain an error that requires further investigation that can be time and resource intensive. This may cause a delay in the provision of the result to the healthcare provider or entail recollection of the patient sample. Delta checks have been used primarily to detect sample misidentification (sample mix-up, wrong blood in tube), and recent advancements in laboratory medicine, including the adoption of protocolized procedures, information technology and automation in the total testing process, have significantly reduced the prevalence of such errors. As such, delta check rules need to be selected carefully to balance the clinical risk of these errors and the need to maintain operational efficiency. Historically, delta check rules have been set by professional opinion based on reference change values (biological variation) or the published literature. Delta check rules implemented in this manner may not inform laboratory practitioners of their real-world performance. This review discusses several evidence-based approaches to the optimal setting of delta check rules that directly inform the laboratory practitioner of the error detection capabilities of the selected rules. Subsequent verification of workflow for the selected delta check rules is also discussed. This review is intended to provide practical assistance to laboratories in setting evidence-based delta check rules that best suits their local operational and clinical needs.
Delta 检查是一种分析后验证工具，用于比较属于同一患者的连续实验室结果之间的差异与预设限制。这种独特的质量工具突出了个体患者层面的潜在错误。如果连续实验室结果的差异超过预设限制，则认为可能包含需要进一步调查的错误，这可能既耗时又耗费资源。这可能会导致结果延迟提供给医疗保健提供者，或者需要召回患者样本。Delta 检查主要用于检测样本错误识别（样本混淆、管内错误血液），而最近实验室医学的进展，包括在整个测试过程中采用标准化程序、信息技术和自动化，大大降低了此类错误的发生率。因此，需要仔细选择 Delta 检查规则，以平衡这些错误的临床风险和保持运营效率的需求。从历史上看，Delta 检查规则是根据参考变化值（生物学变异）或已发表的文献由专业意见设定的。以这种方式实施的 Delta 检查规则可能无法告知实验室人员其实践性能。本综述讨论了几种基于证据的方法，以最佳设置 Delta 检查规则，直接告知实验室人员所选规则的错误检测能力。还讨论了对所选 Delta 检查规则的工作流程进行后续验证。本综述旨在为实验室提供实用的帮助，以便根据其当地的运营和临床需求制定基于证据的 Delta 检查规则。
