Department of Pathology and Immunology, Washington University School of Medicine, St. Louis, Missouri, USA.
Quest Diagnostics, San Juan Capistrano, California, USA.
J Clin Microbiol. 2024 Oct 16;62(10):e0096024. doi: 10.1128/jcm.00960-24. Epub 2024 Sep 30.
Diagnostic stewardship (DxS) has gained traction in recent years as a cross-disciplinary method to improve the quality of patient care while appropriately managing resources within the healthcare system. Clinical microbiology laboratorians have been highly engaged in DxS efforts to guide best practices with conventional microbiology tests and more recently with molecular infectious disease diagnostics. Laboratories can experience resistance to their role in DxS, especially when the clinical benefits, motivations for interventions, and underlying regulatory requirements are not clearly conveyed to stakeholders. Clinical laboratories must not only ensure ethical practices but also meet obligatory requirements to steward tests responsibly. In this review, we aim to support clinical microbiology laboratorians by providing the background and resources that demonstrate the laboratory's essential role in DxS. The heart of this review is to collate regulatory and accreditation requirements that, in essence, mandate DxS practices as a long-standing, core element of high-quality laboratory testing to deliver the best possible patient care. While examples of the clinical impact of DxS are plentiful in the literature, here, we focus on the operational and regulatory justification for the laboratory's role in stewardship activities.
近年来,诊断管理(DxS)作为一种跨学科的方法,在适当管理医疗系统内资源的同时,提高了患者护理的质量,受到了广泛关注。临床微生物学家一直积极参与 DxS 工作,以指导常规微生物学检测和最近的分子传染病诊断方面的最佳实践。实验室可能会对其在 DxS 中的角色产生抵触情绪,特别是当临床效益、干预动机和潜在的监管要求没有向利益相关者明确传达时。临床实验室不仅必须确保符合道德规范,还必须满足强制性要求,以负责任地管理检测。在这篇综述中,我们旨在通过提供背景和资源来支持临床微生物学家,这些资源证明了实验室在 DxS 中的重要作用。这篇综述的核心是整理监管和认证要求,这些要求实质上规定了 DxS 实践是高质量实验室检测的长期核心要素之一,旨在为患者提供尽可能好的护理。虽然文献中有大量关于 DxS 临床影响的例子,但在这里,我们重点关注实验室在管理活动中的作用的操作和监管依据。