卫生组织管理 大流行病应对 激增诊断需求的要求

[中文适用范围]： 1 适用范围 本文件概述了医疗机构在应对疫情时，为及时、准确提供检测服务，利用创新方法克服实验室能力局限的相关要求，具体包括：减轻疫情期间提供检测服务所面临的风险；确保疫情背景下检测服务的质量保障；应对检测需求激增的可能措施。 本文件不涉及提供疫情响应医疗检测的具体操作流程，例如标本采集单元或筛查站（如步行式或驾车式）的标本采集规程、实验程序及医学实验室的质量管理体系。此外，本文件亦不涉及疫情背景下医疗单位（如急诊科和住院病房）对确诊患者的治疗响应，以及确诊患者在医疗机构内部的转运事宜。 [外文原描述]： This document outlines requirements for healthcare organizations to deliver diagnostic tests timely and accurately in a pandemic by leveraging innovative approaches to overcome the limitations of laboratory capacity as follows: mitigation of threats encountered in providing diagnostic services during a pandemic; consideration for quality assurance of diagnostic service provision in a pandemic context; possible response measures to the surge in diagnostic demand. This document does not cover the specific procedures involved in providing pandemic-response medical tests, such as the specimen collection protocols in the specimen collection units or screening stations (e.g. walk-through or drive-through), experimental procedures and the quality management systems of medical laboratories. Furthermore, this document does not address the pandemic responses related to the medical treatment of infected patients in care units (e.g. emergency unit and in-patient unit) and the transferring of confirmed patients within the healthcare organization during a pandemic.