标准摘要
[中文适用范围]： 本文件规定了一种流程，供医学实验室识别并管理与其医学检验活动相关的患者、实验室工作人员及服务提供方的风险。该流程包括风险的识别、评估、评价、控制与监测。本文件的要求适用于医学实验室检验与服务的所有方面，涵盖检验前、检验中及检验后阶段，包括将检验结果准确传输至电子病历系统，以及ISO 15189标准中描述的其他技术与管理流程。本文件未规定可接受的风险水平。本文件不适用于医疗机构在检验后作出的临床决策所引发的风险。本文件是对ISO 31000所涵盖的医学实验室企业管理风险的补充，后者涉及商业、经济、法律及监管等领域的风险管理。 [外文原描述]： This document specifies a process for a medical laboratory to identify and manage the risks to patients, laboratory workers and service providers that are associated with medical laboratory examinations. The process includes identifying, estimating, evaluating, controlling and monitoring the risks. The requirements of this document are applicable to all aspects of the examinations and services of a medical laboratory, including the pre-examination, examination, and post-examination aspects including accurate transmission of examination results into the electronic medical record, as well as other technical and management processes described in ISO 15189. This document does not specify acceptable levels of risk. This document does not apply to risks from post-examination clinical decisions made by healthcare providers. This document complements the management of risks affecting medical laboratory enterprises that are addressed by ISO 31000, such as business, economic, legal, and regulatory risks.
英文名称Medical laboratories — Application of risk management to medical laboratories