Jayamani Jayagandan, Janardan Chandrashekar C, Appan Sadai V, Kathamuthu Kumaresan, Ahmed Manal Eldein
Laboratory, New Mowasat Hospital, Al-Salmiya, KWT.
Orthopaedics, Hywel Dda University Health Board, Wales, GBR.
Cureus. 2022 Dec 21;14(12):e32774. doi: 10.7759/cureus.32774. eCollection 2022 Dec.
Risk management constitutes an essential component of the Quality Management System (QMS) of medical laboratories. The international medical laboratory standard for quality and competence, International Standards Organization (ISO) 15189, in its 2012 version, specified risk management for the first time. Since then, there has been much focus on this subject. We authors aimed to develop a practical tool for risk management in a clinical laboratory that contains five major cyclical steps: risk identification, quantification, prioritization, mitigation, and surveillance. The method for risk identification was based on a questionnaire that was formulated by evaluating five major components of laboratory processes, namely i) Specimen, ii) Test system, iii) Reagent, iv) Environment, and v) Testing. All risks that would be identified using the questionnaire can be quantified by calculating the risk priority number (RPN) using the tool, failure modes, and effects analysis (FMEA). Based on the calculated RPN, identified risks then shall be prioritized and mitigated. Based on our collective laboratory management experience, we authors also enlisted and scheduled a few process-specific quality assurances (QA) activities. The listed QA activities intend to monitor new risk emergence and re-emergence of those previously mitigated ones. We authors believe that templates of risk identification, risk quantification, and risk surveillance presented in this article will serve as ready references for supervisors of clinical laboratories.
风险管理是医学实验室质量管理体系（QMS）的重要组成部分。国际医学实验室质量和能力标准，即国际标准化组织（ISO）15189，在其2012年版本中首次规定了风险管理。从那时起，该主题受到了广泛关注。我们这些作者旨在开发一种临床实验室风险管理实用工具，该工具包含五个主要的循环步骤：风险识别、量化、优先级排序、缓解和监测。风险识别方法基于一份问卷，该问卷通过评估实验室流程的五个主要组成部分来制定，即：i）标本，ii）检测系统，iii）试剂，iv）环境，以及v）检测。使用该问卷识别出的所有风险都可以通过使用失效模式与效应分析（FMEA）工具计算风险优先级数（RPN）来进行量化。根据计算出的RPN，对识别出的风险进行优先级排序并加以缓解。基于我们共同的实验室管理经验，我们这些作者还列出并安排了一些特定于流程的质量保证（QA）活动。列出的QA活动旨在监测新出现的风险以及之前已缓解风险的再次出现。我们这些作者相信，本文中呈现的风险识别、风险量化和风险监测模板将为临床实验室主管提供现成的参考。
