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中华临床实验室管理电子杂志 ›› 2026, Vol. 14 ›› Issue (02) : 174 -181. doi: 10.3877/cma.j.issn.2095-5820.2026.02.012

综述

医学实验室剩余风险管理现状和进展
关贺元, 孙琪, 杜佳, 李赜, 许建成()   
  1. 130021 吉林长春,吉林大学第一医院检验科
  • 收稿日期:2025-11-29 出版日期:2026-05-28
  • 通信作者: 许建成
  • 基金资助:
    国家卫生健康委医院管理研究所检验检查结果智能互认应用研究(二期)项目(JYHRXZ2025B20)

Current status and progress of residual risk management in medical laboratories

Heyuan Guan, Qi Sun, Jia Du, Ze Li, Jiancheng Xu()   

  1. Department of Clinical Laboratory, the First Hospital of Jilin University, Changchun Jilin 130021, China
  • Received:2025-11-29 Published:2026-05-28
  • Corresponding author: Jiancheng Xu
引用本文:

关贺元, 孙琪, 杜佳, 李赜, 许建成. 医学实验室剩余风险管理现状和进展[J/OL]. 中华临床实验室管理电子杂志, 2026, 14(02): 174-181.

Heyuan Guan, Qi Sun, Jia Du, Ze Li, Jiancheng Xu. Current status and progress of residual risk management in medical laboratories[J/OL]. Chinese Journal of Clinical Laboratory Management(Electronic Edition), 2026, 14(02): 174-181.

剩余风险是指在采取风险控制和管理措施后,仍然存在且难以完全消除的风险。本文围绕医学实验室剩余风险管理的现状与进展进行综述,概述检验科和输血科实验室中常用风险管理工具在剩余风险识别、再评估、持续监测与改进中的应用现状;总结临床检验和输血安全领域中疾病相关剩余风险及输血相关剩余风险的研究进展。现有研究提示,剩余风险管理有助于持续识别现有技术与流程中的薄弱环节,并推动风险管理由实验室内部控制进一步延伸至患者安全和临床决策支持,对提升检验质量和输血安全具有重要意义。

Residual risk is the risk that remains and cannot be completely eliminated after risk control and management measures have been implemented. This review summarizes the current status and progress of residual risk management in medical laboratories. It outlines the current application of commonly used risk management tools in clinical and transfusion laboratories for residual risk identification, reassessment, continuous monitoring, and improvement, and further reviews recent advances in disease-related residual risk in clinical laboratory testing and transfusion-related residual risk in transfusion safety. Available evidence suggests that residual risk management facilitates the ongoing identification of weaknesses in existing technologies and workflows, and promotes an expansion of risk management from internal laboratory control to patient safety and clinical decision support, thereby contributing to improved laboratory quality and transfusion safety.

表1 医学实验室剩余风险管理常用工具
工具/方法 工具类型 主要用途 在剩余风险管理中的作用
鱼骨图 风险来源识别 从人员、设备、试剂、方法、环境等方面梳理潜在风险因素。 识别控制后仍可能存在的风险来源。
FTA 风险来源识别 针对严重不良事件追溯原因,分析关键致因。 分析高危剩余风险的形成机制。
根本原因分析(root cause analysis,RCA) 原因分析 对已发生的不良事件、不符合项或差错进行追因。 解释剩余风险在控制后仍存在的原因。
5Why分析法 原因分析 通过连续追问查找问题根源。 细化剩余风险的具体来源。
帕累托图 优先级分析 按发生频率或影响程度排序主要问题。 确定剩余风险管理的优先方向。
FMEA 风险量化评估 对失效模式进行风险排序和比较。 比较控制前后风险变化及剩余风险水平。
LRA 风险量化评估 将风险识别、控制、再评估纳入完整流程。 对剩余风险进行系统性再评估。
风险矩阵 风险分级 根据严重度和发生概率对风险进行分级。 判断控制后风险是否仍处于可接受范围。
质量指标监测 持续监测 通过关键指标进行长期跟踪。 实现剩余风险的动态监测和长期比较。
PDCA 持续改进 对控制后的风险进行反复检查和持续改进。 维持控制措施有效性,防止风险反弹。
六西格玛(DMAIC) 持续改进 对可识别、可量化的流程性问题进行优化。 持续优化高频、可量化的剩余风险。
表2 不同疾病领域中剩余风险标志物的应用现状
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