Huang Li-Li, Yang Ju-Hong, Hong Wei-Wen, Wang Bin-Liang, Chen Hai-Fei
Department of Quality Management, Huangyan Hospital Affiliated to Wenzhou Medical University, Taizhou, Zhejiang, People's Republic of China.
Infusion Room, Taizhou First People's Hospital, Huangyan, Zhejiang, People's Republic of China.
Risk Manag Healthc Policy. 2025 Jun 27;18:2139-2150. doi: 10.2147/RMHP.S527015. eCollection 2025.
In 2022, a critical incident occurred at a Chinese hospital where a surgical specimen from a rectal prostate procedure was misplaced, necessitating repeat surgery for the patient. This event underscored systemic vulnerabilities in specimen handling processes and catalyzed an investigation into how healthcare systems manage medical errors to uphold patient safety.
Using root cause analysis (RCA), we dissected the workflow gaps and organizational factors contributing to the specimen loss. Key failures identified included unclear role delineation among staff, inadequate specimen labeling protocols, and lack of real-time tracking mechanisms. Three interventions were implemented: (1) Redesigning specimen handling workflows with explicit role responsibilities; (2) Developing standardized, color-coded specimen bottles and racks to improve visual identification; (3) Integrating an electronic tracking system for closed-loop management of specimens.
Post-intervention, the recognition rate of post-use specimen vials improved from 0% to 100% after implementing a dual-color sealing system (white cap with red ring), enabling visual confirmation of proper sealing. Over two years, no surgical pathology specimens were lost post-intervention.
The RCA-driven reforms effectively addressed systemic flaws in specimen management, demonstrating that targeted process redesign, ergonomic tools, and digital tracking can mitigate risks of medical errors. This case highlights the importance of analyzing localized workflow failures within broader systemic contexts to build resilient, patient-centered medical care systems.
2022年，中国一家医院发生了一起严重事件，直肠前列腺手术的手术标本被放错位置，患者需要再次手术。这一事件凸显了标本处理流程中的系统漏洞，并促使人们对医疗系统如何管理医疗差错以维护患者安全展开调查。
我们采用根本原因分析法（RCA），剖析了导致标本丢失的工作流程差距和组织因素。确定的主要失误包括工作人员之间职责划分不明确、标本标签协议不完善以及缺乏实时跟踪机制。实施了三项干预措施：（1）重新设计标本处理工作流程，明确职责；（2）开发标准化的、带有颜色编码的标本瓶和标本架，以改善视觉识别；（3）整合电子跟踪系统，对标本进行闭环管理。
干预后，在实施双色密封系统（带红色环的白色瓶盖）后，使用后标本瓶的识别率从0%提高到100%，能够通过视觉确认密封是否正确。两年多来，干预后未发生手术病理标本丢失的情况。
由根本原因分析法推动的改革有效解决了标本管理中的系统缺陷，表明有针对性的流程重新设计、人体工程学工具和数字跟踪可以降低医疗差错风险。本案例强调了在更广泛的系统背景下分析局部工作流程失误对于构建有弹性的、以患者为中心的医疗系统的重要性。
