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追踪丢失的手术标本:基于根本原因分析的不良事件质量改进策略
Authors Huang LL, Yang JH, Hong WW , Wang BL, Chen HF
Received 8 March 2025
Accepted for publication 23 June 2025
Published 27 June 2025 Volume 2025:18 Pages 2139—2150
DOI https://doi.org/10.2147/RMHP.S527015
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Dr Jongwha Chang
Li-Li Huang,1 Ju-Hong Yang,2 Wei-Wen Hong,3 Bin-Liang Wang,4 Hai-Fei Chen5
1Department of Quality Management, Huangyan Hospital Affiliated to Wenzhou Medical University, Taizhou, Zhejiang, People’s Republic of China; 2Infusion Room, Taizhou First People’s Hospital, Huangyan, Zhejiang, People’s Republic of China; 3Department of General Surgery, Taizhou First People’s Hospital, Taizhou, Zhejiang, People’s Republic of China; 4Department of Hospital, Taizhou First People’s Hospital, Taizhou, Zhejiang, People’s Republic of China; 5Operating Room, Taizhou First People’s Hospital, Taizhou, Zhejiang, People’s Republic of China
Correspondence: Hai-Fei Chen, Operating Room, Taizhou First People’s Hospital, Taizhou, Zhejiang, China, No. 218, Hengjie Road, Huangyan District, Taizhou, Zhejiang, 318020, People’s Republic of China, Tel +86-13575807288, Email chenhaifei0803@163.com Bin-Liang Wang, Hospital Department, Taizhou First People’s Hospital, No. 218, Hengjie Road, Huangyan District, Taizhou, Zhejiang, 318020, People’s Republic of China, Email billywangchina@foxmail.com
Background: 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.
Methods: 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.
Results: 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.
Conclusion: 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.
Keywords: rectal prostate specimens, medical errors, root cause analysis, patient safety, quality improvement