De Micco Francesco, De Benedictis Anna, Scendoni Roberto, Tambone Vittoradolfo, Di Palma Gianmarco, Alloni Rossana
Research Unit of Bioethics and Humanities, Department of Medicine and Surgery, Università Campus Bio-Medico di Roma, 00128 Roma, Italy.
Department of Clinical Affair, Fondazione Policlinico Universitario Campus Bio-Medico, 00128 Roma, Italy.
Healthcare (Basel). 2024 Nov 14;12(22):2279. doi: 10.3390/healthcare12222279.
: The frozen section intra-operative consultation is a pathology procedure that provides real-time evaluations of tissue samples during surgery, enabling quick and informed decisions. In the pre-analytical phase, errors related to sample collection, transport, and identification are common, and tools like failure mode, effects, and criticality analysis help identify and prevent risks. This study aims to enhance patient safety and diagnostic quality by analyzing risks and optimizing sample management. : The failure mode, effects, and criticality analysis was conducted by a multidisciplinary team to analyze the workflow of frozen section sample handling from collection in the operating theater to acceptance at the pathology lab. Six steps were identified, each assigned tasks and responsibilities, with risks assessed through the risk priority number, calculated from severity, occurrence, and detectability. Severity was classified based on the WHO framework, ranging from "No Harm" to "Death", to prioritize risks effectively. : The study identified 12 failure modes across 11 sub-processes, prioritized by risk. Key failures included missing patient identification, incorrect sample retrieval, missing labels, misdirected samples, and samples sent to the wrong lab. : Pre-analytical errors in pathology pose risks to diagnosis and patient care, with most errors occurring in this phase. A multidisciplinary team identified key issues, such as sample mislabeling and delays due to staff unavailability, and implemented corrective actions, including improved signage, staff re-training, and sample tracking systems. Monitoring and regular checks ensured ongoing adherence to protocols and reduced the risks of misidentification, transport delays, and procedural errors. : The frozen section intra-operative consultation is vital in surgical pathology, with the pre-analytical phase posing significant risks due to potential errors in sample handling and labeling. Failure mode, effects, and criticality analysis has proven effective in identifying and prioritizing these failures, despite resource demands, by allowing corrective actions that enhance patient safety and healthcare quality.
冷冻切片术中会诊是一种病理学程序，可在手术期间对组织样本进行实时评估，从而做出快速且明智的决策。在分析前阶段，与样本采集、运输和识别相关的错误很常见，失效模式、影响及危害性分析等工具有助于识别和预防风险。本研究旨在通过分析风险和优化样本管理来提高患者安全性和诊断质量。多学科团队进行了失效模式、影响及危害性分析，以分析从手术室采集到病理实验室接收的冷冻切片样本处理工作流程。确定了六个步骤，每个步骤都分配了任务和职责，并通过风险优先数评估风险，该风险优先数由严重性、发生率和可检测性计算得出。根据世界卫生组织的框架对严重性进行分类，范围从“无伤害”到“死亡”，以便有效地对风险进行优先级排序。该研究在11个子流程中识别出12种失效模式，并按风险进行了优先级排序。关键失误包括患者身份识别缺失、样本取回错误、标签缺失、样本发送错误以及样本被送往错误的实验室。病理学中的分析前错误对诊断和患者护理构成风险，大多数错误发生在这个阶段。一个多学科团队识别出关键问题，如样本标签错误和因工作人员无法到位导致的延误，并采取了纠正措施，包括改进标识、对工作人员进行再培训以及样本追踪系统。监测和定期检查确保持续遵守协议，并降低了错误识别、运输延误和程序错误的风险。冷冻切片术中会诊在外科病理学中至关重要，分析前阶段由于样本处理和标签方面的潜在错误而带来重大风险。尽管需要资源，但失效模式、影响及危害性分析已被证明在识别这些失误并对其进行优先级排序方面是有效的，因为它允许采取提高患者安全性和医疗质量的纠正措施。
