Australian Organ and Tissue Authority, Canberra, Australia.
Austin Health, Melbourne, Australia.
Transpl Infect Dis. 2024 Nov;26 Suppl 1:e14315. doi: 10.1111/tid.14315. Epub 2024 Jun 10.
Systems for quality and safety assurance in organ donation and transplantation are vital, especially those that seek to minimize donor disease transmission. Australia has developed a national vigilance and surveillance system to identify, review, and analyze actual and potential donor-derived infections and other disease transmissions.
The system involves notification of incidents to the Australian Organ and Tissue Authority for review by a Vigilance and Surveillance Expert Advisory Committee (VSEAC). The VSEAC grades incidents, O makes recommendations, and issues communications both publicly and to the clinical donation and transplant sector.
Annual notifications have increased since the inception of the system in 2012 until 2022. The vast majority relate to procedural aspects including donor assessment, information/data issues, and the recovery, offer, allocation, preservation and transportation of organs. Possible donor-derived disease accounted for 19% of all notifications, and those related to possible donor-derived infection only 12%. The VSEAC, as a result of reviewing these incidents, has made recommendations resulting in revisions to donor screening, organ allocation, packaging and transportation. The review of incidents has led to changes in clinical guidance for increased viral risk donor assessment, testing, and ensuing organ utilization and recipient surveillance. Guidance has also been reviewed for other infectious risks including strongyloides, human T-lymphotropic virus, and HEV.
The Australian vigilance and surveillance system has enabled national retrospective reporting and evaluation of serious adverse events or reactions to identify trends and inform processes and guidelines, therefore improving the safety of donation and transplantation.
器官捐献和移植中的质量和安全保障系统至关重要，特别是那些旨在最大限度减少供体疾病传播的系统。澳大利亚已经开发了一个国家警戒和监测系统，以识别、审查和分析实际和潜在的供体源性感染和其他疾病传播。
该系统涉及向澳大利亚器官和组织管理局报告事件，由警戒和监测专家咨询委员会（VSEAC）进行审查。VSEAC 对事件进行分级，提出建议，并向公众和临床捐献和移植部门发布公开和内部通讯。
自 2012 年该系统成立以来，年度通知数量逐年增加。绝大多数与程序方面有关，包括供体评估、信息/数据问题，以及器官的回收、提供、分配、保存和运输。可能的供体源性疾病占所有通知的 19%，仅与可能的供体源性感染有关的通知占 12%。VSEAC 通过审查这些事件提出了建议，导致对供体筛查、器官分配、包装和运输进行了修订。对事件的审查导致对增加病毒风险供体评估、检测以及随后的器官利用和受者监测的临床指南进行了修改。还对其他传染病风险的指南进行了审查，包括 Strongyloides、人 T 淋巴细胞病毒和 HEV。
澳大利亚的警戒和监测系统使国家能够进行回顾性报告和评估严重不良事件或反应，以确定趋势并为流程和指南提供信息，从而提高捐献和移植的安全性。
