Abstract：
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
摘要：
背景：器官捐献和移植的质量和安全保证系统至关重要，尤其是那些试图尽量减少捐赠者疾病传播的人。澳大利亚建立了国家警戒和监测系统,review,并分析实际和潜在的供体来源的感染和其他疾病传播。
方法：该系统涉及将事件通知澳大利亚器官和组织管理局，由警惕和监视专家咨询委员会（VSEAC）进行审查。VSEAC对事件进行评级，O提出建议，并公开与临床捐赠和移植部门进行沟通。
结果：自2012年该系统启用以来，到2022年，年度通知有所增加。绝大多数涉及程序方面，包括捐助者评估，信息/数据问题，和复苏，offer,分配，器官的保存和运输。可能的供体来源疾病占所有通知的19%，而那些与可能的供体来源感染有关的只有12%。VSEAC,由于审查了这些事件，提出了建议，导致对捐赠者筛查的修改，器官分配,包装和运输。对事件的审查导致了对增加病毒风险供体评估的临床指导的变化，测试,以及随后的器官利用和接受者监测。还审查了其他传染病风险的指南，包括圆线虫，人类嗜T淋巴细胞病毒，和HEV。
结论：澳大利亚的警觉和监测系统使国家对严重不良事件或反应的回顾性报告和评估能够确定趋势，并为流程和指南提供信息。从而提高捐献和移植的安全性。
方法：该系统涉及将事件通知澳大利亚器官和组织管理局，由警惕和监视专家咨询委员会（VSEAC）进行审查。VSEAC对事件进行评级，O提出建议，并公开与临床捐赠和移植部门进行沟通。
结果：自2012年该系统启用以来，到2022年，年度通知有所增加。绝大多数涉及程序方面，包括捐助者评估，信息/数据问题，和复苏，offer,分配，器官的保存和运输。可能的供体来源疾病占所有通知的19%，而那些与可能的供体来源感染有关的只有12%。VSEAC,由于审查了这些事件，提出了建议，导致对捐赠者筛查的修改，器官分配,包装和运输。对事件的审查导致了对增加病毒风险供体评估的临床指导的变化，测试,以及随后的器官利用和接受者监测。还审查了其他传染病风险的指南，包括圆线虫，人类嗜T淋巴细胞病毒，和HEV。
结论：澳大利亚的警觉和监测系统使国家对严重不良事件或反应的回顾性报告和评估能够确定趋势，并为流程和指南提供信息。从而提高捐献和移植的安全性。
