A2ALL- Patient Safety System Improvements in Living Donor Liver Transplantation

描述(由申请人提供)：医疗保险和医疗补助服务中心越来越注重在降低成本的同时提高医疗保健安全和质量，并采取了一项政策，即不再报销医院治疗指定的可预防住院并发症的费用。活体供肝移植(LDLT)涉及复杂的系统和护理过程，特别容易受到医疗差错和可预防的并发症的影响。事实上，供者和受者的并发症发生率分别为20-30%和75%，其中70%被认为是可预防的。要有效消除最低限度减贫方案中可预防的并发症，需要认真注意为最低限度减贫方案捐赠者和接受者提供护理的系统和程序中的脆弱性。预防这类事件在照顾活着的捐赠者时尤其重要，因为他们是健康的志愿者，他们纯粹是为了利他的原因正在接受重大手术，而没有任何直接利益。鉴于今年早些时候在美国发生的两起LDLT捐赠者死亡事件，捐赠者安全的重要性被放大。在减少医疗差错和可预防的并发症方面已经取得了相当大的进展。在移植领域，用于确认供受者ABO相容的新方案已经非常有效。这项研究建议将在其他高风险行业中成功使用并适用于医疗保健的前瞻性、系统性和综合性方法应用于LDLT系统和护理流程。对潜在漏洞的主动、系统和全面识别将使开发和实施旨在缓解这些漏洞的解决方案成为可能，从而减少LDLT中的医疗差错和可预防的并发症。这项研究将建立在成人到成人活体肝移植队列研究(A2ALL)作为A2ALL联盟的辅助研究的相当大的优势的基础上。A2ALL已经认识到提供安全可靠的LDLT护理的重要性，并已将供者安全作为次要目标，并全力支持这项研究。九个A2ALL中心中的七个将作为干预或控制中心参与这项研究，因此，占美国进行的所有LDLT的50%以上。这项研究具有新颖性和创新性，因为它试图将对医疗差错的反应范式转变为一种积极主动的方法，即评估和改进系统和过程的安全性，以防止活体供肝移植(LDLT)中的医疗差错发生。这项研究将采用其他高风险行业成功应用的适应方法，以产生有关LDLT安全的新的重要信息。LDLT提供了一个很好的机会来充分评估医疗差错和可预防的并发症的机制，因为几乎不存在因捐赠者合并疾病而引起混淆的风险。

DESCRIPTION (provided by applicant): The Centers for Medicare and Medicaid Services have become increasingly focused on improving healthcare safety and quality while decreasing costs and adopted a policy of no longer reimbursing hospitals for the costs of treating designated preventable inpatient complications. Living donor liver transplantation (LDLT), involves complex systems and processes of care that are particularly vulnerable to medical errors and preventable complications. In fact, complication rates for LDLT donors and recipients are 20-30% and 75%, respectively, of which 70% are deemed preventable. Effective elimination of preventable complications in LDLT will require careful attention to the vulnerabilities in the systems and processes of care for LDLT donors and recipients. Prevention of such events is especially important when caring for living donors, given that they are healthy volunteers undergoing a major procedure purely for altruistic reasons without any direct benefit. The importance of donor safety is magnified in light of the two LDLT donor deaths, earlier this year in the United States. Considerable advances in reducing medical errors and preventable complications have already been achieved. In the field of transplantation, new protocols such as those used to confirm ABO compatibility between the donor and recipient have been highly effective. This study proposes to apply the proactive, systematic, and comprehensive approaches successfully used in other high risk industries and adapted for healthcare, to LDLT system and processes of care. The proactive, systematic, and comprehensive identification of potential vulnerabilities will permit the development and implementation of solutions designed to mitigate these vulnerabilities and, thus, reduce medical errors and preventable complications in LDLT. This study will build on the considerable strengths of the Adult-to-Adult Living Liver Transplant Cohort Study (A2ALL) as an ancillary study of the A2ALL consortium. A2ALL has recognized the importance of providing safe and reliable LDLT care, and has made donor safety a secondary aim and fully supports this study. Seven of the nine A2ALL centers will be involved in this study either as an intervention or a control center, thus, representing more than 50% of all LDLTs performed in the US. This study is novel and innovative, because it seeks to shift the paradigm of response to medical errors to a proactive approach of assessing and improving the safety of systems and processes to prevent medical errors in living donor liver transplant (LDLT) before they occur. This study will apply adapted methods successfully applied by other high risk industries to generate new and important information about LDLT safety. LDLT provides an excellent opportunity to fully assess the mechanisms of medical errors and preventable complications as there is little risk of confounding by donor co-morbid conditions.