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提高医疗保健安全和质量，同时降低成本，并采取了不再报销医院治疗指定可预防住院并发症的费用的政策。活体肝移植（LDLT）涉及复杂的护理系统和过程，特别容易发生医疗错误和可预防的并发症。事实上，LDLT供体和受体的并发症发生率分别为20-30%和75%，其中70%被认为是可以预防的。有效消除LDLT中可预防的并发症将需要仔细关注LDLT供体和受体护理系统和过程中的漏洞。在护理活体捐献者时，预防此类事件尤为重要，因为他们是健康的志愿者，纯粹出于利他主义的原因接受重大手术，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供体死亡事件，供体安全的重要性被放大了。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，新的方案，如用于确认供体和受体之间ABO相容性的方案，已经非常有效。本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主动，系统和全面的方法应用于LDLT系统和护理过程。对潜在漏洞的主动、系统和全面识别将允许开发和实施旨在缓解这些漏洞的解决方案，从而减少LDLT中的医疗错误和可预防的并发症。这项研究将建立在成人至成人活体肝移植队列研究（A2 ALL）的相当大的优势上，作为A2 ALL联盟的辅助研究。A2 ALL已经认识到提供安全可靠的LDLT护理的重要性，并将供体安全性作为次要目标，并完全支持本研究。9家A2 ALL中心中的7家将作为干预或对照中心参与本研究，因此，代表了在美国进行的所有LDLT的50%以上。这项研究是新颖和创新的，因为它试图将应对医疗错误的范式转变为评估和改善系统和流程安全性的积极方法，以防止活体肝移植（LDLT）中的医疗错误发生。本研究将应用其他高风险行业成功应用的适应性方法，以生成有关LDLT安全性的新的重要信息。LDLT提供了一个很好的机会，以充分评估医疗错误和可预防的并发症的机制，因为几乎没有受供体共病条件混淆的风险。

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.