Pancreas Transplantation Committee 2 What p roblem will the proposal solve Current islet Bylaws personnel requirements do not reflect the need for islet experience and expertise Suitable candidates with extensive isletspecific experience may not qualify ID: 1034220
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1. 1Changes to Islet BylawsPancreas Transplantation Committee
2. 2What problem will the proposal solve? Current islet Bylaws personnel requirements do not reflect the need for islet experience and expertiseSuitable candidates with extensive islet-specific experience may not qualifyCandidates without islet-specific experience could achieve leadership positions in islet programsIslet programs are required to be connected to pancreas programs
3. Summary of changes:3Current BylawsProposed Changes2 primary personnel – primary surgeon, primary physician1 primary person to lead the program – clinical leaderRecommended expert personnelRequired, revised expert medical personnelConnection with pancreas programNo connection with pancreas program required
4. “Clinical leader” replaces “primary personnel”: more islet-specific requirementspre-, peri, post tx care of 6 islet patientsAt least 1 allogeneic islet patient3 islet isolationsAt least 1 allogeneic islet isolationBackground in transplant medicine, immunosuppression management endocrinology, beta cell biologyPhysician or surgeon, with standard accreditation What are the proposed solutions?4
5. “Expert Medical Personnel” to ensure islet program has adequate level of careAbdominal surgeon to handle complicationsSurgeon or interventional radiologist for portal vein accessPhysician to handle immunosuppressionEndocrinologist or physician to oversee metabolic outcomes Free-standing islet programsNot required to have connection to pancreas programWhat are the proposed solutions?5
6. Transplant HospitalsMembership applications updated to reflect the new islet personnel requirementsMember hospitals with approved islet transplant programs must submit one of these during application submission period:Completed islet transplant program applicationOpt out form indicating the hospital is voluntarily inactivating or withdrawing its program approvalHow will members implement this proposal?6
7. ImplementationOMB approvalNew islet transplant program application formOnce OMB approves, application periodMonitoringNumber of islet program applications - # approved, # declinedNumber of islet transplantsHow will the OPTN implement this proposal?7
8. Do you support the proposed requirements for the clinical leader position? Should we add or remove anything from these requirements?Do you agree/disagree with the proposed change to allow islet programs to be free-standing?Questions for the Community:8
9. Questions?9
10. MPSC identified continued concern with islet personnel Bylaws in March 2017 & recommended Pancreas Committee revisitProject put on hold in 2015, taken off hold in 2017Throughout 2017-2018, Subcommittee worked to improve islet program BylawsClinical consensus in Islet Bylaws Subcommittee included: various perspectives (tx surgeon, tx administrator, islet expertise) special emphasis on islet-specific experience, including 2 leaders of islet programsProvided updates to MPSC, AST, ASTS, CITR before public commentHow was this proposal developed?10