Proposal to Require Reporting of Every Islet Infusion to the OPTN Contractor within 24 Hours of the Infusion Pancreas Transplantation Committee Fall 2012

 No current requirement to report islet infusion  Which islet recipients have received infusions?  patient safety implications  disease transmission implications The Problem

 Accurate and timely reporting of each islet infusion  Policy and bylaw language to reflect current practice Goal of the Proposal

 Requirement to report each islet infusion within 24 hours  candidate can still retain waiting time through 3 islet infusions  Remove outdated bylaw language (re: submitting islet logs)  logs currently not collected  Accurately reflect the current programming regarding registration fees and relisting How the Proposal will Achieve its Goal

 217 islet candidates as of 12/31/11  70 islet recipients in 2011  21 approved islet programs  Islet recipients benefit from efficient notification of patient safety or disease transmission events Impact

 June 2013—Board will consider  Sept 1, 2013—Effective Date Expected Implementation

 Remove islet recipients from the waiting list within 24 hours of islet infusion  Follow patient notification protocol for re-listing transplant candidates, if listing candidate for another infusion  Do not submit cumulative islet logs What Members will Need to Do

 Does the proposal state clearly that islet candidates can still accrue waiting time through three islet infusions, even though they must now be removed from the waiting list within 24 hours of each infusion instead of only after the third infusion?  Policy language can be found on pages XX – XX in the public comment document. Specific Request for Comment

 Chair: David Axelrod, MD   Vice-Chair: Jonathan Fridell, MD   Committee Liaison: Ms. Vipra Ghimire   (804) Pancreas Committee Contacts