1. Proposal to Require the Collection of Serum Lipase for all Pancreas Donors (Resolution 5) Pancreas Transplantation Committee Jonathan Fridell, MD, Chair

2.  Serum lipase is a direct indicator of pancreas quality  Serum lipase is not reported for all potential pancreas donors The Problem

3. Lipase is a pancreatic enzymes that catalyzes the hydrolysis of fats  Elevated serum lipase is a marker of pancreatic injury or inflammation  When PA injured or inflamed, lipase is released into the circulation  Unlike serum amylase, lipase is more specific to the PA and the levels remain elevated longer  Most essential test to evaluate PA quality for transplant Why serum lipase?

4. Increase number of transplants Strong probability to increase number of high- quality pancreata available Improve survival for patients with end stage organ failure Promote best use of donated organs Better matched donated organs to recipients Strategic Plan

5. Data

6. Goal  Provide transplant professionals with critical information about the quality of the pancreas offered Change  Require collection of serum lipase for all pancreas donors  Report lab’s upper limit of normal value for serum lipase test How the Proposal will Achieve its Goal

7. Public Comment Response Tally Type of Response Response Total In Favor In Favor as Amended Opposed No Vote/ No Comment/ Did Not Consider Individual2617 (65.38%)N/A5 (19.23%)4 (15.38%) Regional1111 (100%)N/A0 (0%) Committee191 (5.26%)N/A1 (5.26%)17 (89.47%) Public Comment Feedback

8.  Geographically remote OPOs may not be able to comply with serum lipase requirement  Some OPOs’ labs do not run a serum lipase test  Some OPOs’ labs currently run the serum lipase test once a day  Question whether serum lipase is a strong indicator of pancreatic quality Public Comment: Common Themes

9.  Outreach to OPO Committee  Pancreas Committee investigated numerous alternatives but none could be supported by both committees  Pancreas Committee is recommending policy be approved with no post-public comment changes Post Public Comment Outreach/Follow Up

10. Product Policy 2.11.E Target Population Impact: Total IT Implementation Hours 560/10,680 Total Overall Implementation Hours 705/17,885 Overall Project Impact All pancreas donors, candidates, and recipients

11. RESOLVED, that Policies 2.11.E Required Information for Deceased Pancreas Donors are modified as set forth below, are hereby approved, effective pending programming and notice to OPTN membership. Resolution 5 (page 13)

12. Back-up Slides

13. Exception language If serum lipase results are not available at the time of the pancreas offer because the laboratory could not provide the results prior to the pancreas offer, the host OPO must do both of the following: 1. Report to the OPTN Contractor that the serum lipase results were not available at the time of the pancreas offer. 2. Provide serum lipase results to the transplant hospital as soon as they become available.

14. RESOLVED, that Policies 2.11.E Required Information for Deceased Pancreas Donors are modified as set forth below, are hereby approved, effective pending programming and notice to OPTN membership. Resolution 6 (page 14)

15. A closer look at the data 25% < 45 50% < 55 Age 50% < 27.5 BMI 25% < 2 PDRI N = 4011 donors with no serum lipase reported on DDR, and PA not recovered for Tx

16.  Suggestion that P-PASS score (which includes lipase) does not show impact on graft survival  Pointed out that Pancreas Donor Risk Index (PDRI) does not include lipase as PA donor risk factor Details About Other OPO comments