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Proposal to Require the Collection of Serum Lipase for all Pancreas Donors (Resolution 5)

This proposal aims to require the collection of serum lipase for all potential pancreas donors, as it is a critical test for evaluating the quality of the pancreas offered for transplantation. Serum lipase is a direct indicator of pancreatic injury or inflammation and provides transplant professionals with important information about the pancreas quality. This resolution has been recommended by the Pancreas Transplantation Committee and is pending approval.

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Proposal to Require the Collection of Serum Lipase for all Pancreas Donors (Resolution 5)

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

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

  3. Why serum lipase? Lipaseis 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

  4. StrategicPlan

  5. Data

  6. How the Proposal will Achieve its Goal 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

  7. Public Comment Feedback

  8. Public Comment: Common Themes • 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

  9. Post Public Comment Outreach/Follow Up • 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

  10. Overall Project Impact All pancreas donors, candidates, and recipients

  11. Resolution 5 (page 13) 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.

  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. Resolution 6 (page 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.

  15. A closer look at the data N = 4011 donors with no serum lipase reported on DDR, and PA not recovered for Tx

  16. Details About Other OPO comments • 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

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