Proposal to Require Serum Lipase for Pancreas Donors
This proposal advocates for the mandatory collection of serum lipase for all pancreas donors to improve transplant outcomes. Serum lipase serves as a crucial indicator of pancreatic quality, offering valuable insights for better organ matching and patient survival.
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Presentation Transcript
Proposal to Require the Collection of Serum Lipase for all Pancreas Donors (Resolution 5) Pancreas Transplantation Committee Jonathan Fridell, MD, Chair
The Problem Serum lipase is a direct indicator of pancreas quality Serum lipase is not reported for all potential pancreas donors
Why serum lipase? 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
Strategic Plan Improve survival for patients with end stage organ failure Increase number of transplants Strong probability to increase number of high- quality pancreata available Promote best use of donated organs Better matched donated organs to recipients
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
Public Comment Feedback Public Comment Response Tally No Vote/ No Comment/ Did Not Consider In Favor as Amended Response Total Type of Response In Favor Opposed Individual 26 17 (65.38%) N/A 5 (19.23%) 4 (15.38%) Regional 11 11 (100%) N/A 0 (0%) 0 (0%) Committee 19 1 (5.26%) N/A 1 (5.26%) 17 (89.47%)
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
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
Overall Project Impact Product Policy 2.11.E Target Population Impact: All pancreas donors, candidates, and recipients Total IT Implementation Hours 560/10,680 560 0 1000 2000 3000 4000 5000 Total Overall Implementation Hours 705/17,885 705 0 2000 4000 6000
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.
Back-up Slides
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.
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.
A closer look at the data N = 4011 donors with no serum lipase reported on DDR, and PA not recovered for Tx 25% < 45 50% < 55 Age BMI 50% < 27.5 PDRI 25% < 2
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
