Proposal to Require the Collection of Serum Lipase for all Pancreas Donors (Resolution 5) Pancreas...
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Transcript of Proposal to Require the Collection of Serum Lipase for all Pancreas Donors (Resolution 5) Pancreas...
Proposal to Require the Collection of Serum Lipase for all
Pancreas Donors (Resolution 5)
Pancreas Transplantation CommitteeJonathan Fridell, MD, Chair
Serum lipase is a direct indicator of pancreas quality
Serum lipase is not reported for all potential pancreas donors
The Problem
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?
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
Data
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
Public Comment Response Tally
Type of Response Response Total In Favor
In Favor as Amended Opposed
No Vote/No Comment/
Did Not Consider
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 Feedback
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
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
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
0 1000 2000 3000 4000 5000
Se-ries1
0 1000 2000 3000 4000 5000 6000
Se-ries1
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)
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.
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)
A closer look at the data
•25% < 45•50% < 55Age•50% < 27.5BMI•25% < 2PDRI
N = 4011 donors with no serum lipase reported on DDR, and PA not recovered for Tx
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