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