1. Proposal for the Definition of Pancreas Graft Failure
Pancreas Transplantation Committee
Fall 2014
Hi, my name is _____________ and I am going to present the Pancreas Committee’s Proposal for the Definition of Pancreas Graft Failure.

2. The Problem No consistently used definition for pancreas graft failure
leads to inconsistent reporting
impacts MPSC outcome reviews
Currently, there is no nationally and consistently used definition for how to identify and document pancreas graft failure. This leads to great variation in how transplant programs report pancreas graft failure to UNOS and, consequently, limits the MPSC’s ability to consistently analyze and compare pancreas program outcomes.
For example, programs report graft failures at different endpoints. Some report a graft as failed if there is any return to insulin therapy whereas others only report failure if insulin use rises above a certain threshold. Dosage of insulin, duration of insulin therapy, c-peptide levels, and Hba1c are some parameters that can vary widely in patients who have been determined to have graft failure at their respective institution.
As the MPSC implements use of statistical models to assess pancreas program performance, this difference in reporting could impact whether a pancreas program is identified for outcome review. Essentially, reported pancreas graft failure cannot be compared across centers if it is not being reported according to the same standards.

3. Goal of the Proposal
Consistent determination of what events constitute pancreas graft failure
Develop policy to define when graft failure occurs which will subsequently lead to consistent reporting
Therefore, we are proposing to use a consistent determination of what events constitute pancreas graft failure. We will do this by developing policy to define when graft failure occurs, which will subsequently lead to consistent reporting.
Although the proposed changes are a significant step forward in the effort for transplant professionals to consistently identify and document pancreas graft failure on a national basis, the Pancreas Transplantation Committee acknowledges the proposed language has room for growth.

4. How the Proposal will Achieve its Goal
Draft policy to define when pancreas graft failure occurs:
recipient’s transplanted pancreas is removed
recipient re-registers for a pancreas
recipient registers for an islet transplant after receiving a pancreas transplant
recipient’s insulin use is greater than or equal to 0.5 units/kg/day for a consecutive 90 days
recipient dies
The proposed changes define pancreas graft failure when any of the following occurs:
A recipient’s transplanted pancreas is removed
A recipient re-registers for a pancreas
A recipient registers for an islet transplant after receiving a pancreas transplant
A recipient’s insulin use is greater than or equal to 0.5 units/kg/day for a consecutive 90 days
A recipient dies

5. How the Proposal will Achieve its Goal
Updates to pancreas and kidney-pancreas OPTN Recipient Registration and Recipient Follow-Up forms:
Remove “Partial Function”
Modify instructional language
Create additional fields
If this proposal is approved, Tiedi help documentation will be added surrounding how to document pancreas graft failure.
There will also be several updates to the Tiedi forms including:
Removing the “Partial Function” option on the adult pancreas and kidney-pancreas OPTN Recipient Registration and Recipient Follow-Up forms
Modifying the instructional language, in red, to coincide with the proposed definition of pancreas graft failure
Programming additional fields
Fasting C-peptide serum level (ng/ml)
HbA1c (%)
Insulin use – amount per kg/day and duration of use
Potential language changes to instructional language:
“If the recipient does not fall within one of the OPTN policy definition categories of pancreas graft failure, at the time of death, then report the graft as “Functioning” OR
“ If death is indicated for the recipient, report graft status up until the instance of death.”

6. What Members will Need to Do
Transplant centers will need to:
Report pancreas graft failure according to the definition
Report additional information when filling out the pancreas and kidney-pancreas OPTN Data Collection forms
In order to comply with the policy change a pancreas program will need to report pancreas graft failure according to the new definition and be aware of the changes to the pancreas OPTN Data Collection Forms.  
Further, the transplant center will be required to provide additional information when filling out the pancreas and kidney-pancreas OPTN Data Collection Forms.

7. Specific Request for Feedback
Policy 1.2 Definitions
Graft failure: Occurs when an organ is removed, a recipient dies, or a recipient is placed on a chronic allograft support system.
Should there be one general definition for graft failure that applies across all organ types?
Alternatively, should there be organ specific definitions of graft failure?
As part of this effort, we are also soliciting feedback on the current general definition of graft failure used to assess outcomes. In addition to your feedback, we are asking the organ specific committees to provide their feedback as well.
Currently, the general definition of “Graft Failure”, in Policy 1.2 Definitions, has room for improvement.
The definition of “Graft Failure” currently in policy states that graft failure “occurs when an organ is removed, a recipient dies, or a recipient is placed on a chronic allograft support system”.
Should there be one general definition for graft failure that applies across all organ types?
Alternatively, should there be organ specific definitions of graft failure?
Once we have this feedback, we’ll determine how to proceed (whether each organ specific committee will take up the issue separately or a committee with cross organ representation (like POC) might take up the issue).

8. Questions? Jonathan Fridell MD Committee Chair jfridell@iupui.edu
Regional representative name (RA will complete) Region X Representative address
Kristina Tyler JD Committee Liaison