1. Membership & Professional Standards Committee Spring 2014
Proposal to Allow MPSC Recommendation to the Board of Directors for Approval Consideration of a Non-qualifying Transplant Program Applicant in a Geographically Isolated Area
Membership & Professional Standards Committee
Spring 2014

2. The Problem
MPSC cannot designate and approve an applicant that does not satisfy qualifying requirements
MPSC may want to recommend an applicant to the Board that doesn’t meet qualifying requirements
No process exists to do so
The MPSC reviewed an application for a new pancreas transplant program at The Queens Medical Center in Hawaii. The applicant proposed key personnel who had successfully performed pancreas transplantation at a now closed Hawaiian transplant hospital. The original pancreas transplant program was approved in 1992, and pancreas transplant surgery had been performed there continuously under the direction of the new program’s proposed primary surgeon until its closured in December A majority of the pancreas transplant staff from the closed transplant hospital also moved to the new facility. The submission of a new pancreas transplant program application was unavoidable, and the MPSC was obligated to review it for compliance using current approved program designation and approval requirements. While the proposed primary surgeon originally met qualifying requirements in 1992, he did not satisfy current approval criteria. The reason for this was his inability to perform a sufficient number of pancreas transplants in Hawaii in order to meet or maintain primary pancreas surgeon qualifying criteria. The average number of pancreas transplants historically performed in Hawaii is less than two a year. An acknowledged explanation as to why so few pancreas transplants were performed was the geographic isolation of Hawaii from the mainland US.
Since essentially the same pancreas transplant team which led the pancreas transplant program at the closed transplant hospital would be the basis for the new hospital’s program and the committee cannot recommend approval of a non-qualifying transplant program application, the MPSC voted to recommend that the Board consider approving this applicant given prior pancreas transplant program success. They felt that the program should not be denied an opportunity for approval because of its inability to qualify due to the primary’s lack of opportunity due to geographical isolation.
No mechanism exists for the MPSC to request the Board of Directors to consider transplant program approval, nor does the Board of Directors have a process to accept such a request. This proposed bylaw sets up a process and is not intended to set approval criteria or conditions for the Board of Directors.

3. Goal of the Proposal
Create a process for MPSC to recommend the Board consider approving a program not meeting all qualification criteria
Set exact circumstances when such a recommendation can be made
Establish that transplant program designation and approval is effective only upon approval of the Board of Directors (no interim approval)
It is important to keep in mind that the goal of this proposal is just to create a process by which the MPSC can recommend to the Board of Directors that they consider approving a transplant program applicant which does not meet all the qualification criteria. The proposal does not attempt to establish approval principles.
The MPSC does not want to generate an expectation within the transplant community that non qualifying applicants can appeal an application rejection when they felt that their situation is unique and existing qualifications should not apply in their case. So, to limit the exception arguments, this proposal defines exactly under what conditions this process can be used. The conditions are:
geographically isolated –a transplant program located entirely within a state or commonwealth, noncontiguous with the mainland United States. This includes, but is not limited to, Alaska, Hawaii, and Puerto Rico.
applicant inability to meet current key personnel requirements is the only unmet qualifier under consideration
applicant demonstrates previous peer acceptable transplant performance operating as a unit with primarily the same personnel and is free from any MPSC and OPTN imposed sanctions for performance and compliance-related issues.
The MPSC makes recommendations to the Board for approval consideration. The MPSC cannot designate and approve a transplant program if the applicant does not meet all requirements. Transplant program designation and approval is only granted by the Board of Directors.
By adding a few words to the existing policy language, the proposal will clarify member obligations and will reduce the amount of time spent by staff and the MPSC when investigating potential noncompliance issues.
The proposed bylaw language makes available a mechanism by which the MPSC can recommend to the Board of Directors that the Board might consider designating and approving a transplant program which currently cannot meet key personnel qualifying criteria because the applicant is located in an acknowledged geographically isolated area.
Currently, if an applicant cannot meet transplant program qualification criteria, the application is rejected by the MPSC and the applicant notified of the reasons for rejection. To pursue transplant program approval further, the applicant can do one of the following: submit additional qualification documentation, withdraw the application, or invoke its due process rights. Due process rights are covered in Appendix L of the OPTN bylaws. These rights include offering the applicant an interview and/or a hearing with the OPTN. In addition, the applicant can at any time directly appeal the decision to the Secretary of Health and Human Services (HHS). This is in accordance with OPTN Final Rule, 42 CFR Part 121.

4. What Members Will Need to Do
No action required
Affects a very small number of select hospitals and their programs
Application submission and review process continues by the MPSC
If MPSC recommends an exception consideration to the Board, applicant will be notified
This proposal will not change the application process for transplant program designation and approval. The MPSC will handle these cases in the same manner as before.
Only transplant hospitals in a state or commonwealth, noncontiguous with the mainland United States could be affected by this bylaw change.

5. Request for Feedback
Should the Board of Directors make any exceptions to transplant program designation and approval requirements?
If yes, is allowing transplant program approval because of limited ability to transplant in defined geographically isolated areas an acceptable exception?
It would be very helpful if the region provided feedback on these principles.
Since the qualification standards approved by the Board of Directors represent the minimum criteria which must be met by an applicant for transplant program designation and approval, is it appropriate to accept less than full qualification compliance regardless of the applicant’s situation? Is there a patient safety issue? Are the patients potentially at risk for receiving inferior care when allowing any qualification exception? These answers are pivotal in determining whether or not to provide this proposed process.
Is geographical isolation an acceptable exception for approval? Is the definition of geographical isolation too broad? too limiting? appropriate? If allowances are amenable to you what other allowances might be appropriate?

6. Questions? Carl Berg, MD Committee Chair carl.berg@duke.edu
Name Region # Representative
David Kappus Committee Liaison