1. Geographically Isolated Transplant Program Applicants (Resolution 10) Membership & Professional Standards Committee (MPSC) Jonathan Chen, MD, Chair November 12-13, 2014

2.  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 all, but satisfies most, qualifying requirements  No process exists to do so The Problem

3. #2 – Increase Access to Transplants Reduce geographic disparities in access to transplantation Strategic Plan

4.  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) Goal of the Proposal

5.  The proposed changes will help to maximize the number of donors and transplants by approving capable transplant program applicants who serve a defined geographically isolated area.  The designation and approval of capable transplant programs in geographically isolated areas provides an opportunity for the patients to seek transplant treatment for end stage organ disease which might not be available due to their place of residence. How will the Proposal Achieve its Goal

6. Product Bylaw Addition Target Population Impact: Transplant Hospitals Total IT Implementation Hours 0/10,680 Total Overall Implementation Hours 65/17,885 Overall Project Impact

7.  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 What Members Will Need to Do

8. Public Comment Response Tally Type of Response Respon se Total In FavorIn Favor as amended Oppos ed No Vote/No Comment/ Did not consider Individual1813 (93%) 01 (7%)4 Regional11*10 (91%) 000 Committee19*001 (50%) 17 *Region 2 & Pancreas Transplantation Committee both had equal votes of support and opposition.

9.  Exceptions for program approval undermine the importance of, and established Bylaws requirements for, the program approval process.  Define what constitutes “geographic isolation” to accommodate future scenarios instead of simply listing Alaska, Hawaii, and Puerto Rico as the only areas where this exception could apply. Public Comment Themes

10. RESOLVED, that section A.3.F. (Geographically Isolated Transplant Program Applicants) is added to the OPTN Bylaws, as set forth in Resolution 10, effective February 1, 2015. Resolution 10 (page 19)

11.  A.3.F. Geographically Isolated Transplant Program Applicants  The MPSC may recommend to the Board of Directors the approval of a designated transplant program if the prospective program cannot satisfy the current key personnel requirements due to its geographical isolation. Geographically isolated applicants must demonstrate to the MPSC that the proposed key personnel have both a satisfactory level of transplant experience and an established history of transplant success for the specific organ type indicated in the application for designated transplant program status.

12.  A.3.F. Geographically Isolated Transplant Program Applicants cont…  MPSC recommendation of approval of a geographically isolated program that is not otherwise qualified does not give interim approval to the prospective program. The designated transplant program status of a geographically isolated program that is not otherwise qualified is effective only upon approval of the Board of Directors.  For purposes of this provision, “geographically isolated” is defined as a program located entirely within a state or commonwealth noncontiguous with the mainland United States. This includes Alaska, Hawaii, and Puerto Rico.