Vascularized Composite Allograft Transplantation Committee Fall 2014 Progress Report Vascularized Composite Allograft Transplantation Committee Fall 2014

Ongoing Committee Initiatives VCA Program Membership VCA Graft Failure We are also working on the following additional policy and bylaws changes. Refining VCA Membership Criteria – The committee drafted the current VCA Program Membership requirements to put minimum membership standards into place for VCA program approval beginning July 3, 2014. Our Membership Subcommittee is working on future public comment proposal for specific criteria for upper limb, lower limb, face, abdominal wall, and “other VCA” transplant programs. These will be similar to the primary surgeon and primary physician requirements of other organ specific requirements to the extent possible. The Subcommittee is considering challenges faces by other organs and restrictive membership requirements. The intent is to be inclusive as possible to surgeons and physicians interested in VCA transplantation. We anticipate these proposed requirements will be shared for Public Comment in 2015. VCA Graft Failure Definition – The current OPTN definition of “graft failure” is very broad and the committee is concerned that this definition does not fit VCA graft failure well. The Data Subcommittee will work on a VCA-specific definition of graft failure in the future. If you have specific feedback concerning the development of these two elements, please contact your Regional Administrator.

New Committee Initiatives VCA Allocation The VCA Committee’s initial allocation algorithm was intended to allow broader access to VCA grafts from donors. Yet, in the future, the committee hopes to move away from the “regional, then national” algorithm to a more advanced model. This future model may resemble the algorithm currently used for hearts; concentric distances from the donor hospital. Data is central to this VCA allocation enhancement. The Committee wants to better understand the role of cold ischemic time as it relates to graft and patient outcomes. This may impact future allocation modeling for VCAs. Donor Hospital Regional National

Educational Resources VCA Donor Authorization Guidance Document Memo: VCA Grafts in Reconstructing Abdominal Wall VCA Membership Application Help Document We are working on a number of educational resources to help transplant programs and OPOs comply with the new policies and bylaws: The VCA Committee developed a Guidance Document for VCA Donor Authorization. The Board will review this document at its November 2014 meeting and, if approved, it will be available on the OPTN and Transplant Pro websites. In this document, OPOs with experience in VCA recoveries share best practices. Another resource includes a memo that clarifies the use VCA grafts when reconstructing the abdominal wall. The VCA Committee recognized the potential for surgeons in the United States to need tissue that meet the nine criteria of a VCA in abdominal procedures for both transplant and non-transplant patients. Furthermore, the Committee was concerned that surgeons may be unaware of the regulatory change and the processes that required before they engage in this clinical practice. Finally, if you are considering adding a VCA program at your transplant hospital, help documentation to walk you through the application process will be available. You will be able to access all of these resources on the OPTN website in the coming months.

OPO Responsibilities Access OPTN VCA Candidate List in Secure Enterprise Add note in Donor Highlights for any VCA Donor “VCA Donor [type]” Allocate VCAs only from VCA candidate list to OPTN approved VCA programs Record allocation efforts and return to OPTN (vca@unos.org) OPOs must: Access the OPTN VCA Candidate List in Secure Enterprise. Your UNet Site Administrator can make these permission changes. For any VCA Donor, add a comment in the Donor Highlights section of DonorNet “VCA Donor [type]” Allocate VCAs only from the VCA Candidate List to OPTN approved VCA transplant programs. Record allocation efforts for each VCA that consent was obtained on separate copies of the VCA candidate list. Please do not use one copy of the VCA candidate list to record allocation for multiple VCA types, i.e.: a hand and face donor. Return completed copies via secure email to vca@unos.org.

Transplant Program Responsibilities Submit VCA application to OPTN After approval, email vca@unos.org to obtain worksheets Complete contact information worksheet to receive VCA offers Use registration and removal worksheets to add or remove VCA candidates VCA Transplant programs must: Submit a letter of intent to transplant VCAs to the OPTN . Requirements for this letter can be found in the OPTN Bylaws, Appendix J. After your program is approved, you will receive a packet of information including copies of several worksheets used in the process of listing and removing VCA candidates. These are for reference only. Electronic copies of the worksheets must be used to list or remove a VCA candidate. Please email vca@unos.org to request the needed worksheets. Complete the VCA Contact Information worksheet with the names and contact information for individuals from your program who will receive VCA offers from OPOs. Send via secure email to vca@unos.org. Complete the VCA Candidate Registration worksheets for patients you want to list. Send via secure email to vca@unos.org. You will receive a confirmation receipt once your patient is listed. Complete a VCA Candidate Removal worksheet for a candidate who is transplanted, dies, or is removed for other reasons. Send via secure email to vca@unos.org. You will also receive a confirmation receipt once the removal is processed. More detailed data collection on VCA candidates and recipients will follow in the future. A Public Comment proposal from the VCA Committee on VCA Data Collection and Submission is out consideration now.