This proposal updates existing OPTN policy and bylaw language and establishes new requirements to add Vascularized Composite Allografts (VCAs) to the definition of organs covered by the rules governing the operation of the Organ Procurement and Transplantation Network (OPTN). Specifically, it contains the following elements:

1. Definition of a VCA
2. VCA Membership Criteria
3. VCA allocation
4. Donor authorization to recover VCAs
5. Policy and bylaw language necessary to specifically exempt application to VCAs and avoid eliminating existing safeguards that apply to all other organs.

By statute, the Secretary of HHS may expand the definition of human organs and has exercised this authority by adding VCAs to the covered list of human organs under the OPTN modified Final Rule. This proposal is in response to a directive from the Health Resources and Services Administration (HRSA) to develop VCA policies prior to implementation of the modified Final Rule which became effective July 3, 2014. Because of the pending statutory change at the time, these policy changes were approved by the OPTN Board of Directors during its June 23-24, 2014 meeting with an 18 month “sunset” date on December 24, 2015. The Board will review and consider these public comments for approval during the June 1-2, 2015 meeting. More discussion within the VCA transplant community will be necessary to develop a refined system guiding OPTN, OPO, and transplant center processes for VCA transplantation.

The Bylaws and Policies contained within this proposals mirror those approved by the Board in June 2014. Concurrent with that effort, the VCA Committee began work on more long-term, substantive data collection policies. A separate proposal concerning those efforts is also being released during this public comment period. If comment is favorable on the separate data collection proposal, those provisions would be forwarded for final approval instead of the proposed amendments to Policies 18.1 and 18.2 in this proposal.

Read the full proposal