Vascularized Composite Allograft (VCA) transplant programs are currently not regulated by the Organ Procurement and Transplantation Network (OPTN) or by the Centers for Medicare and Medicaid Services (CMS) which regulate solid organ transplant programs. This may soon change as the U.S. Department of Health and Human Services issued a proposed rule in January 2012 to include these allografts within the definition of organs under the authority of the OPTN. Transplant programs that perform VCA transplants would then be subject to oversight by the OPTN for compliance with policies in the Final Rule.

As the VCA Transplant Program was evolving it was clear that it could benefit from the resources of the Transplant Center. This included administrative support; clinical support of transplant surgeons, infectious disease consultants and immunology staff; as well as the human resource support of transplant coordinators, social workers, nutritionists, psychiatrists, pharmacists, financial coordinators and quality/compliance staff. In addition to the personnel support the Transplant Center also provided the regulatory framework for policies and procedures, quality/compliance and patient education which would further enhance the program’s structure. The CMS requirements of patient selection, informed consent, patient rights, organ recovery and receipt, multidisciplinary care and quality assessment/performance improvement were all incorporated into the VCA program. As there is currently no SRTR data regarding VCA graft and patient survival, the most recent data from the International Registry of Hand and Composite Tissue Transplant and the American Society for Reconstructive Transplantation was reviewed with the candidate.

The Massachusetts General Hospital has performed its first vascular composite allograft transplant. The structure, patient evaluation/education/notification, organ verification and discharge planning all mirrored that of the solid organ transplant patients. The policies, procedures and QAPI program have all been modified to incorporate the VCA program. A quality audit of the process from evaluation to discharge ensured that all key elements abided by OPTN and CMS regulations of that of solid organ transplants.

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