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Applying for OPTN vascularized composite allograft transplant program approval

Federal laws and regulations were revised in 2014 to expand the classification of “human organ” to include vascularized composite allografts (VCA). Bylaws approved by the OPTN Board of Directors set criteria for the designation and approval of a VCA transplant program. The rules state that a VCA transplant program must have and maintain approval for a separate organ transplant program to be approved to perform VCA transplants. This means that the VCA transplant program cannot be the sole active and approved transplant program at the member hospital.

Here’s a list of membership requirements for VCA programs. You will find more details in the OPTN Bylaws Appendix D, Section D.2, and Appendix J. Go to Resources > By Organ > VCA for additional information.

For designation and approval as a VCA transplant program, the applicant must:

  1. Be an OPTN approved transplant hospital member,
  2. Have at least one active and approved transplant program at all times (the VCA transplant program cannot be the only active transplant program), and
  3. Submit written notification on hospital letterhead to the OPTN Contractor declaring the hospital’s intent to perform VCA transplants and requesting OPTN designation and approval as a VCA transplant program. This notification must: a) Specify the type or types of VCAs the hospital will transplant b) Include the names and contact information of the following individuals for each type of VCA the hospital will transplant:   (1) The reconstructive surgical director with experience in microsurgical reconstruction, prior experience in VCA, or in lieu of actual VCA experience, extensive experience in the applicable reconstructive procedure, and   (2) The transplant specialist (transplant surgeon or transplant physician) directing medical care. c) Include a copy of written assurance from its local OPO specifying the VCA allograft organs it will provide from deceased organ donors; and d) Be signed by all three of the following VCA program principals:   (1) Designated reconstructive surgical director (same as above)   (2) Designated transplant specialist directing medical care (same as above)   (3) Transplant hospital’s Chief Administrative Officer, i.e. CEO or COO.

Submit the written notification to:

Jacqueline O’Keefe, Assistant Director, Member Quality at UNOS
700 North 4th Street
Richmond, VA 23219

Email: jacqueline.okeefe@unos.org
Phone: 804-782-4857
Fax: 804-782-4896

UNOS staff will send the VCA transplant program applicant written initial (interim) approval immediately after review and confirmation that the submitted information meets the requirements. Interim approval permits immediate listing of VCA candidates and mandates compliance with approved OPTN requirements for VCA transplantation by the approved program. Final approval will be considered by the board at a later date.

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