Sponsoring Committee: Pediatric Transplantation
Strategic Goal: Promote living donor and transplant recipient safety
Effective date: Pending programming and notification of members
Original policy notice (PDF; 1/2016)
Updated policy notice (PDF; 7/2018)
Amend requirements for primary liver transplant physician
Bylaws language without lines and strikeouts (503 K PDF; 12/2018)
The National Organ Transplant Act (NOTA) requires that the OPTN “recognize the differences in health and in organ transplantation issues between children and adults throughout the system and adopt criteria, policies, and procedures that address the unique health care needs of children.” Although pediatric transplantation is an accepted subspecialty within the field of transplantation, the current OPTN Bylaws do not include any requirements in order for programs to be approved to perform pediatric transplants.
As early as 1993, the Membership and Professional Standards Committee (MPSC) has sought guidance from the Pediatric Transplantation Committee in establishing pediatric requirements so it could better assess key personnel applications. The Committee proposes that a designated transplant program must have an approved pediatric component in order to perform transplants in patients less than 18 years old. To be approved for a pediatric component, a program must identify a qualified primary pediatric surgeon and a qualified primary pediatric physician to serve as key personnel. By establishing pediatric membership requirements, this proposal contributes to the OPTN Strategic Goals of improving transplant outcomes and promoting patient safety, while protecting access to transplantation.
This proposal was available for public comment in August 2015.
It was approved by the board in December 2015.
An earlier version of this proposal was available for public comment in January 2015.
Summary of Changes
The Bylaws will require that a designated transplant program have an approved pediatric component in order to perform kidney, liver, and heart transplants in patients less than 18 years old. To be approved for a pediatric component, a program must identify a qualified primary pediatric surgeon and a qualified primary pediatric physician who will serve as key personnel.
What Members Need to Do
UNOS will distribute a pediatric component application to any member transplant program that has had at least one pediatric patient on its waiting list in the last five years. If you do not automatically receive an application based on this criteria, contact the UNOS Membership Analyst for your region to request one. If you receive an application but don’t intend to apply, please document your intention and submit it to UNOS.
Your program must complete and submit your application to UNOS within 90 days in order to guarantee that we process them before the Bylaws are implemented. UNOS and the MPSC will process each application over the next 18 months. We will notify you of the status of your application before the Bylaws are implemented.
Once the Bylaws are implemented, if your program has pediatric patients on the waiting list and you don’t have approval for a pediatric component, you must follow the transition plan described in Appendix K.5: Transition Plan during Long-term Inactivity, Termination, or Withdrawal.
If your liver or heart transplant program does not have a pediatric component, you may register a patient less than 18 years old on the waiting list if you believe the transplant would prevent a serious or imminent threat to your patient’s health or safety and if the patient qualifies as pediatric liver or heart Status 1A. Your program must submit a pediatric membership exception request to UNOS within 72 hours of the candidate’s registration. The MPSC will retrospectively consult with the Pediatric Transplantation Committee to determine whether an emergency was present and that it was medically inadvisable or commercially impractical to transport the patient to a program with a pediatric component. If the MPSC denies an emergency exception request, that candidate’s registration will be in violation of OPTN obligations and result in punitive action. Approval of an exception is limited to the individual case and does not mean that your program has been approved for a pediatric component.