1. Revisions to Pediatric Emergency Membership Exception
Pediatric Transplantation Committee

2. What problem will the proposal solve?
Current requirements for pediatric emergency exceptions are unclear and subjective
Lack of clear, objective requirements could lead to adverse action
As currently written, the language for the pediatric emergency membership exception pathways would require the MPSC to retrospectively review a transplant team’s clinical decisions. A transplant team making the decision would have no frame of reference for how much risk would be considered acceptable while they make the decision because of the subjective nature of the requirements. For example, the listing transplant program must demonstrate that it "believes" the patient must be transplanted, and that transfer to a pediatric hospital is "medically inadvisable or commercially impractical.“
The lack of objective guidance to OPTN members could put a transplant program at risk of an adverse action for performing an unapproved organ transplant.

3. What are the proposed solutions?
Improvements to Pediatric Emergency Membership pathways only
Clarifies when heart and liver programs must transfer patients to a transplant hospital with an approved pediatric component
Address concerns from the OPTN/UNOS Board and MPSC over:
OPTN’s ability to monitor and enforce the requirements
Subjective and unclear criteria
The scope of this proposal only includes improvements and modifications to the emergency membership exception pathways for heart and liver transplant programs. Modifications to the minimum training and experience requirements approved by the Board in 2015 are not being made. During two rounds of public comment (January and August 2015), the transplant community and general public expressed support for creating a pathway for adult heart and liver transplant programs. The amendments to the pathways contained in this proposal add clarity, objective criteria that are consistent with other areas of OPTN policy, and address concerns in the earlier language.
The Committee collaborated with the OPTN/UNOS Membership and Professional Standards Committee (MPSC) to amend the pathway in The proposed changes include objective requirements for heart and liver transplant programs that want to register a candidate less than 18 years old. These changes will address concerns over:
the OPTN’s ability to monitor and enforce the requirements,
subjective and ill-defined language in the prior version of the pathway,
how the pathways will work operationally, and
what objective criteria will be used to determine when it is acceptable to transplant a pediatric candidate using one of the pathways.

4. What are the proposed solutions?
Adult Heart Program Requirements
Unable to be transported to a transplant hospital with an approved pediatric component
Consulted with pediatric heart transplant program
On ECMO, or a VAD not FDA-approved for out-of-hospital use
This proposal would allow an adult heart transplant program to register a transplant candidate less than 18 years old on the waiting list, if specific emergency criteria are met. The requirements for a liver transplant program following on the next slide. Based on the data reviewed by the Committee, the frequency these pathways may be used is expected to be very low.
These requirements are:
For heart transplant programs – the patient is not able to be transported to a transplant program with an approved pediatric heart component, a consultation with a pediatric heart transplant program affirms the inability to transport the patient, and the patient is on either ECMO or a VAD that is not approved for out-of-hospital use by the U.S. Food and Drug Administration (FDA).

5. What are the proposed solutions?
Adult Liver Program Requirements
Unable to be transported to a transplant hospital with an approved pediatric component
Consulted with pediatric liver transplant program
Status 1A criteria for fulminant hepatic failure, acute decompensated Wilson’s disease, primary non-function, or hepatic artery thrombosis
For liver transplant programs - the patient is not able to be transported to a transplant program with an approved pediatric liver component, a consultation with a pediatric liver transplant program affirms the inability to transport the patient, and the patient meets liver Status 1A requirements for fulminant hepatic failure, acute decompensated Wilson’s disease, primary non-function, or hepatic artery thrombosis.

6. What are the proposed solutions?
Candidates no longer meeting the requirements need to be removed within 24 hours
The adult transplant program must assist candidates in transferring to a transplant hospital with an approved pediatric component

7. How will members implement this proposal?
Become familiar with the justification forms in WaitlistSM
Maintain documentation to satisfy requirements of the pathway
No expected impact on OPOs or histocompatibility laboratories
Heart and liver transplant programs without an approved pediatric component will need to become familiar with the justification forms in UNetSM. A heart or liver transplant program that elects to use one of the pathways will need to maintain documentation as outlined in the proposal. If a candidate is registered using one of these pathways, the clinical status must be continually met. Candidates not meeting the clinical requirements of the pathways need to be removed from the waiting list within 24 hours.
This proposal will not impact organ procurement organizations (OPOs) or histocompatibility laboratories.

8. How will the OPTN implement this proposal?
Anticipated Board of Directors Review – Dec. 2017
Programming – required in WaitlistSM for Status 1A justification forms
Implementation – will take effect along with pediatric Bylaws proposal approved by the board in Anticipated date: 2019
Monitoring – transplant hospitals will be required to submit documentation to the OPTN
The anticipated date for Board consideration is December If approved, this proposal will require programming in WaitList and new Status 1A justification forms. However, the criteria used on these forms will be unchanged. The implementation of these changes will be in tandem with the implementation of the minimum requirements for key personnel at pediatric transplant programs, likely in 2019.
OPTN members will only be allowed register a transplant candidate using the pathways after the exception criteria are met and entered in UNet℠. Thus, all data entered in UNet℠ may be subject to review by the OPTN. Members using one of the pathways will be required to provide documentation to support the emergency exception criteria as requested.

9. Questions? William T. Mahle, M.D. Committee Chair mahlew@kidsheart.com
Christopher L. Wholley, M.S.A.
Committee Liaison

10. Reserve Slides

11. Supporting Evidence
Pediatric Status 1A Heart Candidates Listed in 2016 by Life Support Treatment at Listing
Based on OPTN data as of May 26, 2017.
Data subject to change based on future data submission or correction.
Year
2012
2013
2014
2015
2016
Heart 91
104
103 99 76
Liver 1 3

12. Supporting Evidence
Pediatric Status 1A Heart Candidates Listed in 2016 by Life Support Treatment at Listing
Life Support Method N %
Extra-corporeal Membrane Oxygenation (ECMO) 34 12
Intra-aortic Balloon Pump (IABP) 3 1
Prostaglandin infusion 29 10
Intravenous inotropes
193 70
Inhaled Nitrous Oxide (NO) 4
Ventilator support
111 40
Ventricular Assist Device (VAD) 57 21
Other 14 5
Based on OPTN data as of June 2, 2017.
Data subject to change based on future data submission or correction.