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Revisions to Pediatric Emergency Membership Exception. Pediatric Transplantation Committee. 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.
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Revisions to Pediatric Emergency Membership Exception Pediatric Transplantation Committee
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
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
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
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
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
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
How will the OPTN implement this proposal? • Anticipated Board of Directors Review – Dec. 2017 • Programming – required in WaitlistSMfor Status 1A justification forms • Implementation – will take effect along with pediatric Bylaws proposal approved by the board in 2015. Anticipated date: 2019 • Monitoring – transplant hospitals will be required to submit documentation to the OPTN
Questions? William T. Mahle, M.D. Committee Chair mahlew@kidsheart.com Christopher L. Wholley, M.S.A. Committee Liaison christopher.wholley@unos.org
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.
Supporting Evidence • Pediatric Status 1A Heart Candidates Listed in 2016 by Life Support Treatment at Listing Based on OPTN data as of June 2, 2017. Data subject to change based on future data submission or correction.