Liver and Intestinal Organ Transplantation Committee Spring 2014

1. Proposed Membership and Personnel Requirements for OPTN Designation & Approval of Intestine Transplant Programs Liver and Intestinal Organ Transplantation Committee Spring 2014

2. Problem Statement • No OPTN/UNOS requirements exist regarding who may perform intestine transplants and care for intestine transplant recipients • Currently, any transplant program that is approved to perform liver transplants can perform intestinal transplants upon submitting a written request to UNOS membership department

3. Goals of the Proposal • Define a designated intestine transplant program • Establish minimum qualifications for primary intestine transplant surgeons and physicians • Done without compromising quality or restricting new program formation

4. Additional Background • Prior Proposal: August 2006 • Not well-supported, withdrawn • Concerns from 2006: • Many well-qualified programs would not meet requirements • Did not contain a transition plan for existing programs

5. Additional Background • Current Proposal • Lower thresholds • Full approval and conditional approval pathways

6. Supporting Evidence • Low-volume procedure with most programs performing fewer than 5 IN or LI-IN transplants in 2012 • Thresholds not derived from statistical analyses • Represent level of experience to set minimal standards without restricting access or new program development • Similar to initial thresholds for other organs

7. Summary ofProposed Bylaws

8. Designated Intestine Transplant Program • For OPTN approval, the Transplant Hospital must have current approval as a Liver Transplant Program • Identify a designated physician or surgeon to act as the Transplant Program Director • Identify a qualified primary transplant surgeon and physician

9. Primary Surgeon Requirements A Designated Intestine Transplant Program must have a primary surgeon who meets all of the following requirements: • M.D., D.O., (or equivalent from another country), current medical license in hospital’s state or jurisdiction • Accepted on the hospital medical staff, on site at that hospital, in good standing • Documentation from the hospital credentialing committee verifying state licensure, board certification, training, and transplant CME

10. Primary Surgeon Requirements (Cont’d) • Current certification by the American Board of Surgery, the American Board of Osteopathic Surgery, or the International Board of Medicine and Surgery (IBMS) • Must have completed at least one of the training or experience pathways

11. Primary Surgeon Experience Pathways

12. Primary Physician Experience Pathways

13. Provision for Combined Adult/Ped Programs • Adult & pediatric components in same Program: • Primary pediatric IN transplant physician can function as primary IN transplant physician for the adult component, if an adult gastroenterologist is also involved in the care • Programs serving predominantly pediatric patients: • Should have a board certified pediatrician who meets the criteria for primary IN transplant physician • If no qualified pediatrician on staff: • Physician meeting primary IN transplant physician criteria for adults can function as primary IN transplant physician for the pediatric program • Pediatric gastroenterologist must involved in the care

14. What Members will Need to Do • On a given date ALL current intestine transplant program designations will terminate • At least 120 days before the termination date an intestinal transplant program application will be available • Members must submit an application and receive approval by the termination date in order to perform intestine transplants

15. Centers Performing at Least One Intestine Transplant 2009-2013 (n = 26 “active” out of 41 registered IN programs)

16. Questions? • David C. Mulligan, MD Committee Chair david.mulligan@yale.edu • Name Region # Representative Email • Ann Harper Committee Liaison ann.harper@unos.org