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

 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 Problem Statement

 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 Goals of the Proposal

Additional Background  Prior Proposal: August 2006  Not well-supported, withdrawn  Concerns from 2006:  Many well-qualified programs would not meet requirements  Did not contain a transition plan for existing programs

Additional Background  Current Proposal  Lower thresholds  Full approval and conditional approval pathways

 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 Supporting Evidence

Summary of Proposed Bylaws

 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 Designated Intestine Transplant Program

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 Primary Surgeon Requirements

 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 Primary Surgeon Requirements (Cont’d)

Full ApprovalConditional Approval  At least 7 IN transplants as primary surgeon, 3 in past 5 years  Performed at least 3 IN procurements, at least 1 liver- inclusive recovery  Direct involvement in IN transplant patient care w/in last 2 years  Training: ASTS-accredited program (or appropriately trained foreign graduate)  At least 4 Intestine transplants in the previous 5 years and then 3 intestine transplants over the next 3 consecutive years  Performed at least 3 intestine procurements with at least 1 liver-inclusive recovery  Direct involvement in intestine transplant patient care within the last 2 years OR Proctor/Mentor Relationship Primary Surgeon Experience Pathways

Full ApprovalConditional Approval  Direct involved in primary care of at least 7 newly transplanted intestine recipients, followed for a minimum of 3 months  Direct involvement in intestine transplant patient care within the last 2 years  Observed at least 1 isolated intestine transplant and 1 combined liver-intestine or multi- visceral  Directly involved in primary care of at least 5 newly transplanted IN recipients, followed for a minimum of 3 months  Directly involved in IN transplant patient care within last 2 years  Observed at least 1 isolated intestine transplant & 1 combined liver-intestine or multi-visceral transplant  12 months experience (active intestine transplant service) as primary intestine transplant physician or under direct supervision of a qualified intestine Transplant physician within a 24-month period  Demonstrate progress towards meeting full requirement (care of 7 intestine transplant recipients) Primary Physician Experience Pathways

 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 Provision for Combined Adult/Ped Programs

 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 What Members will Need to Do

Centers Performing at Least One Intestine Transplant ( n = 26 “active” out of 41 registered IN programs) CenterN A 125 B 97 C 89 D 57 E 54 F 46 G 40 H I 27 J 18 K 14 L 13 M 11 N 9 CenterN O 6 P 6 Q 5 R 4 S 4 T 2 U 2 V 2 W 1 X 1 Y 1 Z 1 Total # 675

 David C. Mulligan, MD Committee Chair  Name Region # Representative  Ann Harper Committee Liaison Questions?