1. Liver and Intestinal Organ Transplantation Committee Spring 2014
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
At present, there are no OPTN requirements regarding who may perform intestine transplants or take care of intestine patients, other than the requirement that the transplant program be approved to perform liver transplants.
Several previous attempts have been made to develop qualification criteria for OPTN designation and approval of intestinal transplant programs. For various reasons these attempts were unsuccessful. HRSA has expressed the desire to have codified intestine transplant program qualification criteria and this proposal hopefully will result in that.

3. Define a designated intestine transplant program
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
The goals of this proposal are to define a designated intestine transplant program and to establish minimum qualifications for the primary intestine transplant surgeon and physician.
The proposed bylaw is structured in the same way as other organ transplant program designation and approval requirements. The number of transplant hospitals performing intestine transplants in combination with the small number of procedures performed makes it challenging for establishing statistically significant criteria. Regardless, this proposal is sound and will accomplish the need for some minimum set of requirements to designate and approve intestinal transplant programs.

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Not well-supported, withdrawn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
The Liver Committee and MPSC submitted a proposal for these requirements in 2006, but that proposal was not well supported and was withdrawn. The primary concerns were that the proposed thresholds for the number of transplants performed (surgeon) and the number of patients cared for (physician) would exclude well-qualified programs. Further, there was no transition plan for existing programs.

5. Additional Background
Current Proposal
Lower thresholds
Full approval and conditional approval pathways
The current proposal addresses these concerns. Recognizing that the number of intestine transplants and fellowship training opportunities are decreasing, lower thresholds are proposed. In addition, multiple pathways for primary surgeon and physician qualification are proposed.

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
Due to the low volume of intestine transplant performed annually, it was not possible to determine thresholds based on statistical analysis. However, the Committee felt that the thresholds proposed represent a level of experience necessary to provide appropriate care to these patients without restricting access to transplant by closing programs or preventing new program development. This is how the initial thresholds were set when transplant volumes were low.

7. Summary of Proposed Bylaws
I will provide you a summary of the highlights of the proposed bylaws. These were patterned closely after the existing bylaws for liver surgeons and physicians, although tailored to include lower requirement thresholds for intestine programs. Please be sure to review all the details by reading the language included in the public comment proposal.

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
These are the proposed criteria for a designated intestine program.
First, the transplant must have current approval as a Liver Transplant Program – this is in the bylaws currently.
The center must also identify a primary surgeon and a primary physician – and the criteria for each will be described in the next several slides.
The primary liver surgeon may also be intestine surgeon if all other criteria are met
The proposal includes detailed program personnel coverage plan consistent with the bylaws for other organs..

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
Full Approval
Conditional 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
If the surgeon does not meet the currency requirements for either pathway, approval may be granted if the surgeon develops a formal mentor/proctor relationship with a primary intestine transplant surgeon at another fully approved intestine transplant program.

12. Primary Physician Experience Pathways
Full Approval
Conditional 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)

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
Many of the “inactive” programs have either done 1 or less since their start up date. The intent is to eliminate all currently approved intestine transplant programs (no grandfathering) and start the approval process anew with all programs having to meet the qualification requirements set forth in this proposal, if approved.

15. Centers Performing at Least One Intestine Transplant (n = 26 “active” out of 41 registered IN programs)
Center N 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 9
Center N O 6 P Q 5 R 4 S T 2 U V W 1 X Y Z
Total #
675

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