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Changes to Islet Bylaws

Proposal Overview

Status: Review

Sponsoring Committee: Pancreas Transplantation

Strategic Goal 4: Promote living donor and transplant recipient safety

Executive summary

Current islet Bylaw personnel requirements do not reflect the need for islet transplantation experience and expertise. This may prevent qualified candidates from leading programs and could prevent the field from growing. Inappropriate requirements may be harmful to patients if personnel who are inexperienced in islet transplantation oversee islet programs and islet patient care.

The OPTN/UNOS Pancreas Transplantation Committee (the Committee) has developed new requirements for islet programs that reflect the needs particular to islet programs and their patients. Currently, the OPTN Bylaws Appendices G.5: Primary Pancreatic Islet Transplant Surgeon Requirements and G.6: Primary Pancreatic Islet Transplant Physician Requirements, specify requirements for islet program key personnel that are identical to pancreas program requirements despite significant differences in the experience and backgrounds of key islet personnel. The overarching goals in seeking to improve islet program Bylaws are to provide a simple, achievable experiential pathway for islet program leaders that facilitates the initiation and development of clinical islet transplant programs, while ensuring sufficient experience to provide for safe patient care. The proposed changes include three critical elements:

  1. Require a single clinical leader of the islet program to replace the transplant surgeon and transplant physician roles. This person must have experience inclusive of pre-, peri- and post-operative care, islet isolation, and a demonstrated background in transplantation medicine, immunosuppression management, beta cell biology, or endocrinology.
  2. Require four different expert medical personnel roles with defined skill sets to provide key support in the delivery of islet transplant therapy: an abdominal surgeon, portal vein access specialist, immunosuppression management specialist, and endocrinologist. A single person can fill one or more of the aforementioned roles.
  3. Permit islet transplant programs to be free standing and not affiliated with an established pancreas transplant program. Allowing free-standing islet programs reflects the difference in background and experience for islet program personnel compared to pancreas program personnel.

The proposed changes apply only to programs that perform allogeneic islet transplants. Bylaw program requirements that provide accountability and reflect the necessary expertise and experience in program personnel promote patient safety. Changing the Bylaws to provide more flexibility for islet programs while enhancing program accountability with more detailed islet experience requirements should contribute positively to increased transplant recipient safety.

Read the proposal (PDF - 212 K; 8/2018)

Contact: Abigail Fox 

Specific feedback

Because islet programs are directly impacted, the Committee appreciates any feedback from islet program personnel on the proposed changes. In particular, the Committee requests feedback on the following two questions:

  1. The proposal requires islet programs to have a clinical leader who meets islet-specific requirements including experience with islet isolation, pre- peri- and post- operative care, and completion of a clinical fellowship in a related field (transplantation medicine or surgery, immunosuppression management, beta cell biology, or endocrinology). Should anything be added or removed from these requirements?
  2. Currently, islet programs are required to be at the same hospital as a pancreas program, or meet exception requirements specified in Appendix G.4.D: Programs Not Located at an Approved Pancreas Transplant Program. This proposal would allow islet programs to be free-standing from pancreas programs. Do members support or have concerns about this change?

Members are asked to comment on both the immediate and long term budgetary impact of resources that may be required if this proposal is approved. This information assists the Board in considering the proposal and its impact on the community.

Please use this form to provide your feedback. Your comments relating to the proposal will be displayed in the comment section below (within 24 hours).

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Anonymous | 8/9/2018

It is clear that the islet cell transplant is a different undertaking than whole organ transplant; requiring a primary surgeon for a cell infusion makes little since and so the concept of a clinical leader (who may be a physician or surgeon) instead of having both a primary physician and surgeon makes great sense.

AOPO | 9/10/2018

AOPO supports the proposed changes to the OPTN Bylaws regarding Islet Surgeon and Physician requirements to better align these requirements to the more specific needs of Islet transplant as opposed to their current state which aligns with Pancreas transplant. These changes will allow for more suitable physician candidates from leading transplant programs to qualify to lead Islet transplant programs. This will provide more free standing Islet transplant programs, not directly affiliated with existing Pancreas transplant programs. These changes could result in expansion of the use of Islet cells to improve patients' lives and increase the utilization of the precious gift of organ donation. AOPO supports changes to policy that promotes the increased utilization of organs and tissue from donors.

Region 3 | 9/11/2018

This proposal was a non-discussion agenda item. The Region 3 vote was as follows:

12 strongly support; 12 support; 8 abstentions/neutrals; 1 opposed; 0 strongly oppose

Region 8 | 9/12/2018

This proposal was a non-discussion agenda item. The Region 8 vote was as follows:

11 strongly support; 3 abstentions/neutrals; 0 opposed; 0 strongly oppose

Region 5 | 9/14/2018

The Region 5 vote was as follows:

11 strongly support; 18 support; 4 abstentions/neutrals; 0 opposed; 1 strongly oppose

Region 1 | 9/17/2018

Region 1 Vote: 4 strongly support, 8 support, 1 abstentions/neutrals, 0 oppose, 0 strongly oppose

OPTN/UNOS Membership and Professional Standards Committee (MPSC) | 9/24/2018

The MPSC thanks the Pancreas Transplantation Committee for presenting its proposal. MPSC members did not express any concerns about the proposal, but they asked the Pancreas Committee Chair several questions about the implications of allowing free-standing islet transplant programs.

1. What was the original rationale for requiring islet transplant programs to be located at a hospital with a pancreas transplant program?

One of the main reasons was to ensure that patients were presented with options for both pancreas and islet transplantation. The Pancreas Committee chair explained that the current bylaws allow for a free-standing islet transplant program as long as the program is affiliated with a pancreas transplant program at another hospital. However, the Pancreas Committee felt that requirement was unduly restrictive because of a decreasing number of pancreas transplant programs.

2. Are there any risks to patients at a free-standing islet transplant program, and are there any common complications that might require surgical management?

The risk of complications exists; the worst complication would be portal vein thrombosis requiring liver resection. However, these types of complications would not require affiliation with a pancreas transplant program. The proposed bylaws require an abdominal surgeon as one of the expert medical personnel, so islet transplant programs will have to have a surgeon to manage these types of complications.

3. Would all free-standing islet transplant programs be required to have an affiliation with an OPO?

The same general transplant program requirements will apply to islet transplant programs, so they would have to be affiliated with an OPO. Going forward, a transplant hospital that only has an islet transplant program would look like any other transplant hospital with a single transplant program from the perspective of OPTN requirements.

Region 2 | 9/26/2018

Non-discussion agenda:
Region 2 Vote: 8 strongly support, 24 support, 2 abstentions/neutrals, 0 oppose, 0 strongly oppose

American Nephrology Nurses Association (ANNA) | 10/01/2018

ANNA supports.

Region 9 | 10/01/2018

The Region 9 vote was as follows:

8 strongly support, 10 support, 2 abstentions/neutrals, 1 oppose, 0 strongly oppose

American Society of Transplant Surgeons (ASTS) | 10/2/2018

The American Society of Transplant Surgeons (ASTS) appreciates the work of the OPTN/UNOS Pancreas Transplantation Committee in promoting transplant recipient safety. ASTS supports and acknowledges the importance of requiring islet-specific experience from its team members. We consider it imperative, however, that the policy must require a transplant surgeon with expertise in solid organ procurement of the pancreas, and with experience in managing immune suppression and complications of the immune suppressed state on the islet team. ASTS does not support the proposal to permit islet programs to function as free-standing entities apart from UNOS approved pancreas transplant programs.

American Society of Transplantation (AST) | 10/2/2018

The American Society of Transplantation supports the proposal as written. We find these requirements to be sufficient. The chance from two physician leaders to a single clinical leader should simplify the administrative procedures and help program leadership concentrate on patient care and clarify roles among providers. We do encourage establishing multidisciplinary collaboration for the management of islet cell transplantation. We suggest that the required expert medical personnel roles are expanded to include a pharmacist as immunosuppression access and management expert in the delivery of islet transplant therapy - in collaboration with the islet cell coordinator and physicians that specialize in abdominal surgery, portal vein access, and endocrinology.

The American Society for Histocompatibility and Immunogenetics (ASHI) | 10/2/2018

The American Society for Histocompatibility and Immunogenetics (ASHI) strongly supports this proposal.  ASHI has no additional comments regarding the specific feedback requests.

Region 11 | 10/2/2018

Region 11 Vote: 8 strongly support, 14 support, 1 abstentions/neutrals, 0 oppose, 0 strongly oppose

Elizabeth Rubinstein | 10/3/2018

In promoting transplant recipient safety, I can appreciate the importance of requiring islet-specific medical experience from specifically trained and identified members of a transplant program team.  I do not support the concept of islet programs to function as free standing programs independent of a transplant center as noted under Executive Summary 3#: 'Permit islet transplant programs to be free standing and not affiliated with an established pancreas transplant program. Allowing free-standing islet programs reflects the difference in background and experience for islet program personnel compared to pancreas program personnel.' There needs to be a depth of expertise in both organ transplant and islet-specific procedures to provide the best decisional options for patients at one location (transplant center) and not place patients and their families in the position of having to weigh potentially competing transplant alternatives. I support the proposal overall but caution the promotion of free standing islet programs purely from a patient/family safety perspective.

Region 7 | 10/3/2018

Region 7 Vote: 11 strongly support, 11 support, 5 abstentions/neutrals, 0 oppose, 0 strongly oppose

Region 6 | 10/3/2018

Region 6 Vote: 26 strongly support, 17 support, 1 abstentions/neutrals, 1 oppose, 0 strongly oppose

Region 10 | 10/3/2018

Region 10 Vote: 10 strongly support, 12 support, 2 abstentions/neutrals, 1 oppose, 2 strongly oppose