OPTN Proposing Contentious Changes to Long-Standing Policy Creation Process

By Dr. Alejandro Diez

Recently, the Organ Procurement Transplant Network / United Network for Organ Sharing (OPTN / UNOS) executive committee published a concept paper[i] which is currently under public comment.  The paper proposes that the current committee structure utilized to develop and implement policy should be drastically altered.

Background

OPTN policies are the regulations by which all member transplant hospitals, organ procurement organizations (OPOs), and histocompatibility labs in the United States are governed.  These policies are created through a robust and collaborative process.  A committee first identifies an issue, investigates options for its solution and drafts a proposal.  Feedback on a proposal is then requested from the public.  After public feedback, data are reviewed by the OPTN board on a semester basis.  Proposals approved by the board become policy and are subsequently implemented. Key to this process is the grassroots nature of how proposals arise within committees and the multidisciplinary input of the various committees and their members.

There are currently 16 permanent UNOS standing committees[ii], each with an average of 18 members including a representative from each of the eleven UNOS regions; emphasizing geographic diversity within a committee.  The committees are generally either organ-specific (e.g. Liver, Pancreas, Kidney) or non-organ specific; representing special populations and stakeholders in the field (e.g. Ethics, Minority Affairs, Living Donors, Pediatrics).

Proposed changes

The stated goal of the current proposal under consideration is to increase opportunities for participation as they pertain to diversity perspective and minority representation while at the same time increasing connections between the UNOS board and individual committees.  Operationally, the current proposal intends to achieve these goals by modifying the existing committee structure.  The new structure creates two types of groups:

  • “Subject Committees” (SC), defined as an organ specific or other group where policy development occurs and
  • “Expert Councils” (EC), defined as a group with a “perspective that is needed on 3 or more subject committees”.  


A review of the proposed listing of SC show the majority to be composed of organ specific groups, whereas other non-organ specific committees, those representing special populations and stakeholders, would be relegated to EC.

The main controversial points brought forth by this proposal are that many of the currently existing committees would be reclassified to EC and, as such, would no longer have regional representatives or be able to sponsor proposals for public comment – potentially diminishing the perspective of several important participants within the transplant community.  Historically, these committees have been active in introducing new proposals for policy changes based on the perspective of an observed need or inequity; a perspective that may be significantly tempered under the current proposal.  The Minority Affairs Committee (MAC), in collaboration with other OPTN committees, offers insight into how a unique perspective may effect change in policy.  Some of these policies include:

  • transplanting Non-A1/Non-A1B (A2/A2B) donor kidneys into blood group B candidates (which historically have the longest wait times),
  • modifying the definition for transplant candidate wait-time (utilizing date of dialysis initiation as opposed to date of listing), and
  • changing HLA matching criteria for wait list considerations.  


The current proposal does not afford the same opportunity for involvement should a full standing committee become relegated to an EC.

This concept paper is currently under public comment until March 23, 2018[iii].  Broadly, many comments to the proposal applaud and support efforts to increase participation and diversity in policy development.  However, some note that with the proposed changes the transplant community may risk overlooking issues unique to special populations possibly mitigating efforts for greater diversity, inclusion, and equity within the policy creation process.

The current structure utilized to develop and implement policy is not perfect.  By decreasing the number of committees which can sponsor new policy, the current proposal may possibly add greater flexibility and efficiency to the policy creation process.  The current proposal is well-intentioned, yet may ultimately not be an ideal modification to the current status quo.  The far-reaching implications of OPTN policies demand that an inclusive, deliberative, and considerate process be followed.  This is one of the underlying strengths of the current structure; the collective contributions of many will always be stronger than that of a few. 

For any questions or comments, please contact Kidney News Online.

The opinions expressed by Dr. Diez may not represent the opinions of all MAC members, ASN members, UNOS, or their institutions and are his opinions only.

 

[ii] Ethics, Histocompatibility, Kidney Transplantation, Liver and Intestinal Organ Transplantation, Living Donor, Membership and Professional Standards, Minority Affairs, Operations and Safety, Organ Procurement Organization, Pancreas Transplantation, Patient Affairs, Pediatric Transplantation, Policy Oversight Committee (POC), Thoracic Organ Transplantation, Transplant Administrators, and Transplant Coordinators.

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Recently, the Organ Procurement Transplant Network / United Network for Organ Sharing (OPTN / UNOS) executive committee published a concept paper[i] which is currently under public comment.  The paper proposes that the current committee structure utilized to develop and implement policy should be drastically altered.

Background

OPTN policies are the regulations by which all member transplant hospitals, organ procurement organizations (OPOs), and histocompatibility labs in the United States are governed.  These policies are created through a robust and collaborative process.  A committee first identifies an issue, investigates options for its solution and drafts a proposal.  Feedback on a proposal is then requested from the public.  After public feedback, data are reviewed by the OPTN board on a semester basis.  Proposals approved by the board become policy and are subsequently implemented. Key to this process is the grassroots nature of how proposals arise within committees and the multidisciplinary input of the various committees and their members.

There are currently 16 permanent UNOS standing committees[ii], each with an average of 18 members including a representative from each of the eleven UNOS regions; emphasizing geographic diversity within a committee.  The committees are generally either organ-specific (e.g. Liver, Pancreas, Kidney) or non-organ specific; representing special populations and stakeholders in the field (e.g. Ethics, Minority Affairs, Living Donors, Pediatrics).

Proposed changes

The stated goal of the current proposal under consideration is to increase opportunities for participation as they pertain to diversity perspective and minority representation while at the same time increasing connections between the UNOS board and individual committees.  Operationally, the current proposal intends to achieve these goals by modifying the existing committee structure.  The new structure creates two types of groups:

  • “Subject Committees” (SC), defined as an organ specific or other group where policy development occurs and
  • “Expert Councils” (EC), defined as a group with a “perspective that is needed on 3 or more subject committees”.  


A review of the proposed listing of SC show the majority to be composed of organ specific groups, whereas other non-organ specific committees, those representing special populations and stakeholders, would be relegated to EC.

The main controversial points brought forth by this proposal are that many of the currently existing committees would be reclassified to EC and, as such, would no longer have regional representatives or be able to sponsor proposals for public comment – potentially diminishing the perspective of several important participants within the transplant community.  Historically, these committees have been active in introducing new proposals for policy changes based on the perspective of an observed need or inequity; a perspective that may be significantly tempered under the current proposal.  The Minority Affairs Committee (MAC), in collaboration with other OPTN committees, offers insight into how a unique perspective may effect change in policy.  Some of these policies include:

  • transplanting Non-A1/Non-A1B (A2/A2B) donor kidneys into blood group B candidates (which historically have the longest wait times),
  • modifying the definition for transplant candidate wait-time (utilizing date of dialysis initiation as opposed to date of listing), and
  • changing HLA matching criteria for wait list considerations.  


The current proposal does not afford the same opportunity for involvement should a full standing committee become relegated to an EC.

This concept paper is currently under public comment until March 23, 2018[iii].  Broadly, many comments to the proposal applaud and support efforts to increase participation and diversity in policy development.  However, some note that with the proposed changes the transplant community may risk overlooking issues unique to special populations possibly mitigating efforts for greater diversity, inclusion, and equity within the policy creation process.

The current structure utilized to develop and implement policy is not perfect.  By decreasing the number of committees which can sponsor new policy, the current proposal may possibly add greater flexibility and efficiency to the policy creation process.  The current proposal is well-intentioned, yet may ultimately not be an ideal modification to the current status quo.  The far-reaching implications of OPTN policies demand that an inclusive, deliberative, and considerate process be followed.  This is one of the underlying strengths of the current structure; the collective contributions of many will always be stronger than that of a few. 

For any questions or comments, please contact Kidney News Online.

The opinions expressed by Dr. Diez may not represent the opinions of all MAC members, ASN members, UNOS, or their institutions and are his opinions only.

 

[ii] Ethics, Histocompatibility, Kidney Transplantation, Liver and Intestinal Organ Transplantation, Living Donor, Membership and Professional Standards, Minority Affairs, Operations and Safety, Organ Procurement Organization, Pancreas Transplantation, Patient Affairs, Pediatric Transplantation, Policy Oversight Committee (POC), Thoracic Organ Transplantation, Transplant Administrators, and Transplant Coordinators.

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Date:
Wednesday, March 14, 2018