Policy step number1 Gather ideas

Identify and analyze: All Board and committee projects begin with an idea. Ideas can some from multiple different sources, such as Board and committee members, COR representatives, UNOS staff, transplant conferences, innovation events, and the community. The idea must be defined and may involve UNOS research department, literature reviews, Failure Mode Effects Analysis (FMEA), or other tools to understand the potential and impact of the idea.

Project approval: All formalized ideas become committee projects that require review and approval from the Policy Oversight Committee (POC) and Executive Committee (EC) to move forward.

Policy step number2 Develop proposals

Gather evidence: OPTN committees and UNOS support staff develop and analyze potential solutions for projects. During this time, UNOS support staff for the sponsoring committee will solicit input from key constituencies, including conversations between committees to develop the proposals. For example, ethical topics may be discussed by the Ethics Committee, pediatric topics may be discussed by the Pediatric Committee, and issues impacting vulnerable populations may be discussed by the Minority Affairs Committee.

Policy step number3 Public comment and committee review

Provide feedback

Public comment: There are four methods used to gather public comment: 1) specific outreach to relevant stakeholder organizations (both transplant professionals and patient groups); 2) comments submitted directly from other OPTN committees; 3) in-person meetings in the 11 regions; and 4) online public comment forum on the OPTN website that is open to everyone.

Committee review: The sponsoring committees review public comments on the proposed policies and make any appropriate changes to the proposal. Sometimes, feedback collected during the public comment period results in the proposal language being revised or rewritten entirely before being sent to the OPTN Board of Directors for a vote. If significant changes are made, the revised language goes out for public comment a second time.

Policy step number4 Finalize and approve

Board approval: The OPTN Board of Directors meets twice a year to consider and vote on proposals recommended by the committees. Approval requires evidence that the proposal addresses the stated problem, complies with NOTA and the Final Rule, and agrees with the Strategic Plan. A proposal will be adopted as policy only if the board approves it. Rejected proposals are sent back to the appropriate committee to be reworked.

Policy step number5 Implement and evaluate

Implement: After the Board adopts policy proposals, the OPTN notifies the community through a policy notice, which is then archived on the OPTN website. Implemented policies are known as “OPTN policies.” The UNOS Professional Education Department will seek the advice of members on the sponsoring committee about the key information on which to educate the community about the policy changes.

Evaluate: The OPTN reviews effectiveness of implemented policies. The plan for this review is agreed upon by committee leadership and documented in the Board briefing paper. The UNOS Research Department presents analyses to the committee that sponsored the original policy proposal and interested stakeholders. Analysis and evaluation could result in new projects to refine the policy further.