Feedback requested

1. The Committee is interested in feedback concerning whether there are other informed consent processes or consent elements that should be considered as requirements for living kidney, liver, lung, pancreas or intestine donors but are not addressed in current policy or in these proposed changes.
2. The Committee is requesting specific feedback on whether elements of the proposal would be problematic for members to implement. Feedback is especially encouraged from living lung, intestine, and pancreas donor programs because of the low volume of these types of live donations.
   For any identified problem, please provide potential solutions for the Committee to consider.

UNOS and OPTN member impact summary

Project size/Complexity

UNOS

The majority of hours (80) is required from IT to program changes. Communications and Regional Administration each estimate 20 hours to communicate changes to members.

Implementation and ongoing effort is minimal.

Project size = Very Small

Member

Transplant center

Implementation timeframe for Transplant Centers is estimated at six months for most centers. Time is needed primarily to conduct legal review, implement process and workflow changes, and create print materials and to educate existing staff and patients on new requirements.

Implementation cost to transplant centers results from additional staff hours. The legal review team conducts analysis and approves new requirements, project management staff implements changes, and administrative and clinical staff educates existing staff and patients on new requirements. Printing costs exist, as well, but may be minimal. Cost and financial burden varies based on size of transplant program.

Transplant center methodology notes

• One-time implementation cost impact estimate (for most transplant centers) of $10,000-$25,000 is based on 200-500 hours of staff implementation time at a blended rate of
  $50/per hour.
• Recurring annual additional budget cost post-implementation ranges from $1,500-$5,000 for annual legal team review of policy requirements and printing. Cost depends on
  size/volume of transplant program.
• There is no cost savings.

OPOs and Labs

OPOs and labs are not affected.