Membership & Professional Standards Committee Fall 2014 Establishing a Quality Assessment and Performance Improvement Requirement for Transplant Hospitals and Organ Procurement Organizations Membership & Professional Standards Committee Fall 2014

The Problem Many programs under review for compliance or performance do not have well-developed QAPI programs No OPTN requirement No basis for MPSC to take action A quality process is a widely accepted tool for evaluating and implementing process and performance improvements in healthcare. The transplant community also recognizes the value of more thorough quality improvement initiatives. More specifically, we have noted that members who are under review by the MPSC and are having difficulty with compliance or performance often do not have well-developed quality assessment and performance improvement programs. This problem has been observed during peer visits and in reviews of members with a significant non-compliance history or extended periods of underperformance. Although CMS requires transplant hospitals and OPOs to have QAPI programs in place, the OPTN has no such requirement. So, we may request information about a member’s QAPI processes and ask them to submit their plans for performance improvement, corrective action or quality improvement. However, the MPSC has no basis within OPTN policy or bylaws for requiring a member to implement or strengthen its QAPI program. We also cannot hold members accountable where the lack of an adequate QAPI program has resulted in a serious lapse in compliance or performance. In addition, not all transplant programs are CMS approved so CMS conditions of participation do not apply to those programs.

Goal of the Proposal Help members improve performance and remain compliant with OPTN obligations Provide basis for MPSC to take action If member fails to improve or implement QAPI If member has non-existent or inadequate QAPI This proposal will give us a tool to more effectively help members as they work to improve performance and remain in compliance with OPTN obligations.

How the Proposal will Achieve its Goal Requirement for QAPI plan– applies to both OPOs and Transplant Hospitals QAPI goals and statement of scope Guidelines for governance and leadership Data systems and monitoring Guidelines for conducting, monitoring & evaluating process improvement projects Adverse event, error identification & investigation Communications Evaluation of QAPI process Must implement the plan While developing this proposal, we reviewed the requirements of CMS and made sure that the proposal was consistent. We tried to reach a balance between a requirement that did not provide enough detail for members to know what was expected of them and a requirement that was too detailed and proscriptive. We included an obligation for the organization to develop a QAPI plan with enumerated broad components. The broad components for both OPOs and transplant hospitals include the items listed here. You will find more detail on some of these components in the proposed language, which is on page XX of your PC booklet. The member is also required to implement that plan.

What Members will Need to Do Review and maintain QAPI plan Include all required components Implement QAPI plan as documented If you have an identified performance or compliance matter Provide QAPI plan and documentation of implementation of the plan If the proposal is approved by the Board, members should review their QAPI plans before the proposal effective date to determine that it contains all the required components. Since QAPI plans are living documents, you should review the required components whenever you make changes to your QAPI plan to make sure the plan is still in compliance. In addition, you need to implement your QAPI program and document its implementation, in other words provide documentation that you are following the plan. Based upon the flexibility written into this bylaw requirement, there will be as many programs and ways to document as there are members. Some examples of documentation include meeting minutes, dashboards, root cause analyses, plans for quality improvement etc. Finally, QAPI plans and documentation of implementation will not be routinely monitored by the OPTN. You will only need to provide this information if requested when the MPSC is in the process of reviewing a performance or compliance matter.

Questions? Jonathan Chen, M.D. Committee Chair jonathan.chen@seattlechildrens.org Regional representative name (RA will complete) Region X Representative email address Sharon Shepherd, Committee Liaison sharon.shepherd@unos.org