Membership & Professional Standards Committee (MPSC) Fall 2014

Recent Public Comment Proposals Requests for Exceptions Based on Geographic Isolation Board Approved – Nov. 2014 Implementation - Feb. 1, 2015 Post-public comment change: “For purposes of this provision, “geographically isolated” is defined as a program located entirely within a state or commonwealth noncontiguous with the mainland United States. This includes, but is not limited to, Alaska, Hawaii, and Puerto Rico.” During the 2014 spring public comment period, the MPSC received positive feedback on its proposal that provides a mechanism for the Committee to recommended to the Board that it consider an exception to the key personnel qualifications when it receives a program application from a hospital that geographically isolated. There were no substantial changes to the proposed language. The MPSC presented this proposal to the Board during its November 2014 meeting and it was adopted. It will be implemented on February 1, 2015. IF QUESTIONS ABOUT THE MINOR POLICY CHANGE: The proposed Bylaw we submitted to the board did not contain the phrase, “but is not limited to.” The MPSC agreed that this phrase had the potential to cause confusion, and deleting it would not compromise the intent. In the future, if the board believes the Bylaw should apply to other geographically isolated areas, the Committee will submit a public comment proposal to modify these Bylaws accordingly.

Recent Public Comment Proposals Submitting Accurate Data and Providing Documentation to Verify Data Board Approved – November 2014 Implementation - Feb. 1, 2015 Post-public comment change: "Members are responsible for providing documentation upon request to verify the accuracy of all data submitted to the OPTN through the use of standardized forms." This proposal clarifies that members are responsible for submitting accurate data and for providing documentation to verify the data’s accuracy. The MPSC received primarily positive feedback when it was out for public comment this past spring. A few negative comments suggested that the existing policy is sufficient and the clarification is not needed. The remainder of the opposition can generally be grouped in two categories. First, as misunderstanding the proposal to require source documentation rather than appropriate supporting documentation. Second, as misunderstanding the proposal as a requirement that members maintain all documentation in a central location and make it available for routine auditing. The proposal does not add any new requirements, it simply clarifies existing requirements. However, the MPSC approved one post-public comment change that was sent to the Board in November. To stress that members are not required to make additional documentation available for regular auditing and are only asked to provide documentation to support data’s accuracy as a part of a necessary investigation, the Committee added “upon request” as seen on this slide. This proposal was approved by the Board of Directors’ during its November 2014 meeting. The policy change will be implemented on February 1, 2015.

Policy Implementation Dates Patient Notification of Functional Inactivity Due to Lack of Transplant Activity Implementation Date – September 1, 2014 Revise the Current Method for Flagging for Transplant Program Post-transplant Performance Reviews Implementation Date – January 1, 2015 At the June Board of Directors meeting, the Board adopted two proposals sponsored by the MPSC. Patient notification of functional inactivity due to lack of transplant activity was implemented on September 1, 2014.  The purpose of this Bylaw change is to provide candidates and potential candidates with information about the program’s activity levels that will allow the patient to make informed decisions about whether to move to another more active program or multiply list at another program. Programs that receive an inquiry from the MPSC about the program’s functional inactivity are required to send a notification letter to all candidates and potential candidates. The Bylaw contains specific information that needs to be included in the letter. The Board also adopted revisions to the current method for identifying transplant programs for post-transplant performance reviews. These changes will go into effect on January 1, 2015. These Bylaws changes were adopted to better identify those transplant programs that may be underperforming in the area of patient and graft survival. These Bylaws changes establish that Bayesian methodology will be utilized by the SRTR in the production of the public transplant program performance metrics and establishes new thresholds that maximize the true positive flags while minimizing false positive flags. In doing so, the transplant programs most in need of MPSC review and assistance in improving outcomes will be identified. The new Bayesian methodology and thresholds will be used in the reports provided by the SRTR to programs on their secure sites in December 2014. The MPSC will review these reports at its Spring 2015 meeting.

Ongoing Initiatives Review of bylaw requirements/qualifications for primary surgeons and physicians Approved Transplant Fellowship Training Programs Foreign Board Certification Primary Physician specialty, subspecialty board certifications Consider multi-organ procurement requirement for primary surgeon criteria Primary Surgeon Procurement Requirement Consider primary surgeon qualification - primary or first assistant on transplant cases Reassess currency requirements for primary surgeons and primary physicians Consider requirement for primary physician observation of procurements Pancreas Bylaws Review (Pancreas Committee) Define working knowledge for primary physician qualification pathways Earlier this spring the Joint Society Steering Group- comprised of representatives HRSA, UNOS, AST, ASTS, and NATCO- decided that a number of MPSC projects, and one Pancreas Committee project, related to key personnel requirements in the OPTN Bylaws should be addressed by a Joint Society Working Group. This group will be reviewing and making recommendations on Bylaws pertaining to the topics seen on this slide. The Joint Society Working Group is in the midst of discussing these topics, and will update the MPSC on its progress during its December 2014 meeting. Proposed modifications pertaining to these topics can be anticipated in fall 2015.

Questions? Jonathan Chen, MD Committee Chair jonathan.chen@seattlechildrens.org Name Region X Representative email Sally Aungier Committee Liaison sally.aungier@unos.org