1. Membership & Professional Standards Committee (MPSC)
Spring 2015

2. Recent Public Comment Proposals
Definition of a Transplant Hospital
Further work necessary before Board consideration
Implement Pre-Transplant Performance Review by the MPSC
Establish a Quality Assessment and Performance Improvement Requirement for Transplant Hospitals and Organ Procurement Organizations
Board review – June 2015
You will recall during the fall 2014 public comment cycle the MPSC sponsored three proposals, which are listed here. All three of these proposals received substantial and varying feedback, running the gamut from complete support to complete opposition. The MPSC reviewed the public comment feedback provided for each of these proposals during a teleconference in early February. During this discussion, we decided that the definition of a transplant hospital and pre-transplant performance review needed additional consideration, and should not be presented to the Board of Directors at its upcoming June meeting. Two separate working groups were tasked to address the significant concerns raised in response to each of these proposals.
As for the proposal to establish a Quality Assessment and Performance Improvement requirement for transplant hospitals and OPOs, the Committee heard the community’s concerns about OPTN QAPI policy conflicting with CMS QAPI requirements. To accommodate these concerns, the MPSC voted to simplify the proposed language eliminating the required components of the plan. This simplified proposal will be presented for the Board of Directors consideration during its June 2015 meeting.

3. Policy Implementation Dates
Clarify Data Submission and Documentation Requirements
OPTN Policy 18.1 (Data Submission Requirements)
Requests for Exceptions Based on Geographic Isolation
OPTN Bylaws Appendix A.3.F (Geographically Isolated Transplant Program Applicants)
Feb. 1, 2015 Implementation
The OPTN/UNOS Board of Directors’ adopted two MPSC-sponsored proposals at its November 2014 meeting. The Board approved the proposal to clarify data submission and documentation requirements and the proposal to request exceptions for key personnel requirements based on geographic isolation. These changes will take effect on February 1, 2015.

4. Ongoing Committee Initiatives
Multi-Organ Transplant Outcomes Review
Joint Societies Working Group
Approved Transplant Fellowship Training Programs
Foreign Board Certification
Primary Physician specialty, subspecialty board certifications
Consider primary surgeon multi- organ procurement requirement
Primary Surgeon Fellowship Pathway Procurement Requirement Time Period
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
In addition to the MPSC’s standard, ongoing efforts, you should be aware of two particular initiatives that the Committee continues to work on. The MPSC has a working group focusing on the best way to assess multi-organ transplant outcomes for the purpose of including multi-organ transplant outcomes in post-transplant performance reviews. Along with the SRTR, the working group is reviewing data to determine the best approach for evaluating multi-organ transplant outcomes.
Additionally, the Joint Societies Working Group that is focusing on a number of topics related to improving key personnel requirements in the OPTN Bylaws continues to meet regularly and work on its recommendations. The Joint Societies Working Group is aiming to have the recommendations for the topics it has already addressed out for public comment during the fall public comment cycle.
Public comment is contingent upon the Joint Societies Steering Committee’s endorsement of the Joint Societies Working Group’s recommendations, and subsequent to that, the MPSC’s support of the recommendations. Assuming those endorsements are provided, you can expect public comment proposals on the following topics to be distributed this fall: foreign board certification, primary OR first assistant on reported transplant cases requirement for primary surgeons, and those topics pertaining to key personnel procurement requirements (those bullets that are italicized on this slide).

5. New Committee Initiatives
Organ Perfusion Membership Standards Working Group
Membership questions raised by Thoracic Committee EVLP Working Group
Consider the potential for future technologies  make recommendations applicable across all organ groups
Problem- Numerous patient safety concerns associated with using organ perfusion companies that are not OPTN members and there is no direct oversight to monitor these concerns and promote improvement.
Finally, I would like to mention a working group that has recently been formed to consider membership standards for non-OPTN member organ perfusion companies that are providing services with emerging lung perfusion technology. The OPTN/UNOS Thoracic Committee formed an EVLP (ex vivo lung perfusion) Working Group to discuss how this new technology may impact lung allocation. During its discussions, concerns were raised about how potential patient safety issues would be monitored and addressed considering the lungs are physically handled during the perfusion process. Stemming from these patient safety concerns, the possibility of OPTN membership was suggested. The EVLP Working Group agreed that membership questions were best suited for the MPSC to address, and referred the topic to us.
MPSC leadership agreed this topic needed further discussion and requested that a working group be formed to include members of the MPSC and the Thoracic Committee’s EVLP Working Group. Considering the potential for additional perfusion technologies for other organs, the working group was tasked with thinking about this topic from a broad perspective such that its recommendations could be applicable across all organ groups.
This group had its first meeting in November, and recognized numerous patient safety concerns that could arise from the use of third-party, non-OPTN member perfusion companies. With respect to these concerns, the group believes it is problematic if there is no direct oversight to monitor outcomes and promote improvement of these third-party perfusion companies that will be handling and packaging organs for transplant. The Working Group met again at the beginning of February and discussed possible oversight options that fall within the OPTN’s current purview. Possible options raised by the group during this call are currently being evaluated further by HRSA and UNOS.
Additional notes:
Working Group includes
Members of Thoracic Committee EVLP WG
MPSC members with varying backgrounds and expertise (i.e., thoracic, abdominal, OPO representation)
Patient safety concerns recognized:
Patient safety implications associated with the packaging, labeling, and handling of organs
Limited awareness of graft and patient outcomes
Disease transmission risks
potential disease transmission at the organ perfusion facility
potential risks involved with communication failures if a disease is recognized after allocation
Accountability for potential policy violations
potential policy violations that originate at the perfusion facility
potential policy violations originating elsewhere that are recognized at the perfusion facility

6. Questions? Jonathan Chen, M.D. Committee Chair
Regional Rep name (RA will complete) Region X Representative
address
Sally Aungier
Committee Liaison