1. Updating the OPTN Definition of a Transplant Hospital
OPTN/UNOS Membership and Professional Standards Committee
This presentation will focus on an MPSC-sponsored proposal that is currently out for public comment, entitled, “Updating the OPTN Definition of a Transplant Hospital.”

2. What problem will the proposal solve?
Definition originally adopted by the Board in 1986 is too simplistic
Evolving structure of hospitals and medical systems
Vulnerable to differing interpretations
The OPTN’s current definitions of a transplant hospital in OPTN Policy and Bylaws have not been modified since their original implementation in Development of the OPTN’s definition of a transplant hospital at that time focused appropriately including members in the development of the national transplant system and organ allocation policies. The evolving structure of hospitals and medical systems has rendered the current definitions too simplistic, and vulnerable to differing interpretations. Recently, the OPTN/UNOS Board of Directors requested that the MPSC work to better define a transplant hospital.

3. Current Transplant Hospital Definitions
OPTN Policy
Transplant hospital- A health care facility in which transplants of organs are performed.
OPTN Bylaws
Transplant Hospital Member- A membership category in the OPTN for any hospital that has current approval as a designated transplant program for at least one organ.
To illustrate this problem, here are the current OPTN transplant hospital definitions.

4. What are the proposed solutions?
A transplant hospital:
Must continue to meet all requirements in Appendix D (Membership Requirements for Transplant Hospitals and Transplant Programs)
Can only have one transplant program for each respective organ
Each transplant program may include multiple ORs, ICUs, post-operative care units for transplant patient care
All ORs used for transplantation in one transplant program must:
Have common executive leadership and governance oversight, demonstrated to satisfaction of the OPTN
Be preemptively documented with the OPTN
To address this problem, the MPSC proposes several Bylaws changes that elaborate and further refine the current OPTN definition of a transplant hospital. The MPSC aimed to strike a balance between a clear framework for the MPSC to consistently and objectively evaluate transplant hospital applications, while also creating a system with some flexibility to accommodate reasonable, but unique, circumstances.
Specifically, the proposed Bylaws changes establish that-
A transplant hospital can only have one transplant program for each respective organ, but each transplant program may include multiple operating rooms, intensive care units, post-operative care units, etc.
All operating rooms used for transplantation in one program must have common executive leadership and governance oversight, demonstrated to the satisfaction of the OPTN, and all operating rooms used for transplant must be preemptively documented with the OPTN. (cont.)

5. What are the proposed solutions?
Transplant hospital geographic considerations:
All of the hospital’s transplant operating room facilities must be within a single DSA and either:
within a “contiguous campus”
within a one-mile walking distance of the main hospital address
other scenarios outside of these criteria, as approved at the discretion of the OPTN
Continuing from the previous slide, this proposal also recommends that all of the transplant hospitals transplant operating room facilities must be within a single DSA and either:
within a “contiguous campus”
within a one-mile walking distance of the main hospital address
other scenarios outside of these criteria, as approved at the discretion of the OPTN

6. What are the proposed solutions?
Transplant hospital definition- additional considerations
Only one transplant hospital can be approved for any given hospital campus
Exception: the proposed transplant hospital within the same campus is a children’s or Veterans Affairs hospital
Eliminate “Veteran’s Administration Dean’s Committee Hospital” designation
OPTN Bylaws Appendix D.11.F
Proposed deletion will require every transplant hospital to submit its own individual membership application
Currently there are two Dean’s Committee transplant hospitals
The proposed Bylaws also establish that only one transplant hospital can be approved for any given hospital campus. This proposed requirement is an additional consideration to support and reinforce that a transplant hospital may only have one approved program for any given organ. Veterans Affairs hospitals and transplant hospitals that primarily serve pediatric patients may cite the same campus as another transplant hospital, and are exceptions to this requirement.
Finally, this proposal recommends eliminating the “Veteran’s Administration Dean’s Committee Hospital” designation that is outlined in OPTN Bylaws Appendix D.11.F, which is currently granted to two members. The primary impact of this change is that it requires each member to submit its own individual membership application. Currently, Veteran’s Administration Dean’s Committee Hospitals do not have to submit a separate membership application, and are considered members under the university hospital with which it is affiliated.
Additional info FYI- two remaining Veteran’s Administration Dean’s Committee Hospital are Nashville Veterans Administration Hospital (TNVU-VA1, Vanderbilt) and Iowa City VA Medical Center (IAIV-VA1, University of Iowa)

7. Spring 2016 Consensus Building Discussions
Concepts reviewed and discussed with OPTN/UNOS members
Operations and Safety Committees
Pediatric Transplantation Committee
Policy Oversight Committee
Transplant Administrators Committee
2016 Transplant Management Forum- breakout session
June 2016 Board of Directors Meeting- breakout session
Feedback was supportive and complimentary; no reservations expressed
The Committee presented the concepts of this proposal to six different groups this spring – all of which are listed on this slide - to get feedback and build consensus around the recommendations included in this proposal. The MPSC received supportive feedback during these discussions, resulting in what is detailed and recommended in this proposal which do not include any changes from the concepts presented in the spring.

8. Proposal DOES NOT Include
Any changes to key personnel Bylaws
Qualified individuals may still serve as key personnel at multiple transplant hospitals
Explicit alignment with CMS definition of a transplant hospital
Different focuses
Already precedent for multiple OPTN transplant hospitals having a single CMS provider number, and for a single OPTN transplant hospital to have multiple CMS provider numbers
The discussions I referenced on the previous slide did prompt two questions that a few participants raised. In case someone today may have these same questions, it is important to note that this proposal does not change any of the current key personnel Bylaws. Individuals who are qualified to serve as key personnel may still do so at multiple transplant hospitals.
It is also important to note that this definition does not explicitly align with the CMS definition of a transplant hospital. The MPSC considered the CMS transplant hospital definition during its development of this proposal, but ultimately decided that it was not feasible just to incorporate what is already used by CMS. CMS and the OPTN have different purposes and focus, and the MPSC felt the CMS transplant hospital definition does not completely suit the responsibilities of the OPTN. Differences between these two definitions of a transplant hospital were not thought to be a major point of contention because there is already precedence for a single OPTN transplant hospital to have multiple CMS provider numbers, and vice versa.

9. How will members implement this proposal?
ALL transplant hospitals will be expected to complete an updated application in response to these Bylaws changes
Upon completion of membership database programming, federal government approval of updates to membership application form, and notice to members: there will be a 60-day period for members to submit the new information required by this proposal
Type of campus arrangement (i.e., contiguous campus, 1-mile walking distance radius)
Transplant operating room documentation
Proposed Bylaws will be slated for implementation ~12 months after the 60-day data collection period
UNOS staff to work with transplant hospitals to get all in compliance with new Bylaws prior implementation
After UNOS programs the necessary updates to the membership database, the federal government approves edits to the new transplant hospital membership application, and upon notice to the members, EVERY transplant hospital will need to provide the new information required by this proposal-
Type of campus arrangement (i.e., contiguous campus, 1-mile walking distance radius)
Transplant operating room documentation
Collection of these data will occur during a 60-day period, and these Bylaws are expected to be implemented approximately 12 months after the conclusion of the 60-day data collection period. UNOS staff and the MPSC will process the information provided during these 12 months, and assuming members satisfactorily provide the necessary information introduced by these proposed Bylaws, no other action will be necessary.
During this 60-day period, transplant hospitals with operating rooms beyond the established geographic boundaries seeking approval through an informal discussion with the MPSC will also be able to indicate their intent to proceed in this manner. These members will need to explain their specific situation and why the MPSC should consider an exception to the explicit boundaries included in the Bylaws used to define a transplant hospital. UNOS staff will contact these transplant hospital members to make arrangements for conducting an informal discussion with the MPSC.
After the 60-day data collection period, UNOS staff will be in contact with transplant hospitals, as necessary, in an effort towards making sure that all are compliant with the new Bylaws prior to their implementation.

10. How will the OPTN implement this proposal?
Board consideration – December 2016
Monitoring
No ongoing compliance monitoring process
After implementation, if transplant hospital makes changes with respect to these proposed Bylaws:
Contact UNOS Member Quality Department
Submit an updated application to document changes
MPSC will inquire if it becomes aware of transplant hospital arrangement and facilities changes not previously documented in an application
If public comment is favorable, this proposal is slated to be considered by the OPTN/UNOS Board of Directors during its December 2016 meeting. If the Board adopts this proposal, programming will be required. Programming efforts will primarily entail updating the UNOS membership database so that the new information required by this proposal can be collected and stored. Upon completion of this programming, OMB approval of the new data collection forms updated to incorporate the new information required by this proposal, and notice to members, as previously mentioned- there will be a 60-day period for members to submit the new information required by this proposal. During the 12 months that follow this 60-day data collection period, UNOS staff and the MPSC will review and process the information provided. UNOS staff will work with members to get all in compliance with these new Bylaws prior to their implementation.
Once these Bylaws are implemented, there will not be an ongoing compliance monitoring process. If a transplant hospital plans to make changes with regards to how it is arranged, or any of the other information required by this proposal, it will be expected to contact the UNOS Member Quality Department so the necessary changes can be made to the transplant hospital’s record. Should the MPSC become aware of information that is contradictory to what the OPTN has on file (e.g., a hospital transplanted a patient in an operating room not previously documented with the OPTN), then the MPSC will send an inquiry to that member.

11. Questions? Jeffrey Orlowski, MS, CPTC Committee Chair
Chad Waller
Committee Liaison