1. Pediatric Transplantation Committee Fall 2015
Proposal to Establish Pediatric Training and Experience Requirements in the Bylaws
Pediatric Transplantation Committee
Fall 2015

2. What problem will the proposal solve?
NOTA requires the OPTN to “recognize the differences in health and in organ transplantation issues between children [under the age of 18] and adults…and adopt criteria, policies and procedures that address the unique health care needs of children.”
Pediatric training and experience not currently required at programs that perform pediatric transplants
The National Organ Transplant Act (NOTA) requires that the OPTN “recognize the differences in health and in organ transplantation issues between children [under the age of 18] and adults throughout the system and adopt criteria, policies, and procedures that address the unique health care needs of children.” Pediatric transplantation is an accepted subspecialty within the field of transplantation, not unlike the 19 pediatric subspecialties recognized in other areas of medicine. Yet, the current OPTN Bylaws do not include any requirements in order for programs to be approved to perform pediatric transplants. As early as 1993, the MPSC has sought guidance from the Pediatric Committee in establishing pediatric requirements so it could better assess key personnel applications.

3. What is the goal of the proposal?
Require programs to have an approved pediatric component to perform transplants in patients less than 18
Approved = must identify a primary pediatric surgeon and a primary pediatric physician to serve as key personnel
Requirements only apply to pediatric key personnel, not all surgeons and physicians who care for pediatric patients
This proposal fulfills a longstanding need to define pediatrics as a subspecialty within the field of transplantation. The proposal resulted from strong clinical consensus involving multiple stakeholders, including the ASTS, and strikes an appropriate balance between the competing interests of quality of care and access to transplantation. The Committee proposes that a designated transplant program must have an approved pediatric component in order to register and perform kidney, liver, heart, and lung transplants in patients less than 18 years old. To be approved for a pediatric component, a program must identify a qualified primary pediatric surgeon and a qualified primary pediatric physician to serve as key personnel.
It is important to reiterate that these proposed requirements only apply to individuals applying to be the primary pediatric surgeon or the primary pediatric physician at a program that will perform transplants in patients under 18. These requirements do not apply to all surgeons that perform pediatric transplants or physicians that care for pediatric transplant patients.

4. Recent history of this proposal
2.5 year development
Presented to the Board of Directors in June 2015
Failed to pass by a majority of the Directors (19-Y,16-N,3-A)
Achieved consensus on need to recognize pediatrics as a subspecialty through membership requirements
Stratify the case requirements
After an intensive two and a half year effort, the Committee presented the Board of Directors with a proposal this past June. Although the proposal failed to pass by a majority of the Directors (19-Yes, 16-No, 3-Abstain), the Committee achieved consensus on the need to recognize pediatric transplantation as a subspecialty through pediatric membership requirements. The Board directed the Committee to work with interested stakeholders, including the ASTS, to revise the proposal to include stratified case volume requirements and submit it for public comment in August 2015.
For those unfamiliar with the previous proposal, a surgical case volume requirement is the number of pediatric transplants a surgeon must perform in order to qualify as the pediatric primary surgeon. Rather than simply requiring a caseload in patients less than 18 years old, Board members felt it was appropriate to stratify the case volume requirement such that the surgeon must perform a minimal number of transplants in younger pediatric patients in order to qualify as the pediatric primary surgeon.

5. Recent history of this proposal
Joint OPTN-ASTS working group developed stratified case volume requirements for kidney and liver
Reached out to thoracic colleagues to develop stratifications for heart and lung
New proposal – stratifies requirements for primary surgeon by age
Still lifetime experience, with currency
To fulfill the Board’s directive, the Chair convened a joint OPTN-ASTS working group to develop stratified case volume requirements for kidney and liver surgeons. The Committee members who participated in the working group then reached out to colleagues in the thoracic community to develop the stratified case volume requirements for the pediatric heart and lung key personnel. The following four slides detail these newly stratified requirements, which still may be achieved over a lifetime so long as the surgeon demonstrates currency of experience (as defined in the Bylaws).

6. Pediatric Kidney Component Qualifying Criteria
Pediatric Primary Kidney Surgeon
Meet current Bylaw requirements for the Primary Kidney Surgeon
10 kidney transplants in patients less than 18 years old, including 3 transplants in patients less than 6 years old or less than 25 kg
Pediatric Primary Kidney Physician
Meet current Bylaw requirements for the Primary Kidney Physician and completed at least one of the following training or experience pathways:
E.3.C (Three-year Pediatric Nephrology Fellowship Pathway)
E.3.D (Twelve-month Pediatric Transplant Nephrology Fellowship Pathway)
E.3.E (Combined Pediatric Nephrology Training and Experience Pathway)
The pediatric primary kidney surgeon must meet the current requirements in the Bylaws for the primary surgeon. For kidney, liver, heart, and lung, the pediatric primary surgeon must meet the current requirements in the Bylaws for the primary surgeon. In addition, the surgeon must have performed at least 10 of the kidney transplants in patients less than 18 years old, including 3 transplants in patients less than 6 years old or less than 25 kilograms at the time of transplant. The pediatric primary physician must also meet the current requirements in the Bylaws for the primary physician and must have completed at least one of the three pediatric training or experience pathways that are currently in the Bylaws.
It is important to note that for all caseload requirements, the surgeon or physician must demonstrate currency of experience, already defined in the Bylaws as within the last 2 years.

7. Pediatric Liver Component Qualifying Criteria
Pediatric Primary Liver Surgeon
Meet current Bylaw requirements for the Primary Liver Surgeon
15 liver transplants in patients less than 18 years old, including 8 transplants in patients less than 6 years old or less than 25 kg
Pediatric Primary Liver Physician
Meet current Bylaw requirements for the Primary Liver Physician and completed at least one of the following training or experience pathways:
Three-year Pediatric Gastroenterology Fellowship Pathway (F.3.C)
Pediatric Transplant Hepatology Fellowship Pathway (F.3.D)
Combined Pediatric Gastroenterology/Transplant Hepatology Training and Experience Pathway (F.3.E)
The pediatric key personnel requirements for liver have the same structure as the kidney requirements. The pediatric primary liver surgeon must meet the current requirements for the primary liver surgeon and must have performed at least 15 of the liver transplants in patients less than 18 years old, including 8 transplants in patients less than 6 years old or less than 25 kilograms at the time of transplant. The pediatric primary physician must meet the current requirements in the Bylaws for the primary physician and have completed at least one of the three pediatric training or experience pathways that are currently in the Bylaws.

8. Pediatric Heart Component Qualifying Criteria
Pediatric Primary Heart Surgeon
Meet current Bylaw requirements for the Primary Heart Surgeon
8 heart transplants in patients less than 18 years old, including 4 transplants in patients less than 6 years old or less than 25 kg
Pediatric Primary Heart Physician
Meet current Bylaw requirements for the Primary Heart Physician
Board-certified in pediatric cardiology
Cared for 8 heart transplant patients less than 18 years old, including 4 patients less than 6 years old or less than 25 kg
The pediatric primary heart surgeon must meet the current requirements in the Bylaws for the primary surgeon. In addition, the surgeon must have performed at least 8 of the heart transplants in patients less than 18 years old, including 4 transplants in patients less than 6 years old or less than 25 kilograms at the time of transplant. The pediatric primary physician must meet the current requirements in the Bylaws for the primary physician, must have current certification in pediatric cardiology by the American Board of Pediatrics, and must have cared for 8 heart transplant patients less than 18 years old, including 4 patients less than 6 years old or less than 25 kilograms at the time of transplant.

9. Pediatric Lung Component Qualifying Criteria
Pediatric Primary Lung Surgeon
Meet current Bylaw requirements for the Primary Lung Surgeon
4 lung transplants in patients less than 18 years old, including 1 transplant in a patient less than 12 years old or less than 40 kg
Pediatric Primary Lung Physician
Meet current Bylaw requirements for the Primary Lung Physician
Board-certified in pediatric pulmonary medicine
Cared for 4 lung transplant patients less than 18 years old, including 1 patient less than 12 years old or less than 40 kg
The pediatric primary lung surgeon must meet the current requirements in the Bylaws for the primary surgeon. In addition, the surgeon must have performed at least 4 of the lung transplants in patients less than 18 years old, including 1 transplant in a patient less than 12 years old or less than 40 kilograms at the time of transplant. The pediatric primary physician must meet the current requirements in the Bylaws for the primary physician, must have current certification in pediatric pulmonary medicine by the American Board of Pediatrics, and must have cared for 4 lung transplant patients less than 18 years old, including 1 patient less than 12 years old or less than 40 kilograms at the time of transplant.

10. Conditional Approval for Pediatric Component
Conditional approval for 24 months, if
One of the key personnel, either surgeon or physician meets criteria and
Other meets all the requirements and has at least half the required number of pediatric transplant cases in patients less than 18 years old:
Possible 24 month extension for substantial progress
Kidney
5, including 1 in a patient less than 6 years old or less than 25 kg
Liver
7, including 2 in patients less than 6 years old or less than 25 kg
Heart
4, including 1 in a patient less than 6 years old or less than 25 kg
Lung
2, with no stratification
A pathway for Conditional Approval for a Pediatric Component is included in the proposal to help preserve access for pediatric transplantation. A Pediatric Component can apply for conditional approval for 24 months, if one of the key personnel, either physician or surgeon, is fully qualified and the other meets all of the requirements and has at least half the required number of pediatric transplant cases with stratification for kidney, liver and heart. Because the small number of pediatric lung transplants, no stratification is specified for pediatric lung conditional approval. If a program provides substantial evidence of progress toward fulfilling the requirements, but is unable to complete the all of the requirements within the initial 24 months, granting an additional 24 month extension of conditional approval may be considered.
THIS WILL DECREASE THE CONCERNS OVER IMMEDIATE LOSS OF ACCESS… HAVE UPTO SIX YEARS TO GET READY FOR THIS!!!!!!!!!!!!!!!

11. Supporting Evidence Quality Access
Programs performing any transplants in <18 year old
Case volume stratification proportionate to frequency of transplant by age, weight
Organ-specific, stratified case volumes
Lifetime experience with currency
Requires currency (last 2 yrs)
Delayed implementation
No exceptions
Conditional pathway
This is not the first time in the history of this project that the Committee has considered stratified case volume requirements. During the fall 2013 regional meetings, the committee presented initial requirements that included stratified case volumes. These requirements were far more restrictive than the current proposal and were met with overwhelming concern for access to transplantation. In response to your feedback, the Committee modified the proposal significantly to protect access for pediatric patients, including removing the stratified caseloads.
Although the current proposal reintroduces stratified caseload requirements, it strikes a more appropriate balance between quality of care and access to transplantation. The proposed case volumes by organ are lower overall than those considered in 2013 and are roughly proportionate to the frequency of transplant in these age groups. Key personnel can achieve the required caseload over a lifetime instead of five years, so long as they demonstrate that their pediatric transplant experience occurred within the last 2 years. Programs will have at least 18 months after Board approval before the application period opens. Your program may still take advantage of the conditional pathway when establishing a new pediatric component or to accommodate changes in key personnel at programs with an existing pediatric component. If we assume center volume is an adequate proxy for primary surgeon volume (due to limitations of OPTN data), an estimated 93% of all pediatric transplants from January 1, 2010 to December 31, 2014 were performed at programs that would meet these more robust requirements today.
93% of pediatric transplants performed at programs that met the proposed volume criteria in last 5 years

12. How will members implement this proposal?
If applying for a pediatric component:
Obtain and complete application
Notify OPTN of any personnel changes
If not applying for a pediatric component:
Notify OPTN
Follow transition plan to remove pediatric candidates from waiting list
This proposal requires large programming changes to UNetSM and the UNOS Membership Database. Once programming is completed, UNOS will distribute a pediatric component application to any member transplant program that has had at least one pediatric patient on its waiting list in the last five years. The application will be similar to the current transplant program application forms, but will incorporate the additional pediatric key personnel elements that the proposed Bylaws establish. This process is expected to begin approximately 18 months after the board approves the proposal. Programs must submit completed applications within 90 days in order to guarantee that UNOS will process them before the Bylaws are implemented. All transplant programs have the same application due date, regardless of center or organ. Programs that receive an application but do not intend to apply are asked to document this intention and submit it to UNOS. Programs that have not registered any pediatric patients in the previous five years, and therefore did not automatically receive an application, may contact the UNOS Membership Analyst for their region and request one.
Over the next 18 months, UNOS will process the estimated 380 applications and submit them to the MPSC for review. If a program reports any personnel changes during that time, UNOS will update the active application. UNOS will notify members of the status of their applications before the Bylaws are implemented, specifically whether the MPSC is recommending that the Board of Directors approve the pediatric component. Once the Bylaws’ are implemented, which will be approximately 3 years after Board approval, any program without pediatric component approval that has pediatric patients on its waiting list must follow the transition plan described in OPTN Bylaws* for all remaining pediatric patients.
*Speaker’s note: Appendix K.5 (Transition Plan during Long-term Inactivity, Termination, or Withdrawal)

13. How does this proposal support the OPTN Strategic Plan?
Goal 3: Improve Outcomes
Establish pediatric membership requirements
Goal 4: Promote Patient Safety

14. Questions? Eileen Brewer, MD Committee Chair ebrewer@bcm.edu
Christine Flavin, MPH
Committee Liaison

15. Number of pediatric transplants at centers meeting the proposed pediatric volume criteria, 1/1/10-12/31/14
Organ
Transplanted
Number of Pediatric Transplants
Number and Percent of Pediatric Transplants at Centers
Meeting Volume Criteria* N %
Kidney
3,733
3,398 91
Liver
2,667
2,533 95
Heart
1,918
1,838 96
Lung
255
227 89
All Organs
8,573
7,996 93
The majority of pediatric transplants during the last 5 years were performed at centers that would have met the proposed pediatric volume criteria.
Across all organs, 93% of pediatric transplants were performed at centers that would have met the proposed pediatric volume criteria.
Volume criteria:
Kidney: 10+ transplants in recipients <18 years, and 3+ of these in recipients <6 years or <25 kg
Liver: 15+ transplants in recipients <18 years, and 8+ of these in recipients <6 years or <25 kg
Heart: 8+ transplants in recipients <18 years, and 4+ of these in recipients <6 years or <25 kg
Lung: 4+ transplants in recipients <18 years, and 1+ of these in recipients <12 years or <40 kg

16. Number of pediatric transplants by age and weight, 1/1/10-12/31/14
Organ
Transplanted
Number of Pediatric Transplants
Number and Percent of Pediatric Transplants in Recipients <6 years or <25 kg N %
Kidney
3,733
1,279 34
Liver
2,667
1,961 72
Heart
1,918
1,142 60
Number and Percent of Pediatric Transplants in Recipients <12 years or <40 kg
Lung
255
159 62
To illustrate the justification for stratifying the volume criteria by age and weight, this slide shows frequency of pediatric transplants during the last 5 years by age and weight.
The percent of pediatric transplants that were performed in recipients <6 years or <25 kg was 34% for kidney, 72% for liver, and 60% for heart. The cut-off used for stratification criteria is 3 out of 10 (30%) for kidney, 8 out of 15 (53%) for liver, and 4 out of 8 (50%) for heart.
For lung, 62% of pediatric transplants were performed in recipients <12 years or <40 kg and the cut-off used for stratification is 1 out of 4 (25%).
Volume criteria:
Kidney: 10+ transplants in recipients <18 years, and 3+ of these in recipients <6 years or <25 kg
Liver: 15+ transplants in recipients <18 years, and 8+ of these in recipients <6 years or <25 kg
Heart: 8+ transplants in recipients <18 years, and 4+ of these in recipients <6 years or <25 kg
Lung: 4+ transplants in recipients <18 years, and 1+ of these in recipients <12 years or <40 kg

17. Unadjusted Kaplan-Meier Survival by Center Volume Category for Pediatric Kidney Transplants, 1/1/02-12/31/11
p < 0.01
This slide illustrates the unadjusted Kaplan-Meier graft and patient survival within 5 years of transplant for pediatric kidney transplants performed between 2002 and 2011, stratified by whether the transplants were performed at centers meeting the proposed volume criteria (shown in green) or at centers not meeting the volume criteria (shown in pink).
As a group, centers that met the volume criteria during had significantly better graft and patient survival within 5 years as compared to centers that did not meet the volume criteria.
*Centers Meeting Volume Criteria: Centers with at least 10 transplants in recipients <18 years, including at least 3 transplants in recipients <6 years or <25 kg.

18. Unadjusted Kaplan-Meier Survival by Center Volume Category for Pediatric Liver Transplants, 1/1/02-12/31/11
p < 0.01
This slide illustrates the unadjusted Kaplan-Meier graft and patient survival within 5 years of transplant for pediatric liver transplants performed between 2002 and 2011, stratified by whether the transplants were performed at centers meeting the proposed volume criteria (shown in green) or at centers not meeting the volume criteria (shown in pink).
As a group, centers that met the volume criteria during had significantly better graft and patient survival within 5 years as compared to centers that did not meet the volume criteria.
*Centers Meeting Volume Criteria: Centers with at least 15 transplants in recipients <18 years, including at least 8 transplants in recipients <6 years or <25 kg.

19. Unadjusted Kaplan-Meier Survival by Center Volume Category for Pediatric Heart Transplants, 1/1/02-12/31/11
This slide illustrates the unadjusted Kaplan-Meier patient survival within 5 years of transplant for pediatric heart transplants performed between 2002 and 2011, stratified by whether the transplants were performed at centers meeting the proposed volume criteria (shown in green) or at centers not meeting the volume criteria (shown in pink).
As a group, centers that met the volume criteria during had better patient survival within 5 years as compared to centers that did not meet the volume criteria, although the difference did not reach statistical significance.
*Centers Meeting Volume Criteria: Centers with at least 8 transplants in recipients <18 years, including at least 4 transplants in recipients <6 years or <25 kg.

20. Unadjusted Kaplan-Meier Survival by Center Volume Category for Pediatric Lung Transplants, 1/1/02-12/31/11
This slide illustrates the unadjusted Kaplan-Meier patient survival within 5 years of transplant for pediatric lung transplants performed between 2002 and 2011, stratified by whether the transplants were performed at centers meeting the proposed volume criteria (shown in green) or at centers not meeting the volume criteria (shown in pink).
As a group, centers that met the volume criteria during had significantly better patient survival within 5 years as compared to centers that did not meet the volume criteria.
*Centers Meeting Volume Criteria: Centers with at least 4 transplants in recipients <18 years, including at least 1 transplant in recipients <12 years or <40 kg.

21. Geographic locations of centers performing pediatric kidney transplants, 1/1/10-12/31/14
91% of pediatric transplants were performed at
centers meeting the proposed volume criteria
KI criteria: > 10 transplants in recipients <18 years and >3 of these were in recipients <6 years or <25 kg.
The geographic locations of centers performing pediatric kidney transplants between 2010 and 2014 are illustrated on this slide. In the last 5 years, 91% of pediatric kidney transplants were performed at centers that met the criteria in the last 5 years (shown in blue dots).
Centers meeting the proposed volume criteria (10+ transplants in recipients <18 years and 3+ of these in recipients <6 years or <25 kg)
Centers not meeting the proposed volume criteria

22. Geographic locations of centers performing pediatric liver transplants, 1/1/10-12/31/14
95% of pediatric transplants were performed at
centers meeting the proposed volume criteria
Liver criteria: >15 transplants in recipients <18 years and >8 of these were in recipients <6 years or <25 kg.
The geographic locations of centers performing pediatric liver transplants between 2010 and 2014 are illustrated on this slide. In the last 5 years, 95% of pediatric liver transplants were performed at centers that met the criteria in the last 5 years (shown in blue dots).
Centers meeting the proposed volume criteria (15+ transplants in recipients <18 years and 8+ of these in recipients <6 years or <25 kg)
Centers not meeting the proposed volume criteria

23. Geographic locations of centers performing pediatric heart transplants, 1/1/10-12/31/14
96% of pediatric transplants were performed at
centers meeting the proposed volume criteria
Heart: >8 transplants in recipients <18 years and >4 of these were in recipients <6 years.
The geographic locations of centers performing pediatric heart transplants between 2010 and 2014 are illustrated on this slide. In the last 5 years, 96% of pediatric heart transplants were performed at centers that met the criteria in the last 5 years (shown in blue dots)
Centers meeting the proposed volume criteria (8+ transplants in recipients <18 years and 4+ of these in recipients <6 years or <25 kg)
Centers not meeting the proposed volume criteria

24. Geographic locations of centers performing pediatric lung transplants, 1/1/10-12/31/14
89% of pediatric transplants were performed at
centers meeting the proposed volume criteria
Lung: >4 transplants in recipients <18 years and >1 in recipients <12 years or <40 kg.
The geographic locations of centers performing pediatric lung transplants between 2010 and 2014 are illustrated on this slide. In the last 5 years, 89% of pediatric lung transplants were performed at centers that met the criteria in the last 5 years (shown in blue dots)
Centers meeting the proposed volume criteria (4+ transplants in recipients <18 years, 1+ of these in recipients <12 years or <40 kg)
Centers not meeting the proposed volume criteria