Update Transplant Program Key Personnel Training and Experience Requirements At a glance Current practice The OPTN has bylaw requirements for transplant program key personnel training and experience as required by the OPTN Final Rule. Changes have been made to sections of the training and experience bylaws, but a review of all bylaw requirements has not been done in over 10 years. As an initial phase, a review of the bylaws has been conducted to reveal inconsistencies between similar bylaws, outdated sections, and overly complex requirements. Supporting media Presentation View presentation slides Requested feedback Bylaw changes are being considered for the training and experience of key personnel bylaw sections. In a separate proposal, the Membership and Professional Standards Committee (MPSC) recommends changes to the membership and application bylaw sections. MPSC requests the following feedback from the community: Any unintended consequences for these proposed changes to primary surgeon and physician training and experience requirements: Consolidation of multiple pathways into one recent experience pathway Limiting procurement requirement for surgeons and observation requirements for physicians to surgeons or physicians that have not been a primary in last 10 years. Replace letters of reference and recommendation with online OPTN certification form Inclusion of conditional approval for both primary surgeons and physicians where there is an unanticipated vacancy Do you support the addition of an OPTN Orientation Curriculum for individuals who have not served as a primary surgeon or physician in the last 10 years? What should the curriculum cover? For individuals with foreign training or experience: How does one evaluate equivalent training to a board certified practitioner? Should an individual proposed as primary be required to have US transplant system experience? Can OPTN orientation curriculum replace experience? For future project evaluating alternatives to the current requirement that primary surgeons and physicians be “on site”: What responsibilities should the primary surgeon and physician have? What level of commitment should be demonstrated to fulfill the role of primary surgeon and physician? Anticipated impact What it's expected to do Inform future bylaw proposals for revision of organ-specific primary surgeon and primary physician training and experience requirements What it won't do Will not change bylaws at this time Themes Primary surgeon and primary physician training and experience Minimum requirements for transplant program leaders Terms to know OPTN Final Rule: The Final Rule defines a standard framework for policies, requiring the OPTN to establish Policy Criteria, Policy Objectives and Performance Measures with procedures for continuous evaluation and reporting. Procurement: The surgical procedure of removing an organ from a donor. Also referred to as recovery. Transplant Program: The organ-specific facility within a transplant hospital. Transplant Physician (See Transplant Team): Doctors who manage the patient's medical care, tests, and medications. He or she does not perform surgery. The transplant physician works closely with the transplant coordinator to coordinate the patient's care until transplanted and provides follow-up care to the recipient. Transplant Surgeon (See Transplant Team): Doctors who perform the transplant surgery and may provide the follow-up care for the recipient. The transplant surgeon has special training to perform transplants. Click here to search the OPTN glossary Comments International Society for Heart and Lung Transplantation | 03/23/2021 ISHLT members were notified of this opportunity for public comment, but we did not have sufficient time to discuss the proposal in an open forum. We are not aware of any specific concerns beyond those posted online OPTN Heart Transplantation Committee | 03/23/2021 The Heart Transplantation Committee thanks the MPSC for the opportunity to provide feedback on the Update Transplant Program Key Personnel Training and Experience Requirements proposal. The members encourage the MPSC to consider how to align the proposed pathway with members’ institutional restrictions, specifically as it relates to individuals hired with foreign experience and training. A member commented that the hiring program should have discretion over what foreign experience and training would qualify a candidate for the position of primary surgeon or physician. Members supported the development of curriculum to train prospective primaries on OPTN requirements. Members raised concern about the burden associated with maintaining logs and documentation required for applying for a primary positions and support continued work by the MPSC to develop ways to assist members through this process. Region 10 | 03/23/2021 Several members expressed concerns over how cumbersome it can be to update a program’s key personnel training and experience requirements. The process seems especially onerous for physicians who have been with their program for many years. One member suggested that instead of focusing on transplant logs an orientation module could be developed to meet the OPTN Bylaw requirements. Another member commented that the process is not user friendly and requires a lot of back and forth between the program and UNOS. It would be helpful if there was a way for programs to review their applications instead of having to request their application each time. In regards to key personnel training requirements for foreign trained individuals, one member commented that it should still be protocoled to maintain consistency since training and experience could differ depending on where the individual trained. Maintaining a minimum requirement for number of cases for surgeons should still be required. A certain number of those should be while in the US to ensure consistency of technique and expertise amongst surgeons at centers. An OPO member mentioned that they are responsible for entering recovery surgeon’s ACIN details as evidence of qualification and suggests that the work of the MPSC should complement with OPO surgeon approval. Lastly, a member added that the MPSC should consider work load for smaller programs with limited staff as they propose changes. Region 2 | 03/23/2021 Overall, the region is supportive of the direction the MPSC is going with the project. One member supports the consolidated pathways and recommends that the committee identify a process to deal with unique circumstances where volume/experience requirements not met. They also encourage the MPSC to consider an alternative pathway for medical physicians that do not meet volumes for procurement observations (and whether this is organ-specific). As a result of the pandemic, travel and restricted access to donor hospitals for non-employees has proved difficult for current trainees to gain this experience. This is further compounded by geography. They recommend the committee consider a virtual alternative can be identified to address this experience requirement. Additionally, the conditional pathways should be made available to surgery and medicine physicians. Another member noted that the committee needs to recognize getting experience logs and multiple letters of support are not efficient. Also propose changing procurement observation experience for primary physicians (not surgeons) to remove specificity of organ. It was noted that the MPSC feels strongly that observation adds value to the relationships between transplant centers and OPOs. This seems to be a fair point so allowing the doctor to observe any organ type procurement would be helpful; especially as it relates to low volume organs such as pancreata or intestines. In terms of foreign equivalency one member noted that it would helpful to have foreign graduates become primary physicians, but they would need to be Board certified. In the nephrology community foreign doctors have to wait for three years to become board certified. Anyone that is going to become a primary physician should have the board certification at hand. Another member agreed that it is a difficult balance between US and non-US schooled/trained physicians but the standard should still be board certification with few exceptions. Another member noted that the issue of "on site" is particularly problematic for many pediatric programs in free standing children's hospitals covered by surgeons from associated adult programs. Clarity from the committee would be very useful. Another member noted that in getting rid of the on-site requirement they would advocate for ensuring that one physician cannot be the primary for two different programs. Lastly, another member noted frustrations with the application process as it is often cumbersome. They noted that requirement for procurement observations for a physician with over twenty years of experience seems burdensome. Additionally, they appreciate that the application process is now online, but there could still be more transparency with the application process. Region 9 | 03/23/2021 During the meeting there were comments voiced during the discussion, submitted online and submitted as comments from the OPTN representatives. An attendee commented that responsibilities for procurements with the local OPO should be clarified, and that it is more an issue of availability and service, than training. A couple attendees commended the MPSC for working on these changes, as the process is cumbersome. A comment was made that 10 years is a long time for grandfathering and perhaps a shorter period of 5 years might be appropriate. Another member commented that the idea for an OPTN curriculum for directors sounds great. American Society of Transplant Surgeons | 03/23/2021 The American Society of Transplant Surgeons (ASTS) opposes the policy proposal as written but supports the concept overall and respectfully submits the following comments with regard to training and experience requirements for Primary Transplant Surgeons and Primary Transplant Physicians. We recommend the OPTN partner with ASTS to develop criteria focused on simplifying the certification process for foreign trained surgeons seeking to serve in the Primary Transplant Surgeon or Program Director role. Upon review of “common requirements,” we believe: Requirement 1D still uses the term “on site” which remains vague and ambiguous (see more discussion below), Requirement 2 requires board certification which will certainly exclude many foreign trained professionals, and Requirement 3 is poorly written and is assumed to mean that a letter must be submitted endorsing the candidate. The requirement for “honesty and integrity” is too vague and is subject to broad interpretation. With regard to “on site,” ASTS agrees with the MPSC that this is a cumbersome and difficult designation that cannot be fulfilled in a literal sense by any one individual. The use of the phrase “on site” seems to imply the surgeon needs to be in-house. We would recommend removing the phrase and providing more clarity. The obligation of the Primary Surgeon/Physician should be to ensure that the program meets all OPTN regulations, complies with all regulations, maintains 24/7/365 coverage of the program by competent surgeons and physicians, and is available should questions arise. In addition, the Primary Surgeon/Physician should be able to designate a surrogate to cover these duties should the Primary Surgeon/Physician be temporarily unavailable to perform these duties in instances of a personal health crisis, leave of absence, or extended vacation. We have no objections to the proposal specifically regarding Board Certification, letters of reference and recommendation, and the personal letter of qualification. The OPTN Orientation curriculum may be a useful and helpful concept, but since this has not been developed and the product is not available to assess, including this requirement is premature and should be eliminated from this revision. It can be added later once developed and vetted. Overall, the “Conditional Pathway” is a good idea. The area of weakness is the establishment of a mentorship/consulting agreement with another Primary Surgeon/Physician from a separate transplant program that would submit progress reports. This puts the conditional program in a difficult position and relies exclusively on the good will of the separate program to perform its duties. If a competing program decides to issue a negative report, is this to be believed and/or scrutinized? Such a report could reduce the clinical activity of the conditional program and benefit the supervising program. Further, this relies on busy and overworked Surgeons and Physicians to mentor and supervise a program other than their own. We propose that the spirit of this endeavor be retained but that the mentorship/consulting agreement take place at the level of UNOS, perhaps with the MPSC, to monitor compliance and outcomes. The proposed changes to primary transplant surgeon requirements, in general, address the weakness of the requirement involving participation on preoperative care, transplant candidate selection, and post-operative care. The 10-year time frame for experience is not based on any evidence that we are aware of and is instead, a randomly round number of years of experience. We remain neutral on such a designation until further evidence is presented supporting that number. Selecting the number of transplants performed and the number of procurements performed will be equally difficult, random, and subject to debate. Clearly, the extremes are obvious in terms of experience or lack thereof. Where the line is drawn in terms of minimal experience is what is important and proposed for the next phase of work. The proposed changes to primary transplant physician requirements are again mostly an improvement. We feel strongly that the requirement for a transplant physician to attend one transplant procurement and transplant procedure is unnecessary. Physicians have long provided outstanding care for peri-surgical patients without watching the actual operation. There are countless examples in all areas of medicine. This presents an unnecessary burden on a physician to take time away from patient care to observe these surgical procedures. It does not make them a better Transplant Physician. Indeed alternatives are available if the MPSC really feels that this adds to their competency. For example, the OPTN could establish a video library of a multiorgan procurement and transplant procedures and require that the physician watch these videos. We agree with the MPSC that foreign equivalency to board certification is an important pathway; yet a difficult one. We disagree with the option that the individual should be required to complete a US based fellowship, however it would be important to have some guarantee that they have worked and/or trained in US based programs for some time with an attestation from supervisors of those programs. We would support the last option as the most comprehensive and fair mechanism to achieve foreign equivalency. For both board certification and experience, ASTS recommends using a similar process to the alternative pathways for predominately pediatric programs. It would require submission of documentation of training and experience with an explanation of how the training or experience is equivalent, letters of recommendation from primary surgeons or physicians at OPTN designated transplant programs, completion of an OPTN orientation curriculum if no experience at an OPTN designated transplant program, and participation in an informal discussion with the MPSC subcommittee. Lung Transplantation Committee | 03/23/2021 The Lung Transplantation Committee appreciates the opportunity to contribute to the MPSC’s Update Transplant Program Key Personnel Training and Experience Requirements request for feedback. The Committee noted that individuals that meet requirements for the current fellowship pathways for primary surgeon and physician may not encompass the knowledge base needed to lead a transplant program, especially regarding knowledge of the OPTN. Also, the Committee discussed that roles and training programs can have variation in relation to the responsibility levels and knowledge of OPTN requirements and that should be considered. The Committee felt positively about the goal of the more broad pathways being proposed which aim to alleviate overall experience concerns and barriers. Region 1 | 03/23/2021 OPTN Membership and Professional Standards Committee presented by Richard Formica, MD Comments: One member stated this is a great initiative and asked how does MPSC coordinate and communicate initiative with other Committees, stating they are working on a committee looking at uterus transplants and trying to think about such criteria for uterus programs. The member also asked what is value of letters of recommendation and also inquired about foreign training. Another member stated they are glad to see grandfathering pathway and asked when the changes will be implemented. One member suggested the letters of recommendation be replaced with a checklist. American Society of Transplantation | 03/22/2021 The American Society of Transplantation is supportive of this proposal to address potential changes to transplant program primary surgeon and primary physician training and experience requirements in concept, and offers the following comments: Five overarching principles are defined: currency of experience; consolidation of pathways; consistency of organ-specific requirements; stratification based on previous experience; incorporating an option allowing for foreign training and transplant experience. Comments: Page 4 - Currency This appropriately emphasizes the need for the primary physician/surgeon to have current experience and includes the establishment of periodic assessment of compliance with membership requirements. The requirements for and process of periodic assessment need to be further defined. Establish a five-year term and renewal process for the primary physician/surgeon to assure that transplant experience and knowledge of OPTN bylaws and policies remain current. This is addressed in another section, but the only caveat would be to consider that the renewal process should consider certain specifics that may be appropriate at initial election for primary physician/surgeon (albeit not at renewal). An example would be ‘witnessed procurements in an experienced primary physician’ – these should not be required for person in their role as an experienced primary (and they should not have to re-demonstrate that experience at renewal). The bottom line is that the requirements for renewal will be different than the initial qualifications and that these will be reasonable to expect from any practicing primary who is still highly involved in transplantation. Page 5 – Consolidation It has been a challenge show currency in procurements for a surgeon and for a physician who has been out of fellowship or residency for more than 2-5 years. Once they become faculty at a transplant institute, there is minimal likelihood of them doing a procurement. Many large, academic programs have surgeons who are procurement surgeons. Thus, the concept of a combined fellowship and clinical experience through a consolidated single pathway is ideal. We do have some reservations about consolidation of the fellowship and clinical experience pathways into one pathway. Currently, as per OPTN bylaws, the candidates applying for a primary surgeon or physician position via clinical experience pathway require a higher number of procedure logs compared to those applying via a fellowship pathway (e.g., performance of 45 kidney transplants over a 2–5-year period vs. 30 kidney transplants during the 2-year fellowship period for surgeons). The plan to consolidate the fellowship and clinical experience pathways implies less stringent criteria to become eligible for primary position via clinical experience pathway than what we have now. Consolidating the pathways may undermine the value of more structured fellowship programs and consequently the training of candidates, especially for Transplant Nephrology in the times when AST accredited transplant nephrology fellowship applicant pool is already depleted. From a pediatric perspective, the consolidation of fellowship and clinical experience is appropriate for a limited time frame. With the new pediatric program certifications, some have been asked to submit logs from patients from more than 10 years ago. This should not be required if you have been approved prior and if you are still working as a transplant medical director. Limiting procurement requirement for surgeons and observation requirements for physicians to surgeons or physicians that have not been a primary in last 10 years would help. We are supportive with the online OPTN certification. Although, we suggest that UNOS might require a letter from the applicant’s current facility stating they are the current acting medical director meeting minimum volume standards. Page 5 – Stratification of Select Key Personnel Requirements: One of the most common issues is the inability of senior clinicians with significant experience to produce documentation for some aspects of their experience that they may have gained early in their career or during their fellowship but no longer routinely perform as a senior clinician, such as procurements for surgeons or observations of transplants and procurements for physicians. If someone has previously served as a primary physician in another institution, we believe the requirements for primary physician should be more consistent with that of the maintenance requirements being considered for someone who is a primary physician at a facility. The need to demonstrate currency should be consistent with current primary physicians or surgeons and should be updated every 5 years, not 10. But the requirements should be more on volume and outcomes in a one-two page form. This section appears generically to have addressed the point above about differentiating initial requirements vs renewal requirements We agree with the proposal to exempt individuals from certain requirements if they have previously served as a primary (proposed within 10 years). We wonder about an exemption for senior transplant physicians who have been functioning as high- level transplant attendings for a threshold number of years (perhaps 5 or 10 years) also being exempt from certain initial requirements (that we believe are geared at new physicians becoming primaries soon after completing training). For example, an experienced transplant attending (> 10 years’ experience for example at an established program) becoming a primary physician may find it difficult to find old case logs for procurements/implants witnessed during transplant fellowships > 10 years earlier. Given the significant experience as a full-time established transplant attending it may be appropriate to waive certain requirements similar to those being proposed for primaries that had previously served as a primary within 10 years. Page 6 – Requirements that appear in both primary transplant surgeon and primary transplant physician requirements. Current certification: add: “or meet defined equivalency criteria” Page 8- On-Site We recommend further consideration into defining on site (or its removal) so the mandate can be clearly followed and fairly assessed. The OPTN defines what they don’t expect on site to be defined as (e.g. – not physically present) but do not currently define what they do expect it to be. If not addressed, this will be ambiguously interpreted. Maintain the requirement that “the primary surgeon and physician be physically available to provide leadership to the program, actively participate in the provision of transplant services, and ensure the operation of the program is in compliance with OPTN obligations.” Consider requirement that the transplant center/hospital be the physician/surgeon’s primary location of practice. (although consider an exception being for those who have separate adult and pediatric programs that are part of the same health system but may be physically different locations) Some of the AST membership questioned the rationale for a single individual being allowed to serve in a primary role for multiple programs and would like the MPSC to elaborate and clarify when this would be permitted. As noted above, unique circumstances may exist for adult/pediatric programs that are part of the same health system. Page 8 – Board Certification There is variability here within the U.S. system – meaning that there are sanctioned boards for transplant in some areas (Heart/Kidney etc.) and not in others (Lung)… It might be reasonable to mandate board certification in the area of organ specific transplantation if that exists (Heart/Kidney others) and to expect Board Certification in the underlying related subspecialty of medicine/surgery in those organs that don’t have a transplant specific board (i.e. BC in Pulmonary Medicine for Lung Transplant) Page 9 – OPTN orientation curriculum We are supportive of this new requirement for transplant program key personnel as it provides a unique opportunity for individuals to be educated on OPTN policies and procedure and the transplant system. We would request consideration that the requirement window of ten years be narrowed to five years for transplant surgeons and physicians who have not recently served as a primary surgeon or physician given the frequency of bylaw and policy changes. We agree that OPTN orientation curriculum would be helpful to all the candidates applying for a primary position for the first time. The curriculum may include education in OPTN bylaws, transplant system, leadership course, and roles and responsibilities of the program primaries. As this OPTN orientation curriculum is yet to be developed, we would encourage that curriculum include a thorough overview of the transplant multidisciplinary team including member roles and requirements. Ideally, we would suggest incorporating multidisciplinary team members into the development of this curriculum. Additionally, we suggest consideration that this curriculum or a similar curriculum be available in the future for other members of the multidisciplinary team A recently published paper by AST Medical Directors Task Force has described the roles and responsibilities of medical directors of kidney transplant programs (“A.C Wiseman at al. Defining the roles and responsibilities of the kidney transplant medical director: A necessary step for future training, mentoring, and professional development. Am J Transplant. 2020 Oct 5”). In addition, AST’s Kidney Pancreas Community of Practice and the AST Medical Directors Task Force recently conducted a survey of primary physicians of kidney and pancreas transplant programs to assess their demographics, training pathways, job satisfaction, and their roles and responsibilities vis-à-vis primary surgeons and transplant administrators (awaiting publication). The gamut of administrative responsibilities the program primaries are involved with (as described in Wiseman et al. paper and what we learnt from the medical director survey) include- demonstration in active participation in listing, QAPI, OPO, and OPTN/UNOS meetings, outreach, marketing, development of program goals and objectives, writing policies and protocols, ensuring adherence to OPTN/UNOS, CMS and other regulatory agencies’ policies, and acting as a liaison with other departments/support services in the hospital. We believe that these data would be helpful to the OPTN in defining the expected roles and responsibilities of primary physicians and surgeons. Page 10 – Conditional approval This pathway is intended to accommodate for sudden vacancies. Consider a process that allows non-primary transplant physicians/surgeons to formally establish “OPTN primary requirements/certification” as part of succession planning and to establish a pool of qualified individuals to fill vacancies. Page 10-11- Primary transplant surgeon requirements See previous comments re. OPTN curriculum Transplant experience - no comment as document states that this will be determined in a later phase of the project. Agree that the requirement for participation in pre-operative assessment and post-operative care adequately addresses the range of care. We agree that the candidates applying for primary position must be required to have recent clinical experience (within past 2 years) at least in some aspects of transplantation (irrespective of whether they have served as primary in the past or not), and the requirements can be set by MPSC. A primary surgeon should commit minimum 50% of time to practice of transplant and minimum 10% of time in transplant administration. For the individuals trained in the United States and Canada applying for primary position, board certification is a requirement. For the individuals trained outside the United States and Canada applying for primary position, we suggest that they must be at least board eligible if not certified and must have U.S. transplant experience for a minimum 2-3 years before applying. Page 12- Primary transplant physician requirements See previous comments re. OPTN curriculum We agree that the candidates applying for primary position must be required to have recent clinical experience (within past 2 years) at least in some aspects of transplantation (irrespective of whether they have served as primary in the past or not), and the requirements can be set by MPSC. A primary physician should commit minimum 50% of time to practice of transplant and minimum 10% of time in transplant administration. For the individuals trained in the United States and Canada applying for primary position, board certification is a requirement. For the individuals trained outside the United States and Canada applying for primary position, we suggest that they must be at least board eligible if not certified and must have US transplant experience for a minimum 2-3 years before applying. Consider expanding requirement for observation of at-least two transplants and one procurement. Should not be a requirement for renewal (as per prior discussion) No comment on number of recipients cared for and evaluations required as document states that this will be determined in a later phase of the project. Requested feedback re whether a requirement for participation in evaluations, pre-operative care and post-transplant care adequately addresses the range of care for primary physicians. Consider adding the phrase “longitudinal post-transplant care” to emphasize the need for experience with care of patients at all points post-transplant. Page 14 – Board Certification Equivalency Agree that it is reasonable to have a pathway that considers alternatives to board certification for individuals trained outside of the U.S. or Canada. OPTN/MPSC should carefully consider whether it wants to be the arbiter of board equivalency as this will also be addressed by state licensing boards. Maintain the requirement for board certification for individuals who trained in the U.S. or Canada The requirement for “CME that is equivalent to requirements for board certified individuals” is appropriate but the document provides no means of documentation as would occur under maintenance of certification for board certified individuals Letters of recommendation – agree on this requirement. MPSC may wish to consider whether these letters will be from references provided by the applicant or solicited by the MPSC. In addition, ABIM should not be the only certification body. The NBPAS (National Board of Physicians and Surgeons) has been in existence nearing a decade, serving as a checks and balances vs ABIM. Page 15- Transplant Experience Equivalency Experience with the United States transplant system is critical for primary transplant physicians/surgeons given international variation in clinical practice and organ allocation. Review and oversight of non-U.S. experience is complex but assuming the availability of appropriate documentation logs as well as MPSC subcommittee review this could be accomplished. We suggest adding requirements similar to those for conditional approval to allow for ongoing review and oversight. Attachment C, “Lists of aspects of care a surgeon or physician is currently required to document but are not included in the proposed framework”: Consider revising the requirements for heart a lung primary surgeons and physicians to maintain consistent verbiage and order content as follows: • Add “histocompatibility and tissue typing,” “immediate post-operative and continuing inpatient care,” “differential diagnosis of cardiac dysfunction in the allograft recipient,” “histological interpretation of allograft biopsies,” and “interpretation of ancillary tests for cardiac dysfunction” to the requirements for primary surgeons in a heart program. • Add “histocompatibility and tissue typing,” “performing the transplant operation,” “immediate post-operative and continuing inpatient care,” “differential diagnosis of pulmonary dysfunction in the allograft recipient,” and “interpretation of ancillary tests for pulmonary dysfunction” to the requirements for primary surgeons in a lung program. • Add “histocompatibility and tissue typing,” “immediate post-operative and continuing inpatient care,” “differential diagnosis of cardiac dysfunction in the allograft recipient,” and “interpretation of ancillary tests for cardiac dysfunction” to the requirements for primary physicians in a heart program. • Add “histocompatibility and tissue typing,” “immediate post-operative and continuing inpatient care,” “differential diagnosis of pulmonary dysfunction in the allograft recipient,” and “interpretation of ancillary tests for pulmonary dysfunction” to the requirements for primary physicians in a lung program. OPTN Liver & Intestinal Organ Transplantation Committee | 03/22/2021 The OPTN Liver and Intestinal Organ Transplantation Committee appreciates the opportunity to comment on the Update Transplant Program Key Personnel Training and Experience Requirements request for feedback. The Liver Committee asked that the MPSC consider any unintended or operational consequences that could occur during future implementation of member requirements. NATCO | 03/22/2021 NATCO appreciates the MPSC bringing this matter forth to public comment. We support the suggested changes and see a benefit with standardizing training as much as possible by requiring an OPTN orientation. This addition should also improve efficiency in the current process especially if the method is electronic as suggested eliminating numerous letters and references for each surgeon. NATCO supports limiting procurement/observation requirements for those surgeons who have not been in the field for some time; however, 10 years may be too long. Nebraska Medicine | 03/18/2021 As a transplant staff member who has completed more applications than I care to count, the process has been both time consuming, frustrating, and demanding so I am very excited that changes are coming. It does worry me though, that with policy changes, there are sometimes unintended consequences that actually counteract any of the intended positive changes. 1. I agree that the physician training and experience requirements are very difficult to understand. There have been times that I’ve completed an entire application and submitted only to find that the physician didn’t meet the requirements. There has to be an easier way to assess a physician’s training and experience qualifications prior to completing the application. Sadly, in some situations, our newer physicians meet the qualifications and our more experienced physicians don’t, often due to currency. I’ve also encountered times when a surgeon or physician meets the qualifications for a specific program’s primary physician/surgeon role however they are not as actively involved in the program as the physician we intended to be primary (one meets currency and quota verses the physician who meets currency but not the quota of past experience). I agree, that the consolidation of multiple pathways into one might be a better solution. 2. Regarding OPTN Orientation Curriculum, I do think this is a good idea. Not every primary physician, primary surgeon, and/or director are as involved with UNOS as I would expect to see. But prior to orientation, it would be nice to be able to explain the “job description” of these positions. I think the curriculum could be structure much like a “mini” UNOS Bootcamp. Orientation to policies and procedures and how and why they are developed and the physicians role within the transplant center to actively influence and monitor compliance. Additionally, there is access to so much data available to transplant centers and their leadership but I’m not entirely sure that are primary physicians/surgeons are aware of the data and how it can help the programs. 3. Physician logs: It would be helpful if physician logs were transferrable within UNOS without the transplant center having to track them down again. This goes for procurement logs, transplant logs, donor observation logs and recipient transplant logs. I also disagree that the transplant physician’s requirements to view 3 transplants and participate in 3 deceased and/or living donor cases qualifies them as a primary physician. Most are required to do some of this during their fellowship however have no records. This became a significant obstacle when submitting all of the pediatric applications and was the number one factor that threatened to keep us from submitting the applications on time. 4. I agree that the list outlining the aspects of care is tedious, repetitive, difficult to monitor and really portrays the structure of the individual transplant programs and in the end, there is very little difference from one application to another both in terms of fellowships and current programs. I agree that participation in pre-operative assessment and post-operative care would adequately address the range of care. 5. The letters of reference needed from physicians outside of the applying organization can be challenging. I like the idea of an electronic OPTN produced certification form in place of the letters of reference and recommendation however everyone is getting so many emails on a daily basis, I wonder how responsive individuals will be in completing them? Kidney Transplantation Committee | 03/18/2021 The Kidney Committee thanks the MPSC for their work to improve consistency and clarity in the requirements for transplant program key personnel. Committee members agreed that there should be at least some minimal onsite requirement for primary physicians and surgeons, in order to ensure responsibility to patients. The Committee asked for further clarity on the degree to which a primary physician or surgeon should be present, for example in a certain number of weeks per year or hours per month. It was noted that transplant administration in the United States operates very differently from other countries, and that some requirement of time practicing in the US would be an appropriate quality measure to ensure new providers can navigate the transplant allocation and administration systems. Region 11 | 03/18/2021 During the meeting there were comments voiced during the discussion and submitted online. Overall, there was general support for this proposal. One attendee recommended a re-entry program for international medical graduates (proctored for a specified period, usually one year) prior to "full" designation as a UNOS primary physician or surgeon. Another attendee commented that most hospitals require active status physicians to maintain board certification for privileges at their hospital. Two attendees commented that procurement surgeons with transplant and procurement experience in the past 10 years should be considered exempt. One attendee commented that providing case logs and a current CV that also includes previous experience as well as letters of reference can be acceptable to approve an exception. Another attendee commented that an individual’s current surgical position, such as Hepatobiliary Surgeon, would be acceptable as supportive documentation for the application. One attendee commented that once a physician is deemed competent by the transplant center, they should be able to operate without a primary surgeon on-site for procurements. They went on to comment that having more procurement surgeons available will reduce the burden on the primary transplant surgeons. Another attendee commented that foreign physicians should be required to show equivalent transplant training including volumes. Anonymous | 03/16/2021 Supportive of all proposed changes, especially the reduced observation requirements for the transplant physician. Region 7 | 03/12/2021 During the meeting there were comments voiced during the discussion, submitted online and submitted as comments from the OPTN representatives. Overall, there was general agreement and support for this proposal. One attendee recommended that that 10 years is too long to be away from a transplant program without some form of re-training if you’re going to be a primary. The attendee also asked about any exceptions for pediatrics. Another attendee suggested taking the update from 10 years to 5 years. One attendee asked a question regarding foreign training, and if the policy proposal affected in any way the changes in US national work visa policy. Another attendee commented that, the field has been revolving around innovation, many of which come from foreign countries. He hoped that the language would not be restrictive and would allow for progress like, advanced robotic surgery. Adding that there are other countries that may be in the lead, with many doing robotic donor liver transplant for right or left hepatectomy. He added that we need to be inclusive and allow innovators to come to US and provide training. Several attendees stated they were in favor of proposed changes. Region 6 | 03/10/2021 The region strongly supports efforts to simplify and streamline this process. One member commented they believe creating a curriculum should be sufficient for primaries who have foreign experience to learn about the U.S. transplant system and that the "on site" requirement is tricky for transplant centers – if a new primary surgeon or physician has signed an offer letter and committed to the transplant center but is not able to move to the transplant area for some logistical reason, they should still be considered as able to fulfill their roles as primary because they can oversee protocols and programmatic operations. There were several comments supporting the idea of applicants being able to submit the necessary information once and have it retained by the OPTN, or even the idea of having a way to designate someone who has already gone through the process that they can carry from them if they change centers. One attendee commented on the question regarding whether anyone other than the primary designated physician/surgeon should be required to meet criteria and said that one of the pathways to become the designated primary physician/surgeon, if a fellowship was not completed, is to obtain a certain number of years’ experience on a transplant service, and if all providers were required to qualify, this pathway would no longer be available. A member stated that it should be up to individual centers to determine the required qualifications for foreign-trained physicians and surgeons. An attendee brought up the use of the American Board of Internal Medicine (ABIM) certification being used as a requirement and how there is currently some controversy among some doctors around requiring ABIM certification. The attendee also commented that when it can take up to 10-15 years to become a primary physician, it would be nice if the committee could come up with an easier way to submit their records without having to go back to the center where the physician trained. One member mentioned liking the online reference support form, but wondered if this might result in losing the more personal information that comes from letters. An attendee also remarked that it’s hard to separate out this process from the center certification process. Region 8 | 03/09/2021 During the meeting there were comments voiced during the discussion, submitted online and submitted as comments from the OPTN representatives. Several members voiced support for updating the requirements stating that the current process is complicated and time consuming and this would help simplify and standardize this process. Several attendees discussed the transplant and procurement observation requirements and suggested they could potentially be reduced. One of the members commented that transplant physicians should have a requirement to observe transplants but that there is no benefit for a transplant physician to observe procurements. A member suggested that some transplant log information could potentially be pulled from UNet. Another member commented that it would be valuable to change the requirement for a primary surgeon or physician to re-apply as a primary if they move to a new transplant hospital. One of the members stated that they support training for primary physician/surgeon. They also commented that clarifying responsibilities of the primary would help with physician contracts for how much administrative time is appropriate for physicians in these roles. OPTN Pancreas Transplantation Committee | 03/08/2021 The Pancreas Committee thanks the OPTN Membership and Professional Standards Committee (MPSC) for the opportunity to review their Update Key Personnel Training and Experience Requirements request for feedback. The Committee provides the following feedback: The process can be onerous and programs change over quickly. Making this process easier and standardized is important for physician and surgeons. It was agreed with the idea of keeping logs on transplants performed and of transplant programs to keep this log, but stated that this is sometimes harder in practice. When a key personnel leaves a program, they should be able to obtain a log of everything they’ve done at that time so they would have those records going forward. There was a comment made regarding the curriculum requirements for individuals who have not served as a primary surgeon or physician in the last 10 years. This is a long time and is hard to train pancreas primaries. There should be more recognition for on the job learning pathways. A member stated that another challenge faced is the issue of showing currency in procurements from moving from one center to another. If the criteria has been met at one center in the past, is this still relevant? For procuring alone, this should be reconsidered. The member continued by suggesting some considerations regarding to criteria related to foreign physicians and surgeons. There may be some challenges for those physicians and surgeons to being board certified as they would not be coming from a training program from the United States (U.S.) or Canada. Additionally, there may also be variability in the trainings across countries; the programs can vary from one country to the next and may or may not be comparable to training the U.S. Another member stated that for the on-site requirements, there is some concern for surgeons who are not on site in a particular city, but are provided outlets among programs over wide geographic spaces to travel on their behalf. There would be some unintended consequences if off site surgeons were allowed to run these transplant programs. A member commented that there is going to be a reality in maintaining good outcomes, but at the same time, the less programs or the harder it is to access a pancreas program, the less likely the pancreas transplant will happen. Priorities should be established to address this. The member continued by suggesting that that for physicians and surgeons who move from one program to the other, there should be a way for there to be a primary certification that can be taken to show some activity as opposed to going back to a center years letter to ask for a fellowship director to write a letter. OPTN Transplant Administrators Committee | 03/05/2021 The Transplant Administrators Committee appreciates the opportunity to comment on the Update Transplant Program Key Personnel Training and Experience Requirements proposal. Overall, the members support this proposal. Members commented that they have experienced issues with currency and provided an example of a pediatric surgeon who was not able to count a newly 18-year-old patient’s liver transplant toward their volume of pediatric transplants which affected the required volume numbers and now the program is inactive. The Chair asked if these scenarios could be reviewed and discussed. Members also asked if there could be equivalent training accepted from other countries. ANNA | 02/25/2021 ANNA supports this proposal. Region 5 | 02/19/2021 During the meeting there were comments voiced during the discussion, submitted online and submitted as comments from the OPTN representatives. Overall, there was general agreement and support for this proposal. One member stated that Foreign Equivalency is an extremely difficult topic to approach. People struggle with it on the hospital level, the credentialing level, the state level and state licensing. This is their own opinion but a number of the American Society of Transplant Surgeons (ASTS) committee members struggle with this. There are quite well trained surgeons who come from various non-US countries who would be wonderful surgeons here but struggle with boarding and licensing issues. The member stated it is almost like you have to do it on a case-by-case basis. People’s training varies, and where, and what you did in your training. They did not know how to advise on this, but the foreign equivalence will be challenging. One member asked if UNOS has tried to put together a consortium of physicians from the American Society of Transplantation (AST) or ASTS to get on the same page with UNOS and CMS. They think we should get all the entities on the same page so we are not trying to reinvent the wheel. Another member asked if there is value in separating minimum standards versus some physicians who clearly exceed the experience standards required. The member stated that if you are making regulations to apply to everyone, it can be difficult to get a one size fits all. Whereas you can probably recognize a very experienced surgeon or physician that is able to fulfill all the requirements. These are two different things that you are aiming for. I am speaking as a foreign surgeon. For Foreign Equivalence, there is a concern about making requirements too broad. One of the concerns is that if they are not transparent to members, they would not find out until they have finished the application process that they are not considered qualified under the bylaws. There is tension between specificity and flexibility to not exclude qualified individuals. One member stated that one of the areas along with partnering with ASTS and AST, where they run into the biggest problem is not in the transplant community, it is the chairs who are not transplantors and the privileging credentialing folks who are not in the loop. They find themselves where commitments have been made outside of the transplanting community in those higher levels. Wherever the opportunities are to pull chairs, higher ups, and increase their awareness to what they need to think about in recruiting or the requirements would really save a lot of challenges in the space. One member commented that the ACS and ABS certification for international candidates has a conditional/alternative pathway that is a potentially powerful and standardized tool for our surgeons at least. Getting all these governing bodies on board so there is consistency. They agreed with getting other governing bodies onboard. They would recommend including the ACS and ABS as they have developed an international pathway to get foreign surgeons a ABS pathway through an alternative pathway. Region 3 | 02/18/2021 During the meeting there were comments voiced during the discussion, submitted online and submitted as comments from the OPTN representatives. There were several comments supporting the effort to make the process simpler. Two attendees commented that providing the required patient log can be challenging due to HIPPA regulations and suggested that these logs should be sent directly to UNOS. Another member suggested that patient logs might be pulled from NPI numbers that are entered into UNet. A follow up comment was made that this would not help with the compilation of logs for fellows because fellows are first assistants in the surgeries, and that data is not entered into UNet. Several comments were made about primary surgeon/physician approvals included that there should be more flexibility, incorporating minimum requirements to assess besides log numbers, and consideration for someone who has been primary at another transplant hospital. Region 4 | 02/04/2021 During the meeting there were comments voiced during the discussion, submitted online and submitted as comments from the OPTN representatives. Overall, there was general agreement and support for this proposal. One attendee recommended that the committee address individuals who lead programs and then change centers, understanding that they are very experienced and not new to the role. Another attendee cautioned the committee about using performance standards, including volume requirements, adding that volume changes over time without changes in quality. There was concern from one attendee about the bias between having the same currency standards for high and low volume programs, adding that some small volume programs may be forced to close. One attendee suggested implementing a grandfather clause for foreseeable succession challenges. Finally, an attendee strongly supported decreasing the burden on transplant centers when making changes or submitting applications. Kenneth Andreoni | 02/03/2021 I completely agree with the committee's goal of clarifying primary physician / surgeon requirements and for allowing prior primary physician / surgeon status to carry over into a new transplant hospital position. I would propose that 'logs' no longer be required once a physician / surgeon has been approved as a primary physician / surgeon. Some of us are still being asked to provide logs from fellowships completed 20 years ago and this should no longer be required. -Replace letters of reference and recommendation with online OPTN certification form - yes, and this should not be required after one has been approved as a primary physician / surgeon -addition of an OPTN Orientation Curriculum for individuals who have not served as a primary surgeon or physician in the last 10 years: this would be helpful and the MPSC and organ specific comm should create the content. For future project evaluating alternatives to the current requirement that primary surgeons and physicians be “on site" - I believe the intent of this concept has always been that a transplant physician / surgeon should be available in such as manner so that no organ offer / transplant is denied to a listed candidate. There also must be available expertise to care for transplanted patients post-transplant. I believe the primary physician / surgeon are responsible to work with the transplant administrator and ensure program compliance with all regulatory bodies, as well as ensure adequate medical / surgical care exists for transplant patients at that transplant hospital. The primary physician / surgeon should have a reasonable amount of direct patient care responsibilities (patient clinic and inpatient care for physicians, as well as operations for surgeons) at the transplant hospital on an ongoing basis.