Abstract
Pancreas transplantation remains a highly specialized and life-enhancing procedure for selected patients with insulin-dependent diabetes mellitus. As national transplant volumes have declined over the past decade, many U.S. transplant centers are finding it increasingly difficult to satisfy the personnel credentialing standards established by the Organ Procurement and Transplantation Network (OPTN). These standards, designed to ensure safety and competency, require documented case volumes and training experience that are difficult to achieve in today's landscape, where most programs perform fewer than 10 pancreas transplants annually, and training opportunities are limited. This growing mismatch between regulatory expectations and real-world practice highlights the need to reassess current personnel criteria and consider more flexible, competency-based approaches that maintain quality while supporting program viability and patient access.
Keywords
Introduction
Pancreas transplantation, whether performed as simultaneous pancreas–kidney, pancreas after kidney, or pancreas transplant alone, offers metabolic stability and improved quality of life for patients with brittle diabetes. 1 Despite these benefits, the number of pancreas transplants performed annually in the United States has steadily declined, with fewer than 1000 procedures nationally per year since 2014. 2 This contraction in procedural volume presents a significant challenge for transplant centers attempting to meet the personnel criteria established by the Organ Procurement and Transplant Network (OPTN). These criteria are intended to ensure high-quality, safe patient care, but they also assume a procedural frequency that is increasingly uncommon across most institutions.
Clinical Relevancy to Practice
These requirements are designed to ensure patient safety and optimize transplant outcomes, promote competence and accountability among members of the transplant team, and align clinical practice with national standards of care and training. 3 It should also be considered that more than 60% of pancreas transplant programs in the United States perform less than 10 cases annually. 2 Additionally, fewer than 30% of abdominal transplant fellowships are accredited by the American Society of Transplant Surgeons (ASTS) as pancreas training programs (https://ASTS.org/fellowships). 4 While these requirements were designed for an era of higher pancreas transplant volume, they now impose significant operational and personnel hurdles for most centers.
Practice Issues
Pancreas transplantation remains a highly specialized and life-enhancing procedure for selected patients with insulin-dependent diabetes mellitus. As national transplant volumes have declined over the past decade, many U.S. transplant centers are finding it increasingly difficult to satisfy the personnel credentialing standards established by the OPTN. These standards, designed to ensure safety and competency, require documented case volumes and training experience that are difficult to achieve in today's landscape, which limits training opportunities.
The OPTN defines personnel requirements for pancreas transplant programs in the United States through its Management and Membership Policies. These requirements are outlined in Appendix G, which addresses membership and personnel requirements for pancreas and pancreatic islet transplant programs, with key personnel qualifications described in Sections G.2 and G.3. 3
Current Primary Pancreas Transplant Surgeon Requirements
Pancreas transplant surgeons must meet the current OPTN personnel requirements through one of the approved qualification pathways, including the formal 2-year transplant fellowship pathway, the clinical experience pathway, or the alternative pathway for predominantly pediatric programs.
Formal 2-Year Transplant Fellowship Pathway
The formal 2-year transplant fellowship pathway requires completion of an accepted surgical transplant fellowship. In this pathway, the surgeon must have performed at least 15 pancreas transplants as primary surgeon or first assistant during the fellowship period, with documentation in the fellowship operative log. The surgeon must also have performed at least 10 pancreas procurements as primary surgeon or first assistant. 3
Clinical Experience Pathway
The clinical experience pathway allows qualification through postfellowship pancreas transplant experience. This requires documentation of 20 or more pancreas transplants over a 2- to 5-year period as primary surgeon, co-surgeon, or first assistant, including at least 10 cases as primary surgeon or co-surgeon. The surgeon must also have performed at least 10 pancreas procurements, including at least 5 as primary surgeon or co-surgeon. 3
The policy also includes an alternative pathway for predominantly pediatric programs when the surgeon does not meet the fellowship or clinical experience pathways, but the program can demonstrate equivalent training or experience. 3
Current Primary Pancreas Transplant Physician Requirements
The current OPTN personnel requirements for pancreas transplant physicians require completion of at least one approved qualification pathway. These include the 12-month pancreas transplant fellowship pathway, the clinical experience pathway, the alternative pathway for predominantly pediatric programs, or conditional approval when the primary pancreas transplant physician changes at an approved program. 3
Under the 12-month fellowship pathway, the physician must complete specialized pancreas transplant training under the supervision of a qualified pancreas transplant physician and pancreas transplant surgeon. The physician must also be directly involved in the primary care of at least 8 newly transplanted pancreas recipients and follow these recipients for at least 3 months after transplant. 3
Under the clinical experience pathway, the physician must be directly involved in the primary care of at least 15 newly transplanted pancreas recipients, with at least 3 months of follow-up after transplant, over a 2- to 5-year period on an active pancreas transplant service. 3
All programs are required to maintain continuous compliance with these personnel standards to retain transplant program approval by OPTN. Credentialing documents, case logs, and letters of verification are typically required during the initial program application process as well as during site reviews.
Declining National Case Volume
Several factors contribute to the ongoing decline in pancreas transplantation. One major reason is the advancement of improved glycemic control technologies, such as insulin pumps, continuous glucose monitoring, and closed-loop systems. 5 These therapies have improved diabetes management and reduced the progression to severe complications, thereby decreasing the number of patients who meet criteria for transplantation. Additionally, persistent hesitancy exists due to historically inferior graft survival rates compared to kidney or liver transplants. 6 This perception may influence both patient acceptance and provider referral patterns, further contributing to lower transplant volumes. Another contributing factor is the increasing centralization of pancreas transplant services into high-volume academic institutions.
According to OPTN/Scientific Registry of Transplant Recipients (SRTR) data, more than 60% of U.S. pancreas transplant programs perform fewer than 10 cases annually. 2 This distribution limits exposure for both new trainees and experienced surgeons at mid-size or regional programs, thereby reducing the pool of individuals eligible to serve as primary program personnel under current OPTN guidelines.
Impact on Program Development and Equity
Rigid application of volume-based criteria has significant downstream effects on the field of pancreas transplantation. Pancreas transplant services remain unevenly distributed across the United States, which may contribute to geographic barriers to access for patients in lower-volume regions, 2 and it inhibits the establishment of new pancreas programs in regions with geographic or socioeconomic need and precludes experienced abdominal transplant surgeons, such as liver or kidney transplant surgeons, from leading pancreas programs despite their procedural competence. Furthermore, it also reduces access to care for patients who live outside major urban centers and discourages program development in institutions that cannot justify personnel investment under the current thresholds. This unintended regulatory rigidity conflicts with broader health equity and access goals.
Implications for Practice
The transplant community increasingly recognizes the limitations of using procedure counts alone as a surrogate for competence. Alternative credentialing approaches may include a competency-based model, which may include documented case logs that clearly define operative roles and structured mentorship or proctorship with formal evaluation of technical performance. Letters of attestation from experienced colleagues and program leadership may further support documented competence. While simulation and supplemental training may provide additional reinforcement in lower-volume settings, these measures should be paired with continued outcome monitoring and institutional oversight. Such approaches reflect a shift toward competency-based training and assessment in graduate medical education while maintaining appropriate accountability and reflecting the evolving philosophy of surgical education. 7
Volume correlates with better pancreas transplant outcomes in several studies,8,9 but this association is largely observational and reflects multiple interacting factors (team and institutional experience, protocols, donor selection) rather than volume alone. Fixed minimum case thresholds can improve quality but risk reducing access and training if applied rigidly. Competency-based assessments are promising, but not yet fully validated specifically for pancreas transplantation. Competency-based assessment could be used to complement rather than replace outcome monitoring and institutional readiness measures. We therefore recommend framing volume as one important component of a multifaceted quality framework that pairs volume-informed policies with transparent outcome reporting, validated competency assessment where available, proctorship or mentorship, and regional collaboration to improve care without unduly restricting access. The evolving landscape of pancreas transplantation warrants thoughtful reassessment of current OPTN personnel requirements. While preserving patient safety and quality care remains essential, consideration should be given to incorporating greater flexibility within a competency-informed regulatory framework. Aligning personnel standards with contemporary procedural realities, outcome monitoring, and validated assessment tools may help sustain pancreas transplant programs while promoting equitable patient access.
