Pancreas Program Functional Inactivity
Sponsoring Committee: Pancreas Transplantation
Strategic Goal: Improve waitlisted patient, living donor, and transplant recipient outcomes
Read the policy notice (PDF; 1/2019)
View the Board briefing paper (PDF; 12/2018)
Proposal executive summary
The majority of programs under review for functional inactivity by the OPTN/UNOS Membership and Professional Standards Committee (MPSC) are pancreas programs. At least one pancreas transplant must be performed during a six consecutive month time period or a pancreas program will be identified as “functionally inactive” according to OPTN Bylaws Appendix D.10.A: Review of Transplant Program Functional Inactivity. From January 2011 to September 2016, 61 pancreas programs have come under review for functional inactivity at least once, which is approximately 44% of currently approved pancreas programs (138).
Review of the literature and OPTN data analyses indicate that these low-volume pancreas programs may perform at a level that impacts patient safety and access to transplant. The solution proposed by the Pancreas Committee (hereafter, the Committee) seeks to reduce MPSC review of functionally inactive pancreas programs by narrowing review to programs that have longer waiting times and low volumes. The definition will be more tailored to concerns about patient safety and access to transplant by focusing on programs with longer waiting times, and avoid reviewing programs that are small volume but transplant their patients quickly. Pancreas programs will be reviewed for functional inactivity if they fail to perform two transplants in 12 consecutive months and have an average waiting time above the national average for pancreas programs.
The Committee’s solution also addresses the concerns with patient access to transplant and patient safety by increasing communication with patients waitlisted at programs reviewed for functional inactivity. These programs will need to inform patients and potential candidates about other pancreas programs in-state or within 125 miles of the program, and provide information about the program’s waiting time compared to the national average. Providing this additional information may empower patients to make informed decisions about their transplant care, and will provide an incentive to pancreas programs to increase their volume and shorten waiting time in order to avoid sending this letter.
The proposed changes will improve waitlisted patient and transplant recipient outcomes by creating new thresholds for identifying functionally inactive pancreas programs that operate below the level that is adequate for their waitlisted candidates.
Effective date: 4/8/2019
Read the proposal (PDF - 378 K; 8/2018)
The Committee is adding two elements to the notice that functionally inactive pancreas programs have to send to their patients and potential candidates: information about other pancreas programs in proximity to the functionally inactive pancreas program, and the program’s waiting time average compared to a national average. Should other organ programs be required to send comparable information to their patients and potential candidates if flagged for functional inactivity?
Members are asked to comment on both the immediate and long-term budgetary impact of resources that may be required if this proposal is approved. This information assists the Board in considering the proposal and its impact on the community.