Implementing pre-transplant performance review by the Membership and Professional Standards Committee Membership & Professional Standards Committee Fall 2014

 Performance review includes only post-transplant performance and functional inactivity  Unbalanced review of transplant programs  Previous high profile incidences of waiting list mismanagement The Problem

 Need tool to identify and review programs that need pre-transplant performance improvement  Areas to monitor:  Acceptance of deceased donor organ offers  Transplantation of patients on the waiting list  Mitigation of waiting list mortality Goal of the Proposal

 Use composite pre-transplant metric (CPM) that includes:  Waiting list mortality rates (liver programs)  Geography-adjusted transplant rates  Organ offer acceptance rates  Safety net metric based on waiting list mortality  Identify outlier programs that may need pre- transplant performance review  Balanced program performance review How the Proposal will Achieve its Goal

 July CPM concept initially presented to MPSC  CPM work group  December pilot and survey  Presentations/Discussions  American Transplant Congress  Transplant Management Forum  PSR Consensus Conference Long Term Effort

 Incorporate acceptance rates but temper impact  No single metric fully represents pre-transplant performance  Mitigates effect of geography  Identifies programs needing improvement that would not be identified by single metric  Summary statistic to prioritize MPSC resources Composite Metric?

 Using acceptance rates alone  Using transplant rates alone  Using independent acceptance, transplant, and mortality rate thresholds  Life Years from Listing (LYFL)  CUSUM –potential complementary tool to CPM in the future Alternative Approaches Considered

 Weighting the CPM sub-components  Accounting for varying sample sizes among programs  Adjusting for geography (supply-to-demand)  Including both living and deceased donor transplants  Including both active and inactive patients  Choosing a threshold for identifying programs  Use of a “safety net” Other Key Decision Points

 Review transplant program based on pre-transplant performance if the program meets either of the following criteria over a 1-year period:  CPM >1.5  waiting list mortality rate O/E ratio > 2.0 and one-sided p- value < 0.05  At first, only liver and kidney programs  In an example analysis, 14 programs were newly identified for review Thresholds for Identification

Supporting Evidence Based on 2011 data, 6 (5%) liver programs had CPM above 1.5.

Supporting Evidence (cont’d) Based on 2011 data, 16 (7%) kidney programs had CPM above 1.5.

Supporting Evidence (cont’d) “Safety net”: 3 kidney and 2 liver programs had statistically significant waitlist mortality O/E > 2.0.

Supporting Evidence (cont’d) The two high profile cases of waitlist mismanagement from the mid-2000’s had outlying CPM values. Program 1 Program 2

 No additional data submission for CPM analysis  Respond to inquiry from MPSC if identified for review. Will request information on:  waiting list management process  any unique clinical aspects (i.e., potential mitigating factors) that may influence ability to meet the thresholds What Members will Need to Do

 Age  Blood type  History of cancer  BUN  Death circum.  Insulin administered  Antihypertensive admin.  Liver biopsy & % macro fat  PHS increased risk  Proteinuria  SGP/ALT  Location & distance Liver Acceptance Rate Model  Lab MELD  Match MELD & status  Serum sodium  Albumin  Dialysis past week  HCC exception  Previous malignancy  Height  Time on waitlist  other factors… Candidate factors Donor factors  SGP/ALT  HTLV  EBV

 Jonathan Chen, M.D. Committee Chair  Regional representative name (RA will complete) Region X Representative address  Sharon Shepherd Committee Liaison Questions?