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Oversights: Utilization of Data Indicators in the Transplant, and Organ Procurement Organization's Programs

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Under new Hospital Conditions of Participation: Requirements for Approval and Re-Approval of Transplant Centers To Perform Organ Transplants (CoPs) implemented in 2007 by the Centers for Medicare and Medicaid Services (CMS), transplant centers must meet strict outcomes and transplant volume requirements. The outcomes requirements are based on patient and graft survival statistics reported in the Scientific Registry of Transplant Recipients (SRTR) Program Specific Reports CMS receives quarterly Transplant Volume Reports and semi-annual Transplant Outcomes Reports and Transplant Outcomes Trend Reports from the University of Michigan Kidney Epidemiology and Cost Center (UM-KECC) in support of this process.

Over the past several years, UM-KECC has worked with CMS to develop a series of periodic reports useful in CMS’ oversight of Transplant Programs. Templates for these reports were developed with CMS. These reports include outcomes from the SRTR Center Specific Reports and volume statistics for each transplant center and are produced at monthly, quarterly, or annual intervals as determined by CMS. One of the key reports we developed during the previous contract period, the Outcomes Report, shows post-transplant graft and patient survival outcomes information by program as published in the SRTR Program Specific Reports. This report also includes waiting list outcomes by program, specifically waiting list mortality and transplant rates and is now provided after each SRTR PSR release. We also developed a quarterly Volume Report showing transplant counts, or volume, by program.

UM-KECC also worked to develop an interactive Trend Report that allows the user to select an organ and any program transplanting that organ to see the outcomes represented both numerically and graphically. Furthermore, UM-KECC developed a complementary Flagging History Report showing all programs that have ever been flagged and which cohorts in which they were flagged. Both of these reports are now provided to CMS on a regular basis with each SRTR PSR release every six months.

More recently, CMS asked UM-KECC to develop new reports including more recent graft and patient survival follow-up from available data sources, such as the Social Security Death Master file and SRTR/OPTN follow-up form data. UM-KECC developed both a summary report showing these “extended” time period outcomes relative to recent expected values to help CMS gauge possible improvement in outcomes, and also a more detailed report showing which patients incurred graft failure or died. These reports have also been added to the list of regular reports provided to CMS.

Similarly, new Conditions for Coverage for Organ Procurement Organizations (OPOS) require OPOs to meet outcomes requirements in terms of organs per donor and donors per eligible death in each Designated Service Area (DSA) under Section 486.318. UM-KECC calculates the three OPO Measures every six months and provides them to CMS. UM-KECC has worked with CMS to develop a series of periodic reports useful in CMS’ oversight of OPOs. These reports include the following three outcomes: (1) Donation rate; (2) Observed donation rate compared to the expected donation rate; and (3) yield measures for organs transplanted and organs used for research per donor.