Organ Transplantation Looking Forward:

1. Organ Transplantation Looking Forward: The Challenges of Regulatory Compliance and Quality Outcomes: An OTTR Solution Gene Ridolfi, RN, BA, MHA Administrative Director

2. Introduction • The numbers are well known: • >100,000 people are currently waiting for a life saving transplant. • >6,000 people per year die while waiting for a life saving organ transplant. • Waitlist for organ transplant grows annually on an average of 19%. • Rate of organ donation from deceased donors in the U.S. has averaged around increases of 3.7% over the last decade. • Only about half of the families of potential organ donors consent to organ donation.

3. Solid-Organ Transplantation: • Regulatory Oversight A number of sources for regulatory oversight exist, each with its own perspective regarding solid-organ transplantation activities. Additional agencies oversee bone marrow transplantation, but for programs providing only solid-organ transplantation the important sources are the following: • OPTN • UNOS • Scientific Registry of Transplant Recipients (SRTR) • CMS • HHS • ESRD Network • JCAHO • Office of the Inspector General (OIG) • ACOT Progress in Transplantation, Vol 17, No. 2, June 2007

4. Solid-Organ Transplantation: • What does Regulatory Oversight Look Like HHS US Department of Health and Human Services HRSA Health Resources and Services Administration CMS Centers for Medicare and Medicaid Services SRTR Scientific Registry of Transplant Recipients OPTN Organ Procurement and Transplantation Network

5. Solid-Organ Transplantation: • What does Regulatory Oversight Look Like OPTN Organ Procurement and Transplantation Network UNOS United Network for Organ Sharing Kidney Committee Liver Committee MPSC Membership and Professional Standards Committee Board

6. Solid-Organ Transplantation: • Regulatory Oversight For programs providing histocompatibility laboratory services and/or operating their own organ procurement agency, the following agencies provide oversight: • Clinical Laboratory Improvement Amendments • American Society for Histocompatibility and Immunogenetics • Association of Organ Procurement Organizations • Transplant administrators should pay particular attention to the activities of the OPTN, UNOS, SRTR, CMS, HHS, ESRD Network, the OIG, JCAHO, and ACOT with respect to current and future regulations. Progress in Transplantation, Vol 17, No. 2, June 2007

7. Regulatory Compliance in Solid-Organ Transplantation The risk of non-compliance with policy and by-laws and/or poor outcomes in solid organ transplantation is significant and may lead to: • Probation • Suspension • Loss of Insurance Contracts (COE) • Program closure Any and all of the above outcomes will negatively effect the ability for a program to grow and has the absolute possibility of financial devastation. Progress in Transplantation, Vol 17, No. 2, June 2007

8. Regulatory Compliance in Solid-Organ Transplantation Most, if not all, regulatory compliance requirements support Patient Safety. Failure in compliance can lead to medical error and risks for patient safety. • Medical error and patient safety issues are, unfortunately, ubiquitous in health care delivery environments • About 1 in 10 patients is harmed while receiving care • 44,000 to 96,000 people die each year as a result of preventable errors Progress in Transplantation, Vol 17, No. 2, June 2007

9. Regulatory Compliance in Solid-Organ Transplantation • Lets put this in perspective. Compare the above statistics to the chances of being harmed in a commercial airliner or in a nuclear power plant; • 1 in 1,000,000 Progress in Transplantation, Vol 17, No. 2, June 2007

10. Do errors occur at high profile transplant centers?

11. Do errors occur at high profile transplant centers?

12. Do errors occur at high profile transplant centers?

13. The Regulatory Environment • Who is watching us and how? • SRTR (mandatory outcomes analysis) • MPSC (UNOS/OPTN) (peer review) • CMS (certification) • Who watches the watchers? • SRTR: STAC, HRSA, UNOS committees • MPSC: HRSA, UNOS committees and board • CMS: Congress

14. Evaluating Performance What Could be Evaluated? • Use and effectiveness of a QAPI/RCA • Adherence to systems guidelines (ABO, etc.) • Ability to transplant those in need (access to the waitlist, waitlist outcomes, organ refusals, live-donor programs, innovation) • Short-term outcomes (length of stay, infections) • Patient/referring-provider satisfaction • Patient and Graft Survival

15. Top Policy Violations Identified During Site Visit Documenting patient notification Documenting ABO verification at time of listing ABO typing x2 prior to listing candidates Data entry errors of candidate status or errors in documenting status Not removing recipients from the waiting list within 24 hours of transplant Communicate multiple listing

16. Top Safety Issues Reported / Identified • Errors in ABO typing, verification, and documentation • Data entry, transcription and other discrepancies • ABO/ABO subtyping • HLA • Donor ID • Donor and recipient height and weight • Incorrect packaging and/or labeling of organs or extra vessels • Incorrect organ sent or switched laterality • Failure to submit extra vessel disposition

17. Where do we go from here? • Facts: • Reimbursement is declining • Increased scrutiny of center compliance and outcomes • Additional resources will be limited • Charitable care is increasing • Focused efforts to advance organ availability • Paired Donation • ABO incompatible • Highly sensitized patients • Living liver transplant • These efforts require close scrutiny to detail and increases resource utilization.

18. Where do we go from here? • We must enhance efficiency through work force reform. There are multiple avenues to achieve this: • Six Sigma / Lean Transformation • Standardize • Automate • Hard wire

19. What can HKS Solutions do to support our effort? • First and foremost, its users must educate HKS Solutions about our requirements for compliance and measurement. • Simplify interfacing of HKS Solutions with multiple other databases and EMRs. • Automate hard stops around key steps of the transplant process in support of safety and compliance. • Build key process and quality scorecards. • Enhance application functionality to better support outcomes research. • Identify common practice to allow for development of standardization

20. HKS Solutions Opportunity (Examples) • Hard stop checklist supporting all documents completed. • Checklist complete confirmation. • Notification of transplanted patients in past 24 hours. • Add missing data to SRTR • Support real time graft and patient survival. • Living donor follow-up. • Drop down for diagnoses, removal codes to match UNOS • Expand statistical tools.

21. HKS Solutions Continued • Standardize/automate compliance metric scorecard. • Develop/automate process metric scorecards. • Simplify 1-year graft and patient survival. • Track/alert program specific patient death in 1-year. • Integrate SRTR donor and recipient covariates for risk adjustment.

22. HKS Solutions Continued • Block different ABO from being entered without verification step. • Round labs to match UNet form. • Add matching drop down menu from UNOS (ex: Reason removed from waitlist) • Address functionality for tracking patients with multi-organ transplant

23. HKS Solutions Opportunity (Examples)

24. HKS Solutions Opportunity (Examples)

25. HKS Solutions Opportunity (Examples)

26. In Closing Transplant Centers need HKS Solutions help in support of CMS and OPTN policies. We cannot add more people. We need IT solutions.