Living Donor Committee Non Action Items Connie Davis, MD June 26, 2012

1. Living Donor Committee Non Action ItemsConnie Davis, MDJune 26, 2012

2. Evaluation of OPTN Living Donor Data During the past several years, the OPTN Living Donor Committee has evaluated available living donor data in an attempt to establish performance metrics for living donor transplant programs. Unfortunately, no performance metrics could be developed because the data submitted on Living Donor Follow-up (LDF) forms were too incomplete for analysis.

3. Why Do We Need Living Donor Data? Pre-Donation Issues • Demographics - who becomes a living donor? • Health status and medical screening of donors Post-Donation Outcomes • Peri-operative complications • Post-donation adverse events

4. Current OPTN Living DonorData Collection Forms Current forms used for data collection – • Living Donor Registration (LDR) form • Due at earlier of discharge or 6 weeks post-donation • Living Donor Follow-up (LDF) form • 6 months • 1 year • 2 years* *required for all living donors after March 2008, first 2 year LDF forms were due March 2010

5. Living Donor Data Collection Questions • Are programs in compliance with OPTN policy? • Do forms contain current data? (e.g., data on the 1-year LDF were collected around the one-year anniversary of the donation) • Are the data complete?

6. Living Donor Data Collection Questions • Are programs in compliance with OPTN policy? • Do forms contain current data (i.e., data on the 1-year LDF were collected around the one-year anniversary of the donation)? • Are the data complete?

7. Current Policy • Policy 7.8.1 Each OPO, Transplant Center and Histocompatibility Laboratory must meet the following standard for submission of data collected on all forms to the Transplant Registries: 95% of expected forms complete within three months of the due date and 100% of expected forms complete within six months of the due date. 100% of the potential recipient refusal code data must be submitted within 30 days of the match run date.

8. Compliance with OPTN Policy 7.8.1 Living Kidney and Liver Donors Cohort : July 1, 2009 – June 30, 2010

9. Living Donor Data Collection Questions • Are programs in compliance with OPTN policy? • Do forms contain current data (i.e., data on the 1-year LDF were collected around the one-year anniversary of the donation)? • Are the data complete?

10. Current Policy • Policy 12.8.3 Living Donor Registration Forms (LDR) must be submitted to the OPTN within 60days of the form generation date. Recipient transplant centers must complete the LDR form when the donor is discharged from the hospital or by six weeks following the transplant date, whichever is first. The recipient transplant center must submit LDF forms for each living donor at six months, one year and two years from the date of donation. • Most centers are compliant with Policy 12.8.3, because the current policy only requires the submission of forms. Current policy does not address timeliness or completeness of the forms.

11. Living Donor Committee’s Metrics • Percent of living donors who have a 1-year LDF form with a known patient status (alive or dead; NOT lost-to-follow-up) dated within 2 months of the anniversary of the donation (10-14 months post-donation)

12. Percent of Living Kidney and Liver Donors who have a 1 Year LDF Form with a Known Patient Status Dated within 2 Months of the Donation Anniversary – National Numbers

13. Living Donor Data Collection Questions • Are programs in compliance with OPTN policy? • Do forms contain current data (i.e., data on the 1-year LDF were collected around the one-year anniversary of the donation)? • Are the data complete?

14. Living Donor Committee’s Metrics • Percent of living donors who have a 1 year LDF form with a known patient status (alive or dead; NOT lost-to-follow-up) dated within 2 months of the 1 year anniversary of the donation (10-14 months post-donation) • Percent of living kidney donors who have a numerical serum creatinine / bilirubin value on a 1 year LDF form with a known patient status (alive or dead; NOT lost-to-follow-up) dated within 2 months of the 1 year anniversary of the donation (10-14 months post-donation)

15. Percent of Living Kidney and Liver Donors who have Lab Values on a 1 Year LDF Form Dated within 2 Months of the Donation Anniversary – National Numbers

16. Percent of Living Kidney and Liver Donors who have a 1 Year LDF Form with Lab Values or a Known Patient Status Dated within 2 Months of the Donation Anniversary – National Numbers

17. Percent of Living Kidney Donors who have a 1 Year LDF Form with a Known Patient Status (Alive or Dead, Not Lost-to-Follow-up) Dated within 2 Months of the Donation Anniversary by Program Note: Each bar represents 1 program. Includes living kidney donors who donated between 7/1/09 and 6/30/10. 3 programs (blank area on right side of graph) reported status for 0% of their donors.

18. Percent of Living Kidney Donors with a 1 Year LDF Form with a Known Patient Status Dated within 2 Months of the Donation Anniversary by Program Volume

19. Percent of Living Kidney Donors who have a Serum Creatinine Value on a 1 Year LDF Form with a Patient Status (Alive or Dead, Not Lost-to-Follow-up) Dated within 2 Months of the Donation Anniversary by Program Note: Each bar represents 1 program. Includes living kidney donors who donated between 7/1/09 and 6/30/10. 17 programs (blank area on right side of graph) reported serum creatinine values for 0% of their donors.

20. Percent of Living LiverDonors who have a 1 Year LDF Form with a Patient Status (Alive or Dead, Not Lost-to-Follow-up) Dated within 2 Months of the Donation Anniversary by Program Note: Each bar represents 1 program. Includes living liver donors who donated between 7/1/09 and 6/30/10. 5 programs (blank area on right side of graph) reported status for 0% of their donors.

21. Percent of Living Liver Donors with a 1 Year LDF Form with a Known Patient Status Dated within 2 Months of the Donation Anniversary by Program Volume

22. Percent of Living LiverDonors who have a Bilirubin Value on a 1 Year LDF Form with a Patient Status (Alive or Dead, Not Lost-to-Follow-up) Dated within 2 Months of the Donation Anniversary by Program Note: Each bar represents 1 program. Includes living liver donors who donated between 7/1/09 and 6/30/10. 10 programs (blank area on right side of graph) reported bilirubin values for 0% of their donors.

23. Why are LD Follow-Up Data Missing? • Unlike recipients, living donors usually are not patients of the transplant program after the transplant occurs. • Donors recover and are followed by their own doctors. • Follow-up visits at the transplant program are not reimbursed. • Many programs are not assertive in tracking donors. • Programs are in compliance with policy if they merely submit the forms or report the donor to be lost to follow-up.

24. Selected Results from the Living Donor Kidney Site Survey • April 2012 - the Committee received an update on the living donor program audits. • Committee members were concerned about some of the most common violations identified and would like to share that information with the Board.

25. Most Common Violations Identified during routine surveys: UNOS Bylaws

26. Most Common Violations Identified during the routine surveys: UNOS Bylaws, cont.

27. Most Common Violations Identified from the Pilot Surveys: UNOS Bylaws, cont