Living Donor Committee Update

Christie Thomas, MB, FRCP, FASN, FAHAMedical Director, Kidney Transplant Program

University of Iowa HospitalsChair, OPTN/UNOS Living Donor Committee

Advisory Committee on Organ Transplantation

Living Donor Committee’s Charge

The Living Donor Committee develops policy and guidance related to the donation and transplantation of organs from living donors to recipients. The goal of the Committee’s work is to continue to improve the informed choice of prospective living donors, and the safety, protection and follow-up of all living donors.

Living Donor Committee – Current Membership

27 Members

14 Physicians (3 are living donors)

1 Transplant Coordinator

1 Living Donor Program Manager

3 Professors (2 are living donors)

12 Living Donors (2 attorneys, a bank VP, and engineer, an insurance executive, a pharmaceutical sales rep, and an executive director of a family and children’s services organization)

The Living Donor Committee Chair presented an update to ACOT in November, 2008.

This presentation will focus on activities after November 2008.

Living Donor Committee Update

June 16, 2006 – Federal Register Notice- the Secretary of HHS directed the OPTN to develop policies regarding living organ donors and organ donor recipients.

The Notice stated: the consequence of centers non-compliance with living donor

policy matches that of centers non-compliance with deceased donation policy; and

policies should “promote the safety and efficacy of living donor transplantation for the donor and recipient.”

Significant Change in Living Donation Oversight

November 2009 - The OPTN/UNOS Board resolved that the Committee should develop a policy proposal to establish a threshold for acceptable submission of living donor follow-up.

During this same meeting, the Board directed the Committee to develop and disseminate a resource outlining best practices for the submission of living donor follow-up based on its review of high performing programs.

Living Donor Committee Update

Living Donation Oversight

The OPTN approved “voluntary guidance” for the consent and medical evaluation of living donors that have since been available through the OPTN website.

December 2009 - HRSA notified the OPTN that although helpful, the resources developed to date were not sufficient and that policies were still required.

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

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

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

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.

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.

Living Donation Policy Development

April 2010 - Representatives of the ASTS, the AST, NATCO, OPTN/UNOS, and HRSA met to discuss and develop a new process for incorporating clinical input into developing OPTN/UNOS policies with the potential to direct or prescribe medical care – ‘the Rockville Document’

A Joint Societies Policy Steering Committee (comprised of members from the AST, ASTS, NATCO, OPTN/UNOS, and HRSA) would be given an opportunity to make recommendations on any OPTN policy under development that has the potential to prescribe medical care, to include policies for the consent, medical evaluation, and follow-up of living donors.

Living Donation Policy Development

The goal of the new process: earlier involvement from the professionals societies in any

policy that might impact clinical practice; quicker policy development; and greater acceptance by the transplant community at large.

Living Donation Policy Development

The Joint Societies Steering Committee established a Joint Societies Workgroup (JSWG) with representation from AST, ASTS, NATCO and UNOS LD committee to begin work on making recommendations to the LD committee on consent, medical evaluation, and follow-up of living donors.

Living Donation Policy Development

The JSWG completed work on three resources representing the consensus of its members:

• Guidance Document for the Informed Consent of Living Kidney Donor

• Position Paper on the Medical and Psychosocial Evaluation of Living Kidney Donors; and

• Recommendations for Donor Follow-up and Data Submission

June 2011 - These JSWG resources were approved by the Executive Committees of the parent societies (AST, ASTS, and NATCO) and provided to UNOS and the Living Donor Committee for consideration in policy development.

Mandatory follow-up at 6 months, 1 year and 2 years following surgery is the transplant community’s responsibility to maintaining the public’s trust and demonstrating a sincere interest in that contract we share with current and future living donors.

JSWG Recommendations for Donor Follow-up and Data Submission

Living Donor Follow-up Proposal

12.8.3.1 - Transplant centers that recover living donor organs must report accurate and timely follow-up data on the LDF form for at least 90% of their living kidney donors at the required reporting intervals, which at a minimum must include: Donor Status

Patient status Cause of death, if applicable and known Working for income, and if not working, reason for not

working Donor developed hypertension requiring medication Diabetes

Original proposal language distributed for public comment

Kidney Clinical Information Serum creatinine Urine protein Maintenance dialysis Donor developed hypertension requiring medication Diabetes

Complications Has the donor been readmitted since last LDF form was

submitted? Kidney complications

Original proposal language (2)

Type of Response Response Total In Favor

In Favor as Amended Opposed

No Vote/No Comment/

Did Not Consider

Individual 102 83 (81.2%) 0 (%) 15 (14.7%) 4 (3.9%)

Regional 11 5 (45.5%) 4 (36.4%) 2 (18.2%) 0

Committee 19 5 (83.3%) 0 (%) 1 (16.6%) 4

Follow-up Proposal – Public Comment Results

LDC Recommended Final Proposal Language

Living Donation Policy Development

April 2012 – The Committee approved final language for the three proposals and voted to send the proposals for Board consideration (June 25-26)

June 18, 2012 – The professionals societies objected to “substantive changes” in the proposals and failure to follow procedures required under the Rockville document – in response, the OPTN President agreed to table Board consideration of the proposals pending further discussion between JSWG and the LD committee.

Questions

Living Donor Policy Changes since 2008

November 2008 -Board approved Policy 3.3.7 which requires OPTN member transplant programs that perform living donor transplants to only transplant organs recovered at an OPTN member institution

June 2009 - Board approved the establishment of a new and separate policy section (Policy 12.0) for living donation.

- Board approved a resource titled Guidance for the Medical Evaluation of Potential Living Liver

Donors.

Living Donor Committee Update

November 2009- Board approved:• Policy 12.3 which improved the ABO verification process for

living donors;• An update to a resource titled “Guidance for the Informed

Consent of Living Donors.”

Living Donor Committee Update

June 2010- The Board approved adding a valuable consideration disclosure to the bylaws.

Living Donor Committee Update

November 2010 – The Board approved new Policies 12.8.5 and 12.8.6 to require the organ recovery center to report all instances of living donor organs recovered but not utilized for transplant, and living donor organs recovered but then redirected and transplanted into a recipient other than the intended recipient, through the Patient Safety System.

The Board approved new Policy 12.5.6 which established procedures for the placement of non-directed living donor kidneys. Under the proposal, transplant centers would select the recipient of non-directed living donor kidneys based on a list generated by the OPTN computer system to identify potential recipients for transplant.

Living Donor Committee Update

June 2011- The Board approve modification of several policies to clarify which transplant program has responsibility for elements of the living donation process and to reassign reporting responsibility for living donation from the recipient transplant program to the transplant program performing the living donor nephrectomy or hepatectomy

November 2011- The Board approved modifications to Policy 12.7 to improve the packaging, labeling and shipping of living donor organs, vessels and tissue typing materials

Living Donor Committee Update

Transplant center performance for Liver LDF forms

Percent of Living Liver Donors 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.

Percent of Living Liver Donors 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.