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Kidney Transplantation Committee Update

Spring 2012

Regional Meetings

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Ongoing Projects

Progress to develop a new national kidney allocation system

Recommendations regarding variances Living donor priority policy Kidney paired donation (KPD) proposals• Creating policy for KPD to replace KPD

Operational Guidelines• Allowing bridge donors in the OPTN KPD Program

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NATIONAL KIDNEY ALLOCATION SYSTEM

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Top 20 % KDPIto

Top 20 % EPTSAllocation under “current rules”

Opt in system of highest 15% KDPI

kidneys“Think improved ECD”

Patients rank ordered by•Waiting /ESRD time•DR matching•Sliding scale CPRA System features•A2 -> B•Nat’l sharing CPRA>=98%

Patients rank ordered by• Waiting/ESRD timeSystem features• Regional sharing• A2 -> B•Nat’l sharing CPRA>=98%

Current Working Model

0--------------------------------20-------------------------------------------------85------------------------100KDPI Scale

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Addressing System LimitationsStated Limitation of the Current System Applicable Concepts

Mismatch between potential survival of the kidney and the recipient

Longevity matching

Variability in access to transplantation by blood group and geographic location

A2/A2B, broader sharing

High discard rates of kidneys that could benefit candidates on the waiting list

KDPI, expedited placement

Reduce differences in transplant access for populations described in NOTA (e.g., candidates from racial/ethnic minority groups, pediatric candidates, and sensitized candidates).

ESRD time, broader sharing, CPRA sliding scale, maintain peds priority

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Highlights (1) Allocation based on longevity matching is

accepted and sustains legal scrutiny The majority of kidneys are still allocated

very similarly to current rules Waiting time remains the primary

determinant of kidney allocation with a more inclusive definition

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Highlights (2)

Improved “ECD” system addresses concerns of older recipients• “Opt in” preserves choice• Allows trade off of a kidney with more longevity

for more rapid transplantation• Regional allocation might improve recovery and

placement• Allocation on time alone makes it predictable

and allows list management.

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Current Status

Awaiting final simulation modeling of• Sharing for candidates with CPRA>=98%• Regional sharing of ECD kidneys

Earliest proposal release: Fall 2012 with earliest Board consideration in June 2013

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VARIANCE REVIEW PROCESS

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Variances

The Committee received rationales from the above OPOs wishing to keep existing variances in the new allocation system

PADVPATF

TXSBTXGC

OKOP VATB

Reg 1

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Decisions

The Committee decided to recommend discontinuation of all variances except for• Dialysis waiting time study

• A2/A2B

The Committee will recommend these changes to take place at the time a new system is implemented

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Next Steps

OPOs that currently have a variance not recommended for inclusion• May apply for a 1-step transition• May apply for a new variance

Details for each option were sent to OPOs which submitted appeals

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TimelineEstimated Date Action

April 6, 2012 Policy Oversight Committee Review of Committee’s recommendations

May 15, 2012 Transition plan applications dueJune 25, 2012 OPTN/UNOS Board of Directors reviews

recommendations for discontinuation(no action at this time)

Fall 2012 Public Comment for new national kidney allocation system and transition plans approved by the Committee

June 2013 Board of Directors considers proposal and transition plans

Fall 2013 Approved transition plans implementedTBD (likely 2014) New kidney allocation system implemented and

transition plans ended

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LIVING DONOR PRIORITY PROPOSAL

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Problem Statement

Current policy does not clearly state whether prior living organ donors should get priority with each and every kidney registration or just one registration

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Data

280 prior living donors listed for kidney transplant since 1996

33 prior living donors have been listed for more than one kidney

transplant

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Proposal

Policy language now clearly states that the local priority and 4 points for prior living donors applies with each and every kidney registration.

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KPD Proposals: Spring 2012 Public Comment

Kidney Transplantation Committee

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KPD Proposals

Proposal to Establish Kidney Paired Donation (KPD) Policy

Proposal to Include Bridge Donors in the OPTN Kidney Paired Donation (KPD) Program

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KPD Work Group Composition

Kidney Transplantation, Living Donor, and Histocompatibility Committee representatives

Representatives from Members participating in the OPTN KPD Pilot Program

An OPO representative, and Technical advisors who wrote the

optimization algorithms used in the OPTN KPD Pilot Program.

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Proposal to Establish Kidney Paired Donation (KPD) Policy

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Background

The pilot program is governed by a set of rules called Operational Guidelines.

The OPTN contractor has operated the OPTN KPD Pilot Program since October 2010.

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Background Participating transplant hospitals signed

a contract stating that they agreed to abide by the Operational Guidelines.

If the Membership and Professional Standards Committee (MPSC) found a transplant hospital to be in material non-compliance with the Operational Guidelines, it could remove that transplant hospital from the OPTN KPD Pilot Program.

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Background

There were no other actions available to the MPSC.

With KPD policy, the full range of adverse actions will be available to the MPSC for violations of KPD policy, up to and including member not in good standing.

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Rules that apply only to the OPTN KPD program:• Enrollment•OPTN program specific consent • Required data, including HLA•Rules for choosing matches•Preliminary crossmatch

Rules that apply to all pairs, but only to pairs:• additional items for informed consent specific to KPD

Policy for all living donors:• OPTN policy section 12

Living Donation & KPD Policy Structure

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Details of Proposal

Table 1 of the proposal outlines the requirements in each section of the bylaws and policy and how it was developed.

Many elements were in the Operational Guidelines or part of KPD Manual Solution operations (i.e., the way day to day operations works; they are being included in KPD policy to promote transparency)

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Policy for All Living Donors

Located in Policy 12- Living Donation

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Proposed Policies that Apply to All Paired Donation

All KPD donors must be informed of the risks and benefits of participating in KPD • 8 specific items outlined in policy

All KPD non-directed donors (NDDs) must be informed of options for NDDs• 3 specific items outlined in policy

If a center will ship a kidney, the donor must specifically consent to it.

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Responsibility for KPD Informed Consent

Responsibility for informed consent is with the center entering the candidate or donor in the KPD Program• Typically, this is the donor’s evaluating

hospital, which is also the intended recipient’s transplant center

The recovery hospital is still responsible for all informed consent elements in Policy 12.

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Proposed Policies for Transplant Centers that apply

only to the OPTN KPD Program

Donors must be informed of the OPTN KPD Process requirements

The donor and candidate must specifically consent to:• Release of PHI• Participate in the OPTN KPD Program

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Proposed Policies for Transplant Centers that apply

only to the OPTN KPD Program

Requirement for a preliminary crossmatch before the donor recovery.• The need for a final crossmatch is left up to

the candidate’s Transplant Hospital based on its crossmatching standards.

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Proposed Policies for Transplant Centers that apply

only to the OPTN KPD Program In the OPTN KPD Program, the

recovery Transplant Hospital must specify the name and telephone number of any person or company who will be packaging, labeling, or transporting the kidney.

Rules for when participants can meet

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Proposed Policies for how the OPTN Contractor operates the OPTN KPD

Program

From KPD Operational Guidelines:• Histocompatibility Requirements

• A2 and A2B Matching

• Unacceptable Antigens and All Other Antibody Specificities

• Prioritization Points• Donor Chains

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Proposed Policies for how the OPTN Contractor operates the

OPTN KPD Program From current KPD Manual Solution

operations:• Requirements for match run eligibility for

candidates• Requirement for match run eligibility for donors• Screening Criteria: Blood Type• Screening Criteria: Candidate and Potential

Donor Choices• Two and Three-Way Matches

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Specific Requests for Comments

Is it clear what the policy requirements are for Transplant Hospitals? Is it clear how the OPTN Contractor will audit these requirements?

Is the process for matching participants in the OPTN KPD Program transparent?

Are the informed consent elements that are specific to KPD appropriate and complete?

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Proposal to Include Bridge Donors in the OPTN Kidney

Paired Donation (KPD) Program

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Bridge Donor Definition

A donor who does not have a match identified during the same match run as his paired candidate

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Details of Proposal

The bridge donor policy modifies policy language currently out for public comment in the KPD Policy proposal.

A donor chain in the OPTN KPD Program may end with a donation to a waiting list candidate or a bridge donor.

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Details of the Proposal: Choices

A chain will end with a bridge donor only if all of the following are true:• The donor at the end of the chain agrees to

be a bridge donor• The potential bridge donor’s center is willing

for the donor to be a bridge donor• The center entering the NDD that started the

chain agrees for the chain to end with a bridge donor

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Details of the Proposal: Consent

In order for a potential donor to be a bridge donor, the potential donor must consent to be a bridge donor at the following times:

1. Before the potential donor’s Transplant Hospital enters that the potential donor is willing to be a bridge donor in the KPD application in UNet (typically ℠ ℠at the time of informed consent to participate in the OPTN KPD Program),

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Details of the Proposal: Consent (cont.)

In order for a potential donor to be a bridge donor, the potential donor must consent to be a bridge donor at the following times:

2. When the potential donor is identified as a bridge donor in a chain, and

3. Every 3 months after match run in which the potential donor has been identified as a bridge donor.

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Details of the Proposal: Consent

Each time the potential donor consents to be a bridge donor, the potential donor’s Transplant Hospital must inform the potential donor that he may • continue to be a bridge donor, • donate to the waiting list, or • decline to donate.

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Details of the Proposal: Consent

The potential donor’s Transplant Hospital must inform potential bridge donors:• of the process for determining

whether a potential donor will be a bridge donor, and• that they may have to have another

medical evaluation in the future.

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Details of the Proposal

The potential donor’s Transplant Hospital may refuse to allow the potential donor to serve as a bridge donor.

When a chain breaks, the final donor in the chain may become a bridge donor provided that they meet the bridge donor requirements defined in the policy.

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Specific Requests for Comment

Should there be a limit on how long a bridge donor will be allowed to wait in the OPTN KPD Program after his candidate receives a transplant?