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Kidney Transplantation Committee Update

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Kidney Transplantation Committee Update Spring 2012 Regional Meetings Proposed Policies for how the OPTN Contractor operates the OPTN KPD Program From current KPD ... – PowerPoint PPT presentation

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Title: Kidney Transplantation Committee Update


1
Kidney Transplantation Committee Update
  • Spring 2012
  • Regional Meetings

2
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

3
National Kidney Allocation System
4
Current Working Model
  • Patients rank ordered by
  • Waiting /ESRD time
  • DR matching
  • Sliding scale CPRA
  • System features
  • A2 -gt B
  • Natl sharing CPRAgt98
  • Patients rank ordered by
  • Waiting/ESRD time
  • System features
  • Regional sharing
  • A2 -gt B
  • Natl sharing CPRAgt98

Top 20 KDPI to Top 20 EPTS
Allocation under current rules
Opt in system of highest 15 KDPI kidneys Think
improved ECD
0--------------------------------20---------------
----------------------------------85--------------
----------100
KDPI Scale
5
Addressing System Limitations
Stated 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
6
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

7
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.

8
Current Status
  • Awaiting final simulation modeling of
  • Sharing for candidates with CPRAgt98
  • Regional sharing of ECD kidneys
  • Earliest proposal release Fall 2012 with
    earliest Board consideration in June 2013

9
Variance Review Process
10
Variances
Reg 1
PADV PATF
VATB
OKOP
TXSB TXGC
The Committee received rationales from the above
OPOs wishing to keep existing variances in the
new allocation system
11
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

12
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

13
Timeline
Estimated Date Action
April 6, 2012 Policy Oversight Committee Review of Committees recommendations
May 15, 2012 Transition plan applications due
June 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 implemented
TBD (likely 2014) New kidney allocation system implemented and transition plans ended
14
Living donor priority proposal
15
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

16
Data
  • 280 prior living donors listed for kidney
    transplant since 1996
  • 33 prior living donors have been listed for
    more than one kidney transplant

17
Proposal
  • Policy language now clearly states that the local
    priority and 4 points for prior living donors
    applies with each and every kidney registration.

18
KPD Proposals Spring 2012 Public Comment
  • Kidney Transplantation Committee

19
KPD Proposals
  • Proposal to Establish Kidney Paired Donation
    (KPD) Policy
  • Proposal to Include Bridge Donors in the OPTN
    Kidney Paired Donation (KPD) Program

20
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.

21
Proposal to Establish Kidney Paired Donation
(KPD) Policy
22
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.

23
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.

24
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.

25
Living Donation KPD Policy Structure
  • 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

26
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)

27
Policy for All Living Donors
  • Located in Policy 12- Living Donation

28
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.

29
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 donors evaluating
    hospital, which is also the intended recipients
    transplant center
  • The recovery hospital is still responsible for
    all informed consent elements in Policy 12.

30
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

31
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
    candidates Transplant Hospital based on its
    crossmatching standards.

32
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

33
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

34
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

35
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?

36
Proposal to Include Bridge Donors in the OPTN
Kidney Paired Donation (KPD) Program
37
(No Transcript)
38
Bridge Donor Definition
  • A donor who does not have a match identified
    during the same match run as his paired candidate

39
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.

40
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 donors 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

41
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
  • Before the potential donors 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),

42
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
  • When the potential donor is identified as a
    bridge donor in a chain, and
  • Every 3 months after match run in which the
    potential donor has been identified as a bridge
    donor.

43
Details of the Proposal Consent
  • Each time the potential donor consents to be a
    bridge donor, the potential donors 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.

44
Details of the Proposal Consent
  • The potential donors 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.

45
Details of the Proposal
  • The potential donors 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.

46
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?
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