Kidney Transplantation
Committee Update
Spring 2012
Regional Meetings
OPTN
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
OPTN
NATIONAL KIDNEY
ALLOCATION SYSTEM
OPTN
Current Working Model
Patients rank ordered by
• Waiting /ESRD time
• DR matching
• Sliding scale CPRA
System features
• A2 -> B
• Nat’l sharing CPRA>=98%
Top 20 % KDPI
to
Top 20 % EPTS
Allocation under “current rules”
Patients rank ordered by
• Waiting/ESRD time
System features
• Regional sharing
• A2 -> B
•Nat’l sharing CPRA>=98%
Opt in system of
highest 15% KDPI
kidneys
“Think improved ECD”
0--------------------------------20-------------------------------------------------85------------------------100
KDPI Scale
OPTN
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
OPTN
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
OPTN
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.
OPTN
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
OPTN
VARIANCE REVIEW PROCESS
OPTN
Variances
Reg 1
PADV
PATF
OKOP
VATB
TXSB
TXGC
TheOPTN
Committee received rationales from the above OPOs wishing to keep existing
variances in the new allocation system
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
OPTN
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
OPTN
Timeline
Estimated Date
April 6, 2012
May 15, 2012
June 25, 2012
Fall 2012
June 2013
Fall 2013
TBD (likely 2014)
OPTN
Action
Policy Oversight Committee Review of Committee’s
recommendations
Transition plan applications due
OPTN/UNOS Board of Directors reviews
recommendations for discontinuation
(no action at this time)
Public Comment for new national kidney allocation
system and transition plans approved by the
Committee
Board of Directors considers proposal and transition
plans
Approved transition plans implemented
New kidney allocation system implemented and
transition plans ended
LIVING DONOR PRIORITY
PROPOSAL
OPTN
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
OPTN
Data
 280
prior living donors listed for kidney
transplant since 1996
 33 prior living donors have been listed
for more than one kidney transplant
OPTN
Proposal
 Policy
language now clearly states that
the local priority and 4 points for prior
living donors applies with each and
every kidney registration.
OPTN
KPD Proposals:
Spring 2012 Public Comment
Kidney Transplantation
Committee
OPTN
KPD Proposals
 Proposal
to Establish Kidney Paired
Donation (KPD) Policy
 Proposal to Include Bridge Donors in
the OPTN Kidney Paired Donation
(KPD) Program
OPTN
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.
OPTN
Proposal to Establish Kidney
Paired Donation (KPD) Policy
OPTN
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.
OPTN
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 noncompliance with the Operational
Guidelines, it could remove that
transplant hospital from the OPTN KPD
Pilot Program.
OPTN
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.
OPTN
Living Donation & KPD Policy
Structure
OPTN KPD
Program
All paired donation
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
All living donation
Policy for all living donors:
• OPTN policy section 12
OPTN
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)
OPTN
Policy for All Living Donors
 Located
OPTN
in Policy 12- Living Donation
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.
OPTN
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.
OPTN
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
OPTN
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.
OPTN
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
OPTN
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
OPTN
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
OPTN
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?
OPTN
Proposal to Include Bridge
Donors in the OPTN Kidney
Paired Donation (KPD)
Program
OPTN
OPTN
Bridge Donor Definition
A
donor who does not have a match
identified during the same match run as
his paired candidate
OPTN
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.
OPTN
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
OPTN
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),
OPTN
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.
OPTN
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.
OPTN
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.
OPTN
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.
OPTN
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?
OPTN