Transcript FAQ-Dialysis Start Date

Kidney Transplantation Committee
Spring 2014
Allocation component changes
1. Waiting time calculation - pre-registration dialysis
time added
2. Candidate classification - Estimated Post
Transplant Survival (EPTS) score
3. Kidney donor classification - replace SCD/ECD
with Kidney Donor Profile Index (KDPI)
4. Priority for sensitized candidates - calculated
panel reactive antibody (CPRA) sliding scale
Allocation component changes
5. Blood type eligibility - A2 and A2B to B compatible
6. Pediatric kidney allocation – KDPI priority
7. Kidney payback policy – eliminated
8. Kidney variances – eliminated
Action: Input and confirm data
Begin Now
Late May 2014
System tools
• Get familiar with the EPTS calculator
• Enter data in fields used to calculate EPTS
• Editable data in the system
• Cross-references to OPTN and CMS dialysis dates
• Flags for data inconsistency
Action: Update donor acceptance
criteria
Begin now
Late May 2014
• Review listed candidates for criteria entered
• Discuss acceptance criteria for local versus import
• Determine candidates that may benefit from a
shipped KDPI>85% organ
• Enter KDPI acceptance criteria
• Assess for KDPI and “other” criteria conflicts
Acceptance criteria

Be mindful that other independent acceptance
criteria may conflict with KDPI

Examples:
o
candidate opts out of DCD but selects KDPI max of 60%
= will not see any DCD offers, even from KDPI 50% or
less donors
o
candidate selects max donor age of 55 and KDPI of 60%
= will not see offers from 56 y/o donor with KDPI 36%
Action: Update consent forms
Begin now
• Update consent forms - KDPI > 85% instead of ECD
At implementation
• New candidates listed must be consented if willing
to accept KDPI>85%
• Currently listed candidates • Willing to accept ECD? default to 0-100% KDPI
• Not willing to accept ECD? default to 0-85% KDPI
Tools available
Summer 2014
• Sample language for discussing KDPI with patients
• Patient brochure
Action: Assess candidates for
prior living donation

Prior living donors get 4 points
Begin now
• Check candidates for prior organ donation
• Retain documentation of prior donation
Action: Update unacceptable antigens
(UAs)
Begin now
Prior to
implementation
• Review unacceptable antigens reported
• Enter any unacceptable antigens not previously
entered (according to your center’s protocol)
Action: Review and Approve UAs
Mid–2014
• Reports will appear to allow Lab director and
transplant physician/surgeon to approve
unacceptable antigens for candidates already listed
with CPRA greater than 98%
System tools
• Message and printable form will display when CPRA
99-100% is reached
• Report listing candidates who require approvals
Action: Develop written policy for
Blood Type B Candidates
Begin now
• Create a written protocol - maximum titer levels
acceptable for blood type B candidates to blood type
A2 or A2B donors
Prior to
Implementation
(December 2014)
• Create consent forms for candidates in this category
• Enter whether candidate meets criteria - yes or no
• Retain documentation of titer levels
After
implementation
• Obtain consent from patients in this category
• Confirm eligibility in system every 90 days
Implementation
Phase I
• Data updates begin
• New reports released
• Calculators available now
Spring/Summer 2014
Phase II
• New allocation rules applied
• Variances turned off
• Payback system turned off
December 2014
More information
Recorded webinars, podcasts, toolkits, etc. available
on:
OPTN web site - http://optn.transplant.hrsa.gov (click
‘Resources’ and ‘Professional Resources’)
Transplant Pro* - http://transplantpro.org (click ‘I am
Looking For’ and ‘Kidney Allocation System’)
*These are a service of United Network for Organ Sharing and are not produced
under the OPTN contract.
Subscribe to RSS feeds and a monthly newsletter at
http://www.transplantpro.org
OPTN Kidney Paired Donation
(KPD) Histocompatibility Testing
Policies
Kidney Transplantation Committee
Spring 2014
Background

Kidney Committee distributed KPD policies for
public comment in March 2012

A number of commenters had concern with histo
section due to missing requirements

Professional societies brought together a KPD
consensus conference around same time

This proposal incorporates



spring 2012 OPTN public comment feedback
findings from KPD consensus conference
recommendations from OPTN Histo Committee
The Problem

Low match success rate in KPD program

Antibody related issues and positive crossmatches
continue to account for a number of match failures

Insufficient histocompatibility testing requirements
to prevent match failure
Goal of the Proposal

Increase match success rate in KPD program by
preventing unexpected positive crossmatches that
can break chains and prevent candidates and
donors from accessing subsequent match runs and
transplant opportunities

Promote transplant safety through more effective
screening of kidney offers
Proposed: HLA Typing

Molecular HLA typing required for donors and
candidates

Loci required for donors: HLA-A, B, Bw4, Bw6, C, DR,
DR51, DR52, DR53, DPB, DQA, DQB

Loci required for candidates: HLA-A, B, Bw4, Bw6, DR

If candidate has unacceptable antigens, additional loci
required: C, DR51, DR52, DR53, DPB, DQA, DQB

Candidate’s hospital must retype donor to confirm HLA
type
Proposed: Antibody Screenings

Candidate’s transplant hospital must screen for
antibodies at all of the following times:




every 90 days
when potentially sensitizing event occurs
if candidate reactivated after more than 90 inactive days
if unacceptable positive crossmatch occurs that prevents transplant with
matched donor

Labs must use method at least as sensitive as
crossmatch method

Physician/surgeon (or designee) and lab director (or
designee) must review and confirm UA’s listed for
candidate
Proposed: Crossmatching

Candidate’s transplant hospital must perform physical
crossmatch before donor’s nephrectomy is scheduled and
final crossmatch before surgery

Must report crossmatch results to donor’s transplant
hospital and UNOS

If unacceptable positive crossmatch occurs between
candidate and matched donor, candidate’s hospital must
inactivate candidate before next match run, review the
unacceptable antigens (UA), and report reason to UNOS
w/in 7 days

Candidate can be reactivated once review and update (if
applicable) of UAs is complete
Supporting Evidence

Crossmatch-related refusals (positive crossmatch
or unacceptable antigens) account for ~30% of
failed matches

61 programs had accepted at least one match offer
for which the entire exchange fell through

Some programs may have had a disproportionately
high number of crossmatch-related refusals

39 programs refused at least one match offer due
to a crossmatch-related reason
Specific Feedback Request

If unacceptable positive crossmatch occurs
between candidate and matched donor,
candidate’s hospital must inactivate candidate in
the KPD program before next match run

If this change is approved, is it less burdensome for
transplant programs if the inactivation is automatic
(completed by UNOS)?
Specific Feedback Request

Is it burdensome to require antibody screenings
every 90 days for ALL candidates (even if not
sensitized?)

Should longer timeframe between screenings apply
for non-sensitized candidates?

180 days?
What Members will Need to Do

Donor’s transplant hospital responsible for
reporting donor HLA info, arranging shipment of
donor blood sample to candidate’s hospital or histo
lab

Candidate’s transplant hospital responsible for
reporting candidate HLA info, confirming donor HLA
info, antibody screening requirements,
crossmatching requirements
Questions?

Richard Formica, MD
Committee Chair

Name
Region # Representative
Email

Gena Boyle
Committee Liaison
[email protected]
Backup Slides
KDPI
Point changes: Sensitization
Points
CPRA Sliding Scale (Allocation Points)
20
18
16
14
12
10
8
6
4
2
0 0
0
(CPRA<98%)
17.30
New
12.17
10.82
Current
0
0
10
0.21
0.08
20
30
0.48
0.34
40
50
CPRA
CPRA
0.81 1.09
60
70
6.71
1.58
4.05
2.46
80
90
100
Summary: Member responsibilities
Communicate importance of early
referral
Establish protocols for A2 and A2B
donors to B candidates
Report/update data to calculate
EPTS and waiting time
Review candidates to identify prior
living organ donors
Establish KDPI acceptance criteria Review waiting list for unacceptable
and update consents for KDPI>85% antigens
Review “other” donor screening
criteria
Educate candidates and potential
candidates on changes
FAQ-Waiting Time Eligibility Criteria
Q: Will patients in the current system who have begun
accruing waiting time based on GFR or CrCl criteria lose
the waiting time they have accrued thus far?
A: No, these candidates will not lose the waiting time
already accrued.
FAQ-Waiting Time Eligibility Criteria
Q: Does the new KAS also allow credit if the GFR/CrCl
criteria was met prior to registration?
A: No, this remains unchanged in the new policy. The
patient will begin accruing waiting time at or after
registration when the GFR or CrCl criteria are met.
FAQ-Dialysis Start Date
Q: Will programs now have the ability to edit the dialysis
start date for the candidates on their list?
A: Yes. The dialysis start date (and other waiting time
eligibility criteria) is now an editable field on the
candidate record in UNet. Programs no longer have to
submit a work order to UNOS in order to change it.
FAQ-Dialysis Start Date
Q: What documentation will UNOS accept as sufficient for the
dialysis start date?
A: For candidates listed prior to KAS Phase 1 (summer 2014),
UNet℠ will display references to CMS data on dialysis start date (if
a reliable date was found based on SSN). If the program confirms
or updates a dialysis start date that matches the CMS date provided
in UNet℠, the program does not need to provide additional
documentation.
If the program selects a different date or enters one when no
reference date is provided, the program will need to provide
additional documentation (list of acceptable documents is the
same as with current monitoring plan. The list includes 2728 form,
H&P, progress notes, etc in the medical record)
FAQ-KDPI and Consent
Q: If a candidate currently listed did not consent to accept
an ECD offer, but would like to set a max KDPI greater
than 85% in the new system, does the program need to
obtain informed consent from the candidate?
A: Yes. While programs do not need to obtain additional
consent from candidates who previously consented to
accept an ECD offer, any candidate who has not
previously consented and newly added candidate willing
to accept offers from kidneys with KDPI greater than 85%
needs to provide consent.
FAQ-CPRA Approvals
Q: Are these signatures required each time the
unacceptable antigens change?
A: No. Once the approvals have been obtained, the
program is not required to obtain any additional
documentation or re-enter the names in the system. The
system will continue to provide access to greater sharing
priority as long as the CPRA is greater than 98% and the
approver names have been entered previously.
FAQ-Placement Issues for CPRA 100%
Candidates
Q: When making national offers to candidates with CPRA
100%, can OPOs require the transplant program to
perform a crossmatch and ensure that it is negative prior
to shipping the kidney?
A: OPOs can request that the crossmatch be performed
prior to shipping the kidney. However, if the transplant
program accepts the offer and refuses this condition, the
OPO must still ship the kidney to the transplant program.
FAQ-Placement Issues for CPRA 100%
Candidates
Q: What allocation sequence is used if the kidney is shipped
nationally and the intended recipient cannot be transplanted?
A: Per OPTN policy, the transplant program must release the
organ back to the host (originating) OPO. The host OPO may
allocate the kidney according to its own match or delegate to
the importing OPO. Similarly, the host OPO can backup the
organ offer according to its match list prior to shipping the
kidney or allow the importing OPO to back up the offer
according to its match sequence. The decision lies with the
host OPO.
FAQ-Variances
Q: When will the Committee consider new variances?
A: The Committee will need to allow some time to pass
after the policy is fully operational in order to establish a
baseline from which to assess any new variance. The
Committee has decided that no variances will be
considered until the policy has been operational for at
least one year.
Other FAQs
Q: How will dual kidney allocation work in the new
system?
A: The same kidneys that were eligible for dual allocation
under the current system will be eligible under the new
KAS. In both the current and new KAS, programs will not
have the ability to differentiate donor criteria between
dual v. single offers. Programs should consider this when
selecting the maximum KDPI for each candidate.