1. Kidney Transplantation Committee
Spring 2014

2. Allocation component changes
Waiting time calculation - pre-registration dialysis time added
Candidate classification - Estimated Post Transplant Survival (EPTS) score
Kidney donor classification - replace SCD/ECD with Kidney Donor Profile Index (KDPI)
Priority for sensitized candidates - calculated panel reactive antibody (CPRA) sliding scale
As you know, the new kidney allocation system was passed by the Board of Directors last June and will become effective with programming at the end of this year. I want to quickly remind you of the major changes and let you know what your program should be doing over the summer and fall to prepare for the implementation. I’ll also let you know what UNOS will be providing to help with this preparation.
There are several major kidney allocation components being implemented later this year:
The first is waiting time - pre-registration dialysis time will be added to the candidate’s calculated waiting time;
The next change has to do with how candidates are classified. The allocation rules are designed to promote better longevity matching between donor and recipient in order to utilize the maximum amount of graft years through an estimated post transplant survival or EPTS score.
The current kidney classification relies on the donor quality metrics - Standard Criteria Donors or SCD and Expanded Criteria Donors or ECD – these are being replaced with a more refined metric known as the Kidney Donor Profile Index or KDPI.
The new system will also increase priority for sensitized candidates through additional sharing and a sliding scale points system for calculated PRA or CPRA scores;

3. Allocation component changes
Blood type eligibility - A2 and A2B to B compatible
Pediatric kidney allocation – KDPI priority
Kidney payback policy – eliminated
Kidney variances – eliminated
The new rules are also designed to provide greater access to Blood Type B candidates who can safely accept a kidney from an A2 or A2B blood type donor; and
For pediatric candidates, priority will be based on a kidney donor profile index or KDPI. Simulation modeling has shown that pediatric candidates will continue to receive a similar level of access to kidneys as in the current system.
The payback system is being eliminated altogether; and
Several existing variances were incorporated nationally into the new system: for example, backdating waiting time for pre-listing dialysis and allocating A2/A2B kidneys to B candidates, as discussed previously. All remaining variances will be eliminated.
I am going to explore many of these new components in greater detail and describe what role transplant programs, OPOs, and laboratories will play in each.

4. Action: Input and confirm data
Get familiar with the EPTS calculator
Begin Now
Enter data in fields used to calculate EPTS
Mid–2014
Editable data in the system
Cross-references to OPTN and CMS dialysis dates
Flags for data inconsistency
System tools
Let’s talk about the main steps that programs can take now and in the very near future to prepare for implementation of the new system.
The EPTS calculator is now available to help you become familiar with the new scoring system for candidates. The calculator and an accompanying guide is available on the OPTN website as well as Transplant Pro.
A number of new data elements are needed to calculate the EPTS score and assess pre-registration dialysis time for candidates. At the end of May, transplant programs will be given the opportunity to begin entering or confirming EPTS data variables in the system. This includes ensuring that the dialysis start date fields are accurate and inputting new information about prior organ transplants and diabetes type.
System tools will be available to help transplant programs with the data entry. Programs will be able to edit candidate data in bulk or through individual candidate records. As a reminder, the fields for waiting time eligibility criteria (dialysis start date and GFR or CrCl are now editable on the candidate record).
In late May, an EPTS data verification page will display as a landing page in UNet with editable fields to ease data confirmation and entry. Since the dialysis start date is used both in calculating waiting time and the EPTS score, the dialysis start date entered on this page will be used to calculate both in the system.
A new feature is being added in the system to show the date reported by the CMS Crown database as the patient’s dialysis start date for candidates that were already on the list prior to late May 2014 as well as the date previously entered in the system for your candidates. If you update or confirm the dialysis start date to the date that matches the CMS date referenced in UNet on this page, the dialysis date will be considered documented for the purposes of UNOS site visits and monitoring.
The system will also provide a report that flags missing or unverified data in the system, so that programs can see where data updates are needed.
It’s important to know that if all EPTS data variables are not entered prior to implementation of the system, the candidate will be assumed to have an EPTS greater than 21 percent and will not have access to offers for kidney with KPDI at or less than 20 percent.

5. Action: Update donor acceptance criteria
Review listed candidates for criteria entered
Discuss acceptance criteria for local versus import
Determine candidates that may benefit from a shipped KDPI>85% organ
Begin now
Enter KDPI acceptance criteria
Assess for KDPI and “other” criteria conflicts
Mid-2014
During this time period (summer 2014), programs will also have the ability to start entering KDPI and other donor acceptance criteria for candidates.
Programs should begin now:
Reviewing donor acceptance criteria previously entered into the system for their candidates, and determine whether updates are needed. Be mindful that the system will still allow you to screen off donor offers for independent donor criteria like age, DCD, etc. These things are also factors considered in the KDPI. So, you may want to only use KDPI as screening criteria instead of listing other independent screening criteria.
Also discuss acceptance criteria for local versus import offers, and determine candidates that may benefit from a shipped KDPI>85%. Programs will be able to select a maximum KDPI for each candidate and the maximum can be different for local v. import offers, as well as zero mismatch v. non-zero mismatch offers.
These are things that programs should be considering and discussing at this point.

6. Action: Update consent forms
Update consent forms - KDPI > 85% instead of ECD
Begin now
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
Implementation
Sample language for discussing KDPI with patients
Patient brochure
Tools available
Summer 2014
Remember that ECD and SCD criteria will no longer be applied in allocation, only KDPI. Transplant programs are required to obtain informed consent from candidates willing to accept offers for kidneys with KDPI greater than 98%. You should begin now updating your consent forms to reference KDPI greater than 85% instead of ECD. Programs do not need to obtain consent from every patient.
For currently listed candidates, the system will be programmed to default to KDPI criteria based on the SCD/ECD criteria that the candidate had already consented to.
the system will set the maximum KDPI score to 100% for existing candidates that have consented to receive ECD offers. No offers will be screened based on KDPI for these candidates.
If a currently listed candidate did not consent to receive ECD offers, the maximum KDPI will default to 85%.
As a resource, sample language for patient discussions about KDPI will be available in the summer of UNOS will also provide a patient focused brochure as a resource for programs.

7. Action: Assess for living donors
Prior living donors get 4 points
Check candidates for prior organ donation
Retain documentation of prior donation
Begin now
Prior living organ donors will also get 4 additional priority points with every registration in the new allocation system.
Begin now reviewing candidate records for prior organ donation and retain documentation.
If the prior living donor information is incorrect in the system, programs will need to contact the UNOS Organ Center to update the data.

8. Action: Update unacceptable antigens (UAs)
Review unacceptable antigens reported
Begin now
Enter any unacceptable antigens not previously entered (according to your center’s protocol)
Prior to implementation
CPRA points will now be assigned based on a sliding scale, instead of just two categories (above or below 80%) as in the current system.
We encourage you to assess the unacceptable antigens listed for your candidate, and enter any that you may not have previously entered. Of course, this should be done according to your center’s specific protocol for identifying unacceptable antigens.

9. Action: Review and Approve UAs
Reports will appear to allow Lab director and transplant physician/surgeon to approve unacceptable antigens for candidates already listed with CPRA greater than 98%
Mid–2014
Message and printable form will display when CPRA % is reached
Report listing candidates who require approvals
System tools
Candidates with CPRA greater than 98% will receive additional sharing priority (national for 100% and regional for 99%). For those candidates with a CPRA of greater than 98%, the new system will require that the sensitized candidate’s physician or surgeon and the histocompatibility laboratory director review and approve the accuracy of the unacceptable antigens entered in to the system. Approval is required in order for the candidate to be eligible for regional and national sharing priority. Documentation of this dual review and approval must be maintained in the candidate’s medical record, and the approver names must be entered into the system in order for the candidate to receive this additional priority. As long as the physician or surgeon and the HLA laboratory have provided a written approval in the candidate’s medical record, a designee can enter the appropriate names into the fields provided in UNet.
This approval will be required for existing candidates in this category once the new allocation system is effective. Beginning mid-2014, transplant programs and laboratories will have the ability to begin entering approvals for this existing candidates in this category.
To help transplant programs and to remind them of this new requirement, the system will be programmed with helpful tools:
An approver form and message will display in UNetSM when a candidate’s score reaches 99% or 100% reminding the program that approvals are needed. The approver form will contain signature fields for the required approvers. After entering the required approvals, you will have the option to print the form so that the documentation can be maintained in the candidate’s record.
The system will also provide a report with a list of candidates that have one or both missing approvals.

10. Action: Develop written policy for Blood Type B Candidates
Create a written protocol - maximum titer levels acceptable for blood type B candidates to blood type A2 or A2B donors
Begin now
Create consent forms for candidates in this category
Enter whether candidate meets criteria - yes or no
Retain documentation of titer levels
Mid–2014
Obtain consent from patients in this category
Confirm eligibility in system every 90 days
After
implementation
Under the new system, blood type B candidates will have access to A2 and A2B donors if they meet their center’s defined protocol for maximum titer levels. The transplant program is responsible for establishing a written policy concerning clinical criteria for blood type permissibility in the new system and obtaining informed consent from blood type B candidates willing to accept offers from A2 or A2B donors.
Programs will need to begin now to develop a written policy setting a maximum titer level and consent forms for candidates in this category.
In mid- 2014, a data field will be added to the system for programs to enter a check next to “yes” or “no” box to indicate whether a candidate meets the programs titer level criteria. Programs will not be required to report titer levels in the system. However, they should retain documentation of titer levels.
After implementation, programs will be required to confirm in the system every 90 days that the candidate is still eligible to accept these offers. Again, the only confirmation needed is to check a box for “yes” or “no” to indicate eligibility.
As a reminder of the update requirement, every 90 days the system will provide a report to display the number of days remaining before confirmation is needed on each candidate.

11. Implementation Summer 2014 December 2014 Phase I Phase II
Data updates begin
New reports released
Calculators made available
New allocation rules applied
Variances turned off
Payback system turned off
Summer 2014
December 2014
Let’s talk about the implementation timeline so that you know when to expect the changes.
The new allocation system will be implemented in two phases. Phase I (data update phase) will begin in late May and continue into the fall The system will display data verification pages and reports that allow for entry and update of required patient data. Programs will have approximately six months to make sure that all patient data is entered and completed before the new system goes live.
Phase II is when the system will go live and will be fully implemented. As a reminder, once the new system is fully implemented, all variances and the payback system will no longer be active.

12. Save the date April 24, 2014 @ 2 p.m. (ET)
The New Kidney Allocation System: Resources for Protocols and Processes webinar
A number of educational events will take place that you will want to be a part of to ensure that you are up to date on the coming changes and are prepared prior to the new system implementation.
The next educational event is happening in April. On April 24, 2pm (ET): “The New Kidney Allocation System: Resources for Protocols and Processes” webinar that will be more focused on protocols and processes that need to be in place. How to comply with the new kidney policies will be shared as well as practices to help you in the preparation phase.

13. More information
Recorded webinars, podcasts, toolkits, etc. available on:
OPTN web site - (click ‘Resources’ and ‘Professional Resources’)
Transplant Pro* - (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.
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If you would like more information about the new kidney allocation system, these websites will be updated frequently with tools and resources on the topic:
The OPTN website;
Transplant Pro.
There is an entire page dedicated to the new kidney allocation system on both of these websites.