OPTN/UNOS HISTOCOMPATIBILITY COMMITTEE

REPORT TO THE BOARD OF DIRECTORSJUNE 25-26, 2012RICHMOND, VA

Nancy L. Reinsmoen, PhD., Chair

1. Update HLA frequencies used to calculate CPRA for kidney, kidney/pancreas and pancreas registrations

2. Add HLA-C to CPRA calculation

3. Add mandatory field to Waitlistsm to better interpret 0% CPRA value

14-Support, 0-Opposed, 0-Abstain

Updates to CPRA

Problem: CPRA calculation is based on outdated data.

CPRA currently calculated using HLA frequencies gathered from deceased kidney donors from Jan 1, 2003-Dec 31, 2004

Updated data are available (gathered from January 1, 2007-December 31, 2008)

Data show updated frequencies will improve accuracy and substantially increase CPRA values (above 80%) for some kidney registrations (=500)

Updating HLA Frequencies

Problem: The current CPRA calculation disadvantages candidates sensitized to HLA-C

Candidates with HLA-C are screened from match runs but do not receive points toward higher CPRA value

More than 10,000 kidney registrations have at least one unacceptable HLA-C antigen reported

Addition of HLA-C to CPRA Calculation

Problem: The current field displaying CPRA score does not provide needed information on candidates with 0% CPRA who have unacceptable antibodies or have not been tested

Current field does not describe reason for 0% CPRA or indicate if testing occurred /patient is sensitized

Mandatory field in Waitlist℠ will provide info on testing and presence of antibodies

Question: Was this candidate tested for antibodies?

Yes, antibodies detected

Yes, no antibodies detected

No, not tested

Mandatory Waitlist℠ Field for 0% CPRA

Number of Positive Crossmatches Reported as a Reason for Organ Refusal for Adult Kidney Alone Registrations

Note: The data are based on deceased donor kidney match runs for donors with at least one kidney accepted for transplant. Offers that could not be accepted for a registration were excluded from the total offer count except for those refused due to the positive crossmatch. Multiple offers for the same donor were counted only once per registration.

10,545

Update to CPRA: Public Comment

Type of Response

Response Total In Favor

In Favor as Amended Opposed

No Vote/No

Comment/ Did not Consider

Individual 31 24 (92.3%) 0 2

(7.7%) 5

Regional 11 10(90%)

1 (10%) 0 0

Committee 19 7(100%) 0 0 12

RESOLVED, that the CPRA calculation and related fields in Waitlist℠ shall be modified as set forth in Resolution 17, effective pending programming and notice to the membership: Update the HLA frequencies used to calculate CPRA; Add HLA antigen C to the CPRA algorithm; and Add mandatory field to Waitlist℠ for all kidney,

kidney/pancreas, and pancreas candidates to determine if a candidate has been tested for antibodies and having this field display in reports and on match runs.

Resolution

Problem: The UNOS/OPTN bylaws governing histocompatibility laboratories are antiquated.

Part of larger effort to consolidate, re-organize and simplify OPTN/UNOS bylaws

Some amendments made and language withdrawn post-public comment period; Committee will revisit later this year

Final committee vote was in support with amendment to retain word “exempt” in subcontracting language

Committee vote:

3-Support , 9-Support with Amendment , 1-Opposed; 0-Abstain

Revisions to Appendix C

Revisions to Appendix CPublic Comment

Type of Response

Response Total In Favor In Favor as

AmendedOpposed

No Vote/No

Comment/ Did not Consider

Individual 89 27 (32.1%) 0 57

(67.9%) 5

Regional 11 10(100%)

1 (10%) 0 1

Committee 19 1(50%) 0 1

(50%) 17

RESOLVED, that the following modifications to Appendix C (Membership Requirements for Histocompatibility Laboratories) are hereby approved as set forth in Resolution 2, effective September 1, 2012:

Resolution

RAIS was recently revised

Original assessment assumed need for match run testing but only change is a display field in candidate information section in DonorNet

Clarification resulted in more than a 50% decrease in the number of hours associated with the proposal.

Cost of proposal is under $100K

CPRA Update: Cost Assessment