OPTN/UNOS board-approved policy (Nov. 2014) will establish new histocompatibility testing requirements for any transplant programs participating in the OPTN KPD Program. When this policy becomes effective on January 21, KPD donor hospitals are responsible for all HLA typing for donors and for arranging shipment of the donor blood sample to the candidate’s hospital or lab for crossmatch.
Use the checklist below to help you prepare for this important upcoming policy change.
If you have any questions, call your UNOS regional administrator at 804-782-4800.
OPTN Kidney Paired Donation (KPD) Histocompatibility Testing Requirements Checklist
Ensure testing results are available and complete for all newly required fields for all candidates and donors, including those listed before and after the implementation. (Note that complete HLA for A, B, C, DR, DQB1, DQA1, and DPB1 includes both values. “No second antigen detected” is a valid option.)
- Report the following types for candidates: HLA-A, B, Bw4, Bw6, and DR.
- If candidate has unacceptable antigen(s) entered for the locus, report the corresponding candidate’s typing for HLA-C, DR51, DR52, DR53, DQB1, DQA1 or DPB1.
- Report following HLA types for potential donors: HLA-A, B, Bw4, Bw6, C, DR, DR51, DR52, DR53, DQB1, DQA1, and DPB1
- HLA typing for candidates and donors must be performed using molecular methods and reported at the level of serological splits.
Establish procedures for retesting active candidate unacceptable antigens when events outlined in OPTN policy occur.
- Retest every 110 days from the date of the most recent test.
- Retest when a potentially sensitizing event occurs.
- Retest when a candidate is reactivated after being inactive more than 90 days.
- Retest if there is an unacceptable positive physical crossmatch (that precludes transplantation).
- Unacceptable antigens detected must be identified using a solid-phase single phenotype or solid-phase single-antigen test. The method used to test candidates for antibodies must be at least as sensitive as the crossmatch method.
Establish procedures for two individuals to review and verify data entry of candidate’s unacceptable antigens before a candidate appears on their first KPD match run. One individual must be the laboratory director (or designee).
Establish procedures when declining match offers due to virtual or physical unacceptable positive crossmatch.
- Before declining due to unacceptable antigens, KPD candidate’s physician or surgeon (or designee) must review the matched donor’s antigens and matched candidate’s unacceptable antigens with the histocompatibility laboratory director (or designee) and document the joint review in the candidate’s medical record.
- Submit an explanation of the reason for declining to the OPTN Contractor within 7 days after declining the offer.