How labs, OPOs, and transplant centers need to prepare.
A policy change takes effect on January 21, 2016 that will require OPOs to provide donor HLA results for DQA1 and DPB1 in order to make kidney or pancreas offers. It will also require that HLA typing on deceased donors be performed using molecular typing methods. See policy notice from November 2014. See system notice that specifically indicates what will change in UNet. See related system notice about HLA typing requirements for KPD donors and candidates.
Additional important information for labs and transplant centers
When entering candidate unacceptable antigens for DQA1, if you select only a parent DQA1 value, it WILL NOT automatically exclude the candidate from donors with the corresponding subtype values.
Beginning January 21, 2016, when entering DQA1 unacceptable values for candidates, you will see this warning message in UNet:
WARNING: For DQA1, select all unacceptable antigens that apply (parent and subtype). For example, if candidate is to be excluded from donors with parent values for DQA1*03, select DQA1*03 (parent) and all subtypes of DQA1*03 (e.g. 03:01, 03:02, etc.). Selecting only value DQA1*03 will NOT exclude donors reported as 03:01, 03:02, etc.
Training
A recorded training to acquaint you with the upcoming policy and system changes is available on January 11. Once you have completed the training session, you will be able to detail the HLA typing requirements for candidates and deceased donors across all organ types. Once you have listened to the recording, you can evaluate its effectiveness here.
Here’s what you need to do now to make sure you are ready.
OPOs
- Talk to your labs. Make sure they can perform serological split level molecular level testing for all of your HLA testing. Specifically, make sure that they can test for DQA1 and DPB1, which are new requirements. If your lab is not able to give you these results, you will not be able to make kidney or pancreas offers on January 21.
- Update all of your written agreements with labs to reflect the new HLA requirements.
Labs
- Make sure your facility is capable of performing serological split level molecular level testing for HLA, including DQA1 and DPB1, and providing those results to your OPOs.
- Update all of your written agreements with OPOs and transplant centers to reflect the new HLA requirements.
- Prepare to enter new HLA data on Go Live date.
Transplant Centers
- If you have pancreas islet candidates, you must enter their HLA (HLA-A, B, Bw4, Bw6 and DR) in order to add new candidates to the waitlist or make any changes on the waitlist for pancreas islet candidates listed before January 21.
- Update all of your written agreements with labs to reflect the new HLA requirements.
- You should be aware that certain DPB1 alleles/antigens are not represented in single antigen bead assays. For donors with such DPB1 alleles/antigens, candidates possessing DPB1 antibodies may not be appropriately excluded from the UNOS match run. The final assessment of donor compatibility for candidates with DPB1 antibodies should be made in consultation with the local HLA laboratory.
Questions?
If you have any questions about how this change will affect your organization, contact your UNOS regional administrator at 804-782-4800.
