As we previously wrote, once again we have the opportunity to comment on OPTN/UNOS proposals. This time we need to consider the proposed changes to the OPTN kidney allocation system developed by the OPTN/UNOS Kidney Transplantation Committee. The proposed policy and accompanying data analyses are on the first line on this page. These changes are quite substantial and will have dramatic effects on the way kidneys are allocated, especially for high PRA transplant candidates.
The ASHI Board worked together with the ASHI National Clinical Affairs Committee to prepare this response. There are three aspects to this proposal that we thought should be considered carefully. The first is the fact that the proposal is expected to reduce the number of kidneys transplanted to recipients with "zero" mismatches. The second is the component that allocates A2 and A2B kidneys to eligible group B recipients. Please keep in mind that the additional allocation of A2 kidneys to eligible group O recipients has been previously included in some local variances and in the recently proposed kidney paired donor policies. Finally, please consider the proposal's increased priority for transplants to very highly sensitized patients. This is a much needed component but the proposal expects no increase in the rate of turn-downs for real or virtual positive crossmatches without including a requirement for donor DPB1 or DQA1 typing.
You are encouraged to also read all of the other proposals and comment on any of them. Remember, it is important for ASHI members to comment on these proposals individually because all comments, whether submitted by an individual or an organization, are counted equally. The deadline for submission of comments is December 14, 2012.
We are also writing now to let you know about an opportunity to learn more about possible proposed FDA regulations for Laboratory Developed Tests (LDT). This webcast is free. Publication of such regulations could seriously impact laboratory use of HLA assays available from vendors that don't yet have FDA registration or clearance.
This notice about the webcast was distributed by G2 Intelligence.
Thank you for your continued support of ASHI and its mission.
Sincerely,
The ASHI Executive Committee
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