U.S. Department of Health and Human Services
Recommendations 66 through 67
The Advisory Committee on Organ Transplantation (ACOT) met on April 7, 2020, on a conference call, and unanimously agreed on the following recommendations:
ACOT recommends that the Secretary direct NIH and CDC to re-examine impediments to expanding transplants performed pursuant to the HIV Organ Policy Equity (HOPE) Act. Specifically, ACOT recommends that this reexamination include the following considerations:
- How HOPE donors could be better managed in the organ allocation process
- Mechanisms through which teams willing to recover HOPE organs can be more expeditiously identified
- Best practices for experience in HIV+ transplants.
ACOT suggests that this consideration might be appropriately managed by allowing centers with relevant experience in HIV- transplants in each specific organ, in combination with appropriate Transplant Infectious Disease and HIV care experience, to participate in these studies/procedures.
- Best practices for biopsies in living donors
ACOT further notes that the requirement for pre-donation biopsy in living HOPE donors seems potentially unnecessary – this is worth considering in the context of research vs. standard of care practice. The data for the requirement for living donor biopsies merits reexamination. Less than 0.05% of living donors in the United States currently undergo pre-donation biopsy. A back-table research biopsy can be performed without harm to the donor.
ACOT further recommends that the Secretary direct HRSA to address impediments to expanding transplants performed pursuant to the HIV Organ Policy Equity (HOPE) Act. Specifically, ACOT recommends that HRSA work with the OPTN to:
- Unmask national centers in test match runs, which may have caused the loss of many HIV+ organ donors
- Consider a statement to OPOs that HIV status alone is not a valid donor rule out
- Require OPOs to identify and work with teams willing to recover HIV+ donors
- Add the evaluation of HIV+ referrals to the OPO process audit.
ACOT recommends that the Secretary consider HHS actions and provision of recommendations to improve testing, including the communication and reporting of test results and other data to the OPTN, with respect to the microbiological evaluation of organ donors and transplants.
One aspect for consideration is an improved centralized mechanism for reporting/viewing donor culture and serology results that become available post-transplant.
Another aspect that the ACOT urges the Secretary to consider is improved validation of laboratories performing serologic and other assays and the role of histocompatibility laboratories.