Effective May 27, 2021, OPTN policy will require organ procurement organizations to perform lower respiratory COVID-19 (SARS-CoV-2) testing for all potential lung donors and have test results available prior to transplant of the lungs. This will allow lung transplant programs to evaluate the risk of donor-derived COVID-19 for potential recipients.
The OPTN Executive Committee, at a virtual meeting April 26, 2021, approved this policy upon the recommendation of the OPTN Ad Hoc Disease Transmission Advisory Committee (DTAC). Multiple cases reported to DTAC in recent months demonstrate the potential for donor-derived COVID-19 transmission to lung recipients when lower respiratory samples are not tested and results confirmed prior to transplant. The DTAC developed the proposal in consultation with the OPTN OPO and Lung Transplantation Committees, as well as OPO representatives on various other OPTN committees.
The Executive Committee approved the policy as an emergency action because of its significant patient safety implications, including the risk of patient mortality. The policy will be submitted for retrospective public comment for the summer 2021 cycle.
Many OPOs are already testing lower respiratory samples for COVID-19 in potential lung donors. This will be required for any potential lung donor as of May 27. For OPOs continuing to expand their capabilities, this resource document lists tests authorized by the Food and Drug Administration to analyze lower respiratory tract specimens.
For additional information, please read the Summary of Current Evidence on SARS-CoV-2 prepared by DTAC in collaboration with representatives from AST, ASTS, AOPO, HRSA and the CDC. This document will continue to be updated to reflect new information and developments.