Require Lower Respiratory SARS-CoV-2 Testing for Lung Donors At a glance Current policy On May 27, 2021, the Organ Procurement and Transplantation Network (OPTN) implemented an emergency policy to require nucleic acid testing (NAT) for SARS-CoV-2 (COVID-19) on lower respiratory specimens for all lung donors prior to transplant. This emergency proposal is being submitted for retrospective public comment. The OPTN Board of Directors will vote on the proposal in December and decide if this policy should be made permanent. Supporting media Presentation View presentation Proposed changes The policy change defines what a lower respiratory specimen is and requires all lung donors receive lower respiratory specimen testing by NAT. The policy specifies testing results must be available before the lungs are transplanted. Anticipated impact What it's expected to do Ensure organ procurement organizations (OPOs) perform testing on lower respiratory specimens for all potential deceased lung donors Ensure testing results are available prior to lung transplantation Promote patient safety and avoid COVID-19 transmission to lung recipients What it won't do Require lower respiratory COVID-19 testing for non-lung donors Specify what type of lower respiratory specimen OPOs must use for NAT testing Require reprogramming in UNetSM Themes SARS-CoV-2 (COVID-19) Respiratory testing Timing of test results Patient safety Terms to know Lower Respiratory Specimen: A sample taken from the respiratory system within the trachea or below. Sputum, tracheal aspirate, bronchial suction, bronchial wash, bronchoalveolar lavage (BAL), and lung biopsy are considered lower respiratory specimens. Nucleic Acid Testing (NAT): A test that uses genetic material to detect viruses and bacteria. Click here to search the OPTN glossary Comments Region 11 | 09/30/2021 Region 11 sentiment: 7 strongly support, 7 support, 3 neutral/abstain, 1 oppose, 0 strongly oppose Comments: This was not discussed during the meeting but OPTN representatives were able to submit comments with their sentiment. The region supported this proposal, and one attendee commented that rural hospitals may lack infrastructure for this testing and the need to transport samples to other labs for processing, could cause delays. Another attendee noted that sometimes it is difficult to get a bronch done prior to the OR for DCD donors. It was also noted that donors who test positive should still be eligible for abdominal organ donation. Finally, an attendee supported this requirement for all potential lung donors to ensure a safe lung transplant for recipients. NATCO | 09/29/2021 NATCO strongly approves the proposal for lower respiratory screening of all lung donors for SARS-CoV-2. As some programs are already performing upper and lower respiratory testing, we believe this should be standard practice throughout the country. It would allow for safer lung transplantation and could expand access if centers are more confident in the donor’s covid status, thus creating a good impact. Patients would be informed by straightforward communication at listing and at time of organ offer. Potential concerns we can foresee would be delays in procurement and resistance from donor hospitals. Timeliness of performing the test, as well as the false positive rates will also need to be monitored and outcomes of the recipients for a period after transplantation. American Society of Transplant Surgeons | 09/29/2021 The American Society of Transplant Surgeons (ASTS) strongly supports making permanent the OPTN Executive Committee’s policy requiring lower respiratory testing (by NAT) for all lung donors to address the significant patient safety implications of donor-derived COVID-19 and the risk of patient mortality. Attachment Association of Organ Procurement Organizations | 09/29/2021 The Association of Organ Procurement Organizations (AOPO) supports any policy changes that decrease the risk to transplant the precious gift of a human organ. In May of 2021 the Organ Procurement and Transplantation Network (OPTN) implemented an emergency order to require nucleic acid testing (NAT) on lower respiratory specimens for all lung donors. The members of AOPO quickly adapted and implemented this change. We are in support of this policy change being made permanent because it clarifies the definition of a lower respiratory specimen and requires the results of the NAT to be available before donated lungs are transplanted. This would support the ongoing efforts of every Organ Procurement Organization (OPO) to provide recipients a successful second chance at life. American Society of Transplantation | 09/29/2021 The American Society of Transplantation strongly supports this proposal. This is a necessary and reproducible safeguard against the potential transmission of a known donor-derived SARS-CoV-2 infection. The implementation of a nucleic acid amplification test (NAAT) to specifically identify the RNA sequences that comprise the genetic material of the SARS-CoV-2 (COVID-19) virus on lower respiratory specimens for all lungs donors prior to transplant is appropriate and consistent with the UNOS policy to prioritize the recipients’ safety by avoiding COVID-19 transmission to lung recipients. NAAT testing results should be used in combination with clinical history and examination, radiographic findings (i.e.: CT Chest), other labs, and BAL results in the assessment of lungs prior to acceptance. Safely optimizing the number of transplantable organs under the pandemic is the highest priority. It is important to keep abreast of all available updates in diagnostics regarding the scientific advancements to carry out this aim. Use of lower respiratory COVID 19 NAAT testing from within or below the trachea is more likely to provide lung transplant clinicians with information needed to make the best decision in accepting or declining lungs for transplantation. We offer the following comments for the DTAC’s consideration: • No timeframe for collection is included in the current proposal. We believe that timing should be made explicit and suggest that the relevant specimen be obtained, and proposed testing be conducted within 72 hours of organ recovery. This is in line with recommendations previously offered by the DTAC in other COVID-19 resources. We support this timeline to capture transmissible infections and to better assess risk to lung recipients and individuals coming in close contact. • We suggest adding policy language so that once the COVD-19 public health emergency is resolved the DTAC conducts regular review of this testing requirement to confirm that it remains appropriate to continue. ASHI | 09/28/2021 The American Society for Histocompatibility (ASHI) and its National Clinical Affairs Committee (NCAC) appreciate the opportunity to comment on the proposal requiring lower respiratory SARS-CoV-2 testing for all potential deceased lung donors prior to transplantation. ASHI is in favor of this proposal for the purpose as it ensures the safety of lung transplant recipients. Region 10 | 09/28/2021 Region 10 sentiment: 11 Strongly Support; 6 Support; 3 Neutral/Abstain; 0 Oppose; 0 Strongly Oppose Comments: This was not discussed during the meeting but OPTN representatives were able to submit comments with their sentiment. The proposal was supported by the region and it was noted that this is a responsible approach given the current state of the pandemic both domestically and globally. Region 1 | 09/24/2021 Region 1 sentiment: 4 Strongly Support, 3 Support, 1 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose. No comments. Region 6 | 09/23/2021 Region 6 sentiment:3 Strongly Support; 5 Support; 2 Neutral/Abstain; 0 Oppose; 0 Strongly Oppose. Comments: One attendee noted this testing is already being done, so there doesn’t need to be a policy mandating it. Region 8 | 09/22/2021 Region 8 sentiment: 12 strongly support, 9 support, 5 neutral/abstain, 0 oppose, 0 strongly oppose Comments: Region 8 supports this proposal. A member commented that his institution strongly supports the emergency implementation of this policy. They had two additional questions: Whether COVID-19 testing will be required in perpetuity; or whether, at some point, it will no longer be necessary (and if so, how this will be determined), and Whether the OPTN will be creating a contingency policy language to handle the next pandemic. A member commented that this should be required for all lung donors. A member commented that standardization among OPOs for COVID testing makes sense as it would likely reduce donor to recipient infection transmission. Further, they know that there are differences in samples between upper and lower airways and ideally both samples should be required. Region 7 | 09/15/2021 Region 7 sentiment: 9 strongly support, 7 support, 4 neutral/abstain, 0 oppose, 0 strongly oppose. Comments: Region 7 supported the proposal. One attendee commented that the SARS-CoV-2 test result be required and completed prior to the donor entering the OR. OPTN Organ Procurement Organizations Committee (OPO) | 09/15/2021 The OPO Committee appreciates the opportunity to provide feedback on the Ad Hoc Disease Transmission Advisory Committee’s proposal to address SARS-CoV-2 Testing for Lung Donors. The Committee supports the effort to collect additional data and provides the following comments: Several members agreed that most lung centers ask for this testing anyway, and expressed support for this policy. A member asked if tracheal aspirate would qualify as a lower respiratory sample, and the DTAC Chair confirmed that the lower respiratory sample specified by policy includes a tracheal aspirate. He noted that the DTAC chose to use “lower respiratory tract sample” as opposed to BAL due to the potential for difficulties accessing BAL testing in certain areas and with donation after circulatory death (DCD) donors. Another member agreed that allowing both BAL and tracheal aspirate testing eased compliance with this policy. A member noted that there was not necessarily a delineated timeframe for performing a BAL, and asked if there were recommendations for a timeframe. Staff clarified that the policy was written to be flexible for OPOs as far as timeframe, requiring that the results be available by the time of lung transplant in order to allow OPOs ample time to get testing done. Another member shared that transplant centers often ask for repeat tests closer to OR time, noting that the policy and the reality of trying to place and get the lungs transplanted may not be the same. One member expressed concern about adding a specific timeframe. The Vice Chair agreed, adding that if a timeframe was set, it should mirror the infectious disease timeframe of a maximum of 96 hours prior to crossclamp. A member asked if any non-lung recipients have experienced COVID-19 transmissions. The DTAC Chair clarified that there has not been any proven or probable transmissions for non-lung transplants. The DTAC Chair explained that this review process is linked to the summary of evidence regarding donors with a history of or positive COVID-19 test, and that there is a recent effort to update the summary of evidence. Region 9 | 09/14/2021 Region 9 sentiment: 4 Strongly Support; 6 Support; 0 Neutral/Abstain; 0 Oppose; 0 Strongly Oppose. No comments. Region 2 | 09/10/2021 • Region 2 sentiment: 18 Strongly Support, 7 Support, 4 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose • Comments: This was not discussed during the meeting but OPTN representatives were able to submit comments with their sentiment. The proposal was supported by the region and it was noted that more testing during the pandemic meets the goal of protecting recipients. Another member commented that this is a challenge for OPOs because a majority of labs do not test BAL samples. Region 3 | 09/09/2021 • Region 3 sentiment: 9 strongly support, 4 support, 2 neutral/abstain, 1 oppose, 0 strongly oppose • Comments: Region 3 supported the proposal. One attendee commented the policy should become permanent, noting there is a high risk of death from SARS-CoV-2 in lung transplantation recipients, which this policy has prevented. The commenter also observed a bronchoscopy is the standard of care for patients with COVID on a ventilator, so clinicians can readily perform lower respiratory testing. Another attendee questioned the significance of a low-level positive lower respiratory sample when other samples are negative, and expressed concern that donor organs are not being utilized based on this result. This attendee stated transplant centers will decline all organ offers when negative test results exist, but the lower respiratory sample is a low-level positive. Region 5 | 08/30/2021 Region 5 sentiment: 17 strongly support, 13 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose. : Region 5 supports the Ad Hoc Disease Transmission Advisory Committee’s proposal to Require Lower Respiratory SARS-CoV-2 Testing for Lung Donors. Several members commented that this is an important test for recipient safety. One member noted that there is not a reason to do this test during a pandemic. Region 4 | 08/27/2021 4 strongly support, 6 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose. Region 4 supported the proposal. One attendee commented that the committee needs a consensus opinion from transplant ID for how long a period from known COVID positive status to donation represents transition to "non-viable" status. University of Maryland Pulmonary Transplant | 08/23/2021 Would favor testing all potential donors. Knowing COVID status in this situation is of high importance. Anonymous | 08/17/2021 Lung recipients should get the best donor lungs possible. Continued testing for SARS-COV-2 for lung donors will help this happen. Hardeep | 08/11/2021 I am in favor of Lower SARS-COV-2 testing lung donors , since COVID 19 has significant impact to outcome of the transplant. Transplant process is complicated challenging process in all aspects as is. Every step should be taken for safety and to ensure success for chance for second life for the recipients. Robert Goodman | 08/04/2021 I am in favor of ensuring that transplant recipients receive the best possible organs giving them a second chance at life. Given the impact of Covid-19 on lungs specifically, testing should absolutely be done in all instances of assessing lungs for transplant.