Comments

UC San Diego Center for Transplantation | 03/15/2023

The UC San Diego Center for Transplantation supports the proposal to Improve Deceased Donor Evaluation for Endemic Diseases and appreciates the Disease Advisory Committee's work to continue improving patient safety.

We agree universal strongyloidiasis screening should be conducted for all donors but do not think it necessary the results be made available at time of the organ offer or transplant. Results following transplantation still allow for timely and appropriate treatment, should any be indicated.

While we recognize the Committee's aim to strive a balance between safety and necessary burden and that the prevalence of Chagas is significantly lower than that of strongyloidiasis, given the subjective nature of donor screening histories, the significant increase in individual travel and migration as well as the substantial morbidity and mortality in the post-transplant setting particularly for heart transplant recipients, we would urge the Committee to require universal testing for heart donors. Given the anticipated false positive rate (1- specificity) we would also support requiring two initial samples as recommended in the testing protocol published in the 2021 Journal of Infectious Disease, Recommendations for Screening and Diagnosis of Chagas Disease in the United States; and if the results are discordant, requiring a third distinct test be performed.

New England Donor Services | 03/15/2023

New England Donor Services is supportive of expanding testing, but is concerned that the proposal in its current iteration will negatively impact organ utilization. In particular, the requirement for Chagas screening results to be available prior to transplant is a logistical impossibility for most donors. Chagas testing is not performed at many OPO-contracted infectious disease laboratories on a stat basis, and is instead sent out to reference laboratories or performed at centralized larger facilities. The turnaround time for Chagas testing is 24 hours or more. When also factoring in transportation time, test results may not return for 36 hours, or longer for some OPOs. The proposal for Chagas disease testing as written will create a barrier to the expedited recovery of liver and kidneys in unstable donors or those with specific recovery timelines required by the family. Evidence demonstrates that organs can be safely transplanted from Chagas positive donors if close post-transplant monitoring is in place for early diagnosis and treatment of recipients, should acute infection occur. NEDS strongly supports the expanded testing guidance for donors at risk of Chagas to help inform recipient management, and recommends removing the requirement that results be available prior to transplantation, consistent with requirements for Strongyloides testing. Removing the proposal’s requirement to have results available before transplant will improve safety for recipients without negatively impacting organ utilization. NEDS supports the policy as written for expanding strongyloides testing to all donors (with no requirement for results to be made available pre-transplant), based on the classification of some areas of the US as endemic and unknown travel history for some donors.

NJ Sharing Network | 03/15/2023

I recognize the importance of routine donor screening for endemic diseases to improve transplant patients' safety further. However, I OPPOSE the proposal due to the following concerns:

1. Donor screening test for Strongyloides antibody does not currently exist.

2. The proposed additions of testing for Strongyloides and Chagas will increase the financial burden, process, and time for the OPO on deceased donor evaluations.

3. Donor case time will likely be negatively impacted.

4. False positive/false negative results are inherent to clinical assays. What should an OPO do about organ allocation for potential donors with any initially positive test results that are not confirmed by a confirmatory or a secondary test to prevent the loss of transplantable organs?

5. As OPOs are required to send a donor sample to the CDC within 72 hours of identifying a positive Chagas screening antibody test result, what is the testing turnaround time at the CDC? Is the CDC aware that they will be receiving these samples? What will that process be? Will there be a charge? Is the CDC able to handle the projected confirmatory test volume? Organ donation opportunities may be lost if the turnaround time at the CDC is excessive.

6. I'm worried about this proposal being premature. I want the committee to do their homework, know the testing availability, and share that with the community.

7. If Chagas screening is required, I would argue the decision to test selectively. A person born in the US to parents born in an endemic area is equally as likely to have Chagas as someone born in an endemic area since Chagas can be passed down from their parents. Selective testing also leaves the chance for human error in test ordering.

8. Often, donors from endemic areas are here illegally, leading to misinformation during the Donor risk assessment questionnaire. Another reason to not selectively test.

Robin Rice | 03/15/2023

This directly affects informed consent. It increases the level of trust between the recipient and their transplant team as well as directly improves patient care. Otherwise the choice not to test for treatable infections would have to be disclosed in preoperative setting. I strongly urge this to be adopted. R Rice MD, kidney recipient

Mid-America Transplant | 03/15/2023

See attachment.

View attachment from Mid-America Transplant

Midwest Transplant Network | 03/15/2023

Thank you for the opportunity to submit comments on the Organ Procurement and Transportation Network’s (OPTN’s) policy development process. Midwest Transplant Network and our HLA Laboratory which serves two OPOs and 11 solid organ transplant programs, are Strongly Opposed to the proposal Improve Deceased Donor Evaluation for Endemic Diseases due to the following concerns and would appreciate additional guidance from DTAC on best practices to overcome these concerns:

1. To our knowledge, an FDA approved, cleared, licensed donor screening test or diagnostic test for strongyloides antibody does NOT currently exist. How will the OPO comply with the proposed policy change?

2. The proposed additions of testing for strongyloides and Chagas will be an increased cost and time burden for the OPO on deceased donor evaluations.

3. Donor case time will likely be negatively impacted, while waiting for initial and/or confirmatory results.

4. False positive/false negative results are inherent to any clinical assays. What should an OPO do with regards to organ allocation for potential donors with any initially positive test results that are not confirmed by a confirmatory or a secondary test to prevent the loss of transplantable organs?

5. As OPOs are required to send donor sample to the CDC within 72 hours of identifying a positive Chagas screening antibody test result, what is the testing turnaround time at the CDC? Is the CDC able to handle the projected confirmatory test volume? Organ donation opportunities may be lost if the turnaround time at the CDC is excessive.

LifeShare Transplant Donor Services of Oklahoma | 03/15/2023

Our OPO has significant concerns with requiring Strongyloides testing for all donors. While these cases are among the more frequent donor derived infections to come before the DTAC, they are far from common in the deceased donor population.

DTAC data shows that for the period of 2008-2017, only 335 of 147,661 donors had a proven or probable disease transmission event (0.18%; source: Kaul DR et al., AJT 2021:21(2):689-702). Further, while infections represented 71% of this number (approx. 238 cases), only 13% of infections were parasitic (same source). In practicality, this represents roughly 3 cases per year of proven or probable parasitic infection of all types.

Given the ability to screen for donor risk factors, mandatory testing for Strongyloides is not justified by the extensive experience of the DTAC. Further, given that it is unclear whether this testing is available in a timely fashion in all areas of the country, we oppose this policy proposal.

Region 6 | 03/15/2023

1 strongly support, 6 support, 4 neutral/abstain, 2 oppose, 0 strongly oppose

This was not discussed during the meeting, but OPTN representatives were able to submit comments with their sentiment. Several attendees raised concerns about testing all donors due to the availability of testing and resources needed for higher risk cases. Another attendee commented that this testing would be cumbersome and waiting for results could delay donor evaluation.  

Region 11 | 03/15/2023

4 strongly support, 14 support, 5 neutral/abstain, 1 oppose, 0 strongly oppose

Overall approval in the region. A member stated we must consider availability and cost of testing and weigh the risk of donor organ non utilization or delays due to the additional requirements. Another member suggested it is important that the pre recovery requirement be removed due to the limited availability of testing and timing of test results.

Kasper Statz | 03/15/2023

As an OPO Professional, I support the proposal with concerns for the implementation. The safety of organ recipients is of utmost priority to this community and I trust the judgement of DTAC that they have seen adverse events related to these two parasitical infections that could have been either prevented or quickly treated after transplantation if universal or targeted testing had been in place. Many OPOs have independently decided to move towards either universtal or targeted testing for Strongyloides and t.Cruzi/Chagas and moving the entire community towards conformity makes sense.

I do have concerns about the implementation of this policy and the unintended impacts on the fragile lab ecosystem. Right now I am not aware of any laboratory in the United States that performs testing for either parasite in a STAT manner. Even in Florida where these parasites are more endemic these tests are typically send-outs for even our large hospital labs. It appears that it would be minimially burdensome for labs to onboard STAT testing for Strongyloides but t.Cruzi/Chagas could potentially be challenging, especially if the requirement is for results to be available pre-recovery. When we currently test for t.Cruzi/Chagas, it can take up to 72 or 96 hours for us to get those results back. We expect the labortory community will adjust when this proposal is approved, but not every lab currently used by an OPO will be able to accomodate STAT t.Cruzi/Chagas testing and some might even struggle with Strongyloides STAT. We have also in our past experience have received results for t.Cruz/Chagas that were ultimately determined to be false positives and the proposed process for confirmatory testing in this proposal is not clear.

An unanticipated consequence of this proposal might be to force the OPO community to use the few national labs capable of meeting this policy requirement, which would cause a risky amount of consolidation of this important process to one or two companies. I urge the responsible committee to consider how patient safety could be assured without necessarily needing results pre-recovery.

Association of Organ Procurement Organizations | 03/14/2023

Thank you for the opportunity to submit comments on the Organ Procurement and Transportation Network’s (OPTN’s) policy development process on behalf of the Association of Organ Procurement Organizations (AOPO). AOPO collectively represents 48 federally designated, non-profit Organ Procurement Organizations (OPOs) in the United States, which together serve millions of Americans. As an organization, AOPO is dedicated to providing education, information sharing, research, technical assistance, and collaboration with OPOs, other stakeholders, and federal agencies to continue this nation’s world-leading transplantation rates while consistently improving towards the singular goal of saving as many lives as possible. We offer the following comments for your consideration:

AOPO supports the ongoing efforts of the OPTN to maintain transplant recipient safety. In general, AOPO agrees that reducing the risk of disease transmission through infectious disease testing can directly impacts recipient lives and transplant outcomes. AOPO concurs with the Committee’s determination that diseases historically considered “endemic” to an area have become geographically widespread due to changes in migratory patterns and increased travel.

AOPO supports the universal antibody screening of deceased donors for strongyloides, with results not being required pre-recovery since organs can be transplanted with a positive screening test due to availability and effectiveness of treatment.

There are several barriers to implementing this proposal. Few labs in the US meet criteria for strongyloides and Chagas testing. Not all of them are operational 24/7, turn-around-times (TAT) for results can exceed 24 hours, and several prefer batch testing. Additionally, geographically isolated OPOs (including HIOP and PRLL among others) already experience challenges with specimen transportation. The inadequate sensitivity and specificity of Chagas screening tests is concerning, as a positive screening result would require confirmatory testing using two different FDA cleared, approved, or licensed antibody diagnostic tests OR involving the CDC to confirm a positive screening test. AOPO is concerned about 1) the possibility that false positive screening tests, as well as 2) the amount of time to send the initial screening, obtain the result, send confirmatory testing, and wait for results will jeopardize the availability of organs for transplants [importantly hearts, a less available organ], especially in unstable donors, donors with time constraints, and donors located in geographically isolated hospitals.

AOPO therefore requests from DTAC: 1) the rate of false positive Chagas screening tests, 2) information regarding which US labs are approved to perform Chagas testing, 3) the availability of the CDC to help with any needed confirmatory testing, 4) the development of an algorithm to determine donors at higher risk for Chagas transmission to limit the potential damage of false positive test results, 5) expectations of TAT for the performance of Chagas screening and confirmation tests, 6) a policy provision to allow OPOs to move forward with recovery in cases where results will not be available prior to OR for unstable donors / family time constraints, and 7) the opportunity to collaborate with DTAC towards a policy which promotes recipient safety while balancing operational expectations and maximizing organ recovery and transplant, understanding both strongyloides and Chagas are treatable.

Donor Network of Arizona | 03/14/2023

Donor Network of Arizona supports this proposal in part. While it does add burden to OPOs for both testing and reporting, the burden is not insurmountable, and it will improve patient safety at comparatively low cost, and without contributing to delays and inefficiencies. We note, however, that the policy requires Chagas screening antibody testing results to be available pre-transplant. The only other infectious disease testing required pre-transplant is SARS-CoV-2, and then only for lung transplantation. We are concerned that not every OPO will have access to STAT Chagas screening antibody testing, and this could delay procurement unnecessarily. We believe that transplant centers and OPOs should be allowed to judge the risk of delayed Chagas testing results for themselves.

Region 7 | 03/14/2023

4 strongly support, 6 support, 1 neutral/abstain, 3 oppose, 0 strongly oppose

An attendee, in support of the proposal, recommended the proposal could allow an informed decision to use known infected organs with decreased probability of problems for the recipient. There were several comments that this would increase cost, add logistical challenges that could potentially result in loss of donation opportunities.

Gift of Life Michigan | 03/14/2023

Our laboratory currently does not test for either parasite, we would need to send the testing out to Warde laboratory at this time. Here is the information for our lab that should be considered across all OPOs:

1. Strongyloides: The turn-around time is 3-5 days at $23.00 per test. The total cost would be ~ $16,000 for our OPO.
2. Chagas: Turn-around-time is 2-4 days with a cost of $85.00 per test. We cannot estimate the total cost since we are unsure how many donors would qualify for testing.
3. It is important that before implementing this proposal we understand the expense and time required to validate any test to be used for clinical testing.

We are in support of the proposal. However, I think it is important to point out:

1. The additional time added to donor cases if testing must be sent out. If the Chagas antibody testing is positive, a confirmatory test would add another few days.
2. The additional financial cost associated with testing.
3. Currently there is no FDA-approved donor screening or diagnostic test for Strongyloides.

View attachment from Gift of Life Michigan

Center for Organ Recovery and Education | 03/14/2023

Thank you for your work on this proposal. From an OPO perspective we certainly support screening for endemic diseases to improve the safety of recipients however we do oppose this proposal. Increasing testing for strongyloides and chagas will increase the financial burden for the OPO. Additionally sending the sample to the CDC can impose stringent timing issues on an OPO.

Region 1 | 03/14/2023

3 strongly support, 4 support, 1 neutral/abstain, 1 oppose, 0 strongly oppose

Region 1 supported this proposal. This was not discussed during the meeting, but OPTN representatives were able to submit comments with their sentiment. A member commented that requiring testing on all potential donors will add substantial costs and time and is not sufficiently justified by the data. The member suggested it would be better to test where indicated based on donor factors.

American Society of Transplantation | 03/14/2023

The American Society of Transplantation (AST) offers the following comments for consideration in response to the public comment proposal, “Improve Deceased Donor Evaluation for Endemic Diseases:”

• The AST opposes universal testing of all donors for Strongyloides and recommends targeted testing instead. There are concerns that universal Strongyloides testing is too broad of a solution considering the frequency of this disease in the deceased donor population and the increased costs and time to the process with very little improvement benefit.
• There are concerns that the testing requirements included in this proposal are not readily accessible in all areas of the country. The long turnaround time for T. cruzi testing and confirmatory testing could lead to critical delays, especially as the OPO community increasingly works to recover organs from rapid donors.
• Underscoring these concerns is the unintended consequence that false positives or misinterpreting the clinical significance of test results will lead to the underutilization of organs appropriate for transplant.
• The AST supports targeted deceased donor testing for Strongyloides and T. cruzi. To mitigate some of these concerns noted above, the AST suggests modifying the proposal to include donor residency, residency of donor’s mother, previous diagnosis of Strongyloides and T cruzi, and previous receipt of ivermectin as new parameters in the Donor Risk Assessment Interview (DRAI); a thorough educational program, including just-in-time resources, focusing on prophylactic strategies for recipients of Strongyloides and T. cruzi Ab positive donors; recommendations for how recipient transplant centers can engage the CDC parasitic division for support; and future analyses of organ utilization from donors with positive tests results.

American Society for Histocompatibility and Immunogenetics (ASHI) | 03/14/2023

See attachment.

View attachment from American Society for Histocompatibility and Immunogenetics (ASHI)

NATCO | 03/14/2023

NATCO members support universal testing of Strongyloides, and if we are to add this (due to the unreliability of reported patient histories) we should add T.Cruzi. By doing this we believe it will improve overall transplant recipient safety. We would however like to see a cost analysis, or discussion on the expected associated costs of screening all donors and any resource consumption impact on the OPO versus preventative treatment to the recipients. What would the expected turnaround time be? Many times, donation occurs under stringent time constraints, thus the utilization of additional testing will add time. Is there an opportunity to bolster the donor risk assessment interview questions to be more pointed and clarify the risk for endemic diseases before requiring antibody screening? Overall, as living globally and global travel continues, we will need to take measures to prevent the endemics discussed from causing death and issues when we could have treated them quite easily from the get-go. New testing measures will bring forth various issues that we will need to discuss (false positives and negatives, for one) but this will be a positive change and we can continue to work on how to best implement it in terms of logistics and associated costs.

Region 8 | 03/14/2023

2 strongly support, 13 support, 2 neutral/abstain, 2 oppose, 3 strongly oppose

The majority of Region 8 members support this proposal with some members in opposition. During the discussion, an attendee commented on his support of safe transplants, he believes the addition of strongyloides and T. cruzi is not advantageous nationally applied. It is not endemic in all regions. The proposed requirement to screen the entire donor population adds additional burden that is not appropriate in regions without significant prevalence. In addition, the laboratory burden is prohibitive to sweeping requirements. There is no FDA approved assay for strongyloides. There is no standard approved assay for the confirmatory testing for T. cruzi. Its’ institution does not have the equipment available for testing and would have to incur additional costs. It would have to assess staffing capacity to determine the need for additional staff, to perform the additional testing. And this will likely increase donor screening turn-around times and will increase donor screening costs. Another attendee expressed concern about national testing availability and increases turn-around time for testing. An attendee pointed out that it will be important to ensure adequate ID consultation and/or education, at the time of organ offer, to be sure that organs are not turned down even when prophylactic treatment for these diseases is available. An attendee thought it would be helpful for the committee to provide guidance on the testing. An attendee pointed out that the incidence is so small that they don't see the need to test every donor. 

OPTN Transplant Coordinators Committee | 03/14/2023

The Transplant Coordinators Committee thanks the Ad Hoc Disease Transmission Advisory Committee for their work on this proposal. 

A member expressed support but added that donor screening is subjective if based on the next of kin providing information about the donor’s history. She recommended testing for Chagas and Strongyloides be required for all donors, since someone could live in an endemic area for a short period of time or have a family member diagnosed with the diseases. 

A member stated that she appreciated DTAC’s decision to not require Strongyloides results prior to proceeding with transplant, but what happens if the results are available. 

A member asked if the screening should be required for hearts only versus all transplants. She suggested starting with heart because the POC is reviewing post implementation metrics and maybe it would inform the decision to apply this to all transplants since the number of cases is low.

OPTN Organ Procurement Organization Committee | 03/14/2023

The OPO Committee thanks the Ad Hoc Disease Transmission Advisory Committee for their work on this proposal and members offers the following comments and questions:

No concerns about the proposed universal screening for Strongyloides

Concern about gaps that might allow Chagas transmissions to still occur. For example, it doesn’t matter where the donor was born because if their parents lived in an endemic area, the donor could still potentially transmit the disease. There was also concern about undocumented donors who may not have an accurately recorded background. Universal testing would provide protection for gaps in donor history or window for transmission. 

Concern about the cost and turnaround time for conducting two tests. One member believed the testing should only apply to heart donors because the symptoms of Chagas can be effectively treated for the other organs. 

Concern about some labs not having the capability to run the screening tests and needing to ship them out to another lab for routine testing. Lab staffing concerns were also noted.

Concern that an FDA approved, cleared, licensed donor screening test or diagnostic test for Strongyloides antibody does not currently exist.

As OPOs are required to send donor sample to the CDC within 72 hours of identifying a positive Chagas screening antibody test result, what is the testing turnaround time at the CDC? Organ donation opportunity may be lost if the turnaround time at the CDC is excessive. 

OPTN Operations & Safety Committee | 03/13/2023

The Operations and Safety Committee thanks the OPTN Ad Hoc Disease Transmission Advisory Committee (DTAC) for their efforts on the Improve Deceased Donor Evaluation for Endemic Disease proposal.

The Committee voiced general support for the proposal. The Committee asked how widely available the testing being proposed is, specifically for Chagas confirmatory testing and if there is any concern for potential barriers to this type of testing. The Committee also inquired about whether other tropical disease testing requirements are being considered. 

The Committee voiced concern in regards to the timing of the testing results being available before transplant. Some members shared that these labs are sometimes shipped out for testing for Chagas. If shipping and availability of testing is limited and there is a need to get the results back prior to allocation for some organs, there is concern that there will be some organs that may not be able to be recovered from a timing perspective. This could be attributed based on the stability of the patient and the donor family’s requests. The extending time on donor cases doesn’t lead to more organs being more suitable for donation but instead can lead to less organs actually becoming suitable. 

The Committee commented that in order for what is being proposed to work universally, it would be up to proper education of OPO staff. The Committee suggested there be specific questions in the OPTN Computer System that would ask where a patient was born or traveled to be able to identify these precursors.

International Society for Heart and Lung Transplantation | 03/10/2023

ISHLT generally supports the concept of universal screening to ensure that these preventable diseases do not impact post-transplant outcome. However, the proposal does not provide sufficient data to demonstrate that the benefit of having universally available serology will outweigh the risk of increased non-utilization of otherwise suitable organs or provide sufficient information about how the latter risk would be mitigated if the proposal is adopted. Specifically:

·      The proposal fails to provide specific details about expected positivity rates for Strongyloides and failed to note that there are subpopulations of patients at higher risk of Strongyloides than others. The proposal allows results to be provided after allocation but does not establish a required time frame for results to be made available.

·      The proposal does not provide adequate information about how transplant centers will be adequately educated to ensure that Strongyloides and Chagas results made available prior to allocation do not lead to increased non-utilization of organs.

Region 9 | 03/09/2023

5 strongly support, 11 support, 0 neutral/abstain, 0 oppose, 0 strongly oppose

Region 9 supported this proposal. This was not discussed during the meeting, but OPTN representatives were able to submit comments with their sentiment. One member requested that the committee include recommended actions by transplant centers when donors test positive in order to avoid organ non-utilization and help centers with limited infectious disease support on the weekend or overnight. Another attendee suggested testing based on travel to countries where these diseases are endemic.

American Nephrology Nurses Association (ANNA) | 03/08/2023

See Attachment

View attachment from American Nephrology Nurses Association (ANNA)

Anonymous | 03/08/2023

There is no FDA approve Strongyloides assay. So what are we supposed to use? If the test doesn't exist, this proposal is premature. How often is this assay actually positive?

Anonymous | 03/04/2023

I am a laboratory professional, and my laboratory performs a high number of deceased donor infectious disease testing. I STRONGLY OPPOSE the proposal due to the following concerns:

1. An FDA approved, cleared, licensed donor screening test or diagnostic test for strongyloides antibody does NOT currently exist.

2. The proposed additions of testing for strongyloides and Chagas will be an increased cost and time burden for the OPO on deceased donor evaluations.

3. Donor case time will likely be negatively impacted, while waiting for results.

4. False positive/false negative results are inherent to any clinical assays. What should an OPO do with regards to organ allocation for potential donors with any initially positive test results that are not confirmed by a confirmatory or a secondary test to prevent the loss of transplantable organs?

5. As OPOs are required to send donor sample to the CDC within 72 hours of identifying a positive Chagas screening antibody test result, what is the testing turnaround time at the CDC? Is the CDC able to handle the projected confirmatory test volume? Organ donation opportunities may be lost if the turnaround time at the CDC is excessive.

Region 5 | 03/03/2023

8 strongly support, 21 support, 3 neutral/abstain, 1 oppose, 0 strongly oppose

Region 5 supports the proposal. A member commented that currently donors are being correctly evaluated and that more testing will increase the complexity of allocation, further delay and perhaps even preclude some donors. The member will only support the proposal if there is compelling data that shows an increase in disease transmission. A member institution noted that while it recognizes the prevalence of Chagas is significantly lower than that of strongyloidiasis, given the subjective nature of donor screening histories, the significant increase in individual travel and migration as well as the substantial morbidity and mortality in the post-transplant setting particularly for heart transplant recipients, it urges the Committee to require universal testing for both Strongyloides and T. Cruzi. If the Committee does not agree there is sufficient evidence to support universal testing, it argues that, at minimum, the criteria for testing should be expanded to include those with travel history, those that lived in an endemic area for greater than 6 months, close relatives of people previously diagnosed, and those with clinical indications of potential infection. Given the anticipated false positive rate (1- specificity), it also supports requiring two initial samples as recommended in the testing protocol published in the 2021 Journal of Infectious Disease, Recommendations for Screening and Diagnosis of Chagas Disease in the United States.

Region 10 | 02/28/2023

3 strongly support, 16 support, 2 neutral/abstain, 1 oppose, 0 strongly oppose

This was not discussed during the meeting, but OPTN representatives were able to submit comments with their sentiment. One member expressed their support of the project as long as the necessary testing assays are available. Another member stated that while this may marginally improve recipient safety, the risk of losing transplantable organs is expected to significantly increase due to the inherent false positives with any serological testing. The cost of donor workup will continue to rise, and the complexity of organ allocation will further increase with the need to juggle 14 different infectious disease tests with different time and reflex requirements.

Region 3 | 02/24/2023

2 strongly support, 14 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose

This was not discussed during the meeting, but OPTN representatives were able to submit comments with their sentiment. The proposal was generally supported by the region. One attendee recommended keeping Chagas testing for all donors who meet the requirement but modify the pre-recovery testing requirement due to availability of the testing and the amount of time it takes to get the results. Another attendee commented that the second confirmatory lab for T. cruzi could be difficult to get in a timely and cost-effective manner. 

Shweta Anjan | 02/23/2023

Universal testing of deceased donors (and even living donors) for Strongyloides should be standard of care. Disseminated strongyloidiasis has a very high mortality and can be easily prevented with appropriate treatment and/or prophylaxis. However, certain assays can be false negative, this should be taken into consideration as well. Also support Chagas testing for donors from endemic areas, delays with confirmatory test and PCR testing which is done at CDC should also be considered.

Anonymous | 02/22/2023

Donor screening assays are not available for all endemic diseases, so what tests would we perform to satisfy this? And what guidance will OPOs and transplant teams use if a donor is positive for one of these? Proceed with transplant? Cancel donor entirely? And the costs alone of bringing in additional assays are enormous for testing facilities to handle. Would all donors be tested? Do we trust historical accounts of travel and residency? If confirmatory testing is needed, who and where are those going? While I am in support of keeping our recipients safe, I think we have to weigh the impact this will have on testing facilities and the lack of direction on how to implement.

LifeGift | 02/21/2023

This proposal is problematic due to 1) the stringent time requirements for final results and 2) the variation in access to labs/locations in large OPOs with vast geography.

Region 2 | 02/21/2023

8 strongly support, 13 support, 1 neutral/abstain, 1 oppose, 1 strongly oppose

This was not discussed during the meeting, but OPTN representatives were able to submit comments with their sentiment. It was noted that both Chagas and Strongyloides should be required across the board. Limiting to those born in an endemic country and for only six months in an endemic country, leaves a gap for a potential missed diagnosis. Chagas can be passed down from mother to child, so if a child is born in the US, but the parents lived in the endemic country that is a potential missed diagnosis. Getting information from historians is challenging at best and relying on their information regarding travel can lead to a potential missed diagnosis. Another member noted their strong support given that the local community has a fair amount of people who are from nations where Chagas and Strongyloides are endemic, and this proposal will help the community be vigilant in early diagnosis and treatment. Strongyloides within the US is predominantly in the Southeastern states (especially rural Appalachia) so screening all donors would be significantly beneficial for centers in Region 2. One attendee did note opposition to the proposal given the inability to perform Strongyloides at their local OPO, which requires testing kits to be sent out of state for reading.

Region 4 | 02/21/2023

3 strongly support, 19 support, 1 neutral/abstain, 0 oppose, 1 strongly oppose

This was not discussed during the meeting but OPTN representatives were able to submit comments with their sentiment. The proposal was generally supported by the region. One attendee commented that the proposed required test is not endemic or reported with any frequency in many areas of the country. They went on to comment that this testing may not be readily available in a timely fashion. They added that there is no analysis of the additional cost to OPOs or the impact on donor process delays, and really no cost-benefit. Given the fact that literally thousands of donors are recovered in this country for which this parasite is not a problem, continuing to test for known risk or endemic locations makes infinitely more sense.

Kareena Patel | 02/19/2023

Due to the increasing frequency of travel in the United States, endemic viruses from other nations are becoming more widespread. I believe it would be prudent to make certain that those endemic infections aren't spreading through recipients based on a donor's most recent travel history. The implementation of this idea, which is quite inexpensive, would enhance patient safety and promote organ donation around the world.

Alycia Jensen | 02/16/2023

I am a student at Portland State University. As I learn more about organ donation, I fear that people will become ill due to other factors, such as disease. This plan to test Strongyloides and Trypanosoma cruzi helps relieve this concern. It also improves my opinion in medicine and my ideas of the care patients will receive. I am grateful and honored to have my opinion matter. I appreciate the public being taken into consideration and becoming informed as we are the people who may be giving, receiving, or informing others of organ donation.

Joanna Schaenman | 02/14/2023

Strongyloides can cause severe disease including death in transplant recipients after donor transmission with start of immunosuppression. However, it is easy to treat with prophylactic therapy. Changing policy to require universal screening would potentially save lives by providing information for proactive treatment of infection before symptoms can develop. Similarly, T. cruzi can reactivate after transplantation, and having donor information can provide transplant centers with the information they need for surveillance and treatment. These relatively straightforward and low cost interventions should be put in practice immediately to improve patient safety while continuing to support organ utilization across a range of donor geographic exposures.

Megan Morales | 02/13/2023

I strongly support expanding donor screening for endemic diseases, and here particularly strongyloidiasis and Chagas which are being considered. These infections can have a profound impact on patients if not detected and addressed early on. Relying on available travel history is not an adequate approach as military members may have latent disease, and both are also endemic in pockets within the United States. Expanded universal screening of donors will allow for recipients to receive optimal matches and post operative care via prophylaxis or expanded monitoring where appropriate.

Anonymous | 02/09/2023

Endemic viruses found in foreign countries are becoming more common in the United States due to our high rate of travel and the large number of people who emigrate here. Based on a donors' recent travel history, it would be smart to ensure that those endemic viruses aren't being circulated through recipients.

Anonymous | 02/01/2023

I support improved evaluation for endemic screening of deceased donors. As we know, there is a shortage of donors from other ethnicities that may have lived in these endemic areas. We understand that there is a higher chance of survival with donation within the same ethnicity. This will allow them to feel like they can still donate their organs, and will encourage them to sign up to be a donor. I think that recipients should be aware of this risk, as they do if their donor organ is high risk. It should be said that there may be side effects from the medication that would be used to treat these diseases. But overall, I think that the improved evaluation for endemic diseases is necessary for equality of organ donation among different ethnicities.

Ashrit Multani | 01/27/2023

I strongly support universal Strongyloides screening. Many of our donors have resided in or traveled to endemic areas. Some of our donors may not have complete travel histories obtained. There is a significant risk for donor-derived infection. I strongly support epidemiologic risk factor-based screening for T cruzi for donors from all endemic countries including the southern US given known autochthonous infections. However, the geographic criteria for this would need to be carefully considered. We have had a number of transplant candidates and recipients have T cruzi who do not have "classic" risk factors (e.g., residence in rural areas, thatch roofs, adobe walls, etc.) but instead hail from urban areas. I would support screening donors from all endemic countries. The other factor here is the known false-positive rate for serologies and the time-sensitive nature of organ procurement. It would be ideal if two different Chagas serologies could be sent simultaneously.