Comments

Colleen O'Donnell Flores | 03/19/2025

I am the Director of Quality for a high-volume transplant program performing nearly one transplant daily. Therefore, this proposed policy impacts us, and we fully support its intent.
Specifically, we agree with the proposal's statement that "The Committee agreed that an unexpected transmission event should be clearly defined in OPTN policy to distinguish it from an expected event. The Committee proposes defining an unexpected transmission event as a pathogen, disease, or malignancy that was not known in the donor at the time of cross-clamp."
However, we urge DTAC to address operational inconsistencies in how Public Health Service (PHS) risk donor organs are labeled within UNet, particularly in DonorNet Mobile. While the policy itself will be clear, the current labeling practices should be reviewed. The current labels create potential compliance challenges for transplant programs. A standardized, unambiguous labeling system is important for accurate and consistent implementation of this important policy.

Joanna Schaenman | 03/19/2025

We appreciate the efforts of the DTAC group to improve clarification in donor derived infection reporting, which would benefit from standardization across centers. We agree that defining the timing of expected versus unexpected results will help to provide clarity for when results should be reported. As mentioned in other comments, it will be important to clarify whether post-cross clamp timing refers to when cultures were collected versus when results became available.

Given the complexity of lung transplantation, it is often difficult to distinguish when hypoxia or respiratory distress is related to respiratory pathogens as opposed to other clinical causes. Therefore, we are concerned that these new guidelines will not be helpful given the difficulty of adjudicating sick versus non-sick status, as well as the fact that clinical status may vary from day to day. Changing reporting requirements may lead to underreporting of potentially important pathogens including bacteria such as Pseudomonas or Staphylococcus, viruses such as adenovirus, and fungi including molds not on the Pathogens of Special Interest list but that would be important for the mate lung transplant recipient or recipients of non-lung organs. Given that these findings may lead to potential changes in post-transplant antibiotic treatment, the proposed change in reporting could stop or slow down the process of sharing time-sensitive information with other transplant centers.

Joanna Schaenman, Lauren Ogawa, and Hannah Nam

Infinite Legacy | 03/19/2025

Infinite Legacy generally supports the proposal and is pleased to provide the following comments and recommendations. We are supportive of the expected versus unexpected definitions and the timeframe standard of pre- and post-cross-clamp. This would promote accurate and clinically relevant reporting. We appreciate the work of the committee on the colonization versus clinically significant language with the proposed ‘sick’ or ‘non-sick’ lung recipient. The language seems vague and ambiguous and appears to require the OPO to determine whether the remote organism “directly contributes to the lung recipient’s illness based on the clinical judgment of the treating physician or team.” This information may not be readily available to the OPO and is reasonably subjective. We suggest requiring a list of organisms that, if present, should be reported by the OPO. The Pathogens of Special Interest may not be the same organism that is leading the transplant center to identify a lung recipient as ‘sick.’ The patient safety portal is the starting point of notification for potential disease transmissions.

International Society for Heart and Lung Transplantation | 03/19/2025

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OPTN Patient Affairs Committee | 03/19/2025

 The OPTN Patient Affairs Committee thanks the OPTN Disease Transmission Advisory Committee for their work on this proposal. The proposal received general support, with the majority agreeing on the proposed changes, including the definition of unexpected transmission events and the associated timeframes. There were some concerns about gaps in reporting, particularly regarding pathogens identified by the transplant program but not the donor center or OPO before the cross-clamp event. Additionally, questions were raised about the clarity of the "Purpose" and "Background" sections, and suggestions were made for better communication and educational efforts to ensure both transplant professionals and patients understand the changes. Some members expressed concerns about using blood cultures for infection determination due to risk of both false positive and false negative results. The proposal does not address pathogens from organ transport media or how additional testing at transplant centers is handled. Lastly, there was a discussion around ensuring recipients have access to necessary medications following acceptance of increased-risk organs and a member recommended the OPTN should consider insurance coverage in developing policies for transplant programs to follow.

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Region 10 | 03/19/2025

Sentiment: 1 strongly support, 11 support, 0 neutral/abstain, 0 oppose, 0 strongly oppose

Comments: Overall, the region is supportive of the proposal, but several suggestions were offered. There were concerns raised about the definition of "sick" versus "unsick" in the proposal, particularly for lung transplant recipients who may develop complications post-transplant. It was suggested that a "sick" recipient should be defined as experiencing unexpected disease from the donor. It was noted that the definition is included in the proposal and is determined by the judgment of the managing team, with a guidance document in development to provide further clarity. Questions were also raised about reporting requirements for lung transplant recipients who initially do well but later develop pneumonia, as other pathologies aside from donor transmission could be responsible. It was suggested that the policy should incorporate a reasonable timeframe beyond which donor transmission is unlikely. There was additional concern that the current language could lead to mandatory reporting of all posttransplant infections in lung recipients, even if unrelated to donor transmission. Clarification was requested on the definition of “expected” infections. It was noted that the definition relates to the timing of donor cross-clamp—if an infection is identified before cross-clamp, the information is already shared and does not require reporting. However, infections identified after cross-clamp must be reported. Overall, the changes were seen as an improvement, though concerns about the implications for lung transplant recipients remain. A distributed FAQ was suggested to provide further clarification and would likely need adjustments over time.

University of California San Diego Medical Center | 03/19/2025

Particularly affecting lung transplant programs, the policy reads defining timelines, true infection vs colonization based on the data collected, and defining expected vs unexpected donor transmission. It provides better guidance for the transplant team with minimal administrative burden. Supportive of this proposal.

The Society of Thoracic Surgeons | 03/19/2025

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Region 6 | 03/19/2025

Sentiment: 0 strongly support, 16 support, 0 neutral/abstain,0 oppose, 0 strongly oppose

Comments: Region 6 generally supports the proposal, though one attendee noted that clearer guidance is needed on what specific information should be reported.

OPTN Lung Transplantation Committee | 03/19/2025

The Lung Transplantation Committee thanks the DTAC for their efforts to clarify lung reporting requirements for donor-derived transmission events (PDDTE). Overall. The Lung Committee is supportive of this proposal.

The definition for sick vs. non-sick recipient allows flexibility for clinical judgment to delineate what lung transplant programs need to report. This does leave some ambiguity about what should be reported, as it may be difficult to discern whether the recipient is ill from a donor-derived infection. For example, if a recipient were on extracorporeal membrane oxygenation (ECMO), it would be difficult to know whether an infection is contributing to illness. This may be especially ambiguous in instances where transplant hospital protocol is to immediately begin treatment for potential infections before the recipient would show signs or symptoms of infection. While the proposed definitions are imperfect, Lung Committee members agreed this is a significant step forward, considering policy is currently silent on the matter.

Region 9 | 03/18/2025

Sentiment:  2 strongly support, 8 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose 

A member requested clarification of the definition of “known disease”, for example a positive culture resulted and communicated to the appropriate party at the transplant center prior to cross clamp. An attendee expressed support for this proposal, sharing that clear and consistent guidelines will enhance communication between OPOs and transplant centers, improve the accuracy and timeliness of reporting, and strengthen the ability to identify and mitigate transmission risks.  

OPTN Membership and Professional Standards Committee | 03/18/2025

The Membership and Professional Standards Committee (MPSC) appreciates the work of the DTAC in responding to this referral, developing this proposal, and presenting it to the MPSC. The MPSC was overall in support of the proposal developed by the DTAC and provided some comments and suggestions for consideration.

In considering the donor cross clamp timeframe outlined in the definition of expected versus unexpected disease transmission, several MPSC members noted that particularly in kidney allocation, there could be an extended period between the cross clamp and transplant, and it would be possible for testing to result in that window of time that potentially should then be considered expected. From a compliance standpoint, this could create a burden for members and the committee for events to be submitted and reviewed as unexpected even when the results were known prior to the acceptance or transplant. It was suggested that utilizing differing definitions for the start time for different organs when outlining expected versus unexpected would help bridge the gap between something like a lung offer where acceptance is usually well before cross clamp, and a kidney offer where acceptance could be well after cross clamp. The Chair suggested using donor cross clamp for heart, lung, and liver cases and a recipient-based indicator for kidney cases, such as incision or anastomosis.

The MPSC also discussed the definition for sick and non-sick lung recipients, and a member inquired if the DTAC would consider a different terminology than sick or non-sick so that it is less ambiguous in its meaning. They also asked if the lung recipient illness is always so dichotomous, and how the policy could address any potential ambiguity between the two options. Another member noted situations where the community may see bronchial cultures showing the same organism seen in donors, but there is a grey area in calling that a pathogen or just colonization. In terms of compliance, it is important to have clarity about when reporting is required or not. A member suggested limiting the definition of sick versus non-sick lung recipients to just organisms isolated from the respiratory tract and not include any “other sites” as noted in the proposal. There was concern that with other sites there is a large amount of ambiguity about certain pathogens that may not fall onto the Pathogens of Special Interest list but still contribute to a recipient’s illness, and that including those sites in the non-sick definition could lead to possible underreporting.

Finally, the Chair noted that the language of the proposed policy is very duplicative, particularly in the subsection titles, which leads to some possible confusion regarding content and requirements and that taking another look at clarifying that could be beneficial to the community. The MPSC is appreciative of the DTAC’s effort on this proposal and their consideration in addressing the MPSC’s concerns as outlined in the initial referral.

Region 11 | 03/18/2025

Sentiment: 5 strongly support, 15 support, 3 neutral/abstain, 0 oppose, 0 strongly oppose

Comments: Region 11 supports this proposal. An attendee voiced concern regarding insurance coverage, however the proposal does not address insurance coverage. Another attendee asked if disease transmissions that are known or expected need to be reported, this proposal only addresses unexpected disease transmissions.

Region 8 | 03/18/2025

Sentiment: 4 strongly support, 9 support, 0 neutral/abstain, 1 oppose, 0 strongly oppose 

Comments: Several attendees suggested the committee consider changing the word “sick” to “symptomatic” or using the terms “colonized” versus “infected”. Several attendees agreed that it is necessary to establish a specific timeframe to determine when an infection should be considered donor-derived. Another expressed concern that this proposal could lead to potential lung donor rule-outs due to confusion.

University of Arkansas | 03/18/2025

After review, our center supports this proposal. We agree that adding clarifying definitions and standardizing the reporting process for potential disease transmission will help eliminate confusion and over/under reporting. Defining unexpected transmission events will help eliminate excessive reporting and assist transplant centers in identifying legitimate events that impact patient safety. We agree that adding a time period for suspected donor-derived disease transmission will help transplant centers navigate the reporting process. We believe that a system that would notify centers when initial serologies were negative but later turned positive would be beneficial.

NATCO | 03/17/2025

NATCO supports this proposal. The definition of unexpected transmission is clear and gives a consistent time-point (at the time of cross-clamp) rather than just saying “post-transplant”. The definition of sick lung recipient reduces reporting for colonization. We agree that focusing only on “pathogens of special interest” for non-sick lung recipients is appropriate and will avoid over-reporting.

Furthermore, we recommend that consideration is given to the addition of a field for a PSC for serious Potential Disease Transmission Events. Often the day to day handling of positive donor cultures is very different than a notification on a disease-transmission.
Although patient safety is of utmost importance, it is extremely burdensome to have someone from the transplant center to be available 24/7 for the amount of positive donor cultures and updated post-clamp lab results that are reported at any time of day or night.

American Society of Transplant Surgeons | 03/17/2025

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Vanderbilt Transplant Center | 03/17/2025

On behalf of Vanderbilt Transplant Center, we appreciate the opportunity to provide feedback on this proposal. We support the proposed definition of an unexpected transmission event and feel the suggested time frame is appropriate. We also agree with the definition of a sick lung recipient; these changes should reduce both over- and underreporting of disease transmission events.

OPTN Transplant Coordinators Committee | 03/17/2025

The OPTN Transplant Coordinators Committee appreciates the opportunity to comment on the OPTN Ad-Hoc Disease Transmission Advisory Committee proposal, Clarify Requirements for Reporting a Potential Disease Transmission. The Committee offers the following feedback for consideration:

•The Committee suggests further guidance on the definition of sick lung recipients.

•The Committee suggests further guidance on timeframes, particularly around availability of testing where results are discovered post-cross clamp.

Overall, the Committee is supportive of the DTAC’s proposal.

Region 1 | 03/17/2025

Sentiment:  3 strongly support, 5 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose 

Comments: Overall, the Region supported the proposal. Concerns were raised during the meeting regarding the use of broad terminology such as "sick" and "non-sick" in relation to disease transmission, as this may cause confusion within the community, and more specific definitions were suggested. Additionally, there was a discussion about cross-clamp time during Normothermic Regional Perfusion (NRP) procedures, with a recommendation for the committee to define "cross-clamp time" in cases where multiple instances occur. 

Association of Organ Procurement Organizations | 03/17/2025

AOPO appreciates the opportunity to comment on the DTAC Public Comment Proposal Clarify Requirements for Reporting a Potential Disease Transmission. AOPO and its Members are committed to ensuring recipient safety and prompt communication to OPOs regarding any potential unexpected donor-derived transmissions events is critical to ensuring recipient safety for all recipients of organs from the same donor, and to disease transmission monitoring with a goal of preventing future transmissions.

Definition of Unexpected Potential Transmission Known at time of Cross-clamp

AOPO commends DTAC for its efforts to clarify and more precisely define the scope of potential transmissions transplant centers are required to report to OPOs and the OPTN. The proposal defines unexpected potential transmission with reference to known pathogens and malignancies “at the time of cross-clamp” and then refers to “pre-transplant specimen” in the sentence introducing the reporting requirements. AOPO recommends that DTAC address pre-transplant specimen testing that does not result until after cross-clamp due to the time needed to perform the testing (e.g., Strongyloides). While there may be benefit to reporting transmission of pathogens or malignancies identified in donor testing that results post-transplant, such potential transmissions should not be categorized as unexpected.

Anonymous | 03/15/2025

As a transplant recipient, I strongly support the effort to clarify the types of disease transmissions that need to be reported, and the timing of the reporting. Given the number of tasks that the medical transplant community has to complete, I recommend working to streamline and facilitate reporting so that it becomes routine and not a burden on the transplant community. I also recommend continual monitoring to make sure there are no disconnects in the reporting system. 

I appreciate that the OPTN continues to study patient safety issues and develop proposals to improve patient safety.  

Region 2 | 03/14/2025

Sentiment: 8 strongly support, 7 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose 

Comments: Members of the region are supportive of the proposal.  There is support for clarifying the distinction between colonization and clinical infection, recognizing that this determination takes time and may not be clear within the first 24 hours. The impact of pathogens varies by organ type, with some being more concerning for certain recipients than others. There is agreement on the need for clearer guidelines on potential disease transmission and support for the recently refined Pathogen of Special Interest list. However, access to this list within OPTN policy should be improved, with clearer links to reporting requirements in Policy 15.4 to help meet the 24-hour reporting deadline. Additionally, there is a recommendation to adjust the reporting timeframe to account for business days, aligning better with transplant program workflows. 

American Society of Transplantation | 03/13/2025

The American Society of Transplantation (AST) generally supports the proposal, “Clarify Requirements for Reporting a Potential Disease Transmission.” The AST agrees with the proposed definition for an unexpected potential donor-derived transmission event and the proposed time frame in which an event should no longer be considered expected is appropriate. The AST also agrees with the reporting requirements for non-sick lung recipients.

The AST recommends greater alignment with language in Policy 15.5 and the proposed timeframe for determining a transmission event as “unexpected.” The overview of the proposal recommends and explains the rationale for defining an unexpected transmission event based on the information known about the donor at the time of cross-clamp; however, the proposed policy language references “pre-transplant” donor specimen collection. For the purposes of this policy, should “pre-transplant” as used in line 10 of the proposed policy language more specifically refer to donor testing specimens recovered prior to cross-clamp? The AST suggests clarity here to avoid potential confusion in situations where donor testing specimens are recovered at the time of procurement. To address this concern, an alternative to consider is to replace “pre-transplant” in line 10 of the proposed policy language with “pre-cross-clamp.”

Finally, this policy may be strengthened with supplemental education at the time of implementation to highlight that some suspected donor derived transmission events could occur more than a year after transplant (e.g., DOI: 10.1001/jama.2013.7986) and should be considered when assessing unusual infectious disease events, or the development of potential donor derived malignancies.

American Society for Histocompatibility and Immunogenetics (ASHI) | 03/13/2025

The American Society for Histocompatibility and Immunogenetics (ASHI) and its National Clinical Affairs Committee (NCAC) appreciate the opportunity to provide feedback on the proposal for reporting requirements for potential post-transplant disease transmission and are in support of the proposed modifications. Creating transparency with consistent reporting practices offers an opportunity for enhancing patient safety.

Anonymous | 03/12/2025

I agree with this change

Amir H | 03/11/2025

I have family I agree with this change

OPTN Transplant Administrators Committee | 03/11/2025

The OPTN Transplant Administrators Committee appreciates the opportunity to comment on the OPTN Ad-Hoc Disease Transmission Advisory Committee proposal, Clarify Requirements for Reporting a Potential Disease Transmission. The Committee offers the following feedback for consideration:

•The Committee suggests rephrasing language to "or other infectious agents the team is concerned might pose a threat to the patient.”

•The Committee suggested that once initially reported to host OPO, then all reporting should go to OPTN, and there no need to keep host OPO up to date.

Overall, the Committee is supportive of the DTAC’s proposal.

Region 4 | 03/11/2025

Sentiment: 6 strongly support, 9 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose

Comments: Region 4 supported the proposal. During the discussion, one attendee raised concern about  how this change might affect insurance for patients. Other attendees commented from an OPO perspective, that they support efforts to define reportable events more clearly, as this could help reduce unnecessary reporting. They added that currently, they receive follow-up requests for events that are unlikely to be donor-related but are reported by the center, so greater clarity would be beneficial. Additionally, they commented that there should be a straightforward way to identify pathogens of special interest with clear definitions, as the lack of clarity has previously led to non-reporting.

American Nephrology Nurses Association (ANNA) | 03/10/2025

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Johns Hopkins Hospital | 03/10/2025

We appreciate DTACs work to streamline and clarify reporting requirements, and the creation of a list for "pathogen of special interest" which would apply to all recipients. We recommend further clarity on the following:

1. The timing of reporting requirements for a “sick lung recipient”, as in some cases, pathogens may be identified before we can determine if the patient is falls within a “non-sick” clinical course or is a “sick lung recipient” due to the effects of said pathogen.

2. For the "sick lung recipient" is there a list of additional pathogens that should be applied. Our program has noted the guidance below but a link to this or any other lists within the body of policy 15 would be helpful for accurate reporting.

https://optn.transplant.hrsa.gov/professionals/by-topic/guidance/guidance-for-reporting-potential-donor-derived-disease-transmission-events-pddte/

OPTN Organ Procurement Organization Committee | 03/06/2025

The OPTN Organ Procurement Organization Committee appreciates the opportunity to provide input on the OPTN Ad Hoc Disease Transmission Advisory Committee’s request for feedback and provides the following comments for consideration: 

• The Committee supports this proposal and believes it will help reduce reporting incidents. 
• The Committee noted that the language in OPTN policy still requires OPOs to report anything that is reported to them by a recipient center which results in double reporting and wondered if there was any discussion of changing that language. The Committee was pleased to learn this issue is being addressed in another policy proposal that is awaiting implementation. 

The Committee appreciates the opportunity to provide their feedback on this project and looks forward to further collaboration on the topic with the DTAC Committee.  

Region 7 | 03/04/2025

Sentiment:  2 strongly support, 7 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose 

The region is supportive of this proposal. Attendees noted that the changes would help improve OPO operations by reducing the number of unnecessary reports that OPOs are required to follow up on, though this benefit was not explicitly addressed in the policy proposal. Multiple attendees emphasized the importance of limiting required reporting to only unexpected disease transmissions that were not known prior to procurement. They explained that currently, many notifications are submitted for transmissions that were already known and expected, which clutters the system and places unnecessary strain on resources. One attendee suggested incorporating a way to date and timestamp result updates, such as when a culture that was initially reported as negative later turns positive. Another attendee noted that the proposal would provide greater clarity for transplant centers regarding when they should report a disease transmission as unexpected. Additional comments highlighted the need for clearer guidance or an endpoint to determine when an infection is less likely to be donor-derived. One attendee recommended avoiding redefining the term “sick” for the purposes of this proposal and instead using alternative terminology. Another attendee stated that the addition of the word “unexpected” to the policy would be very helpful in distinguishing which cases should be reported. There was also discussion about incorporating a method to track serologies that were initially entered as negative or pending but later converted to positive in the OPTN computer system. Finally, attendees raised concerns about how to differentiate donor-acquired infections from those acquired post-transplant and recommended establishing a specific timeframe to determine when an infection should be considered donor-derived. 

Lorrinda Gray-Davis | 03/04/2025

As a transplant recipient and advocate for patient safety, I support the OPTN Ad Hoc Disease Transmission Advisory Committee's proposed changes to OPTN Policy 15.5 regarding the reporting of potential disease transmission. These clarifications are essential to ensuring transparency, accuracy, and efficiency in how transplant programs identify and report unexpected donor-derived disease transmissions.

By defining an "unexpected transmission event" as a pathogen, disease, or malignancy not known at the time of donor cross-clamp, this proposal establishes a clear and standardized timeframe for reporting. This change will help prevent over- and under-reporting, ensuring that transplant centers focus on genuinely unexpected events that impact patient safety.

Additionally, the proposed distinction between sick and non-sick lung recipients is a critical step in refining reporting requirements. Given the complexities of lung transplants—where airway colonization does not always indicate disease—this clarification helps streamline reporting while maintaining patient safety as a priority. Requiring reporting for non-sick lung recipients only when a Pathogen of Special Interest (POSI) is identified is a reasonable and evidence-based approach.

To ensure the success of these policy changes, I recommend:

Providing educational resources for both transplant professionals and recipients, so they understand how these reporting changes impact their care.

Implementing a monitoring system to track the effectiveness of these new definitions and adjust them as necessary.

Ensuring that transplant programs receive clear guidance on borderline cases to maintain consistency in reporting.

These changes are a positive step toward improving patient safety and communication across transplant centers and Organ Procurement Organizations (OPOs). I support this proposal and encourage the OPTN Board of Directors to approve it, with a strong emphasis on ongoing education and evaluation to maximize its impact.

Region 3 | 03/03/2025

Sentiment: 1 strongly support, 14 support, 0 neutral/abstain, 0 oppose, 0 strongly oppose

Region 3 generally supports the proposal. One attendee commented that the proposed definition of an unexpected transmission event makes sense and provides clear guidelines. They added that using the cross-clamp time frame as the cutoff point is a good way to decide when an event is no longer expected. They also commented that the definition of a sick lung recipient effectively clarifies reporting requirements, reducing unnecessary reports for mere colonization. Additionally, the reporting requirements for non-sick lung recipients are appropriately balanced, focusing only on Pathogens of Special Interest and reducing unnecessary reporting. 

Calvin Henry | 03/02/2025

I understand the need for consistency across programs and the desire to reduce reporting burden for the programs and would like DTAC to consider the following for this policy:

As I understand a number of programs do additional testing at their center, what will be the method of reporting pathogens discovered after cross-clamp and before the actual transplant?

As non-sick lung recipient disease transmission reporting may only be based on POSI, will DTAC consider an interim review of the list if this policy is implemented? Not fully sure of criteria, other than alignment with the CDC, but see that the 12/2024 CDC Emerging Infectious Diseases reference a framework for reducing transmission of Bartonella quintana for organ transplant recipients and that bacteria is not currently on POSI (last update 10/2024).

Although the existing policy clarifies the responsibility of the organ receiving program to communicate with the recipient if a living donor center reports PDDTE (up to 2 years post-donation), I'm not sure if this policy addresses where the responsibility of communication to the recipient lies if the recipient transfers to another program. Can/should this be spelled out in policy?

Region 5 | 02/28/2025

Sentiment:  12 strongly support, 16 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose 

Comments: The region supported this proposal, believed it provided concrete information, and requested clarification on the proposal’s requirements.