HRSA Directive to Reduce the Risk of Donor Derived Rabies Transmission

Comments

At a glance

Current policy

Rabies is a rare but very serious disease that affects the brain and nerves. People usually get rabies from the bite or scratch of an infected mammal. There is no test to diagnose rabies before symptoms start, and once symptoms begin, it is almost always fatal. Rabies can also spread through blood transfusions or organ transplants. This happened most recently in 2024. In April 2025, the Health Resources and Services Administration (HRSA) directed the Organ Procurement and Transplantation Network (OPTN) to find ways to lower the chance that a person will get a donated organ that has rabies. The OPTN is updating policies and collecting more information to better identify when an organ donor may have rabies.

Supporting media

Presentation

View presentation (PDF - 156 KB)

Proposed changes

  • Create screening criteria (questions) to help identify if a living or deceased organ donor may have come in contact with and could have rabies
  • If any risk of rabies is found from screening the donor, then organ procurement organizations (OPOs) and living donor transplant programs must contact the Centers for Disease Control (CDC) for additional help in reviewing the risk
  • Require transplant programs to inform transplant candidates when an organ being offered has any known risk of having rabies
  • Require recipients of organs at risk for rabies to be monitored after transplant and given post-exposure prophylaxis (PEP) when needed

Anticipated impact

  • What it's expected to do
    • Help keep patients safe by lowering the risk of getting rabies from an organ transplant
    • Provide standard criteria (questions) to use to review an organ donor’s risk of exposure to rabies
    • Require transplant programs to tell transplant candidates of possible rabies exposure risk when offered potentially affected organs
  • What it won't do
    • It will not automatically prevent someone from being an organ donor just because there is the possibility that they may have been exposed to rabies

Terms to know

  • Post-Exposure Prophylaxis (PEP): Any preventative medical treatment started after exposure to a pathogen, like rabies, to prevent the infection from occurring.
  • Rabies: A deadly viral disease affecting the brain and nervous system. 

Search the OPTN glossary

Read the full proposal (PDF - 557 KB)

Submit a comment

Please submit all comments via email to OPTNWeb@hrsa.gov. Comments will be posted on this page. Please share in your email if you would like your comment published anonymously. 

Comments

Glenna Frey | 12/19/2025

I am a nephrology nurse, my family has kidney disease, and I am a living kidney donor. 

  • I support: Reduce the Risk of Donor Derived Rabies Transmission.

George Bayliss | 12/19/2025

This seems a very rare but devastating transmitted infection. My experience in asking patients if they’ve been exposed to skunks, raccoons is limited, but no one has acknowledged worrisome exposure. There is another rare, devastating infection in transplant patients – LCMV, from infected hamsters. There have been three cases of transplant infection from an infected donor – Wisconsin in 2003, Rhode Island in 2005 and Massachusetts in 2008. There hasn’t been a move to screen donors for this infection, which is as deadly as rabies in transplant patients. I would consider broadening this warning to cover limited but deadly infections and not limit it to rabies. That would allow it to be updated as new infections are discovered. 

Jennifer A. Cowger | 12/19/2025

Thank you for the opportunity to submit a public comment on the HRSA Directive to Reduce the Risk of Donor Derived Rabies Transmission. For context, I am a heart transplant physician. I have also seen a rabies death once in my career (as a medical student). I am no rabies expert but I appreciate that death from rabies in the US is RARE. Less than TEN PEOPLE die of rabies every year in the US. The occurrence of death after an organ transplant was what a nonmedical person would call a clear fluke. I think it is reasonable to proactively ask about exposure to any animal known to be infected by rabies, or any known exposure to a bat, racoon, mongoose, fox, or skunk bite/scratch but table 1 data in the redacted proposal suggests that family are often not aware of contact with a rabid animal. Thus true benefit is of question (ie- what is the true positive predictive value of the question and what is true negative predictive value of the rabies question- both likely low). 

The inclusion of feral or stray cats may create unnecessary anxiety and expose people to unnecessary PEP. People often have no clue if a cat is or is not stray/feral. Is it a distant neighbor’s cat that one does not know or truly a cat that lives outside and has not had rabies vaccination? I would suspect it is more likely that a person will get scratched or bit by an indoor cat that ran out of their house, got terrified, and scratched or bit a person agitating the scared feline. Is a cat that lives outside 24/7 on a farm- yet is fed and watered and lives in a barn- feral? Maybe that cat has or has not had a rabies vaccination? Much of America is still rural and keeps cats outside and may or may not vaccinate their cat, even as a pet. When we call the CDC, we are not going have clear answers to the question of feral vs domestic cat and vaccinated vs nonvaccinated cat. Given the rarity of rabies and frequency of cats and cat bites/scratches in the US, I feel this will potentially trigger a lot of angst, expensive testing and PEP that is unnecessary at this time for rare condition. If the frequency of rabies rises in the US beyond a given threshold of risk, then perhaps this is reasonable. 

Mythreyi Govindarajan | 12/19/2025

Thank you for the opportunity to comment on the proposed changes related to rabies screening and risk mitigation in organ donation and transplantation.

I support this proposal and believe it represents a thoughtful and balanced approach to improving patient safety while preserving access to life-saving organ transplants. Rabies is a rare but fatal disease once symptoms develop, and the added safeguards outlined in this proposal are appropriate given the severity of the risk.

The creation of standardized screening questions will help ensure consistent evaluation of donor rabies exposure risk across organ procurement organizations and transplant programs. Requiring consultation with the Centers for Disease Control and Prevention when potential risk is identified is a practical and crucial step that adds expert guidance without automatically excluding donors.

I also strongly support the requirement to inform transplant candidates when an organ that is offered has a known potential risk of rabies exposure. Transparency is essential for informed consent and ethical decision-making. Additionally, post-transplant monitoring and the use of post-exposure prophylaxis when indicated provide more protection of recipients.

I strongly feel that the questions provided to the donor should avoid false positives, at the same time, not miss out any critical points. 
Finally, this proposal does not unnecessarily restrict organ donation based solely on possible exposure, and this helps balance safety concerns with the ongoing need to maintain the organ supply.

Overall, I believe these changes will enhance patient safety, promote consistency, and strengthen trust in the transplant system.

Thank you for considering my comments.

University of Arkansas for Medical Sciences Solid Organ Transplant Department | 1/2/2026

We appreciate the opportunity to comment on the OPTN proposal to implement measures to reduce the risk of donor derived rabies transmission. We agree that implementing donor screening criteria to identify potential rabies exposure or infection could be beneficial and may provide valuable information to transplant centers when evaluating organ offers. Targeted screening questions have the potential to uncover rare but serious risks and support informed clinical decision making. While we acknowledge that consultation with the Centers for Disease Control and Prevention (CDC) can be helpful in assessing rabies risk, we caution against policies that would mandate CDC notification in a manner that could delay organ recovery and transplantation. Screening criteria that are overly sensitive or prone to false-positive risk flags may result in required CDC consultation that increases cold time, delays allocation decisions, and ultimately contributes to organ non-utilization or waste. We encourage OPTN to carefully balance risk mitigation with operational feasibility and organ preservation. 

We agree that transparency with transplant candidates is critical and support timely notification to transplant centers when a donor is identified as potentially at risk for rabies. We recognize that discussing this information with candidates at the time of organ offer may be appropriate in certain circumstances. However, we note that transplant centers already counsel candidates regarding the possibility of unknown or undetected donor-derived infections. Requiring a specific discussion of rabies risk in all cases where screening criteria are met, particularly when the actual risk is low, may cause unnecessary anxiety and could lead to candidates declining otherwise suitable organs. 
We support monitoring transplant recipients for rabies following transplantation when donor risk is identified and agree that post-exposure prophylaxis should be recommended as part of clinical guidance. However, we strongly believe that decisions regarding prophylactic treatment should remain under the clinical discretion of the transplant center, allowing care teams to individualize management based on recipient factors, donor risk assessment, and evolving clinical guidance. 

In summary, we support efforts to enhance donor screening and reduce the risk of donor-derived rabies transmission. We encourage OPTN to ensure that screening requirements, CDC notification processes, and communication expectations do not inadvertently delay transplantation, increase organ discard, or limit transplant center autonomy in post-transplant management. Thoughtful implementation of this policy will be essential to protecting recipients while preserving timely access to organs.

Courtney Jett | 1/9/2026

As a candidate/recipient family member and a transplant professional, I strongly support this proposal. My two recommendations are the following:

  1. Clarify what “Direct contact with bats” means. It is fairly standard for patients to receive rabies PEP if a bat is found in their house, as there is a potential for exposure without an obvious wound. 

Anonymous | 1/9/2026

I would think it would be reasonable to inquire whether a potential donor works or has worked in an animal hospital zoo or any business in which the donor could come into contact with an animal that could scratch. 

Erin E. Simone | 1/10/2026

While I am very happy you have attempted to improve the policy regarding rabies risk in organ transplants, the proposed policy does not adequately address the risk. Policy decisions should not be based solely on the rarity of a disease. Clearly rabies is underdiagnosed and underreported. Policies should be tailored to protect people from deadly disease. Real people with real families are being affected by these policy decisions. No one ever again should have to watch their loved one die from rabies transmitted from an organ transplant. Organ transplants should save lives, not take them.

Rabies is nearly 100% fatal once symptoms begin, especially if not treated promptly and appropriately with post-exposure prophylactic (“PEP”). Receiving an organ that contains the rabies virus is a death sentence. For many people, it is worse than receiving no organ at all, especially for people who are not at risk of imminent death. A person receiving a life-saving organ should not have to worry about dying a few weeks later because the organ had rabies. Rabies is a horrible way to die and rabies transmission through organ donation is preventable.

Your policy goal should be to prevent transmission of rabies in organ donations. Unfortunately, the proposed policy falls short for three (3) reasons.

  1. Organs at high risk of rabies should not be used. Period.
  2. PEP in immunocompromised people is not 100% effective. Organ transplant recipients are given immunosuppression drugs and are at risk of rabies breakthrough despite PEP.
  3. Unless notice provisions are uniform, clear, detailed and provided not only to the recipient, but also the recipient’s advocates, the notice may not adequately inform the recipient of the seriousness and deadliness of the risk of receiving a high rabies risk organ.

Each of these issues are discussed in detail below.

High Risk Organs Should not be Used.

Expanded screening is important to help identify organs at high risk of transmitting rabies. However, ignoring the warning signs after screening identifies a high rabies risk organ simply cannot occur. This is when rabies in organ transplants occur. In the case of the Michigan man who contracted rabies, the U.S. Center for Disease Control and Prevention (“CDC”) reported that “[t]he Donor Risk Assessment Interview (DRAI) questionnaire reported that the donor had received a skunk scratch.” https://www.cdc.gov/mmwr/volumes/74/wr/mm7439a1.htm, last visited 1/11/2026. Based on this information, the donor should have been rejected. Yet, the organs were still used, and the result was that the transplant recipient contracted rabies.

Wildlife scratches and bites pose unreasonable risks of rabies. The CDC has reported that in the U.S., “[w]ild animals account for more than 90% of reported cases, with bats (35%), raccoons (29%), skunks (17%), and foxes (8%) most often exposing Americans to rabies.” https://www.cdc.gov/rabies/php/protecting-public-health/index.html, last visited 1/11/2026. Data on rabies in animals is published each year by the American Veterinary Medical Association (“AVMA”) each year in the Journal of American Veterinary Medical Association (“JAVMA”).

Based on JAVMA data, rabies is most prevalent in bats, foxes, racoons, skunks, and mongoose, each of whom have their own rabies variants. However, these variants do not remain exclusively in their host animals. In 2023, JAVMA reported that the bat variant infected not only bats but also skunks and foxes. Rabies surveillance in the United States during 2023 in: Journal of the American Veterinary Medical Association Volume 263 Issue 10 (2025) (XML), last visited 1/11/2026. Racoon variant, can infect a variety of wild animals, but skunk variant and grey fox variant can also infect other animals. Animals susceptible to contracting different variants including skunks, foxes, racoons, groundhogs, deer, coyotes, lynx, bobcats, beavers, mountain lion, otters and opossum. See Rabies surveillance in the United States during 2023 in: Journal of the American Veterinary Medical Association Volume 263 Issue 10 (2025) (XML) and https://avmajournals.avma.org/view/journals/javma/262/11/javma.24.05.0354.xml?tab_body=pd (XML). The CDC reports that rabid bats are found in every state except Hawaii. https://www.cdc.gov/rabies/php/protecting-public-health/index.html, last visited 1/11/2025. Thus, any wild animal scratch or bite must be presumed to have transmitted rabies to humans unless it was affirmatively ruled out by a negative rabies test of the animal or the incubation period (at least 1 year) has passed.

For people traveling abroad, a high risk of rabies exists from dog bites and scratches. The CDC reports that “[d]ogs cause 99% of human rabies deaths outside the United States.” https://www.cdc.gov/rabies/around-world/index.html, last visited 1/11/2026. Any scratch or bite from a dog in any country outside the United States should also be presumed to have transmitted rabies unless it was affirmatively ruled out by a negative rabies test of the animal or the incubation period (at least 1 year) has passed.

The risk of contracting rabies and its deadly implications is far too great to allow these organs to be used. Based on data collected by seven (7) Organ Procurement Organizations (“OPOs”), and reported by the CDC, “an estimate of 12 (95% CI 7-20; 0.07%) of 16,989 deceased US donors had high-risk exposures.” https://wwwnc.cdc.gov/eid/article/31/12/25-1486_article, last visited 1/11/2026. Let me repeat that: only12 of the 16,989 total donors had high risk exposures. That is equal to 0.07%. Compare that to the 2,872 persons that were ruled out for donation for other reasons. https://wwwnc.cdc.gov/eid/article/31/12/25-1486_article, last visited 1/11/2026. Of these, 2,872 donors, donors with racoon and porcupine exposures were already ruled out for donation. In fact, the only donors with wild animal scratches who were used were two (2) donors who had bites/scratches from rats.

Not only is ruling out donors with a high risk of rabies the only ethical thing to do, it would have virtually no impact on number of viable donations available given the reported low number of such donors compared to the overall pool of donors.

Merely notifying local health departments or the CDC creates the potential for having multiple and/or conflicting decisions on how to deal with such organs. Recommendations could vary based on non-scientific reasons, such as political party affiliations or personal experiences or lack thereof, including lack of experience with rabies. Notifying the CDC of any donor who dies with a wild animal scratch or bite or a dog scratch or bite who traveled abroad is important to help with rabies identification and reporting, but it does not ensure that organ transplantation is safe from rabies.

Immunocompromised Patients, Like Organ Transplant Recipients are at Risk for PEP Failure.

While the United States has generally had success in preventing rabies with timely PEP, there is one group of people for which PEP is not 100% effective: immunocompromised people. Research indicates that immunocompromised people do not always create rabies antibodies in appropriate levels to prevent a rabies infection. In 2012, it was reported that immunocompromised persons do not create the minimum acceptable level of rabies antibodies in response to PEP. https://pmc.ncbi.nlm.nih.gov/articles/PMC3437714/, last visited 1/11/2026. More recently, in 2023, a review of rabies breakthrough infections occurred due to the immunocompromised status of some of the patients. https://pmc.ncbi.nlm.nih.gov/articles/PMC11403119/pdf/nihms-2022214.pdf (PDF - 1 KB), last visited 1/11/2026. Also in 2023, it was reported that an 84-year-old man from Minnesota died from a break-through rabies infection despite being given PEP. https://academic.oup.com/cid/article/77/8/1201/7093064, last visited 1/11/2026.

This high risk of rabies PEP failure in immunocompromised people caused the CDC to issue the following recommendations in 2008 for people who need pre-exposure prophylaxis (vaccine before exposure): “[p]atients who are immunosuppressed by disease or medications should postpone pre-exposure vaccinations and consider avoiding activities for which rabies pre-exposure prophylaxis is indicated. When that is not possible, immunosuppressed persons who are at risk for exposure to rabies should be vaccinated and their virus neutralizing antibody titers checked.” https://biotech.law.lsu.edu/cdc/mmwr/rr57e507.pdf (PDF - 260 KB), last visited 1/11/2026.

For patients to receive PEP after rabies exposure, the CDC’s current recommendations are as follows:

Help patients understand that their immune response may be inadequate.

Avoid immunosuppressive agents during rabies PEP unless essential for treating other conditions. Patients on immunosuppressive medications should consult with their healthcare providers about the possibility of delaying these treatments during PEP.

https://www.cdc.gov/rabies/hcp/clinical-care/post-exposure-prophylaxis.html, Last visited 1/11/2026.

Since administering immunosuppressive medicine to transplant recipients is necessary in order to avoid rejection of an organ, any person offered a rabies high risk organ is faced with a potentially life and death dilemma: (1) undertake PEP but stop immunosuppressive medicine and run the risk of organ rejection; OR (2) undertake PEP and continue taking immunosuppressive medicine and run the risk of dying from rabies. No one should have to be put in that position. This does not make the organ transplant process safe from rabies.

Given the extremely high risk of death in offering any organ with a rabies risk and given the high risk of a breakthrough rabies infection despite administration of PEP in immunocompromised persons, the only safe and reasonable choice is to not offer such organs to anyone.

Notice of the Dangers of Accepting a Potentially Rabid Organ Must be Uniform, Clear, Complete and Adequately Documented.

If any high rabies risk organ is offered to anyone, the extreme dangers of such a choice must be unequivocally clear, and the choice must be made with full knowledge and understanding by the recipient and the recipient’s family/advocate. At a minimum any notice must be in writing and provided not only to the recipient, but also to the recipient’s family or advocate. People on the organ transplant list may not be in the correct state of mind to understand all of the risks. Organ recipients are often given many papers to sign and may not be reading or understanding every document they receive. Ensuring that someone who is protecting the recipient’s interests also knows and understands the rabies risks is critical to saving lives.

In addition, at a minimum, the notice must clearly and unequivocally advise the patient of the deadly risks, in simple language that an average person can understand. This must include:

  1. Explicitly stating that the organ being offered has a high risk of containing rabies.
  2. Advising that rabies can be transmitted from the organ to the recipient.
  3. Advising that PEP is not always effective at preventing rabies in immunocompromised people.
  4. Advising that the recipient’s immune system may not be adequate to prevent rabies.
  5. Advising that rabies is nearly 100% fatal once symptoms develop.

This notice should be uniform across organ recipient facilities. Unless clear and understandable informed notice is given, the organ recipient will have been deprived of a meaningful opportunity to make an informed decision that could have deadly consequences.

Demetria Capone | 1/15/2026

What a wonderful opportunity to participate in this discussion. Living the southern region of the U.S. hunting is a recreational hobby. Exposure to rabid meat is possible when handling game meat. So, a question during assessment from the donors family would be about preparation of game meat. Are gloves used during preparation, and cleaning of tools. 

Scott Hartman | 1/15/2026

We appreciate the opportunity to comment on the HRSA directive to implement measures to reduce the risk of donor derived rabies transmission. Donor derived rabies is an extremely rare occurrence, and it is important to consider carefully the impact of any change in policy on the transplant system prior to implementation.

Our Transplant Institute generally agrees that it is reasonable to create screening criteria to help identify potential rabies exposure or infection in order to take appropriate actions. It is important to note that previously published and established guidance from 2012 (updated in 2014) regarding avoidance of donors with unclear neurologic syndromes would have similarly averted the transmission of rabies in the reported cases of rabies transmission. In order to maximize benefit and reduce unnecessary organ discard, we offer the following considerations.

We acknowledge that engagement with the Centers for Disease Control and Prevention (CDC) can be helpful in assessing rabies risk and regional surveillance. We are concerned about the feasibility and effectiveness of waiting for the process to be completed in a timely fashion so as not to delay the organ offers or result in unnecessary organ non-utilization. If any 3rd party organization is required to validate actions, guidelines and clear processes must be defined by policy and access and responsiveness of such 3rd party, or their designee should be facilitated directly via the OPTN on behalf of the transplant center with specific time limits for action/response.

Regarding a screening instrument, our sentiment is that there needs to be a recognition for the level of specificity of criteria used and must be a widely accepted and validated instrument with a high degree of sensitivity. As noted previously, guidance by the OPTN regarding the avoidance of donors with undefined neurologic syndromes should be followed. A tool such as the one referred to by McCormick et. al in their recently published article in Emerging Infectious Diseases (Wild and Domestic Animal Exposure among Deceased Persons Referred for Organ Procurement, United States” Emerging Infectious Diseases • www.cdc.gov/eid • Vol. 31, No. 12, December 2025) may be helpful, but we think that it is unrealistic to expect this level of granular detail from individuals providing medical histories to the OPO.

We encourage OPTN to assess the true level of risk / mitigation vs. with operational feasibility of small to large transplant centers with varying internal resources such as infectious disease expertise. A risk benefit analysis will be critical to determine if this additional procedure will improve safety without resulting in negative impacts on donation.

We agree that informing candidates of suspected or confirmed risk of rabies is crucial and note that this disclosure can be included among the existing list of risk disclosures (HIV, Hep B, etc.).  This information can be included in transplant candidate education (via transplant centers) so as to prepare the candidate for the potential of such disclosure – and at that time of education, include the steps that OPOs and transplant centers will take for donor testing as well as post-transplant monitoring and prophylaxis (if necessary) to ensure recipient safety.

Anonymous | 1/15/2026

I am a heart transplant recipient.  I support careful review of potential risks to determine if an organ is appropriate for transplant, but such review needs to be prompt so viable organs will not go to waste.  I am concerned because the proposed change means if a risk of rabies is found during donor screening, the OPO/living transplant programs must contact the CDC for additional help in reviewing the risk.  Time is of the essence for organ viability.  My concern is that if the CDC is not properly staffed to respond to these matters promptly, the result might be the loss of a suitable organ.   
 
Candidates must be provided the information they need to make informed decisions.  I support the requirement that transplant programs inform candidates when an organ being offered has any known risk of having rabies, and the requirement that a transplant recipient of an at risk organ be monitored and given PEP when needed.  This is similar to a policy in place when I received my transplant.   This policy gave candidates the information needed to determine if they were willing to accept an organ if there was a risk of Hepatitis C.  OPTN must require that patients be informed of all known risks and mitigation strategies, and then leave it to them to decide if they want to accept the risk.

UCHealth Transplant Program | 1/16/2026

This policy is highly problematic. Rabies in humans is exceedingly rare and these proposed efforts to detect potential cases will likely lead to many organs not being utilized and deaths among patients awaiting lifesaving deceased donor organs. The 'risk factors' for a decedent to have rabies are vague as listed and very difficult to verify in a timely manner. The logistical considerations of contact with the CDC in an efficient and effective manner are not reasonable to adjudicate the likelihood of rabies detection.  Unless there are extraordinary circumstances suggesting that a rabies case is likely, this process should be revised given the balance of benefits to patients with end stage organ disease and the extreme rare incidence of deceased donors with rabies infection.

Association of Organ Procurement Organizations (AOPO) | 1/16/2026

The Association of Organ Procurement Organizations (AOPO) welcomes the opportunity to comment on the Organ Procurement and Transplantation Network (OPTN) Directive to Reduce the Risk of Donor Derived Rabies Transmission to improve the safety of organ donation and transplantation in the United States. AOPO will limit its comments to the effects on deceased donors and organ procurement organizations (OPOs) and defer to others with more expertise on the impact on living donors as well as the discussions with transplant candidates.

AOPO collectively represents 46 federally designated, non-profit 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 transplantation success while consistently improving towards the singular goal of saving as many lives as possible.

We agree that donors identified as being at higher risk for rabies exposure should not be excluded automatically. Transplant centers are in the best position to judge the risk of transmission (with or without prophylaxis) vs. the risk of not transplanting a particular candidate. AOPO appreciates the collaboration with the Centers for Disease Control (CDC) that provides a direct link to the CDC Emergency Operation Center and note that in a test call1, the CDC representative could quickly find the resources needed to help an OPO assess a donor’s risk of rabies transmission. The information provided by the CDC will help to inform all decision-making. We are also interested to learn if the CDC has an additional list of questions that OPOs can pose if a donor is deemed high risk (i.e., in preparation for the CDC call) and whether there is an expected way to document these conversations in the donor chart.

The specific questions in the policy proposal do not currently exist as proposed on the uniform donor risk assessment interview (UDRAI) tool2 used by OPOs and tissue recovery agencies throughout the world, so modification of this standardized tool3 would be necessary, along with training for OPO staff performing these interviews, and for OPO clinical leadership in contacting CDC and documenting that contact. Donor-derived rabies transmissions are low-frequency/high-risk events, and as such, training for O PO staff is critical.

AOPO believes that the criteria described in the policy proposal are adequate. The UDRAI already asks whether the donor recently had symptoms such as “rapid decline in mental ability” and/or “difficulty walking;” it may be worthwhile to include these in training materials as additional cause for concern in the presence of recent high-risk animal contact.

We do not believe it necessary for OPTN to collect data on the specific animal contacts. These data are available from OPOs if needed and adding them to the OPTN database (and requiring OPOs to submit the data points) is an unnecessary burden for a low-frequency event.

AOPO notes with some concern that the estimated costs to implement and support this proposal, although apparently known to OPTN, are redacted from this proposal. While cost should not be a primary driver of this decision, transparency compels their publication. We hope that OPTN will reconsider this decision.

Thank you for this opportunity to comment on this proposal. We look forward to collaborating with OPTN to implement this important safety initiative.

  1. As a test, we called the hotline, quickly announced that this was a drill, but then asked how the call taker would handle a call from an OPO asking
    about rabies risk. She looked it up and said she would connect the caller to a CDC rabies specialist. We were duly impressed.
  2. UDRAI Question #9 asks “In the past 12 months was [the donor] bitten or scratched by any pet, stray, farm, or wild animal?”, but if it’s answered
    affirmatively, the “child” questions do not call out the specific animals/scenarios in the policy proposal.
  3. We believe it is “owned” by the American Association of Tissue Banks.

Anonymous | 1/16/2026

Rabies is a rare but almost universally fatal disease once clinical symptoms begin. Because there is no reliable ante-mortem diagnostic test and transmission has occurred through organ transplantation as recently as 2024, every feasible preventive safeguard should be implemented to protect transplant recipients.

I strongly support the April 2025 directive from the Health Resources and Services Administration (HRSA) requiring the Organ Procurement and Transplantation Network (OPTN) to strengthen policies that reduce the risk of rabies transmission through organ donation.

In addition to enhanced donor screening and data collection, I recommend that OPTN require or strongly encourage the use of State Immunization Information Systems (IIS) as part of the donor evaluation process.

Specifically:

  1. Use of State Immunization Information Systems (IIS)
    Organ procurement organizations (OPOs) should query state IIS databases, when available, to determine whether a potential donor has documented rabies vaccination, post-exposure prophylaxis, or other relevant immunization history. This information could provide critical context when evaluating donors with unexplained neurological illness, animal exposure, or unknown cause of death.
  2. Improved Risk Stratification
    Incorporating IIS data into donor risk assessments would strengthen the ability to identify donors at elevated risk for rabies while avoiding unnecessary organ discard when vaccination history supports lower risk.
  3. Standardized Access and Documentation
    OPTN should develop standardized guidance for accessing and documenting IIS data across states to ensure consistency, timeliness, and compliance with privacy regulations.
  4. Enhanced Informed Consent and Communication
    When IIS data is unavailable or incomplete, transplant centers should be notified so that recipients can be appropriately informed of residual infectious risk prior to transplantation.
  5. Public Health Alignment
    Leveraging existing state immunization infrastructure aligns OPTN policy with broader public health systems and improves coordination between transplant medicine and infectious disease surveillance.

Given the catastrophic consequences of rabies transmission, integrating state immunization data into donor screening represents a practical, evidence-based step to improve transplant safety while preserving access to life-saving organs.

Thank you for the opportunity to comment on this critical patient safety issue.

Donor Alliance | 1/16/2026

Donor Alliance appreciates the opportunity to provide feedback on the proposed policy language addressing the HRSA Directive to Reduce the Risk of Donor-Derived Rabies Transmission. Overall, the proposed changes align with the goal of identifying the potential risk of donor-derived rabies infection. Donor Alliance agrees that donors identified as at higher risk of rabies exposure should not be automatically excluded and that transplant centers are best suited to evaluate the risk of transmission (with or without prophylaxis) versus the risk of not transplanting a particular waitlist candidate. However, it would be helpful to better understand the implications of the CDC’s guidance for potential donors. What types of guidance can the OPO expect to receive from the CDC/HRSA/OPTN as it pertains to questions that OPOs can pose if a donor is deemed high risk? Does the CDC already have questions available to share at this time?

Life of Michigan | 1/16/2026

Gift of Life Michigan appreciates the proposal to identify potential exposure to rabies among organ donors and the opportunity to comment.

While transmission of Rabies is rare in transplantation, its effects are devastating. We support the proposal to require questions about possible donor exposure to the virus, and the notification of potential recipients if risk is identified. We support framing questions specific to Rabies exposure and avoid overly broad inquiries that can be symptomatic of myriad infections. We emphasize the need to ensure that this additional screening does not interfere with the donation process so that organs are not lost.

We also support seeking assistance from the Centers for Disease Control (CDC); however, again, real time communication is essential to ensure donation.

LifeGift | 1/16/2026

LifeGift appreciates the Committee’s thoughtful and evidence-based response to the HRSA directive and the careful collaboration with the Centers for Disease Control and Prevention (CDC) and OPTN stakeholder committees. We support the overall intent of this proposal and commend its focus on improving patient safety in the setting of a rare but nearly universally fatal disease once clinical symptoms develop. The proposal appropriately recognizes the limitations of pre-symptomatic rabies testing and relies on risk assessment, expert consultation, and post-exposure prophylaxis (PEP) as the primary means of prevention.

While we support the direction of the proposal, we offer the following considerations to support consistent and effective implementation:

  1. While the proposed rabies screening criteria are generally clear, we request further clarification regarding the definition of “direct contact with bats.” Specifically, it would be helpful to clarify whether this criterion is limited to physical contact or close indoor exposure (e.g., a bat in a room), as opposed to incidental environmental exposure such as being outdoors in an area where bats are present or flying overhead. Clear distinction among these scenarios would support consistent application and avoid unintended over-screening.
  2. The screening criteria depend heavily on donor or next-of-kin recall of animal exposures, which may be incomplete or unreliable, particularly for deceased donors. This variability may result in inconsistent identification of risk criteria and uneven consultation practices. The OPO personnel conducting these interviews should receive periodic comprehensive training and competency testing on collecting medical/social information from subjects with varying degrees of knowledge, or an OPO should develop a policy addressing this need in their own organization.
  3. We support mandatory notification of potential exposure / suspicion of rabies to the designated point of contact at the CDC. It would be immensely helpful to develop supplemental OPTN guidance or educational materials to support consistent donor screening, documentation, and CDC consultation workflows. A template should be developed and shared of what information is needed by the CDC so that OPOs can be prepared to efficiently share information in a timely manner. In addition, it would be important to share a flow map of what process the CDC follows for communication, notification and consultation after a notification from an OPO, transplant center or hospital.
  4. We suggest step 3) above should also apply to transplant centers as well as OPOs.
  5. Please clarify the required sequence of notifications to the CDC as well as the OPTN Patient Safety portal/point of contact.

Kasper Statz | 1/16/2026

As an OPO professional, I approve of the proposed inclusion in OPTN Policy 2.4 to include further detail needed in the potential deceased donor’s medical and behavioral history. In particular, it appears current best practices supports obtaining knowledge whether the potential donor had any direct contact with bats in the last 12 months as bats can be a carrier of rabies and bat bites can happen without the person’s knowledge.

I am, however, cautious about the requirement that the OPO must contact the CDC for additional evaluation prior to organ procurement if there are any risk factors for rabies infection. In theory it sounds like a wise step that would assure recipient safety, yet I am concerned about the CDC’s ability to meet the community’s potential demands for STAT consults 24/7/365. Has the CDC committed to staffing a support phone line or emergency email inbox that may not exist today for these additional evaluations?

It is my belief that the additional donor history information will better equip transplant centers, most if not all who have the ability to obtain rapid consultations from internal Infectious Disease physician resources, with data to make an informed decision if the risk is worth the benefit to their patient. Hopefully the CDC would have resources available to give guidance on Post-Exposure Prophylaxis to recipients of at-risk organs.

Mid-America Transplant (MOMA) | 1/17/2026

Mid-America Transplant (MOMA) appreciates the OPTN’s efforts to improve the organ procurement and transplantation system. We believe continued process improvement will lead to more lives being saved and look forward to collaborating with industry stakeholders in this work.

MOMA offers the following comments with regard to the HRSA Directive to Reduce the Risk of Donor Derived Rabies Transmission:

Screening Criteria Comments

MOMA supports screening for rabies transmission with the existing screening questions in the Donor Risk Assessment Interview (DRAI) and not adding additional screening criteria. Currently, MOMA does not run the allocation list if existing screening questions indicate a rabies risk.

MOMA supports the time period of 12 months for all screening criteria. MOMA does not support contacting the CDC for evaluation, as timing on each case is variable.

Since 1979, there have only been 4 cases of rabies transmission in transplant recipients. MOMA is committed to patient safety and given the inherent risk of organ transplantation, and the extremely low rate of occurrence of rabies transmission, MOMA believes HRSA’s efforts to address patient safety risks would be better placed in areas in which the likelihood of occurrence is higher.

MOMA remains committed to improving the organ donation and transplantation process and thanks the OPTN for the opportunity to comment.

Jullie Hoggan | 1/17/2026

I am submitting this comment in my personal capacity, informed by my experience as a transplant recipient from a deceased donor.

I support the intent of this proposal. Rabies transmission through organ transplantation is extremely rare, but once symptoms develop it is almost always fatal, and there is no reliable way to test for it ahead of time. From a patient perspective, screening, disclosure, and post-transplant monitoring and treatment when appropriate make sense when the consequences are this severe.

At the same time, how this is implemented matters. If CDC consultation is required, there needs to be a clear plan for an urgent response from the CDC. Otherwise, patients may lose access to viable organs not because the risk is too high, but because the system cannot move fast enough.

With screening, clear expectations, and interagency planning, this proposal can improve safety without creating unnecessary fear or preventable organ loss.

American Nephrology Nurses Association (ANNA) | 1/18/2026

ANNA agrees with improved donor screening, data collection, and strengthening safety.  Although transmission is very rare and positive testing pre-donation is difficult, when a donor risk is identified, it is important to notify and disclose this information to potential recipients.

American Society of Transplant Surgeons | 1/18/2026

Transplant-transmitted rabies is a rare event. From 1978 to 2013, three transplant-transmitted rabies events in the United States affected nine tissue or organ recipients. Most recently in 2024, a kidney transplant recipient died 51 days after receiving an organ from a donor who had been scratched by a skunk approximately 6 weeks before death. While the incidence is low, rabies has a fatality rate approaching 100% once symptoms develop, making prevention through risk assessment and timely post-exposure prophylaxis (PEP) critical.

The OPTN proposal responds to an April 2025 directive from the Health Resources and Services Administration (HRSA) to further reduce the risk of donor-derived rabies transmission. Following this directive, the OPTN Ad Hoc Disease Transmission Advisory Committee engaged in consultation with multiple OPTN stakeholder committees, HRSA, and the Centers for Disease Control and Prevention (CDC). The CDC conducted analysis of data from seven organ procurement organizations (OPOs) to estimate the frequency of animal exposures in the deceased donor population, finding that approximately 913 deceased donors per year report mammal exposure and approximately 9 deceased donors per year report wild mammal exposure.

The proposal establishes screening criteria for high-risk rabies exposures in both deceased and living donor populations, requires OPOs and living donor transplant programs to contact CDC for additional risk assessment when screening criteria are identified, and requires transplant programs to inform potential recipients when screening criteria are present and provide appropriate clinical monitoring after transplant, including monitoring specific to receipt of rabies PEP.

The proposal represents a reasonable, low-burden intervention for OPOs and transplant programs. The screening questions are already present in current donor risk assessment questionnaires, minimizing the need for new data collection processes or significant workflow modifications. Based on CDC analysis, the number of donors requiring further investigation will be very small—an estimated median of 9 deceased donors annually (reported 95% uncertainty interval: 1-31 donors annually). This represents fewer than one case per week nationally and will likely cause minimal operational burden. The proposal does not exclude potential donors from consideration for organ donation if screening criteria for high-risk rabies exposure are present, preserving donor opportunities while enabling informed risk assessment. The CDC has established a 24-hour hotline for the transplant community to ensure that OPOs can reach subject matter experts at any time, including federal holidays. The proposed criteria are limited to the highest-risk exposures based on available evidence, including direct contact with bats, bites or scratches from wild mammals in the United States, bites or scratches from stray or feral cats, and bites or scratches from any mammal outside the United States within the last 12 months. These criteria avoid overly broad screening while capturing the exposures most likely to result in rabies transmission.

Given the extremely low incidence of transplant-transmitted rabies but the uniformly fatal nature of the disease once symptoms develop, this represents a proportionate response. Post-exposure prophylaxis is nearly 100% effective in preventing rabies if received after exposure and prior to symptom development. Three organ recipients who received PEP 18 months post-transplant from a rabid donor survived without developing rabies, demonstrating acceptable antibody responses despite immunosuppression. This underscores the value of identifying risk and enabling timely PEP administration. The requirement for transplant programs to inform potential recipients when screening criteria are identified and to provide appropriate clinical monitoring, including monitoring specific to receipt of rabies PEP, is consistent with existing OPTN policy requirements for donors with other identified risks and represents a logical extension of current practice.

ASTS supports this proposal as a measured approach to reducing the risk of transplant-transmitted rabies while preserving access to life-saving organ transplantation. The proposal balances patient safety with operational feasibility, leverages existing screening infrastructure, provides access to expert CDC consultation, and preserves donor opportunities by not automatically excluding donors who meet screening criteria.

Considerations for the community:

Does the community support extending rabies screening requirements to living donors? Are there different considerations for screening living donors for rabies risk that the Committee should contemplate?

While all four documented cases of transplant-transmitted rabies in the United States involved deceased donors, the variable incubation period of rabies makes it biologically possible for rabies to be present and undetected in a living donor. The same screening criteria and CDC consultation process are appropriate for living donors, though do represent a slightly increased burden on transplant centers who may have to update their screening protocols, educate the providers involved in screening and consult the CDC on any positive screens. The screening of living donors also raises the question of management of positive screens – specifically responsibility for follow up regarding CDC recommendations regarding the donor including administration of PEP. This should be clarified and education and resources provided to centers regarding post positive screen protocol.

Are the proposed requirements for programs to inform patients when screening criteria are identified in a donor sufficient, or should more explicit informed consent requirements be adopted?

The proposed requirements that programs provide information on donor risk and post-transplant management and monitoring if a high-risk donor should be used are in line with that of other high risk donor conditions and do not require unique informed consent.

What educational resources would be beneficial for potential recipients who may accept an offer from a donor meeting rabies screening criteria? How can information around the implications, benefits, and risks of receiving PEP best be provided to potential recipients in a transplant setting?

Information from the CDC regarding risk and efficacy of PEP, plan for post-transplant management and monitoring and resources for further information should be provided during discussion of organ offer.

What additional information would help OPOs and living donor programs operationalize the requirement to contact CDC when a donor meets one of the rabies screening criteria?

Programs would need information on how to contact the CDC and how this should be documented and followed up.

What experiences have OPO and living donor programs had with evaluating donors with reported animal exposures in their medical and social history? Does your program experience match the Committee’s assumptions that donors meeting the proposed screening requirements will be low?

It is our program experience that the rate of living donors meeting screening requirements is likely to be low.

Are the proposed rabies screening criteria clear and understandable to the community?

Yes.

Are there different or additional strategies to prevent rabies transmission in solid organ transplant that should be considered?

The proposed screening represents a relatively easy to implement, low cost, low burden strategy that we feel to be a measured response to an extremely low incidence donor risk. We do not feel further screening or prevention measures to be necessary.

How would OPOs and programs consider operationalizing the new requirements if the OPTN pursues a phased implementation approach? Under this scenario, the policy requirements would take effect prior to rabies screening data collection being standardized in the OPTN Computer System, and OPOs would be required to consult CDC if they observed any of the screening criteria in the donor history.

Requirements being in effect prior to data collection and screening requirements being standardized in the system may cause confusion and could lead to over reporting of possible high-risk patients, which could cause increased work for OPOs or lead to alarm in the community, or under reporting. Both situations would make the efficacy of the policy difficult to track. It would be preferable to have infrastructure in place when the policy is implemented.

New England Donor Services | 1/18/2026

New England Donor Services supports efforts to improve transplant safety and enhance donor surveillance to minimize the risk of donor-derived infections, including rabies. The devastating consequences of the rare, recently reported transplant-transmitted rabies case underscores the importance of careful donor risk assessment and timely communication with transplant programs.

However, given the extreme rarity of donor-derived rabies transmission, we urge careful consideration of how this policy is operationalized to avoid unintended reductions in donor and organ utilization. Reliance on historical exposures that includes a very broad range of animals—including dogs, cats, and other domesticated mammals, in addition to bats and wildlife— many of which may involve remote, minor, or poorly characterized encounters that are difficult for families to recall accurately, risks over-identifying theoretical risk in a setting where no screening test exists and true incidence is exceedingly low.

We are particularly concerned that expanding mandatory CDC consultation and recipient notification may introduce delays, uncertainty, and risk aversion that could disproportionately impact organ acceptance that has real consequences for patients waiting without a clear corresponding improvement in safe outcomes for transplant recipients. We encourage the OPTN to ensure that implementation remains narrowly focused, evidence-based, and proportionate, with ongoing monitoring for effects on donor utilization and organ non-use.

Donor Network West | 1/18/2026

Donor Network West appreciates the opportunity to provide feedback on the HRSA Directive to Reduce the Risk of Donor Derived Rabies Transmission. We strongly support the intent of this directive to enhance patient safety through improved donor screening, standardized risk assessment, and clear communication with transplant professionals and candidates. Rabies is rare but uniformly fatal once symptomatic, and even very low risk warrants thoughtful safeguards in the transplant setting.

We support the proposal to create standardized screening criteria to help identify if a living or deceased organ donor may have had exposure to rabies. Clear, evidence based questions regarding risk factors can help detect rare but serious risks and strengthen uniform evaluation across Organ Procurement Organizations (OPOs) and transplant programs. Screening criteria should be carefully developed and maintained to avoid excessive false positives that could lead to unnecessary testing or delay, while still capturing meaningful risk.

The requirement that OPOs and transplant programs consult with the Centers for Disease Control and Prevention (CDC) when any risk of rabies is identified adds an important layer of expert input. We encourage the development of clear SOPs for how and when such consultations occur to minimize delays in organ allocation and reduce cold ischemia time, while ensuring expert risk assessment is available.

We strongly support the requirement that transplant programs inform candidates when an offered organ carries risk of rabies exposure. Transparent communication with candidates is essential to support informed, patient-centered decision making. Clear guidance should ensure this information is understandable and contextualized within the candidate’s overall risk profile.

Requiring that recipients of organs identified as at risk for rabies are monitored after transplant and given post exposure prophylaxis (PEP) when indicated aligns with best practices. Additionally, standardized outcome reporting and data collection will support continuous policy refinement.

We also recommend ongoing evaluation regarding the performance of the proposed screening criteria, including how often screening flags translate to meaningful risk. Monitoring will ensure that the policy remains responsive to emerging evidence and minimizes unnecessary barriers to organ utilization while protecting recipients.

Overall, Donor Network West supports the HRSA directive’s focus on patient safety and transparency. By implementing standardized screening criteria, facilitating CDC consultation when appropriate, ensuring clear communication of risk to transplant candidates, and supporting post transplant monitoring when needed, this directive can reinforce trust in the organ donation and transplantation system while preserving timely access to organs. We appreciate the opportunity to offer input and look forward to continued collaboration to improve transplant safety practices.

Infinite Legacy | 1/18/2026

Infinite Legacy appreciates the opportunity to comment on this proposal and supports efforts to increase patient safety. However, we have significant concerns regarding the proposal's potential impact on Organ Procurement Organizations (OPOs). Given that there is no test to diagnose rabies pre-symptomatically, OPOs that comply with the proposed disclosure requirements could face disproportionate liability for post-transplant complications. While Infinite Legacy agrees with the CDC consultation and living donor reporting requirements, we request that the final policy include confidentiality provisions and legal safeguards to protect OPOs that act in good faith.

Infinite Legacy also questions whether the proposal's burden is proportionate to the actual risk. Rabies transmission via transplantation is exceedingly rare, and donor families or providers are often unable to answer the proposed screening questions with certainty. Adding these questions to the already lengthy Donor Risk Assessment Interview (DRAI) process could dissuade families from consenting to donation. We believe other patient safety efforts may merit higher priority than implementing the rabies screening process as currently proposed.

Finally, should this proposal move forward, Infinite Legacy strongly suggests that the guidance include a standardized process for notification and specimen testing with the CDC. Currently, the procedures for obtaining requisitions, submitting specimens, and coordinating testing with the CDC are fragmented. Therefore, clear, standardized guidance is essential for effective implementation and to avoid delays.

The American Society of Transplantation (AST) | 1/18/2026

The American Society of Transplantation (AST) agrees that clear, well-defined donor screening criteria to identify potential rabies exposure could be valuable in preventing the exceedingly rare but potentially life-threatening transmission of rabies from donor to recipient. While AST supports this goal, certain aspects of the proposal would benefit from further clarification and discussion.

AST is concerned that the proposed policy could unintentionally increase non-utilization of otherwise suitable organs. Historical experience with the former “Public Health Service Increased Risk” designation demonstrated that overly cautious consent requirements led to organ refusal and non-utilization, even when the absolute risk of transmission was low. Requiring similar consent language for rabies exposure, despite its extremely low epidemiologic risk, could produce comparable outcomes. To support balanced decision-making that accounts for both transmission risk and waitlist morbidity and mortality, AST recommends that approval of this proposal includes educational resources for patients and transplant centers. AST also recommends explicitly stating in Policy 2.4 (Deceased Donor Medical and Behavioral History) that meeting rabies risk criteria does not preclude organ donation.

AST acknowledges that consultation with the Centers for Disease Control and Prevention (CDC) may be helpful in assessing rabies risk; however, such consultation may also introduce delays that contribute to organ non-utilization. Clarification regarding expected response times for the CDC’s 24/7 consultation service would be valuable. AST further recommends development of a clear process map outlining steps from CDC notification to receipt of guidance and encourages OPTN to balance risk mitigation with operational feasibility and organ preservation.

In addition, AST recommends that OPTN provide clear guidance on minimum documentation requirements for OPOs and transplant hospitals, including whether documentation of CDC contact alone is sufficient or if a brief exposure summary is also required. Clarification is also needed regarding whether CDC guidance is advisory or mandatory, and how CDC notification intersects with OPTN patient safety reporting. AST further recommends explicitly stating that incomplete or unavailable history alone should not be interpreted as elevated rabies risk (e.g., “history unavailable but no known exposure”).

AST agrees that identification of donor rabies risk warrants appropriate post-transplant vigilance and consideration of rabies post-exposure prophylaxis when indicated. While AST appreciates alignment between deceased and living donor policies, additional clarification is requested regarding recommended deferral periods following qualifying
exposures and guidance for donors with remote exposures who have completed appropriate post-exposure prophylaxis. AST also recommends greater specificity in defining potential rabies exposure from animal interactions, including clarification of “direct contact with bats” and classification of “stray/feral” cats.

Finally, AST supports the proposed one- and two-year policy evaluations and strongly recommends earlier and more frequent assessments to ensure the policy achieves its intended goals without disproportionately increasing organ non-utilization among donors evaluated for rabies exposure.

Janie Carlisle | 1/19/2026

Support change in policy to reduce the likelihood and incidence of transmission.

I support the recommended changes to the HRSA Directive for OPTN Donation after Circulatory Death Policy.

Date Last Reviewed: