HRSA Directive for OPTN Donation after Circulatory Death Policy Development

Comments

At a glance

Current policy

Donation after Circulatory Death (DCD) is the organ recovery process that may occur following death where the heart and lungs have stopped. Current Organ Procurement and Transplantation Network (OPTN) DCD policy covers areas such as having protocols and authorization that Organ Procurement Organizations (OPOs) must follow. On May 28, 2025, Health Resources and Services Administration (HRSA) directed OPTN to propose policies to better safeguard DCD patients and improve family communication. The directive requires that stakeholders in the DCD process (such as family members) may call a pause in the donation process if there is concern for the patient. It also requires creating a standard list of information that OPOs must share with families regarding DCD organ procurement.

Supporting media

Presentation

View presentation (PDF - 185 KB)

Proposed changes

• Create a requirement for people involved in the DCD process (such as family members, OPO staff, and healthcare staff) to have the ability to call for a pause if there are concerns or a belief that the patient is experiencing increase neurological function or is at risk of experiencing pain
• Create a process for informing stakeholders of their ability to call a pause. Stakeholders include:
  • Patient or patient’s agent: At the time of authorization
  • Donor hospital staff, transplant center staff, OPO staff, and third-party procurement and preservation staff: As they become involved in the DCD process
• Require OPOs to verify with hospital staff that they are conducting neurological assessments
• Create a procedure for resolving pauses and resuming procurement efforts
• Require OPOs to report unplanned DCD pauses to the OPTN Patient Safety Reporting Portal within 24 hours of the OPO becoming aware of the request
• Require OPOs to provide a certain level of information about the donation process to potential donor families
• Standardize procurement practices among OPOs, including the timing of family discussions about donation and the use of DCD recovery protocols for brain death donors
• Update definitions and terminology for currency and clarity

Anticipated impact

• What it's expected to do
  • Improve safeguards for potential donor patients during the DCD process
  • Increase information shared with families of potential deceased donors (both DCD and non-DCD) regarding what to expect during organ procurement
  • Ensure that people involved in the DCD process, including family members, know that they can call for a pause if they have concerns about the patient
  • Standardize procurement practices among OPOs and the patient family experience
• What it won't do
  • It will not create a pathway to stop authorization for DCD donation

Terms to know

• Organ Procurement Organization (OPO): An organization authorized by the Centers for Medicare and Medicaid Services, under Section 1138(b) of the Social Security Act, to procure organs for transplantation.
• Donation after Circulatory Death (DCD): describes the organ recovery process that may occur following death by irreversible cessation of circulatory and respiratory functions. A DCD donor may also be called a non-heart beating, asystolic, or donation after cardiac death donor.
• Donation after Brain Death (DBD): describes the organ recovery process that may occur following death by irreversible cessation of cerebral and brain stem function; characterized by absence of electrical activity in the brain, blood flow to the brain, and brain function as determined by clinical assessment of responses. A brain dead person is dead, although his or her cardiopulmonary function may be artificially maintained for some time.
• Unplanned DCD pause: An unexpected suspension of the DCD process due to a difference of opinion as to whether a patient meets the donor hospital’s criteria for withdrawal of life sustaining therapies. An unplanned DCD pause is not intended to address issues or questions related to authorization for donation.

Click here to search the OPTN glossary

Read the full proposal (PDF - 880 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

Anonymous | 12/19/2025

I want to commend HRSA and the OPTN for addressing the OPTN policy for DCD as I think that more detail and clarity regarding procedures will certainly help to standardize the way this important subtype of donation is carried out which is of the utmost importance in maintaining trust and transparency with the public.

That said, I find some of the language regarding proposed DCD pause to be confusing. While I can see that there may be very very very rare circumstances in which the clinical status of a patient may change unexpectedly leading to the need to inform the medical decision maker of the change in case that change were to directly influence the prior made decision to withdraw life sustaining medical therapy and donate, I am not aware of any hospital policies regarding clinical status that take away a patient’s (if the patient is determined to have capacity) or a medical decision maker’s right to choose withdrawal of life sustaining support or donation (if qualified). I am concerned that parties present to the DCD process that may either not agree with or understand the decision to withdraw support and donate may be given the power to stand in the way of the patient’s or medical decision maker’s decision. This needs to be protected too. In the medical field, we do not get to decide who remains on life support unless the patient has no ability to speak for themselves and no one to speak for them. I do not want unplanned “pauses” to interfere with the timing of that life support withdrawal or the patient’s ability to donate life if that is what they want.

Steven Weitzen | 12/19/2025

The following are my comments on the DCD Workgroup Proposal:

Thank you to the DCD work group for its efforts on this topic of great concern. While, I am not a person knowledgeable in the area of science or medicine, I can detect that a significant degree of thought has gone into this proposal.

Although I cannot comment with any authority on the medical aspects of the proposal, I did wish to state the following:

1. Certain critics of the organ donation process have questioned the validity of the consent provided by a donor or a donor agent in the organ donation process. I believe such criticism is deserved, and the proposal does attempt to deal with this issue. However, I would suggest the following changes:
   1. All references to consent or authorization provided by a donor or donor agent (collectively, a “Donor”) should be stated to be in writing. This can be done by a single reference to such requirement in the proposal (as opposed to each time reference is made to a consent or authorization). This would rectify any inadvertent oversight in the proposal.
   2. Any such writing should be in the language of the Donor, plain and understandable and at the sixth grade level.
   3. Ample time should be provided to the Donor to ask questions at each stage when information is provided to the Donor.
   4. Any conversation with the Donor should be in the language of the Donor, plain and understandable and at the sixth grade level.
   5. If necessary, an interpreter should be provided to the Donor at each stage.
2. While the topic of this proposal involves DCD, issues involving normothermic regional perfusion (“NRP”) are appropriately mentioned in Policy 2.15.F.2 Authorization for DCD. With respect to NRP, I would suggest the following:
   1. I would amend the fourth bullet point of Policy 2.15.F.2 Authorization for DCD to state something along the lines of: Appropriate explanation of the potential for, and a detailed description of the process of, normothermic regional perfusion (NRP) if the OPO anticipates that NRP maybe be used in the organ recovery process, including: …
   2. I would also add to Policy 1.2 Definitions a definition of “Normothermic Regional Perfusion (NRP)”. 

Thanks again to the DCD Workgroup for their valuable work.

Elizabeth Crossley | 12/19/2025

Families should be made aware of what goes on INCLUDING use of NRP (if used).

I do not think that signing up on drivers license should be the only required consent for DCDs and the next of kin/poa should have the right to say no even if the patient had previously signed up to be an organ donor.

I also think nursing staff should have a right to decline participating based on religious, moral and/or ethical concerns, in such cases up to and including if it means no one is willing to particiapate.

Organ donation has changed so much for the worst. I would recommend completely stopping nrp.

Glenna Frey | 12/19/2025

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

I support: Donation After Circulatory Death Policy Development.

Claire Morgan | 12/19/2025

There are many problems with this proposal. On the 9th slide of the presentation is a reference to thoracoabdominal normothermic regional perfusion. First - there is no definition or explanation of “Thoracoabdominal Normothermic Regional Perfusion.” How is anyone not already familiar with this concept supposed to know what this refers to? This would be the first mention of NRP anywhere in OPTN policy, and it is not identified or defined either in the glossary or the layman’s explanation. Is there some reason that a procedure that can reanimate the donor while they are being operated on is glossed over like this? (And there are cases of reanimation during NRP verified by the OPTN.) The OPTN’s Ethics Committee White Paper recommended that a separate informed consent, including a discussion of risks, should be obtained for both abdominal and thoracoabdominal NRP, but this proposal does not require consent or discussion of the risks of either procedure. There are currently no policies in place that require “safeguards... to prevent blood flow to the brain”. Interestingly, the OPTN just posted a Safety Notice last month about NRP that acknowledges at least some of the risks, so to then publish this proposal that completely denies the possibility of harm to the donor is very strange. The Safety Notice was published in response to the case of donor reanimation in NJ – this was a case of abdominal NRP (which this presentation does not even mention), in which the donor’s brain was perfused for nearly an hour after the organ procurement had begun.

A side note – while the presentation slides reference TA-NRP, the proposed text just says normothermic regional perfusion. Which is it?

This public comment period, which was started immediately before the holiday week, will likely be ignored initially as people are preparing for the holidays, and forgotten afterwards as they return to work. Only the most diligent reader of the proposal will even notice NRP is mentioned. (I sent a copy of the proposal to an MD/PhD who didn't see it until I pointed it out.) Those from within the transplant community will skim past the mention of it because it is not the focus of the proposal, and the general public will skim past it because they don’t know what it means and assume it is ok. This appears to be an attempt at whitewashing the concept of NRP and will give the OPTN cover to say the community agrees that NRP does not require informed consent. 

Second, this document implies that both hospitals and OPOs have neurological criteria for withdrawal of life sustaining treatment and DCD organ procurements, neither of which is true. The choice to withdraw care is a decision between the physician and the family, and occasionally between the physician and the patient - for example if someone is a quadriplegic and no longer wishes to have their life extended with ventilators and tube feeds. From the OPO perspective, each case is evaluated individually on its merits, which is how it should be. I am not aware of any OPO that has neurological criteria for DCD cases. The presentation slide deck says the potential donor must meet the hospital’s criteria for DCD, and the language of the policy says they must meet the OPO’s criteria. Again, any member of the public reading this proposal would believe that there are a set of standards that simply don't exist in reality, and they may support this proposal based on inaccurate information.

When HRSA mandated the development of this proposal, their clear intent was to require that the OPOs encourage the potential donor’s physician to remain engaged after the decision to withdraw life sustaining therapies is made, and document any unexpected neurological recovery. The current proposal only requires that every 12 hours "The OPO and primary healthcare team must confirm that withdrawal of life-sustaining therapies remains appropriate." At the minimum, this policy should require documentation of any sedatives or paralytics being administered at the time of each exam, whether the meds had been held and for how long, and what testing was performed. I am sure there are more issues with this that are important – was any member of the neurocritical care community consulted on the development of this proposal?

Finally, I am concerned that there are some important issues not addressed in the “pause” section. Who makes the decision that the pause has been resolved, and why is the family of the donor not involved at that time? Many OPOs utilize contract workers as organ procurement coordinators who are often poorly trained, if at all, on OPO-specific policy. The current proposal would allow a short-term contractor to navigate this process without any input or oversight from the OPO administration. Should there be a conflict, that contractor may have left that OPO by the time it is discovered. The OPO should be required to identify a full-time employee at the level of manager or above that must acknowledge the pause, monitor the process, and then sign off on the decision to continue the case. And while this proposal requires the OPO to inform the donor family of the start of a pause, they are not mentioned in the list of those that need to be informed if the case is restarted. Failure to inform them may be profoundly distressing for the family and further erode the delicate trust between the public and the organ donation community.

Jason Vannatta | 12/19/2025

As a 30-year professional in this field, with direct responsibility for conducting and coordinating DCD donors, I would like to highlight several critical oversight issues that this approach fails to address.

First and foremost, the single greatest contributor to challenges with DCD cases nationwide is the failure of hospitals and attending healthcare teams to adequately assess and document neurological function prior to withdrawal of life-sustaining therapy. Existing policies governing death pronouncement—both cardiac death and brain death—are frequently not followed or documented as required. In many cases, physicians inadvertently or intentionally obscure these processes, and families are not consistently or clearly informed about what to expect. This lack of adherence and transparency undermines both the integrity of the process and the experience of donor families.

The second major issue relates to the withdrawal process itself, particularly in DCD cases, where there are no consistent national standards. In many hospitals, physicians are managing withdrawals for the first time and are not sufficiently trained or equipped to provide appropriate comfort measures. Too often, this critical process is left entirely to “physician discretion,” creating significant variability and increasing the likelihood of adverse experiences. In my experience across hundreds of withdrawals, the most successful and compassionate outcomes occur when hospital-based Palliative Care teams are actively involved. Their expertise in managing comfort medications, supporting families, and guiding the process improves outcomes dramatically—without exception.

As long as HRSA continues to place primary responsibility for these outcomes on OPOs without providing mechanisms to ensure meaningful hospital accountability, the system will remain fundamentally flawed. OPOs do not perform transplants, do not manage withdrawals, and do not pronounce death. Holding OPOs solely responsible for outcomes that are largely driven by hospital practices is ineffective and counterproductive. Meaningful improvement will only occur when hospitals, transplant centers, and OPOs are all held to aligned standards and expectations. Without shared responsibility, this process never has—and never will—function as intended.

Lastly, I would welcome the opportunity to offer additional insight to support meaningful improvement within this industry. I have worked as a frontline clinician for over three decades and have supported cases at 29 of the 52 OPOs nationwide. I believe this breadth of experience provides a valuable perspective, and I would be glad to contribute in any way that benefits patients, donor families, and the transplant system as a whole.

Crystal Bibbee | 12/19/2025

My opinion on this matter is that OPO place a time frame on the pause as to not interrupt the process. There shall not be an extended period greater than 6 hours. 

Mythreyi Govindarajan | 12/19/2025

1. Should the proposed policies be approved by the Secretary and made enforceable by HHS?
   Yes. Making these policies enforceable will make patient safety stronger, ensure families are informed of their right to put a pause, and standardize procurement practices across OPOs while maintaining access to DCD donation.
2. How might the OPTN identify, report, or evaluate undue influence in decisions to withdraw life-sustaining therapy?
   OPTN could require documentation of family discussions, independent verification by hospital staff, and mandatory reports of concerns through the Patient Safety Reporting Portal. Clear guidance on the timing of family discussions, before withdrawal decisions, would reduce potential conflicts and ensure more transparency.
3. Should OPTN add automatic triggers for unplanned DCD pauses or provide guidance on caution when assessing neurological status?
   Yes. Automatic triggers could include sudden changes in vital signs, evidence of neurological activity, or family concerns. Extra guidance and education for staff on these triggers would help protect patients and support consistent decision-making.
4. Should OPTN define a minimum waiting period of circulatory cessation?
   Yes. A minimum waiting period ensures that organ recovery occurs only after death is clearly established. Based on current clinical practice, a waiting period of 2–5 minutes is commonly used to balance certainty of death with organ viability.

Thank you for considering my comments.

Michael Davis | 12/19/2025

Being involved in transplant surgery for over 2 decades and seeing DCD donation multiple times, there should be an algorithm developed that can predict whether a patient will expire after withdraw of life support. Similar to the KDPI system, this would help to minimize the probability, resource expense and trauma to the families of patients being taken to the OR for DCD donation and not expiring in the allotted time for organ procurement, or not expiring at all. Using a score from this algorithm, the procurement team can then discuss with the family and members of the healthcare team whether to proceed with this type of donation based on probability of death after withdraw of support. Obviously, Glascow Coma Score would be a part of this new scoring system. My opinion with DCD donation is too many OPOs are aggressively pursuing patients for this type of donation and some of these patients are not candidates or shouldn’t be approached.

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

We appreciate the opportunity to comment on the OPTN proposal to develop a formal policy guiding Donation after Circulatory Death (DCD) practices. We support the development and implementation of a standardized DCD policy and believe this effort is an important step in strengthening transparency, consistency, and public trust in the organ donation system. We agree that all individuals involved in the DCD process, including OPO staff, hospital clinicians, and donor families, should have the clear and explicit ability to call for a pause at any point if concerns arise. It is essential that families and healthcare staff feel empowered and supported in voicing concerns without hesitation. Preserving this ability is fundamental to maintaining trust between the public, donor families, and the organ donation community.

We strongly support standardizing how stakeholders are informed of their right to request a pause. Clear, consistent communication of this right will help ensure regulatory compliance, reduce the risk of misinterpretation, and reinforce transparency throughout the donation process. Importantly, we emphasize that this policy must in no way alter or override the donor’s or donor family’s wishes regarding end-of-life care, life-sustaining measures, or the decision to proceed with or decline organ donation. Families should retain the right to decline donation or pause the process at any time should concerns arise.

Additionally, we support the requirement that OPOs verify with hospital staff that appropriate neurological assessments are being conducted. Care decisions and the potential progression toward donation are heavily reliant on these assessments, and verification promotes accuracy, ethical decision making, and patient safety. We also support the requirement for OPOs to report unplanned DCD pauses to the Patient Safety Reporting Portal. This reporting will allow for thorough documentation and review, ultimately promoting standardized practices and continuous quality improvement across OPOs. Full transparency with donor families throughout the DCD process is critical.

We encourage updates to definitions and terminology to ensure clarity, consistency, and shared understanding among all stakeholders. Furthermore, we support efforts to standardize procurement practices across OPOs, including the timing of family discussions and recovery practices. Consistency in these areas is essential to maintaining public trust and ensuring that families experience a respectful, predictable, and ethically sound donation process. 

Anonymous | 1/2/2026

The OPTN should require that families be told if NRP may be used during the organ procurement, and to be ethical, explain to families. The OPTN should consider a requirement to obtain separate consent NRP in organ donation operations. 

Betseygail Rand | 1/2/2026

I am submitting a comment regarding any policy proposal that may involve normothermic regional perfusion (NRP). Please ensure that the NRP policy fully addresses all risks associated with the procedure, and that risks be discussed with family and require a separate consent for its use. 

Anonymous | 1/2/2026

Any policy that addresses Normothermic Regional Perfusion (NRP) should fully address all the risks posed by it, and propose measures to reduce those risks and disclose them to donors and donor families. 

Chris Hill | 1/2/2026

I'm concerned that there aren't more specific recommendations about normothermic regional perfusion, just a quick mention that the potential to use NRP should be explained to the families of donors. This is vague language, and there is no reason to expect families to understand the risks of NRP, and that it is a relatively newly adopted procedure, unless they are specifically informed what it is and what the risks are and what safeguards are in place to prevent any reanimation when using NRP. I feel the directive should be more forthright and specific in requiring disclosure of risks to families.

Morris Jackson | 1/2/2026

My comment is to express concern about the procedure known as Normothermic Regional Perfusion (NRP). The problem is that if it goes wrong, it is potentially removing organs without anesthesia from a still-living person who may be experiencing the whole thing. Any policy that addresses NRP should fully address all the risks posed by it, and propose measures to reduce those risks and disclose them to donors and donor families.

Anonymous | 1/2/2026

The organ donation framework is built on trust. In particular, people volunteer to become organ donors based on a trust that their own care will not be short-changed as a result. But because of practices documented by, for example, the New York Times in the article "A Push for More Organ Transplants Is Putting Donors at Risk", that trust is wavering. The New York Times article describes "a pattern of rushed decision-making that has prioritized the need for more organs over the safety of potential donors." Any guidelines surrounding organ donation must acknowledge and preemptively address the institutional pressures that led to the rushed decision-making and misprioritization described in that article. Otherwise, the trust that underlies the whole organ donation framework may be lost.

I am concerned that loose guidelines concerning Normothermic Regional Perfusion (NRP) could result in a catastrophic loss of trust in the organ donation framework in this country. My understanding is that NRP is being rapidly adopted across the country without sufficient safeguards in place. In particular, there have been reported cases of blood flow to the brain during NRP, and some cases in which the donor has shown signs of life during the procedure. And this is occurring against the background of serious ethical concerns about NRP, as described in the American College of Physicians Statement of Concern of April 17, 2021.

Simply put, we lack sufficient understanding of the effects of blood flow to the brain during NRP on donor patients. The history of medicine is replete with examples of the convenient minimization of patient cognitive function, ranging from the belief that infants do not feel pain and therefore do not require anesthesia during surgery to the recently challenged belief that patients with severe brain injury lack cognitive function. These examples seem particularly relevant here. While it would be convenient for the donor patient to remain unconscious and insensate, animal data suggests that neurologic function can return with reperfusion.

When setting guidelines for NRP, the agency would do well to consider the effect on the organ donation framework of future articles like the New York Times article mentioned above. Perhaps an article describing the anguish of a family that learned, after the fact, that their child's or parent's brain was reperfused during NRP. And that their child or parent exhibited signs of life during the multi-hour organ-harvesting process. At the very least, donors and their families should be made aware of this procedure, aware of the risks surrounding this procedure, and be afforded the opportunity to provide separate, informed consent to this procedure. 

A.R. Cooke | 1/2/2026

Regarding Normothermic Regional Perfusion, I am concerned about the prospects of adopting a policy that fails to address the risks associated with it.

There are two elements of risk regarding which the current proposal appears to be inadequate: Mandated measures to minimize the risk associated with blood flow to the brain, and appropriate disclosure of those risks to the family members of the donor.

Donors, as I understand it, are not brain-dead when this method of organ harvesting takes place, and the impact of NRP on the brain seems unclear. Given the reasonable concerns over this process, I would urge policymakers to clarify the steps taken to ensure that organs are not donated by people who are potentially still alive, and that family members are fully informed of the process and their options.

Kris Raab | 1/2/2026 

I am a huge supporter of organ donation and welcome policies that make more organs available to those who need them. But any policy that addresses normothermic regional perfusion (NRP) should fully address all the risks posed by it, and propose ways to reduce risks and disclose them to potential donors and donor families.

This is both an ethical and a practical matter. Ethically, potential donors and their families should have all of the relevant information to make their decisions, including the risks of NRP. Practically, if reports of blood flow to the brain and signs of life during NRP become more widely known, it's likely to reduce the willingness of potential donors and families to participate in organ donation.

Elizabeth Morgan | 1/2/2026 

I am commenting to raise my concern with the treatment of normothermic regional perfusion in the referenced policy proposal. To the best of my knowledge, there are currently no policies governing NRP, and the mention in this proposal will be the first treatment of NRP in a policy document of this nature.

As I understand from other sources, NRP is unusual among organ procurement procedures, in that if carried out improperly, such that oxygenated blood is permitted to re-perfuse the brain, it poses a risk that organ procurement may be carried out on a still-living donor. Furthermore, there are no policies currently existing to reduce the possibility of such errors. Given those facts, I believe that any policy, such as this one, addressing NRP, should require full disclosure to donors at the point of consent and to families at the time of donation that NRP poses significant risks that medical error may result in organ procurement being carried out on a donor who is arguably still living, in that oxygenated blood is perfusing their brain.

Rebecca Baranoff | 1/2/2026 

I agree that this policy should be implemented to protect the safety of the potential donors and their families. It is important that the families are well informed and are aware of their options, so that they can ask for a Pause if they are uncertain about their loved one's status. This policy will also improve communications between the ICU and hospital staff and the OPO.

This policy will also help create more oversight when there is a pause.

And Standardize procurement practices among OPOs, including the timing of family discussions about donation and the use of DCD recovery protocols for brain death donors

Lainie Ross | 1/2/2026 

To the OPTN: I noticed on the slide deck that on slide 9: Explanation of potential for thoracoabdominal normothermic regional perfusion (NRP), if applicable

I find this problematic because the UNOS/OPTN white paper questioned whether NRP is consistent with the dead donor rule. As such, I am surprised that it is included as if it were standard of care. (I should note that I was an additional member to the white paper). It is controversial to presume that reperfusion is not the same as resuscitation especially since the heart at times reanimates spontaneously with NRP.

I also find this problematic because there is no discussion of consent. Nor is there a discussion of the possible risks—first whether there is cerebral blood flow and whether there are any techniques being used to ensure that there is no blood flow in order to ensure no sensation. At minimum, if NRP is to be performed (Despite it possibly being in violation of the dead donor rule), NRP should only be conducted with cerebral blood flow measurements.

Finally, it is important to note that normothermic regional perfusion (NRP) is not mentioned in the list of terms on the main page, it is not defined in the linked glossary, and there are currently no policies that address normothermic regional perfusion - this would be the first reference to it. 

Please revise this deck. NRP should not be included as if it were standard of care. At minimum, it should mention that NRP is controversial and that there are several ex vivo perfusion machines that can help procure organs without raising ethical challenges. Lastly, if NRP is to be performed, it should never be performed without cerebral blood flow measurements. 

Melissa Rodkey Skalicky | 1/9/2026 

I do believe we need to tighten the protocol on stopping a DCD process if there is noted neuro activity. Especially as hospitals in Indiana are hiring their own neurologists, who are not always equivalent to the private practice staff. I personally know of a patient who was ID’d as a DCD candidate that made a full, but long recovery. This recovery was pushed by the OPO and had the mother not called the right person at the right time, he would have went to the table as a donor.

Anonymous | 1/9/2026 

This public comment is in regards to development of the HRSA Directive for OPTN Donation after Circulatory Death Policy to Normothermic Regional Perfusion (NRP). As a registered organ donor who is reconsidering whether to remain so given the risks of NRP, I feel strongly that any policy that addresses NRP should fully address all the risks posed by it, and should also propose strong measures to reduce those risks and disclose them to donors and donor families.

Jason Roth | 1/9/2026 

While NRP has a legitimate role in organ donation, policies regarding its use need to be made in consideration of its risks, and to include both risk reduction procedures and disclosure policies for donors and their families.

Eric Siskind | 1/9/2026 

I writing to express my concern regarding the new changes related to DCD procurement and the changes to expedited or out of sequence allocations in kidney transplant.

Although the unos data has reported that nationally the organ discard rate has not gone down; I believe that this does not tell the full story.
Locally in Texas, we have seen the discard rate go up and the transplant rate go down.  This has been seen in our center in fort worth and has been echoed by the centers in Dallas as well.  We have also spoken to the local opo’s in Texas and Oklahoma and they have all said they are suffering from the new policies.  The discard rate may not be going down because the opo’s are going after less donors.  They know that expanded criteria donors such as DCD will have increased scrutiny, and then the allocation will be more difficult because the expedited pathway is closed, so they are forced to go after less donors.  The transplant programs that are aggressive, wanting to utilize expanded criteria donors for more recipients are being punished.  The transplant programs that are conservative are being rewarded for being conservative, as for them, it is business as usual, doing less transplants, from only standard criteria donors.

I think the focus of the optn/hrsa directives should be to increase the number of transplants for recipients. I am concerned that the current focus is hurting the transplant patients and the transplant centers.

Darrell Mathis | 1/9/2026 

As someone who is received a DCD heart (gift) , I am writing to express my concerns about the misinformation, fearmongering, and disregard for scientific evidence that seems to be prevalent in the current administration's approach.

This sensationalized handling of such a critical issue can have very real and potentially dangerous impacts on people's lives, potentially leading to unnecessary loss of life. It is imperative that we prioritize factual accuracy and responsible communication to ensure the well-being of those affected.

If you genuinely want to help, please step back until you rehire qualified doctors and scientists who are experts in the health and transplant field.

Thank you for your attention to this matter.

Alexander A. Kon | 1/9/2026 

Multiple institutions are now employing Normothermic Regional Perfusion (NRP) during DCD.  This procedure raises serious ethical concerns.  Multiple clinicians and ethicists have raised concerns specifically regarding whether such patients are actually dead given that the circulatory system is restored and therefore such patients do not meet current definitions of death by circulatory criteria.  Many have argued that because the carotid arteries are ligated, there is no blood flow to the brain and therefore the patient is indeed dead.  However, this argument supposes that the patient is actually dead by neurological criteria.  If that is true, then a complete brain death evaluation should be performed.  Further, if the patient is dead by neurological criteria, then the cause of death is the surgeon's ligation of the carotid arteries, which is highly problematic.  Given the significant ethical concerns regarding NRP, I suggest that HRSA not allow NRP as this practice is inconsistent with the law, good medical practice, and ethical norms.  Should NRP continue to be implemented, then clearly families of donors must be made fully aware of the process and informed of the ethical and clinical concerns surrounding NRP.  Unfortunately, some institutions do not inform families that their loved one's circulation will be restored, the arteries to the brain will be severed, and that many clinicians and ethicists have significant concerns with this practice.  At a minimum, families should be fully informed of the procedure and the controversy surrounding this practice.

Anonymous | 1/9/2026 

I think that the most important change that could be done at the DCD level is to reiterate that the first person authorization does not come into effect until death.  That family should need to authorize DCD donations at all times to ensure that the correct decision is being made for patients that are still living.

The donation registry does not do enough to educate prior to people agreeing to donate and nobody considers DCD as a possibility.

Heidi Klessig | 1/9/2026 

Donation after Circulatory Death (DCD) organ procurement begins after just 2-5 minutes of pulselessness. But people are routinely resuscitated within this timeframe.

Dr. Ari Joffe has published a list of patients who auto-resuscitated up to 10 minutes after cardiac arrest, with some making a full recovery. 

A case report from Illinois of a young DCD donor whose heart began beating again and who began gasping for breath during the removal of her kidneys also shows that people cannot be known to be dead within this short period of time. (The county coroner determined her death to be a homicide.)

The New York Times recently published the case of Misty Hawkins, who was found to have a beating heart when her breastbone was sawed open during her DCD organ procurement surgery.

DCD donors are not known to be dead after just 2-5 minutes of pulselessness, and the public deserves to be informed about this violation of the Dead Donor Rule. Continuing to procure organs after this short stand-off period guarantees that more people will be found to have beating hearts during the surgery to remove their organs.

Neeraj Sinha | 1/9/2026 

I appreciate HRSA and the OPTN for taking on the difficult but necessary work of standardizing DCD practice, which is essential for maintaining public trust and transparency while preserving access to donation after circulatory death. At the same time, the current language around unplanned DCD pauses feels insufficiently clear about one core principle: nothing in this policy should dilute or delay a competent patient’s, or their duly authorized decision maker’s, right to withdraw life-sustaining treatment and to donate, if clinically feasible and legally valid. Pauses intended to safeguard patients must not become a de facto veto for individuals who disagree with the decision to withdraw or to donate, or who misunderstand the goals of care.

Given the unresolved ethical and legal debate surrounding NRP and the dead donor rule, I favor a moratorium on NRP in this policy framework until there is clear legal resolution, rather than embedding a contested practice that risks undermining public trust.

M. Jeanne Wirpsa | 1/9/2026 

As many of the comments have already focused on NRP and criteria of OPO vis a vis hospitals for neurologic testing, I will refrain from adding my own here and instead weigh in rather on the section on suggestion revisions to the section entitled, “Timing of Family DCD donation discussion.”  The Workgroup is correct in observing that the requirement to maintain a clear division between the care for a patient and the possibility of organ donation was established to maintain individual and public trust. Allowing the OPO to engage in discussions with donor families BEFORE the decision to withdraw life supporting therapies is, however, exceedingly problematic for several reasons: 1. It will create the appearance (whether accurate or not) that the treating teams clinical assessment/prognostication/and even support for possible withdrawal is influenced by pressure to help the OPO get more organs thereby undermining that fiduciary relationship and trust; 2. It creates undue influence on families as stated to withdraw; and 3. because it may also lead some families to delay withdrawal or decide NOT to withdraw life sustaining therapies altogether if they object to organ donation and/or are made aware of their loved one’s first person authorization status. We already struggle to maintain the trust of families during sensitive end-of-life discussions and when the treating team is appropriately trying to partner with families to set some limits on “potentially inappropriate care” in the ICU settings.

Karen DeGeorge | 1/9/2026 

Is there increase in cost?  Will CMS cover it?  Safety comes first to patients and increased lab test coverage is needed.  

James Trotter | 1/15/2026 

Thx for opportunity to submit a comment.

I think a greater question is "what is going on with UNOS and transplant policy in the United States"

As a former head of the UNOS liver cmte and experienced 30+ years I have never seen such lack of organization or clarity in our transplant professions.

I have no understanding now of what UNOS is, what they do, who is making policy or how this is being accomplished.

You need to provide clarity to the transplant professionals who have a lifetime of commitment to this process.

The lack of communication and apparent total disarray in the US liver transplant policy area is a national embarrassment and places the organized development of thoughtful policy at great risk.  You also are going to totally disenfranchise experienced, highly qualified professionals like me because I cant commit to participate in any process which is so unclear, disorganized and chaotic.  Again, to have reached this point is a national embarrassment.

Questions/comments
I talked to two heads of UNOS committees and they said on 12/28/2025 their UNOS admins said, "here are our files on your committee, we have no role in 12/29/20225, good luck"

Our surgeons of our program where we did 230 livers last year said on 12/10/2025 that they thought the "transplant list will go dark on 12/29/20-25 and all allocation will be done ad hoc on paper and our OPO is preparing for this."

What do we do if we need to appeal cases to the liver cmte when they have no administrative support?

So before you ask us for a comment on a specific policy, you need to provide us clarity that there is any infrastructure around the policy, because I see nothing but confusion and chaos.

James L. Bernat and Francis L. Delmonico | 1/15/2026 

HRSA and the OPTN have released a proposal on donation after circulatory determination of death (DCD) that is “aimed at improving patient safety and transparency and aimed at improving safeguards for potential DCD patients and enhancing information sharing with patient families regarding DCD organ procurement.”

We respectfully suggest that this HRSA/OPTN proposal is inadequate to address the reality of the current practice of recovering organs for transplantation in the setting of DCD. This HRSA/OPTN proposal improves neither safety, transparency nor safeguards.

Improving Safety:
The HRSA/OPTN proposal omits a needed clarification of the roles of the intensive care unit (ICU) team responsible for the donor’s terminal care and the OPO team responsible for organ recovery.   The OPO team has no responsibility for the potential donor’s end-of-life care, withdrawing life-sustaining therapy (WLST), agonal palliative care, and most importantly, death determination. The critical care community has accepted standards for making the patient’s diagnosis and prognosis justifying WLST, how a dying patient’s treatment preferences are determined and followed, how the process of WLST is conducted including optimal agonal palliative treatment, and how death is determined on the grounds of permanent cessation of circulation and respiration. OPO personnel should restrict their role to merely reviewing the critical care staff progress notes to assure that these prerequisite steps were taken prior to organ donation. These proper roles and distinct responsibilities must be appropriately detailed in the HRSA/OPTN proposal.

Improving Transparency:
In some regions of the country, such as New England, DCD comprises more than half of the deceased organ donor population; and in virtually all DCD, normothermic regional perfusion (NRP) of transplantable organs is practiced. That reality requires thoughtful OPTN guidance in the controversial topic of NRP that is not provided other than by a single mention in a bullet on slide 9.

The donor family should understand following a transparent discussion that NRP will be implemented upon the determination of death and that the resumption of circulation does not contravene a death declaration because the brain receives no circulation with properly performed NRP. Improving transparency must include an elaboration of NRP in the HRSA/OPTN proposal.

Improving Safeguards:
The sequence of declaring death requires a 5-minute interval from the observation of asystole to witness that no autoresuscitation has occurred. Any cases in which patients recover heartbeat/circulation or respiration during the 5-minute interval or after being declared dead should be solely the responsibility of the critical care team managing the donor’s end-of-life care.  If autoresuscitation were to occur or if circulation did not cease within the timeframe after WLST allowed for DCD, the patient should be returned to the ICU for further care.  If autoresuscitation occurs after the declaration of death and during the surgical recovery of organs, the OPO recovery team will re-engage the ICU physician to manage the situation. This unusual situation will require observing another five-minute interval before death is declared and before a resumption of the donation procedure. These HRSA/OPTN safeguards are urgently needed to derive a consistent standard of DCD practice nationwide.

George Bayliss | 1/15/2026 

The DCD policy proposal  should include a timeline of responsibilities for patient care. The medical team caring for the  patient ultimately makes the decision that neurologic damage is irreversible and the family agrees to remove life support. The OPO explains the DCD process to the donor/donor family and obtains permission to proceed using a standardized consent in language understandable to people not in medicine. It is up to the medical team to monitor neurologic function and confirm continued irreversibility, both to determine when to withdraw life support, through cessation of circulation and respiration, and during the 5-minute hands-off period and declaration of death. Organ recovery staff become responsible for monitoring continued absence of neurologic function or reanimation of the heart and lungs once they assume  care of the potential donor.

The policy should spell out that a pause may be declared at any point by any member of the OPO, family,  hospital team until death is declared and by any member of the organ recovery team once they assume care of the patient. OPO coordinator and physician caring for the patient on site could certify that the reason for the pause has been resolved. The number and length of pauses after the patient has been removed from the ventilator should also be detailed in Donor Net since pauses at that point may lengthen warm ischemic time and cause a transplant team to refuse an organ offer. Donor Net reporting is in addition to reporting unplanned pauses to OPTN Patient Safety Reporting Portal.

I agree with the comments that DCD policy should not include detailed discussion of normothermic regional perfusion (NRP). NRP is too complex and requires a separate NRP policy in line with the OPTN Ethics Committee  NRP white paper on NRP. Since the procedure is already in use. there needs to be some discussion of NRP with the family if it is planned about the risk to the patient that blood flow the brain may occur and the need for anticoagulation before death in NRP cases since it is not given for the patient’s benefit. The OPTN and HRSA should work on NRP language to include in the DCD policy.

Lois Shepherd | 1/15/2026 

This comment addresses two aspects of the proposed changes to deceased donor organ procurement policies: (1) the required disclosures to patients or authorized agents with respect to the possibility that NRP procedures will be used in procurement, and (2) allowing OPO personnel to discuss DCD donation prior to the patient/authorized healthcare agent’s decision to withdraw life supporting therapies.

Required disclosures on NRP.  

I agree with Lainie Ross’s comment that the proposal treats NRP as accepted and even standard of care, when there remain clear ethical and legal questions about its use.  (See the White Paper of the OPTN Ethics Committee, of which I am a member, and citations contained therein.) If, as other commenters note, this is the only OPTN policy that specifically addresses NRP, it sidesteps the most important issues associated with it. The OPTN should address the controversy surrounding NRP directly. If, after doing so, it concludes that NRP is, in theory, acceptable, it should (as Ross indicates) specify the practices that must be employed for it to be acceptable in practice. (In my opinion, TA-NRP clearly violates the dead-donor rule.) 

That being said, assuming NRP is acceptable, and substantive safeguards are in place regarding its use, specific informed consent for its use should be obtained from the patient or patient’s agent. The proposal does not indicate that specific consent is required, but merely that disclosures about its potential use must be provided along with other disclosures. (The DCD Pause Scenarios in Appendix B make clear that the proposal does not require consent for NRP—see further discussion of this, below.)

The types of disclosures described in the proposal also do not go far enough to ensure adequate understanding and appreciation of NRP procedures and NRP’s risks, and about how NRP relates to determinations of death. 

For example, requiring that OPOs disclose that “select organ function will likely occur” is vague, and this requirement might be satisfied with vague language. A vague disclosure about “organ function” does not adequately convey that heart function will likely occur in TA-NRP and that an intended and desired effect of TA-NRP is that heart function will occur. Patients/authorized agents should be given sufficient information to understand that the patient’s heartbeat and circulation will be restored and that this restoration will occur after a determination of death has been made based on the permanent loss of circulation. 

Patients/healthcare agents should also be made aware that although “safeguards . . . will be taken to prevent blood flow to the brain,” no measurement of brain function or determination of death based on neurological criteria will be undertaken. They should be told the nature of the procedures used to prevent blood flow to the brain, and that in the absence of these procedures, once circulation is restored as intended, blood would flow to the brain. In other words, but for the actions of the procurement team to prevent blood flow to the brain, it would occur. 

Finally, the patient/authorized agent should be informed that they have the choice to authorize DCD donation without the use of NRP if desired. (This should not be presented as a take-it-or-leave-it situation.)

Scenario 1A in Appendix B on reportable vs. non-reportable pause scenarios illustrates an alarming possibility that the document glosses over. There a patient agent is considering withdrawing life support. The patient is a registered donor. The patient’s agent is given information about the procedures for withdrawing life support in the DCD context, including NRP, but is not asked for consent to any common procedures that might be done to the patient prior to death that are not for the patient’s benefit, but to facilitate donation. (Consent for such procedures is required, because the patient is still living.) The agent is not asked to consent to NRP procedures either. At this point in the scenario, she has not yet communicated a decision to withdraw life support. Then, out of concern about what she has learned, the patient’s agent expresses she wishes to withdraw life support immediately. The OPO and hospital staff explain that withdrawal will occur as soon as the resources for organ recovery are in place. The patient’s agent declares a pause.

This scenario is deeply troubling. First, the patient’s agent has not yet made an informed decision to withdraw support, or if she did make it when she expressed a desire for withdrawal to be done immediately, she has changed her mind. The OPO and hospital staff should not then say it will occur, as if she has no say in the matter. Because the patient is a registered donor, the agent may not have authority to decide whether to donate his organs after he is dead, but she does have authority (using substituted judgment and in the patient’s best interests) to determine healthcare decisions for the patient while living (which, many believe, is the case when NRP procedures are begun). These decisions include the decision to withdraw life support. We should all be able to imagine the alarm a patient’s agent might feel if truly informed about NRP; patients’ agents should not be put in a position of having to continue life support in order to avoid the risks of NRP.

I appreciate that this scenario is provided in the Appendix only for the purpose of explaining what is reportable, and that it explains that “Hospitals and OPOs should work collaboratively to address issues regarding authorization with donor agents consistent with state law and local policy.”  However, it leaves the impression that the OPO and hospital staff are correct, or arguably correct, and it avoids the big questions that the scenario raises.      

Timing of family discussion of DCD donation.  As a member of the DCD Policy Review Workgroup, I found the description of the Workgroup’s discussion incomplete and somewhat unclear. The document identifies the following as the reason for eliminating the requirement that discussions of organ donation should take place prior to decisions having been made about withdrawing life supporting therapies: 

“[The Workgroup . . . acknowledged that it creates issues for potential donor families, as this requirement creates situations where they must make difficult decisions at the last minute. These last-minute changes can extend the timeline of events and alter the families’ plans, resulting in additional grief for the family.”  

While it is true that the Workgroup discussed concerns about the family’s emotional well-being, a driving factor behind this proposed policy change has been potential lost donations. Anecdotal evidence was presented in the Workgroup that some families who have been approached for organ donation after deciding to withdraw life supporting therapies have declined to donate but said they would have donated had they known about the possibility earlier.  Now, for them, it was too late—they were not willing to delay treatment withdrawal in order to facilitate organ donation. If this proposed change is adopted, it should be with the transparent understanding that one of its aims is to secure more organ donations. It may also reduce grief for families, but in my view this was not the primary consideration discussed in the Workgroup meetings. 

This is a big policy change and should be carefully considered, as it eliminates the traditional firewall between care for a patient and decisions about organ donation. That firewall was not simply about “donor families not being subjected to undue influence by the donation decision,” as described in the discussion section of the document (emphasis added), but that healthcare agents, in determining care decisions for the patient, not be subjected to any influence by the donation decision. The longstanding view has been that the decision to withdraw life supporting therapies should be made only with patient care in mind. The language of the actual proposed policy is as follows: “The decision to withdraw life sustaining therapies should not be influenced by the donation decision.” This language suggests the OPTN remains committed to the traditional view of exclusive focus on patient care, but the discussion section of the document about “undue influence” introduces uncertainty on the matter.  

Richard Choi | 1/15/2026 

As a neurointensivist who frequently cares for neurologically devastated patients who are being considered for DCD donation, this area is of particular importance to me. I agree that revisions are necessary due to the increasing number of DCD donations vis a vis brain dead donors. The following is a list of suggestions:

1. It is unclear to me, after reading this document, the correct circumstances under which an unplanned pause can be called. Does this occur at any time, or is this designed to be done in the OR? The definition of an unplanned pause listed as "an unexpected suspension of the DCD process due to a difference of opinion as to whether a patient meets the donor hospital’s criteria for withdrawal of life sustaining therapies" is unsatisfactory in answering this question and should be more clearly defined, and the case scenarios still leave some uncertainty and should be developed further.
2. Instead of focusing on the pause, we should focus on what are the independent criteria the OPOs are using to determine that a patient is a candidate for DCD. In my experience, OPOs will push for DCD even when the primary team knows that the patient will not expire within the allotted time, which is not only inappropriate, but also resource wasteful. We should ensure all OPOs use a vetted list of criteria, reviewed by the OPTN, to determine those eligible for DCD.
3. Instead of unplanned pauses, a strict algorithm of expected ongoing eligibility for DCD should be in place before the next step is taken. It is the current process that is flawed, and the addition of a pause will not solve the problem. Certain automatic triggers for a pause should be included in the protocol, specifically if the patient has an improvement in mental status and appears to be more awake or responsive (such as improvement in GCS score >2 points, spontaneous following commands when this is a new finding, or clinical change leading to patient not being critically ill any longer) with criteria to be vetted by OPTN, especially when there is disagreement.
4. The OPO should NOT be the organization ensuring neurological exams are being completed appropriately. It should be the individual hospitals that are ensuring that these steps are taking place. The alternative would suggest that these hospitals are allowing inappropriate DCD organ procurements to occur in otherwise ineligible patients, and if so, should be investigated for negligence. Each hospital system must ensure in their internal policies that the patients meet all criteria for DCD and are undergoing appropriate neurological evaluations. The OPO securing this is a conflict of interest and will be hard to enforce
5. Page 9 - DCD process may also interfere with any potential autopsy evaluation and should also be disclosed at the time of authorization
6. Page 10 - regarding the sentence "Time frame between withdrawal of life sustaining therapies and declaration of death for DCD to occur" - it should be specifically mentioned that this time must also align with any hospital internal policy. There are occasions when the OPO wishes to prolonged the DCD process longer, up to 120 minutes sometimes, regardless of hospital policy. This is inappropriate and all requests should conform to local policy.
7. Page 10 - The disclosure about NRP should also include specific mention that even despite appropriate surgical cessation of blood flow to the brain, a potential for collateral blood flow to the brain and brainstem, though unlikely, is possible, with unclear significance regarding the possibility for the patient to experience or regain some brain function. Disclosure should also focus on alternatives (such as direct procurement and perfusion) to NRP. If NRP will be discussed at a federal level, further vetting by ethical and legal societies would be warranted to ensure that we are in compliance with all federal laws during NRP and should also include, at a minimum, clear specific separate consent forms, brain monitoring (EEG, TCD, or other) at the request of the family or team, abortion of NRP procurement should brain monitoring demonstrate activity, and allowance for any staff to be a conscientious objector.
8. Page 11 regarding the sentence " They settled on altering the language to allow discussions for organ donation to take place once end of life discussions are taking place with the potential deceased donor's agent." The approach of an OPO to a family PRIOR to a decision to withdrawal of life sustaining therapies is inappropriate not only due to the potential for public mistrust, but also due to the fact that this would potentially violate the Dead Donor Rule. If a family is aware of the potential for donation and this information is what makes them elect to withdraw life sustaining therapies, it would then lead to the permission for someone to be killed in order for organ donation to occur - this is ethically impermissible. Continued clear separation of goals of care conversations with determination of withdrawal occurring prior to any decision to donate organs must remain, even if doing so affects the number of available organs for transplantation, as this is an ethical standard that cannot be bypassed.
9. Page 11 - allowing families of brain dead patients to proceed with a DCD protocol undermines the medical and legal withstanding of brain death as equivalent to death declaration, and alternative arrangements designed to accommodate the retrieval of additional organs should not be permissible for the sake of increasing organ availability.

Additional suggestions include:
-clarification of whether organ donation registry in your driver's license transfers to mandatory donation including DCD. This varies by state, but is a practice that is very commonly pursued by some OPOs and not ultimately what the general public signs up for when checking the box in their DMV application. This should be addressed at the federal level to reduce interstate variation, in that organ donation registry does not equate to automatic DCD upon decision to withdrawal of life sustaining therapies, and that a separate consent/authorization is necessary.

Thank you for your time and for your work on this important matter.

Katherine Mayer | 1/15/2026 

Thank you for the work in this important and evolving field. 

I think the proposed changes will promote patient safety, and I hope transparency to family members of potential organ donors. 

I agree with the comments already made about developing a policy that addresses Normothermic Regional Perfusion (NRP) and that it should fully address all the risks, and propose measures to reduce those risks and disclose them to donors and donor families. 

Anonymous | 1/15/2026 

There appears to be some support in the transplant medical community for the use of normothermic regional perfusion (NRP) after circulatory death.  Their view  is that without NRP, organs can be damaged by oxygen depletion.  The use of NRP evidently restores the viability of the organ, thus increasing the chance of successful transplants.  As a heart transplant recipient, I can understand the need to identify procedures and technology that will increase the pool of viable organs as long as there is no risk to others in the process. 
 
There are concerns associated with NRP that need to be addressed.  I believe recipients and potential recipients would agree with me that we do not want harm or discomfort to occur during the organ removal process as these patients have so generously agreed to be donors.  I am concerned by recent media reports claiming NRP may cause the donor to have some level of consciousness or sensation after NRP occurs.  If there are studies that address this concern, OPTN needs to highlight them in a way that would resolve those concerns or develop safeguards to assure that the generous donors will not experience any feelings or pain during the organ removal process. 
 
My understanding is OPTN seeks a wide range of comments during the public comment period, to include comments not just from the medical experts but from patients, potential donors and donor families.  (See the public comment section of the OPTN website that "all interested individuals are welcome to participate, especially transplant candidates, who are most affected by policies.") 
 
If OPTN wants transplant candidates and other members of the public to comment, the proposals need to be written so that these commenters can understand the medical issues.  I find these proposals and presentations challenging at times because medical terms are not well explained to the lay community.  Perhaps including links within the proposals/presentations to materials that explain the terms would be more helpful than making readers have to switch back and forth from the presentation to the glossary to find the meaning of terms.  
 
I would also note that there are some terms that are not addressed in the glossary that are relevant to the proposed changes.  The term normothermic regional perfusion is not in the glossary.  The term perfusion is, but the definition does not address what NRP is. 

Adam Omelianchuk | 1/15/2026 

These are my responses to the queries under the heading "Considerations for the Community" in the linked document (PDF - 880 KB).

How might the OPTN identify, report, or evaluate whether the decision to withdraw life sustaining therapies was subjected to undue influence by the donation decision? Is there a clearer way to define responsibilities regarding the timing of the family discussion for donation? 

If the Patient Safety Reporting Portal is to be used for reporting pauses, then it could also be used for identifying incidence of "undue influence" or "unshared decisions" that matter to families and OPO reps. Those are just as ethically concerning as pauses and are likely to be what caused pauses. OPTN should be interested in capturing this data. But there is more than just "undue influence" at work. Some states allow for unilateral decisions to withdraw life sustaining treatment to be made by the treating team (e.g. California, Texas). I was involved in a case like this; because a "decision" to withdraw was made, the OPO reps believed they could approach. I did not believe this was right and explained the situation to them. Once they understood, they backed off. Because there are more categories than "undue influence" at work, this should be of interest to OPTN. Moreover, this portal ought to be something accessible to the treating teams as well, not just OPO reps. Language about how to find it and use it should be included in the final policy.

Should the OPTN add any automatic triggers for an unplanned DCD pause into policy, or provide any supplemental guidance or education regarding situations that may warrant additional caution when assessing patient neurological status? 

Yes, I do. Any brainstem reflex, pain response, or breathing action that is observed after the declaration of death ought to signal to anyone involved that the patient is alive and ought not be subject to organ recovery. The Workgroup argued that "a change in neurologic status is not indicative of recovery." Maybe so, but the standard for deceased organ donation is death, not whether the patient can recover. I have observed a conflation between determining death and determining whether someone will recover among transplant professionals that is simply erroneous. The former is a diagnosis, the other a prognosis. While there are enduring arguments over whether death can be determined in the way DCDD requires, this tendency to believe the donation process can move forward because of a poor prognosis is precisely the problem that was identified in the New York Times reporting this summer. Someone from the recovery team observed neurologic signs of life and was told to continue the recovery process. That is simply horrifying, and it was the final straw for me personally (I created an advanced directive saying no to DCDD). Even if the treating team did a bad job in determining death, everyone is responsible for respecting signs of life and responding to them appropriately, including organ recovery teams and OPO team members.

Should the OPTN define a minimum waiting period of circulatory cessation in Policy 2.15.J Organ Recovery? If so, how long should the minimum waiting period be, and why? 

There seems to be an international consensus that the minimum "no touch" period is at least five minutes. The best evidence available for this is documented in a large observation study reported in the New England Journal of Medicine, which recorded the longest time autoresuscitation occurred after asystole at four minutes, twenty seconds. (Dhanani S, Hornby L, van Beinum A, et al. [2021] Resumption of Cardiac Activity after Withdrawal of Life-Sustaining Measures. N Engl J Med 384:345–352. https://doi.org/10.1056/NEJMoa2022713). It is high time that the "2 to 5" minutes standard be discarded. Two minutes is not long enough to establish a permanent/irreversible cessation of function. The patient should also be normothermic; it is well known that hypothermic patients have recovered spontaneous circulation well after 5 minutes of pulselessness.

Are the requirements for OPOs to report unplanned DCD pauses clear? Are there areas where the OPTN should consider improvements to make the language clearer?

The proposal speaks of a "difference of opinion as to whether a patient meets the hospital's criteria for withdrawal of life sustaining therapies" which are the not same as "situations in which the DCD donation process is proceeding in an inappropriate or potentially unsafe manner". The difference of opinion should be about safety and appropriateness, which are concepts that go beyond whatever a hospital might arbitrarily stipulate. I recommend removing this reference to whatever the hospital thinks since that can vary from hospital to hospital, and it unwisely presumes that the hospital has even documented criteria for appropriate withdraw. See my comments about "unilateral withdraw" above.

I echo the public comments already written in this thread from Lainie Ross about whether NRP is appropriately discussed in this policy. A previous document from OPTN advised that there are "serious" ethical problems with it. However, if it is to be done, I appreciate the recommendation to inform decision-makers about the need to take measures to block flow to the brain. Yet if that is to be required, then it ought to follow that certain "automatic triggers" should be in place for halting the operation, e.g. breathing and pain responses. To effectively monitor whether blood flow is, in fact, reaching the brain members from the treating team ought to monitor whether the flow is reaching the brain so as to avoid conflict of interest and report to OPTN the results, whether good or bad. This should be added to the recommendations to hospitals and OPOs.

Lastly, I would like OPTN to stop using "DBD" and "DCD" and replace them with "DBDD" and "DCDD" — to highlight that the recovery methods follow not some invoked abstraction such as "brain death" or "circulatory death" but rather a "brain death determination" or a "circulatory determination of death." What matters for the division of labor between the treating and recovery teams is a determination of death. This would especially help clarify the section on using a recovery method normally used in a circulatory determination of death after a brain death determination. 

Darcy Beckler  | 1/15/2026 

Lifeline of Ohio commends HRSA and the OPTN for advancing patient safety safeguards and promoting industry standardization in the DCD process. We support the directive’s intent and the overall goals of this proposal. To strengthen clarity, feasibility and role delineation, we offer specific feedback. Lifeline of Ohio recommends revisions before submission to the Secretary of Health and Human Services for approval.

Accountability and Care Coordination – Hospital Participation in the Process 

We appreciate the intent to strengthen safeguards for DCD patients.  We do have concerns about how accountability is framed, particularly regarding OPO versus hospital responsibilities. Several sections assign OPOs responsibilities that imply direct involvement in patient care, creating ambiguity and the potential for unintentional undue influence on patient care and decision making. Donor hospitals play a critical role in DCD cases, and clear delineation of responsibilities will foster collaboration toward shared goals. We recommend revising language to reflect practical accountability and coordination. For example: 

• Section 2.2.8 requires OPOs to “ensure accuracy in neurological assessments,” which suggests clinical responsibility and the auditing of the hospital’s clinical patient care. Instead, OPOs should confirm completion of neurological assessments performed by the health care team.  
• Section 2.15.C states that “the OPO and primary healthcare team must confirm that withdrawal of life-sustaining therapies remains appropriate,” which could be interpreted as OPO involvement in withdrawal decisions. Instead, OPOs should confirm that the healthcare team and patient or agent agree withdrawal remains appropriate.  OPOs would then confirm that DCD remains appropriate.   
• Section 2.15.F requires OPOs to provide “the plan for continued patient care if the patient does not expire in a timeframe,” which crosses into hospital care responsibilities. Instead, OPOs should provide the hospital’s plan for continued patient care.  

We strongly encourage the OPTN to work with HRSA and CMS to strengthen hospital Conditions of Participation regarding organ donation. Hospitals should have clearer requirements and accountability to ensure consistency, compliance and appropriate separation of roles.

Authorization and Consent for DCD Practices 

Lifeline of Ohio recommends revising these sections to clarify OPO expectations and responsibilities. Section 2.15.G requires that consent be obtained and that the patient or agent is advised of potential complications if pre-mortem cannulation occurs. Lifeline of Ohio recommends revising the language to specify that the individual or entity performing the procedure is responsible for obtaining consent. For example, if the hospital performs the procedure, the hospital must obtain consent, and the OPO will verify that consent was obtained. If the OPO performs the procedure, the OPO will obtain consent directly.

Lifeline of Ohio requests clarification on Sections 2.3 and 2.15.F to explicitly distinguish between: (1) information that must be disclosed, and (2) information that must be included and specifically authorized within the documented authorization for DCD donation. In addition, Lifeline of Ohio recommends rephrasing 2.15.F line 178 (“That the donation process will stop if there is a decision not to move forward with withdrawal of life sustaining therapies”) to “That the decision to authorize donation does not prevent the patient or agent from changing their decision to withdraw life-sustaining therapies and that if they do, the donation process will stop.”  Additional context can reduce the risk of unintentional undue influence.    

We also request clarification regarding how first-person authorization applies to pre-mortem procedures and if this requirement applies to all potential DCD donors.  

Unplanned DCD Pause Process  

Lifeline of Ohio supports the proposed policy requiring an unplanned DCD pause. This safeguard is critical for maintaining trust, ensuring ethical standards and prioritizing patient safety during the donation process. Lifeline of Ohio has already begun implementing a similar pause process internally, and we look forward to industry-wide standardization of this practice. We encourage the OPTN to provide clear guidance, including additional scenarios and reporting templates with data definitions, to support consistent implementation.

Responses to Committee Questions: 

1. How might the OPTN identify, report or evaluate whether the decision to withdraw life sustaining therapies was subjected to undue influence by the donation decision? 
   Establishing clear delineation of responsibilities between the donor hospital and the OPO is critical. Elements of this proposal—such as documenting that end-of-life discussions have been initiated—will help the OPTN evaluate whether withdrawal decisions were made independently of donation considerations.
2. Should the OPTN add any automatic triggers for an unplanned DCD pause into policy or provide supplemental guidance? 
   Lifeline of Ohio agrees with the Committee’s decision to not incorporate specific automatic triggers for an unplanned DCD pause into the policy due to the variability and applicability of various circumstances. The scenarios provided are helpful and enhance understanding of practical application. Additional examples and education would further support implementation.
3. Should the OPTN define a minimum waiting period of circulatory cessation? 
   Lifeline of Ohio supports the implementation of a standardized minimum waiting period to ensure consistency across the industry.
4. Are the requirements for OPOs to report unplanned DCD pauses clear? 
   Additional clarification regarding the desired information for reporting would be beneficial. For example, in section 2.2(4) line 22 it is unclear what is meant by “no later than the time at which the OPO decides to proceed with the donation process.”  Does this refer to initial identification of the donor, approach, authorization or resumption after a pause? Similarly, section 18.5.C.1 lines 280 and 289 when requesting details on pause notifications, clarify whether OPTN expects names, dates/times or simple confirmation that notifications occurred. 

Thank you for the opportunity to participate in the public comment period and for the OPTN’s thoughtful consideration of feedback provided. With refinement, this proposal can increase alignment across stakeholders, reduce variation in the process and ultimately create a better experience for donor families.

- Lifeline of Ohio, Organ Procurement Organization 

Gabriel Loor | 1/15/2026 

As a transplant surgeon with over a decade of experience I am privileged to work in a country that values organ donation as much as ours. There are so many lives saved every year because of the extraordinary efforts made by healthcare staff and OPOs around the nation. DCD is a fast growing mode of donation that may even surpass DBD soon. I have complete confidence in most if not any surgical team that goes to recover a standard DCD recovery. When it comes to ex vivo systems or NRP it’s a different story. These systems call for greater nuances that can affect outcomes. I am happy that teams like Transmedics have standardized their procurement processes for OCS-DCD runs. I believe it is time that we move towards standardizing surgical processes for NRP. NRP outcomes depend on the skill and experience of the surgeon opening, cannulating and retrieving the donor organ. Over time, there have been lessons learned that have led to improved outcomes in lung transplants using NRP. I recommend that surgeons who are recovering NRP be asked to maintain a log of cases, CME related to NRP, and be asked to adhere to some generally agreed upon practices that have been shown to ensure optimal outcomes. Moreover, given the relative rarity of NRP cases, it would not be unreasonable to consider employing specific third party organizations that have shown excellent results with NRP as preferred providers for this technology.  At the same time, it is critical that we not reduce donor utilization due to excessively cumbersome requirements. The goal should be to increase transplants along with quality. Lastly, without necessarily deterring family members from donation, I believe it is essential that donor families have transparency about the NRP process so that they understand their loved one will be placed on a circuit to perfuse their body and organs.  I am glad that HRSA is providing safeguards to allow procurement staff to speak up and pause if they are concerned about any reestablishment of neurologic function. 

Anonymous | 1/15/2026 

I am supportive of the proposed policy change related to DCD practices.

I believe these will further support safety measures for these patients and increase trust in the use of procurement approaches such as NRP (TA-NRP specifically) which need to be utilized in these cases.

We are continuing to see many donor hospitals that are not allowing NRP (TA-NRP specifically) as a procurement approach because of ethical concerns around this. What I would like the committee to take into consideration is that when transplant centers are turning down offers for this reason, it is being counted towards our offer acceptance rate. This is not a true reflection of our willingness to take an organ and offer filters should be created which indicate the organ would have been accepted but, we were unable to as the donor hospital would not allow NRP. As a heart transplant center, you need NRP or DPP to take these organs and some of us do not have access to DPP which is proving to be challenging in these situations and while we are trying to expand our access to organs by accepting DCD organs, this could impact our offer acceptance rates and get us flagged by the MPSC.

Robert Roth | 1/15/2026 

In the midst of profound loss, families who choose to donate a loved one's organs offer an extraordinary gift, one that brings hope, healing, and new life to others in desperate need. It's a decision rooted in compassion and courage, and we deeply honor the emotional weight it carries during such a tender time. As we celebrate the selfless heroes who make this possible, we must also safeguard the systems that turn these gifts into miracles, ensuring that every opportunity to save lives is cherished and protected.

We hold unwavering confidence that dedicated physicians, hospital teams, Organ Procurement Organizations (OPOs), and the broader healthcare community have always approached organ donation with the utmost reverence for life. Their tireless efforts reflect a profound commitment to ethical practices, never intentionally diminishing the sacred nature of this process. Yet, as we look ahead, it's important to consider how recent proposals from the Health Resources and Services Administration (HRSA) might unintentionally introduce challenges that could hinder the vital work of the Organ Procurement and Transplantation Network (OPTN) and OPOs, potentially leading to fewer life-saving donations.

The HRSA directive, shared on May 28, 2025, aims to refine policies on Donation after Circulatory Death (DCD) by emphasizing additional safeguards, such as allowing pauses in the process if concerns arise about a donor's condition, and standardizing practices nationwide. While the intention to enhance safety and clarity is heartfelt and certainly well-meaning, we kindly urge a thoughtful pause to reflect on how these changes could ripple through our donation ecosystem. Here's a compassionate exploration of the key elements and their potential effects, always with the goal of nurturing a system that maximizes every precious gift:

• Encouraging Thoughtful Pauses, Yet Risking Delays: By adding requests for reassessment, the proposal seeks to address any uncertainties with care. However, in the delicate, time-sensitive world of DCD, which now represents about half of all U.S. donations and grew by over 23% in 2024 to 7,280 donors, this could introduce more interruptions. Even well-intentioned pauses might extend critical timelines, leading to fewer successful procurements and potentially eroding the confidence that encourages families to say yes. Experts, with deep empathy for all sides, have shared concerns that this added layer might create hesitation, subtly slowing the momentum that has saved so many lives.
• Nurturing Trust, While Navigating Public Perceptions: Following stories of rare but heartbreaking lapses, such as those involving signs of life or coordination issues, the HRSA directive calls for reporting pauses and fostering consistency. I certainly agree with the desire to heal these wounds, but heightened scrutiny and mandatory reviews could unintentionally amplify worries, making it harder for OPOs and hospitals, especially in rural areas, to pursue donations. This might lead to a decline in participation, as families or teams feel a pull toward continuous caution, further straining a waitlist where over 100,000 patients hope for a second chance, and sadly, more than 11,000 pass away each year without one. In ethical discussions around innovations like Normothermic Regional Perfusion (NRP), a technique used in organ donation after DCD to provide vital oxygenated blood flow to organs, a monumental improvement toward organ viability, we see how balancing progress with trust is key, yet an overemphasis on pauses could tip the scales away from growth. Clarity surrounding organ donation after DCD, specifically, the approvals required for organ procurement to proceed are clearly defined. Independent healthcare professionals, employed by the hospital (not the OPO), determine the initial time of death. A defined wait period occurs, then independent healthcare professionals once again confirm death. Only then will the procurement process proceed.
• Embracing Standardization, With Awareness of Challenges: The HRSA directive proposes uniform practices across all 56 OPOs could foster harmony and equity, no doubt a beautiful goal and seemingly a simple task. However, for under-resourced organizations, this might mean a shift away from pursuing more complex cases, like those involving overdose victims. In the near term, this will reduce the number of donations, even as long-term benefits eventually (hopefully) emerge through renewed confidence.

Beyond the flow of donations, these changes could also affect the viability of organs themselves, where every moment counts:

• Honoring Time-Sensitive Needs Amid Pauses: DCD organs, like livers and hearts, thrive within narrow windows, often just 30-60 minutes, before they risk losing their potential to heal. The proposal's focus on thorough assessments is kind-hearted, but pauses, and potentially repeated pauses, limit real-world implementation and will introduce inconsistencies in organ viability. More importantly, the gift is compromised or even lost for the next miracle.
• Fostering Collaboration, While Addressing Coordination: The directive aims to prevent oversights, such as those in drug-related cases (seen in 75% of overdose reviews), by accessing alternatives like expanded perfusion. This certainly could help preserve these gifts, but the emphasis on pauses without prioritizing access to such tools adds a layer of complexity, particularly for poorly funded healthcare facilities. All communities should have successful organ donation programs and, subsequently, successful transplant programs, irrespective of geographic locations.
• Supporting the System's Heart, Amid Resource Shifts: Increased reporting is always a welcome effort, and congressional voices have noted that DCD's nuances require a balanced approach to avoid unintended losses in both supply and the hope they bring. However, the lack of additional funding support is a serious problem.

In essence, while these proposals stem from a place of genuine care to mend vulnerabilities, they will likely lead to fewer available organs and reduced viability, placing a strain on OPTN and OPOs' ability to fulfill their mission of saving lives. Moreover, with heartfelt concern, such ideas could "irreversibly harm trust," leading to fewer transplants overall. Yet, with collaborative wisdom between the most amazing families, the OPTN and OPOs, highly skilled surgeons, and our communities at large, we can nurture solutions that protect without diminishing organ donations and focus on "knowable and fixable" enhancements that uplift everyone.

Let us continue to embrace organ donation as a beacon of humanity's kindness, supporting families in their grief and honoring their gifts. By thoughtfully advocating for policies that empower rather than encumber our dedicated OPOs and OPTN, we can ensure more lives are touched by this profound act of love.

Marie T. Hilliard  | 1/15/2026 

The National Catholic Bioethics Center, the Catholic Medical Association, the National Association of Catholic Nurses, USA, and the National Catholic Partnership on Disability recognize that the gift of organ donation is a charitable act and should be encouraged. Organ donation after death is a noble and meritorious act and is to be encouraged as an expression of generous solidarity; and the transplantation of organs from living donors is morally permissible when such a donation will not sacrifice or seriously impair any of the donor’s essential bodily functions, and when the anticipated benefit to the recipient is proportionate to the harm done to the donor.

We represent health care providers, and advocates for our patients and the constituents of our organizations. As providers and advocates who believe that all human life is to be respected and protected, we want to support morally licit organ donation; but the parameters we identify, attached, must exist for persons of conscience to cooperate in organ donation for transplantation. Thus, for the wellbeing of organ and tissue donors, as well as for the integrity of policies, and success of the Organ Procurement and Transplantation Network, we request that HRSA and OPTN implement these attached recommendations.

We thank you for the opportunity to comment on this critical matter, not only impacting the dignity of human life, but public trust in the Organ Procurement and Transplantation Network.

James Trotter | 1/15/2026 

Before requesting public comments on policies related to Transplant, you need to describe the current infrastructure of policy, making for  transplant in the United States. As a professional who's been doing this for over 30 years and has served as head of various UNOS  committees, the entire system is in complete disarray and it's not clear to any of the experience professionals how the policy is even being developed.

Therefore, before you make this sort of request you need to provide communication to the Transplant community about the infrastructure and integrity of the entire process is because it's not clear to any of us how this is being done.

The current state of policymaking of transplant in the United States is a national embarrassment, and it's putting the well-being of our patients in peril.

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

The Association of Organ Procurement Organizations (AOPO) welcomes the opportunity to comment on the Health Resources Services Administration (HRSA) Directive for Organ Procurement and Transplantation Network (OPTN) Donation after Circulatory Death (DCD) Policy Development to improve the safety of organ donation and transplantation in the United States.

AOPO collectively represents 46 federally designated, non-profit Organ Procurement Organizations (OPOs) in the United States, which together serve millions of Americans. As an organization, AOPO is dedicated to providing education, information sharing, research, technical assistance, and collaboration with OPOs, other stakeholders, and federal agencies to continue this nation’s transplantation success while consistently improving towards the singular goal of saving as many lives as possible.

DCD continues to grow year after year, enabling life-saving transplants for thousands of patients who might otherwise miss a chance at a new life. AOPO believes that maintaining access to DCD is critical and agrees that all OPTN members must collaborate with donor hospitals and donor families to ensure the safety of donors throughout the process, with OPOs most affected by this new rule.

The decision to withdraw life-sustaining therapy (WLST) is one that lies with the patient’s family/agent and the patient’s health care team. OPTN members must not influence decisions regarding WLST. AOPO believes in offering all patients and their loved ones the opportunity to save and heal lives regardless of whether life sustaining measures are being withdrawn due to neurologic death or other nonsurvivable, catastrophic illnesses or injuries. Prematurely and needlessly restricting a patient’s opportunity to become a donor hero thwarts the mission of AOPO, OPTN, CMS and the entire system’s goal of saving more lives through organ donation and transplantation. Families/agents who are considering WLST must be informed about donation and how the donor evaluation process may affect the timing of the WLST. Many families have expressed frustration with learning about this timing impact after planning for other family members to be present at the time of WLST. Waiting until the family has made the decision is too late, and AOPO supports this change in policy as well.

At present, there is no reliable way to predict whether a patient will die within a time frame that allows for donation. Accordingly, AOPO does not believe there should be specific clinical requirements in policy that trigger a DCD pause. As part of ongoing educational efforts, OPOs and donor hospitals can describe patients who may be at greater risk of inaccurate neurologic assessment and offer guidance on how to properly assess such patients. However, specific neurologic deficit requirements for DCD could risk excluding donors with sustained neurologic function who cannot survive without artificial support (e.g., ventilator, mechanical circulatory assist device, medications, etc.). The current neurologic-deficit requirement excludes potential donors whose life support is being withdrawn for other irreversible and non-survivable conditions, such as end-stage cardiovascular or respiratory failure, which do not meet the neurologic criteria but are nonetheless terminal.

Increasing experience with DCD suggests that observation periods (from the time of pulselessness to the time of incision) of less than five minutes may be inadequate to exclude autoresuscitation. In the era of machine preservation and normothermic regional perfusion (NRP), the warm ischemic time argument in favor of shortened observation periods is increasingly indefensible. Accordingly, AOPO supports an OPTN policy mandating a five-minute period of continuous observation following circulatory arrest prior to organ recovery. AOPO notes that declaring providers may not feel that this entire observation time is necessary or warranted, and thus, if the provider refuses to observe the patient for the full five minutes of pulselessness, the OPO must complete this observation period and document this in the donor record.

AOPO is unsure of the necessity of the requiring OPOs to report pauses within 24 hours of their origination. OPOs navigate tenuous situations with families and donor hospitals routinely, and singling out this one particular type of incident and requiring reporting seems overly burdensome and excessive. However, if OPOs must report, it is recommended the reporting requirement be a single report within 24 hours of the outcome of any pause, not to exceed 72 hours. Pauses without defined outcomes could be reported within 72 hours of the start of the pause (to allow time for resolution of the pause). Once such an extended pause is resolved, OPTN could require a report within 24 hours of the resolution.

We agree that key individuals involved in the DCD process should be informed that they can request an unplanned pause at any time; however, to what level is this expected? To notify every new nurse, RT, physician, etc. that comes on shift throughout the process will be difficult and onerous to document. Could a solution be for hospital and OPO policies to outline an unplanned pause protocol, and for staff to be educated on it?

OPOs should have a policy that requires them to provide every hospital staff member involved with a document on the DCD pause process, without having to document that step for every hospital staff member in every case.

AOPO understands the appeal of the requirement that any stakeholder in the process (donor or donor’s agent, donor hospital staff, OPO staff, and third-party procurement and preservation staff) have the authority to pause the DCD process. AOPO agrees this pause cannot be attributed to anyone’s objection to donation, but rather to a concern that WLST is inappropriate for this patient. It is important to reiterate that OPOs are not involved in the decision to withdraw life support, this is the prerogative of the donor family and the hospital’s patient care team. OPO staff should defer to the patient care team and the patient/patient’s agent regarding the suitability of WLST, as OPO staff are not experts in this area and should not be involved in these decisions for patients who are potential donors. All stakeholders also have the option to request a consultation with the hospital’s in-house ethics team. OPOs should have a policy for informing these stakeholders of this requirement but should have broad leeway in how they meet it. Further, transplant centers should be required to educate their own staff on this topic so that OPOs are not required to do so.

AOPO feels that OPO staff cannot be responsible for the neurological assessment of the donor nor for “ensuring the accuracy” thereof. We recommend rephrasing this requirement in 2.15.C to require that the OPO document the exam performed by a member of the patient care team. Further, we recommend that the frequency of documented assessments not be prescribed in policy, only that continued assessment of WLST suitability is required.

Lastly, AOPO supports the clarifications to existing policy regarding brain dead donors whose organs are recovered under DCD protocols, usually at family/agent request.

We agree that these proposed OPTN policies should be approved by the Secretary of Health and Human Services and made enforceable by HHS, in accordance with the process outlined in the OPTN Final Rule.

American Society of Transplant Surgeons (ASTS) | 1/16/2026

The American Society of Transplant Surgeons (ASTS) appreciates the opportunity to provide public comment on the Health Resources and Services Administration (HRSA) directive to the Organ Procurement and Transplantation Network (OPTN) regarding Donation after Circulatory Death (DCD) policy development.

ASTS recognizes the seriousness of allegations made in recent media reports and Congressional hearings related to DCD organ donation. Many of these concerns reflect complex realities that can be difficult to fully convey outside of clinical context, and it is essential that the system respond to these allegations thoughtfully and transparently. The protection of organ donors and their families at the end of life and the preservation of public trust are foundational to the organ donation and transplantation system. Clear, consistent, and enforceable safeguards serve not only to protect vulnerable patients and families, but also to reinforce confidence in the professionals and organizations entrusted with this work.

ASTS commends the OPTN Committees and Workgroups for undertaking this exceptionally complex effort. DCD policy development exists at the intersection of ethics, critical care medicine, neurology, law, and transplantation. Balancing donor protection, family experience, clinical realities, and the urgent need for organs requires careful deliberation and collaboration. The committee’s work reflects a sincere commitment to strengthening safeguards while recognizing the operational and ethical complexities inherent in end-of-life care and organ donation.

ASTS generally supports the direction of the proposed policies, recognizing their intent to enhance clarity, consistency, and transparency across DCD practices. ASTS offers several considerations intended to further strengthen patient protections, support shared accountability, and ensure continued public confidence in the donation system.

ASTS strongly affirms that informed consent standards must be explicitly and rigorously applied in all DCD scenarios. In instances of first-person authorization where the individual is mentally capable of making informed medical decisions, ASTS recommends that the informed consent standards currently applied to living organ donation serve as the appropriate benchmark. The potential donor should receive comprehensive education regarding the donation process, potential risks, uncertainties, and available alternatives. The potential donor must retain the unequivocal right to change their mind or withdraw authorization at any point, including up to the withdrawal of life sustaining therapies and/or death, for any reason. This right must be clearly communicated, thoroughly documented, and consistently respected. Similarly, when authorization is provided by a legally authorized representative, the authorizing individual should receive explicit education regarding the voluntary nature of donation, the right to pause or withdraw authorization at any time, and the clear separation between decisions related to life-sustaining treatment and decisions related to organ donation.

ASTS recognizes the essential role that organ procurement organizations play in facilitating safe, ethical, and effective organ donation. At the same time, policies governing unplanned DCD pauses and reconciliation prior to resumption should promote collaboration and shared responsibility between organ procurement organizations and donor hospitals and their medical personnel. Joint development of such policies, meeting defined minimum criteria and incorporated into formal operating agreements, would reinforce mutual accountability, and help ensure that safeguards are applied consistently across clinical settings.

ASTS supports the establishment of minimum standards governing the timing and sequencing of donation discussions. Donation discussions should occur only after the authorized agent has been fully informed of the potential donor’s grave prognosis and the unlikelihood of meaningful recovery, preferably after the agent has already expressed intent toward withdrawal, comfort focused care or do not resuscitate status. Because it may be difficult or impossible to retrospectively assess whether the decision to donate influenced the decision to withdraw life-sustaining therapies, particularly during the natural grief process, clear standards for timing and sequencing serve to protect donors and patients alike. To support these safeguards, ASTS recommends clear documentation demonstrating that the decision to withdraw life-sustaining therapies preceded donation discussions. Responsibilities of donor hospital clinicians and organ procurement organization staff should be clearly delineated, with continued emphasis on ethical boundaries and role separation. Ensuring organ procurement organization compliance with communicating these standards to donor hospitals is achievable.

ASTS supports defining a minimum waiting period following circulatory cessation in OPTN Policy 2.15.J. A standardized minimum interval promotes consistency, transparency, and public confidence, while supporting donor protection. ASTS recommends alignment with existing medical evidence and ethical consensus, which is in support of a five-minute observation period.

ASTS supports the inclusion of automatic triggers for unplanned DCD pauses in limited and well-defined circumstances, particularly when there is uncertainty regarding neurological status, unexpected patient responsiveness, or discrepancies between anticipated and observed clinical progression. Supplemental education accompanying such triggers would further support appropriate clinical judgment and consistency; we do however also recognize that this may be difficult to codify in this initial iteration of policy. The Committee should continue to review data as it is submitted and consider policy revision as necessary based on learned experience.

Clear definitions of reportable events, standardized thresholds, and consistent reporting timelines would enhance transparency and support quality improvement efforts. The process of peer review and goal of process improvement and bringing members into compliance should remain a central goal, and an unplanned DCD pause should not automatically be viewed as a negative outcome, given the innate variability in the progression and pathophysiology of injury. It is difficult to determine if the proposed reporting requirements are appropriate given that the example form does not include all presumably pre-populated options for selection. ASTS believes the existing reporting process is generally appropriate while recognizing that the OPTN or MPSC may seek additional information and clarification at any time. The community may benefit from additional lived experience with this new process to provide the clarity needed to ensure consistent understanding and application.

Given the importance of maintaining public trust and national consistency, ASTS supports submission of these policies to the Secretary of Health and Human Services for approval and enforceability in accordance with the OPTN Final Rule. Federal enforceability reinforces accountability while affirming the transplant system’s commitment to donor safety and ethical practice. Prior to doing so, however, clarification around the language relating to member actions and potential penalties would be necessary. For example, donor hospitals would potentially be subject to investigation, but they are not considered OPTN members. Further, this raises concern that transplant hospitals, as OPTN members, may be found out of compliance for acts of omission or commission by donor hospitals or OPOs.

ASTS also encourages continued coordination between the OPTN and the Centers for Medicare and Medicaid Services, which maintains statutory oversight of organ procurement organizations. Alignment between OPTN policy requirements and CMS Conditions for Coverage is essential to ensure consistency in expectations, avoid duplicative or conflicting requirements, and reinforce shared accountability across the donation system. Such coordination would further support donor safety, operational clarity, and public confidence.

Based on these considerations, ASTS hesitantly recommends a position of Support for the proposed policies. This position reflects endorsement of the overall direction and intent of the proposals, while recognizing the value of continued refinement to ensure clarity, collaboration, and sustained public confidence in the organ donation and transplantation system.

Leslie A. Kuhnel | 1/16/2026

I appreciate the work OPTN and others are doing to assure safe, ethical, and equitable donation opportunities. I worry that the language about stakeholders (including family members) being able to call a pause “if there are concerns with the patient” could be stretched to allow for family members who disagree with a patient’s decisions to become a registered donor to override that decision. I realize that the implication is that the concern would be related to the clinical status of the patient (particularly if the stakeholder/family member believes they are seeing increased neurological function or improvement) so-as not to move too quickly to procurement, but the wording could be interpreted to allow for over-riding first-person consent. In the materials for family education and in any policy and practice recommendations, more emphasis on this distinction would be helpful. 

Jim Sharrock | 1/16/2026

Briefly perusing the massive comments, I find little addressed to donor family concerns. I have one suggestion.

Complete disclosure of NRP procedures may not be necessary or helpful for family members. I suggest the family be told each of the listed disclosure items are available for discussion if they so choose. They may want to know where the patient is being treated but have no desire to consider the mechanics of perfusion after death. Give them the option, but don’t push it on them.

The International Society for Heart and Lung Transplantation (ISHLT) | 1/16/2026

The International Society for Heart and Lung Transplantation (ISHLT) appreciates the opportunity to review the OPTN proposal, “HRSA Directive for OPTN Donation after Circulatory Death Policy Development.” As a global professional society representing clinicians, scientists, and allied health professionals dedicated to advanced heart and lung disease and transplantation, ISHLT welcomes the OPTN’s efforts to strengthen safeguards, transparency, and consistency in the donation after circulatory death (DCD) process.

ISHLT supports the overall direction and intent of the proposed policy changes and views them as a timely and necessary step to enhance patient safety, standardize practices across organ procurement organizations (OPOs) and donor hospitals, and reinforce public trust as DCD continues to expand, including within thoracic transplantation. The proposal appropriately emphasizes ethical rigor, clear accountability, and improved communication at critical decision points in the donation process.

ISHLT supports the proposal’s focus on standardized and transparent communication with donor families. Clear, consistent disclosure of what families may expect during the DCD process—including applicable safeguards, potential contingencies, and retained rights—is essential to informed decision-making and maintaining trust during emotionally acute circumstances. ISHLT recognizes, however, that the scope and complexity of required disclosures may pose implementation challenges in real-time clinical settings, underscoring the importance of accompanying education, training, and coordination among OPOs and clinical teams.

ISHLT also supports the establishment of a clearly defined and enforceable unplanned DCD pause mechanism. The ability to pause procurement when concerns arise regarding neurologic function or patient comfort is a critical safeguard, particularly in high-acuity and time-sensitive environments. As these policies are implemented, ISHLT encourages continued attention to operational clarity and flexibility, including clearer delineation of which situations should and should not trigger a pause, how differences of opinion are evaluated and resolved, and how decisions are documented and communicated.

ISHLT further notes that the range of real-world clinical scenarios may extend beyond those explicitly described in the proposal and encourages the OPTN and HRSA to remain responsive during early implementation and to refine guidance as needed. In complex cases, engagement of ethics, palliative care, or risk management expertise may further support objective decision-making and reinforce confidence in the process.

With respect to the proposal’s “Considerations for the Community,” ISHLT offers the following observations. To mitigate the risk of undue influence on decisions to withdraw life-sustaining therapies, ISHLT believes it is appropriate to consider clearer separation between education about DCD and formal authorization, while maintaining the principle that authorization may only occur after a decision to withdraw support has been made. ISHLT agrees with the committee’s rationale for not incorporating automatic neurologic triggers for an unplanned pause, given the variability of clinical presentations, but supports the development of shared, evidence-informed guidance and education to assist clinicians and OPOs in identifying concerning changes in neurologic status or patient comfort.

ISHLT supports defining a minimum waiting period of circulatory cessation and notes that a five-minute interval is supported by available evidence and aligns with the goal of minimizing the risk of autoresuscitation. ISHLT also finds the proposed reporting requirements for unplanned DCD pauses to be generally clear and encourages the OPTN to emphasize the use of reported data for safety learning and quality improvement rather than punitive oversight. In addition, ISHLT encourages consideration of how donors who are initially activated but later deemed unsuitable are captured within reporting and evaluation frameworks, to support both patient safety and system efficiency and to avoid premature designation of donors who may not yet meet appropriate clinical criteria.

ISHLT further notes that additional clarity or reference to objective criteria used in assessing adverse neurologic prognosis—such as neurophysiologic testing or other established clinical markers—may help promote consistency across centers and strengthen confidence in determinations related to withdrawal of life-sustaining therapies, while recognizing that such assessments appropriately remain within the purview of the treating clinical team.

Summary of Key Recommendations

• Clarify operational expectations for the unplanned DCD pause mechanism, including who may initiate a pause, how concerns are evaluated, and how decisions are documented and communicated.
• Maintain flexibility during early implementation and refine guidance as real-world scenarios emerge.
• Consider clearer separation between DCD education and formal authorization to mitigate risk of undue influence, while maintaining that authorization occurs only after a decision to withdraw life-sustaining therapies has been made.
• Support shared, evidence-informed guidance and education for neurologic assessment and identification of concerning changes, without requiring rigid automatic triggers.
• Define a minimum waiting period of circulatory cessation; ISHLT supports a five-minute interval to minimize the risk of autoresuscitation.
• Ensure reporting supports safety learning and quality improvement and consider how donors initially activated but later deemed unsuitable are captured to support safety and system efficiency.
• Consider additional clarity or reference to objective criteria used in assessing adverse neurologic prognosis to promote consistency across centers.

ISHLT appreciates the OPTN’s leadership in addressing these complex and evolving issues and encourages continued engagement with the transplant community, OPOs, donor hospitals, and donor families as these policies are finalized and implemented.

ISHLT Level of Support: Support the Proposal

Versiti Blood Health, Inc.’s Organ Procurement Organization | 1/16/2026

Versiti Blood Health, Inc.’s Organ Procurement Organization welcomes the opportunity to comment on the Health Resources Services Administration (HRSA) Directive for Organ Procurement and Transplantation Network (OPTN) Donation after Circulatory Death (DCD) Policy Development to improve the safety of organ donation and transplantation in the United States.

DCD continues to increase year after year, enabling life-saving transplants for thousands of patients who might otherwise lose the opportunity for a second chance at life. Versiti believes that preserving access to DCD is essential and agrees that all OPTN members must work collaboratively with donor hospitals and donor families to ensure donor safety throughout the process, particularly as Organ Procurement Organizations (OPOs) are
among those most directly impacted by this policy change. We appreciate efforts to standardize DCD to maintain the integrity of the altruistic organ donation system in the U.S. Sadly, we are aware that mischaracterizations and misunderstandings about DCD donation have led thousands of people to remove
themselves from donor registries, negatively impacting organ transplantation. We hope the standardization of DCD practices will help to strengthen patient safety and rebuild public trust in donation.

The decision to withdraw life-sustaining therapy (WLST) lies with the patient’s family/agent and the patient’s
health care team. The OPO must remain uninvolved in the patient’s care prior to WLST in keeping with the
ethical requirement to separate care, withdrawal, and declaration processes before death and the donation recovery that occurs afterward. Families/agents who are considering WLST must be informed about donation and how the donor evaluation process may affect the timing of the WLST. Many families have expressed frustration with learning about this timing impact after planning for other family members to be present at the time of WLST. Waiting until the family has made the decision is too late and puts families in the position of making difficult decisions at the last minute.

Versiti agrees that a neurological assessment should be conducted by the hospital before a decision to withdraw
support, but is concerned that assigning specific neurologic deficit requirements for DCD would risk excluding conscious donors who wish to withdraw support and other potential donors with some level of neurologic function. Withdrawal of support is not dependent upon neurological assessments, and the potential for organ donation should not be limited to patients with neurologic deficits only. We believe the policy is unclear on this fact. Furthermore, there are no neurological or validated assessment tools that reliably predict the time of death.

In 2.2.8, the statement implies a responsibility for the OPO to assess the potential donor neurologically. We recommend revising the statement to clarify that the OPO’s role is to document the assessment in the OPO's donor record rather than to perform or interpret the assessment made by the healthcare team. Similarly, proposed language in 2.15.C states that the OPO and primary healthcare team must confirm whether lifesustaining therapies should be withdrawn. The OPO should not participate in these discussions as doing so compromises the integrity of the donation process. Any involvement could create the perception that the OPO is advocating for donation rather than support of the patient, family, and clinical team in determining the appropriate plan of care. To reiterate, the OPO should not be involved in any assessment or determination of the appropriateness of withdrawal of support.

Versiti supports stakeholders having the ability to pause the process when there is disagreement among providers and families about whether withdrawal of support is appropriate. We do not believe there should be specific clinical requirements in policy that trigger a DCD pause. Decisions to withdraw support are often emotionally complex for families and can be challenging for the care team. The OPO's role is to engage in clear,
transparent communication with providers and families, including regular huddles to ensure shared understanding throughout the process. It is also essential that families understand that their loved one may not die within a time frame that permits donation. Versiti supports the requirement to educate the hospital team regarding the process for DCD through huddles and to educate the patient or the patient’s agent regarding the
process for requesting an unplanned pause.

We believe the proposed requirement to report an unexpected pause in the donation process would benefit
from greater clarity, particularly regarding whether required only when a pause is unresolved. We agree that these proposed OPTN policies should be approved by the Secretary of Health and Human Services and made enforceable by HHS, in accordance with the process outlined in the OPTN Final Rule.

David Bruno | 1/16/2026

We support the enhanced measures for DCD donors. It is paramount that we restore trust in the community surrounding DCD donation and this proposal may serve that end.

Gift of Life Michigan | 1/16/2026

Gift of Life Michigan appreciates efforts to standardize Donation after Circulatory Death (DCD). We support evidence-based guidelines and/or policies that provide realistic direction and boundaries to maintain the integrity of the altruistic organ donation system in the U.S. We are aware that mischaracterizations and misunderstandings about DCD donation have, unfortunately, led many to remove themselves from donor registries, negatively impacting organ transplantation. We hope the standardization through these guidelines will help to strengthen patient safety and rebuild public trust in donation and specifically DCD.

We firmly believe the OPO best serves donors, families, and communities by being prepared to facilitate DCD donation if death occurs within a time frame suitable for organ recovery and by clearly communicating with the families about what will occur if the patient does not die within that prescribed time frame. It is essential that the OPO remain uninvolved in the patient’s care prior to withdrawal in keeping with the ethical requirement to separate care, withdrawal, and declaration processes before death from the donation recovery that occurs afterward.

The decision to withdraw life-sustaining therapy (WLST) lies with the patient’s family/agent and the patient’s healthcare team. OPTN members must not influence the decision about WLST. Any patient from whom life-sustaining therapy is being withdrawn in anticipation of natural death can be a suitable organ donor. While we agree that neurological assessment should be considered by the hospital prior to a decision to withdraw support to confirm appropriateness, assigning specific neurologic deficit requirements for DCD would run the risk of excluding conscious donors who wish to withdraw support or potential donors who may be removed for other reasons. Withdrawal of support is not dependent upon neurological assessments, and the potential for organ donation should not be limited to patients with neurological deficits only. We believe the policy is unclear on this fact. Furthermore, there are no neurological or validated assessment tools that reliably predict the time of death. In our experience with our cases, predictive accuracy of death is approximately 50%.  

In 2.2.8, the statement implies a responsibility for the OPO to assess the potential donor neurologically. We recommend revising the statement to clarify that the OPO’s role is to document the assessment in the OPO's donor record rather than to perform or interpret the assessment made by the healthcare team. Similarly, proposed language in 2.15.C states that the OPO and primary healthcare team must confirm whether life-sustaining therapies should be withdrawn. The OPO should not participate in these discussions as doing so compromises the integrity of the donation process.  Any involvement could create the perception that the OPO is advocating for donation rather than support of the patient, family, and clinical team in determining the appropriate plan of care. To reiterate, the OPO should not be involved in any assessment or determination of the appropriateness of withdrawal of support. We are present only at the request of the patient or the patient’s agent to be ready for donation if the patient dies within the prescribed amount of time.

Gift of Life supports stakeholders having the ability to pause the process when there is disagreement among providers and families about whether withdrawal of support is appropriate. We do not believe there should be specific clinical requirements in policy that trigger a DCD pause.

Organ donation is a donor’s legacy and often provides lasting comfort for families and loved ones. Decisions to withdraw support can be emotionally complex for families and challenging for the care team. The OPO's role is to engage in clear, transparent communication with providers and families, including regular huddles with the healthcare team to ensure shared understanding throughout the process. It is also essential that families understand that their loved one may not die within a time frame that permits donation. Gift of Life supports the requirement to educate the hospital team regarding the process for DCD through huddles and to educate the patient or the patient’s agent regarding the process for requesting an unplanned pause.

We believe the proposed requirement to report an unplanned pause in the donation process would benefit from greater clarity, particularly whether reporting is required only when a pause is unresolved. That may be the intent; however, the current language can be interpreted to include any pause, even though pauses are common even today, and are often resolved as part of routine coordination. 
Based on the OPTN communication posted on November 7th, a recommendation was made to standardize the observation period to be 5 minutes following pulselessness yet before declaration to ensure that autoresuscitation of the heart occurs. This was not part of the policy recommendations, but Gift of Life supports this additional standardization.

We agree that these proposed OPTN policies should be approved by the Secretary of Health and Human Services and made enforceable by HHS, in accordance with the process outlined in the OPTN Final Rule.

Cassandra Smith-Fields | 1/16/2026

• Line item 68/69-2.3.c. regarding required laboratory evaluations. Want to ensure that the nuances of pediatric patients are considered – specifically the volume of blood that may be required and the resulting implications. If all labs are obtained too quickly in small patients, the volume of blood required could cause the critically ill patient to become more unstable.
• Line item 5-6 highlighting the differences between informed consent and authorization. Our read is that this language is pertaining to 1st person authorization issue. In the pediatric and young adult population there is a difference between authorization and informed consent and this should be recognized.
• NRP – this is not yet considered standard of care in the pediatric population and need to be careful here. Field is evolving, but our surveys of pediatric organizations do not show this to be standard practice.

Baylor Scott & White Health (BSWH) | 1/16/2026

Donation after Circulatory Death Policy Development
Baylor Scott & White Health (BSWH) would like to thank Health Resources and Services Administration (HRSA) and Organ Procurement and Transplantation Network (OPTN) on their efforts to provide additional clarity on the Donation after Circulatory Death (DCD) Policy. BSWH is broadly supportive of the OPTN Organ Procurement Committee’s (Committee) proposed policy update.  However, we believe that a number of areas within the policy would benefit from further clarity and clearer definitions.    

As one example, in Section 2.2 OPO Responsibilities the policy states “The host OPO is responsible for…(e)nsuring accuracy in neurological assessment and appropriate neurological reassessments in accordance with Policy 2.15.C: Potential DCD Donor Evaluation.” This wording has the potential to create confusion regarding the OPO and the donor hospital’s roles in this requirement.  Accordingly, BSWH recommends that the proposed language in this section be revised to reflect OPTN’s proposal in the overview, clearly stating that it is the OPO’s responsibility to verify that neurological assessments are being conducted, and it is the donor hospital staff’s responsibility to conduct the neurological assessments and the appropriate neurological reassessments.

Thank you again for the opportunity to provide feedback on the proposed DCD Policy.

Donor Alliance | 1/16/2026

Donor Alliance appreciates the opportunity to provide feedback on the proposed policy language addressing the HRSA Directive for OPTN Donation after Circulatory Death Policy Development. Donor Alliance supports policy changes to safeguard patients during the evaluation and DCD recovery process.

We also encourage HRSA and the OPTN to utilize this opportunity to make clear to the public the roles of the donor hospital intensive care unit (ICU) team responsible for the potential donor’s care (end-of-life) and the OPO team responsible for organ recovery practices.   The OPO team does not participate in or have responsibility for the potential donor’s end-of-life care, withdrawal of life-sustaining therapy (WLST), agonal palliative care, or, most importantly, death determination. The critical care community does have accepted practice standards for determining and following a patient’s treatment preferences, for conducting WLST, including optimal agonal palliative treatment, and for determining death on the grounds of permanent cessation of circulation and respiration.

We support the following key concepts for the DCD evaluation and recovery process. 1) Patient and donor safety remain the top priority in every stage of the DCD evaluation and donation process. 2) All decisions regarding WLST are made exclusively by the healthcare team and family, independent of the OPO and the donation decision. 3) Active collaboration and communication between the healthcare team, family, and OPO are essential for successful outcomes. 4) OPO personnel should understand the goals of both the healthcare team and family and ensure alignment with goal-concordant care. 5) Clarity of roles and responsibilities across all stakeholder groups fosters transparency, efficiency, and high-quality care. 6) Neurologic assessments and re-examination guidelines are effective and support consistency throughout the process. 7) Advanced perfusion strategies allow donation and transplantation opportunities that historically would not have been possible for both donor families and recipients.

HonorBridge | 1/16/2026

Section 2.15.C (lines 115–116)
The requirements for reassessment “at least every 12 hours” and “within 2 hours prior to planned withdrawal” are overly prescriptive. Neurologic assessment should be determined by the treating medical team based on the patient’s clinical condition. The OPO should confer with the medical team regarding neurologic status, and reassessment timing should be clinically driven, with findings communicated to the OPO rather than mandated by fixed intervals.

Section 2.15.E (line 137)
It is unclear what value suspending allocation adds during an unplanned DCD pause. Allocation can be time-intensive, particularly for DCD cases, and pausing allocation risks losing transplantable organs due to time constraints. For OPOs with dedicated allocation staff who are not involved in the on-site donation process, continuing allocation does not impede the assessment required during an unplanned pause and should be permitted.

Section 2.15.F (lines 170–174)
The requirement to disclose the use of Normothermic Regional Perfusion (NRP) to families raises concerns. NRP is a surgical technique, similar to other techniques routinely used during recovery, which are not individually disclosed. The policy does not distinguish between A-NRP, TcA-NRP, and TA-NRP, implying all would require disclosure. Rather than singling out NRP, this information could be addressed under a broader disclosure statement such as: “Procedures and technologies may be required to determine organ suitability and sustain organ function during the recovery process.” This approach would be more consistent with current practice and family understanding, as many families are unfamiliar with technical terms such as ECMO, VAD, or NRP.

Table 18-1 (page 24, final item)
The requirement for feedback for “individuals … for whom authorization for donation is granted” requires clarification. In cases of First-Person Authorization (FPA), family disclosure should be the triggering event for required feedback. Without clarification, the policy could be interpreted to require feedback for all FPA referrals, which may not be the intent.

Appendix B
The inclusion of implementation scenarios is appreciated and will be helpful to the community in operationalizing these policies.

Community Considerations (page 16)
While we agree with the comments already noted, it is unclear what specific feedback is being requested. The proposal asks whether the OPTN should recommend approval of these policies by the Secretary of Health and Human Services and make them enforceable under the OPTN Final Rule. Based on review of the cited regulatory sections, this question appears to be asking whether these policies should be incorporated into the standard OPTN policy framework, which already includes Secretarial approval and enforcement mechanisms. Clarification of the intent of this question would be helpful.

General Comment
The document is lengthy and, in places, redundant. While this is common for policy documents of this nature, it could be more concise. Additionally, approval of these processes should involve review by subject matter experts to ensure clinical feasibility and operational practicality.

American College of Physicians (ACP) | 1/16/2026

The American College of Physicians (ACP), the largest physician specialty society in the United States with more than 162,000 internal medicine physician, related subspecialist and medical student members, appreciates the opportunity to comment on this proposal. ACP strongly supports organ donation and the lifesaving potential of organ transplantation, including donation after circulatory determination of death (DCD).

The “HRSA Directive for OPTN Donation after Circulatory Death Policy Development” proposal from the OPTN Organ Procurement Organization Committee includes some provisions that can support patients and families and that do not interfere with health care professionals meeting their ethical obligations of beneficence and respect for patient autonomy, such as noting the need to ensure “the decision to withdraw life sustaining therapies should not be influenced by the donation decision,” which reflects the ethical obligation to put the patient’s best interests first; and that standardized required information elements should be provided regarding organ procurement, which could support respect for patient autonomy. However, unclear language calls into question whether the document maintains the necessary bright line between the donor care team and the OPO regarding withdrawal of life-sustaining therapies and neurological assessments, or is sufficiently transparent in required information elements.

In addition, the policy proposal’s brief inclusion, without explanation, of normothermic regional perfusion (NRP) is very problematic, incorrectly implying NRP is an ethically accepted practice. In doing so, OPTN:

• Neglects the fact that significant disagreement about NRP exists in the scientific and ethics community and that many countries do not permit NRP. Many agree with statements that have been issued that NRP is “neither ethical nor prudent” (Omelianchuk A, Capron AM, Ross LF, Derse AR, Bernat JL, Magnus D. Neither Ethical nor Prudent: Why Not to Choose Normothermic Regional Perfusion,” Hastings Center Report. 2024; 54:14–23).
• Disregards OPTN’s own Ethics Committee, which states in a recent report that “NRP raises concerns about compliance with the Dead Donor Rule;” “concerns about the potential for harm to the donor if cerebral flow occurs from the procedure” (which have been borne out in cases reported to OPTN); and that “uncontrolled scenarios for NRP…raise very serious concerns for respect for persons.”
• Does not describe or define NRP, its risks, or its ethical problems anywhere in the document.

ACP reiterates its opposition to NRP as a method of organ procurement, as voiced in Ethics, Determination of Death, and Organ Transplantation in Normothermic Regional Perfusion (NRP) with Controlled Donation after Circulatory Determination of Death (cDCD) (PDF - 237 KB) and in position papers on Standards and Ethics Issues in the Determination of Death: A Position Paper from the American College of Physicians and Ethical Issues in Organ Transplantation: A Position Paper From the American College of Physicians. NRP violates the Dead Donor Rule (DDR), violates patient do-not-resuscitate orders, raises ethical concerns about causing brain death, and jeopardizes public trust in donation. And it is unnecessary, as ethical alternatives to NRP exist, such as the use of ex vivo perfusion devices. 

As recent articles in the New York Times and Washington Post have documented disturbing organ procurement cases, distrust among patients and families about organ transplantation is growing—and for good reason. This policy proposal should not slip in NRP; NRP should be considered separately and rigorously, and OPTN should call for its use to be paused. What ACP has said about NRP in the past remains true: “The burden of proof regarding the ethical and legal propriety of this practice has not been met. Sound ethical arguments, not just assertions, must underpin organ procurement methods and such efforts must be consistent with US legal and ethical standards for determination of death. Without this, we risk decreasing public confidence in health care and undermining support for organ donation, further exacerbating the problem this protocol seeks to address.”

LifeGift | 1/16/2026

LifeGift, the OPO based in Houston, Texas appreciates the opportunity to comment on this timely and important policy proposal regarding multiple aspects of the donation after circulatory death (DCD) process.

LifeGift wants to first point out that many of the proposal’s main requirements are focused on aspects of end-of-life care for living patients that are – and should remain – directly in the purview of hospital health care teams and providers, not organ procurement organizations or their staff. This separation of responsibility is the ethical foundation and intentional design of our organ procurement and transplant network and has been for decades wisely designed to prevent conflicts of interest. This principle unfortunately is ignored in many of the proposal areas and in our view, is not only concerning but also unworkable but also could unintentionally undermine the trust and partnership essential to effective DCD practice.

CMS has the authority to develop mandates for hospital interventions with living patients who are candidates for donation and the responsibility to monitor compliance through existing regulations (for example at 45 CFR §482.45 - CoPs for hospitals re organ, tissue and eye procurement). HRSA/OPTN should work directly with CMS on these key topics and request the proper CMS division that regulates hospitals to revise existing requirements accordingly in the Conditions of Participation (CoP)s (§482.45 - CoPs for hospitals re organ, tissue and eye procurement) regarding organ donation and/or end of life care.

Definition and Scope of an Unplanned DCD Pause

Policy 2.15.D.i permits an unplanned DCD pause from authorization through cross clamp, but the pause definition and process is focused on WOLST appropriateness, which occurs well before cross clamp. If OPTN intends to address post-declaration events (such as auto-resuscitation beyond the observation period), those circumstances should be addressed separately with clear expectations for immediate actions rather than folded into the unplanned pause framework. Any request from hospital staff, OPO staff, transplant center staff, etc., to pause should be honored as currently practiced.

We need to point out two (2) major concerns in this proposed section: 1) Interactions and communications with third party providers and vendors as stakeholders are vastly inconsistent in situations where the OPO does not have a contractual or other employment relationship with a perfusion device staffing group. HRSA/OPTN needs to develop approaches to oversight of these groups rather than defer this requirement to OPOs which is extremely burdensome and adds regulatory liability to disenfranchised OPOs, especially in such a critically important area. 2) Notification of the ability to call a time-out when there are unplanned pauses can easily be added to both hospital and OPO policies if not already present. We support the notification of this right to families of all donors.

LifeGift fully supports the intent and need for the unplanned DCD pause in policy as an important safeguard to ensure serious concerns are addressed. However, the current language in this section and Appendix B risks implying that external stakeholders (OPOs, transplant programs, or third parties) have decision-making authority in a living-patient WOLST, which undermines the required ethical separation between end-of-life care and organ donation. WOLST decisions must remain solely between the hospital clinical team and the patient or legally authorizing party. While concerns may be raised and escalated, external parties do not have veto authority. Once concerns are addressed and documented and WOLST is confirmed to proceed, the OPO should be allowed to resume DCD coordination to avoid the loss of donation opportunity.

Minimum Waiting Period

We support a minimum waiting period. Evidence supports a five-minute standard, supports consistency, safety, and public trust and aligns with ASTS guidance (Croome et al., American Journal of Transplantation, 2023).

Neurological Assessment

We are strongly opposed to Policy 2.2.8 requiring OPOs to ensure “accuracy in neurological assessment” and Policy 2.15.C requiring “the OPO and primary healthcare team must confirm that withdrawal of life-sustaining therapies remains appropriate.” Assessment accuracy lies solely with the healthcare team. OPO requirements should be limited to documenting assessments performed by the patient’s healthcare team as documented in the medical record. The OPOs role should confirm the withdrawal decision has not changed, not to determine if the decision is appropriate.

Not all DCD candidates are unconscious, and some patients with decision-making capacity may self-direct donation, including individuals with ALS, patients dependent on mechanical support, or those who personally direct withdrawal of life-sustaining therapies in conjunction with donation. OPTN guidance is needed to clarify the required steps and safeguards in these circumstances to support consistent and ethical practice.

Requirements for family information

Most of the elements outlined in the “Requirements for family information,” section are already addressed by the OPOs in discussions with families. The proposal is unclear on the level of specificity required on elements: a) Laboratory evaluations including testing for infectious diseases and b) Description of procedures and medications that may be administered to the patient during the organ donation process. Both items are covered in the authorization that the family is informed that critical care support, labs, medication and evaluation procedures will be administered to maintain the patient and evaluate organ suitability for transplant. LifeGift suggests that this general information continues to be provided to families along with an assurance that any questions or concerns they have will be promptly addressed at the level of specificity the family requests. Should a family express the preference not to receive any or all the information listed in this proposal, LifeGift suggests that the OPO abide by the family’s decision and documents that request in the electronic donor record, ensuring that the family has the OPO’s contact information should they change their mind.

Consent for Procedures Pre-DCD

We support clarifying that authorization for organ donation does not constitute consent for pre-mortem procedures performed by the hospital healthcare team on living patients. However, the proposal places responsibility on the OPO to ensure hospital consent is obtained. Standards for informed consent for living patients are governed by hospital policies and state law, not OPTN Policy. The responsibility for determining when consent is required and obtaining that consent remains with the hospital healthcare team.

Timing of Family DCD Donation Discussion

Decisions to withdraw life sustaining therapies are in the purview of the health care team and hospital in conjunction with the patient’s next of kin or surrogate decision maker. It is important to note that the OPO’s communication with patient’s next of kin or surrogate is to first provide information about opportunities for donation and the general process. Families often request information about next steps in the end-of-life phase of care, and this is distinct and separate from seeking authorization for donation.

LifeGift agrees that the donation decision must not influence the decision to withdraw life sustaining therapies. We also agree with the workgroup’s conclusion that families may decline donation due to the extended time needed to facilitate donation after the family has decided to withdraw life-sustaining care; and that the timing of this decision may cause undue stress upon a family. We support the workgroup’s proposal that the authorization discussion occur once end-of-life discussions are taking place with the patient’s next of kin, unless the family has requested information.

LifeGift respectfully emphasizes that the timing and quality of the donation discussions are inherently dependent on timely referral by the hospital once clinical triggers are met. Accordingly, we encourage greater accountability for hospitals to refer patients promptly when they meet clinical triggers, allowing time for evaluation of clinical suitability to be a donor and for coordinated communication among the healthcare team and the OPO to support thoughtful planning of care and family discussions.

Lastly, in reference to the workgroup’s suggestion to use the word “agent” instead of “next-of-kin,” LifeGift points out that the term “agent” is already defined in the UAGA as an individual: (A) authorized to make health-care decisions on the principal’s behalf by a power of attorney for health care; or (B) expressly authorized to make an anatomical gift on the principal’s behalf by any other record signed by the principal. To avoid confusion, LifeGift recommends to instead use a term such as “Legally Authorized Representative (LAR)” to replace the term “next-of-kin.” LAR aligns with healthcare and regulatory usage and signals legal authority, not relationship and avoids the conflict with “Agent” in the UAGA, may not always be the highest-priority decision maker.

Data Submission, Reporting Requirements and Oversight Considerations

The requirement to register all authorized donors and submit donor disposition data, even when no organs are recovered, will improve transparency. OPTN should clarify that this expanded reporting will not negatively impact CMS performance assessments or be used for enforcement without appropriate risk adjustment. However, Policy 2.2.4 requires OPOs to register authorized donors “no later than the time at which the OPO decides to proceed with the donation process,” a trigger that is not clearly defined and operationally impractical given staffing models and geography. Authorization may also be obtained, but donation may appropriately stop prior to DonorNet registration (e.g., contraindication identified during UDRAI). OPTN should clarify whether OPOs would still be expected to generate a donor ID solely for reporting purposes in these cases and should instead establish a separate data submission mechanism to capture authorization events and outcomes when donation does not proceed to donor registration or allocation.

We support timely reporting of unplanned DCD pauses as a mechanism to promote transparency, patient safety, and system learning. At the same time, we recommend that OPTN explicitly frame these reports as quality improvement and patient safety signals, rather than as presumptive indicators of noncompliance. To support consistent interpretation and appropriate reporting, the definition of an “unplanned” DCD pause should be refined to end at the time of WOLST since the definition of unplanned DCD pause with difference opinion as to if the patient meets criteria for WOLST, before WOLST in, when the individual remains a living patient. We request autoresuscitation be clearly defined by clinical standards.

In summary, we support the goals and direction of this proposal and believe it represents a meaningful step toward strengthening DCD safeguards and public trust. We respectfully recommend additional clarification and guidance in the areas noted above to promote consistent implementation, protect appropriate clinical judgment, and ensure that quality improvement remains the focus of these important policy changes.

Indiana Donor Network | 1/16/2026

Indiana Donor Network appreciates the opportunity to submit comments regarding the HRSA Directive for OPTN Donation after Circulatory Death (DCD) Policy Development. We acknowledge and thank the OPTN Organ Procurement Organization (OPO) Committee and the HRSA Directive for OPTN DCD Policy Development Workgroup for their efforts to develop policy guidance intended to promote transparency, consistency, and stakeholder alignment in the DCD donation process. Indiana Donor Network supports policy frameworks that foster collaboration among stakeholders and strengthen public trust in the organ donation and transplantation system.

Authorization and Consent for Procedures
With respect to authorization and consent requirements, Indiana Donor Network requests clarification regarding which donor-related procedures require specific informed consent. In particular, we ask that OPTN clearly distinguish between invasive procedures and those that are routinely required under OPTN policy, such as blood draws and non-invasive diagnostic testing. Absent this distinction, there is a risk of creating unintended barriers to donation. We further request that OPOs be permitted to incorporate discussion of such procedures into the donor authorization process and address them with authorized decision-makers at the time of authorization, rather than requiring separate procedural consents.

Timing of Donation Discussions and Early Triggers
Indiana Donor Network agrees with the proposed policy language addressing the appropriate timing of donation discussions with donor families. We recommend, however, that the policy be expanded to explicitly recognize early donation conversation triggers. These would include a communicated poor prognosis; determination that continued care is futile in the setting of clinical instability; provider communication indicating imminent death and the need to preserve the opportunity for donation; an impression of brain death; family-initiated discussion of donation; or hospital-initiated family readiness or informational discussions. Explicit inclusion of these triggers would support consistent practice and timely referral while maintaining ethical safeguards.

Policy 2.15.L – Brain-Dead Donors Recovered Using DCD Protocols
Indiana Donor Network supports the addition of Policy 2.15.L to provide guidance for brain-dead donors recovered using DCD protocols. We request clarification that when a patient has been formally declared brain dead prior to initiation of the DCD recovery process, no additional declaring physician or advanced practice provider is required at the time of recovery. Additionally, we encourage OPTN to consider policy language that supports offering families a dignified presence in the operating room when appropriate, in collaboration with the donor hospital, and to the extent practicable, in a manner that respects cultural or religious practices.

NOTA and Final Rule Considerations
Indiana Donor Network agrees with the requirement that donor hospital physicians and other healthcare professionals be provided with information regarding safeguards for patients in the organ donation process. We recommend that responsibility for this education not be limited to OPOs, but that donor hospitals assume accountability for ensuring that staff receive, acknowledge, and integrate this information into hospital donation policies and procedures.

Documentation and Implementation Considerations
For implementation of the proposed policy changes, Indiana Donor Network recommends that OPTN require documentation of the timing of donor authorization, including the specific clinical information or communication provided to the OPO that triggered the donation discussion.

We caution against the use of automatic triggers for unplanned DCD pauses, given the clinical complexity of DCD eligibility. Certain patients may not meet neurologic criteria yet remain dependent on life-sustaining therapies, such as extracorporeal membrane oxygenation (ECMO), where withdrawal of support is expected to result in death. Evaluation of DCD candidacy must account for the full clinical context and not rely solely on neurologic parameters.

Indiana Donor Network supports OPTN in establishing a defined waiting period of five (5) minutes of circulatory cessation, consistent with existing OPTN recommendations.

Unplanned DCD Pauses and Notification Requirements
Indiana Donor Network agrees with the requirement for OPOs to report unplanned DCD pauses and that transplant programs with accepted organs at the time of a pause should be notified. However, we do not support a requirement to notify future transplant programs of a prior unplanned pause when DCD is subsequently resumed, particularly in circumstances where a patient is later determined to be an appropriate candidate for withdrawal of life-sustaining therapies and such withdrawal is elected by the patient or the patient’s authorized decision-maker in conjunction with the hospital care team.

Saravanan Thangarajan | 1/16/2026

I appreciate the work on these DCD updates. After reviewing the proposal, my main concern is that the draft is stronger on documenting problems after the fact than preventing harm in real time.

If the goal is patient safety and public trust, I recommend strengthening three areas:

1. Define “verification” with a minimum clinical standard
   The policy asks OPOs to verify that neurological assessments are being conducted, but it does not define what qualifies as an adequate assessment at the moment of DCD progression or an unplanned pause. Without a shared checklist and minimum documentation expectations, “verification” becomes subjective. The policy should require standardized documentation of neurological status and relevant confounders such as sedation or paralytics.
2. Make a DCD pause a true stop-work mechanism
   Allowing staff and families to call a pause is important, but the policy must ensure the pause has operational force. In real hospital settings, hierarchy and OR time pressure can discourage escalation. Once a pause is initiated, forward procurement steps should be automatically suspended until the concern is reviewed and formally resolved by an accountable hospital authority independent of the OPO.
3. Require specific authorization for NRP, not only disclosure
   NRP is treated as a required disclosure item, but disclosure is not consent. A process that restores circulation after death determination is ethically sensitive and should require explicit opt-in authorization in plain language, including what safeguards will be used to prevent cerebral perfusion. Families should also have a clear option to authorize donation without NRP where feasible.

These changes would make the policy more enforceable at the bedside, strengthen trust with families, and better align the pause mechanism with patient safety rather than administrative reporting.

Kasper Statz | 1/16/2026

As an OPO Professional, I support the proposed inclusion of new OPTN Policy 2.15.L Potential Brain Dead Donors Recovered Using DCD Protocols. It is not uncommon for families of brain dead donors to wish to be present during their loved one’s last heartbeat and it is welcome to have policy guidance for the OPOs on appropriate organ allocation in these circumstances and lack of a need for a waiting period after circulatory cessation (new language in 2.15.J).

I do fear that the proposed requirements for unplanned pauses in the context of disagreements of medical opinion between the potential DCD donor’s hospital care team sets alarmingly unreal expectations for the OPO to slow or halt the withdrawal of life sustaining therapies when we come to agree with the dissenting opinion that the patient is neurologically improving. In Appendix B, one of the hypothetical examples of situations that would constitute a reportable unplanned pause (Scenario 2B) has a bedside nurse who believes the patient’s neurological status is obscured by medications but does not have the support of the attending physicians to overturn the decision to withdraw life support. As an OPO we can certainly agree that there is a serious concern that there is a chance for the patient’s recovery and refuse to move forward with organ donation so as to not ethically taint the process, but it not at all within our power to intervene and stop the withdrawal. The potential donor at all times remains a patient of the hospital and it is ultimately the hospital’s responsibility to do what is best for the patient.

Sharing Hope SC | 1/16/2026

Thank you for the opportunity to comment. We are Sharing Hope SC (SHSC) supports the OPTN's goal of advancing transparency, consistency, and trust in Donation after Circulatory Death (DCD) protocols. We agree with key proposals, including standardizing family information and consent processes, establishing an operational pause for unplanned DCD, conducting regular neurological reassessments, and strengthening monitoring and reporting. Our specific recommendations are detailed below.

DCD policy must remain distinct from palliative care standards and delivery. Palliative care responsibilities include developing protocols for pain relief and sedation, as well as managing symptoms effectively. These hospice workflows are clinical decisions and must not be prescribed by DCD policy. DCD activities should only begin after a palliative plan is established and must not alter or delay comfort‑focused care. Because OPOs do not provide health care as a matter of law, palliative decision-making must not be delegated to OPOs or other groups.

SHSC supports a pause for unplanned DCD, but it requires a national, clear, and time-bound pathway. The OPTN should define steps for resolution, set criteria for resumption, and mandate neutral facilitation to mitigate conflicts, rather than delegating outcomes to individual hospitals. The family's right to pause must be included in standardized authorization forms for uniform disclosure and documentation. We suggest that the OPTN provide essential implementation tools, such as a DCD case note template for disclosures and a standardized Patient Safety Portal reporting template. We also agree that OPO contact with families should occur only after the clinical team initiates end-of-life discussions.

While not contemplated in the OPTN’s policy proposal, the OPTN should issue guidance for DCD transfers to donor care units (DCUs), especially when the DCUs are free-standing and not hospital based. Because patients have not been declared at the time of transfer, standardized criteria and safeguards for appropriate care, coordination, and handoffs are necessary to protect patients and families and to maintain public trust.

SHSC supports regular neurological reassessments but does not endorse a universal twelve-hour cadence, which can be clinically inappropriate. Instead, SHSC recommends a neurological confirmation within two hours prior to withdrawal of life-sustaining treatment (WLST), with any further reassessment left to the clinical team’s judgment and hospital policy. The OPO’s role is to verify that this confirmation occurred; it is critical that OPOs do not direct or influence WLST determinations.

For clarity, any policy “waiting period” should refer to the non-perfusing rhythm observation period used to confirm circulatory cessation (for example, five minutes), not the operational WLST-to-death window. The latter may vary by case and facility. The OPTN should use precise terminology, “observation period,” for the non-perfusing rhythm requirement to avoid conflating it with WLST-to-death timing. Operational WLST-to-death windows (for example, the commonly used 120-minute threshold) should remain within OPO protocols in collaboration with hospitals, rather than being defined as a national policy “waiting period.”

WLST is a clinical decision made with the patient or their proxy in conjunction with the health care provider. OPOs must not be involved. The OPO role should be limited to determining DCD eligibility, disclosure, and documentation. While OPOs can report neurologic status changes, the WLST decision is strictly a clinical one. A pause in care is a clinical or family decision that OPOs only document. Additionally, the term "unresolved differences" must be clarified or removed to avoid ambiguities or imply that OPOs resolve WLST disputes.

SHSC urges the OPTN to recognize that OPOs function as the “messenger” of policy in these sensitive timelines and to pair new OPTN requirements with HRSA/CMS-backed compliance mechanisms for hospitals. Specifically, SHSC recommends a centralized complaint channel for hospital non-support, or non-compliance tied to HRSA/CMS oversight, to ensure uniform adherence and avoid placing OPOs in an adjudicative posture.

Information provided to the family about NRP should be uniform, where appropriate, and should include an explanation of the risks, safeguards, and procedure, with a separate acknowledgment so OPOs can document disclosure without overwhelming families. 

Informed consent is required for premortem interventions, and under the current and proposed policy, the OPO's role is to confirm consent was obtained. We would appreciate clarity from the OPTN regarding all procedures and administrations related to donation that require informed consent and guidance regarding whether the OPTN requires the provider or the OPO to obtain informed consent. It may be preferrable, instead of separate consent for medications like heparin, for the OPO to confirm that the patient or family was informed of all medications administered near the time of withdrawal.

Responses to the OPTN’s Considerations for the Community

• How might the OPTN identify, report, or evaluate whether the decision to withdraw life sustaining therapies was subjected to undue influence by the donation decision? Is there a clearer way to define responsibilities regarding the timing of the family discussion for donation?
  • The OPTN should require documentation that end‑of‑life discussions were initiated by the clinical team before any OPO donation discussion, coupled with a standardized attestation that the WLST decision was not influenced by donation. Post‑implementation monitoring should include targeted review of cases flagged for potential undue influence based on predefined indicators (e.g., timing of authorization relative to WLST discussions), with the OPTN Contractor sampling records for policy compliance. Role clarity should reflect that hospitals lead clinical EOL and WLST decisions; OPOs may speak with families once EOL discussions begin, and OPOs must not participate in WLST determinations.
• Should the OPTN add any automatic triggers for an unplanned DCD pause into policy, or provide any supplemental guidance or education regarding situations that may warrant additional caution when assessing patient neurological status?
  • The OPTN should not hard‑code automatic triggers in policy due to clinical variability but should issue supplemental guidance and education identifying higher‑risk contexts (e.g., overdose, anoxic injury, discordance between exam and imaging) where heightened caution and immediate reevaluation are warranted. The OPTN’s Policies should continue to empower any stakeholder to request a pause and require an OPO/hospital convening to reassess WLST appropriateness.
• Should the OPTN define a minimum waiting period of circulatory cessation in Policy 2.15.J Organ Recovery? If so, how long should the minimum waiting period be, and why?
  • Yes. SHSC supports codifying a five‑minute non‑perfusing rhythm observation period to confirm circulatory cessation, consistent with the OPTN/HRSA safety alert, while explicitly stating that this observation period is distinct from the WLST‑to‑death operational window.
• Are the requirements for OPOs to report unplanned DCD pauses clear? Are there areas where the OPTN should consider improvements to make the language clearer?
  • The requirements for reporting unplanned DCD pauses are unclear. The proposed 24-hour reporting window is unrealistic, as it is often difficult to obtain timely information from clinical teams. The OPTN should extend this to 72 hours. To improve the process, the OPTN should: (1) provide a plain‑language decision tree to distinguish reportable "pauses" from routine clinical events; (2) embed the reporting template (Appendix A) directly into the portal form for efficiency; and (3) require OPOs and hospitals to maintain a joint pause‑response protocol that includes neutral facilitation and clear criteria for resumption.
• Should the OPTN recommend these proposed OPTN policies be approved by the Secretary of Health and Human Services and made enforceable by HHS, in accordance with the process outlined in the OPTN Final Rule?
  • Yes. Given the patient‑safety focus, the cross‑stakeholder roles, and the need for hospital compliance, SHSC supports HHS approval and enforceability under the Final Rule. This would bring necessary federal oversight, align with HRSA’s directive, and provide the compliance leverage required for uniform execution across hospitals and OPOs.

Hospital of the University of Pennsylvania, Penn Transplant Institute | 1/16/2026

The Penn Transplant Institute commends HRSA and the OPTN for their leadership and commitment to enhancing the Donation after Circulatory Death (DCD) policy. We support the ongoing efforts to improve safeguards, transparency, and uniformity in the DCD process. Our comments below provide specific examples and actionable recommendations to further clarify and strengthen the policy for the benefit of patients, donor families, and the transplant community.

Clamp Time Definition

• Case Example: In a recent DCD case, an OPO recorded the clamp time at the start of abdominal normothermic regional perfusion (NRP), while the transplant center documented it at the initiation of cold flush. This discrepancy led to confusion regarding the official warm ischemic time, ultimately delaying organ allocation decisions and raising concerns about organ quality.
• Recommendation: Adopt a standardized definition of “clamp time” (such as initiation of aortic cross-clamp for cold flush or start of NRP) to be used by all OPOs and transplant centers. Clearly state this in policies and reflect it in data reporting and quality metrics. Specify handling when DCD cases involve two clamp times (e.g., for thoracic vs. abdominal organs), since NRP in abdominal organs may have a different clamp time than for lungs.

Reporting Requirements

• Example: Current reporting requirements mandate submission of multiple overlapping time points and procedural details for each DCD case. In practice, OPO personnel have reported spending significant time reconciling minor discrepancies between systems (e.g., EHR vs. OPO logs), which detracts from clinical duties and may not meaningfully improve oversight.
• Recommendation: We recommend streamlining reporting by focusing on essential, high-value data elements directly related to donor safety, organ quality, and recipient outcomes. Non-essential fields should be eliminated or made optional, reducing administrative burden while preserving transparency.

Neurological Assessment

• Scenario: In some regions, OPO staff have participated in neurological assessments to expedite DCD authorization. This has led to concerns among hospital staff and donor families regarding impartiality and potential conflicts of interest, as OPOs have a vested interest in proceeding with donation. For example, in one instance, questions arose when an OPO coordinator co-signed a neurological reassessment, resulting in the family requesting an ethics review.
• Recommendation: To ensure trust and transparency, we recommend requiring that all neurological assessments and reassessments for DCD eligibility be performed and documented by an impartial third party, such as a hospital-employed neurologist or critical care physician unaffiliated with the OPO or transplant team. Alternatively, an independent ethics consultant or designated hospital oversight committee could fulfill this role. The policy should specify the required qualifications and independence of these individuals.

Pre-mortem Interventions

• Comment: The current allowance for certain pre-mortem interventions, such as cannulation, raises ethical concerns, as these procedures do not benefit the donor and may cause discomfort, especially in cases where sedation is incomplete or variable.
• Recommendation: We recommend revising the policy to prohibit non-therapeutic pre-mortem interventions unless explicit comfort measures are provided and documented. The policy should include clear consent requirements and guidelines for pain management when pre-mortem procedures are deemed necessary.

Conclusion

In summary, we urge HRSA and the OPTN to address the above issues by clarifying key definitions, streamlining reporting, mandating independent third-party neurological assessments, and revising the approach to pre-mortem interventions. We welcome further dialogue and collaboration to ensure the DCD policy advances both ethical and clinical best practices.

Vanderbilt Transplant Center | 1/16/2026

On behalf of Vanderbilt Transplant Center, we appreciate the opportunity to provide feedback on this proposal. We support the proposed changes, particularly the requirement that individuals involved in the DCD process have the authority to initiate a pause, the standardization of procurement practices among OPOs, and the expansion of information provided to potential donor families.  We also recommend that the OPTN define a standardized minimum waiting period following circulatory cessation and advance greater standardization of the DCD donation process overall.  Additionally, we encourage the OPTN to evaluate the need for distinct protocol requirements for adult versus pediatric donors, as these populations present different clinical and ethical considerations and should not be governed by a single uniform approach.

Missouri Kidney Program | 1/16/2026

The Missouri Kidney Program appreciates the opportunity to provide public comment on the OPTN proposal for developing a formal policy guiding Donation after Circulatory Death (DCD) practices. We support the creation and implementation of a standardized DCD policy, which is a crucial step toward enhancing transparency and public trust in the organ donation system.

We agree that all individuals involved in the DCD process, including OPO staff, donor families, and hospital clinicians, should have an explicit ability to request a pause at any point if concerns arise. Preserving this opportunity is fundamental to maintaining trust between donor families, the organ donation community, and the general public.

We also support the requirement for Organ Procurement Organizations (OPOs) to confirm with hospital clinicians that appropriate neurological assessments have been conducted. This ensures accuracy and aids in ethical decision-making. These assessments also facilitate thorough documentation and support the review process, ultimately promoting standardized practices and continuous quality improvement across OPOs, which is crucial in maintaining full transparency with donor families throughout the Donation after Circulatory Death (DCD) process.

Gloria DeBlanc | 01/16/2026

As a nonmedical member of the public with no clinical background, I am concerned that the current proposal related to Donation after Circulatory Death (DCD) does not sufficiently explain the specific procedures involved—particularly Normothermic Regional Perfusion (NRP)—in a way that is understandable to donors, donor families, donor patient agents, and caregivers.

For informed consent to be meaningful, all parties must have a clear and transparent understanding of what will occur during the donation process. This includes how NRP is performed, what physiological functions are restored or supported, how circulation is managed, and what safeguards are in place to ensure respect for the donor and adherence to ethical standards.

I believe the proposal would be strengthened by explicitly requiring detailed, plain-language explanations of NRP as part of the consent and education process. Without full disclosure and clarity, families and donor representatives may not be able to make truly informed decisions at an already difficult and emotionally vulnerable time.

I respectfully urge OPTN to ensure that any policy involving NRP includes comprehensive, understandable information for nonmedical stakeholders so that transparency, trust, and informed consent remain central to the organ donation process.

Anonymous | 1/17/2026

I am opposed to the suggestion to allow discussions for organ donation to take place once end of life discussion is introduced with the potential deceased donor’s agent, and before a final WLST decision is made, for the following reasons.

1. The ethical cornerstone for DCD is the avoidance of conflict of interest. The decision to WLST must be made before the discussion of organ donation to avoid conflict of interest. This has been clearly defined in the published literature by all of the appropriate major medical societies, starting with the Institute of Medicine in 1997, the ethics committee of the Society of Critical Care medicine in 2001, and the combined ethical statement of the AST/ISHLT/SCCM/AOPO/UNOS in 2012. The decision to WLST must be decoupled from the authorization for organ donation to preserve the integrity of the transplant system and public trust.
   OPOs now want to support and educate the families on organ donation before they have made the final decision to WLST. I see this as an ethical slippery slope, and there is no way to objectively state that after introducing the topic of organ donation that it did not have an undue influence on the decision to WLST. Everybody agrees that the decision to WLST should be made independently. I do not believe there is any way that a policy can be made that excludes undue influence unless the WLST decision is made beforehand.
   Although this practice of timely conversations has been going on for several years, I made a PubMed search and could not find a single article supporting this process from an ethical standpoint. In fact, I could not find any peer-reviewed publication on this topic.
2. Many hospital DCD policies specifically state that the decision to WLST must occur before the discussion of organ donation. Allowing the OPO to discuss organ donation before a firm decision to WLST could potentially violate the hospital policy. As a critical care physician with over 35 years of experience discussing end of life care with families, I feel that early discussion of organ donation could impair, if not destroy, the intensivist-OPO relationship. The CCMD has developed a trusting relationship with the family to provide the best care for the patient. If the concept of organ donation is introduced before the family and doctor have agreed that WLST is the best course of action for the patient, that could destroy all trust with the family. Personally, I would never allow the OPO to approach the family prior to the WLST decision is made, unless the family requested information about organ donation on their own volition.
3. As mentioned above, I believe early organ donation conversations are an ethical slippery slope. Given the current hypercritical environment of OPOs by the government, journalists, OPO employees, and the public, I would not do anything that remotely hints at being an ethical “gray area”, i.e. blurring the lines of conflict of interest. Given the overwhelming historical support for keeping the decision of WLST independent of organ donor authorization, with WLST first and donor authorization second, any attempt to approach a family before a WLST decision is made could be construed as unethical and potentially flame the fires of public distrust.
4. Since there are no published statements on the ethics of early conversation of organ donation, I recommend that the OPTN or HRSA request an opinion from the ethics committees of the transplant and critical care societies about timing of family discussion about DCD organ donation and the decision to WLST, before making any policy changes. I understand that the Workgroup had representatives from multiple specialties, including ethics, and they suggested that the organ donation discussion could be allowed once EOL discussions have started, but it should not influence the decision to WLST. In this situation, I see no way that avoidance of undue influence can be regulated by the OPTN. A formal statement from the Ethics committees would be very helpful.

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 for OPTN Donation after Circulatory Death (DCD) Policy Development:

Accuracy in Neurological Assessment and Appropriate Neurological Reassessments

MOMA is supportive of accurate neurological assessments conducted every 12 hours and two hours prior to going to the operating room; however, it is not the responsibility of the OPO to ensure accurate neurological assessments, nor can OPOs dictate hospital timing of such assessments. Because the potential donor is still living, the responsibility to conduct accurate neurological assessments off sedation and identify appropriate times to conduct neurological reassessments is that of the hospital’s medical staff.

Unplanned DCD Pause

MOMA’s standard practice is to allow a donor family to pause the DCD process at any time.

MOMA supports defining and reporting unplanned pauses. MOMA has concerns with the language that allows for a pause if there is “potential for a patient to experience pain during the act of procuring organs.” At the point of organ procurement, the patient has already been declared dead and therefore would not have potential to experience pain. MOMA has concerns that this language could result in misconceptions about when organ procurement occurs, and alarm the general public, resulting in fewer authorizations for donation and ultimately reducing lives saved through transplant.

MOMA agrees that all stakeholders should be educated on unplanned pauses and related protocols as part of routine hospital training. MOMA supports the inclusion of language around unplanned pauses in hospital contracts with OPOs. MOMA is concerned with the requirement that all hospital personnel involved in the case be informed of the unplanned pause; this would have to occur with every shift change and would be tedious and difficult to track for compliance. MOMA believes that conducting routine training for hospital personnel on this topic would have a stronger impact and be less burdensome to hospital staff and the OPO.

MOMA agrees that transplant centers need to be aware of a pause and/or the decision to resume procurement if a transplant center has already accepted an organ. However, MOMA seeks to understand the benefit of requiring operating room staff, preservation staff, and other third-party stakeholders to be informed of a pause if the family, hospital staff, and OPO ultimately agree to move forward. This requirement seems to be an undue burden and could result in unnecessary confusion.

MOMA does not believe there should be automatic triggers for an unplanned DCD pause added into policy.

Information Shared with Donor Families

MOMA agrees that families should be well-informed of the DCD process.

MOMA has concerns with:

• Providing families with estimated time frames for donor evaluation and organ recovery, as these vary widely for each case, and are dependent on a variety of factors outside of the OPO’s control, e.g., hospital practice, organ eligibility, and transplant center logistics.
• Describing the need and process for a donor risk assessment interview. The language is in the existing donor risk assessment interview already provides information to families on this.
• Providing families with allocation process information and timeframes for updates on allocation process. As stated above, timeframes depend on a variety of factors outside of the OPO’s control, and it could cause confusion and additional distress for families if timeframes do not adhere to what was provided to them.
• Additional information specific to the DCD process as outlined in the Committee’s proposal. Currently, the DCD process is explained to the family and is described in the DCD authorization form. There is no way to document this information in DonorNet; how would this information be tracked by the OPTN? What is the problem the Committee is seeking to solve by requiring this information?.

Timing of Family DCD Donation Discussion

MOMA supports standardizing practice and policy surrounding the timing of discussions with families about DCD Donation, to ensure they are making an informed decision about donation, without influencing the decision to withdraw life sustaining therapies. The decision of whether or when to withdraw life sustaining therapies is not one that an OPO should have a role in. MOMA believes the role of the OPO is to provide support to families, educate about donation and seek authorization for donation in alignment with family and hospital staff As such, MOMA recommends that policy should include an explanation of the evaluation process to trigger a discussion about donation, and a requirement that consistent communication between hospital staff and OPO staff occur to determine the appropriate time to have such discussions with the family based on family dynamics.

Use of DCD Recovery Protocols for Brain Death Donors

MOMA supports this language and believes it provides clarification and appropriate direction for how OPOs, hospitals, and transplant centers should conduct their responsibilities in such instances. If a donor is brain dead, but the family elects to treat the process as a DCD, MOMA does not believe a five minute wait period is needed.

Additional Questions posed by OPTN:

1. Should the proposed policies be approved by the Secretary and made enforceable by HHS, in accordance with the process outlined in the OPTN regulations at 42 CFR 121.4(b)(2) and c? MOMA believes that there should be standardized processes across the OPO industry to ensure that every community is served by a high-performing OPO.
2. How might the OPTN identify, report, or evaluate whether the decision to withdraw life sustaining therapies was subjected to undue influence by the donation decision? Is there a clearer way to define responsibilities regarding the timing of the family discussion for donation? MOMA believes that the decision to withdraw life sustaining therapies should not involve the OPO. As such, MOMA recommends standardization of process around this, along with clear and consistent documentation to ensure clearly defined responsibilities among the OPO, hospital, and the family.
3. Should the OPTN define a minimum waiting period of circulatory cessation in Policy 2.15J organ recovery? If so, how long should the minimum waiting period be and why? MOMA believes a five-minute waiting period is considered best practice.

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

Southwest Transplant Alliance | 1/17/2026

Unplanned DCD Pause
We believe the language used to describe a pause is insufficient. All stakeholders identified (the patient or patient’s agent, donor hospital staff, OPO staff, and third-party procurement and preservation staff) should be informed of their ability to call for a pause in the DCD donation process – not just what is defined as an unplanned one. A stakeholder’s ability to call for a pause (similar to a “stop the line”) should not be conditioned on whether, following the pause, there may be a difference of opinion regarding the appropriateness of the withdrawal of life sustaining therapies. It is not until after the pause itself is called that the circumstances regarding the patient’s status as a potential DCD donor would be evaluated and a determination made whether to proceed with the DCD donation process. Only if the decision to proceed is not unanimous among all stakeholders involved at the time, and only if the DCD donation process continues following that disagreement, should the pause itself then become what is referred to as an “unplanned DCD pause” and be reportable to the OPTN. We believe this needs to be expressed clearly in the revised policy to achieve what we believe to be the intended result: (a) that all are informed of their ability to pause the process, and (b) only when all do not agree to proceed with the DCD donation process but it does proceed is there an event that is reportable to the OPTN.

Accuracy of Neurological Assessment
We are concerned that, under 2.2.8, OPOs would now be responsible for “ensuring accuracy in neurological assessment . . . .” To ensure accuracy, the OPO would have to conduct their own neurological assessment, which would be inappropriate. OPOs might be able to reflect on whether a neurological assessment seems reasonable, but it is inappropriate for the OPO to be responsible for determining whether it is accurate. Reference to Policy 2.15.C is inconsistent here as well, given the language in 2.15.C instead provides that the “OPO and primary healthcare team must confirm that withdrawal of life-sustaining therapies remains appropriate” without reference to the accuracy of neurological assessments. The language in Policy 2.15.C seems appropriate and should be reflected in 2.2.8.

Condition to OPO Discussions
We agree with and appreciate the revision to 2.15 that provides OPOs the ability to initiate discussions about organ donation after end-of-life discussions have been initiated with the patient or the patient’s agent. This condition is much better reflection of the circumstances and would serve the needs of the patient or the patient’s agent better than current practice, where they are first approached about donation only after electing to withdraw life sustaining medical treatment.

DCI Donor Services, Inc. (DCIDS) | 1/17/2026

DCI Donor Services, Inc. (DCIDS) appreciates the opportunity to comment on the proposals included in the HRSA Directive for OPTN Donation after Circulatory Death (DCD) Policy Development. We believe it is a critical time to reexamine and standardize processes related to DCD and commend OPTN and the OPO Committee for the care and attention given to this topic. We believe any changes in policy should include a transparent process including a variety of stakeholders in order to uphold safety, dignity, and trust in the organ recovery process.

DCIDS is a top-performing, nonprofit healthcare organization committed to saving and improving lives through organ, eye and tissue donation. Our organization is comprised of three federally designated organ procurement organizations: Tennessee Donor Services, Sierra Donor Services, and New Mexico Donor Services. We are dedicated to honoring Donor Heroes and their gifts by pursuing every opportunity to recover, preserve and transport those gifts to the patients who are waiting for their second chance at life. 

DCIDS Commitment to Improving the DCD Process

DCIDS recognizes the importance of this effort and, in 2025, initiated the formation of a Donation after Circulatory Death (DCD) Advisory Board to further strengthen trust and integrity within the DCD process. This multidisciplinary group brings together community healthcare providers, hospital thought leaders, donor family members, and other key stakeholders involved in the donation process.

The Advisory Board is focused on advancing standardized DCD practices, fostering trust among the public and healthcare professionals, and enhancing transparency and engagement throughout the DCD process. Through this initiative—working in parallel with OPTN efforts, DCIDS remains confident in its ability to meaningfully improve DCD practices while reinforcing the safeguards necessary to uphold the integrity of the donation process and the broader transplantation system.

Grounded in our deep history in organ donation and transplant, we offer the following comments for consideration.

Considerations for the Community

• How might the OPTN identify, report, or evaluate whether the decision to withdraw life sustaining therapies was subjected to undue influence by the donation decision? Is there a clearer way to define responsibilities regarding the timing of the family discussion for donation?
  • DCIDS believes the best time to engage a family about DCD donation is after the family and the HCT have discussed goals of care that center around end-of-life.
  • Additionally, DCIDS recommends revising the language surrounding the timing of the donation discussion. We propose the following language: “Decisions regarding the withdrawal of life-sustaining therapies should be determined exclusively by the healthcare team and the patient’s family based on the patient’s medical status, prognosis, and end-of-life goals, and must remain entirely independent of any organ donation considerations”
• Should the OPTN add any automatic triggers for an unplanned DCD pause into policy, or provide any supplemental guidance or education regarding situations that may warrant additional caution when assessing patient neurological status?
  • The OPTN and HRSA should engage the American Hospital Association regarding these new policies and practices to ensure engagement and understanding at the national level, while the OPOs can help drive education at a local level.
  • DCIDS recommends the OPTN engage the critical care community to help identify a defined waiting period for WLST for instances of patients with hypoxic injury.
  • DCIDS supports the implementation of a consistent, standardized process for OPOs when an unplanned pause occurs and recommends the development of a corresponding strategy to ensure hospital accountability and consistent adoption of unplanned pause practices.
• Should the OPTN define a minimum waiting period of circulatory cessation in Policy 2.15.J Organ Recovery? If so, how long should the minimum waiting period be, and why?
  • Yes, DCIDS supports a minimum waiting period of 5 minutes, in alignment with the 2025 ASTS position statement, the Institute of Medicine position, and the NEJM study by Dhanani et al.
• Are the requirements for OPOs to report unplanned DCD pauses clear? Are there areas where the OPTN should consider improvements to make the language clearer?
  • In general, we support the unplanned pause, yet it will be important for the OPTN to share findings and report events to the OPO and transplant community on a routine basis. Learning from the collective experiences will be of paramount importance.
• Workgroup recommended that the OPO and primary healthcare team must confirm that withdrawal of life-sustaining therapies remains appropriate. This reassessment must occur at least every 12 hours from the time the OPO initiates the donation process, and within 2 hours prior to the planned withdrawal of life sustaining therapies.
• DCIDS sees the assessment and planning of the withdrawal of life sustaining therapies (WLST) fully the responsibility of the hospital and family, and not the scope nor responsibility of the OPO. We have concern with scope in this capacity, specifically that this is a living patient and the healthcare team (HCT) has oversight and direction of this patient’s care and assessment. The ability for the OPO to determine if a patient may experience pain is an assessment and intervention outside the scope of the OPO and there is no clear guidance for what the OPO should do if there is the potential for the patient to experience pain. This evaluation lies fully in the scope of the HCT. We experience inconsistency in the hospital processes around WLST and we see value in consistency in practice, at the hospital level. We believe the responsibility to communicate a change in the WLST to fully live with the hospital care team. In fact, in recent discussions with hospital providers regarding this proposal, they reinforced it being their responsibility and scope to fully manage the WLST process and to communicate any changes therein back to the OPO.
• DCIDS supports the need for National standardization of the DCD Process- Creating clear national guidelines to spearhead all steps of DCD (including NRP) so OPO’s and transplant centers follow the same standards across the country. These standards are crucial to help educate families, healthcare providers, and the public, creating more transparency within the organ donation ecosystem.

Conclusion

Thank you for the opportunity to comment on the HRSA Directive for OPTN Donation after Circulatory Death Policy Development. We welcome any further opportunity to provide information to the Organ Procurement and Transplantation Network on our work with our own DCD program and finalizing a DCD policy that keeps patient safety and donor trust as the priority.

LifeLink of Georgia | 1/17/2026

Thank you for the opportunity to provide public comments on the proposed policy changes. We appreciate the OPTN’s commitment to continuous improvement and are grateful to the many volunteer committee members and subject matter experts who dedicate substantial time and expertise to developing and refining OPTN Policy. We submit the following comments in the spirit of collaboration and shared accountability, with the goal of strengthening clarity, safety, and consistency in DCD practice to support donors, families, hospital partners, OPOs, transplant programs, and those awaiting a life-saving transplant.

Question #1: How might the OPTN identify, report, or evaluate whether the decision to withdraw life sustaining therapies was subjected to undue influence by the donation decision? Is there a clearer way to define responsibilities regarding the timing of the family discussion for donation?

The OPTN cannot reliably determine whether the withdrawal of life-sustaining therapies (WLST) was influenced by donation by attempting to assess intent after the fact. However, the OPTN can require auditable safeguards that reduce the risk of undue influence and enable meaningful oversight through documentation-based review. Accordingly, OPTN oversight should focus on verifiable process controls, including role separation and conversation timing, and evaluate compliance through a combination of (1) routine, risk-based sampling of DCD cases during member review/site surveys and (2) triggered review when risk indicators, complaints, or patient safety reports arise.

That said, the OPTN should avoid adopting a rigid sequencing rule that inadvertently undermines patient- and family-centered communication. The proposed requirement of “prior to the OPO initiating any discussion… the host OPO must confirm with the patient’s healthcare team and document that end-of-life discussions have been initiated with the patient or patient’s agent” is directionally appropriate as a guardrail but may be operationally challenging if interpreted narrowly as requiring contemporaneous documentation before any donation-related information may be provided.

Real-world circumstances do not always unfold in a linear, well-documented sequence. For example, the treating team may not document end-of-life discussions in real time; a family (or patient) may signal readiness or directly request information about donation before that documentation exists; or a patient may be critically unstable and near circulatory collapse at the moment they express a desire to discontinue life-sustaining therapies. In these settings, a strict “no discussion until documented” interpretation could delay timely, appropriate information-sharing and create unnecessary distress, or may risk the loss of a donation opportunity.

Policy can protect against coercion while honoring autonomy by distinguishing information-sharing from authorization. Specifically, OPTN policy should permit donation-related information once end-of-life discussions have been initiated (confirmed with the healthcare team), while explicitly allowing earlier limited information when indicated and when the patient/agent requests it, paired with clear guardrails that WLST decisions remain clinician-led and independent of donation. This approach is consistent with the proposal’s intent to establish a defined time point for donation discussions (i.e., after end-of-life discussions are underway) while reinforcing the principle that “the decision to withdraw life sustaining therapies should not be influenced by the donation decision.”

In addition, the OPTN should clarify that end-of-life decision-making relevant to controlled DCD includes not only withdrawal of life-sustaining therapies but also the withholding of life-sustaining therapies when clinically appropriate and when the patient or surrogate agrees (e.g., decisions to forgo escalation, continue ventilatory support without further life-prolonging interventions, or allow death to occur on the ventilator under a comfort-focused plan). This is important because the proposal repeatedly frames the pathway in terms of “withdrawal of life sustaining therapies” and “withdrawing life sustaining medical treatment or ventilated support therapies,” without explicitly addressing withholding decisions as part of the same ethical and procedural separation from donation. Clarifying that both withholding and withdrawal are within scope would better reflect real-world end-of-life care and reduce the risk that policy language inadvertently narrows acceptable practice or creates interpretive gaps.

Finally, it may be helpful for OPTN to clarify responsibilities and oversight by explicitly identifying auditable indicators of appropriate separation (e.g., documented confirmation that end-of-life discussions were initiated; documentation of role boundaries; and use of standardized terminology), rather than attempting to infer undue influence based on subjective impressions. This is particularly important given the proposal’s broader emphasis on standardization, public trust, and consistent safeguards across DCD practice.

Question #2: Should the OPTN add any automatic triggers for an unplanned DCD pause into policy, or provide any supplemental guidance or education regarding situations that may warrant additional caution when assessing patient neurological status?

The OPTN can achieve the underlying intent of “automatic triggers” by defining pause-eligible conditions that may require the OPO and donor hospital to initiate an unplanned DCD pause when credible concerns arise. At the same time, we do not believe it is necessary or prudent to codify automatic triggers as rigid, prescriptive thresholds. The workgroup appropriately noted that apparent neurologic “changes” may not always represent meaningful recovery, and overly rigid triggers could generate unnecessary pauses and unintended operational consequences.

Instead, OPTN should establish a clear definition of pause-eligible concerns. A pause-eligible concern should be defined as one that: (1) implicates ethical or process integrity (e.g., death determination); (2) creates a substantive question or dispute as to whether withdrawal of life-sustaining therapies remains appropriate under the donor hospital’s criteria and the patient’s goals of care; or (3) creates a substantive question or dispute that the DCD process is proceeding in an inappropriate or potentially unsafe manner such that stakeholders must reassess the patient and clinical circumstances.

Routine clinical deterioration that simply changes donor suitability or organ viability should continue to be managed through existing local workflows unless it triggers one of these conditions, consistent with the proposal’s intent that routine reevaluations are not unplanned DCD pauses.

The proposal’s decision not to codify specific triggers is mitigated to an extent by its inclusion of required neurologic reassessments, healthcare team check-ins, and reinforcement of an existing timeout prior to WLST, which together create standardized opportunities to identify concerns. OPTN should ensure these assessments and check-ins function as

meaningful control points by pairing them with clear documentation expectations and escalation criteria (i.e., what must occur when a pause-eligible concern is identified), rather than relying on education alone.

Question #3: Should the OPTN define a minimum waiting period of circulatory cessation in Policy 2.15.J Organ Recovery? If so, how long should the minimum waiting period be, and why?

The OPTN should define a minimum waiting period of circulatory cessation in Policy 2.15.J to reduce practice variation and eliminate the ambiguity that undermines public trust. The proposal already states that organ recovery may proceed only after circulatory death is determined, inclusive of a predetermined waiting period to ensure no auto-resuscitation occurs; however, leaving the duration undefined perpetuates inconsistency across donor hospitals and DSAs.

For controlled DCD, a 5-minute period is the most defensible national floor based on current evidence and professional/ society recommendations. It’s important to acknowledge that OPTN/HRSA issued a safety alert addressing rare cases of autoresuscitation, and five minutes is a reasonable balance between minimizing the risk of autoresuscitation and limiting ischemic injury. A standardized minimum is also necessary to support consistent application of the proposal’s new requirement to report any auto-resuscitation event that occurs beyond the waiting period required by Policy 2.15.J.

The OPTN should also clarify the sequencing in policy to resolve confusion about when death is determined and when recovery may proceed. Specifically, OPTN should: (1) specify a single, continuous 5-minute observation period beginning at confirmed circulatory cessation, and establish this as a standardized national minimum that balances autoresuscitation safeguards against avoidable ischemic injury; (2) clarify that the precise timestamp of pronouncement is less important than ensuring death is determined in accordance with applicable law and donor hospital policy (including who is authorized to declare death and where WLST and death determination occur); and (3) state that incision and organ recovery must not begin until the full 5 minutes of continuous observation have elapsed and a valid determination of death has been made.

In addition, the proposal’s reporting language underscores the need for greater precision. The proposal describes an auto-resuscitation event as the “spontaneous return of cardiac or respiratory activity” beyond the waiting period. That framing risks conflating electrical activity with return of perfusing circulation, which are not clinically equivalent in this context. Autoresuscitation should be clearly defined in policy to mean the unassisted return of perfusing circulation after declaration of death by circulatory criteria, without resuscitative interventions, i.e., the restoration of pulsatile arterial blood flow evidenced by one or more of the following: (i) a palpable pulse; (ii) a measurable arterial blood pressure (noninvasive or invasive), including a pulsatile arterial waveform when an arterial line is present; or (iii) other objective evidence of perfusing circulation documented by the treating team (e.g., doppler-confirmed pulse consistent with pulsatile flow). Electrical activity without evidence of perfusing circulation (e.g., PEA, ventricular fibrillation, agonal rhythms, or isolated myocardial contractions without a pulse or measurable blood pressure) should not constitute autoresuscitation.

Absent a clear definition, the policy risks prioritizing the appearance of a “pause mechanism” over meaningful clarity and safety.

Finally, the OPTN should acknowledge the implementation implications of regulating DCD practice in donor hospitals, most of which are not OPTN members. Any policy requirements related to determination of death (including the observation period) must be drafted to remain consistent with applicable state law and donor hospital policy.

Requirements that assume OPTN can standardize or supersede hospital- or state-governed death determination practices may be impractical. Accordingly, OPOs will need to operationalize these requirements through updated written protocols with donor hospitals.

Question #4: Are the requirements for OPOs to report unplanned DCD pauses clear? Are there areas where the OPTN should consider improvements to make the language clearer?

The proposed requirement for OPOs to report unplanned DCD pauses is directionally appropriate; however, the current policy language is not sufficiently clear to ensure consistent implementation across OPOs. The proposal’s intent of enhanced visibility and oversight is necessary, but the lack of clarity around what constitutes a reportable pause, who has responsibility and authority at each step, and when/how reporting must occur will make the requirement difficult to audit and effectively unenforceable in practice. The proposal’s own definition of an unplanned DCD pause as an “unexpected suspension of the DCD process due to a difference of opinion as to whether a patient meets the donor hospital’s criteria for withdrawal of life sustaining therapies” illustrates its core challenge: The trigger is framed in subjective terms that invite inconsistent interpretation across DSAs.

The proposal suggests the Committee will provide post-finalization education “to further clarify reportable cases.” Education would be helpful, but it is not an adequate substitute for clear policy language. If the rule depends on post-implementation guidance to define what is reportable and how requirements apply, variation and misinterpretation are inevitable. The policy itself should establish the minimum operational definitions and thresholds.

“Difference of opinion” should be replaced or supplemented with objective pause-eligible categories and minimum evidence standards. As written, “difference of opinion” is inherently subjective (who qualifies as “opinion holders,” what threshold matters, and what constitutes “meets criteria”). Policy would be clearer and more enforceable if it identified a limited set of reportable, pause-eligible concern categories and required a minimum documentation standard, including (a) documentation of the concern, (b) documented reassessment steps, and (c) a documented resolution decision to resume or stop. Illustrative categories could include:

• Objective neurologic improvement or credible concern for improving neurologic function as documented by the treating team;
• New evidence that the clinical trajectory no longer supports proceeding with WLST under the donor hospital’s criteria or that proceeding in the DCD pathway is no longer appropriate; and
• Other clearly defined DCD process-integrity concerns within the policy-defined time window between authorization and cross clamp.

Stakeholder definitions and notification requirements are internally inconsistent and create compliance ambiguity. Policy 2.2 lists stakeholders as the patient or patient’s agent, donor hospital staff, OPO staff, and third-party procurement/preservation staff, while the proposal text expands the stakeholder list to include transplant center staff. The proposal also requires convening and informing “all existing stakeholders” when a pause is requested, which is impractical without clear guidance on who counts as an “existing stakeholder” at a given moment and invites inconsistency.

To reduce ambiguity, the OPTN should consider adding a dedicated definition for “DCD stakeholder” that provides an explicit, policy-level list while preserving appropriate operational discretion for the host OPO to identify which stakeholders have a proximate need to be involved in a specific pause event. The policy should also preserve role separation by making clear that determinations regarding whether WLST remains appropriate under the donor hospital’s criteria and the patient’s goals of care are the responsibility of the treating team and patient/surrogate, not transplant programs.

This need for clarity is reinforced by the proposed resumption requirement, which states: “When the OPO determines that the DCD process can resume following an unplanned DCD pause, the OPO must obtain acknowledgment prior to organ recovery from all transplant programs that accept an organ from the donor and any contracted representatives, such as third party contractors, involved in organ recovery that they are aware that the unplanned DCD pause occurred and acknowledge the decision to proceed.” As written, this language does not clearly distinguish between transplant programs as stakeholders who must be informed (i.e., awareness of the pause and its resolution) versus parties positioned as decision-makers regarding whether it is appropriate to proceed with the DCD process. Requiring acknowledgment from “all transplant programs that accept an organ” as a condition of resumption, without clear scoping and documentation standards, risks creating undue operational burden and inconsistent application, particularly if interpreted broadly or applied to non-proximate parties.

Relatedly, OPTN should clarify what is meant elsewhere in the proposal/discussion by “provisional acceptance,” which is not a defined term in OPTN policy. If “provisional acceptance” is intended to mean a “provisional yes,” that could dramatically expand the number of programs implicated and create additional, unnecessary burden without a clear patient safety benefit.

OPTN should therefore: (1) clarify the intended scope of required acknowledgment (limiting it to programs with accepted offers that are actively engaged in the recovery episode and any mobilized recovery/preservation contractors); (2) define what constitutes “acknowledgment”; and (3) ensure the policy framework reinforces that transplant programs retain discretion to accept/decline organs, but are not positioned as arbiters of WLST appropriateness or as open-ended “gatekeepers” for resumption beyond those directly involved.

The OPTN should consider the unintended consequences of an overbroad acknowledgment requirement. Over-inclusion of non-proximate programs/contractors can create administrative churn and delay time-sensitive recovery steps without improving patient safety and may unnecessarily cast doubt on appropriately managed DCD cases once proximate stakeholders have resolved concerns and determined it is appropriate to proceed.

Reporting triggers and timing also require clearer operational definitions. While Table 18-5 and Policy 18.5.C.1 establish a general requirement to report within 24 hours of when the OPO “becomes aware” of a requested pause and specify required data elements, key terms remain ambiguous (e.g., what constitutes a “request,” what qualifies as “awareness,” and how to handle multiple pause episodes). OPTN should improve clarity by (i) distinguishing “pause requested” from “pause initiated”; (ii) defining “OPO becomes aware”; (iii) clarifying the “single episode vs. multiple episode” rule explicitly in policy (Appendix A suggests follow-up should not be a separate portal report unless a subsequent pause occurs after resumption, but policy text should not rely on an appendix in a policy proposal to establish a core compliance rule); and (iv) simplifying follow-up reporting into a universal “outcome update” requirement with a realistic timeframe and a clearly defined clock start including how to handle prolonged pauses that later resume.

Finally, while it is appropriate that the proposal clarifies a paused case may later restart if the patient is again deemed suitable for WLST and the patient/agent and donor hospital elect to proceed, OPTN should clarify whether restart triggers any additional “reset” requirements (e.g., renewed documentation of WLST appropriateness, re-disclosure, re-notification/acknowledgement by transplant programs, and whether a new report is required). Without that clarity, the restart provision may unintentionally create circular or inconsistently applied obligations.

An unplanned DCD pause process is critical to establish, but it must be a clearly defined, standardized, and auditable event. The policy should be replicable and efficient in high-acuity settings and free of ambiguity regarding: (a) who qualifies as a stakeholder and who can call a pause, (b) objective triggers/categories for initiating a pause, (c) authority and process for resolution (including acknowledgement scope and documentation standards), and (d) clear reporting clocks, follow-up requirements, and record-keeping expectations.

Question #5: Should the OPTN recommend these proposed OPTN polices be approved by the Secretary of Health and Human Services and made enforceable by HHS, in accordance with the process outlined in the OPTN Final Rule?

The proposal is directionally appropriate and addresses several important aspects of controlled DCD standardization. However, in its current form, it contains material gaps in clarity and cohesion across critical provisions, while remaining comparatively silent on elements that are central to public confidence and safety. As drafted, the proposal risks prioritizing process visibility (e.g., unplanned DCD pause mechanics and reporting) over the more fundamental need to meaningfully strengthen the safety and integrity of DCD practice through clear definitions and enforceable safeguards.

If these policies are to be approved by the Secretary of Health and Human Services and made enforceable by HHS under the OPTN Final Rule, the policy framework should be procedurally sound, internally consistent, and sufficiently defined to support fair, auditable enforcement. As currently written, several concepts are left too subjective or underdefined (e.g., ambiguity in unplanned pause criteria and reporting mechanics), and at least two omissions warrant particular attention:

Autoresuscitation remains insufficiently defined. The proposal relies on the concept of autoresuscitation as a safety trigger and reporting threshold, but without a clear clinical definition, the policy risks conflating electrical activity with return of perfusing circulation. A lack of definitional precision undermines both enforcement and meaningful safety improvement.

NRP safeguards are not sufficiently addressed. Given the current national debate and the importance of uniform, enforceable safeguards for public trust, the absence of explicit NRP safeguard requirements, paired with a policy framework heavily focused on pauses and reporting, creates a perception that the policy is strengthening administrative oversight without fully addressing the safety and ethical concerns driving stakeholder scrutiny.

In addition, the proposal has significant implementation implications for donor hospital partners. Many donor hospitals are not OPTN members and are not transplant centers; therefore, any enforceable policy requirements related to WLST sequencing, death declaration timing, pause processes, and documentation will require operational alignment through OPO protocols, education, and formalized agreements with hospitals and recovery partners.

For these reasons, LifeLink supports the concept of HHS approval and enforceability once the policy is strengthened, particularly by improving definitional clarity, resolving internal inconsistencies, and incorporating explicit, enforceable safeguards (including NRP-specific safeguards where applicable). A clear, enforceable DCD policy with sound definitions and safeguards is essential to restoring public confidence and trust in the organ donation and transplantation system.

In addition to the responses above, we offer the following comments for the OPTN’s consideration.

Additional Comment #1:

The proposal assigns the OPO responsibility for “ensuring accuracy in neurological assessment and appropriate neurological reassessments,” and then requires neurological reassessment at least every 12 hours and within two hours prior to withdrawal of life-sustaining therapies (WLST). However, the proposal itself recognizes that neurological assessments on DCD patients are performed by donor hospital clinical staff, not OPO personnel. As written, the responsibility statement creates an accountability mismatch and could be interpreted as holding OPOs responsible for the performance or clinical validity of examinations they do not conduct. To align policy expectations with real-world roles while preserving the safety intent, OPTN should consider revising the responsibility language and clarifying minimum standards as follows:

• Replace “ensuring accuracy” with “verifying and documenting in the donor record that neurological assessments are performed by, and documented in the medical record by, the primary healthcare team in accordance with donor hospital policy and accepted medical standards.”
• Define “neurological reassessment” and minimum required elements (e.g., specified exam components).
• Clarify the start point of the reassessment cadence, as the phrase “from the time the OPO initiates the donation process” is vague and may be interpreted inconsistently across DSAs.

Additionally, the requirement that “the OPO and primary healthcare team must confirm that withdrawal of life-sustaining therapies remains appropriate” should be clarified. As written, it is not clear whether OPTN intends the OPO to obtain and document an explicit confirmation from the treating team at each reassessment point (and, if so, what documentation is required), or whether a more general confirmation is sufficient. Without clear minimum documentation expectations, this requirement will be applied inconsistently and will be difficult to audit fairly.

Finally, OPTN should consider whether the requirement for the final neurological reassessment “within two hours prior to withdrawal” is operationally realistic across all settings. Extending this window to within four hours may better reflect real-world logistics (e.g., transplant team arrival variability, operating room readiness, honor walk timing, and family time at bedside) while preserving the policy intent of ensuring timely reassessment close to WLST.

Additional Comment #2:

The requirement that the OPO “confirm” consent for any DCD-related procedures or drug administration prior to death is directionally appropriate. However, OPTN should clarify that the intent is not to prescribe a single, uniform method for how consent is obtained or documented across all donor hospitals. Instead, OPTN should expect the OPO and donor hospital to adopt a locally tailored strategy consistent with applicable state law, donor hospital policy, and OPO policy that ensures pre-mortem procedures and medications are performed only when appropriate consent has been obtained and can be verified.

Additional Comment #3:

Normothermic Regional Perfusion (NRP) is referenced in the proposal, including an expectation that families receive an “appropriate explanation” of NRP if the OPO anticipates it may be used, and that this explanation include “the safeguards that will be taken to prevent blood flow to the brain.” However, the proposal does not define NRP or specify the required safeguards. Given the current public scrutiny of DCD and NRP practice, the absence of defined, enforceable NRP safeguards (and associated documentation requirements) risks creating the perception that the proposal is emphasizing pause mechanics and reporting rather than meaningfully strengthening safety, clarity, and standardization.

The OPTN should (1) define NRP in policy, (2) incorporate explicit safeguard requirements applicable to the type of NRP performed, and (3) require that OPOs develop and use family education materials and processes that explain NRP and its safeguards in plain language, tailored to the family’s needs and stated preferences. Education should ensure families receive an understandable explanation of the purpose of NRP, the anticipated restoration of circulation to selected organs, and the safeguards used to prevent cerebral reperfusion, while allowing the level of technical detail to vary based on the family’s interest and health literacy. In addition, because NRP may involve cannulation and other pre-mortem steps, OPTN should ensure NRP safeguard requirements are harmonized with the proposal’s consent expectations for DCD-related procedures performed prior to death.

Recommended safeguards in OPTN policy should include:

• Abdominal NRP (A-NRP): The aorta should be occluded above the level of celiac origin, either below or immediately above the diaphragm, and the proximal aorta should be transected cephalad to the occlusion and allowed to drain to the atmosphere prior to initiation of perfusion.
• Thoraco-abdominal NRP (TA-NRP): The vessels arising from the aortic arch (brachiocephalic, left common carotid, and left subclavian arteries) should be individually occluded near their origin, and each artery should be transected and allowed to drain to the atmosphere prior to initiation of perfusion.
• Regardless of the method used to achieve proximal occlusion, individual transection and drainage of the cephalad ends of each transected artery is required prior to initiation of perfusion. Occlusion of multiple vessels with a single clamp is not appropriate.

Finally, the OPTN should consider requiring explicit documentation in the donor record confirming completion of the applicable safeguards (e.g., individual vessel occlusion, transection, and drainage prior to perfusion), both to support auditability and to ensure consistent, reproducible safety practice across DSAs.

Additional Comment #4:

The proposal states that “No recovery personnel (surgeons and other recovery practitioners) may be present for the withdrawal of life sustaining medical treatment or ventilated support therapies,” and further provides that “No member of the organ recovery team or OPO staff may guide or administer palliative care or declare death.” While appropriate, this section would benefit from additional clarity to avoid inconsistent implementation and unintended operational barriers.

OPTN should consider the following clarifications:

Define “recovery personnel” and confirm this restriction applies to the recovery team only. The language should explicitly confirm that the prohibition on being “present” during WLST applies to organ recovery personnel (surgeons and recovery practitioners) and does not prohibit the presence of non-recovery individuals who may be necessary for coordination of the donation process, consistent with hospital policy and patient/family preference.

Define “guide or administer palliative care.” OPTN should define this phrase to mean clinical decision-making and/or direct clinical intervention. Conversely, the policy should clearly state that non-clinical, logistical support is not considered “guiding” or “administering” palliative care. OPO staff do not guide or administer palliative care or declare death, and the OPTN should be clear that this prohibition is intended to prevent clinical decision-making and medication administration, not to prevent OPO staff from performing non-clinical coordination functions that are often necessary in real time (e.g., timekeeping, communication relay, coordinating team readiness, ensuring required documentation is complete).

These clarifications would preserve the proposal’s ethical intent by maintaining clear separation between end-of-life clinical decision-making and donation/recovery activities while ensuring the policy is operationally workable and consistently enforceable across donor hospitals and DSAs.

Additional Comment #5:

Policy should clarify the operational and allocation impact when a case converts to a DCD match run after a deceased donor organ has already been accepted for a potential transplant recipient. The proposal highlights the potential of mid-course changes in donation pathway, and the policy should explicitly address how acceptance, notification, and re-allocation are handled when the donor pathway changes in a way that is material to the transplant program’s decision-making.

Consistent with the intent of OPTN Policy 5.5 (Re-Execution of the Match Run Due to New Information), OPTN should consider establishing a clear process when an organ previously accepted under a brain-death pathway is later proposed for recovery under a DCD protocol. At minimum, policy should require:

The host OPO must notify the first transplant program on the match run that accepted the organ that the donor will be recovered under DCD protocol (i.e., conversion from a brain-death pathway to a DCD pathway).

Upon notification, the transplant hospital must inform the host OPO whether it will maintain acceptance or decline the organ within one hour of receipt of the notification.

The host OPO must re-execute the match run and discontinue allocation on the original match run given the material differences in recovery conditions, ischemic exposure, and program acceptance criteria.

Re-execution of the match run should also be used to generate appropriate back-up offers, reflecting the change from a brain-dead donor match run to a DCD match run.

If the organ is declined after the first transplant program receives the information regarding conversion to DCD protocol, the host OPO must continue allocation on the DCD match run.

Clarifying this conversion pathway in policy would reduce ambiguity for OPOs and transplant programs, support consistent patient safety and allocation decision-making, and prevent inconsistent practices across DSAs when a significant change in donor pathway occurs after an organ has already been accepted.

Additional Comment #6:

The proposal’s requirement to register all authorized patients “no later than the time at which the OPO decides to proceed with the donation process” is too vague to be consistently implemented, audited, or enforced. “Decides to proceed with the donation process” is not a discrete, uniformly defined operational moment across OPOs (and may be interpreted as first referral triage, first family authorization, initiation of donor management, intent to allocate, request for recovery resources, etc.). Without an objectively identifiable trigger, the requirement will produce inconsistent compliance determinations.

To preserve the proposal’s intent of ensuring a donor ID exists for reporting and oversight, the OPTN should establish a clear registration deadline. Consistent with current requirements, donor registration must occur prior to generating a match run, and if the OPO later determines not to proceed, registration must occur within 72 hours of that determination.

In addition, the proposal’s expansion of the Donor Organ Disposition (Feedback Form) requirement to apply to any “individual, except living donors, for whom authorization for donation is granted” raises important fringe cases that should be clarified. Specifically, how should this requirement apply when a patient has a valid determination of death, but donation cannot proceed due to family or hospital opposition (including situations involving registry authorization but refusal to honor donation)?

Finally, OPTN should clarify how this expanded disposition reporting requirement aligns with existing OPTN data-collection workflows, including the future Ventilated Patient Form, to avoid duplicative reporting, inconsistent denominators, or unclear sequencing of documentation expectations across referral, authorization, registration, and case closure pathways.

Additional Comment #7:

The inclusion of the “Unplanned DCD Pause Reporting Template” appears to function as supplemental guidance rather than a clearly enforceable reporting mechanism. If OPTN intends specific data elements to be required for compliance, those fields should be built directly into the OPTN Patient Safety Reporting Portal (or otherwise captured through structured portal fields), rather than relying on an external “template” that may be used inconsistently across members. This would improve standardization, reduce variation in reporting completeness, and support auditability.

In addition, the current template is highly redundant and does not clearly address common real-world scenarios, particularly cases that are paused, stopped, and later resumed after an initial report. The proposal describes follow-up expectations (e.g., providing additional information within defined timeframes after resumption or disposition), but it remains unclear whether resumption requires resubmitting the template, submitting an addendum to the original report, or initiating a new report entirely.

OPTN should clarify, in policy, the reporting structure for these scenarios, including:

Whether there is one report per pause episode (pause initiated then resolved by resumption or case stop), and how follow-up updates should be submitted;

Whether a case that is stopped and later resumed constitutes a new pause episode requiring a new report, or a continuation of the original report with an outcome update; and

How OPOs should document and report multiple pauses within the same case (e.g., pause, then resume, then subsequent pause).

Providing this clarity and integrating required fields into the portal would materially strengthen consistency, reduce administrative burden, and ensure the reporting process is practical, standardized, and enforceable.

Thank you again for considering these comments and for the continued work to advance a safe, ethical, and trusted donation and transplantation system. We remain appreciative of the volunteers and OPTN staff who steward policy development and implementation, often under complex clinical and operational realities. We would welcome the opportunity to support further discussion or provide additional operational perspective as the OPTN finalizes this proposal.

LifeLink of Florida | 1/17/2026

Thank you for the opportunity to provide public comments on the proposed policy changes. We appreciate the OPTN’s commitment to continuous improvement and are grateful to the many volunteer committee members and subject matter experts who dedicate substantial time and expertise to developing and refining OPTN Policy. We submit the following comments in the spirit of collaboration and shared accountability, with the goal of strengthening clarity, safety, and consistency in DCD practice to support donors, families, hospital partners, OPOs, transplant programs, and those awaiting a life-saving transplant.

Question #1: How might the OPTN identify, report, or evaluate whether the decision to withdraw life sustaining therapies was subjected to undue influence by the donation decision? Is there a clearer way to define responsibilities regarding the timing of the family discussion for donation?

The OPTN cannot reliably determine whether the withdrawal of life-sustaining therapies (WLST) was influenced by donation by attempting to assess intent after the fact. However, the OPTN can require auditable safeguards that reduce the risk of undue influence and enable meaningful oversight through documentation-based review. Accordingly, OPTN oversight should focus on verifiable process controls, including role separation and conversation timing, and evaluate compliance through a combination of (1) routine, risk-based sampling of DCD cases during member review/site surveys and (2) triggered review when risk indicators, complaints, or patient safety reports arise.

That said, the OPTN should avoid adopting a rigid sequencing rule that inadvertently undermines patient- and family-centered communication. The proposed requirement of “prior to the OPO initiating any discussion… the host OPO must confirm with the patient’s healthcare team and document that end-of-life discussions have been initiated with the patient or patient’s agent” is directionally appropriate as a guardrail but may be operationally challenging if interpreted narrowly as requiring contemporaneous documentation before any donation-related information may be provided.

Real-world circumstances do not always unfold in a linear, well-documented sequence. For example, the treating team may not document end-of-life discussions in real time; a family (or patient) may signal readiness or directly request information about donation before that documentation exists; or a patient may be critically unstable and near circulatory collapse at the moment they express a desire to discontinue life-sustaining therapies. In these settings, a strict “no discussion until documented” interpretation could delay timely, appropriate information-sharing and create unnecessary distress, or may risk the loss of a donation opportunity.

Policy can protect against coercion while honoring autonomy by distinguishing information-sharing from authorization. Specifically, OPTN policy should permit donation-related information once end-of-life discussions have been initiated (confirmed with the healthcare team), while explicitly allowing earlier limited information when indicated and when the patient/agent requests it, paired with clear guardrails that WLST decisions remain clinician-led and independent of donation. This approach is consistent with the proposal’s intent to establish a defined time point for donation discussions (i.e., after end-of-life discussions are underway) while reinforcing the principle that “the decision to withdraw life sustaining therapies should not be influenced by the donation decision.”

In addition, the OPTN should clarify that end-of-life decision-making relevant to controlled DCD includes not only withdrawal of life-sustaining therapies but also the withholding of life-sustaining therapies when clinically appropriate and when the patient or surrogate agrees (e.g., decisions to forgo escalation, continue ventilatory support without further life-prolonging interventions, or allow death to occur on the ventilator under a comfort-focused plan). This is important because the proposal repeatedly frames the pathway in terms of “withdrawal of life sustaining therapies” and “withdrawing life sustaining medical treatment or ventilated support therapies,” without explicitly addressing withholding decisions as part of the same ethical and procedural separation from donation. Clarifying that both withholding and withdrawal are within scope would better reflect real-world end-of-life care and reduce the risk that policy language inadvertently narrows acceptable practice or creates interpretive gaps.

Finally, it may be helpful for OPTN to clarify responsibilities and oversight by explicitly identifying auditable indicators of appropriate separation (e.g., documented confirmation that end-of-life discussions were initiated; documentation of role boundaries; and use of standardized terminology), rather than attempting to infer undue influence based on subjective impressions. This is particularly important given the proposal’s broader emphasis on standardization, public trust, and consistent safeguards across DCD practice.

Question #2: Should the OPTN add any automatic triggers for an unplanned DCD pause into policy, or provide any supplemental guidance or education regarding situations that may warrant additional caution when assessing patient neurological status?

The OPTN can achieve the underlying intent of “automatic triggers” by defining pause-eligible conditions that may require the OPO and donor hospital to initiate an unplanned DCD pause when credible concerns arise. At the same time, we do not believe it is necessary or prudent to codify automatic triggers as rigid, prescriptive thresholds. The workgroup appropriately noted that apparent neurologic “changes” may not always represent meaningful recovery, and overly rigid triggers could generate unnecessary pauses and unintended operational consequences.

Instead, OPTN should establish a clear definition of pause-eligible concerns. A pause-eligible concern should be defined as one that: (1) implicates ethical or process integrity (e.g., death determination); (2) creates a substantive question or dispute as to whether withdrawal of life-sustaining therapies remains appropriate under the donor hospital’s criteria and the patient’s goals of care; or (3) creates a substantive question or dispute that the DCD process is proceeding in an inappropriate or potentially unsafe manner such that stakeholders must reassess the patient and clinical circumstances. Routine clinical deterioration that simply changes donor suitability or organ viability should continue to be managed through existing local workflows unless it triggers one of these conditions, consistent with the proposal’s intent that routine reevaluations are not unplanned DCD pauses.

The proposal’s decision not to codify specific triggers is mitigated to an extent by its inclusion of required neurologic reassessments, healthcare team check-ins, and reinforcement of an existing timeout prior to WLST, which together create standardized opportunities to identify concerns. OPTN should ensure these assessments and check-ins function as meaningful control points by pairing them with clear documentation expectations and escalation criteria (i.e., what must occur when a pause-eligible concern is identified), rather than relying on education alone.

Question #3: Should the OPTN define a minimum waiting period of circulatory cessation in Policy 2.15.J Organ Recovery? If so, how long should the minimum waiting period be, and why?

The OPTN should define a minimum waiting period of circulatory cessation in Policy 2.15.J to reduce practice variation and eliminate the ambiguity that undermines public trust. The proposal already states that organ recovery may proceed only after circulatory death is determined, inclusive of a predetermined waiting period to ensure no auto-resuscitation occurs; however, leaving the duration undefined perpetuates inconsistency across donor hospitals and DSAs.

For controlled DCD, a 5-minute period is the most defensible national floor based on current evidence and professional/ society recommendations. It’s important to acknowledge that OPTN/HRSA issued a safety alert addressing rare cases of autoresuscitation, and five minutes is a reasonable balance between minimizing the risk of autoresuscitation and limiting ischemic injury. A standardized minimum is also necessary to support consistent application of the proposal’s new requirement to report any auto-resuscitation event that occurs beyond the waiting period required by Policy 2.15.J.

The OPTN should also clarify the sequencing in policy to resolve confusion about when death is determined and when recovery may proceed. Specifically, OPTN should: (1) specify a single, continuous 5-minute observation period beginning at confirmed circulatory cessation, and establish this as a standardized national minimum that balances autoresuscitation safeguards against avoidable ischemic injury; (2) clarify that the precise timestamp of pronouncement is less important than ensuring death is determined in accordance with applicable law and donor hospital policy (including who is authorized to declare death and where WLST and death determination occur); and (3) state that incision and organ recovery must not begin until the full 5 minutes of continuous observation have elapsed and a valid determination of death has been made.

In addition, the proposal’s reporting language underscores the need for greater precision. The proposal describes an auto-resuscitation event as the “spontaneous return of cardiac or respiratory activity” beyond the waiting period. That framing risks conflating electrical activity with return of perfusing circulation, which are not clinically equivalent in this context. Autoresuscitation should be clearly defined in policy to mean the unassisted return of perfusing circulation after declaration of death by circulatory criteria, without resuscitative interventions, i.e., the restoration of pulsatile arterial blood flow evidenced by one or more of the following: (i) a palpable pulse; (ii) a measurable arterial blood pressure (noninvasive or invasive), including a pulsatile arterial waveform when an arterial line is present; or (iii) other objective evidence of perfusing circulation documented by the treating team (e.g., doppler-confirmed pulse consistent with pulsatile flow). Electrical activity without evidence of perfusing circulation (e.g., PEA, ventricular fibrillation, agonal rhythms, or isolated myocardial contractions without a pulse or measurable blood pressure) should not constitute autoresuscitation. Absent a clear definition, the policy risks prioritizing the appearance of a “pause mechanism” over meaningful clarity and safety.

Finally, the OPTN should acknowledge the implementation implications of regulating DCD practice in donor hospitals, most of which are not OPTN members. Any policy requirements related to determination of death (including the observation period) must be drafted to remain consistent with applicable state law and donor hospital policy. Requirements that assume OPTN can standardize or supersede hospital- or state-governed death determination practices may be impractical.

Accordingly, OPOs will need to operationalize these requirements through updated written protocols with donor hospitals.

Question #4: Are the requirements for OPOs to report unplanned DCD pauses clear? Are there areas where the OPTN should consider improvements to make the language clearer?

The proposed requirement for OPOs to report unplanned DCD pauses is directionally appropriate; however, the current policy language is not sufficiently clear to ensure consistent implementation across OPOs. The proposal’s intent of enhanced visibility and oversight is necessary, but the lack of clarity around what constitutes a reportable pause, who has responsibility and authority at each step, and when/how reporting must occur will make the requirement difficult to audit and effectively unenforceable in practice. The proposal’s own definition of an unplanned DCD pause as an “unexpected suspension of the DCD process due to a difference of opinion as to whether a patient meets the donor hospital’s criteria for withdrawal of life sustaining therapies” illustrates its core challenge: The trigger is framed in subjective terms that invite inconsistent interpretation across DSAs.

The proposal suggests the Committee will provide post-finalization education “to further clarify reportable cases.” Education would be helpful, but it is not an adequate substitute for clear policy language. If the rule depends on post-implementation guidance to define what is reportable and how requirements apply, variation and misinterpretation are inevitable. The policy itself should establish the minimum operational definitions and thresholds.

“Difference of opinion” should be replaced or supplemented with objective pause-eligible categories and minimum evidence standards. As written, “difference of opinion” is inherently subjective (who qualifies as “opinion holders,” what threshold matters, and what constitutes “meets criteria”). Policy would be clearer and more enforceable if it identified a limited set of reportable, pause-eligible concern categories and required a minimum documentation standard, including (a) documentation of the concern, (b) documented reassessment steps, and (c) a documented resolution decision to resume or stop. Illustrative categories could include:

• Objective neurologic improvement or credible concern for improving neurologic function as documented by the treating team;
• New evidence that the clinical trajectory no longer supports proceeding with WLST under the donor hospital’s criteria or that proceeding in the DCD pathway is no longer appropriate; and
• Other clearly defined DCD process-integrity concerns within the policy-defined time window between authorization and cross clamp.

Stakeholder definitions and notification requirements are internally inconsistent and create compliance ambiguity. Policy 2.2 lists stakeholders as the patient or patient’s agent, donor hospital staff, OPO staff, and third-party procurement/preservation staff, while the proposal text expands the stakeholder list to include transplant center staff. The proposal also requires convening and informing “all existing stakeholders” when a pause is requested, which is impractical without clear guidance on who counts as an “existing stakeholder” at a given moment and invites inconsistency.

To reduce ambiguity, the OPTN should consider adding a dedicated definition for “DCD stakeholder” that provides an explicit, policy-level list while preserving appropriate operational discretion for the host OPO to identify which stakeholders have a proximate need to be involved in a specific pause event. The policy should also preserve role separation by making clear that determinations regarding whether WLST remains appropriate under the donor hospital’s criteria and the patient’s goals of care are the responsibility of the treating team and patient/surrogate, not transplant programs.

This need for clarity is reinforced by the proposed resumption requirement, which states: “When the OPO determines that the DCD process can resume following an unplanned DCD pause, the OPO must obtain acknowledgment prior to organ recovery from all transplant programs that accept an organ from the donor and any contracted representatives, such as third party contractors, involved in organ recovery that they are aware that the unplanned DCD pause occurred and acknowledge the decision to proceed.” As written, this language does not clearly distinguish between transplant programs as stakeholders who must be informed (i.e., awareness of the pause and its resolution) versus parties positioned as decision-makers regarding whether it is appropriate to proceed with the DCD process. Requiring acknowledgment from “all transplant programs that accept an organ” as a condition of resumption, without clear scoping and documentation standards, risks creating undue operational burden and inconsistent application, particularly if interpreted broadly or applied to non-proximate parties.

Relatedly, OPTN should clarify what is meant elsewhere in the proposal/discussion by “provisional acceptance,” which is not a defined term in OPTN policy. If “provisional acceptance” is intended to mean a “provisional yes,” that could dramatically expand the number of programs implicated and create additional, unnecessary burden without a clear patient safety benefit.

OPTN should therefore: (1) clarify the intended scope of required acknowledgment (limiting it to programs with accepted offers that are actively engaged in the recovery episode and any mobilized recovery/preservation contractors); (2) define what constitutes “acknowledgment”; and (3) ensure the policy framework reinforces that transplant programs retain discretion to accept/decline organs, but are not positioned as arbiters of WLST appropriateness or as open-ended “gatekeepers” for resumption beyond those directly involved.

The OPTN should consider the unintended consequences of an overbroad acknowledgment requirement. Over-inclusion of non-proximate programs/contractors can create administrative churn and delay time-sensitive recovery steps without improving patient safety and may unnecessarily cast doubt on appropriately managed DCD cases once proximate stakeholders have resolved concerns and determined it is appropriate to proceed.

Reporting triggers and timing also require clearer operational definitions. While Table 18-5 and Policy 18.5.C.1 establish a general requirement to report within 24 hours of when the OPO “becomes aware” of a requested pause and specify required data elements, key terms remain ambiguous (e.g., what constitutes a “request,” what qualifies as “awareness,” and how to handle multiple pause episodes). OPTN should improve clarity by (i) distinguishing “pause requested” from “pause initiated”; (ii) defining “OPO becomes aware”; (iii) clarifying the “single episode vs. multiple episode” rule explicitly in policy (Appendix A suggests follow-up should not be a separate portal report unless a subsequent pause occurs after resumption, but policy text should not rely on an appendix in a policy proposal to establish a core compliance rule); and (iv) simplifying follow-up reporting into a universal “outcome update” requirement with a realistic timeframe and a clearly defined clock start including how to handle prolonged pauses that later resume.

Finally, while it is appropriate that the proposal clarifies a paused case may later restart if the patient is again deemed suitable for WLST and the patient/agent and donor hospital elect to proceed, OPTN should clarify whether restart triggers any additional “reset” requirements (e.g., renewed documentation of WLST appropriateness, re-disclosure, re-notification/acknowledgement by transplant programs, and whether a new report is required). Without that clarity, the restart provision may unintentionally create circular or inconsistently applied obligations.

An unplanned DCD pause process is critical to establish, but it must be a clearly defined, standardized, and auditable event. The policy should be replicable and efficient in high-acuity settings and free of ambiguity regarding: (a) who qualifies as a stakeholder and who can call a pause, (b) objective triggers/categories for initiating a pause, (c) authority and process for resolution (including acknowledgement scope and documentation standards), and (d) clear reporting clocks, follow-up requirements, and record-keeping expectations.

Question #5: Should the OPTN recommend these proposed OPTN polices be approved by the Secretary of Health and Human Services and made enforceable by HHS, in accordance with the process outlined in the OPTN Final Rule?

The proposal is directionally appropriate and addresses several important aspects of controlled DCD standardization. However, in its current form, it contains material gaps in clarity and cohesion across critical provisions, while remaining comparatively silent on elements that are central to public confidence and safety. As drafted, the proposal risks prioritizing process visibility (e.g., unplanned DCD pause mechanics and reporting) over the more fundamental need to meaningfully strengthen the safety and integrity of DCD practice through clear definitions and enforceable safeguards.

If these policies are to be approved by the Secretary of Health and Human Services and made enforceable by HHS under the OPTN Final Rule, the policy framework should be procedurally sound, internally consistent, and sufficiently defined to support fair, auditable enforcement. As currently written, several concepts are left too subjective or underdefined (e.g., ambiguity in unplanned pause criteria and reporting mechanics), and at least two omissions warrant particular attention:

1. Autoresuscitation remains insufficiently The proposal relies on the concept of autoresuscitation as a safety trigger and reporting threshold, but without a clear clinical definition, the policy risks conflating electrical activity with return of perfusing circulation. A lack of definitional precision undermines both enforcement and meaningful safety improvement.
2. NRP safeguards are not sufficiently Given the current national debate and the importance of uniform, enforceable safeguards for public trust, the absence of explicit NRP safeguard requirements, paired with a policy framework heavily focused on pauses and reporting, creates a perception that the policy is strengthening administrative oversight without fully addressing the safety and ethical concerns driving stakeholder scrutiny.

In addition, the proposal has significant implementation implications for donor hospital partners. Many donor hospitals are not OPTN members and are not transplant centers; therefore, any enforceable policy requirements related to WLST sequencing, death declaration timing, pause processes, and documentation will require operational alignment through OPO protocols, education, and formalized agreements with hospitals and recovery partners.

For these reasons, LifeLink supports the concept of HHS approval and enforceability once the policy is strengthened, particularly by improving definitional clarity, resolving internal inconsistencies, and incorporating explicit, enforceable safeguards (including NRP-specific safeguards where applicable). A clear, enforceable DCD policy with sound definitions and safeguards is essential to restoring public confidence and trust in the organ donation and transplantation system.

In addition to the responses above, we offer the following comments for the OPTN’s consideration.

Additional Comment #1:

The proposal assigns the OPO responsibility for “ensuring accuracy in neurological assessment and appropriate neurological reassessments,” and then requires neurological reassessment at least every 12 hours and within two hours prior to withdrawal of life-sustaining therapies (WLST). However, the proposal itself recognizes that neurological assessments on DCD patients are performed by donor hospital clinical staff, not OPO personnel. As written, the responsibility statement creates an accountability mismatch and could be interpreted as holding OPOs responsible for the performance or clinical validity of examinations they do not conduct. To align policy expectations with real-world roles while preserving the safety intent, OPTN should consider revising the responsibility language and clarifying minimum standards as follows:

• Replace “ensuring accuracy” with “verifying and documenting in the donor record that neurological assessments are performed by, and documented in the medical record by, the primary healthcare team in accordance with donor hospital policy and accepted medical standards.”
• Define “neurological reassessment” and minimum required elements (e.g., specified exam components).
• Clarify the start point of the reassessment cadence, as the phrase “from the time the OPO initiates the donation process” is vague and may be interpreted inconsistently across DSAs.

Additionally, the requirement that “the OPO and primary healthcare team must confirm that withdrawal of life-sustaining therapies remains appropriate” should be clarified. As written, it is not clear whether OPTN intends the OPO to obtain and document an explicit confirmation from the treating team at each reassessment point (and, if so, what documentation is required), or whether a more general confirmation is sufficient. Without clear minimum documentation expectations, this requirement will be applied inconsistently and will be difficult to audit fairly.

Finally, OPTN should consider whether the requirement for the final neurological reassessment “within two hours prior to withdrawal” is operationally realistic across all settings. Extending this window to within four hours may better reflect real-world logistics (e.g., transplant team arrival variability, operating room readiness, honor walk timing, and family time at bedside) while preserving the policy intent of ensuring timely reassessment close to WLST.

Additional Comment #2:

The requirement that the OPO “confirm” consent for any DCD-related procedures or drug administration prior to death is directionally appropriate. However, OPTN should clarify that the intent is not to prescribe a single, uniform method for how consent is obtained or documented across all donor hospitals. Instead, OPTN should expect the OPO and donor hospital to adopt a locally tailored strategy consistent with applicable state law, donor hospital policy, and OPO policy that ensures pre-mortem procedures and medications are performed only when appropriate consent has been obtained and can be verified.

Additional Comment #3:

Normothermic Regional Perfusion (NRP) is referenced in the proposal, including an expectation that families receive an “appropriate explanation” of NRP if the OPO anticipates it may be used, and that this explanation include “the safeguards that will be taken to prevent blood flow to the brain.” However, the proposal does not define NRP or specify the required safeguards. Given the current public scrutiny of DCD and NRP practice, the absence of defined, enforceable NRP safeguards (and associated documentation requirements) risks creating the perception that the proposal is emphasizing pause mechanics and reporting rather than meaningfully strengthening safety, clarity, and standardization.

The OPTN should (1) define NRP in policy, (2) incorporate explicit safeguard requirements applicable to the type of NRP performed, and (3) require that OPOs develop and use family education materials and processes that explain NRP and its safeguards in plain language, tailored to the family’s needs and stated preferences. Education should ensure families receive an understandable explanation of the purpose of NRP, the anticipated restoration of circulation to selected organs, and the safeguards used to prevent cerebral reperfusion, while allowing the level of technical detail to vary based on the family’s interest and health literacy. In addition, because NRP may involve cannulation and other pre-mortem steps, OPTN should ensure NRP safeguard requirements are harmonized with the proposal’s consent expectations for DCD-related procedures performed prior to death.

Recommended NRP safeguards in OPTN policy should include:

• Abdominal NRP (A-NRP): The aorta should be occluded above the level of celiac origin, either below or immediately above the diaphragm, and the proximal aorta should be transected cephalad to the occlusion and allowed to drain to the atmosphere prior to initiation of perfusion.
• Thoraco-abdominal NRP (TA-NRP): The vessels arising from the aortic arch (brachiocephalic, left common carotid, and left subclavian arteries) should be individually occluded near their origin, and each artery should be transected and allowed to drain to the atmosphere prior to initiation of perfusion.
• Regardless of the method used to achieve proximal occlusion, individual transection and drainage of the cephalad ends of each transected artery is required prior to initiation of Occlusion of multiple vessels with a single clamp is not appropriate.

Finally, the OPTN should consider requiring explicit documentation in the donor record confirming completion of the applicable safeguards (e.g., individual vessel occlusion, transection, and drainage prior to perfusion), both to support auditability and to ensure consistent, reproducible safety practice across DSAs.

Additional Comment #4:

The proposal states that “No recovery personnel (surgeons and other recovery practitioners) may be present for the withdrawal of life sustaining medical treatment or ventilated support therapies,” and further provides that “No member of the organ recovery team or OPO staff may guide or administer palliative care or declare death.” While appropriate, this section would benefit from additional clarity to avoid inconsistent implementation and unintended operational barriers.

OPTN should consider the following clarifications:

• Define “recovery personnel” and confirm this restriction applies to the recovery team only. The language should explicitly confirm that the prohibition on being “present” during WLST applies to organ recovery personnel (surgeons and recovery practitioners) and does not prohibit the presence of non-recovery individuals who may be necessary for coordination of the donation process, consistent with hospital policy and patient/family preference.
• Define “guide or administer palliative care.” OPTN should define this phrase to mean clinical decision-making and/or direct clinical intervention. Conversely, the policy should clearly state that non-clinical, logistical support is not considered “guiding” or “administering” palliative care. OPO staff do not guide or administer palliative care or declare death, and the OPTN should be clear that this prohibition is intended to prevent clinical decision-making and medication administration, not to prevent OPO staff from performing non-clinical coordination functions that are often necessary in real time (e.g., timekeeping, communication relay, coordinating team readiness, ensuring required documentation is complete).

These clarifications would preserve the proposal’s ethical intent by maintaining clear separation between end-of-life clinical decision-making and donation/recovery activities while ensuring the policy is operationally workable and consistently enforceable across donor hospitals and DSAs.

Additional Comment #5:

Policy should clarify the operational and allocation impact when a case converts to a DCD match run after a deceased donor organ has already been accepted for a potential transplant recipient. The proposal highlights the potential of mid-course changes in donation pathway, and the policy should explicitly address how acceptance, notification, and re-allocation are handled when the donor pathway changes in a way that is material to the transplant program’s decision-making.

Consistent with the intent of OPTN Policy 5.5 (Re-Execution of the Match Run Due to New Information), OPTN should consider establishing a clear process when an organ previously accepted under a brain-death pathway is later proposed for recovery under a DCD protocol. At minimum, policy should require:

• The host OPO must notify the first transplant program on the match run that accepted the organ that the donor will be recovered under DCD protocol (i.e., conversion from a brain-death pathway to a DCD pathway).
• Upon notification, the transplant hospital must inform the host OPO whether it will maintain acceptance or decline the organ within one hour of receipt of the notification.
• The host OPO must re-execute the match run and discontinue allocation on the original match run given the material differences in recovery conditions, ischemic exposure, and program acceptance criteria.
• Re-execution of the match run should also be used to generate appropriate back-up offers, reflecting the change from a brain-dead donor match run to a DCD match run.
• If the organ is declined after the first transplant program receives the information regarding conversion to DCD protocol, the host OPO must continue allocation on the DCD match run.

Clarifying this conversion pathway in policy would reduce ambiguity for OPOs and transplant programs, support consistent patient safety and allocation decision-making, and prevent inconsistent practices across DSAs when a significant change in donor pathway occurs after an organ has already been accepted.

Additional Comment #6:

The proposal’s requirement to register all authorized patients “no later than the time at which the OPO decides to proceed with the donation process” is too vague to be consistently implemented, audited, or enforced. “Decides to proceed with the donation process” is not a discrete, uniformly defined operational moment across OPOs (and may be interpreted as first referral triage, first family authorization, initiation of donor management, intent to allocate, request for recovery resources, etc.). Without an objectively identifiable trigger, the requirement will produce inconsistent compliance determinations.

To preserve the proposal’s intent of ensuring a donor ID exists for reporting and oversight, the OPTN should establish a clear registration deadline. Consistent with current requirements, donor registration must occur prior to generating a match run, and if the OPO later determines not to proceed, registration must occur within 72 hours of that determination.

In addition, the proposal’s expansion of the Donor Organ Disposition (Feedback Form) requirement to apply to any “individual, except living donors, for whom authorization for donation is granted” raises important fringe cases that should be clarified. Specifically, how should this requirement apply when a patient has a valid determination of death, but donation cannot proceed due to family or hospital opposition (including situations involving registry authorization but refusal to honor donation)?

Finally, OPTN should clarify how this expanded disposition reporting requirement aligns with existing OPTN data-collection workflows, including the future Ventilated Patient Form, to avoid duplicative reporting, inconsistent denominators, or unclear sequencing of documentation expectations across referral, authorization, registration, and case closure pathways.

Additional Comment #7:

The inclusion of the “Unplanned DCD Pause Reporting Template” appears to function as supplemental guidance rather than a clearly enforceable reporting mechanism. If OPTN intends specific data elements to be required for compliance, those fields should be built directly into the OPTN Patient Safety Reporting Portal (or otherwise captured through structured portal fields), rather than relying on an external “template” that may be used inconsistently across members. This would improve standardization, reduce variation in reporting completeness, and support auditability.

In addition, the current template is highly redundant and does not clearly address common real-world scenarios, particularly cases that are paused, stopped, and later resumed after an initial report. The proposal describes follow-up expectations (e.g., providing additional information within defined timeframes after resumption or disposition), but it remains unclear whether resumption requires resubmitting the template, submitting an addendum to the original report, or initiating a new report entirely.

OPTN should clarify, in policy, the reporting structure for these scenarios, including:

• Whether there is one report per pause episode (pause initiated then resolved by resumption or case stop), and how follow-up updates should be submitted;
• Whether a case that is stopped and later resumed constitutes a new pause episode requiring a new report, or a continuation of the original report with an outcome update; and
• How OPOs should document and report multiple pauses within the same case (e.g., pause, then resume, then subsequent pause).

Providing this clarity and integrating required fields into the portal would materially strengthen consistency, reduce administrative burden, and ensure the reporting process is practical, standardized, and enforceable.

Thank you again for considering these comments and for the continued work to advance a safe, ethical, and trusted donation and transplantation system. We remain appreciative of the volunteers and OPTN staff who steward policy development and implementation, often under complex clinical and operational realities. We would welcome the opportunity to support further discussion or provide additional operational perspective as the OPTN finalizes this proposal.

LifeLink of Puerto Rico | 1/17/2026

LifeLink of Puerto Rico appreciates the opportunity to provide public comments on the OPTN DCD policy proposed changes. We acknowledge the OPTN’s commitment to continuous improvement and appreciate the work of the many volunteer committee members and subject matter experts who dedicate substantial time and expertise to developing and refining OPTN Policy. We submit the following comments based on the long-standing practices and experience from our colleagues at LifeLink of Florida, LifeLink of Georgia, and industry partners. It is important to note that DCD is not currently a routine practice in Puerto Rico today because ongoing healthcare challenges on the island impact on the resources and operational conditions required to support DCD. LifeLink of Puerto Rico is working closely with our hospital and transplant partners to advance readiness for future implementation.

Question #1: How might the OPTN identify, report, or evaluate whether the decision to withdraw life sustaining therapies was subjected to undue influence by the donation decision? Is there a clearer way to define responsibilities regarding the timing of the family discussion for donation?

The OPTN cannot reliably determine whether the withdrawal of life-sustaining therapies (WLST) was influenced by donation by attempting to assess intent after the fact. However, the OPTN can require auditable safeguards that reduce the risk of undue influence and enable meaningful oversight through documentation-based review. Accordingly, OPTN oversight should focus on verifiable process controls, including role separation and conversation timing, and evaluate compliance through a combination of (1) routine, risk-based sampling of DCD cases during member review/site surveys and (2) triggered review when risk indicators, complaints, or patient safety reports arise.

That said, the OPTN should avoid adopting a rigid sequencing rule that inadvertently undermines patient- and family-centered communication. The proposed requirement of “prior to the OPO initiating any discussion… the host OPO must confirm with the patient’s healthcare team and document that end-of-life discussions have been initiated with the patient or patient’s agent” is directionally appropriate as a guardrail but may be operationally challenging if interpreted narrowly as requiring contemporaneous documentation before any donation-related information may be provided.

Real-world circumstances do not always unfold in a linear, well-documented sequence. For example, the treating team may not document end-of-life discussions in real time; a family (or patient) may signal readiness or directly request information about donation before that documentation exists; or a patient may be critically unstable and near circulatory collapse at the moment they express a desire to discontinue life-sustaining therapies. In these settings, a strict “no discussion until documented” interpretation could delay timely, appropriate information-sharing and create unnecessary distress, or may risk the loss of a donation opportunity.

Policy can protect against coercion while honoring autonomy by distinguishing information-sharing from authorization. Specifically, OPTN policy should permit donation-related information once end-of-life discussions have been initiated (confirmed with the healthcare team), while explicitly allowing earlier limited information when indicated and when the patient/agent requests it, paired with clear guardrails that WLST decisions remain clinician-led and independent of donation. This approach is consistent with the proposal’s intent to establish a defined time point for donation discussions (i.e., after end-of-life discussions are underway) while reinforcing the principle that “the decision to withdraw life sustaining therapies should not be influenced by the donation decision.”

In addition, the OPTN should clarify that end-of-life decision-making relevant to controlled DCD includes not only withdrawal of life-sustaining therapies but also the withholding of life-sustaining therapies when clinically appropriate and when the patient or surrogate agrees (e.g., decisions to forgo escalation, continue ventilatory support without further life-prolonging interventions, or allow death to occur on the ventilator under a comfort-focused plan). This is important because the proposal repeatedly frames the pathway in terms of “withdrawal of life sustaining therapies” and “withdrawing life sustaining medical treatment or ventilated support therapies,” without explicitly addressing withholding decisions as part of the same ethical and procedural separation from donation. Clarifying that both withholding and withdrawal are within scope would better reflect real-world end-of-life care and reduce the risk that policy language inadvertently narrows acceptable practice or creates interpretive gaps.

Finally, it may be helpful for OPTN to clarify responsibilities and oversight by explicitly identifying auditable indicators of appropriate separation (e.g., documented confirmation that end-of-life discussions were initiated; documentation of role boundaries; and use of standardized terminology), rather than attempting to infer undue influence based on subjective impressions. This is particularly important given the proposal’s broader emphasis on standardization, public trust, and consistent safeguards across DCD practice.

Question #2: Should the OPTN add any automatic triggers for an unplanned DCD pause into policy, or provide any supplemental guidance or education regarding situations that may warrant additional caution when assessing patient neurological status?

The OPTN can achieve the underlying intent of “automatic triggers” by defining pause-eligible conditions that may require the OPO and donor hospital to initiate an unplanned DCD pause when credible concerns arise. At the same time, we do not believe it is necessary or prudent to codify automatic triggers as rigid, prescriptive thresholds. The workgroup appropriately noted that apparent neurologic “changes” may not always represent meaningful recovery, and overly rigid triggers could generate unnecessary pauses and unintended operational consequences.

Instead, OPTN should establish a clear definition of pause-eligible concerns. A pause-eligible concern should be defined as one that: (1) implicates ethical or process integrity (e.g., death determination); (2) creates a substantive question or dispute as to whether withdrawal of life-sustaining therapies remains appropriate under the donor hospital’s criteria and the patient’s goals of care; or (3) creates a substantive question or dispute that the DCD process is proceeding in an inappropriate or potentially unsafe manner such that stakeholders must reassess the patient and clinical circumstances. Routine clinical deterioration that simply changes donor suitability or organ viability should continue to be managed through existing local workflows unless it triggers one of these conditions, consistent with the proposal’s intent that routine reevaluations are not unplanned DCD pauses.

The proposal’s decision not to codify specific triggers is mitigated to an extent by its inclusion of required neurologic reassessments, healthcare team check-ins, and reinforcement of an existing timeout prior to WLST, which together create standardized opportunities to identify concerns. OPTN should ensure these assessments and check-ins function as meaningful control points by pairing them with clear documentation expectations and escalation criteria (i.e., what must occur when a pause-eligible concern is identified), rather than relying on education alone.

Question #3: Should the OPTN define a minimum waiting period of circulatory cessation in Policy 2.15.J Organ Recovery? If so, how long should the minimum waiting period be, and why?

The OPTN should define a minimum waiting period of circulatory cessation in Policy 2.15.J to reduce practice variation and eliminate the ambiguity that undermines public trust. The proposal already states that organ recovery may proceed only after circulatory death is determined, inclusive of a predetermined waiting period to ensure no auto-resuscitation occurs; however, leaving the duration undefined perpetuates inconsistency across donor hospitals and DSAs.

For controlled DCD, a 5-minute period is the most defensible national floor based on current evidence and professional/ society recommendations. It’s important to acknowledge that OPTN/HRSA issued a safety alert addressing rare cases of autoresuscitation, and five minutes is a reasonable balance between minimizing the risk of autoresuscitation and limiting ischemic injury. A standardized minimum is also necessary to support consistent application of the proposal’s new requirement to report any auto-resuscitation event that occurs beyond the waiting period required by Policy 2.15.J.

The OPTN should also clarify the sequencing in policy to resolve confusion about when death is determined and when recovery may proceed. Specifically, OPTN should: (1) specify a single, continuous 5-minute observation period beginning at confirmed circulatory cessation, and establish this as a standardized national minimum that balances autoresuscitation safeguards against avoidable ischemic injury; (2) clarify that the precise timestamp of pronouncement is less important than ensuring death is determined in accordance with applicable law and donor hospital policy (including who is authorized to declare death and where WLST and death determination occur); and (3) state that incision and organ recovery must not begin until the full 5 minutes of continuous observation have elapsed and a valid determination of death has been made.

In addition, the proposal’s reporting language underscores the need for greater precision. The proposal describes an auto-resuscitation event as the “spontaneous return of cardiac or respiratory activity” beyond the waiting period. That framing risks conflating electrical activity with return of perfusing circulation, which are not clinically equivalent in this context. Autoresuscitation should be clearly defined in policy to mean the unassisted return of perfusing circulation after declaration of death by circulatory criteria, without resuscitative interventions, i.e., the restoration of pulsatile arterial blood flow evidenced by one or more of the following: (i) a palpable pulse; (ii) a measurable arterial blood pressure (noninvasive or invasive), including a pulsatile arterial waveform when an arterial line is present; or (iii) other objective evidence of perfusing circulation documented by the treating team (e.g., doppler-confirmed pulse consistent with pulsatile flow). Electrical activity without evidence of perfusing circulation (e.g., PEA, ventricular fibrillation, agonal rhythms, or isolated myocardial contractions without a pulse or measurable blood pressure) should not constitute autoresuscitation. Absent a clear definition, the policy risks prioritizing the appearance of a “pause mechanism” over meaningful clarity and safety.

Finally, the OPTN should acknowledge the implementation implications of regulating DCD practice in donor hospitals, most of which are not OPTN members. Any policy requirements related to determination of death (including the observation period) must be drafted to remain consistent with applicable state law and donor hospital policy.

Requirements that assume OPTN can standardize or supersede hospital- or state-governed death determination practices may be impractical. Accordingly, OPOs will need to operationalize these requirements through updated written protocols with donor hospitals.

Question #4: Are the requirements for OPOs to report unplanned DCD pauses clear? Are there areas where the OPTN should consider improvements to make the language clearer?

The proposed requirement for OPOs to report unplanned DCD pauses is directionally appropriate; however, the current policy language is not sufficiently clear to ensure consistent implementation across OPOs. The proposal’s intent of enhanced visibility and oversight is necessary, but the lack of clarity around what constitutes a reportable pause, who has responsibility and authority at each step, and when/how reporting must occur will make the requirement difficult to audit and effectively unenforceable in practice. The proposal’s own definition of an unplanned DCD pause as an “unexpected suspension of the DCD process due to a difference of opinion as to whether a patient meets the donor hospital’s criteria for withdrawal of life sustaining therapies” illustrates its core challenge: The trigger is framed in subjective terms that invite inconsistent interpretation across DSAs.

The proposal suggests the Committee will provide post-finalization education “to further clarify reportable cases.” Education would be helpful, but it is not an adequate substitute for clear policy language. If the rule depends on post-implementation guidance to define what is reportable and how requirements apply, variation and misinterpretation are inevitable. The policy itself should establish the minimum operational definitions and thresholds.

“Difference of opinion” should be replaced or supplemented with objective pause-eligible categories and minimum evidence standards. As written, “difference of opinion” is inherently subjective (who qualifies as “opinion holders,” what threshold matters, and what constitutes “meets criteria”). Policy would be clearer and more enforceable if it identified a limited set of reportable, pause-eligible concern categories and required a minimum documentation standard, including (a) documentation of the concern, (b) documented reassessment steps, and (c) a documented resolution decision to resume or stop. Illustrative categories could include:

• Objective neurologic improvement or credible concern for improving neurologic function as documented by the treating team;
• New evidence that the clinical trajectory no longer supports proceeding with WLST under the donor hospital’s criteria or that proceeding in the DCD pathway is no longer appropriate; and
• Other clearly defined DCD process-integrity concerns within the policy-defined time window between authorization and cross clamp.

Stakeholder definitions and notification requirements are internally inconsistent and create compliance ambiguity. Policy 2.2 lists stakeholders as the patient or patient’s agent, donor hospital staff, OPO staff, and third-party procurement/preservation staff, while the proposal text expands the stakeholder list to include transplant center staff. The proposal also requires convening and informing “all existing stakeholders” when a pause is requested, which is impractical without clear guidance on who counts as an “existing stakeholder” at a given moment and invites inconsistency.

To reduce ambiguity, the OPTN should consider adding a dedicated definition for “DCD stakeholder” that provides an explicit, policy-level list while preserving appropriate operational discretion for the host OPO to identify which stakeholders have a proximate need to be involved in a specific pause event. The policy should also preserve role separation by making clear that determinations regarding whether WLST remains appropriate under the donor hospital’s criteria and the patient’s goals of care are the responsibility of the treating team and patient/surrogate, not transplant programs.

This need for clarity is reinforced by the proposed resumption requirement, which states: “When the OPO determines that the DCD process can resume following an unplanned DCD pause, the OPO must obtain acknowledgment prior to organ recovery from all transplant programs that accept an organ from the donor and any contracted representatives, such as third party contractors, involved in organ recovery that they are aware that the unplanned DCD pause occurred and acknowledge the decision to proceed.” As written, this language does not clearly distinguish between transplant programs as stakeholders who must be informed (i.e., awareness of the pause and its resolution) versus parties positioned as decision-makers regarding whether it is appropriate to proceed with the DCD process. Requiring acknowledgment from “all transplant programs that accept an organ” as a condition of resumption, without clear scoping and documentation standards, risks creating undue operational burden and inconsistent application, particularly if interpreted broadly or applied to non-proximate parties.

Relatedly, OPTN should clarify what is meant elsewhere in the proposal/discussion by “provisional acceptance,” which is not a defined term in OPTN policy. If “provisional acceptance” is intended to mean a “provisional yes,” that could dramatically expand the number of programs implicated and create additional, unnecessary burden without a clear patient safety benefit.

OPTN should therefore: (1) clarify the intended scope of required acknowledgment (limiting it to programs with accepted offers that are actively engaged in the recovery episode and any mobilized recovery/preservation contractors); (2) define what constitutes “acknowledgment”; and (3) ensure the policy framework reinforces that transplant programs retain discretion to accept/decline organs, but are not positioned as arbiters of WLST appropriateness or as open-ended “gatekeepers” for resumption beyond those directly involved.

The OPTN should consider the unintended consequences of an overbroad acknowledgment requirement. Over-inclusion of non-proximate programs/contractors can create administrative churn and delay time-sensitive recovery steps without improving patient safety and may unnecessarily cast doubt on appropriately managed DCD cases once proximate stakeholders have resolved concerns and determined it is appropriate to proceed.

Reporting triggers and timing also require clearer operational definitions. While Table 18-5 and Policy 18.5.C.1 establish a general requirement to report within 24 hours of when the OPO “becomes aware” of a requested pause and specify required data elements, key terms remain ambiguous (e.g., what constitutes a “request,” what qualifies as “awareness,” and how to handle multiple pause episodes). OPTN should improve clarity by (i) distinguishing “pause requested” from “pause initiated”; (ii) defining “OPO becomes aware”; (iii) clarifying the “single episode vs. multiple episode” rule explicitly in policy (Appendix A suggests follow-up should not be a separate portal report unless a subsequent pause occurs after resumption, but policy text should not rely on an appendix in a policy proposal to establish a core compliance rule); and (iv) simplifying follow-up reporting into a universal “outcome update” requirement with a realistic timeframe and a clearly defined clock start including how to handle prolonged pauses that later resume.

Finally, while it is appropriate that the proposal clarifies a paused case may later restart if the patient is again deemed suitable for WLST and the patient/agent and donor hospital elect to proceed, OPTN should clarify whether restart triggers any additional “reset” requirements (e.g., renewed documentation of WLST appropriateness, re-disclosure, re-notification/acknowledgement by transplant programs, and whether a new report is required). Without that clarity, the restart provision may unintentionally create circular or inconsistently applied obligations.

An unplanned DCD pause process is critical to establish, but it must be a clearly defined, standardized, and auditable event. The policy should be replicable and efficient in high-acuity settings and free of ambiguity regarding: (a) who qualifies as a stakeholder and who can call a pause, (b) objective triggers/categories for initiating a pause, (c) authority and process for resolution (including acknowledgement scope and documentation standards), and (d) clear reporting clocks, follow-up requirements, and record-keeping expectations.

Question #5: Should the OPTN recommend these proposed OPTN polices be approved by the Secretary of Health and Human Services and made enforceable by HHS, in accordance with the process outlined in the OPTN Final Rule?

The proposal is directionally appropriate and addresses several important aspects of controlled DCD standardization. However, in its current form, it contains material gaps in clarity and cohesion across critical provisions, while remaining comparatively silent on elements that are central to public confidence and safety. As drafted, the proposal risks prioritizing process visibility (e.g., unplanned DCD pause mechanics and reporting) over the more fundamental need to meaningfully strengthen the safety and integrity of DCD practice through clear definitions and enforceable safeguards.

If these policies are to be approved by the Secretary of Health and Human Services and made enforceable by HHS under the OPTN Final Rule, the policy framework should be procedurally sound, internally consistent, and sufficiently defined to support fair, auditable enforcement. As currently written, several concepts are left too subjective or underdefined (e.g., ambiguity in unplanned pause criteria and reporting mechanics), and at least two omissions warrant particular attention:

Autoresuscitation remains insufficiently defined. The proposal relies on the concept of autoresuscitation as a safety trigger and reporting threshold, but without a clear clinical definition, the policy risks conflating electrical activity with return of perfusing circulation. A lack of definitional precision undermines both enforcement and meaningful safety improvement.

NRP safeguards are not sufficiently addressed. Given the current national debate and the importance of uniform, enforceable safeguards for public trust, the absence of explicit NRP safeguard requirements, paired with a policy framework heavily focused on pauses and reporting, creates a perception that the policy is strengthening administrative oversight without fully addressing the safety and ethical concerns driving stakeholder scrutiny.

In addition, the proposal has significant implementation implications for donor hospital partners. Many donor hospitals are not OPTN members and are not transplant centers; therefore, any enforceable policy requirements related to WLST sequencing, death declaration timing, pause processes, and documentation will require operational alignment through OPO protocols, education, and formalized agreements with hospitals and recovery partners.

For these reasons, LifeLink supports the concept of HHS approval and enforceability once the policy is strengthened, particularly by improving definitional clarity, resolving internal inconsistencies, and incorporating explicit, enforceable safeguards (including NRP-specific safeguards where applicable). A clear, enforceable DCD policy with sound definitions and safeguards is essential to restoring public confidence and trust in the organ donation and transplantation system.

In addition to the responses above, we offer the following comments for the OPTN’s consideration.

Additional Comment#1:

The proposal assigns the OPO responsibility for “ensuring accuracy in neurological assessment and appropriate neurological reassessments,” and then requires neurological reassessment at least every 12 hours and within two hours prior to withdrawal of life-sustaining therapies (WLST). However, the proposal itself recognizes that neurological assessments on DCD patients are performed by donor hospital clinical staff, not OPO personnel. As written, the responsibility statement creates an accountability mismatch and could be interpreted as holding OPOs responsible for the performance or clinical validity of examinations they do not conduct. To align policy expectations with real-world roles while preserving the safety intent, OPTN should consider revising the responsibility language and clarifying minimum standards as follows:

• Replace “ensuring accuracy” with “verifying and documenting in the donor record that neurological assessments are performed by, and documented in the medical record by, the primary healthcare team in accordance with donor hospital policy and accepted medical standards.”
• Define “neurological reassessment” and minimum required elements (e.g., specified exam components).
• Clarify the start point of the reassessment cadence, as the phrase “from the time the OPO initiates the donation process” is vague and may be interpreted inconsistently across DSAs.

Additionally, the requirement that “the OPO and primary healthcare team must confirm that withdrawal of life-sustaining therapies remains appropriate” should be clarified. As written, it is not clear whether OPTN intends the OPO to obtain and document an explicit confirmation from the treating team at each reassessment point (and, if so, what documentation is required), or whether a more general confirmation is sufficient. Without clear minimum documentation expectations, this requirement will be applied inconsistently and will be difficult to audit fairly.

Finally, OPTN should consider whether the requirement for the final neurological reassessment “within two hours prior to withdrawal” is operationally realistic across all settings. Extending this window to within four hours may better reflect real-world logistics (e.g., transplant team arrival variability, operating room readiness, honor walk timing, and family time at bedside) while preserving the policy intent of ensuring timely reassessment close to WLST.

Additional Comment #2:

The requirement that the OPO “confirm” consent for any DCD-related procedures or drug administration prior to death is directionally appropriate. However, OPTN should clarify that the intent is not to prescribe a single, uniform method for how consent is obtained or documented across all donor hospitals. Instead, OPTN should expect the OPO and donor hospital to adopt a locally tailored strategy consistent with applicable state law, donor hospital policy, and OPO policy that ensures pre-mortem procedures and medications are performed only when appropriate consent has been obtained and can be verified.

Additional Comment #3:

Normothermic Regional Perfusion (NRP) is referenced in the proposal, including an expectation that families receive an “appropriate explanation” of NRP if the OPO anticipates it may be used, and that this explanation include “the safeguards that will be taken to prevent blood flow to the brain.” However, the proposal does not define NRP or specify the required safeguards. Given the current public scrutiny of DCD and NRP practice, the absence of defined, enforceable NRP safeguards (and associated documentation requirements) risks creating the perception that the proposal is emphasizing pause mechanics and reporting rather than meaningfully strengthening safety, clarity, and standardization.

The OPTN should (1) define NRP in policy, (2) incorporate explicit safeguard requirements applicable to the type of NRP performed, and (3) require that OPOs develop and use family education materials and processes that explain NRP and its safeguards in plain language, tailored to the family’s needs and stated preferences. Education should ensure families receive an understandable explanation of the purpose of NRP, the anticipated restoration of circulation to selected organs, and the safeguards used to prevent cerebral reperfusion, while allowing the level of technical detail to vary based on the family’s interest and health literacy. In addition, because NRP may involve cannulation and other pre-mortem steps, OPTN should ensure NRP safeguard requirements are harmonized with the proposal’s consent expectations for DCD-related procedures performed prior to death.

Recommended safeguards in OPTN policy should include:

• Abdominal NRP (A-NRP): The aorta should be occluded above the level of celiac origin, either below or immediately above the diaphragm, and the proximal aorta should be transected cephalad to the occlusion and allowed to drain to the atmosphere prior to initiation of perfusion.
• Thoraco-abdominal NRP (TA-NRP): The vessels arising from the aortic arch (brachiocephalic, left common carotid, and left subclavian arteries) should be individually occluded near their origin, and each artery should be transected and allowed to drain to the atmosphere prior to initiation of perfusion.
• Regardless of the method used to achieve proximal occlusion, individual transection and drainage of the cephalad ends of each transected artery is required prior to initiation of perfusion. Occlusion of multiple vessels with a single clamp is not appropriate.

Finally, the OPTN should consider requiring explicit documentation in the donor record confirming completion of the applicable safeguards (e.g., individual vessel occlusion, transection, and drainage prior to perfusion), both to support auditability and to ensure consistent, reproducible safety practice across DSAs.

Additional Comment #4:

The proposal states that “No recovery personnel (surgeons and other recovery practitioners) may be present for the withdrawal of life sustaining medical treatment or ventilated support therapies,” and further provides that “No member of the organ recovery team or OPO staff may guide or administer palliative care or declare death.” While appropriate, this section would benefit from additional clarity to avoid inconsistent implementation and unintended operational barriers.

OPTN should consider the following clarifications:

Define “recovery personnel” and confirm this restriction applies to the recovery team only. The language should explicitly confirm that the prohibition on being “present” during WLST

applies to organ recovery personnel (surgeons and recovery practitioners) and does not prohibit the presence of non-recovery individuals who may be necessary for coordination of the donation process, consistent with hospital policy and patient/family preference.

Define “guide or administer palliative care.” OPTN should define this phrase to mean clinical decision-making and/or direct clinical intervention. Conversely, the policy should clearly state that non-clinical, logistical support is not considered “guiding” or “administering” palliative care. OPO staff do not guide or administer palliative care or declare death, and the OPTN should be clear that this prohibition is intended to prevent clinical decision-making and medication administration, not to prevent OPO staff from performing non-clinical coordination functions that are often necessary in real time (e.g., timekeeping, communication relay, coordinating team readiness, ensuring required documentation is complete).

These clarifications would preserve the proposal’s ethical intent by maintaining clear separation between end-of-life clinical decision-making and donation/recovery activities while ensuring the policy is operationally workable and consistently enforceable across donor hospitals and DSAs.

Additional Comment #5:

Policy should clarify the operational and allocation impact when a case converts to a DCD match run after a deceased donor organ has already been accepted for a potential transplant recipient. The proposal highlights the potential of mid-course changes in donation pathway, and the policy should explicitly address how acceptance, notification, and re-allocation are handled when the donor pathway changes in a way that is material to the transplant program’s decision-making.

Consistent with the intent of OPTN Policy 5.5 (Re-Execution of the Match Run Due to New Information), OPTN should consider establishing a clear process when an organ previously accepted under a brain-death pathway is later proposed for recovery under a DCD protocol. At minimum, policy should require:

The host OPO must notify the first transplant program on the match run that accepted the organ that the donor will be recovered under DCD protocol (i.e., conversion from a brain-death pathway to a DCD pathway).

Upon notification, the transplant hospital must inform the host OPO whether it will maintain acceptance or decline the organ within one hour of receipt of the notification.

The host OPO must re-execute the match run and discontinue allocation on the original match run given the material differences in recovery conditions, ischemic exposure, and program acceptance criteria.

Re-execution of the match run should also be used to generate appropriate back-up offers, reflecting the change from a brain-dead donor match run to a DCD match run.

If the organ is declined after the first transplant program receives the information regarding conversion to DCD protocol, the host OPO must continue allocation on the DCD match run.

Clarifying this conversion pathway in policy would reduce ambiguity for OPOs and transplant programs, support consistent patient safety and allocation decision-making,

and prevent inconsistent practices across DSAs when a significant change in donor pathway occurs after an organ has already been accepted.

Additional Comment #6:

The proposal’s requirement to register all authorized patients “no later than the time at which the OPO decides to proceed with the donation process” is too vague to be consistently implemented, audited, or enforced. “Decides to proceed with the donation process” is not a discrete, uniformly defined operational moment across OPOs (and may be interpreted as first referral triage, first family authorization, initiation of donor management, intent to allocate, request for recovery resources, etc.). Without an objectively identifiable trigger, the requirement will produce inconsistent compliance determinations.

To preserve the proposal’s intent of ensuring a donor ID exists for reporting and oversight, the OPTN should establish a clear registration deadline. Consistent with current requirements, donor registration must occur prior to generating a match run, and if the OPO later determines not to proceed, registration must occur within 72 hours of that determination.

In addition, the proposal’s expansion of the Donor Organ Disposition (Feedback Form) requirement to apply to any “individual, except living donors, for whom authorization for donation is granted” raises important fringe cases that should be clarified. Specifically, how should this requirement apply when a patient has a valid determination of death, but donation cannot proceed due to family or hospital opposition (including situations involving registry authorization but refusal to honor donation)?

Finally, OPTN should clarify how this expanded disposition reporting requirement aligns with existing OPTN data-collection workflows, including the future Ventilated Patient Form, to avoid duplicative reporting, inconsistent denominators, or unclear sequencing of documentation expectations across referral, authorization, registration, and case closure pathways.

Additional Comment #7:

The inclusion of the “Unplanned DCD Pause Reporting Template” appears to function as supplemental guidance rather than a clearly enforceable reporting mechanism. If OPTN intends specific data elements to be required for compliance, those fields should be built directly into the OPTN Patient Safety Reporting Portal (or otherwise captured through structured portal fields), rather than relying on an external “template” that may be used inconsistently across members. This would improve standardization, reduce variation in reporting completeness, and support auditability.

In addition, the current template is highly redundant and does not clearly address common real-world scenarios, particularly cases that are paused, stopped, and later resumed after an initial report. The proposal describes follow-up expectations (e.g., providing additional information within defined timeframes after resumption or disposition), but it remains unclear whether resumption requires resubmitting the template, submitting an addendum to the original report, or initiating a new report entirely.

OPTN should clarify, in policy, the reporting structure for these scenarios, including: Whether there is one report per pause episode (pause initiated then resolved by resumption or case stop), and how follow-up updates should be submitted;

Whether a case that is stopped and later resumed constitutes a new pause episode requiring a new report, or a continuation of the original report with an outcome update; and How OPOs should document and report multiple pauses within the same case (e.g., pause, then resume, then subsequent pause).

Providing this clarity and integrating required fields into the portal would materially strengthen consistency, reduce administrative burden, and ensure the reporting process is practical, standardized, and enforceable.

Thank you again for considering these comments and for the continued work to advance a safe, ethical, and trusted donation and transplantation system. We remain appreciative of the volunteers and OPTN staff who steward policy development and implementation, often under complex clinical and operational realities. We would welcome the opportunity to support further discussion or provide additional operational perspective as the OPTN finalizes this proposal.

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 goal of improving safeguards and clarity in the DCD process. I also believe it is important to elevate the perspective of donor families who are making an extraordinarily difficult decision on what is often the worst day of their lives. While efforts to optimize organs may feel justified given the long transplant waitlist, shifting the focus too far toward efficiency and preservation risks crossing ethical boundaries that matter deeply to families and the public. If donor families lose trust in the system, we risk losing the very foundation that makes transplantation possible.

Supported policy elements

• Define a national minimum waiting period of at least five minutes after circulatory cessation.
  • Preserve clear separation between end-of-life decision making and donation discussions.
  • Allow anyone to request an unplanned DCD pause and require reporting and tracking of these pauses.
  • Require clear disclosure to families about the DCD process, including the potential use of NRP.

Concerns & Recommendations

• Hospital vs OPO responsibility: Neurologic assessment and death determination are clinical responsibilities of the hospital care team. OPTN policy should clearly define the OPO role as verification that required assessments, documentation, and check-ins have occurred, rather than clinical reassessment or assumption of liability for hospital decisions.
• Normothermic Regional Perfusion (NRP): Organ optimization must not come at the expense of transparency or public trust. Families should receive clear, understandable explanations of what NRP is, when it may be used, how it is done, and what safeguards are in place. Until a formal OPTN NRP policy exists, families should be explicitly informed and allowed to decline NRP in favor of more conservative recovery approaches. Once families who are fully educated about NRP their acceptance or decline of NRP should be tracked for a period of time to help us understand how fully informed families feel about and respond to the risks and benefits of this practice. This data should be used to support OPTN policy as it is created and refined over time.
• Cannulation prior to death: This concept is not self-explanatory when reading the proposal. Plain-language explanations should be required, including when cannulation occurs (before or after death), why it is performed, how it relates to NRP, and what happens if donation does not proceed.
• Plain-language communication: Information provided to families must be understandable to those without medical training and delivered with care and compassion. OPOs should be supported with guidance and templates or standardized language to do this well.
• Unplanned DCD pauses: Pause mechanisms should protect patients but be managed with urgency, so as not to create unnecessary delays while still honoring donor and family wishes.

Closing

Donors and their families must remain the first priority to preserve trust in this system that saves so many lives through organ donation. Donor families deserve time, clear education, kindness, and transparency, along with confidence that their loved one will be treated with respect and dignity while they are alive, after death, and throughout the donation process.

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

ANNA agrees with updating definitions and terminology as well as standardization of procurement practices among OPO’s.  Improving safeguards for potential DCD patients, communication, and transparency are important, especially with the modernization initiatives.  We also feel that increased education with donor families should include a discussion about NRP.

Dea Mahanes | 1/18/2026

I support ongoing dialogue regarding the proposed DCD policy revision and appreciate the opportunity to provide comments. My recommendations include the following:

• Separate, transparent policies for both Abdominal Normothermic Regional Perfusion (A-NRP) and Thoracoabdominal NRP (TA-NRP) are needed. These policies should mandate disclosure of the potential for NRP during the authorization process.
• I support the concept of an unplanned pause but find some of the details problematic. As others have noted, decisions to withdraw life-sustaining treatment are almost always made through shared decision-making in the context of patient preferences and values and are not based on specific hospital criteria.
• I applaud the Workgroup’s focus on requirements for information provided to families. Of note, this work highlights gaps in information provided to individuals who sign up for the donor registry when obtaining or renewing their driver’s license. These individuals often receive minimal details about the donation process, calling into question whether such registries should be considered legally binding.
• I agree with comments made by others regarding the need for separate informed consent for any tests or procedures performed prior to death. Informed consent should be obtained by the person performing the procedure.
  I am concerned that donation practices have expanded in recent years without sufficient transparency and oversight, which has eroded public trust and alienated clinicians. The proposed policy revision is a laudable first attempt at correcting some of these gaps. Although additional work is needed prior to approval and implementation, standardization of policies and practices will ultimately better serve potential organ donors, donor families, and recipients.

Gift of Life Donor Program | 1/18/2026

On behalf of the patients, families, and communities we serve, Gift of Life Donor Program (“GLDP”) thanks you for the opportunity to again provide feedback on the OPTN Public Comment Proposal regarding DCD policies (“the Proposal”). GLDP shares the goal of developing policy to safeguard DCD patients and improve family communication. We thank you in advance for your consideration of our views and recommendations.

GLDP is privileged to be the designated organ procurement organization (“OPO”) for the eastern half of Pennsylvania, southern New Jersey and the State of Delaware serving 11.3 million people. GLDP is one of the nation’s largest OPOs and has long been a national leader. Our unparalleled success in helping save lives is only possible through GLDP’s decades-long commitment to excellence and continual process improvement, fiscal responsibility, and partnership with our healthcare community. GLDP works with 123 acute care hospitals and 12 transplant centers in its region, as well as hundreds of transplant centers throughout the country, to provide the most comprehensive array of services available in the U.S. to the donation and transplantation community. GLDP has coordinated 15,586 donors and 43,108 organs for transplants, the most of any OPO in the country since the start of our national donation system in 1988.

Executive Summary

GLDP coordinated its first DCD donation in 1995. Our clinical experience in the 30+ years since has demonstrated that when carried out thoughtfully and in accordance with long-established medical and ethical standards, DCD is a critical pathway to offer families the opportunity of a life-saving legacy. GLDP’s DCD program has resulted in more than 3,000 DCD donors and more than 5,400 transplants. Operationalizing an effective DCD program involves extensive coordination among donor families, hospital care teams, OPO staff, recovery personnel and transplant programs, with clear communication at every stage.

The non-profit organization serving patients, families and hospitals in the eastern half of Pennsylvania, southern New Jersey and Delaware.

We believe that updates to the OPTN policies regarding DCD will play an important role in assuring the public that patient care decisions are independent of the donation process. To align the policies with the goals set out by HRSA and OPTN, we believe certain changes to the proposed language would be beneficial.

As an overarching theme, GLDP is concerned that the Proposal risks blurring what is currently a clear separation between the hospital care team and donation professionals. The role of the OPO is, and should remain, narrowly tailored to avoid entanglement with the provision of healthcare to a patient, including the family’s end-of-life care decision-making. The importance of this separation has been memorialized at various times by the Institute of Medicine¹ and the American Medical Association.²

In its current form, the Proposal includes policy changes that involve the OPO in the assessment of a patient and in determining the appropriateness of withdrawal of life-sustaining therapies (“WLST”). We feel strongly that such determinations should be made exclusively by a patient’s attending physician or their designee, in accordance with hospital policy and medical ethics standards. Our primary recommendations relate to this subject. In addition, transplant hospitals play a significant role in ensuring an effective DCD process. We believe there are opportunities in the policy to identify those responsibilities that would appropriately reside with the transplant hospital. Finally, GLDP believes that compliance with any policy adopted by OPTN should be objective and measurable. To that end we have included certain suggested technical changes to the Proposal.

Substantive Recommendations

1.2 Definitions (Unplanned DCD pause)

The proposed definition includes the phrase “due to a difference of opinion as to whether a patient meets the donor hospital’s criteria for [WLST]”. The definition in Section 2.15.D is different and more expansive by permitting an unplanned DCD pause to occur even after WLST, contradicting this definition. GLDP recognizes that a different policy or process may be necessary to address safeguards that may be appropriate after WLST (whether during the 5-minute waiting period or between incision and cross-clamp) but the definitions of the pause process should be better aligned to encompass the appropriate time period prior to WLST. We recommend that the definition be modified to read as follows: “An unexpected suspension of the DCD process due to a difference of opinion as to whether a patient meets the donor hospital’s criteria for the withdrawal of life-sustaining therapies. An unplanned DCD pause may occur between the time that authorization for DCD is granted per Policy 2.15.F: Authorization for DCD and the time of withdrawal of life-sustaining therapies. An unplanned DCD pause is not intended to address issues or questions related to authorization for donation.” We further recommend the committee consider additional policy language to better guide a pause practice following WLST, prior to and after incision. There are significant clinical considerations that differ from a pause prior to WLST.

1 Institute of Medicine. 1997. Non-Heart-Beating Organ Transplantation: Medical and Ethical Issues in Procurement. Washington, DC: The National Academies Press.

2 AMA Code of Medical Ethics. Op. 6.1.2. Organ Donation After Cardiac Death (Am. Med. Ass’n). Available at https://code-medical-ethics.ama-assn.org (last visited Jan. 15, 2026).

2.2 OPO Responsibilities

Subsection 7 requires the OPO to inform “all stakeholders” of the process for requesting a pause and defines stakeholders as including “the patient or patient’s agent, donor hospital staff, OPO staff, and third-party procurement and preservation staff.” As drafted, this is a very broad category of people. We agree that all relevant stakeholders should have the opportunity to pause the DCD process in light of concerns that WLST is inconsistent with a hospital’s policy on WLST. We also agree that true stakeholders should be informed of this opportunity, but believe that the scope of individuals informed and the mechanism for providing this information should be modified. Given the nature of a hospital admission, more than 100 hospital staff members could rotate through a particular case. Informing each individually in real time would be impractical and ineffective. A more practical and effective alternative is to ensure education of hospital staff on the opportunity to pause the DCD process is included in the protocols required by Policy 2.15.B so that the training can be planned and delivered in an optimal manner. Making this change will also reinforce that hospital staff are trained in a standardized manner on their responsibilities with regard to their own hospital-specific policies.

Further, we agree with the importance of effective OPO communication with accepting transplant hospitals regarding patient status and DCD protocols. However, transplant hospitals may independently utilize contracted third parties for service (without knowledge or input of the OPO). As such, the transplant hospital, and not the OPO, is the proper and best suited party to ensure that the transplant hospital’s own staff and its own contracted third parties are informed of the details of a particular case (patient’s condition, assessment that WLST is appropriate per hospital policy) as well as the opportunity to request an unplanned DCD pause. With this change, the OPO would retain responsibility for communicating with the key actors, including the transplant hospital, and the transplant hospital would retain responsibility, according to its own protocols, to ensure the flow of information through its employed and retained staff. We recommend this subsection be modified to read as follows: “Informing the patient or patient’s agent of the process for requesting an unplanned DCD pause in accordance with Policy 2.15.D: Process for an Unplanned DCD Pause and maintaining a protocol to inform other stakeholders involved in the donation after circulatory death (DCD) process of the process for requesting an unplanned DCD pause. Stakeholders include the patient or patient’s agent, donor hospital staff providing direct care to the patient, OPO staff, and third-party procurement and preservation staff retained by the OPO.”

Subsection 8, as drafted, states that the OPO is responsible for “Ensuring accuracy in neurological assessment and appropriate neurological reassessments in accordance with

Policy 2.15.C: Potential DCD Donor Evaluation.” The accuracy and appropriateness of neurological assessments must be the sole responsibility of a patient’s healthcare team. OPO staff are not qualified to perform such an assessment or evaluate the performance by a physician. Involving the OPO in oversight of the neurological assessments also creates the appearance of a conflict of interest. We recommend this subsection be modified to read as follows: “Documenting that the patient’s attending physician or their designee has performed neurological assessment(s) and found withdrawal of life-sustaining therapies to be appropriate under hospital policy in accordance with Policy 2.15.C: Potential DCD Donor Evaluation.”

2.15.B Protocols

As discussed earlier, we believe incorporating education about the opportunity for an unplanned DCD pause into the protocols between OPOs and donor hospitals is the most effective method for disseminating this information. We recommend that this section be modified to read as follows: “OPOs must establish written protocols with donor hospitals that define the roles and responsibilities for the evaluation and management of potential DCD donors, educating hospital staff about DCD donation including the unplanned DCD pause process, organ recovery, and organ placement in compliance with OPTN Policy. OPOs must make their written protocols available to the OPTN on request.

2.15.C (Lines 114-117)

The Proposal creates an obligation for “the OPO and primary healthcare team” to assess and reassess at set intervals the appropriateness of WLST. As discussed in more detail above, it would be inappropriate for the OPO to have a role in assessing the appropriateness of WLST. We recommend that this section be modified to read as follows: “The OPO must document that the patient’s attending physician or their designee has confirmed that withdrawal of life-sustaining therapies remains appropriate in accordance with hospital policy. This reassessment must be documented every 12 hours from the time the OPO initiates the donation process (authorization/disclosure process complete, family has made a final withdrawal decision, and the OPO initiates organ suitability testing) and before organ recovery teams are dispatched.”

2.15.D Unplanned DCD Pause

Beginning on line 122, this section provides that a pause may be requested any time between authorization and cross-clamp. The purpose of the pause is to safeguard that a patient’s neurological condition has not changed in a way that renders WLST inappropriate. Following WLST, the pause process could not apply, as withdrawal has occurred, and would not be practicable in application. We agree the policy may require additional language to address concerns that arise during the 5-minute waiting period and between the time of incision and cross-clamp and how those could be appropriately addressed. We recommend that this section be modified to read as follows: “… between the time that authorization for DCD is granted per Policy 2.15.F: Authorization for DCD and the time of withdrawal of life-sustaining therapies.”

Beginning at the end of line 129, we believe there is an opportunity to include certain communication expectations for transplant hospitals to ensure that an unplanned DCD pause occurs in a timely manner. Specifically, we believe it is important for the OPO to communicate detailed information about the patient’s status and how that patient meets the donor hospital’s policy for WLST to the transplant hospital. It is then critical for the transplant hospital to timely communicate this information to its staff and contracted

third-party providers. This will ensure those individuals who may participate in the recovery are fully informed of the patient’s status early in the process and can raise concerns or request an unplanned DCD pause in a timely manner. We recommend adding the followingat the end of line 129: “OPOs must establish and document a process by which itcommunicates to accepting transplant hospitals information regarding the patient’s statusand how the patient meets the donor hospital’s policy for withdrawal of life-sustainingtherapies. Transplant hospitals accepting an organ from a potential DCD donor mustestablish and document a process to communicate this information to their staff andcontracted personnel to ensure timely requests for an unplanned DCD pause.

Beginning on line 132, this section requires notification of the pause process to any hospital staff “as they become involved in the DCD process”. As described above, we believe that informing hospital staff should be the subject of education prior to encountering a DCD case and should not occur on an ad hoc basis. Moreover, this could involve hundreds of individuals during the course of an admission, rendering it highly impractical. We recommend that this section be modified to read as follows: “At the time ofauthorization, the OPO must inform the patient, if applicable, or patient’s agent of theprocess for requesting an unplanned DCD pause. The OPO must also inform the patient’sattending physician or their designee and, if different, the physician that will effectuate thewithdrawal of life-sustaining therapies. The OPO must include in the protocols described inPolicy 2.15.B a process to educate donor hospital staff of the process for requesting anunplanned DCD pause. The OPO must also have protocols to educate its own staff andretained third parties of the process for requesting an unplanned DCD pause.

Beginning on line 138, this section requires the OPO and the donor hospital care team to collaborate to determine whether the patient still meets the hospital’s criteria for WLST. For the reasons discussed in more detail above, it is inappropriate for the OPO to be involved in this determination. We recommend that this section be modified to read as follows: “The OPO will confirm that the patient’s attending physician or their designee has determined that the patient still meets the donor hospital’s criteria for withdrawal of life-sustaining therapies.”

2.15.E Response to a Request for an Unplanned DCD Pause

Beginning on line 144, this section requires the OPO to obtain acknowledgement from all transplant hospitals (and third parties) that accept an organ from the donor before recovery. Because of the nature of kidney recovery and placement, the transplant hospital accepting a kidney may not be known at the time of recovery. In addition, the OPO may not be aware of the third parties a transplant hospital has retained to participate. We recommend this section be modified to read as follows: "When the OPO determines that the DCD process can resume following an unplanned DCD pause, the OPO must notify the transplant hospital participating in the recovery process prior to organ recovery.

Technical Recommendations

1.2 Definitions (Agent) – There is significant variation in state law as it relates to the authority of an “agent” in a healthcare setting. For example, in Pennsylvania, a “healthcare agent” does not have the authority to make decisions regarding anatomical donation unless expressly granted in the document that appointed them. In New Jersey and Delaware, that authority need not be expressly granted. For clarity, the definition of Agent in the Proposal could be modified to read: “A person legally authorized to act on behalf of another person with respect to a particular decision.”

2.2(4) – The phrase “the time at which the OPO decides to proceed with the donation process” is subjective and may lead to inconsistent application by OPOs. We propose including an objective point in the donation process, such as “the time at which the OPO has completed the authorization or disclosure process with the patient’s family or other decision maker, the final withdrawal decision has been made, and the OPO begins organ suitability testing.”

2.3 Required Disclosure – The Proposal currently reads “when the authorization for donation is confirmed.” This could be clarified to read “when authorization for donation is made by the legal next-of-kin or first-person authorization is communicated to the legal next-of-kin.”

2.3(2)(e) – Consistent with (a), this section could be clarified to read “Allocation process

and estimatedtime frames for updates on allocation progress.”

2.15 Requirements for Controlled DCD Protocols – The Proposal adds the following: “The decision to withdraw life sustaining therapies should not be influenced by the donation decision.” GLDP recommends this sentence be removed or modified as it would not be possible to assess what factors a family has decided to consider. GLDP supports the underlying premise of ensuring that the family’s donation decision does not inform the decision for WLST.

2.15.C Potential DCD Donor Evaluation (line 113) – This section could be clarified to read, “the OPO must confirm the plan for continued patient care if the patient, following WLST,does not expire in a time frame …”

• Authorization for DCD (line 166) – Consistent with other provisions, this section

could be clarified to read “Estimatedtime frame between withdrawal …”

2.15.F Authorization for DCD (line 175) – The Proposal adds that the OPO must inform the patient or agent that any stakeholder may request an unplanned pause. We believe informing the patient or family of their opportunity to request a pause is appropriate, but that any other communication regarding a pause in the process (or any matter related to appropriateness of WLST) should be communicated to the family by the patient’s attending physician.

• Required reporting – We believe the timeframe for reporting an unplanned DCD pause or an autoresuscitation event should be set to 72 hours to permit an appropriate amount of time for the gathering of relevant
  • Required Reporting – We believe some clarification is warranted regarding the list of notifications to be documented. Specifically, an unplanned DCD pause that is resolved by the patient’s healthcare team may not warrant notification of that hospital’s leadership

Other Considerations

HRSA and CMS have dedicated resources to encourage alignment in the donation and transplantation goals and objectives advanced by these agencies. The DCD standards being proposed are important and we recommend that they be evaluated for inclusion in the applicable acute care hospital and transplant hospital conditions of participation regarding agreements with their OPO to support the full implementation of the educational and other requirements included in the proposal.

Summary

We appreciate the efforts of HRSA and OPTN in safeguarding patients as well as the public trust in the donation and transplantation system. We thank you for the opportunity to offer these comments and remain available to serve as a resource to you in this important work.

New England Donor Services (NEDS) | 1/18/2026

New England Donor Services (NEDS) appreciates the opportunity to comment on the proposed Donation after Circulatory Death (DCD) policy revisions.

As one of the top 3 largest OPOs by donor volume with more than 60% of its organ donors coordinated through the DCD pathway in 2025, NEDS appreciates the need for clear roles and responsibilities and standardized best practices to ensure the delivery of maximally safe and effective DCD protocols to achieve nationwide system performance at the highest possible level.

In order for the DCD policy to achieve this goal, however, it must be recognized at the outset that DCD requires careful coordination between the hospital care team who appropriately have the exclusive purview over the end-of-life care and the OPO staff whose responsibilities do not include any components of delivery of care prior to death or assessment of patient appropriateness for withdrawal of life-sustaining therapies (WLST). Within this context, the proposed DCD policy states that its purpose is to “improve safeguards for patients who enter the DCD pathway” but the policy fails to describe the nature of the safety concerns for patients or how this policy will prevent them. If the aim is to prevent premature or medically inappropriate withdrawal of life-sustaining treatments, this is not the appropriate policy vehicle. Approximately 20% of deaths in the U.S. occur in the ICU setting with fewer than 1% of those patients potentially becoming organ donors. The hospital care team is solely responsible for determining when WLST is appropriate for a patient and the process for WLST is the same regardless of whether or not the patient is a candidate for organ donation.

This policy does not apply to (and the OPTN does not have jurisdiction over) ICU healthcare professionals responsible for WLST nor the hospitals where DCD occurs (unless the hospital happens to also be a transplant center). Nonetheless, if the goal is to improve safeguards for patients, oversight and accountability must encompass all of the stakeholders involved in coordinating DCD - including those directly responsible for the neurological assessment of patients and WLST. There are multiple opportunities for HHS to address this with aligned accountability that prioritizes safety and quality processes – for example, in the CMS regulatory requirements in 42 CFR 482.45 for hospitals. Misplaced accountability on OPOs for key parts of the process (e.g., monitoring the accuracy of neurological assessments and the hospital care team’s decisions around WLST) that are the responsibility of hospital providers will not result in effective safeguards for patients entering the DCD pathway – or those outside of it.

Neurological Assessment

It is appropriate for OPO staff to be responsible for confirming that neurological assessments are being performed, but OPO staff are not licensed, qualified or trained to evaluate the accuracy of neurological assessments on living patients - this is outside of their practice scope and squarely within the purview of the hospital care team. However, Section 2.2 of the proposed policy provides that “ensuring accuracy in neurological assessment and appropriate neurological reassessments in accordance with Policy 2.15.C” is an OPO responsibility. Nowhere else in the proposed policy does the word “accuracy” appear, including in 2.15.C. Instead, 2.15.C describes the requirement that the “OPO and primary healthcare team confirm the continued appropriateness of withdrawal of life-sustaining therapies at regular intervals.” The OPO is not in a position to evaluate the accuracy of the neurological assessment or the appropriateness of WLST and in fact it would be inappropriate and a potential clinical conflict of interest for OPO staff to perform any such independent assessment on a living patient. For these reasons, this requirement should be removed from Section 2.2. Rather, consistent with current OPO practice, the OPO should be responsible for confirming that the hospital care team has performed and documented neurological assessments and that their assessment remains that WLST is appropriate and consistent with applicable hospital policy.

Unplanned Pause:

Hospital staff are present throughout the withdrawal process and remain responsible for monitoring the patient during the observation period and for declaring death. It is critical that the circumstances requiring an unplanned pause are clearly defined and that the definition be based on changes in the patient’s neurological status that are not consistent with the basis on which the decision for the WLST had been made or are not consistent with a declaration of death that had been made. Because both of these situations fall under the purview of the hospital providers who have the necessary expertise for making these determinations, and who remain primarily responsible for the living patient, HHS must identify a pathway for the appropriate accountability over the unplanned pause function in order for it to be effective towards improving safeguards.

• In section 1.2, an unplanned DCD pause is defined as an unexpected suspension of the DCD process due to a “difference of opinion as to whether a patient meets the donor hospital’s criteria for withdrawal of life-sustaining therapies.” OPO staff are not employed by donor hospitals and are not trained to individual donor hospitals’ criteria for WLST within the many hospitals they serve. Moreover, OPO staff do not and are not licensed to treat living patients and therefore are not qualified to make an assessment of the appropriateness of WLST. There are important ethical reasons for the OPO staff to remain completely independent from the evaluation of WLST decisions to reduce any clinical conflict of interest or the appearance thereof. It is unclear why the OPTN and/or HRSA believe it is appropriate for an OPO to play any role opining, influencing or assessing the appropriateness of a patient/patient agent or healthcare team continuing or discontinuing ICU-level care on a patient. In section 2.15 potential DCD donors are described as limited to those “whose medical treatment no longer offers a medical benefit to the patient as determined by the patient, the patient’s agent, or the patient’s advance directive if applicable, in consultation with the patient’s healthcare team.” Notably and appropriately, the OPO is not included in the list of those weighing in on the assessment of medical benefit. NEDS strongly recommends revising Section 1.2 and again refers to the overall comment that if the patient safety issue this Section 1.2 is intending to solve relates to appropriateness of WLST decisions, it is misplaced in an OPTN donation policy given that the hospital care team (not subject to OPTN policy) is responsible for WLST.
• In section 2.15.D.ii, the policy requires the OPO to inform donor hospital staff, transplant center staff, OPO and third-party procurement and preservation staff of the process for requesting an unplanned DCD pause as they become involved in the DCD process. As proposed, this lacks clarity and enforceability. If a donor is taken to the cardiac catheterization lab, is the OPO obligated to brief that team on the unplanned DCD pause? If a nurse is covering lunch for another nurse, must the OPO provide information to the covering nurse? The number of hospital staff involved in the care of a single ICU patient, particularly in an academic medical center, can outpace an OPO coordinator’s ability to educate/inform and simultaneously carry out their primary responsibilities. The patient/patient agent, primary hospital care team and recovery teams (both OPO and transplant) should be updated to the unplanned pause process. Requirements to inform everyone who may interact with a donor patient every shift and throughout the shift is onerous, unrealistic and does not serve a valuable purpose. WLST decisions are routinely made in hospitals and are not limited to circumstances where a patient is a potential donor. To the extent education related to reassessment of WLST decisions is necessary or appropriate, the hospital, not the OPO should be responsible for that education generally.
• Section 2.15.E requires the OPO to notify and obtain acknowledgement from a list of parties – third party contractors, transplant centers, etc. - “[w]hen the OPO determines that the DCD process can resume following an unplanned DCD pause.” How does this notification, which will result in delays and potential increased warm ischemic time, serve patients? What is the purpose of this notification? If following an unplanned pause it is confirmed that the donation should move forward expeditiously, there would appear to be no added value to this notification and acknowledgement process.
• The proposal states that it is “not expected to impact transplant candidates or transplant recipients.” However, it should be noted that allowing anyone even peripherally involved with donation to call an unplanned pause up to the point of cross clamp may impact a transplant candidate who may be denied the opportunity of a transplant due to warm ischemic time accrued during a pause at the critical juncture between declaration and cross clamp. An unplanned pause that occurs following the declaration of death but prior to cross clamp should be confined to extremely rare circumstances where the declaration itself raises concerns.
• The reporting template requests a “Date and time the OPO decided to proceed with the donation process.” This requires further clarification – does the OPO decide to proceed when the case is ruled-in for DCD? authorized? When a donor ID is generated?

Authorization

• Section 2.15.F requires the OPO to explain to the authorizing party the “safeguards that will be taken to prevent blood flow to the brain” during NRP recovery. The requirement to provide specific information about NRP should be limited to thoraco-abdominal NRP given the concern is focused on restoration of cardiac function and the potential for reanimation in that circumstance. These concerns are not applicable to abdominal-NRP and families should not be required to receive inapplicable information during the authorization process.
• Section 2.15.G states “The OPO must confirm that the patient or the patient’s agent has given consent for any DCD-related procedures or drug administration that occur prior to patient death.” As proposed, this lacks clarity. For a patient whose care plan is comfort measures, and treatment is no longer geared toward life-saving, any medications could be considered “DCD-related.” The policy should be updated to describe specific drugs or types of drugs (such as anticoagulants or vasodilators) that are specifically to benefit recipients and may hold risk for the patient as requiring separate authorization. It should be clarified that medications to maintain or optimize the patient’s organ function prior to withdrawal of life-sustaining treatments do not require specific authorization. This specificity should alleviate unnecessary burden of multiple authorizations during the DCD process. Additionally, this authorization should be obtained by the hospital care team who can seek informed consent for procedures/medications that may carry risk for the living patient under their care.

Timing of Donor Family Discussions

NEDS supports the proposed policy requirements specifying the information required when requesting authorization for donation, as these reflect current OPO practice standards. However, limiting donation discussions until after end-of-life conversations are already underway may be too late. Families often move from end-of-life discussions to end-of-life decisions within minutes or hours, resulting in missed donation opportunities due solely to timing. Accordingly, providing this information simultaneous to end-of-life discussions can be appropriate and important in some cases.

Early identification of families facing a poor prognosis—particularly when first-person authorization exists—is essential. NEDS’ experience shows that delayed donation discussions are the primary reason families decline donation, as they are often ready for closure after prolonged hospitalizations. Providing donation information sooner promotes transparency (especially when the patient is a registered donor) and ensures families can make fully informed decisions. Further, this practice is responsive to what donor families have told NEDS; they want to hear about the opportunity for donation before arrangements for end-of-life care are in motion so that they can understand and set expectations related to timing. 

Terminology and Scenarios:

The proposed policy includes terminology and scenarios that may unnecessarily raise concerns or confusion. For example, stating that a donor might be “at risk of experiencing pain during a procurement attempt” or “in the act of procuring organs” is alarming. Generally, “procurement” is understood as referring to the surgical component of the organ donation process which does not occur until after a patient’s death when the donor is deceased and no longer experience pain. It may be that OPTN/HRSA are referring to earlier steps in the donation process prior to death declaration. It would be helpful to clarify this to avoid confusion and reduce harm to public and professional trust.

Similarly, in several of the scenarios, if the attending physician, nurse or care team member is concerned about a change in neurological status related to the appropriateness of WLST, it is unclear what the OPO’s role is at that moment. The issue presented in those scenarios could occur without donation as part of the case facts. The continued appropriateness of a WLST decision is not the OPO’s to determine. The hospital care team must evaluate this separate and aside from whether DCD is planned and escalate within hospital policy. These scenarios highlight the misplaced accountability regarding effective safeguards for whether a patient meets the donor hospital’s criteria for WLST. Scenario 4 as presented is unnecessarily inflammatory and undermines public trust in donation. That scenario should be rewritten to reflect circumstances that are more likely to arise and will be informative for OPO and hospital staff participating in DCD cases.

Policy evaluation:

It is unclear why the number of unplanned DCD pauses would be a metric of policy success when the stated goal is donor safety. How does a raw number of pauses measure donor safety? Consider evaluating how many unplanned pauses result in a change to the underlying case process with respect to the withdrawal of treatment or donation plan.

Infinite Legacy | 1/18/2026

Infinite Legacy appreciates the opportunity to comment on the OPTN proposal to develop a formal policy guiding Donation after Circulatory Death (DCD) practices. We support standardized measures that improve transparency, consistency, and public trust, including appropriate disclosure to families, regular neurological assessment, and enhanced monitoring. Our feedback is informed by public education experience showing that clear, consistent communication and robust safeguards are essential to support families and maintain confidence in the donation process. To that end, we offer the following input on several critical aspects of the proposal.

First, the policy should clearly delineate roles. Withdrawal of Life-Sustaining Therapy (WLST) determinations belong to the treating clinical team in consultation with the patient or legally authorized decision-maker, not the OPO. It is not within the OPO’s purview to opine on whether WLST is appropriate. Instead, an OPO should limit its role to assessing DCD eligibility and executing disclosures, documentation, and necessary reporting. To reflect this balance, the policy should affirm that communicating changes in neurological status is within OPO purview, while decisions about WLST remain strictly clinical and expressly in the discretion of the provider and patient/patient’s agent.

We also believe the proposal should replace or clarify subjective or ambiguous language (e.g., “unresolved differences”) that could imply or require OPO adjudication of an issue. For unplanned pauses, the OPTN should specify minimum decision-making criteria and documentation elements for assessing risk before resumption. 

Second, we support defining an unplanned DCD pause and recommend a standardized process for convening, assessment, and resumption. Such a framework protects the patient’s or decision-maker’s choice, prevents undue delays, and gives families confidence by clearly articulating how concerns will be managed. To that end, the OPTN should provide baseline “steps to resolution,” including clear risk assessment criteria for resuming after a pause, require neutral facilitation or multidisciplinary confirmation to mitigate conflicts (avoiding potential conflicts when the requester also convenes), and avoid over-delegating decisions related exclusively to organ donation to hospitals.

Third, we support standardized family disclosures, including if NRP may be used. Consistent, plain-language communication helps reduce confusion and supports informed decision-making. To avoid overwhelming families and to promote uniform practice, the OPTN should issue sample or suggested plain language regarding NRP explanation (risks, safeguards, process) with a separate acknowledgment, so OPOs can document disclosures that inform without overwhelming families during discussions.

Fourth, we support and understand the need for informed consent for invasive premortem interventions such as pre-cannulation, but we do not recommend requiring separate informed consent for administration of medications such as heparin because this is not an intervention but is administered immediately prior to withdrawal to help ensure organ viability, making it distinct (in some ways) from other premortem measures. OPOs would still confirm that the family was informed of planned medication administration prior to withdrawal. We encourage the OPTN to provide a policy that expressly outlines the OPO’s duties for ensuring that informed consent is obtained and for what measures/administrations this policy/process explicitly applies to. 

We also support the neurological reassessment cadence and a uniform five-minute post-circulatory waiting time in controlled DCD, and we agree that predetermined circulatory waiting is not required when brain dead donors are managed via DCD protocols. Family-facing explanations should clearly describe this pathway, while also clarifying that pathway selection is a clinical determination and not directed by the family. We commend the updated guidance on donation discussion timing, which permits the OPO to engage with families as soon as end-of-life discussions are initiated, rather than waiting until a decision has been made. Continued HRSA/OPTN engagement on pause triggers, reporting clarity, and enforcement authority will promote consistent, trustworthy implementation

Midwest Transplant Network | 1/18/2026

2.2 OPO Responsibilities

#4: We agree with registering all patients once the DCD process is moving forward. We would suggest that once authorization is obtained and the decision is made to move forward with the evaluation and recovery process, the patient be registered in the DonorNet system. This would eliminate the need to register patients who are ruled out after the DRAI is obtained.

#7: 2.15 D: We agree that key individuals involved in the DCD process should be informed that they can request an unplanned pause at any time and that OPOs should have a policy on how these individuals are informed of this requirement. To notify every new nurse, RT, physician, etc. that comes on shift throughout the process will be difficult and onerous to document. OPOs and hospitals should have a policy on how these stakeholders are informed of this requirement but should have broad leeway in their means of meeting this requirement. MTN affirms that the pause should be due solely to concerns about the appropriateness of withdrawing life-sustaining therapies (WLST) for this patient, not any objection to donation.

#8: MTN feels strongly that OPO staff cannot be responsible for the neurological assessment of the donor nor for “ensuring the accuracy” thereof. We recommend re-phrasing this requirement in 2.15.C to require that the OPO document the exam performed by a member of the patient care team. Further, we recommend that the frequency of documented assessments not be prescribed in policy, only that continued assessment for suitability of WLST is required. This policy is drawing a very fine line between hospital responsibilities for patient care and establishing an end-of-life plan, and the OPO responsibility for donation. This recommendation puts the OPO in a position of overseeing a hospital responsibility.

The decision to proceed with WLST is an individual decision made between the healthcare providers and the patient’s agent, and sometimes the patient themself. It is not always about whether the injury or illness is survivable. It could be about quality of life. This needs to be remembered as part of the DCD process and its appropriateness. We emphasize that the OPO cannot be involved in these decisions.

2.15 Requirements for Controlled DCD Protocols: The decision to WLST is one that lies with the patient’s family/agent and the patient’s health care team. OPTN members must not influence the decision about WLST. We believe that any patient from whom life-sustaining therapy is being withdrawn in anticipation of natural death can be a suitable organ donor. Families/agents who are considering WLST must be informed about donation and how the donor evaluation process may affect the timing of the WLST. Many families have expressed their frustration with learning about this timing impact after they (the families) have already made this decision. Waiting until the family has made the decision is too late, and MTN strongly supports this change in policy.

2.15.E: Response to a Request for an Unplanned DCD Pause: MTN agrees that the OPO should develop a process for how to respond to an unplanned pause. In addition, should an unplanned pause occur, they should report it to the OPTN. We are concerned that requiring these pauses be reported within 24 hours of their origination is overly burdensome on OPOs. We recommend that the reporting requirement be a single report within 24 hours of the outcome of any pause. This would allow the OPO to provide an extensive report about the complete situation and would prevent back and forth unnecessarily.

2.15G Consent for Procedures Pre-DCD: We are in agreement that consent must be obtained for any DCD related procedures or drug administration that occurs prior to the patient’s death. This consent should be obtained per the individual’s hospital policy and the OPO should indeed confirm that has occurred. Some hospitals allow a verbal consent and some require written. This should remain consistent with their policy.

Comments regarding Appendix B: DCD Pause Scenarios

Thank you for providing specific scenarios to illustrate the types of pauses that are reportable vs. non-reportable. We have some comments surrounding scenario 2B. In this scenario, the physician is proceeding with WLST. Although concerning, we STRONGLY suggest that HRSA work with CMS to ensure donor hospitals are made aware of this OPTN policy and also require it among CMS regulations. Since the OPTN has no oversight of donor hospitals, what does HRSA plan to do with this type of report? This could put the OPO and hospital relationship in jeopardy if it is believed the OPO over-stepped in reporting the issue to a governing body.

Erica Laethem | 1/18/2026

We support the goals of this proposal and appreciate the opportunity to submit comments. We write as healthcare ethicists and a retired trauma surgeon with combined 80+ years of experience who field middle-of-the-night calls when ethics-related concerns arise related to organ donation. This is our feedback:

1. In addition to existing proposed language about the need for informed consent for medications or procedures used to sustain organs for donation, which we support, it would be helpful to clarify that First Person Authorization for organ donation does not amount to informed consent for any pre-mortem decisions, including when life-sustaining treatment may be withheld or withdrawn, or any decisions related to medications or procedures oriented toward sustaining organs for donation.
2. We believe the new proposal in “Timing of Family DCD Donation Discussion” is problematic.
   1. First, the decision about when to forgo or withdraw life-sustaining treatment needs to be focused on the well-being of the dying patient. The care team’s fiduciary relationship with the patient requires that they prioritize the dying patient in their vulnerability. Justice to the patient also requires that the family / agent’s primary interest is the good of the dying patient. Introducing the OPO before a withdrawal decision has been made expands the focus from the good of the patient to the good of potential recipients, which at times may be in conflict. Waiting until the withdrawal decision has been made helps to mitigate this conflict.
   2. Second, introduction or involvement of the OPO prior to a decision to withdraw life-sustaining treatment risks blurring the identities, scopes, and roles of the care team and the OPO. We recommend further clarification in policy, process, and education that the OPO has no authority to participate in or interfere with patient care prior to a clear decision to withdraw life-sustaining treatment, and that the standards of appropriate palliative care still apply. After a fully informed decision to withdraw, coordination between the care team and the OPO is appropriate and necessary to facilitate an effective and efficient donor process consistent with patient/agent wishes. As stated in the recommendations, any procedural or medical intervention intended only to optimize organ preservation requires specific informed consent to be obtained by appropriate OPO staff.
   3. Third, given the potential conflicts of interests for care team members managing the withdrawal of life support from potential donors, we strongly support the recommendation of the AMA Code of Ethics 6.1.2 Organ Donation after Cardiac Death, which advises that physicians should “avoid actual or perceived conflicts of interest by:
      1. ensuring that the health care professionals who provide care at the end of life are distinct from those who will participate in retrieving organs for transplant;
      2. ensuring that no other member of the transplant team has any role in the decision to withdraw treatment or the pronouncement of death.”
3. We support the option of an unplanned pause by relevant stakeholders in the DCD process and tracking this.
4. Given the ethical controversy surrounding the use of TA-NRP, at minimum, we support the need for a separate, specific informed authorization process for TA-NRP; a general request for First Person Authorization to organ donation in the DMV does not entail sufficient disclosure to constitute an informed authorization process for TA-NRP.

Donor Network West | 1/18/2026

Donor Network West appreciates the opportunity to provide feedback on the HRSA directive regarding Donation after Circulatory Death (DCD) policies. We commend HRSA and the OPTN for prioritizing patient safety, ethical integrity, and transparency in these evolving practices. Our comments are intended to support clear delineation of responsibilities, robust safeguards, and practical guidance that ensures organs are recovered ethically and safely while maintaining trust with donor families and healthcare teams.

We recognize that the primary responsibility for neurological assessments and decisions regarding withdrawal of life-sustaining therapies rests with the treating hospital and attending clinicians. OPOs play a complementary role in this process, confirming that donation is proceeding appropriately without procuring organs from patients who demonstrate neurological improvement or no longer meet DCD criteria. Language in the current proposal, such as Section 2.2.8, could be misinterpreted to imply that OPOs direct or audit clinical care. We recommend clarifying that OPOs confirm completion and appropriateness of assessments performed by the hospital, maintaining ethical separation while supporting patient safety.

Consent and authorization processes must reflect full transparency and engagement with the patient’s family. We support the standardization to ensure that families be informed of the location and setting where withdrawal of life-sustaining therapies will occur and provided the opportunity to authorize any pre-procurement medications or procedures necessary for organ recovery. In the context of NRP, providing families full disclosure that their loved one will be placed on a circuit to perfuse organs ensures patient-centered care and informed decision-making.

Donor Network West strongly supports the inclusion of an unplanned DCD pause process to protect patient safety and maintain public trust. Clear guidance, reporting templates, and education will help standardize implementation and ensure consistent application across OPOs and hospitals. Likewise, we support establishing a standardized minimum waiting period for circulatory cessation to confirm irreversibility, as evidence suggests that at least five minutes is appropriate to prevent autoresuscitation while protecting patient welfare.

We emphasize that families must be approached for donation discussions only after the independent decision to withdraw life-sustaining therapies has been made. Maintaining this separation ensures adherence to the Dead Donor Rule and reinforces transparency and ethical consistency.

Finally, clear reporting expectations are critical. OPOs should report DCD pauses, distinguishing between organ availability and cases where donor hospitals restrict procedures like NRP. Additional guidance on what information to report (such as names, dates, and responsible parties) will improve consistency and usability of this data.

In summary, Donor Network West appreciates HRSA and OPTN’s efforts to enhance DCD policy. By refining the language around role delineation, consent, NRP, and pauses, these policies can strengthen patient safety and support the donation process without unduly reducing organ availability. We thank the OPTN for the opportunity to provide feedback and look forward to continued collaboration to maximize safe and ethical organ donation.

Ramona Pena-Guerrero | 1/18/2026

As a critical care nurse with 20 years of experience caring for patients and families involved in Donation After Circulatory Death (DCD) cases, I am deeply concerned about the lack of transparency and the significant resource waste involved in pursuing organ donation from patients with a very low likelihood of recovery. While I understand the importance of organ donation, it is critical that we prioritize open communication with families regarding realistic prognoses and ensure that we are not mobilizing large teams for futile outcomes. Safeguards should be put in place to ensure that DCD is pursued only when there is a genuine potential for recovery, and medical teams must be equipped with the tools and training to make these difficult decisions with compassion and clarity. Which in my experience they often lack the tools, training and or autonomy to make appropriate decisions. In my experience, gaps and opportunities for improvement exist and all would benefit from standardized protocols and new policy that address these issues. We need to balance the desire to save lives with a commitment to patient dignity and appropriate resource use. 

Additionally, I have specific concerns regarding the proposed changes to the DCD process. 

• What exactly defines a "pause" in the DCD process?
  • How is the duration of a pause determined, and who makes that decision?
  • Will a pause be based solely on clinical judgment, or will there be standardized criteria for initiating one?
• How long can a "pause" last before it impacts the timing of organ recovery?
  • Is there a specific time limit on how long a pause can last before decisions regarding the patient’s care must be revisited?
• What safeguards will be in place to ensure that the "pause" does not unnecessarily prolong the patient's suffering or distress?
  • How will healthcare teams ensure that a pause does not lead to unnecessary interventions or discomfort for the patient?
• How will families be clearly informed about the option to call for a pause during the DCD process?
  • What tools or communication strategies will be put in place to ensure families understand when they can call for a pause and the implications of doing so?
• What will be the process for resolving a pause, and who will have the authority to make the final decision to resume or stop procurement efforts?
  • Who will be responsible for resolving disputes or concerns during a pause, especially if there is disagreement between the family and the medical team?
• What type of information will be provided to families to ensure they are fully informed about the DCD process?
  • How will OPOs ensure that families receive consistent, clear, and compassionate information about the donation process, particularly regarding the timing and potential risks involved?
• Will the proposed changes lead to any unintended delays in the organ donation process, particularly for families who may already be under significant emotional distress?
  • How will the balance be struck between ensuring safeguards for the patient and family while still ensuring a timely and effective donation process?

These concerns are vital in ensuring that the proposed changes improve both patient safety and the experience of families while maintaining transparency and ethical standards throughout the DCD process. I hope these questions can be addressed to better balance patient dignity, resource allocation, and the overarching goals of organ donation.

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

The American Society of Transplantation (AST) recognizes and shares the concerns raised regarding aspects of the donation after circulatory death (DCD) process that have emerged through recent media reports and congressional hearings. AST supports ongoing efforts to strengthen donor safety and appreciates the intent of this proposal, while noting several areas that may benefit from further clarification.

AST encourages HRSA/OPTN to promptly share this proposal and public comments with the appropriate Centers for Medicare & Medicaid Services (CMS) divisions responsible for hospital Conditions of Participation and Conditions for Coverage related to end-of-life care and organ donation. Continued collaboration between HRSA and CMS is essential, as many elements of the proposal pertain to the care of living patients, which appropriately falls under the responsibility of hospital-based health care teams rather than organ procurement organizations (OPOs). This longstanding separation of roles has been foundational to the transplant system and remains important as new DCD policies are considered. AST recommends that CMS consider updating existing CoP regulations to reflect new policy expectations and support consistent hospital–OPO collaboration.

Hospitals do not establish DCD eligibility criteria, which are developed by OPOs, while hospitals retain responsibility for end-of-life care processes. Likewise, neurological assessment and monitoring of living patients are within the scope of hospital clinicians and not OPO staff. If additional monitoring requirements are contemplated, AST recommends consultation with the Society of Critical Care Medicine and clear guidance on documentation and training expectations.
Decisions regarding withdrawal of life-sustaining therapies appropriately remain with the hospital care team in collaboration with the patient or surrogate decision maker. OPO communication with families is intended to provide information about donation opportunities and the general process, distinct from end-of-life decision-making. AST also strongly supports robust informed consent for any invasive pre-mortem procedures, managed by the patient’s health care team, with OPO documentation of completed consent.

AST supports honoring requests for pauses at any point in the DCD process and emphasizes the importance of shared training for hospitals, OPOs, and transplant centers to ensure consistent implementation. Finally, AST strongly supports the proposed minimum five-minute waiting period of circulatory cessation prior to organ recovery, which reflects common practice and is supported by current evidence.

Bebe Haffarnan | 1/18/2026

Once there is consideration or anticipation that a 'Goals of Care/ Comfort Measures Only' meeting may occur or is mentioned by family, a HCT member should notify the Organ Procurement Organization (OPO).

The OPO is to meet with the patient/decision maker ONLY AFTER a decision to extubate has occurred with the HCT and the patient/proxy. ** In some situations, a patient/family may reach out to the OPO prior to confirming an extubation decision with the HCT (this is very rare).

The OPO shares information regarding donation opportunities possible with the concerned persons. The family is given information that the HCT will remain the caregiver for their loved one throughout extubating and until the patient deteriorates to death.  Should the family agree to organ evaluation and support a decision to donate, the OPO will ask for the HCT's support in essential organ function testing and evaluation. These tests will determine more broadly the anticipated donation opportunity. Only after death (and timelines/constraints) will the recovery of organs occur.

Once the decision is made for donation, the OPO remains readily available for family and requests HCT to complete requested tests and procedures for organ evaluation.

Organs are allocated, and extubation time/place is determined with family, hospital and recovery teams. Note here that the family may also set the date and time for extubation and organs/recovery will meet their needs. Having said this, the hospital HCT is asked to have a provider available at/near bedside for up to two hours, a nurse at bedside for up to two hours, an OR space available for extubation or PACU/nearby space open and comfortable for family should they wish to attend the withdrawal and comfort measure period. ** Note that there are restrictions placed by some hospitals, as an example, DCD only on Monday-Friday, or none after 5pm, etc. This may be in direct conflict with family wishes, but the OPO is a visitor and does NOT control these issues. The OPO may only have a member present for recording vitals with NO involvement in keeping patient comfortable and NO involvement in declaring cardiac death. In some situations, TA NRP - thoraco-abdominal normothermic reperfusion, there may be the request for TWO physicians to evaluate and declare and confirm cardiac death before the OPO enters into the active phase of organ recovery.

The main point of the above is to say that the DCD process is one that is based on the HOSPITAL and Healthcare Team. The OPO has been the recipient of many negative comments, but the basis, when analyzed, falls to hospital HCTs. Determining the appropriateness of a decision by HCTs and patient and/or their advocate is certainly NOT in the purview of OPO members. That decision occurs before OPO involvement, and we should not be instructed that those decisions are ours to make. Are you saying we can be involved and walk away if not appropriate in our thinking. We are NOT in control of the hospitals and their staff, or of a family and their loved one. By having us walk away if we disagree with their action, others may die should donation opportunity have been present.

The recovery surgeons and OPO staff only enter the picture after the HCT has pronounced death. The OPO only proceeds with surgery after the HCT pronounces the patient was dead. Should a contrary finding occur, the case is stopped immediately and care returned to the HCT.

The family/surrogates of donors feeling they are not well informed, that DOES fall to the OPO, and we definitely want to eliminate that deficiency. The decision for NRP / TA-NRP does not become known to the OPO until an accepting transplant center states their plan (most often after allocation of organs). At that point, more information should be shared with the family. We ask a lot of our generous and caring donor families, including time for organ evaluation, placement and then trying to provide full disclosure in a meaningful way on the worst days of their life. Donation is truly a miracle.

The world of Donation and Transplant has changed dramatically during my many years in this field. It is not slowing down. Is that a good thing, or not? I dare say that a majority of donor families would say that having the silver lining of a renewed life for others is extending the legacy of their loved one. And for recipients, need I say more.

Lenore Hicks | 1/18/2026

I have more questions than answers. What education will there be on these new proposals?  The education of hospital staff and OPOs should be on the same level, whereas there needs to be another level for the community. What is Ta-NRP, and how and why is it given? I did not see that in the glossary of terms. Will the family agents and donor be informed of its use? Will they have to give consent for it to be used? What is a certain level of reporting to the agents and donor? What does that mean? Are you going to only tell them certain things about the process?   Must the hospital and OPO be in agreement before pausing donation? I believe that any questions about if the process should be stopped or proceed should be documented for transparency.

University of Wisconsin Organ and Tissue Donation (UWOTD) | 1/17/2026

On behalf of UW Organ and Tissue Donation, please see below for public comments related to the HRSA Directive for OPTN DCD Policy Development and the HRSA Directive to Reduce the Risk of Donor Derived Rabies Transmission. UW Organ and Tissue Donation appreciates the opportunity to provide public comment.

1. HRSA Directive to Reduce the Risk of Donor Derived Rabies Transmission
   1. University of Wisconsin Organ and Tissue Donation (UWOTD) appreciates the intent to enhance safety and expresses concerns about any additional screening criteria asked to donor families. While we agree in ensuring the safe transmission of organs for transplant, even minor additions to the Donor Risk Assessment Interview (DRAI) will continue to extend an already lengthy process further increasing emotional strain on grieving families. Every family member going through acute grief will be asked these questions. The length of the DRAI has continued to grow and donor families already express tremendous fatigue during the interview process. It is concerning that the low frequency of disease finding suggests minimal backend benefit, rendering frontend efforts significantly disproportionate. This slippery slope of incremental additions further increases fatigue and unfortunately will further deteriorate relationships with the donation process among donor hospitals and donor families as the DRAI process grows without proportional safety gains. The question of being bitten by a wild or stray animal already exists and could be further leveraged by re-wording policy so that if concerns for rabies exists, the CDC still is contacted without unnecessary policy language or additional questions imposed on every potential donor’s family. UWOTD appreciates the opportunity to provide comment and urge the system to find ways to support donor families undergoing this process while maintaining safe transplant opportunities.

2. HRSA Directive for OPTN Donation after Circulatory Death Policy Development

   University of Wisconsin Organ and Tissue Donation (UWOTD) appreciates the opportunity to comment on the OPTN proposal around Donation after Circulatory Death (DCD) practices. UWOTD applauds enhancements to patient safeguards, standardization, and transparency to make donation safe, fair, and reliable. UW OTD supports core proposals with the following comments:

   1. Evaluating Referred Patients (Policy 2.2, Item 3): We support adding clarifying language to continue standardization of roles and responsibilities. UWOTD encourages OPO responsibility to be focused on referrals that are made by the hospitals and that it is the potential donor hospital’s responsibility to ensure the referral is made to the OPO. A small change, but important.
   2. Education and Empowerment around Pause Triggers: UWOTD agrees to avoid specific triggers due to clinical variability but acknowledges that any supplemental education provided by HRSA would be meaningful to all stakeholders. The scenarios were helpful to read in the policy proposal and provided greater clarity.
   3. Roles in Neurological Assessments (Policy 2.2, Item 8 and Policy 2.15): UW OTD supports hospital led assessments with the OPO’s role focused on the verification of completion. We recommend revising Policy 2.2.8 to limit the OPO role to ensuring just the completion and avoid liability for accuracy given the OPO is not considered to be the expert around the ‘accuracy’ of the assessment.
   4. Undue Influence on Withdrawal of Life-Sustaining Therapies (WLST) and Timing of Family Discussions: UWOTD supports timing guidelines aligned with the Uniform Anatomical Gift Act (UAGA), where potential donor hospitals facilitate pre-withdrawal conversations remember that some donors make first person authorization decisions or families may want to decide to extubate knowing all relevant information. This is already exemplified when donor hospitals review advance directives (e.g., powers of attorney or living wills) which include a donation decision. Advance directives are often reviewed in advance of a withdrawal decision. The information is already shared and can be shared without undue influence. OPOs then have the responsibility to address donation conversations post-WLST decision but pre-withdrawal. It is of utmost importance that the hospital staff leave an opportunity for a conversation about donation. WLST can be driven by a variety of factors like prognosis, patient preferences, clinician communication, ICU norms, and cultural beliefs. It should not be driven by donation information and can be properly decoupled while still allowing families as much information as possible.

We appreciate the opportunity to provide comment on this important topic.

Iowa Donor Network (IDN) | 1/19/2026

Iowa Donor Network (IDN), the federally designated organ procurement organization serving the state of Iowa, welcomes the opportunity to comment on the proposed OPTN Donation after Circulatory Death (DCD) policy framework put forward by the Health Resources and Services Administration (HRSA). We value HRSA’s efforts to strengthen safety, consistency, and trust in the nation’s donation and transplantation system.

As the OPO for the state of Iowa, IDN is dedicated to saving and transforming lives through the gift of organ and tissue donation. We work to inspire all Iowans to give the gift of life through organ donation while supporting donor families, partnering with hospitals, and upholding ethical, evidence-based practices with a culture that supports continuous quality improvement.

DCD has become an increasingly important pathway for donation, enabling thousands of patients each year to receive lifesaving transplants, patients who would otherwise see their conditions continue to deteriorate leading to persistent pain, mental and emotional distress, and increased costs of care. IDN strongly supports DCD as an essential option and agrees that donor families and clinical teams must be supported to ensure donor safety and dignity throughout the process.

We firmly believe decisions regarding withdrawal of life sustaining treatment (WLST) must remain exclusively with the patient’s legal decisionmaker and the patient’s health care team. OPTN members should not, under any circumstances, influence those clinical or personal decisions. IDN supports offering donation opportunities to every patient who meets clinical criteria, whether WLST is being considered due to neurologic devastation or other irreversible, nonsurvivable conditions. Overly restrictive requirements or constraints that reduce a patient’s chance to donate run counter to the OPTN’s mission and the broader purpose of the national transplant system.

Families who are contemplating WLST must receive timely, transparent information about how donation may influence the timing of withdrawal. In our experience, families frequently express frustration when they learn of these timing impacts after making plans for other family members to be present. Waiting until the WLST decision is finalized is often too late to set appropriate expectations, and IDN supports policy changes that enable earlier education.

Currently, there is no accurate or standardized way to predict whether a patient will pass away within a timeframe compatible with DCD. For this reason, IDN does not support prescriptive clinical criteria in policy that automatically trigger a DCD pause. Education provided jointly by OPOs and donor hospitals can help identify situations where neurological evaluation may be challenging, but rigid policy requirements risk excluding viable donors who do not fit narrow neurologic patterns yet clearly cannot survive without artificial support such as ventilation, mechanical circulatory devices, or vasoactive medications. Patients facing endstage cardiopulmonary disease, for example, may be appropriate DCD candidates even though their deficits are not neurologic in nature.

Growing clinical experience with DCD indicates that observation periods shorter than five minutes from circulatory arrest to incision may not reliably exclude autoresuscitation. With expanding use of technologies such as machine perfusion and normothermic regional perfusion (NRP), the urgency associated with warm ischemic time has diminished, weakening arguments for shorter observation intervals. IDN supports the establishment of a five minute continuous observation requirement prior to organ recovery. We also recognize that some declaring clinicians may feel a full five minute observation is unnecessary; in those cases, the OPO should be permitted—and required—to complete the full observation period and document it in the donor record.

We question the value of requiring OPOs to report DCD pauses within 24 hours of their initiation. OPOs routinely navigate sensitive and complex situations with families and clinical partners, and isolating this one type of event for accelerated reporting appears unnecessarily burdensome. If reporting is required, we suggest a single report submitted within 24 hours of the resolution of the pause, not to exceed 72 hours. Pauses that remain unresolved after 72 hours could be reported at that time, with a followup report after resolution.

We agree that individuals involved in the DCD process should be informed of their ability to request an unplanned pause at any point, and the practical expectations for notifying rotating staff require clarification. Continually informing each new nurse, physician, or respiratory therapist who arrives on shift is not feasible and would be exceedingly difficult to document. A more reasonable solution would be hospital and OPO policies that clearly outline the unplanned pause protocol, incorporated into routine staff education. OPOs could be required to provide educational materials to hospitals without documenting individual receipt for every case.

IDN understands the intent behind allowing any stakeholder, including donor families, hospital staff, OPO personnel, and third party recovery teams, to initiate a pause based on concerns about the appropriateness of WLST. We emphasize that OPO personnel should never be involved in determining whether WLST is clinically or ethically appropriate; those decisions rest solely with the patient’s care team and the patient or their legal representative. Ethics consultations should remain available whenever concerns arise. OPOs should maintain policies describing how stakeholders are informed of these rights, while retaining flexibility in implementation. Transplant centers should also share responsibility for educating their own staff.

IDN does not believe OPOs should bear responsibility for performing or validating neurologic assessments. Policy language in section 2.15.C should be revised to require OPOs only to document the assessment performed by a qualified member of the patient care team. The frequency of assessments should not be mandated in policy; it is sufficient to require ongoing evaluation of WLST appropriateness.

Finally, IDN agrees with the clarifications regarding donors who meet neurologic criteria for death but whose families request recovery under DCD protocols. These clarifications strengthen policy consistency and accuracy.

We support these proposed OPTN policies moving forward for approval.

Laura B. Webster | 1/19/2026

I have a major concern with the wording changes to suggest that the OPO can approach a family prior to the decision to withdraw LST.

First, thank you for the revision and having public comments.  I highly agree with the pause, and as an avid supporter of organ donation I want to see your effort succeed.  There are two specific items that I worry will risk success.

First, on page 19, Section 2.5, lines 89-91 with recommended changes open the door for a patient's agent to have discussions about donation prior to knowing if the patient's treatment should be ended.  This creates a huge conflict of interest and will only further sow distrust within the community and the healthcare staff.  There are ways to ask the hospital policy to have a discussion about goals and leave space for the OPO to talk to the family before a plan is made to when treatment should be withdrawn.  

Second on page 21, line 160, outlines that the patient can give authorization for DCD and does not outline if this is first-person authorization through a driver's license or through advanced care planning.  If first person authorization is being considered, the OPOs have a lot of work to educate the public about DCD and the fact they will discuss organ recovery *before* a person dies and that having it on your license can mean your loved ones will not get to influence how you die.  This is a grave error.  I know countless healthcare staff who have removed themselves from the registry after OPOs told families the patient already 'authorized' DCD.  DCD *REQUIRES* consent until such time it is common knowledge that signing up at the DMV = DCD.  As an ethicist and a nurse, I believe this is a matter of trust through transparency.

University of Utah Organ Donation Program | 1/20/2026

The organ transplantation system has implemented a series of important technical innovations, including NRP, that create opportunities to boost the supply of organs for transplantation, but guidance on safe implementation of these tools has trailed implementation. Our organ donation system is built on the trust and altruism of those members of our community who make the choice to register as organ donors. We must sustain and protect that trust by establishing transparent and robust clinical practice standards for organ donation.

We strongly believe that, with the right protocols and guidelines in place, we can utilize reperfusion technologies to increase the available supply of transplantable organs without compromising the safety of donor patients. We applaud the OPTN for their work in beginning to develop standards and frameworks for ensuring donor safety and we look forward to further steps to improve nation-wide standards for the care of DCD donor patients and their families.

Additional guidance and research in the following areas would be of benefit to the integrity of the organ donation system:

• A robust and comprehensive process for rapid declaration of death in DCD patients
• Protocols for prevention and monitoring for accidental reperfusion of the brain in NRP patients
• Standards for disclosure of NRP processes to donor families are essential, especially given that organ donation permission proceeds under the principle of authorization, rather than informed consent. It is important that members of the general public have access to high-quality information about organ donation.

As our local institutions work to establish best-practice standards for DCD donor care, we look forward to collaboration with and guidance from OPTN in the development of comprehensive nationwide standards for safe and effective organ donation. Our communities are counting on us.

Anonymous | 1/20/2026

I work as a transplant preservationist and believe there needs to be more informed consent when it comes to the donor registry and DCD recovery as a whole. I have witnessed high neuro pt's in distress during OR prep d/t inadequate sedation by hospital care teams. Often this is due to declaring physicians not wanting to be complicit in the death of their patients with too much sedation, but there are other options that do not affect BP or respiratory drive that I wish I could advocate for.  

Before working in organ recovery, I had no idea that donors had to stay on the vent for several days and that DCD was even an option that could be pursued. Let alone the advances like NRP and normothermic pumps. I feel if the lay person knew what they were signing up for there would be a significant drop in FPA, but ethically it feels like the right thing to do.

We also need to abolish the CMS tier system as it creates a push for more donors and creates bias amongst OPOs to stay tier one and not be bought out by someone else. Quality over quantity is the way to go. The tier system breeds more aggressive donor pursuit and doesn't make donation feel like a gift anymore. It also increases the chances of pt safety concerns.