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)

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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. 
 

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