The U.S. Department of Health and Human Services (“HHS”) recently announced a major reform initiative aimed at strengthening oversight of the organ transplant system for donations after circulatory death (“DCD”). This announcement follows an investigation by the Health Resources and Services Administration (“HRSA”) that uncovered instances where HRSA found potentially preventable harm to neurologically injured patients during the organ recovery process. For example, HRSA determined that organ recovery procedures were initiated while patients still exhibited signs of life, raising questions about clinical integrity and ethical oversight.
Prompted in part by the recent federal investigations into organ procurement practices, a recent article by the New York Times highlights the human impact of oversight lapses in DCD cases. The New York Times article has drawn national attention to issues that may contribute to an erosion in public confidence, especially in light of HHS’s reform initiative, in a system that relies heavily on trust and transparency. In this context, health care organizations involved in organ procurement and transplant activities are key participants in reinforcing confidence in the organ donation process by promoting clarity, consistency and patient-centered care.
Why This Matters
Health care organizations, particularly donor hospitals, transplant centers and organ procurement organizations (“OPO”) and affiliated providers, should prepare for increased scrutiny and evolving compliance expectations. These developments may affect protocols for the determination of death, consent documentation and donor eligibility assessments. Notably, these changes come amid growing tension between longstanding federal efforts to increase the number of organs procured and concerns that pressure on OPOs may compromise patient protections.
Background
The U.S. organ transplant system relies on coordination among OPOs, transplant centers, hospitals and oversight bodies. Hospitals typically identify potential organ donors, and OPOs obtain consent, recover organs and coordinate transport. OPOs and transplant centers then match organs to recipients based on medical need and compatibility, among other factors. Despite advancements in transplantation overall, challenges persist, including organ shortages, long wait times, disparities in access and patient safety concerns.
Organ donation typically occurs through two primary pathways:
- Donation after Brain Death: Organs are recovered from patients who are declared brain-dead but maintained on life support to preserve organ viability.
- DCD: Organs are recovered following the irreversible cessation of circulatory and respiratory functions after withdrawal of life support.
DCD donation, once a rare occurrence, now accounts for a growing volume of donations. Organ Procurement and Transplantation Network (“OPTN”) reported that in 2024, there were 7,280 DCD donors, an increase of 23.5% over 2023. DCD enables organ recovery in situations where brain death criteria are not met but the overall prognosis is poor. However, DCD presents unique clinical, legal and ethical risks.
Challenges in DCD Donation
DCD refers to the process of organ donation that occurs after the irreversible cessation of circulatory and respiratory functions—that is, when the heart has stopped beating and cannot be restarted. DCD is typically considered when a patient has suffered a catastrophic injury or illness and does not meet the criteria for brain death, but the care team, in consultation with the patient’s legal next of kin, determines that continued life-sustaining treatment is no longer in the patient’s best interest and decides to withdraw support. Importantly, the decision to withdraw life-sustaining treatment must be made independently of any discussions around organ donation. Consent for organ donation must be obtained after the decision to withdraw life support is made. In its review, HRSA found that sometimes this process is rushed, and OPO involvement can blur the lines between clinical care and organ recovery.
Once consent is secured, the patient is moved to the operating room, life support is withdrawn and death is declared after circulatory cessation and a mandatory waiting period. Procurement then begins.
In its review, HRSA notes that there may be instances in which signs of life persisted after the organ procurement process was initiated. While the hospitals retain clinical authority prior to declared death, HRSA found in its review that in some cases, OPOs may unduly influence decisions. The differing missions of hospitals and OPOs (care vs. recovery) can create tension, especially where there is pressure to increase organ supply. Recent investigations and media reports have spotlighted these risks, prompting calls for reform.
HRSA’s Regulatory Response
As part of the announced initiative, HHS/HRSA have outlined both corrective actions specific to the OPO and national reforms. While many of these corrective actions and HRSA directives apply to specific OPOs, they offer important insights and implications for all OPOs and the broader national procurement system.
OPO-Specific Reforms
- Root Cause Analysis Requirement: The investigated OPO must conduct a comprehensive root cause analysis of its failure to follow internal protocols, including failure to observe the mandated five-minute waiting period after circulatory death.
- Policy Development for Donor Eligibility: The OPO must adopt clear, enforceable policies for determining donor eligibility to prevent premature or inappropriate initiation of procurement processes.
- Safety Oversight Procedure: The OPO must implement a formal procedure by which any staff member or any individual can halt the donation process if patient safety concerns arise.
- Threat of Decertification: HHS has made it clear that failure to meet the noted corrective actions may result in decertification of the OPO.
System-Wide National Reforms
- Reopening of Closed Cases: HRSA has directed the OPTN to reopen a previously closed case involving harm to a neurologically injured patient.
- Independent Review Mandate: HRSA has demanded an independent review of the implicated OPO’s conduct and treatment of vulnerable patients.
- Mandatory Safety Reporting: HRSA’s directives include a requirement that all procurement stoppages due to safety concerns, regardless of who raises them, must be formally reported to federal regulators.
- Policy Updates for Safety and Transparency: OPTN must revise national policies to strengthen procurement safety protocols and ensure accurate, complete information is consistently shared with families and hospitals. HRSA has indicated these policies should, at a minimum, address the following topics:
- A clearly defined process by which a “pause” in organ procurement efforts may be initiated if there is concern regarding unrecognized neurological improvement or the potential for the patient to experience pain during the procurement process.
- Requirements for providing detailed information about DCD organ procurement to the patient’s family at the time of donation authorization.
- Specific revisions to existing OPTN policies to include:
- Empowerment of patient families, hospital staff, transplant center personnel, and third-party procurement and preservation teams to request a “pause” in the procurement process if any patient safety concerns arise.
- Clear description of the OPO’s responsibility to ensure the accuracy of neurological assessments and to conduct appropriate reassessments as needed.
- Each policy must solicit public comment.
More details on all of HRSA’s directives and corrective actions can be found here.
Practical Takeaways
- Donor hospitals and OPOs should review current and future proposed requirements related to mandatory safety reporting in effect, hospitals should ensure appropriate mechanisms are in place to adequately evaluate and report relevant data to federal regulators.
- OPOs and donor hospitals should ensure that they meet their respective obligations related to the organ donation process, including that the patient care team is responsible for medical decisions, particularly regarding withdrawal of life support without OPO advice or pressure.
- OPOs, hospitals and others involved in patient care and donation decisions must abide by all guidelines and guidance regarding communication with patients’ families.
- All clinical criteria for declaring death, especially in DCD cases, must be clearly defined, legally compliant and consistently applied.
- Donor consent processes, including how consent is obtained and documented, should be reviewed to ensure clarity, appropriate timing and legal sufficiency.
- All legal and ethical directives or guidelines regarding DCD should be reviewed and updated, as appropriate.
- HRSA’s actions signal a broader shift in federal oversight. Health care organizations involved in organ procurement and transplant activities should stay informed and consider taking proactive action to identify and address potential vulnerabilities in organ transplantation processes.
If you have any questions or would like additional information on this initiative and how it may impact your practice, please contact:
- Lori Wink at (414) 721-0456 or lwink@hallrender.com;
- Jennifer Skeels at (317) 977-1497 or jskeels@hallrender.com;
- Brian Betner at (303) 802-1298 or bbetner@hallrender.com;
- Megan Culp at (317) 429-3644 or mculp@hallrender.com;
- An additional member of Hall Render’s Transplant & Organ Procurement Service Line; or
- Your primary Hall Render contact.
Special thanks to Summer Associate Nick Baker for his assistance in the preparation of this article.
Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot—outside of an attorney-client relationship—answer specific questions that would be legal advice.
