Strengthening Organ Donation and Procurement Safety

What is the difference between organ donation and organ procurement?

According to national data, more than 90% of Americans support organ donation, which is reflected in the more than 170 million Americans who have registered their intention to donate organs after their death. A national system that serves all organ donors and more than 100,000 patients in need of a transplant must be safe, fair, and effective. Without a strong record of safety, people may not want to register as donors in the future.

Donating organs requires getting that life-saving gift from the donor patient to the waitlist patients in need. There are specialized medical providers, called organ procurement organizations (OPOs), that are the link between donation and transplantation through providing organ procurement clinical care. Organ procurement is the “the surgical procedure of removing an organ, corneas or other tissue(s) from a donor.” Organ procurement organizations interact with more than 1 million patients who are evaluated to donate organs every year— in 2024, nearly 40,000 waitlisted patients received a donated organ from a deceased organ donor.

Improving Organ Procurement Safety to Strengthen Public Trust and Patient Outcomes

The Organ Procurement and Transplantation Network (OPTN) creates, implements, and monitors national policies for organ procurement organizations (OPOs), transplant hospitals, and other OPTN members. As the OPTN modernizes, HRSA and the OPTN are committed to improving procurement safety to protect potential donor patients and strengthen public trust in organ donation. Everyone who chooses to be an organ donor deserves a process that is safe, high-quality, and respectful. When the time comes, getting organ procurement right is essential—because it's not just a procedure, it's the gift of life.

What actions are being taken to address organ procurement safety?

HRSA and the OPTN are actively engaged in ensuring that organ procurement is safe for the over one million patients referred to OPOs annually. These actions span a wide-range of topic areas including: 

Ventilated patient form

  • OMB approved a new ventilated patient form (VPF) (XLSX - 24 KB) and accompanying instructions (PDF - 159 KB). The VPF standardizes reporting on all ventilated patients referred to an OPO for potential organ donation who have a documented pronouncement of death. HRSA is continuing to develop automated data connections specifications to enable information from the VPF to flow directly and securely into national systems. Over time, this enhanced reporting will provide a more comprehensive understanding of how hospitals and OPOs identify potential donors, as well as how OPO processes and clinical practices influence the number of deceased donor organs available for transplantation. 

Normothermic regional perfusion 

Donation after circulatory death

  • The OPTN and HRSA issued a safety alert (PDF - 99 KB) regarding rare cases of autoresuscitation (spontaneous return of cardiac or respiratory activity) during donation after circulatory death (DCD) procedures. Proposed policy updates and data collection measures will follow to enhance system safety and consistency. The OPTN urges all OPOs, in coordination with clinical partners involved in organ donation, to: 
    • Strictly observe the documented waiting period after cessation of circulatory/respiratory activity before incision; 
    • Ensure awareness and coordinated response plans for potential autoresuscitation events; and
    • Promptly report any such incidents through the OPTN Patient Safety Portal. 

Data and reporting

  • HRSA has proposed a new federal data collection requiring OPOs to describe how, when, and where OPO providers interact with patients referred by hospitals for possible organ donation. This proposal was open for public comment, and stems from an HHS Secretarial Data Directive.
  • HRSA notified the OPTN (PDF - 202 KB) to include patient records in data and analytic files for those patients from whom OPOs attempted to procure organs. This action is intended to increase transparency and inform system oversight and quality improvement.
  • HRSA instituted a new process to report allegations of misconduct related to organ donation, organ procurement, or organ transplantation. As reports are received, HRSA directs oversight action and triages complaints to the appropriate investigative body (or bodies) including, as appropriate, the OPTN.

Patient safety

  • The Secretary directed (PDF - 286 KB) the OPTN to develop a new policy that requires OPOs to designate a patient safety officer. These officers will be responsible for: 
    • Monitoring and investigating patient safety events in real time; 
    • Serving as the first point of contact for families, hospital partners, and HRSA; 
    • Documenting and reporting incidents and adverse events to OPTN; 
    • Leading root cause analyses; and 
    • Ensuring corrective actions are implemented.
  • HRSA and the OPTN conducted a special review of allegations of potential preventable harm to a patient under the care of a specific OPO. Additionally, HRSA identified a concerning pattern of risk across OPOs, often linked to staff practices, which included inconsistent assessments, coordination of care, data collection, and lack of clarity on roles and responsibilities within the care team. In response, HRSA directed the OPTN to develop a corrective action plan for the specific OPO (PDF - 2 MB) and directed the OPTN to develop safety standards and policies for the protection of all patients who may donate organs across the nation.

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