Hospital referral and the duty to notify the OPO

Hospital referral is the act by which a hospital notifies its designated organ procurement organization (OPO) of a patient who has died or whose death is imminent, so that the OPO, rather than bedside staff, can evaluate the patient for organ, tissue, and eye donation and, where appropriate, approach the family. In the United States this notification is a federal requirement: under the Medicare and Medicaid Conditions of Participation at 42 CFR 482.45, every participating hospital must notify the OPO (or a designee) of all such individuals in a timely manner.[1][2] The duty exists because most potential donors are identified only at the moment of severe brain injury or death, and because survey data and policy guidance both treat early, complete referral as the single largest determinant of whether a possible donation is ever realized.[3][4]

The referral duty deliberately separates two functions: the hospital's job is to report the death or imminent death, while the determination of donor suitability and the request to the family are reserved to the OPO and to specially trained requestors. This structure is intended to maximize identification of potential donors while protecting families from premature or untrained approaches.[1][5]

Legal and regulatory basis

The duty arises from the hospital Conditions of Participation. 42 CFR 482.45(a)(1) requires a hospital to "have and implement written protocols that incorporate an agreement with an OPO ... under which it must notify, in a timely manner, the OPO or a third party designated by the OPO of individuals whose death is imminent or who have died in the hospital."[1] The same condition requires the hospital to determine, in collaboration with the OPO, which deaths qualify (subsection (a)(1)), to have agreements with at least one tissue bank and one eye bank (subsection (a)(2)), to ensure that the family of each potential donor is informed of its donation options by an OPO representative or a "designated requestor" (subsection (a)(3)), to encourage "discretion and sensitivity" toward the family's circumstances and beliefs (subsection (a)(4)), and to work cooperatively with the OPO and tissue and eye banks on death-record review and staff education (subsection (a)(5)).[1]

Notably, the regulation does not itself define the clinical criteria for "imminent death"; it requires that the hospital and OPO agree on those triggers locally.[1][6] Section 482.45(b) separately requires hospitals that perform transplants to be members of the Organ Procurement and Transplantation Network (OPTN) and to abide by its rules.[1] The referral duty operates alongside the state-law consent framework of the Uniform Anatomical Gift Act, which governs who may authorize donation; the federal rule governs notification, and state UAGA governs authorization.[7]

Clinical triggers and timing

Because the regulation leaves the definition of "imminent death" to local agreement, hospitals and OPOs establish "clinical triggers": objective bedside criteria that, when met, oblige the staff to call the OPO. Commonly used triggers apply to mechanically ventilated patients with a severe, non-survivable neurologic injury and include a Glasgow Coma Scale (GCS) score at or below a set threshold (thresholds in published series range from 4 to 8, with 5 frequently used), loss of one or more brainstem reflexes, or any discussion of withdrawing life-sustaining treatment or of brain-death testing.[3][8] The Organ Donation Breakthrough Collaborative promoted a target of referral within one hour of a patient meeting a clinical trigger, and referral on the trigger (not after death) is essential to preserve the option of donation after circulatory death and to allow timely evaluation in donation after brain death.[8][9] Published audits document substantial variability in the exact triggers hospitals adopt, which is one reason CMS and OPOs emphasize standardized, written trigger agreements.[3]

Who determines suitability

A central feature of the framework is that bedside clinicians do not rule patients in or out as donors and do not raise donation with the family. Medical suitability is determined by the OPO after referral, drawing on the donor evaluation and infectious-disease testing process.[1][5] The donation conversation is conducted by an OPO coordinator or by a hospital-based "designated requestor" who has completed OPO-approved training, as required by 42 CFR 482.45(a)(3).[1] This approach is paired with "decoupling": the notification or discussion of death is separated in time and personnel from the request for donation, so that families are not asked to consider donation in the same breath as being told of the death. Decoupling and the use of trained requestors are associated in the donation literature with higher authorization rates and are reflected in CMS interpretive guidance and OPO best practice.[5][10]

Tissue and eye referral

The same referral that reaches the OPO also serves tissue and eye donation. Whereas organ donation generally requires a ventilated patient with circulation maintained until recovery, most deaths in a hospital can yield donated tissue (such as corneas, skin, bone, heart valves, and vessels) within hours after circulatory death. For this reason 42 CFR 482.45(a)(2) requires hospitals to maintain agreements with at least one tissue bank and one eye bank, and the timely-notification duty extends to all deaths so that tissue and eye suitability can be assessed even when organ donation is not possible.[1] In practice, many OPOs and tissue/eye banks share a single notification line so that one call routes a referral to the appropriate recovery agency.[1][5]

Enforcement and oversight

Compliance with 42 CFR 482.45 is assessed during CMS hospital surveys, guided by the interpretive guidance in the CMS State Operations Manual, Appendix A (Interpretive Guidelines for Hospitals).[2] Surveyors review death-record (decedent referral) logs, the hospital's OPO agreement and protocols, and evidence that designated-requestor training occurred. The hospital duty under Part 482 is paired with a parallel set of duties on the OPO itself under the OPO Conditions for Coverage at 42 CFR Part 486, Subpart G, which set OPO certification and re-certification outcome measures (42 CFR 486.318) and require each OPO to hold a written agreement with at least 95 percent of the Medicare- and Medicaid-participating hospitals in its service area that have both a ventilator and an operating room (42 CFR 486.322).[11][12] The two regimes are complementary: the hospital must call, and the OPO must be ready to receive the call and act on it.[11]

See also

• The donation pathway
• Organ procurement organization
• Deceased donation
• Donor evaluation and infectious-disease testing
• Uniform Anatomical Gift Act (UAGA)

References

• 42 CFR § 482.45, Condition of participation: Organ, tissue, and eye procurement. Electronic Code of Federal Regulations / Cornell Legal Information Institute. https://www.law.cornell.edu/cfr/text/42/482.45
• Centers for Medicare & Medicaid Services. State Operations Manual, Appendix A, Survey Protocol, Regulations and Interpretive Guidelines for Hospitals (Conditions of Participation), §482.45. https://www.cms.gov/medicare/provider-enrollment-and-certification/guidanceforlawsandregulations/hospitals
• Variability in clinical triggers for organ donation referrals. Front Transplant. 2026;5:1701648. https://www.frontiersin.org/journals/transplantation/articles/10.3389/frtra.2026.1701648/full
• Health Resources and Services Administration / OPTN. Deceased donation: the basic path of donation. https://optn.transplant.hrsa.gov/learn/about-donation/the-basic-path-of-donation
• Association of Organ Procurement Organizations (AOPO). The donation process and the role of the OPO. https://www.aopo.org/
• 42 CFR § 482.45(a)(1) (timely notification; deaths qualifying for referral determined in collaboration with the OPO). Cornell Legal Information Institute. https://www.law.cornell.edu/cfr/text/42/482.45
• Uniform Law Commission. Revised Uniform Anatomical Gift Act (2006). https://www.uniformlaws.org/committees/community-home?CommunityKey=015e18ad-4806-4dff-b011-8e1ebc0d1d0f
• Clinical triggers for timely referral. LifeShare University / Organ Donation and Transplantation Alliance educational resources. https://www.lifeshareuniversity.org/clinical-triggers-for-timely-referral.html
• Organ Donation and Transplantation Alliance. Donation after circulatory death educational guide, Essential 2: Identification of a potential DCD donor. https://www.organdonationalliance.org/resources/donation-after-circulatory-death-educational-guide/essential-2/
• Improved time to notification of impending brain death and increased organ donation using an electronic clinical decision support system. Am J Transplant. https://www.sciencedirect.com/science/article/pii/S1600613522251028
• 42 CFR Part 486, Subpart G, Requirements for Certification and Designation and Conditions for Coverage: Organ Procurement Organizations. Electronic Code of Federal Regulations. https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-486/subpart-G
• 42 CFR § 486.322 (OPO agreement with ≥95% of hospitals having a ventilator and operating room); 42 CFR § 486.318 (OPO outcome measures). https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-486/subpart-G