The donation pathway

The donation pathway is the end-to-end process of deceased organ donation, from a hospital's recognition of an imminent or declared death through transplantation of the recovered organs and follow-up of recipients and donor families.[1] It is the field's principal organizing framework: every clinical role, regulatory requirement, and quality measure in deceased donation can be located against a stage of the pathway.[1][2] The pathway is typically described as nine sequential stages: identification and referral, donor evaluation, authorization, donor management, recovery, preservation and transport, allocation, transplantation, and follow-up.[1]

The pathway describes deceased donation. Living donation follows a separate, donor-initiated process described in Living donation.

Stage 1, Identification and referral

Donation begins when a hospital identifies a patient who has died or whose death is imminent and notifies its organ procurement organization (OPO).[3] U.S. federal regulation (42 CFR §482.45, the "Conditions of Participation") requires that hospitals notify the OPO of every individual whose death is imminent or who has died, so that the OPO, not the bedside clinical staff, can evaluate each case for donation potential.[3] Common clinical triggers for referral include a mechanically ventilated patient with a catastrophic, non-survivable neurologic injury or a planned withdrawal of life-sustaining treatment.[1][3] Separating referral from the bedside team is intended to ensure that potential donors are identified consistently and that the care team's focus remains on the patient.

Stage 2, Donor evaluation

Once a referral meets initial criteria, the OPO evaluates the potential donor's medical and social history and orders organ-specific function testing and infectious-disease screening.[4] U.S. Public Health Service guidance calls for universal nucleic-acid testing (NAT) for HIV, hepatitis B, and hepatitis C on every deceased donor, alongside serologic testing; the historical "increased-risk donor" label was retired in the 2020 PHS guideline revision in favor of universal testing and informed consent.[4] Evaluation determines which organs are medically suitable for transplantation.

Stage 3, Authorization

Donation is authorized either through the deceased person's documented first-person authorization (a donor registry, the National Donate Life Registry, or a driver's-license designation) or, absent such a record, by a legally authorized surrogate under the Uniform Anatomical Gift Act.[5] The field uses the term "authorization" rather than "consent" for deceased donation. The authorization conversation is conducted by OPO family-services staff or trained requestors, and the medical-social history is taken at this stage.[5]

Stage 4, Donor management

After authorization (and, for donation after brain death, after death has been declared), the OPO clinically manages the donor in the intensive care unit to preserve organ function until recovery.[6] Donor management aims to meet defined physiologic targets ("donor management goals") and may include hemodynamic support, lung-protective ventilation, and hormone-replacement therapy. Good donor management increases the number and quality of organs that can be transplanted.[6]

Stage 5, Recovery (procurement surgery)

Organs are recovered in a surgical operation, frequently involving multiple organ-specific surgical teams.[7] In donation after brain death, the donor's circulation is intact until the aorta is cross-clamped and the organs are flushed with cold preservation solution; in donation after circulatory death, recovery follows the determination of death by circulatory criteria and proceeds rapidly to minimize warm-ischemia time.[7] Recovery technique differs between donor types and is described in Deceased donation.

Stage 6, Preservation and transport

Recovered organs are preserved and transported to the recipients' transplant centers.[8] The traditional method is static cold storage in a preservation solution (such as University of Wisconsin/Belzer, HTK/Custodiol, or Celsior); increasingly, machine perfusion, hypothermic (HMP) or normothermic (NMP), is used to preserve, assess, and in some cases recondition organs, particularly higher-risk kidneys, livers, hearts, and lungs.[8] Each organ has a practical cold-ischemia time limit that constrains transport logistics.[8]

Stage 7, Allocation (matching)

Organs are allocated to candidates through the national Organ Procurement and Transplantation Network (OPTN) "match run," a computerized process that produces a ranked list of candidates for each donor organ using only medical and logistical factors.[9] Allocation criteria are organ-specific (for example, the MELD score for liver and KDPI together with candidate factors for kidney) and are governed by federal rules.[9][10] Allocation is detailed in dedicated allocation-policy articles.

Stage 8, Transplantation

The recipient's transplant surgeon implants the organ, restoring blood flow (reperfusion).[11] Organs are placed orthotopically (in the native position, as for liver, heart, and lung) or heterotopically (in a different site, as for the kidney). The transition from cold preservation to warm reperfusion produces ischemia-reperfusion injury, a determinant of early graft function.[11] Organ-specific surgical detail appears in each organ's article.

Stage 9, Recipient and donor-family follow-up

Recipients require lifelong immunosuppression and monitoring for rejection and complications; surveillance may include protocol biopsies graded by the Banff classification and donor-derived cell-free DNA testing.[12] In parallel, OPOs and tissue/eye banks provide donor-family aftercare, including bereavement support and, where families wish, facilitated correspondence with recipients.[1] Follow-up closes the pathway and feeds outcomes data back to the national registry.

Roles and regulation along the pathway

Distinct workforce roles act at each stage, for example, OPO referral/triage coordinators (Stage 1), clinical coordinators (Stages 2 and 4), family-services coordinators (Stage 3), organ procurement/recovery coordinators and recovery surgeons (Stages 4 and 5), and center-side pre- and post-transplant coordinators (Stages 7 through 9).[1] Several requirements are federally defined: hospital referral under 42 CFR §482.45; OPO conditions for coverage under 42 CFR Part 486; and transplant-center conditions of participation under 42 CFR Part 482 Subpart E.[2][3]

See also

• Organ donation · Organ transplantation
• Deceased donation · Living donation
• Transplant immunology

References

• OPTN. The basic path of donation. https://optn.transplant.hrsa.gov/learn/about-donation/the-basic-path-of-donation
• HRSA/OPTN. Deceased donation. https://www.hrsa.gov/optn/patients/organ-donation/deceased-donation
• Hospital conditions of participation, organ, tissue, and eye procurement, 42 CFR §482.45. https://www.law.cornell.edu/cfr/text/42/482.45
• Jones JM, et al. Assessing Solid Organ Donors and Monitoring Transplant Recipients for HIV, HBV, and HCV Infection, U.S. PHS Guideline, 2020. MMWR Recomm Rep. 2020;69(4):1-16. https://www.cdc.gov/mmwr/volumes/69/rr/rr6904a1.htm
• Uniform Anatomical Gift Act. StatPearls. NBK470922. https://www.ncbi.nlm.nih.gov/books/NBK470922/
• Deceased donor management/optimization. PMC8445737. https://pmc.ncbi.nlm.nih.gov/articles/PMC8445737/
• Organ procurement (recovery surgery). PMC9994842. https://pmc.ncbi.nlm.nih.gov/articles/PMC9994842/
• Organ preservation and machine perfusion. PMC12692498. https://pmc.ncbi.nlm.nih.gov/articles/PMC12692498/
• United Network for Organ Sharing. How we match organs. https://unos.org/transplant/how-we-match-organs/
• OPTN Final Rule, 42 CFR §121.4. https://www.ecfr.gov/current/title-42/chapter-I/subchapter-K/part-121/section-121.4
• Kidney Transplantation (reperfusion, ischemia-reperfusion injury). StatPearls. NBK567755. https://www.ncbi.nlm.nih.gov/books/NBK567755/
• Transplant Rejection (Banff; surveillance). StatPearls. NBK553074. https://www.ncbi.nlm.nih.gov/books/NBK553074/