Personal Venture — NC Organ-Donation Nonprofit & Founder Toolkit

Organ & Tissue Donation: The US System, Policy, and NC Specifics

Educational domain reference for a North Carolina cause venture working on organ, eye, and tissue donation awareness and donor registration. It explains how the system is structured and governed, how people register, the major policy debates, the myths and equity barriers a campaign must navigate, and the NC-specific law and registry mechanics. It is a knowledge foundation, not medical or legal advice — see the Disclaimer, and always re-verify live numbers and law before publishing.

Quick framing for a venture: in the US you cannot “make” anyone a donor and you do not run the recovery or matching — that is the OPO and OPTN’s job. A donation-awareness nonprofit’s real levers are education, myth-correction, trust-building, and driving registry sign-ups (especially in under-registered communities). Keep that scope in mind throughout.

A note on vocabulary: the field’s preferred phrase is “organ, eye, and tissue donation” (eyes/corneas are tracked separately from other tissue). Say “deceased donor,” not “cadaveric”; say “recover/recovery,” not “harvest.” “Donor” registration normally means deceased donation; living donation is arranged separately.


1. The US donation & transplant system and its oversight

The US system is a public-private structure created by the National Organ Transplant Act (NOTA) of 1984, which banned the sale of organs and established the national network.

The 2023-2024 OPTN Modernization Initiative (important and ongoing)

After 2022 Senate Finance Committee scrutiny and reports of system failures, HRSA launched the OPTN Modernization Initiative in March 2023 to break UNOS’s monopoly and introduce competition.

Takeaway for a venture: the registration and education layer (DMV, Donate Life, organdonor.gov) is stable; the governance/contractor layer is mid-restructuring. Don’t pin messaging to “UNOS runs the system” — say “the OPTN, overseen by HRSA.”


2. Organ Procurement Organizations (OPOs) and CMS performance rules

OPOs are the nonprofits that do the on-the-ground work of deceased donation: responding to hospital referrals, evaluating potential donors, obtaining authorization, coordinating recovery, and getting organs to transplant centers. There are roughly 55 federally designated OPOs, each assigned an exclusive geographic Donation Service Area (DSA) (organdonor.gov; HonorBridge). Hospitals are required by federal law to refer all imminent deaths to their OPO.

OPOs are reimbursed through Medicare and regulated by CMS (Centers for Medicare & Medicaid Services) under “Conditions for Coverage.”

The 2020 CMS OPO Final Rule (the accountability shake-up)

On November 20, 2020, CMS finalized a rule (effective for the cohort starting 2022, with consequences landing in 2026) that replaced self-reported OPO metrics with objective, claims-based outcome measures — a donation rate and a transplantation rate, benchmarked against all OPOs (CMS Fact Sheet, 2020-11-20). It created a three-tier system with non-overlapping performance bands (an OPO’s tier is set by its worse of the two rates relative to the national distribution):

Tier Performance band Consequence
Tier 1 At or above the 75th percentile (top performers) Automatically recertified
Tier 2 Below the 75th percentile but at or above the median Must compete to keep the DSA
Tier 3 Below the median Decertified (the DSA is reassigned)

Analysts have warned that a large share of OPOs (estimates around 42%) could face decertification/competition in the 2026 recertification cycle — a real risk of disruption that the industry (AOPO) has pushed back on (AOPO; Applied Policy; Crowell & Moring). In January 2026 CMS issued a proposed rule offering additional guidance — e.g., an OPO assigned at least one Tier 1 or Tier 2 DSA would not be treated as out of compliance with Conditions of Participation on outcomes alone (Holland & Knight, 2026-03; Crowell & Moring). [UNVERIFIED — status as of mid-2026 is in flux; verify the final rule and 2026 cycle outcomes before publishing.]

Why it matters for NC: NC’s OPOs operate under this regime, and there has been active DSA “turf” conflict in NC (see §9). A venture should understand that OPO performance and territory are contested and politically live.


3. Donor registration pathways

Registering is a declaration of intent to be a deceased organ, eye, and tissue donor. In the US it is opt-in and, for adults, first-person authorization (legally binding — see §7). Main pathways:

For a venture, the practical message is: “Sign up at the DMV, online at your state registry or RegisterMe.org, or in your phone’s Health app — it’s free and you can specify your wishes.” Online registration often lets people specify or exclude organs/tissues; the DMV heart is broader but simpler.


4. Living vs deceased donation

Deceased donation is the large majority of transplants and the focus of “donor registration.” A single deceased donor can save up to 8 lives (organs) and enhance up to ~75 more through tissue/eye donation (organdonor.gov). Roughly 30,000 tissue donors contribute each year; corneal transplant success rates exceed 95% (organdonor.gov).

Living donation — a healthy person donates a kidney or a portion of liver (and rarely lung lobe or other tissue) while alive. In 2024, about 7,030 living donors made roughly 7,000 living-donor transplants — about 15% of the year’s 48,149 total (about 6,400 living-donor kidneys and ~600 living-donor livers) (OPTN/UNOS 2024 data; Donate Life America). (Some sources cite ~18% against a smaller transplant base; the figure here is computed against the 48,149 topline used throughout this skill.) Types:

Living donation is arranged through transplant centers, not the deceased-donor registry — a useful distinction when a campaign gets “how do I donate a kidney to my relative?” questions.


5. DBD vs DCD (donation after brain vs circulatory death)

Two legal pathways for declaring death in deceased donation:

DCD has grown rapidly. In 2024 there were ~7,280 DCD donors, up ~23.5% over 2023 (OPTN/UNOS; The Organ Donation Alliance). Two enabling technologies drove this:

Studies through 2024-2025 generally show NRP-assisted DCD outcomes comparable to DBD for heart, liver, and lung (PMC/PubMed, 2024-2025). NRP is also ethically debated (concerns about restoring circulation after death declaration) — worth knowing if a campaign touches the “how death is determined” myth space (see §8).


6. The waitlist, allocation, and continuous distribution

The waitlist: Over 100,000 people are on the US transplant waiting list (the field commonly cites “~103,000+”; ~85-90% are waiting for kidneys). Someone is added roughly every 8-10 minutes, and on the order of ~13-17 people die each day waiting (figures vary by source and year — pull current numbers from the OPTN dashboard, organdonor.gov). In 2024 the US performed a record 48,149 transplants (+3.3% over 2023), enabled by 16,988 deceased donors and 7,030 living donors (OPTN/UNOS, Jan. 2025).

Allocation basics: organs are matched to candidates by medical and logistical factors — blood/tissue type, organ size, medical urgency, time on the list, geographic/logistical proximity, and pediatric status. There is no payment and no preference by race, gender, income, or celebrity; the matching is run by the OPTN system. Geography historically used fixed DSA/region boundaries.

Continuous Distribution — the OPTN’s current modernization of how organs are allocated. It replaces hard geographic boundaries and rigid tiers with a single weighted “composite allocation score,” combining attributes (medical urgency, candidate biology, expected benefit, access/equity, proximity/efficiency) into points so no single factor is an absolute cutoff (HRSA: Continuous Distribution; optn.transplant.hrsa.gov). Rollout is organ-by-organ:

For a venture: continuous distribution is the headline allocation reform; “lung is done, the rest are rolling out” is the accurate one-liner. Verify which organs have gone live before stating specifics.


The US model is opt-in with first-person authorization. Under the Revised Uniform Anatomical Gift Act (RUAGA, 2006) adopted in most states (including NC), a competent adult’s registered “yes” is a legally binding gift that only the donor can revoke (Donor Alliance; PMC). In practice this means that when a registered adult dies and becomes medically eligible, the law treats the family as informed, not asked — the donor already gave consent. (OPOs still work closely and compassionately with families; honoring first-person authorization over family objection is legally supported but handled sensitively.) If a person never registered, the OPO seeks authorization from the next of kin / legally authorized representative.

Opt-out / “presumed consent”: the alternative model (used in e.g. the UK, Spain, and much of Europe) where everyone is presumed a donor unless they register a refusal. Spain’s high donation rate is often cited for opt-out — but Spain’s success is widely attributed to its OPO infrastructure and in-hospital coordinators (“the Spanish Model”), not the legal default alone.

The evidence and US debate: systematic comparisons find that switching the legal default, by itself, has little reliable effect on actual donation/transplant numbers; system investment (OPO performance, hospital coordination, family approach) matters more (PMC review, “Opt-In vs Opt-Out”; The Organ Donation & Transplantation Alliance). Analysts generally conclude that moving the US to opt-out would not by itself make more organs available, and could even erode public trust if perceived as coercive. The US has therefore pursued better systems and registration rather than presumed consent. A myth to preempt: claims that “the government will take your organs without consent” — false; US donation is opt-in and consent-based.


8. Myths, barriers & faith/cultural considerations

A donation-awareness venture lives or dies on myth-correction and trust, especially in communities with lower registration. Common myths and the factual responses:

Equity and structural barriers (central to NC and US work):

Messaging guidance for a venture: lead with agency, accuracy, and altruism, name and correct the specific myth, partner with trusted messengers (faith leaders, community orgs, patient/recipient voices), and avoid fear or coercion framing (which can backfire and feed the opt-out distrust narrative).


9. North Carolina law & registry

The NC Revised Uniform Anatomical Gift Act

NC adopted the Revised Uniform Anatomical Gift Act, codified at NC General Statutes Chapter 130A, Article 16 (GS 130A-412.3 et seq.) (ncleg.gov). Key provisions a venture should know:

NC donor registry mechanics

NC’s OPOs (two serve the state — important)

NC is split between two federally designated OPOs by territory:

OPO Territory (NC) Population / hospitals Notes
HonorBridge (formerly Carolina Donor Services, rebranded Aug. 2021) 77 NC counties + Pittsylvania County, VA ~7.5M; 100+ hospitals, 200+ transplant centers NC’s largest OPO; HQ Greenville, NC (offices Winston-Salem, Chapel Hill/Durham); registration portal honorbridge.org/registerme (honorbridge.org)
LifeShare Carolinas (LifeShare of the Carolinas) ~22-23 counties in western/southwestern NC (incl. Charlotte, Asheville) ~3.1M; ~40 hospitals Affiliated with Atrium Health; founded 1970 (lifesharecarolinas.org; Donate Life NC)

NC also has a whole-body/anatomical donation path (for medical education/research) handled separately via medical schools / a state anatomical program — distinct from the organ/eye/tissue registry above. [UNVERIFIED — NC anatomical-board specifics not deeply verified here; confirm before advising donors on whole-body donation.]


10. Data sources (pull current numbers from these)

Statistics change yearly; always cite the as-of date and prefer these primary sources over secondhand blogs:

Confirmed reference figures used above (verify before republishing): 48,149 US transplants in 2024 (+3.3%); 16,988 deceased + 7,030 living donors (2024); ~7,280 DCD donors (2024, +23.5%); ~103,000+ on the waitlist; ~170 million registered US donors; ~55 OPOs; 1 donor → up to 8 lives + ~75 enhanced.


Sources

  1. HRSA — OPTN Modernization Initiative, updates (Nov. 2025): https://www.hrsa.gov/optn-modernization/updates/november-2025
  2. HRSA — Continuity of Patient Safety Activities for the OPTN: https://www.hrsa.gov/optn/news-events/news/continuity-patient-safety-activities-optn
  3. UNOS — “UNOS and HRSA agree on new short-term OPTN contract”: https://unos.org/media-resources/releases/unos-and-hrsa-agree-on-new-short-term-optn-contract/
  4. UNOS — “How UNOS’ role in the OPTN has changed under the additional contract extension”: https://unos.org/news/how-unos-role-in-the-optn-has-changed-under-the-additional-contract-extension/
  5. The Regulatory Review — “Organ Transplantation System Modernization” (2024-06-04): https://www.theregreview.org/2024/06/04/organ-transplantation-system-modernization/
  6. OPTN — Proposal to Address the Relationship of the OPTN and OPTN Contractor Boards: https://optn.transplant.hrsa.gov/policies-bylaws/public-comment/proposal-to-address-the-relationship-of-the-optn-and-optn-contractor-boards/
  7. organdonor.gov — Organ Donation Statistics: https://www.organdonor.gov/learn/organ-donation-statistics
  8. organdonor.gov — What Can Be Donated: https://www.organdonor.gov/learn/what-can-be-donated
  9. HRSA/OPTN — “Organ Transplants Exceeded 48,000 in 2024; a 3.3 Percent Increase”: https://www.hrsa.gov/optn/news-events/news/organ-transplants-exceeded-48000-2024-33-percent-increase-transplants-performed-2023
  10. The Organ Donation Alliance — “Organ transplants exceeded 48,000 in 2024”: https://www.organdonationalliance.org/article/organ-transplants-exceeded-48000-in-2024-a-3-3-percent-increase-from-the-transplants-performed-in-2023/
  11. UNOS — “U.S. surpassed 48,000 organ transplants in 2024”: https://unos.org/media-resources/releases/u-s-surpassed-48000-organ-transplants-in-2024/
  12. CMS — OPO Conditions for Coverage Final Rule fact sheet (2020-11-20): https://cms.gov/newsroom/fact-sheets/organ-procurement-organization-opo-conditions-coverage-final-rule-revisions-outcome-measures-opos
  13. Applied Policy — CMS Updates Minimum Standards for OPOs (CMS-3380-F): https://www.appliedpolicy.com/cms-updates-minimum-standards-of-care-for-organ-procurement-organizations-including-revisions-to-outcome-measurements-cms-3380-f/
  14. Crowell & Moring — What OPOs Need to Know About CMS’s New Proposed Rule (2026): https://www.crowell.com/en/insights/client-alerts/what-organ-procurement-organizations-need-to-know-about-cmss-new-proposed-rule
  15. Holland & Knight — “CMS Issues Additional Guidance on the Organ Donation Process” (2026-03): https://www.hklaw.com/en/insights/publications/2026/03/cms-issues-additional-guidance-on-the-organ-donation-process
  16. AOPO — “U.S. OPOs Recovered Record Number of Organs in 2024…”: https://aopo.org/us-organ-procurement-organizations-recovered-record-number-of-organs-in-2024-while-looming-federal-policies-jeopardize-patients/
  17. HRSA — Continuous Distribution policy issue page: https://www.hrsa.gov/optn/policies-bylaws/policy-issues/continuous-distribution
  18. HRSA/OPTN — Establish a Comprehensive Multi-Organ Allocation Policy (2025 public comment): https://www.hrsa.gov/optn/policies-bylaws/public-comment/establish-comprehensive-multi-organ-allocation-policy-2025
  19. OPTN — Lung continuous distribution policy notice (PDF): https://optn.transplant.hrsa.gov/media/b13dlep2/policy-notice_lung_continuous-distribution.pdf
  20. Donate Life America — National Donate Life Registry: https://donatelife.net/donation/donor-registries/national-donate-life-registry/
  21. Donate Life America — “Leads National Registry Initiative” (MyChart/Epic, 2025): https://donatelife.net/news/donate-life-america-leads-national-registry-initiative/
  22. Donate Life America — Living Donor Pathway / living kidney donation pilot (2025): https://donatelife.net/news/donate-life-america-launches-two-year-national-pilot-to-support-living-kidney-donation/
  23. Federal Register — National Donate Life Month, 2025 proclamation: https://www.federalregister.gov/documents/2025/04/09/2025-06160/national-donate-life-month-2025
  24. PMC — “Assessing Global Organ Donation Policies: Opt-In vs Opt-Out”: https://pmc.ncbi.nlm.nih.gov/articles/PMC8128443/
  25. The Organ Donation & Transplantation Alliance — “Opt-In vs Opt-Out Donation Systems”: https://www.organdonationalliance.org/insight/opt-in-vs-opt-out-donation-systems/
  26. Donor Alliance — “Presumed Consent or Opt-Out: What does it mean?”: https://www.donoralliance.org/newsroom/donation-essentials/presumed-consent-or-opt-out-what-does-it-mean/
  27. PMC — “First-Person Authorization and Family Objections to Organ Donation”: https://pmc.ncbi.nlm.nih.gov/articles/PMC12097891/
  28. PMC — “Changes in Organ Donation after Circulatory Death in the United States”: https://pmc.ncbi.nlm.nih.gov/articles/PMC12947068/
  29. Circulation: Heart Failure — “DCD Heart Transplant: Current State and Future Directions”: https://www.ahajournals.org/doi/10.1161/CIRCHEARTFAILURE.124.011678
  30. Mayo Clinic Health System — “Debunking organ donation myths”: https://www.mayoclinichealthsystem.org/hometown-health/featured-topic/organ-donation-dont-let-these-myths-confuse-you
  31. HHS Office of Minority Health — “Organ Transplants and Black/African Americans”: https://minorityhealth.hhs.gov/organ-transplants-and-blackafrican-americans
  32. PMC — “Distrust in the Healthcare System and Organ Donation Intentions Among African Americans”: https://pmc.ncbi.nlm.nih.gov/articles/PMC3489022/
  33. PMC — “Understanding the Role of Clergy in African American Organ and Tissue Donation Decision-Making”: https://pmc.ncbi.nlm.nih.gov/articles/PMC3489162/
  34. NC General Assembly — GS 130A-412.7 (Manner of making anatomical gift before death): https://ncleg.gov/EnactedLegislation/Statutes/HTML/BySection/Chapter_130A/GS_130A-412.7.html
  35. NC General Assembly — Chapter 130A, Article 16 (Revised Uniform Anatomical Gift Act): https://www.ncleg.net/EnactedLegislation/Statutes/HTML/ByArticle/Chapter_130A/Article_16.html
  36. Donate Life NC — Frequently Asked Questions: https://www.donatelifenc.org/content/frequently-asked-questions
  37. Donate Life NC — Donor Registry: https://www.donatelifenc.org/content/donor-registry
  38. NC Secretary of State — “Organ Donation and the North Carolina DMV”: https://www.sosnc.gov/divisions/advance_healthcare_directives/organ_donation_and_the_nc_dmv
  39. HonorBridge — About Us: https://honorbridge.org/who-we-are/about-us/
  40. HonorBridge — Sign up as a Donor (RegisterMe): https://honorbridge.org/registerme/
  41. LifeShare Carolinas: https://www.lifesharecarolinas.org/
  42. North Carolina Health News — “Turf war erupts over organ donation services” (2025-03-25): https://www.northcarolinahealthnews.org/2025/03/25/turf-war-erupts-over-organ-donation-services/

Disclaimer

This is general educational information, not medical or legal advice. It is intended to ground a donation-awareness venture’s understanding of the US and North Carolina donation systems — it does not establish a donor’s legal status, advise on a specific medical situation, or substitute for counsel on nonprofit, healthcare, or consent law. Donation policy, federal contracts/contractors, CMS rules, allocation policy, statistics, and NC statutes all change — several items here are mid-transition as of mid-2026 (OPTN modernization/contractors, the 2026 CMS OPO recertification cycle, continuous-distribution rollout by organ, the NC 2025-60 amendment and the 2027 tax-return method, and NC OPO service-area disputes). Always verify current details against primary sources — HRSA/OPTN (optn.transplant.hrsa.gov, hrsa.gov), organdonor.gov, CMS, the NC General Statutes (ncleg.gov), Donate Life NC, and the relevant NC OPO — before publishing claims, especially statutes, statistics, and citations. Items marked [UNVERIFIED] or with verification caveats above were not fully confirmed against a primary source in this draft.