DCD

Requirements for a hospital’s compliance with donation-related laws, regulations and accreditation standards

Fact-Finding Questions Hospital Leadership Should Ask

1. Is our hospital in compliance with the Centers for Medicare and Medicaid Services (CMS) Hospital Conditions of Participation (CoPs) for organ, eye, and tissue donation?
2. Is our Affiliation Agreement or Memorandum of Understanding or Agreement (MOU/MOA) with our designated Organ Procurement Organization (OPO) up-to-date and congruent with regulatory and accreditation requirements?
3. Do our policies align with our state’s Uniform Anatomical Gift Act (UAGA), Uniform Determination of Death Act (UDDA), CMS CoPs, Trauma Certification criteria (if applicable), and hospital accreditation standards (i.e., The Joint Commission, DNV-National Integrated Accreditation for Healthcare Organizations, or Healthcare Facilities Accreditation Program)?
4. Is our donation policy a separate policy to our death determination policies, such as cardiac death pronouncement policy and the brain death/death by neurologic criteria (BD/DNC) policy?
5. What is our relationship with our designated OPO? Who is our OPO hospital development coordinator?
6. Do we have a navigation protocol in cases when the patient is a designated donor and the family objects to the donation process?
7. Do we have a Donation after Circulatory Death (DCD) process, pathway, or guidance document?
8. Are hospital patient care team members familiar with hospital policies related to donation and declaration of death?

Key Points Hospital Leadership Should Remember

1. CMS Conditions of Participation (CoPs) require hospitals to implement written protocols and to enter into an agreement with their designated OPO, as well as with at least one tissue bank and at least one eye bank, to optimize donation. (Most OPOs are also certified as tissue banks and/or eye banks and thus may be able to provide all services to a hospital.)
2. All accrediting organizations align with CMS CoPs and require hospitals to meet standards on organ, tissue, and eye donation.
3. The Uniform Anatomical Gift Act (UAGA) is model legislation establishing gift law for deceased organ, tissue, and eye donation and has been adopted by all 50 states and the District of Columbia.
4. The UAGA allows individuals to legally designate themselves as an organ, eye, and/or tissue donor, which would take effect upon their death and is irrevocable by another individual. If a family objects to the donation registration of the patient, in most circumstances, the OPO staff will help the family to navigate their questions and concerns, while honoring the patient’s decision. Consistent communication from the hospital patient care team that aligns with the OPO’s communication will help the family gain clarity and avoid misleading or confusing messages.
5. In instances in which a donation decision has not been made by the patient, the UAGA outlines the hierarchy of Legal Next of Kin/Legal Authorizing Party (LNOK/LAP) who could make a decision for the patient.
6. The Uniform Death Determination Act (UDDA) is a model statute for defining death and has been adopted by most states.
7. CMS CoPs regulatory requirements provide hospitals, as Covered Entities under the Health Insurance Portability and Accountability Act (HIPAA), with the permission to disclose protected health information to OPOs or other entities engaged in the organ, eye, or tissue donation and transplantation process.

Regulatory Oversight

Each of these regulatory/accreditation bodies and standards include requirements addressing the organ, eye, and tissue donation process within the hospital.

Regulatory Compliance & Legal Considerations in DCD

Centers for Medicare and Medicaid Services (CMS Conditions of Participation [CoPs])

(42 Code of Federal Regulations (CFR) Part 482.45 for hospitals and 42 CFR 485.643 for critical access hospitals)^1,2

CMS CoPs apply to hospitals that participate in the Medicare program and/or administer Medicaid and the Children’s Health Insurance Program. The CoPs require hospitals to have and implement written protocols (see Sample Content of a Hospital-OPO Agreement and Donation Policy, Appendix A) with a designated OPO, at least one tissue bank, and one eye bank to optimize donation processes outcomes. The regulations are:^1,2

• “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. The OPO determines medical suitability for organ donation and, in the absence of alternative arrangements by the hospital, the OPO determines medical suitability for tissue and eye donation, using the definition of potential tissue and eye donor and the notification protocol developed in consultation with the tissue and eye banks identified by the hospital for this purpose;”
• “Incorporate an agreement with at least one tissue bank and at least one eye bank to cooperate in the retrieval, processing, preservation, storage and distribution of tissues and eyes, as may be appropriate to assure that all usable tissues and eyes are obtained from potential donors, insofar as such an agreement does not interfere with organ procurement;”
• “Ensure, in collaboration with the designated OPO, that the family of each potential donor is informed of its options to donate organs, tissues, or eyes or to decline to donate. The individual designated by the hospital to initiate the request to the family must be an organ procurement representative or a designated requestor. A designated requestor is an individual who has completed a course offered or approved by the OPO and designed in conjunction with the tissue and eye bank community in the methodology for approaching potential donor families and requesting organ or tissue donation;”
• “Encourage discretion and sensitivity with respect to the circumstances, views, and beliefs of the families of potential donors;”
• “Ensure that the hospital works cooperatively with the designated OPO, tissue bank and eye bank in educating staff on donation issues, reviewing death records to improve identification of potential donors, and maintaining potential donors while necessary testing and placement of potential donated organs, tissues, and eyes take place.”
  

Sample Content of a Hospital-OPO Agreement

Some of these agreements are also called Affiliation Agreements, Memorandum of Understanding (MOU), or Memorandum of Agreement (MOA).

At a minimum, the written agreement must address the following:

• Criteria for obligatory timely notification to the OPO (or designated third party) of all individuals whose death is imminent or who have died in the hospital.
• Definitions of “imminent death” and “timely notification.”
• The responsibility of the OPO to determine medical suitability for organ and tissue/eye donation (unless there is a separate tissue and eye bank).
• The hospital will undertake interventions to maintain potential organ donors so that the organs remain viable, i.e., measures necessary to sustain a part will not be withdrawn prior to the OPOs conclusion of assessment.
• The required notification of the potential donor families of their options to donate or to decline to donate. This must be done in collaboration with the OPO.
• Identification of the person to lead the donation conversation with the family, which must either be an OPO representative or a trained designated requestor.
• Permitting the OPO, tissue bank, and eye bank access to the hospital’s records to evaluate for donation suitability and to perform death record reviews (also known as medical record reviews) to evaluate the process and identify any missed opportunities for donation.
• Providing an Operating Room (OR) space for organ recovery and an acceptable location for tissue and eye recoveries.
• Stipulates the hospital does not credential or privilege members of transplant recovery teams, and that the OPO sends only “qualified, trained individuals” to perform organ recovery.

DOWNLOAD PRINTABLE FORMAT [See Appendix B]

Sample Content of a Hospital Policy as it Pertains to DCD

Hospital accreditations stipulate there should be an organ, eye, and tissue donation policy mirroring regulatory and accreditation requirements. The donation policy should detail donation after BD/DNC, as well as DCD processes and protocols.^3,4,5 Hospitals should review and update their donation policy as well as their death determination policy regularly to ensure they are current. Of note, it is important to highlight that the hospital’s BD/DNC determination policy should never be incorporated or combined with the donation policy. Declaring the death of a patient should be based on signs of death and not be driven by donation potential.

Recommended DCD policy inclusion:

• The timing of the donation conversation must be carefully coordinated between the OPO and hospital patient care team. For potential DCD, the donation conversation must occur prior to the death of the patient, therefore the timing of the conversation is delicate. Ideally, the family feels they have sufficient time to process and ask questions, but at the same time, the conversation does not influence the family to make any WLST decisions. This timing will differ based on family and circumstances. When a family has questions about the timing, location, or other logistical aspects of WLST prior to the donation conversation occurring, care should be taken not to provide information or options that contradict potential donation processes, especially if the patient provided First Person Authorization. If a family inquires about donation or a family demonstrates a readiness to consider WLST, it might be appropriate for the OPO to introduce donation to the family even prior to a WLST decision. However, these conversations must be carefully planned and timed between the OPO and the hospital patient care team (see Essential 4).
• Upon notification of a potential donor, the OPO may undertake minimally invasive testing to determine medical suitability for donation.
• The patient’s physician shall document consent for the following pre-mortem interventions when undertaken solely for the purpose of medical management and organ evaluation (e.g., cardiac catheterization, central line placement, bronchoscopies, femoral cannulation, Heparin administration, etc.).
• There will be a need for a large dose of Heparin to be administered to protect the organs during the dying process. (This practice was approved by the National Conference on DCD where the ethics of this need were discussed.)⁷ In normal DCD cases, the typical dosage is 30,000 units administered at the initiation of WLST. In instances when Normothermic Regional Perfusion will be utilized this dosage will be higher (see Essential 8 for further clarity).
• The patient must remain under the care of a licensed physician who cannot be part of the OPO recovery team nor the transplant recovery team.
• The hospital patient care team must provide comfort care as for all end-of-life care patients.
• There must be a designated pronouncing provider (per hospital policy and the state’s UDDA, such as a physician or physician designee) available to declare and document circulatory time of death.
• The location of WLST must be identified which could be the ICU, PACU, Operating Room (OR), or any other location that is logistically close to the OR.
• There must be an observation or “hands-off” time period of at least 2 – 5 minutes from time of cessation of circulation to the time death is declared to verify that the time period for possible autoresuscitation has elapsed.⁶ If autoresuscitation occurs, the hospital patient care team must again wait for cessation of circulation and the “hands-off” observation period restarts (see Essential 7).
• The total OR time is dependent on the transplant recovery team’s assessment of the viability of the organs based on warm ischemic time (WIT) and overall organ function. Time may be required for organ preservation strategies deemed necessary by the transplant recovery team.
• The patient may be prepared and draped for surgery prior to WLST. The transplant recovery team is allowed to verify the set-up of the OR suite prior to WLST. The transplant recovery team must exit the OR prior to WLST and may re-enter the OR suite after the pronouncement of death has occurred. The OPO recovery team may remain present during WLST to document vital signs but may not participate in nor direct WLST (see Essential 7).

In developing a DCD policy, ethical principles to be considered include:

• Respect for autonomy, individual’s decision for self.
• Non-maleficence: DCD involves a living person, therefore the hospital patient care team must avoid harm to the potential donor. Prior to the death of the patient, only procedures that are intended to maximize and preserve organ function are deemed ethically appropriate, despite the potential risk they may pose to the patient.⁶
• Beneficence: maximize benefits and minimize harm in the donor-recipient dyad.
• Dead Donor Rule: The patient must be dead before organ recovery begins and organ recovery cannot cause the death of the patient.⁸

DOWNLOAD PRINTABLE FORMAT [See Appendix C]

Uniform Determination of Death Act (UDDA)

The 1981 UDDA is a model statute for defining death. Versions of it have been adopted in most states⁹ as well as the District of Columbia, and the remaining states have adopted substantially similar rules judicially or legislatively. The UDDA establishes that an individual who has sustained either (a) irreversible cessation of circulatory or respiratory functions or (b) irreversible cessation of all functions of the entire brain, including the brainstem, is dead. A determination of death must be made in accordance with accepted medical standards.¹⁰

Each state has adopted similar language to the originally proposed UDDA, however, there can be significant differences between individual state’s UDDAs. It is vital to follow the state law where the death is occurring.

Uniform Anatomical Gift Act (UAGA)

The UAGA is model legislation that was first issued in 1968 and adopted in all states and the District of Columbia and addresses how to and who can authorize deceased donation.¹¹ In 2006, the Revised Uniform Anatomical Gift Act (RUAGA) was issued to address the ongoing critical organ shortage by maximizing the likelihood of organ donation. It affirmed the rights and the legally-binding nature of the individual’s anatomical gift, i.e., it strengthened the legally-binding nature of an individual’s donor designation. It also strengthened an individual’s rights not to donate by signing a refusal and affirmed the rights and the legally-binding nature of the individual’s anatomical gift.¹² The act has been adopted in some form in every state.^11,12 Both the UAGA and RUAGA outline rules around the gift giving of one’s anatomy, as well as hospital, coroner, and medical examiner, and OPO obligations and responsibilities. Although there is some variation among state laws, the general principles are consistent across states. It is highly advised that hospitals review their state’s entire UAGA. The following is a generalized high-level overview of the provisions of the UAGA:¹¹

1. Allows an individual to designate a legally binding anatomical gift to take effect upon their death. An individual may designate their decision through a donor registry (e.g., a state’s DMV registry and/or Donate Life America’s national registry – registerme.org) or through an alternative document of gift such as an organ donor card/form or advance directive.
2. An individual may decide not to donate his or her organs by signing a refusal, or by communicating their intent during a terminal illness to two individuals, one of whom is a disinterested witness. (Review each state’s UAGA for the definition of a disinterested witness.)
3. If an individual has made an anatomical gift no other individual may amend or revoke that gift.
4. If an individual has not made a gift or refusal, a third-party specified in the Act may authorize donation. The UAGA lists the hierarchy of individuals who may authorize donation. This is a hierarchy and the order must be followed, starting with the person(s) at the top of the hierarchy, who is reasonably available making the donation decision. The OPO is responsible for the organ donation authorization process, including determining who to obtain authorization from and whether a legal authorizing party is available. (Review each state’s UAGA for the definition of ‘reasonably available.’)
5. The hierarchy of authorizing parties may differ by state. It is recommended that the hospital familiarize themselves with their state’s UAGA.
6. If there is more than one member in a given category in the hierarchy to whom the decision is falling, and an objection to donation is noted, the decision must be made by a majority of the members who are reasonably available.
7. The hospital administration and/or other public servants and officers such as coroners and medical examiners are part of the hierarchy of decision makers. Unless separately listed, they commonly fall under the last category in the hierarchy, absent the availability of others above.
8. Most UAGAs include an immunity clause protecting anyone involved in the donation process, including the hospital from civil, criminal, and administrative proceedings, if the UAGA was followed in good faith.
9. When there is a document of gift signed by the donor, but the donor’s advance directive contains terms which may conflict with the gift, the UAGA stipulates that the conflict must be resolved, and until it has been resolved, measures necessary to preserve the opportunity for donation must not be withdrawn.
10. The UAGA permits the OPO to conduct assessments to determine the potential donor’s medical suitability for donation. The hospital must allow the OPO the time to make a determination of medical suitability for donation and to obtain authorization for donation from the legal authorizing party or to confirm the patient’s First Person Authorization designation.

It is worth highlighting a couple of important points on how DCD is treated under the UAGA:

The UAGA was drafted with the knowledge that death may be declared in more than one way. The law is agnostic with regard to how death is declared. How death is determined is spelled out in the UDDA. A legally valid document of gift is binding regardless of how death is declared. This means that as donor designation takes affect after death, it is applicable in both BD/DNC and DCD circumstances.

As of August 2025, the UAGA in every state bars any person, other than the donor, “from making, amending, or revoking an anatomical gift of a donor’s body or part…” (Refer to each state’s UAGA for their requirements.)

An anatomical gift is binding regardless of how death is declared.
An anatomical gift takes effect upon the donor’s death.
A person other than the donor is barred from making, amending, or revoking an anatomical gift.

The clickable map on the Alliance website allows you to review the UAGA and UDDA legislation in each state. These state laws underpin and provide guidance for the organ, eye and tissue donation process.

To facilitate DCD cases, there are actions that need to be taken prior to the patient’s death that allow the organs to be preserved. Some of these activities include the administration of medications and possible procedures (e.g., line insertions, lab tests, radiologic tests, biopsies, etc.). Given that these interventions occur prior to death, additional informed consent from the patient’s decision maker for certain pre-mortem interventions is required. However, additional authorization for DCD is not necessary if the patient is a designated donor, because a legally valid gift has been made by the patient.

The OPO and hospital are required to follow state law; as with any other will that becomes legally-binding upon death, the individual’s decision to donate must also be acted upon after death, even over the objection of the designated donor’s family.

First Person Authorization (FPA)

“First Person Authorization (FPA),” “donor designation,” or a “registered/designated donor” are all interchangeable terms. They describe an individual who has legally determined and documented their donation decision.¹³ The Uniform Anatomical Gift Act (UAGA) includes provisions that support an individual’s right to self-determination and allows them to establish their intent to donate through written authorization of an anatomical gift. This is commonly referred to as First Person Authorization (FPA).

Written authorization of an anatomical gift may be documented in a will or advance health care directive, on a driver’s license or identification card, or through a state or national donor registry. As such, once death is declared by either neurologic or circulatory criteria, a valid First Person Authorization, unless previously revoked by the individual, constitutes a legal and binding decision. (Refer to each state’s UAGA for more specific details.)

Local organ procurement organizations inform the Legal Next of Kin/Legal Authorizing Party (LNOK/LAP) of their family member’s donation decision. Together with hospital care teams, they provide support throughout the donation process and beyond. Honoring a person’s donation decisions requires coordination, particularly regarding the timing and communication of any decision to withdraw life-sustaining measures. This process, along with compassionate care for the family, honors the donor’s generosity and the lifesaving impact of organ and tissue donation.

In the absence of written FPA, other expressions of donor intent will be explored with the patient’s authorized representative.

Health Insurance Portability and Accountability Act (HIPAA)

As Covered Entities, hospitals are subject to HIPAA regulations that address the use and disclosure of protected health information with the patient’s authorization or when the disclosure fits within a regulatory exception to the authorization requirement (45 CFR 164.512).¹⁴ There are two regulatory exceptions that permit hospitals to disclose information to the OPO without authorization:

A healthcare provider may use or disclose information if and as required by law. This exemption allows OPOs and hospitals to comply with CMS CoPs, 42 CFR 482.45, which specifically require notification of imminent deaths to an OPO and require hospitals to allow OPOs to conduct audits of death records.¹

Section 45 CFR 164.512(h) ¹⁴ allows information to be released to OPOs or other entities involved in the procurement, banking or transplantation of cadaveric organs, eyes, or tissue for the purposes of facilitating organ, eye, or tissue donation and transplantation. This permits the release of information by and to hospitals, transplant hospitals, the Organ Procurement Transplantation Network (OPTN) contractor, tissue banks, and laboratories.

OPOs are not vendors, business associates, or contracted service providers of hospitals; therefore standard credentialing programs do not apply to OPOs. Instead, OPOs operate independently and are directly designated by the federal government under the conditions for coverage to perform their duties related to organ, eye, and tissue donation coordination.^15,16 OPOs are also not considered healthcare providers. Per CMS regulations, OPOs must be allowed access to hospitals to perform their duties.^1,2

The Joint Commission (TJC) and Other Accrediting Bodies

TJC maintains standards for organ and tissue donation consistent with the CMS regulations, i.e., all donation related CoPs are included in TJC’s transplant standards. Standards LD.3.110 (for critical access hospitals) and TS.01.01.01 (for hospitals) require that hospitals develop and implement written policies and procedures for the donation and procurement of organs and tissues.

The standards include:³

1. Criteria for identifying potential organ and tissue donors, and directly notifying the OPO or tissue bank of those potential donors (while maintaining records of notification).
2. Mechanisms for notifying the family of potential organ and tissue donors of their option to donate or to decline to donate any organs or tissues, as well as a method of recording the decision for subsequent review. This should be performed by an OPO trained/approved designated requestor.
3. Staff education in the use of discretion and sensitivity towards the circumstances, views, and beliefs of the families of potential donors.
4. Recognition that the OPO determines medical suitability of organs for donation, while the OPO or tissue/eye bank determines medical suitability for donation of tissues or eyes.
5. Medically maintaining the opportunity for donation, and ensuring staff education for donation is occurring.

TJC has clarified that OPOs are not considered contracted services and therefore, hospitals are not required to perform credentialing review.¹⁶

The Healthcare Facilities Accreditation Program (HFAP) – now a brand within Accreditation Commission for Health Care (ACHC) – and the Det Norske Veritas National Integrated Accreditation for Healthcare Organizations (DNV NIAHO, formerly DNV GL NIAHO) are two additional organizations with requirements consistent with TJC standards and CMS regulations. Hospitals utilizing either of these accrediting bodies should familiarize themselves with their respective donation-related standards.

A standard unique to TJC is one that mandates hospitals to address DCD (referred to in the standards as “asystolic donation”). If a hospital does not support DCD, according to TJC, they must have a policy justifying their decision not to support DCD recoveries.³ While patients and families must still be informed about their donation options, if a family wishes to pursue DCD, the patient would need to be transferred to another hospital for organ recovery. It’s essential to recognize that this practice can be challenging for families who want to donate but prefer not to go through the transfer process. In 2022, the National Academies of Sciences, Engineering, and Medicine proposed that CMS should require all hospitals to institute a DCD policy.¹⁷