In accordance with state and federal regulations this policy outlines the process for organ donation after circulatory (previously, cardiac) death (hereinafter, DCD) in order to allow organs and tissues to be donated for the purpose of transplantation, to honor the wishes of the patient and/or to comply with the wishes of the legally recognized health care decisionmaker (hereinafter, decisionmaker). This Hospital (hereinafter, TH) believes it is ethically appropriate to consider DCD in accordance with Policy and Procedures established to ensure that TH’s mission, Catholic identity, and commitment to respect the dignity of the dying are upheld. This policy is written in accord with the Ethical and Religious Directives for Catholic Health Care Services (hereinafter, ERD or ERDs) (ERDs #23, 24, 25, 63, 64).
A. Cardiac Death - Irreversible cessation of cardiopulmonary function/circulatory and respiratory functions. This is evidenced by cessation of both for at least 5 minutes.
C. Donation after Circulatory (Cardiac) Death (DCD) – Donation after Circulatory Death is organ donation that occurs following the medical determination of death by cardiorespiratory criteria. This type of organ donation has been called “non-heartbeating donation” and “donation after cardiac death.” In accordance with developing national and international consensus, this policy uses the term “donation after circulatory death” (DCD). The California Transplant Donor Network (hereinafter, LOCAL OPO) defines DCD “as an organ donation from a patient who is pronounced dead on the basis of irreversible cessation of circulatory and respiratory functions” where death is imminently anticipated. Organ procurement follows a death that occurs after planned withdrawal of life-sustaining measures. In this situation, the legally recognized health care decisionmaker has: (1) refused life-sustaining medical intervention, including but not limited to cardiopulmonary resuscitation (CPR); (2) decided to withdraw ventilator support; and (3) has requested organ donation after death. After the patient expires and death certification occurs and if the organs are viable, procurement may proceed.
D. Imminent Death - A patient with severe irreversible brain injury, who is ventilator dependent, and who meets both of the following criteria:
- Has clinical findings consistent with a Glasgow Coma Scale score of 5 or less and/or has a plan to discontinue ventilator/pharmacological support; and,
- Whose death will likely occur within 60 minutes following the withdrawal of hemodynamic and respiratory support.
E. Legally Recognized Health Care Decisionmaker includes a patient’s agent designated by a power of attorney for health care, surrogate, a conservator, or closest available relative as described in CA Probate Code §§ 4671, 4711, 1880, and Cobbs v Grant, 8Cal3d 229, 255 (1972) respectively.
F. Organ Procurement Organization (OPO) – Organization that is responsible for donor identification and care, organ removal and preservation, and transplantation of organs. A LOCAL OPO should be identified. The OPO employs transplant coordinators who work with donor families and also provide educational programs to the hospital
It is the policy of this Hospital to allow DCD in certain cases as specified in the criteria below. Hospital staff will work in collaboration with LOCAL OPO to facilitate the identification and referral of appropriate potential organ donors. In order to avoid any conflict of interest, LOCAL OPO will not contact the decisionmaker and/or family until after the decision to withdraw ventilator support has been made. If the decisionmaker and/or family requests discussion with the LOCAL OPO during the decision making process, this request will be honored and facilitated by the nurse caring for the patient.
This policy is intended to provide patients and/or families with an option for organ donation that complies with the patient’s advance directive or the decisionmaker’s directive. This policy takes effect only after the decisionmaker has chosen to discontinue ventilatory support and a DNR order is charted.
Criteria for Organ Donation After Circulatory Death
Appropriate candidates for organ donation after cardiac death (DCD) shall be limited to those patients who meet all of the following criteria:
- The patient has a non-recoverable illness or injury that has caused neurologic devastation resulting in ventilator dependency but the patient does not fulfill the criteria for brain death and/or the patient has other system failure resulting in ventilator dependency.
- The patient meets the criteria for imminent death as defined above.
- The patient has no known medical condition that would exclude organ donation.
- The cause of injury/medical insult is known.
- The patient is unable to maintain adequate respiratory effort without support from a ventilator.
- A Do Not Resuscitate Order (DNR) is documented in the medical record by the attending physician.
- It is the opinion of the attending physician that death will likely occur within 60 minutes of the withdrawal of ventilatory support.
- The Medical Examiner’s/Coroner’s release has been obtained and documented in the medical record if the case falls under the Coroner’s jurisdiction.
Procedure and Responsibilities
- Upon determination by the attending physician that the patient has meet the criteria outlined above, a referral to LOCAL OPO will be made in order to discuss the suitability of organ donation. LOCAL OPO will be contacted by the nurse caring for the patient (LOCAL OPO Contact phone number). A Transplant Coordinator will come to the hospital to assist the health care team in determining medical suitability for DCD. All discussions with LOCAL OPO will be documented in the patient’s medical record.
- Initiating Discussion with the Legally Recognized Health Care Decisionmaker Concerning Organ Donation
a. The surrogate decision-maker, in consultation with the medical staff, has decided to withdraw ventilator support. This conversation and decision are documented in the patient’s medical record by the attending physician.
b. The decision to withdraw ventilator support must be made independent of, separate from, and prior to the discussion about organ donation after circulatory death. The discussion about the option of organ donation will not be initiated until the decisionmaker has made the decision to withdraw the ventilator. If the decisionmaker and/or family requests discussion with LOCAL OPO during the decision making process, this request will be honored and facilitated by the nurse caring for the patient.
c. The attending physician will order or give consent to notify the LOCAL OPO Transplant Coordinator who will develop a plan to approach the decisionmaker if the patient has the potential to be an organ donor under this policy; otherwise, the decisionmaker will not be approached by LOCAL OPO.
d. A Bioethics Committee consult is strongly recommended prior to the discussion with the decisionmaker in order to assess the appropriateness of the donation request and the absence of real or perceived conflict of interest. The members of the Bioethics Committee participating in the consult have a special responsibility to serve as advocates for the patient.
e. If the patient is an appropriate candidate for organ donation and meets all of the Criteria for Organ Donation after Circulatory Death described above, the LOCAL OPO Transplant Coordinator will speak with the decisionmaker about the possibility of organ donation.
- Evaluation of Donor Suitability
a. The Transplant Coordinator from LOCAL OPO will present the organ and tissue donation options to the decisionmaker following the decision to withdraw ventilator support. The decisionmaker must be fully informed regarding organ donation options and organ recovery procedures (ERDs #26, 27, 65).
b. With the consent of the decisionmaker, the Transplant Coordinator from LOCAL OPO, with the knowledge of the attending physician, will conduct additional screening tests on the potential donor and assist in coordinating an appropriately timed discussion to share the results of the screening with the decisionmaker. Due to their substantial risk to hasten the patient’s death, bronchoscopy, lung biopsy, and cardiac catheterization will not be done.
c. Any physical interventions that may be requested by the LOCAL OPO as part of the assessment of the potential donor will be communicated to the health care team. The patient’s health care team will have decision making authority on whether to perform the assessments consistent with the standards of reasonable clinical care and will be responsible for undertaking the assessment and clinical management of the potential donor.
- Informed Consent
a. Families and the decisionmaker need to be fully informed regarding donation options and organ recovery procedures.
b. If the decisionmaker consents to organ donation, the LOCAL OPO Consent for Organ Donation After Cardiac Death (Form A) and a DCD Disclosure form (Form B) will be completed.
c. The family and/or decisionmaker will be offered the opportunity to be present for the withdrawal of ventilator support and the death of their loved one.
d. Due to the potential of heparin to cause brain hemorrhaging and death, it will not be administered to patients with active bleeding until death is declared.
1) The decision to administer heparin to patients who do not have active bleeding will be made on a case by case basis.
2) The dosage of heparin is 300u/kg for adult patients and pediatric patients. Antibiotics, vasopressors, antihypertensives may be ordered by hospital medical staff. Other medications, including phentolamine, that could cause potential harm to the patient and/or hasten cardiac asystole and death will not be administered.
3) A separate written consent form (Attachment C) signed by the decisionmaker is required for heparin and all medications associated with organ donation that do not directly benefit the patient and do not cause direct harm to the patient.
- Patient Management
a. To facilitate optimal organ recovery, the patient must be maintained on a ventilator and hemodynamically supported while testing for potential organ donation occurs.
b. The diagnostic studies to determine organ suitability and interventions to optimize organ function will be done following the decisionmaker’s signed informed consent.
c. The hospital care team will be asked to write and implement orders during the evaluation and prior to withdrawal of ventilator support, e.g. blood tests. LOCAL OPO will not write any orders in the potential donor’s medical record.
d. The LOCAL OPO Coordinator will work in conjunction with the hospital medical staff to request medical consultations and laboratory studies to determine the suitability of the organs for transplantation.
e. Responsibility for the clinical care of the patient remains with the health care team caring for the patient until the declaration of circulatory death has been made.
f. The patient has a right to palliative care and to be treated with dignity and compassion. A Palliative Care Consult will occur prior to withdrawal of ventilator support.
g. The use of paralytics is prohibited.
h. Interventions to preserve organ function but which may cause patient discomfort or hasten death are prohibited.
i. All premortem interventions in pediatric donors require explicit parental consent.
j. If the case falls under the jurisdiction of the county coroner/medical examiner, it will be the responsibility of the LOCAL OPO Transplant Coordinator to contact the appropriate coroner/medical examiner staff to authorize organ and tissue recovery. The release will be documented in the medical record by the nurse caring for the patient.
- Care of Family and/or Decisionmaker
a. The patient’s family and/or decisionmaker will receive psychosocial and spiritual support. This care will be provided to the dying patient, the family and/or surrogate from Spiritual Care, Palliative Care, and Social Services Departments.
b. A team member from Spiritual Care, Social Services, or Palliative Care will be assigned by the Director of Palliative Care to accompany and support the family and/or decisionmaker throughout the process.
c. In addition, the family and/or decisionmaker will be accompanied and supported by the LOCAL OPO Family Resource Coordinator.
d. The family and/or decisionmaker may ask to remain with the patient until death is declared. This request will be honored and the dignity of the patient, family, and/or decisionmaker respected. For many persons, dying alone without the presence of loved ones connotes abandonment.
e. Staff will anticipate a family’s or decisionmaker’s request to be with the patient at the time of death and will prepare a plan that allows the family and/or decisionmaker to be present and supported.
f. The family support person/team will prepare the family and/or decisionmaker for what they will see, the sequence of events that will take place and what is expected of them, e.g., that they will be asked to leave the operating room very shortly after death or organ donation may not occur.
- Scheduling an Operating Room and a Potential Comfort Care Room
a. After suitability for organ donation has been determined and consent obtained, a transplant team will be notified and assembled.
b. Operating room staff will be notified of the potential for organ recovery. The time and availability of an operating room will be negotiated and determined with the hospital staff. The donation procedure does not require an operating room ventilator or an anesthesiologist. A scrub nurse/tech and a circulator are needed to assist the recovery team.
c. When the transplant team has arrived at the hospital, the patient is transferred to the operating room while being mechanically ventilated and monitored. The Intensive Care Unit (ICU) nurse and respiratory therapist will accompany the patient to the operating room.
d. When the time for withdrawal of ventilator support has been determined but prior to transfer to the operating room, bed control or the nursing supervisor will be contacted by the nurse caring for the patient in order to pre-assign a bed for the patient in the event that death does not occur within the 60 minutes following withdrawal of ventilator support.
- Withdrawal of Ventilator Support and Extubation
a. The withdrawal of ventilator support and extubation will ordinarily occur in the operating room.
b. The surgical recovery team will prepare and drape the patient in a sterile fashion.
c. Once the patient is prepared and all necessary recovery equipment and preservation solutions are in place, the organ procurement physician and the surgical recovery team will leave the room.
d. The LOCAL OPO Transplant Coordinator or the LOCAL OPO Manager On-Call will remain in the room with the attending physician and the nurse caring for the patient. Under no circumstances will members of the transplant team, the LOCAL OPO Transplant Coordinator and/or the LOCAL OPO Manager On-Call participate in the withdrawal of ventilator support and the declaration of death.
e. Standard comfort care measures will be administered prior to and during the withdrawal of ventilatory support.
f. Under no circumstances will an incision, for the purpose of organ recovery, be made or cold perfusion catheters inserted until death has been pronounced and certified by a member of the hospital medical staff.
- Certification of Death
For certification of circulatory death, the prompt and accurate diagnosis of cardiac arrest is extremely important. Recovery of organs cannot take place until the patient meets the cardiopulmonary criteria for death. Because of the concerns regarding conflict of interest, the criteria in this protocol are stringent. All of the following diagnostic criteria are required to determine the cessation of cardiac function:
1. 5 minutes of complete unresponsiveness to noxious or physical stimuli
2. 5 minutes of electrocardiogram changes consistent with the absence of heart function as evidenced by a or b:
a. electromechanical dissociation (EMD)
b. electrical asystole
3. 5 minutes of absence of pulse/circulation determined by a or b:
a. arterial catheter with a pulse pressure of zero (0) mmHG
b. Doppler and verified by 2 independent observers (can be the attending physician and a nurse but no one from organ recovery team)
4. 5 minutes of Apnea
It is only after the passage of 5 minutes without any return of any of the above four elements that the patient may be declared dead.
The attending physician will certify death and document the date and time of death in the patient’s medical record and the death certificate will be prepared. Following the certification of death by the attending physician, the surgical recovery of organs may commence according to approved protocols.
If the patient does not die within 60 minutes, the donation process will cease and comfort care measures will be maintained. The family will be informed and support will be provided. The patient will be taken to a designated room for comfort care. The family may remain with the patient. Under no circumstances will cardiopulmonary resuscitation (CPR) be performed.
- Case Review
Retrospective case review by the Bioethics Committee will be scheduled after each instance of Organ Donation after Circulatory Death and the attending physician and LOCAL OPO Coordinator will be encouraged to attend.
Ethical and Religious Directives for Catholic Health Services, December 2009.
23. The inherent dignity of the human person must be respected and protected regardless of the nature of the person’s health problem or social status. The respect for human dignity expends to all persons who are served by Catholic health care.
24. In compliance with federal law, a Catholic health care institution will make available to patients information about their rights, under the laws of their state, to make an advance directive for their medical treatment. The institution, however, will not honor an advance directive that is contrary to Catholic teaching. If the advance directive conflicts with Catholic teaching, an explanation should be provided as to why the directive cannot be honored.
25. Each person may identify in advance a representative to make health care decisions as his or her surrogate in the event that the person loses capacity to make health care decisions. Decisions by the designated surrogate should be faithful to Catholic moral principles and to the person’s intentions and values, or if the person’s intentions are unknown, to the person’s best interests. In the event that an advance directive is not executed, those who are in a position to know best the patient’s wishes—usually family members and loved ones—should participate in the treatment decisions for the person who has lost the capacity to make health care decisions.
26. The free and informed consent of the person or the person’s surrogate is required for all medical treatments and procedures, except in an emergency situation when consent cannot be obtained and there is no indication that the patient would refuse consent to treatment.
27. Free and informed consent requires that the person or the person’s surrogate receive all reasonable information about the essential nature the proposed treatment and its benefits; its risks, side effects, consequences, and cost; and any reasonable and morally legitimate alternatives, including no treatment at all.
63. Catholic health care institutions should encourage and provide the means whereby those who wish to do so may arrange for the donation of their organs and bodily tissues, for ethically legitimate purposes, so that they may be used for donation and research after death.
64. Such organs should not be removed until it is medically determined that the patient has died. In order to prevent any conflict of interest, the physician who determines death should not be a member of the transplant team.
65. Use of tissue and organs from an infant may be permitted after death has been determined with the informed consent of the parents or guardians.
“Ethical Controversies in Organ Donation after Circulatory Death.” Pediatrics, 2013 131 (5): 1021-1026
“Non-Heart-Beating Organ Donation: Designing an Ethically Acceptable Protocol.” Health Progress, January – February 2001, Volume 82, Number 1
“Non-Heart Beating Organ Donation: Old Procurement Strategy – New Ethical Problem.” Journal of Medical Ethics 2003, 29:176-181
“Palliative Care Consultation in the Process of Organ Donation after Cardiac Death.” Catherine McVearry Kelso, Laurie J. Lyckholm, Patrick J. Coyne, Thomas J. Smith, Journal of Palliative Medicine 2007, Volume 10, Number 1
“Report of a National Conference on Donation after Cardiac Death.” American Journal of Transplantation 2006, 6:281-291
Policy on “Organ Donation after Cardiac Death.” Seton Medical Center, Daly City, CA, January 16, 2013
Staff Discussion Paper on “The Definition of Death and the Ethics of Organ Procurement from the Deceased.” Institute of Medicine. September 2006
The National Catholic Bioethics Quarterly. Autumn 2007, Volume 7, Number 3