Download - Organ Donation Alliance

CHILDREN’S HOSPITAL OF PITTSBURGH
PATIENT CARE POLICY & PROCEDURE
TITLE:
NUMBER:
SECTION
Origination Date:
Revision Dates:
Review Dates:
APPROVAL:
Donation after Circulatory Death Determination (DCDD)
100.18
PATIENT CARE
September 19, 2007
Medical Executive Committee
Ethics Committee
SCOPE:
Children's Hospital of Pittsburgh Main ("CHP")
Children's Hospital of Pittsburgh Satellites
Children's Hospital of Pittsburgh Ambulatory Clinics
Children’s Hospital of Pittsburgh Ancillary Service
CHP North Surgery Center
CHP South Surgery Center
I.
POLICY
It is the policy of Children’s Hospital of Pittsburgh to respect the rights of patients to have life support
removed under certain circumstances (see Guidelines for Foregoing Life Sustaining Medical Treatment Policy 100.31). Patients and their families also have the right to donate abdominal organs after circulatory
death if they wish to do so, and the organs are medically suitable.
II. Identification of Candidates
Appropriate candidates for donation after circulatory death donation shall be limited to those patients with
acute, severe brain injury receiving life-sustaining treatment, in which withdrawal of that therapy is likely
to result in death within an hour. This will be limited to patients with evidence of severe cortical and brain
stem injury, with impaired respiratory drive and/or severe parenchymal lung disease profoundly limiting
the patient’s ability to sustain adequate ventilation and oxygenation. Patients with severe brain injury and
hemodynamic derangement, critically dependent on vasoactive drug support may also be candidates.
This protocol also may apply in rare clinical circumstance when a patient or family has elected to withdraw
life support and the patient is without severe irreversible neurologic injury, but death is expected within 60
minutes. In all such cases (where organ donation after circulatory death is being considered), the patient’s
attending physician, an additional "attending physician disease expert," and ethicist must concur that
consideration of the patient for organ donation after cardiac death is appropriate. One of the following
must also apply: 1) the patient has an advance directive that indicates their desire to be an organ donor, 2)
the driver’s license indicates the patient’s desire to donate, 3) the family has raised the issue of organ
donation, or 4) there is other objective durable evidence of the patient’s expressed desire to be an organ
donor. All other safeguards and processes below still apply.
Decisions concerning the treatment and management of patients (including but not limited to the decision
to withdraw mechanical support and/or medications) must be made separately from and prior to discussions
of organ donation. This means that appropriate candidates for withdrawal of life support shall be identified
independently of donor status.
Discussion and decision about and consent for organ donation must be made independent of (and
following) any decision about removal of life sustaining treatment in accordance with CHP Policy.
While organ donation may be an important option for the patient and/or patient surrogate, patient and
family harm can result if the timing of a discussion about organ donation is inappropriate. Consequently,
health care professionals familiar with the concerns of the patient’s family must use their judgment to
determine when to recommend a discussion of organ donation whether raised by the patient or family or
not. The health care team should consult with a representative of the Center for Organ Recovery and
Education (CORE) to determine suitability for organ, tissue and eye donation prior to speaking with the
family about organ donation.
Health care professionals shall not be required to participate in the procedures described below if such
participation is against their personal, ethical, or religious beliefs.
III.
MANAGEMENT OF TERMINALLY ILL PATIENTS WHO MAY BECOME ORGAN
DONORS AFTER DEATH
A.
Principles
B.
1.
It is the health care professional's primary responsibility to optimize the patient's care.
The process of removing life support shall be done primarily to promote patient comfort
and respect patient autonomy. It is an important objective of this policy that the interest
in procuring organs does not interfere with optimal patient management.
2.
Interventions intended to preserve organ function but which may cause discomfort to the
patient or hasten death are prohibited.
3.
This policy explicitly prohibits any intervention whose primary intention is to shorten the
patient's life.
4.
Utmost attention and caution shall be taken to protect the dignity and rights of donors and
their families.
5.
In this policy, the term "surrogate" decision maker is defined as specified in CHP policy.
6.
This policy applies only to donation of abdominal organs
Procedures
1.
The discussion of organ donation shall be deferred until after the decision to withdraw
life support has been reached, unless initiated by the family (surrogate). The discussions
with the patient or patient surrogate, leading to the decision to withdraw all lifesustaining therapy, must be appropriately documented in the medical record by the
attending physician. If the attending physician is not available in the hospital, he or she
may designate documentation by a senior fellow (PGY-V or higher) after telephone
discussion.
2.
After it has been decided to withdraw life support, the health care professionals should
consult with a representative of CORE to determine suitability for organ, tissue and/or
eye donation. Drawing blood for testing to determine medical eligibility may occur after
either the decision to withdraw support, or after consent to donate organs.
3.
Organ procurement may proceed only if the patient or patient surrogate agrees to organ
procurement upon death of the patient and signs the appropriate consent form. Consent
for donation can be withdrawn at any time. No pressure or coercion shall be used to
obtain/maintain consent. Donation after circulatory death will only be discussed in
patients with severe acute brain injury as noted above, or following family inquiry.
4.
Organ procurement may proceed only if, prior to signing the appropriate consent form,
the patient or patient surrogate has met with a member of the Ethics Consultation Service.
At that meeting, the ethics consultant should review the decisions to have life support
withdrawn and become an organ donor with particular attention to the process
surrounding the decision to withdraw life-sustaining therapy and to ensure that there was
no coercion related to organ donation. The ethics consultant will write a summary of the
discussion with the patient or patient surrogate in the patient's medical record.
5.
All members of the health care team involved in the care of the potential donor are
encouraged to participate in the discussions related to donation after circulatory death. If
any member of the health care team perceives an ethical problem, he or she is encouraged
to notify the ethics consultant.
6.
The administrator-on-duty (AOD) shall be notified that organ procurement following
circulatory death is being contemplated.
7.
Appropriate support will be provided for the patient, surrogate, or family by the health
care professionals. Discussion should take place with the family regarding whether they
wish to be present at the moment of the patient’s death. If organ donation is agreed to,
health care providers should also discuss with the family their wishes regarding seeing
the patient after organs have been procured. Pastoral care of the patient, surrogate, or
family shall be provided by clergy, if requested.
8.
The patient's attending physician(s) must agree with withdrawal of life-sustaining
therapy, and this should be noted in the chart. If he/she has concerns regarding organ
donation, he/she should discuss with the ethics consultant.
9.
An anesthesiologist or his or her designee (i.e., anesthesiologist in charge or on call) will
be informed of planned withdrawal of life sustaining treatment in the O.R. and the
possibility of organ procurement.
10.
The responsibilities of the ICU physician withdrawing support include the following:
a.
Review of the informed consent procedure to ensure that it has included
discussion with the patient or patient surrogate of the following:

CHP’s current policies regarding providing comfort care during
withdrawal of life-sustaining treatment;

the process of removal of life-sustaining therapy;

the process of organ procurement from donors after circulatory death;

that withdrawal of life-sustaining therapy will be completed in the
operating room;

that a femoral arterial catheter or echocardiogram is required;

that family may be present for removal of life-sustaining therapy, until
the time of death, and then will be asked to leave promptly to permit
organ donation;

that while death is expected during or shortly after discontinuation of
life support, removal of support may not always lead to death of the
patient in a very short time. Should the patient not die within the
expected hour, he/she may not be able to be an organ donor, and will be
returned to the ICU;

that organs will not be procured until after the patient is declared dead
(after at least 5 minutes of asystole);

based on the medical judgment of the transplant surgeon, that organs
designated for donation if medically unsuitable (e.g., if there is
excessive ischemia);

that death will be certified in accordance with existing Pennsylvania
law; and

that consent can be withdrawn at any time without cost or prejudice.
The physician withdrawing life support is also responsible for answering any questions
the patient, family, or surrogate) may have.
11.
b.
Deciding when to initiate transfer of the patient to the O.R.
c.
Managing the patient's care with the assistance of an ICU nurse in the O.R. or
holding area.
d.
Informing the surgeon when it is acceptable to start surgical preparation of the
patient's skin (see below).
e.
Certifying death. The physician certifying death must not be on a transplant
service. Completion of the death certificate and death summary in the medical
record are the responsibility of the attending of record.
f.
Filling out and signing the DCDD record jointly with the ICU nurse.
The following criteria shall be used for selecting the supervising ICU staff physicians:
a.
The physician must attend in an ICU.
b.
The physician must have familiarity with the guidelines on life-sustaining
treatment and the policy for removal of life-sustaining support.
c.
The physician must have personal experience with termination of life support.
d.
The physician shall have no current clinical responsibilities on a transplantation
service. (An intensivist not currently on clinical service may be designated the
“on call” physician to supervise withdrawal of support, should the intensivist on
service feel any conflict of interest in proceeding with DCDD).
e.
Physicians allowed to manage patients for DCDD shall be designated by the
Chief of the service and/or a CHP appointed credentialing committee.
f.
ICU physicians who have any other basis for conflicts of interest in individual
cases shall decline or not be asked to participate in withdrawal of life support
and certification of death.
12.
The surgical staff responsible for organ procurement shall in no way participate
in the donor's care, with the exception that the operating team may prep the
patient on his/her arrival in the OR and then will leave the OR. They shall
subsequently not be present in the O.R. until after certification of death.
13.
Anesthesiologists who later might be involved in the management of recipients
of the donated organs shall not participate in the weaning process or other forms
of the donor's medical management. During transport to the OR and terminal
management, all equipment (e.g., for assisted ventilation and monitoring) and
drugs (e.g., sedatives and narcotics) shall be brought from the ICU. Technical
support, including oxygen, compressed air, and suction equipment may be
provided by any operating room or anesthesiology staff.
14.
If narcotics and sedatives are administered, these drugs must be titrated to the
perceived need for patient comfort. The administration of clinically appropriate
medications in appropriate doses to prevent discomfort is acceptable, with
titration of medication predicated on signs compatible with distress.
15.
Interventions intended to preserve organ function but which may cause
discomfort to the patient or hasten death are prohibited. Medications which do
not harm the patient and which are necessary for DCDD to occur are acceptable.
For example, Heparin, in the time frame being considered, is not harmful to the
potential donor, makes organ donation possible, and may be given.
16.
If organ ischemia is prolonged (e.g., beyond one hour), it may not be possible to
utilize organs designated for donation, and procurement may not be performed.
The decision to cancel organ procurement because of prolonged ischemia rests
with the responsible transplantation surgeon. Under these circumstances, the
designated ICU physician may also decide to return the patient to the ICU.
17.
No organs may be procured until death has been certified. To keep warm
ischemia time to a minimum, all other appropriate preparations for the
procurement operation may take place prior to death but never before the patient
has become totally unconscious and unresponsive to noxious or painful stimuli.
Skin preparation and draping may be performed, if approved, but in general only
if the family has elected not to be present for withdrawal of life support.
18.
Certification Of Death. The prompt and accurate diagnosis of death is
extremely important. Procurement of organs cannot begin until the patient
meets the cardiopulmonary criteria for death, that is, the irreversible cessation of
cardiopulmonary function. The irreversible cessation of cardiac function is
"recognized by persistent cessation of functions during an appropriate period of
observation."1
Because of obvious concerns regarding conflict of interest, the criteria to be
used in this policy are therefore more stringent than the standard clinical practice
for declaring death in other patients who are designated "comfort measures
only" but who are not candidates for organ donation. Clinical definitions of
cardiac arrest, such as the absence of a palpable pulse in a large artery (i.e., the
carotid, femoral, or brachial artery), do not suffice in the setting of DCDD. The
absence of a clinically palpable pulse does not necessarily mean cessation of
circulation or mechanical activity of the heart. Thus, more sensitive and
1
Report of the medical consultants on the diagnosis of death to the President's commission for the study of ethical
problems in medicine and biomedical and behavioral research. Guidelines for the determination of death in the
President's commission for the study of ethical problems in medicine and biomedical and behavioral research.
Defining Death: medical, legal and ethical issues in the determination of death. 1981:162.
objective monitoring must occur as described in the following paragraph. In
addition, continuous EKG and pulse oximetry are required. The physician
should regularly document the rhythm and saturation of the patient.
To diagnose death by circulatory criteria: 1) Asystole by ECG; 2) absence of
circulation must be documented either by absent pulse pressure via a femoral
arterial catheter or by echocardiogram showing absent cardiac contraction (The
pulse pressure must be zero, or by definition the heart is beating); 3) the patient
must be apneic; and 4) the patient must be unresponsive to verbal and tactile
stimuli. These criteria must be simultaneously satisfied, and the patient must be
observed to satisfy those criteria continuously for a minimum of five minutes.
IV.
19.
Immediately after certification of death, organ procurement is to proceed
following CORE protocol.
20.
The procedure for organ procurement, cleaning of the body, and transfer to the
morgue is to be conducted with respect and sensitivity to the deceased and his or
her surrogate. This is the responsibility of the CORE.
21.
Procured organs from donors after cardiac death shall be distributed in
accordance with current UPMCP policies and United Network for Organ
Sharing (UNOS) requirements.
22.
Donor patients (including those who are taken to the OR as potential donors, but
who do not become donors) will not be charged for the costs of organ
procurement (e.g., tests determining medical suitability, the use of the O.R.,
special personnel, or medications used in the O.R.).
23.
Cases will be reviewed by the chairperson of the Medical Ethics Committee or
designee. A member of the Committee on Oversight of Organ Transplantation,
(who are reviewers external to the hospital) will be permitted to observe these
case reviews or receive verbal and/or written reports of the reviews as requested.
The responsible ethics consultant, ICU physician withdrawing life support, ICU
nurse, and transplant surgeon or designee will be expected to provide a verbal or
written report in whatever detail appropriate at the request of the ethics
committee. The physician withdrawing support and the ICU nurse will both
sign the records indicating clinical observations and medications administered.
The purpose of this review is to:
a.
assure that the above principles are adhered to;
b.
assure that the above procedures are complied with;
c.
identify problems and complications, potential or actual, and
recommend changes toward their solution;
d.
protect the interests of the donor, recipients, CHP, and involved health
care workers; and
e.
assess the effect of these procedures on the family’s grief process and
determine whether changes could be made to improve the process for
them.
PATIENTS UNDERGOING "BRAIN DEATH PROTOCOL" WHO ARE PRONOUNCED
DEAD USING CARDIAC CRITERIA
A.
Individuals who are in the process of having death declared using neurologic criteria may become
DCDD organ donors if:
1.
Consent for organ donation has been obtained from the patient or patient surrogate;
and/or
2.
The patient has been pronounced dead by a physician not on the transplant team using
accepted cardiac criteria.
New references:
OPTN/UNOS Guidelines on Donation After Cardiac Death
Presented by the OPTN/UNOS Ethics Committee Sept 20, 2006
http://www.psava.com/dot/Files/Conf_Call_10_4_2006/OPTN_UNOSDCD_Guidelines.doc
(downloaded 011707)
Institute of Medicine, Potts J. Non-Heart-Beating Organ Transplantation: Medical and Ethical Issues in
Procurement. Washington, DC, National Academy Press, 1997
Non-Heart-Beating Organ Transplantation: Medical and Ethical Issues in Procurement (Free
Executive Summary)
http://www.nap.edu/catalog/6036.html
Non-Heart-Beating Organ Transplantation: Practice and Protocols. Committee on Non-Heart-Beating
Transplantation II: The Scientific and Ethical Basis for Practice and Protocols, Division of Health Care
Services, Institute of Medicine 2000
Free Executive Summary
Non-Heart-Beating Organ Transplantation: Practice and Protocols Committee on Non-HeartBeating Transplantation II: The Scientific and Ethical Basis for Practice and Protocols, Division of
Health Care Services, Institute of Medicine http://www.nap.edu/catalog/9700.html
Recommendations for Nonheartbeating Organ Donation.Crit Care Med 2001;29:1826-1831
http://sccmwww.sccm.org/professional_resources/guidelines/table of contents/Documents/Nonheartbeating
pdf