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Non-Heart-Beating Organ Transplantation: Practice and Protocols (2000)

Chapter: APPENDIX F Non-Heart-Beating Donation Protocols

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Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×

APPENDIX F
Non-Heart-Beating Donation Protocols

Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×

LIFECENTER1

Non-Heartbeating Donor Protocol

There are many instances in which families want the opportunity to donate their loved ones organs, but do not wish to prolong the process by awaiting the onset of brain death, or cannot because criteria for formal brain death declaration might never be met prior to cardiac death. Organ donation from patients that are cardiac dead will provide the opportunity to increase the donor pool and most importantly assure that every opportunity is taken to carry out the wishes of the donor family.

  1. Referral

    1. Donor hospitals are encouraged to contact LifeCenter before terminating ventilator or vasopressor support on a patient.

    2. Criteria: Between 2 and less than 65 years of age; no history of HIV infection, malignant cancer outside of the brain, renal failure, or does not meet any High Risk donor exclusion criteria as defined by the Center for Disease Control (addendum 1). The patient must be on a ventilator.

  1. Consent Process

    1. A hospital staff member will contact LifeCenter to inform the agency that a patient exists who is potentially eligible to be a non-heartbeating organ donor. LifeCenter will only become actively involved in a potential NHBD case after a decision has been made to terminate support.

    2. The attending physician or his designee will discuss termination of support on medical grounds with the family of the patient. If the family agrees, a DO NOT RESUSCITATE (DNR) order will be documented in the chart.

    3. A LifeCenter representative will discuss the possibility of procurement with the attending physician or his designee. This is to ensure that the physician agrees with termination of support on medical grounds.

    4. LifeCenter will discuss organ/tissue donation with the family (next-ofkin). The complete donation process and the process for pronouncing death will be explained. The LifeCenter coordinator will obtain informed, written consent for organ and/or tissue donation, from the next of kin, as per the Uniform Anatomical Gift Act.

    5. If there is high probability that the patient will not have spontaneous respirations upon terminating support, the LifeCenter coordinator will discuss the option of termination in the operating room with the family.

    6. If the patient is a “coroner’s case” the LifeCenter representative will contact the appropriate coroners office and obtain clearance for organ/tissue donation.

1  

Provided courtesy of Ohio Valley LifeCenter, Cincinnati.

Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×
  1. The family will be given the opportunity to spend time with the patient prior to discontinuation of support.

  2. Attention should be given to patient comfort measures.

  3. The family will be given the option to see the deceased patient after organ and/or tissue recovery surgery has been completed.

  1. Determining Death

    1. Before termination of support, it should be clear that the patient does not meet brain death criteria.

    2. LifeCenter will utilize the accepted method of terminating support as determined by the attending physician and/or hospital.

    3. The attending physician or his designee will pronounce death.

    4. LifeCenter will wait for five (5) minutes of pulselessness before proceeding with donation.

  1. Donor Management (Laboratory work will only be started after signed family consent is obtained and with a physicians order)

    1. Evaluation—Lab and diagnostic tests to be done for kidneys and liver:

      Kidneys: electrolytes, glucose, PT/PTT, ABO, ABG, CBC, BUN, creatinine, urinalysis, chest x-ray, blood, urine, and sputum cultures.

      Liver: LFT’s, total and direct bilirubin.

    2. Stat serology tests should be done, after family consent is obtained. LifeCenter coordinator is responsible for arranging transportation to the serology lab.

    3. Blood specimens for tissue typing should be drawn at the same time as serology labs are drawn.

    4. Abnormal parameters to be treated (see LifeCenter Donor Management Protocol).

      1. Electrolyte abnormalities—change IV solutions, rates, and adjust additives.

      2. ABG abnormalities—alter ventilator settings

      3. Low hematocrit

      4. Coagulopathy—warm patient to 37 degrees, give FFP

      5. Low urine output—give fluids, mannitol, or lasix

  1. Preparing Patient and Operating Room for Organ Recovery.

    1. Per LifeCenter Donor Management Protocol, the patient will be given IV fluids, medications, blood products, etc. to prepare the patient for organ donation.

    2. All preparation related to equipment and supply set-up needed for surgical removal of the organs will be completed prior to withdrawing support.

Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×
  1. The organ recovery surgeon will be in the donor hospital and available prior to withdrawing support.

  2. The attending physician or his/her designee will order for and orchestrate the termination of support.

  3. The LifeCenter coordinator will be responsible for determining and documenting the warm ischemic time of each organ. The warm ischemic time will be calculated from the time that no pulses are detectable until the organs have been initially flushed and cooled.

  1. Death Declared

    Once death has been declared:

    1. Under no circumstances will chest compression’s be performed after death has been declared.

    2. If not already in the operating room, the patient will be moved quickly to the operating room.

    3. A vertical, midline incision will be made and the abdomen entered.

    4. Lymph nodes and portions of the spleen will be removed for use in tissue typing.

    5. If consent has been obtained from the family, tissues will be recovered in the morgue.

  1. If the patient continues to breathe and has a sustained pulse and blood pressure for more than two-three hours, the donation process will be stopped. The family will be informed of the time limit during the consent process. If the time limit expires, the family will be notified. The care of the patient will remain in the control of the attending physician.

  2. All costs from the time that the family gives permission for donation until the donation occurs, or the patient is no longer a candidate for donation, will be the responsibility of LifeCenter. Also, LifeCenter will pay for any lab tests or medications that are ordered by the attending physician to assess organ suitability or prepare the patient for organ recovery.

  3. Organ allocation and distribution will take place according to federal guidelines established through the United Network for Organ Sharing (UNOS).

ADOPTED: May 1, 1996

REVISED: March 7, 1997

October 7, 1997

January 6, 1998

January 13, 1998

February 23, 1999

Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×

GIFT OF LIFE DONOR PROGRAM1

1  

Provided courtesy of Gift of Life Donor Program, Philadelphia.

Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×
Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×
Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×

SHANDS at the University of Florida Donation Protocols Department of Nursing and Patient Services

Memorandum Number: Pm02-20.01

Category : Medicolegal

Review Responsibility: Legal Services

SUBJECT: DONATION AFTER CARDIAC DEATH (Non-Heart Beating Donors Only)

PURPOSE: To provide the option of organ donation to the families of patients who do not meet the criteria for brain death, but for whom a decision to withdraw life support has been made.

POLICY STATEMENT: Whenever a competent patient or an incompetent patient’s next-of-kin or surrogate/proxy has, in consultation with the attending physician, made the decision to withdraw ventilator support from a patient, a referral shall be made to the Organ Procurement Organization (OPO) prior to disconnection from the ventilator and/or initiation of the terminal wean.

SPECIAL INSTRUCTIONS:

  1. The decision to withdraw life support must be made in accordance with the procedures set forth in PM02-17 (“Withholding or Withdrawing Life-Prolonging Treatments or Measures”).

  2. The OPO shall make the determination of medical suitability for donation.

    1. The patient’s attending physician shall be responsible for the referral, however, the attending, resident, charge nurse, staff nurse or social work may make the call to the 800 number (1-800-535-4483). The consideration of and the discussion between the physician and the family regarding a terminal wean and/or disconnection from the ventilator should take place prior to, and independent from any consideration of and discussion relating to the possibility of organ donation.

    2. The patient’s attending physician shall not be associated with or employed by an OPO, nor shall he/she be affiliated with the Organ Procurement Team or Transplant Team.

Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×

SHANDS at the University of Florida Donation Protocols Continued

SPECIAL INSTRUCTIONS Continued

  1. Medical suitability/unsuitability of the potential donor

    1. Should the patient be deemed medically unsuitable for donation:

      1. The routine referral form shall be completed showing the specific reasons, and placed in the patients medical record by the OPO or other Designated Requester, as defined in PM02-20.

      2. The OPO will be responsible for contacting the attending physician or his/her designee so that a terminal wean/disconnection from the ventilator may proceed.

    1. Should the OPO find that the patient is potentially medically suitable for organ donation, then the OPO shall consult the attending physician or his/her designee and any other staff necessary in order to determine whether a request exemption applies (as defined in PM02-20). If not, then the OPO or designated requester, in consultation with the attending physician or his/her designee, shall approach the next of kin to request donation

      1. Should the next of kin decline the option to donate, the OPO shall complete the routine referral form and place it in the patient’s medical record.

      2. Should the next of kin agree to donation:

        1. A written consent form shall be included in the patient’s medical record (see PM02-20, Appendix B).

        2. The OPO or hospital staff under the direction thereof, may perform any and all tasks to evaluate the patient as a potential donor.

        3. All additional expenses incurred in the procedures to preserve the donor’s organs or tissues shall be paid by the OPO.

    1. Medical Management and Recovery of the Organ Donor

    1. The critical care attending, primary care attending physician, and/or the attending anesthesiologist shall continue full responsibility for the patient until such time as the patient’s death is pronounced.

    2. Comfort measures shall be taken to reduce or eliminate patient discomfort (including discomfort from the insertion of a cold perfusion catheter) and shall continue until such time as the patient’s death is pronounced.

Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×
  1. If the family requests to be at the patient’s bedside when the withdraw takes place, and with the patient’s next of kin or patient healthcare surrogate’s consent, a cold perfusion catheter may be inserted to aide in the viability of organs. Perfusion will not be initiated until five (5) minutes after death has been declared.

    1. The OPO will be responsible for obtaining an informed consent using the hospital’s procedures consent form.

  1. When a cold perfusion catheter is in place, the terminal wean may take place in the operating room or the ICU. Should the terminal wean take place in the ICU, then family members may be present.

    1. Should the family choose to be present during withdraw and the death of their loved one, and consent was not obtained for a cold perfusion catheter, then the OPO must refuse this patient as a potential organ donor.

  1. Perfusion shall not begin until five (5) minutes after death has been pronounced by the Critical Care Medicine, Primary, or Anesthesiology Attending Physician.

  2. Removal of organs shall take place only in the operating room.

  3. No incision, for the purpose of removing organs, may be made until five (5) minutes after death is pronounced.

  4. Death shall be pronounced when the patient meets cardiopulmonary death criteria.

  1. For the purposes of pronouncing death prior to the recovery of organs from non-heart beating donors pursuant to this policy, the following shall be confirmed in order to declare death:

  1. Confirm correct EKG lead placement, AND

  2. Confirm a pulse of zero (0) via the arterial catheter or EKG AND

  3. Confirm a zero (0) blood pressure via arterial catheter or NIBP monitor AND

  4. Confirm the patient is apneic, AND

  5. Confirm the patient is unresponsive to verbal stimuli.

Provided courtesy of SHANDS at the University of Florida, Gainesville.

Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×

NON-HEART-BEATING DONOR GUIDELINES AND PROCEDURES OF THE NEW ENGLAND ORGAN BANK1

Background

The Concept of Death

Most deaths are declared by an absence of cardiorespiratory function. However, as a simple and unifying concept, all deaths occur when there is permanent loss of the entire brain function. Thus, if there is no circulation to the brain for a sustained period, the hypoxic injury to the brain is irreversible. The absence of a heart beat during that period can be simultaneously used to declare death by a traditional criterion of death, but also as a sign that there is insufficient blood flow to the brain. All patients who satisfy the cardiorespiratory criteria of death will also satisfy the criteria of brain death, if there is no restoration of heart beat. Conversely, the loss of the entire brain function (which involves both cerebral and brain stem activity) does not permit the restoration of heart beat.

A loss of brain stem function is detected by an absence of spontaneous respiration (in the presence of hypercarbia). The consequence of permanent and irreparable loss of the entire brain function is death.

Brain Death and Organ Donation

Ninety-nine percent of organ donors in the United States are declared dead by brain death criteria (UNOS, Richmond,VA). Thus, the importance of the brain death formulation in the process of organ donation cannot be underestimated.

The American Academy of Neurology (AAN) definition of brain death is “an irreversible loss of the clinical function of the brain, including the brain stem.”

The three cardinal findings of brain death are: coma or unresponsiveness from a known cause, absence of brain stem reflexes (pupil, ocular, corneal, pharyngeal, and tracheal) and apnea. Confirmatory laboratory testing of brain death may include either an electroencephalogram, contrast or isotope angiography, isotope scanning, or transcranial doppler ultrasonography (1). Although these tests are not mandatory for the diagnosis of brain death in adults, they are recommended in children (2).

Non-Heart-Beating Organ Donation

Prior to the establishment of the brain death diagnosis in 1968, organs were only recovered for transplantation after a patient was declared dead by the absence of heart beat and respiratory activity. Since then however, the number of organs obtained from non-heart-beating donors (NHBD) has been limited, be-

1  

Provided courtesy of the New England Organ Bank, Newton, Mass.

Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×

cause the absence of cardiorespiratory function adversely affects the suitability of organs for successful transplantation, and because of the ethical complexities surrounding the NHBD process. Brain dead donors (versus NHBD) are ideal because organ function is interrupted under controlled conditions which minimize ischemia.

The NEOB experience with NHBD in the last several years has been the successful transplantation of 6 kidneys from 4 NHBD donors at the Massachusetts General Hospital. Nationally, an Association of Organ Procurement Organization survey of 42 member OPOs recovering organs from 4002 cadaver donors in 1997, revealed 51 (1.2%) were NHBD. The rate of transplantation following recovery was 78% for kidneys (98 recovered: 76 transplanted); and 53% for livers (17 recovered: 9 transplanted).

However, as a significant shortage of cadaver organs for transplantation has persisted, many have proposed that the opportunity of recovering organs from NHBD be reconsidered more broadly. With the advent of health care proxies, advance directives, and a societal reluctance for extraordinary measures of medical treatment for the terminally ill, end-of-life decisions are being made in response to patients’ known or presumed choice in the circumstance of such injury or illness. Clinical conditions have become recognized in which non-survivable brain injury may be determined, without fulfilling the criteria of brain death. As with the diagnosis of brain death, the cause of the irreparable brain injury must be determined. With the family’s approval (and often at their request), a joint decision with the physician may be made to withdraw life-sustaining support as appropriate care for the dying patient. This practice has become common and it has evolved to a public acceptance, irrespective of organ donation. Some of these patients from whom life support is withdrawn may be acceptable organ donors after death. At the conclusion of all care rendering decisions, the opportunity for organ donation may also provide the family an important consolation at the time of bereavement. Therefore, in certain instances regarding withdrawal of life support, consideration of organ donation has also become appropriate.

The Institute of Medicine (IOM) Report

In June, 1997, the NEOB Board of Trustees placed a moratorium on the establishment of an NHBD protocol by the NEOB: “It was voted that NEOB not be involved in any further efforts to expand NHBD in the region, pending the results of the IOM committee’s report. It was noted, however, that the two hospitals with current NHBD protocols were free to continue to implement them, and NEOB would assist in the recovery of any such donors as we have in the past.”

In July, 1997, a Committee on Medical and Ethical Issues in Maintaining the Viability of Organs for Transplantation was convened by John Potts, M.D.

Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×

of the Institute of Medicine of the National Academy of Sciences. The ethical aspects of many NHBD protocols were examined.

The IOM subsequently issued a supportive review affirming the following:

  • that NHBD is medically effective and ethically proper;

  • that organ donors must be dead before organs are recovered;

  • that NHBD should not be an entree to euthanasia (3).

The NEOB Board of Trustees subsequently approved the widespread implementation of the NHBD protocol throughout the New England Region.

References

1. Wijdicks EF. Determining brain death in adults. Neurology 1995;45:1003–1011.

2. Mejia RE, Pollack MM. Variability in brain death determination practices in children. JAMA 1995;274:550–553.

3. Non-Heart-Beating Organ Transplantation: Medical and Ethical Issues in Procurement. Institute of Medicine, National Academy of Sciences. National Academy Press, Washington, D.C. 1997.

NEOB Objectives by NHBD

The findings of the IOM are now favorable for the NEOB to develop guidelines for the NHBD process.

Thus, the following NHBD protocol is provided as a model approach consistent with the specific recommendations of the IOM.

The NEOB objectives are:

  • to encourage a consistent practice of NHBD in accordance with the IOM report, in hospitals which refer organ donors to the NEOB;

  • to maximize public confidence in the ethical basis of NHBD;

  • to increase the number of organs available for transplantation.

Because the controversy surrounding NHBD necessitated a review process by the IOM, the NEOB would urge that each medical center present this protocol to its Institutional Ethics Committee, or Institutional Review Board, and to its appropriate Intensive Care Physicians for approval.

We also wish to stress that the process can only be initiated when the family and primary care physician have made a decision to withdraw terminal care, that is entirely independent of organ donation.

Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×

We recognize that NHBD will entail a distinct process of informed consent that is explicit regarding procedure. An informed consent must be obtained that alerts the donor family and the ICU staff of the possibility that the patient may not die within one hour of the withdrawal of life support, in which case organ recovery will not be attempted. Furthermore, we fully anticipate that the NEOB will undertake an extensive education of NEOB staff, transplant center staff, and the staff of all hospitals where an NHBD protocol is developed.

Sequential Time Points of NHBD Process

  • Decision and consent by patient, family, or surrogate + primary care physician to withdraw life support.

  • Separate discussion with family about organ donation by NEOB.

  • Consent to donate organs after declaration of death—will also include consent for:

    • premortem femoral cannulation,

    • administration of heparin (required),

    • administration of morphine (requested and permitted as per PCP)

  • Withdrawal of life support: (extubation from ventilator) administration of phentolamine (permitted)

  • Determination of asystole (as determined by the PCP)

  • 5-minute interval

  • Declaration of death (by the PCP not associated with the transplant service)

  • Commence infusion of preservation fluids: (through femoral cannula) (node recovery for tissue typing permitted)

  • Organ recovery

NEOB Model Protocol for NHBD (Elements for Center Review)

  1. Suitable patient who could be considered for NHBD

  2. Opportunity for pre-mortem cannulation

  3. Administration of medical agents

  4. Conflict of interest safeguards

  5. Request of Medical Examiner’s permission for donation

  6. Determination of death

  7. Location of patient where death is determined.

  • Issue item for further discussion: prognostication of death after the withdrawal of care.

  1. Allocation of organs

  2. Center education

Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×
  1. Procedure prior to declaration of death

  2. Procedure following asystole

NEOB Model Protocol for NHBD

  1. The Suitable Dying Patient to Consider NHBD:

  • Patient age 1 to 55 years.

  • In those clinical situations in which patient, family, or other patient surrogate, and the responsible care physician decide to withdraw care from a patient who is dependent upon life support for survival,

  • and when brain death criteria are not fulfilled because of either detectable cortical activity or persistent brain stem function by detectable intact brain stem reflexes or spontaneous respiratory effort, and when the decision to discontinue life support fulfills hospital established criteria to withdraw life supporting care,

  • and a do not resuscitate order has been written,

  • and the patient has otherwise suitable organ function: liver function tests satisfactory, creatinine <2.0 mg %,

  • the patient will be considered for NHBD.

  1. Opportunity for Pre-mortem Cannulation:

    Femoral cannulation for the installation of preservation fluids:

  • after decision to withdraw care and consent to donate

  • before the heart stops

  • before the patient is declared dead.

The IOM report is quite specific in this regard (page 53):

  • “Cannulation does not hasten death, and it is important in preparing for rapid initiation of organ preservation and enhancing the chances of obtaining quality donor organs and the best graft results for recipients.”

  • “Cannulation is invasive, and, in a conscious person, painful.”

  • “The report finds that cannulation is acceptable in controlled NHBDs after a decision to donate is made and beginning just before withdrawal of life support or at anytime thereafter, but it recommends that consent always be explicitly required and that local anesthesia be used if needed.”

The placement of a femoral venous cannula for exsanguination is optional to the discretion of the recovery surgeon.

Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×
  1. Sedation, Anticoagulants, and Vasodilators:

  1. administration of morphine at the time of femoral cannulation: morphine is not objectionable if the intent is to benefit the dying patient by easing any discomfort at the time of death, even if the morphine may hasten the death through the unintended effect of suppressing breathing.

  2. administration of heparin at the time of femoral cannulation: is required.

  3. administration of regitine or phentolamine:

the IOM report in this regard is as follows (page 52):

  • “Although prescription of these drugs during organ procurement is deemed useful and is undoubtedly safe in the majority of instances … a blanket policy cannot be recommended because of possible untoward effects in some donor patients.”

  • “Physicians responsible for the care of individual donors should be able to make a clinical judgment on the advisability of using either heparin or phentolamine or both without hastening death.”

  • “Protocols should note that donor families should be specifically informed on these matters.”

The administration of phentolamine should be carefully considered by each center only after the withdrawal of life support, before the patient’s heart stops, and before the patient is declared dead, and only if the patient’s family has given specific informed consent to its administration.

  1. Conflict of Interest Safeguards:

    The IOM report provides the following (page 55):

  • “These safeguards require separating major decisions and discussions in patient care (withdrawal of life support, discontinuing CPR, and declaration of death) from major decisions and discussions in organ donation and transplantation (obtaining consent for donation and other transplant-related procedures and involvement in the actual process of organ retrieval).”

  • “Such safeguards include scrupulous separation of patient care personnel from procurement and transplant personnel”

Thus, the NEOB process stipulates the following:

  1. The physician who declares the patient dead must not be directly associated with the transplant team, or simultaneously involved in the care of an inpatient allograft recipient.

Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×
  1. The physician who declares the patient dead must not be an anesthetist whose responsibility of care takes place in the operating room at the time of organ recovery.

  1. Medical Examiner Approval:

No organ recovery will occur unless the Medical Examiner is notified and permission is granted, as is the NEOB policy for all organ donors.

However, since the donor may not be dead when the ME is notified, the ME will be alerted to the circumstance of NHBD.

Thus, the intention of withdrawal of life support etc. must be reviewed with the ME, as a condition of the ME approval for organ recovery after death.

  1. Determination of Death:

    The IOM report provides the following (page 59):

  • “The definition of cardiopulmonary death is irreversible cessation of circulatory and respiratory functions. Clarification of the meaning of irreversibility and of the determination of death must rest on expert medical opinion.”

  • “… an interval of at least 5 minutes [must] elapse after complete cessation of circulatory function … before death is pronounced and organ perfusion or removal begins.”

  • “A patient may be declared dead after the withdrawal of terminal care if 5 minutes elapsed from the determination by the physician that the heart has stopped and that circulation has ceased.”

(Attesting that circulation has stopped )

  • “The accepted medical detection standards include electrocardiographic changes consistent with absent heart function by electronic monitoring and zero pulse pressure as determined by monitoring through an arterial catheter.”

  • “… decisions otherwise regarding the declaration of death are the responsibility of the primary care physician.”

  1. Location of Patient as Death is Determined:

    Options: Intensive care unit or operating room

The advantage of initiating recovery in the ICU is to verify by public observation that no organ donor recovery procedure is begun until the necessary 5 minute interval has elapsed, after the patient is declared dead.

The disadvantage of bringing the patient to the operating room is the dilemma which arises if the patient does not die within an hour of the withdrawal of care.

Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×

The advantage of initiating recovery measures in the operating room is to minimize the warm ischemia time before the organs can be recovered.

The decision to pronounce death in either the ICU or the operating room may be influenced by the ability to prognosticate the cessation of breathing after the ventilator has been withdrawn. Inspiratory force on respiratory mechanics has been suggested as an approach to determine whether the patient will stop breathing after the ventilator is discontinued.

Unless a reliable prognostication regarding death can be forecast consistently, the NHBD process is hampered by the inability to predict a successful organ recovery.

Thus, personnel and resources could be delivered to the operating room with little prediction of death within one hour of life support withdrawal, and require the return of the patient to the ICU from the operating room.

  1. Allocation of Organs:

The NEOB supports the immediate transplantation of organs recovered from NHBD, because of the emphasis of averting ischemic injury to organs already compromised by their recovery from an NHBD.

Thus, the NEOB supports the following UNOS Region 1 approach that would enable:

For livers:

  • the transplant surgeon responsible for the patient who is allocated the liver by the standard UNOS rules will recover the liver for that patient, irrespective of the NHBD donor location.

For kidneys:

  • When the NHBD donor is hospitalized at a transplant center: the transplant center surgeon responsible for the recovery of NHBD kidneys will receive a priority of performing the transplant of these kidneys to patients at that center.

  • When the NHBD donor is at a non-transplant center: the transplant center surgeon identified as responsible for the recovery of kidneys (as previously defined by the current NEOB Policy, July 15, 1997) will receive a priority of performing the transplant of these kidneys for patients under the care of that transplant center.

NEOB Model Protocol for NHBD if initiated in the ICU:

Following decision to withdraw life support and consent to donate given (also following approval from the medical examiner):

Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×
  1. Obtain Instrument Tray and Supplies from OR Instrument Room (1 cannulation kit, 1 cannulation tray, 1 bag sterile supplies, 1 bag non-sterile supplies.). Notify OR Staff of Impending Donor

    To Be Done By: Transplant Staff

  2. Obtain: One set of clean stick blood cultures

    1 purple top (5 ml) + 1 red top (10 ml) (for Serology Testing)

    6 yellow top (10 ml) (for NEOB Tissue Typing)

    To Be Done By: Request by ICU Staff

  3. Place Chilled 6 L. UW + 4 L. LR Solutions into ICU Refrigerator Notify NEOB Tissue Typing Staff of Impending Donor (tel. 617 732 5872)

    To Be Done By: Donation Coordinator

  4. Place Ice Cooler and Ice in ICU (but not at the bedside, to avoid discomfort to family)

    To Be Done By: Donation Coordinator

  5. Mix Additives to UW Solution per Liter:

    PCN 200,000 units

    Decadron 16 mg

    Regular Insulin 40 units

    Mix Heparin Solution:

    50,000 units in 250 ml saline (to infuse separately before UW in that line)

    To Be Done By: Donation Coordinator

  6. Insure Adequate Wall Suction Apparatus at Bedside (sterile tonsil tip in instrument tray)

    To Be Done By: Donation Coordinator

  7. Obtain 2 Portable IV Poles at Bedside

    To Be Done By: Donation Coordinator

NEOB Model Protocol for NHBD:

Following the Consent to Donate, Before Withdrawal of Care:

  1. Notify the OR, and NEOB Technical Staff, via page, of Impending Travel

    To Be Done By: Donation Coordinator

  2. Obtain Blood Samples:

    NEOB Tissue Typing:

    2 red top (10 ml)

Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×

2 green top (10 ml)

Tissue Donor:

2 tiger top (10 ml)

1 yellow top (10 ml) for PCR testing

To Be Done By: Request by ICU Staff

  1. Place Ice Cooler, UW, + LR at Bedside

    To Be Done By: Donation Coordinator

  2. At Bedside: Shave/Prep Groin + Abdomen

    To Be Done By: Transplant Staff

  3. Femoral Artery and Vein Dissection

    To Be Done By: Transplant Staff

  4. Cannulate Femoral Artery with Organ Procurement Catheter or 22 Fr Baxter Fogarty Occlusion Catheter (60 cc sterile saline [250 cc bottle] to balloon) pump tourniquet around femoral artery

    To Be Done By: Transplant Staff

  5. Cannulate Femoral Vein (Argyle chest tube) Transplant Staff

    Extubate Patient Primary Care Physician

    Heparinize: (30,000 units to the central Donation Coordinator venous line)

    Determine Asystole Primary Care Physician

    Declaration of Death Primary Care Physician

After Declaration of Death:

  1. Infuse 4 L. of UW Solution (+Heparin Solution) through femoral artery cannula at 1 meter hydrostatic pressure, raise level if needed or apply pressure bags

    To Be Done By: Donation Coordinator

  2. Exsanguinate femoral vein fluid into urimeter bags change bags at barrel connector

    To Be Done By: Donation Coordinator

  3. Insert Peritoneal (dialysis) Catheters x 2 (inflow and outflow)

    To Be Done By: Transplant Staff

  4. Initiate Iced LR Peritoneal Lavage: (2 L. q 15 minutes)

    To Be Done By: Donation Coordinator

Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×
  1. Proceed to the Operating Room for removal of liver and kidneys as soon as possible.

    To Be Done By: Transplant Staff

*All supplies and equipment to accompany patient to OR.

Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×

UNIVERSITY OF PITTSBURGH MEDICAL CENTER PRESBYTERIAN, POLICY AND PROCEDURE MANUAL1

SUBJECT: Non-Heartbeating Organ Donation

DATE: February 3, 1999

I. POLICY

It is the policy of the UPMC Presbyterian (UPMCP) to strive to provide an ethically justifiable and auditable policy that respects the rig s of patients to have life support removed -and to donate organs if they wish to do so. The UPMCP presently has a policy regarding guidelines on life-sustaining treatment (Policy No. 4007). Patients or their surrogates can decide to forgo life-sustaining treatment, and the guidelines authorize comfort measures for patients wishing to forgo such treatment. Furthermore, all patients have the right to elect organ donation in the event of their death. For the last 20 years, the great majority of organ donors have been persons declared dead by brain death criteria. However, donation by persons who die from cardiac or respiratory failure is legal and was a commonly accepted practice before brain death criteria were established. The UPMCP believes that it is ethically appropriate to consider organ procurement from non-heartbeating donors. For correlating Western Psychiatric Institute and Clinic (WPIC) policy, see “Advance Directives” policy in the WPIC policy manual.

II. MANAGEMENT OF TERMINALLY ILL PATIENTS WHO MAY BECOME ORGAN DONORS AFTER DEATH

A. Principles

  1. 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. Consideration of organ donation shall occur only after a decision has been made by the patient, surrogate, or family and physicians that the patient be assigned the status of “comfort measures only” as indicated in UPMCP policy Guidelines on LifeSustaining Treatment. (Policy No. 4007). Organ donation may be an important option for the patient and/or patient surrogate. However, harm can result if the issue of donation is inappropriately raised.

    Consequently, health care professionals familiar with the concerns of the patient’s family must use their judgement to determine whether to recommend a

1  

Provided courtesy of University of Pittsburgh Medical Center Health System.

Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×

discussion of organ donation when the issue is not raised by the patient or patient surrogate. 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, consistent with UPMCP Policy 5060, Organ and Tissue Donation.

  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. Appropriate candidates for organ donation shall be limited to those patients on life-sustaining treatment in whom withdrawal of that therapy is likely to result in death within a few hours (e.g. patients who are respirator or intraaortic balloon dependent).

  3. Interventions intended to preserve organ function but which may cause discomfort to the patient or hasten death are prohibited.

  4. This policy explicitly prohibits any intervention whose intention is to shorten the patient’s life except when forgoing life support.

  5. Utmost attention and caution shall be taken to protect the dignity and rights of donors.

  6. Health care professionals shall not be recruited to participate in the procedures described below if such participation is against their personal, ethical, or religious beliefs.

  7. In this policy, the term “surrogate” decision maker is defined as specified in UPMCP policy Patient Consent (Policy No. 4011).

B. Procedures

  1. The detailed discussion of organ donation shall be deferred until after the decision to withdraw life support has been reached. An agreement between the patient or patient surrogate and the attending physician at the patient is assigned the status of “comfort measures only” (as described in the Guidelines on Life-Sustaining Treatment (Policy No. 4007)) is required for the patient to be considered an organ donor according to this policy. 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.

  2. After it has been decided to withdraw life support, and if a discussion of the option of organ donation has not been initiated by the patient or patient surrogate, the health care professionals caring for the patient should decide whether it is appropriate to recommend such a discussion. The health care team should consult with a representative of CORE to determine suitability for organ, tissue and eye donation, consistent with UPMCP Policy 5060, Organ and Tissue Do-

Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×

nation. If CORE is not called for organ donation prior to withdrawal of life support, H will always be called for possible cornea and tissue donation in agreement with the required referral law and UPMCP policy (Policy No. 5060).

  1. 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 maintain consent.

  2. Patients who are not competent and are without surrogates shall not be considered for organ donation.

  3. 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. The ethics consultant will write a summary of the discussion with the patient or patient surrogate in the patient’s medical record.

  4. If any member- of the health care team perceives an ethical problem, he or she is encouraged to request a full ethics consultation.

  5. The administrator-on-duty (AOD) shall be notified that organ procurement from a non-heartbeating donor is being contemplated.

  6. 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 in the Intensive Care Unit (ICU) by clergy, if requested.

  7. The patient’s attending physician(s) must agree with the proposed procedure and note this in the chart. He or she may be present in the Operating Room (OR) if he or she desires.

  8. The responsible OR anesthesiologist or his or her designee (e.g., anesthesiologist in charge or on call) will be informed of planned terminal management in the OR and the possibility of organ procurement.

  9. Once the patient or patient surrogate has expressed intent to donate organs, the patient’s attending physicians) or his or her designee must inform the ICU gatekeeper of the request or organ procurement from a non-heartbeating donor. The ICU gatekeeper1 will see that the management of the donor patient is in accordance with this policy. These activities shall involve an ICU staff physician (preferably the patient’s ICU staff physician) under the authority designated for this purpose, who fit the criteria in Section II, part B, paragraph 13.

1  

ICU physician with responsibility for ICU bed allocation.

Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×
  1. The responsibilities of the ICU physician withdrawing support include the following:

  1. Review of the informed consent procedure to ensure that it has included discussion with the patient or patient surrogate of the following:

    • the UPMCP’s current policies regarding patients for whom the goal of care is comfort measures only;

    • the process of removal of life-sustaining therapy;

    • the process of organ procurement from non-heartbeating donors;

    • that withdrawal of life-sustaining therapy will he completed in the operating room;

    • that a femoral arterial catheter will be required;

    • that while death is expected during or shortly after

    • discontinuation of life support, removal of support may not always 1M to death of the patient in a very short time;

    • that organs will not be procured until after the patient is declared dead;

    • based on the medical judgment of the transplant surgeon, that organs designated for donation ma not be procured if certain problems occur (e.g., due to ischemic injury);

    • 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 may have.

  1. Deciding when to initiate transfer of the patient to the OR.

  2. Managing the patient’s care with the assistance of an ICU nurse in the OR or holding area.

  3. Informing the surgeon when it is acceptable to start surgical preparation of the patient’s skin (see below).

  4. Certifying death. The physician certifying death must not be involved either in procuring organs or the care of any of the transplant recipients. Completion of the death certificate and death summary in the medical record are the responsibility of the primary clinical service.

  5. Filling out and signing the Non-Heartbeating Organ Donor record (Form 2013-2255-1293) jointly with the ICU nurse.

  1. The following criteria shall be used for selecting the supervising ICU staff physicians:

Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×
  1. The physician must attend in an ICU.

  2. The physician must have familiarity with the guidelines on life-sustaining treatment and the policy for removal of life-sustaining support in potential non-heartbeating organ donors.

  3. The physician must have personal experience with termination of life support, and specifically with removal of life support from patients who have been designated “comfort measures only.”

  4. The physician shall have no clinical responsibilities on a transplantation service.

  5. No physician who receives direct funding from a grant involving the transplantation team shall be involved in the management of donors in the OR.

  6. Physicians shall be designated by the chairman of the ICU Committee and/or a UPMCP appointed credentialing committee.

  7. ICU physicians who have an 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.

  1. The surgical staff responsible for organ procurement shall in no way participate in the weaning process or in the donor’s care. It is preferable that the operating team not be resent in the OR until certification of death except for skin preparation and draping as in procedure 18.

  2. OR 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 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 the anesthesiology staff.

  3. If narcotics and sedatives are administered, these drugs must be titrated to the patient’s need for provision of 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. Interventions intended to preserve organ function but which may cause discomfort to the patient or hasten death are prohibited.

  4. If organ ischemia is prolonged (e.g., beyond two hours), 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.

  5. No organs may he 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

Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×

has become totally unconscious and unresponsive to noxious or painful stimuli. Skin preparation and draping may be performed by the staff of the Pittsburgh Transplant Foundation.

  1. For certification of death, the prompt and accurate diagnosis of cardiac arrest 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.”2

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 for this application. The absence of a clinically palpable pulse does not necessarily mean cessation of mechanical activity of the heart.

The diagnosis of death by traditional cardiopulmonary criteria requires confirmation of correct EKG lead placement and of absent pulse via a femoral arterial catheter. The pulse pressure must be zero, or by definition the heart is beating. In addition to pulselessness (as defined here), the patient must be apneic and unresponsive to verbal stimuli. Given the above, any one of the following electrocardiographic criteria will be sufficient for certification of death:

  • 2 minutes of ventricular fibrillation,

  • 2 minutes of electrical asystole (i.e., no complexes, agonal baseline drift only),

  • 2 minutes of electromechanical dissociation.

  1. Immediately after certification of death, organ procurement is to proceed following CORE protocol.

  2. 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.

2  

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.

Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×
  1. Procured organs from non-heartbeating donors shall be distributed in accordance with current UPMCP policies and United Network for Organ Sharing (UNOS) requirements.

  2. Donor patients will not be charged for the costs of organ procurement (e.g., the use of the OR, special personnel, or medications used in the OR).

  3. At least initially, cases will be reviewed by a committee composed of the chair person of the Medical Ethics Committee or designee, the director of OR Nursing Services or designee, and the chief of Anesthesiology at Presbyterian University Hospital or designee. A member of the Committee on Oversight of Organ Transplantation, reviewers external to the hospital, will be invited to observe these case reviews and the entire Committee on Oversight of Organ Transplantation will receive the conclusions of these reviews at least quarterly. 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. 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:

  1. assure that the above principles are adhered to;

  2. assure that the above procedures are complied with;

  3. identify problems and complications, potential or actual, and recommend changes toward their solution;

  4. protect the interests of the donor, recipients, the UPMCP, and involved health care workers; and

  5. 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.

III. PATIENTS UNDERGOING “BRAIN DEATH PROTOCOL” WHO ARE PRONOUNCED DEAD USING CARDIAC CRITERIA

  1. Individuals who are in the process of having death declared using neurologic criteria may become non-heartbeating organ donors if:

  1. adequate consent 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.

  1. Consent must specify the following:

  1. The patient will be dead before any interventions for organ preservation are instituted.

Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×
  1. The specific interventions (such as catheter placement, chest compressions, or heparin3) which are used to promote the preservation of organs in non-heartbeating organ donation.

  1. The patient or patient’s surrogate should understand that he or she may consent to organ donation and refuse any specific interventions which enhance non-heartbeating organ donation.

    In these instances the patient may still be a donor only if the transplant team agrees to procure organs after death is declared using cardiopulmonary criteria without the use of the specified interventions.

  2. The transplant team is not obligated to procure organs they feel are not viable.

SIGNED: Gail A. Wolf

Vice President, Clinical Operations

ORIGINAL: March 3, 1993

REVIEW MONTH: February

Policy Review Committee: February 3, 1999

Medical Ethics Committee: January 12, 1999

Medical Executive Committee: February 10, 1999

PRECEDE: April 1, 1998

SPONSOR: Chair, Medical Ethics Committee

3  

Chest compressions may be provided for circulation of heparin if consent has been obtained. If chest compressions are performed, ventilation should not be provided because it is not necessary for circulation of heparin, and may result in unexpected cardiac resuscitation.

Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×

(ATTACHMENT)

GUIDELINES FOR REMOVAL OF LIFE-SUSTAINING SUPPORT IN TERMINALLY ILL PATIENTS WHO MAY BECOME ORGAN DONORS AFTER DEATH

I. GOALS:

1.1 Humane removal of life support.

1.2 Provision of comfort for all dying patients, without direct intention to cause death.

1.3 Promote quality of care.

1.4 Achieve accountability.

Attachment continues on next page.

Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×

II. SPECIFIC GUIDELINES AND CORRESPONDING RATIONALE:

 

GUIDELINES

 

RATIONALE

2.1

Patients will receive comforting medication only for demonstrated need, e.g., this could either be PRN medications or a fixed dose of narcotics for documented signs compatible with pain or other discomfort.

 

 

2.2

Although a drug is given with the primary intent of assuring patient comfort, it is recognized that the drug may have a secondary (unintentional) effect of hastening death. The justification must be noted in the patient’s record.

 

 

2.3

No physician may purposefully deliver or order administration of any medication with the primary intent of hastening or causing death, since this is strictly prohibited by law.

 

 

2.4

All patients who manifest objective-evidence of stress or discomfort will be given comforting medication, unless there is proof that the patient cannot interpret these sensations.

2.4

There will be conscious patients who clearly can sense discomfort (e.g., patients with amyotrophic lateral sclerosis), and those who clearly cannot (e.g., cortical death). Clearly all patients who express discomfort discomfort should be treated. However, there is a continuous spectrum between those patients who clearly cannot sense discomfort and those who clearly can. Therefore, in order that no patient will suffer discomfort, all patients in whom cortical death has not been confirmed must be treated for objective evidence of discomfort. Examples of

Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×

 

 

 

objective evidence compatible with discomfort include (but are not limited to) tachycardia, tachypnea, gasping or use of accessory respiratory muscles.

2.5

The ICU staff physician will titrate dosing of medication.

2.5

Each patient is an individual and his or her response to therapy is not reliably predictable. Some patients will be sensitive, others tolerant.

2.6

The ICU staff physician will adjust the removal of all life support in a sequence and rate that best serves the patient.

2.6

By decreasing the ventilator (or other life support) setting only when the patient is comfortable, it is less likely that the patient will have distress at the next lower ventilator setting. The timing and size of the decrement can be varied, but the patient shall be evaluated for distress prior to proceeding to the next level of support.

2.7

Neuromuscular blockade must be documented to have worn off or been reversed prior to initiating removal of mechanical ventilation.

2.7

See Rationale 2.8.

2.8

Prior to initiating weaning, the ICU physician will verify that the patient is not receiving substantially more medication than needed to provide comfort. Continuous, stable infusions of narcotics or sedatives are not contraindicated if one of the following criteria are met:

1) Spontaneous ventilation.

2.8

When more drugs may have been given than is required to maintain comfort, the concern is that when life support is withdrawn, the high levels of drugs rather than the underlying condition will be the cause of the patient’s death. This concern may be relieved by the criteria listed:

1) Patients who have spontaneous ventilation are by definition not prevented from breathing; weaning may begin if there is no discomfort.

Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×

 

GUIDELINES (continued)

 

RATIONALE (continued)

2.8

2) Signs of discomfort.

2.8

2) Patients may be apneic from narcotics but still manifest discomfort or cognition. Patients who are uncomfortable shall be made comfortable even if a secondary effect is suppression of ventilation) from Guidelines on LifeSustaining Treatment, Policy No. 4007).

 

3) Recovery of cognition (awareness).

 

3) Recovery of cognition adequately indicates reversal of sedation.

 

4) No evidence of sedating drugs by toxicology analysis.

 

4) Sedating drugs are not the cause of unresponsiveness.

The requirement for at least one of the above criteria to be satisfied may result in a patient manifesting some minimal sign of discomfort before receiving additional comfort medication.

2.9

Patients who have received general anesthesia will not have ventilatory support removed until the anesthetic drugs have worn off or been reversed sufficiently to meet any of the following criteria:

1) Spontaneous breathing present,

2) Patient shows signs of discomfort,

3) No evidence of sedating drugs by toxicology analysis, and/or

4) Recovery of cognition (awareness) observed.

 

 

Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×

2.10

The weaning process shall be documented, using the Non-Heartbeating Organ Donor Record (Form 2013-2755-04937). This shall include clinical signs justifying medications and clinical notes including time of loss or consciousness, apnea, etc.

2.10

By making the entire schedule PRN, with objective criteria for each step and physician and nursing documentation, the process may be audited retrospectively to determine that only as much medication as necessary was given to the patient.

2.11

This weaning procedure will be used for any patient during withdrawal of mechanical life support, regardless of the patient’s cognitive state at the initiation of the weaning process.

2.11

The desire of a conscious patient for sedation may influence drug administration in that awareness of condition may be a form of discomfort. Therefore, a loss of awareness, as judged by clinical responses, may be provided at the patient’s request. Profound sedation or narcosis may be provided only if required for comfort, because of the concerns expressed above (see 2.8). Because life support is withdrawn and comforting medications given according to patient need, progression of the weaning is titrated.

2.12

In case of accidental extubation, the patient will usually not be reintubated. The physician may elect to reintubate to manage precipitous signs of discomfort (either subjective or objective evidence (see above)) which are not readily relieved by titrating medication.

 

 

Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×

III. SAMPLE ORDERS AND SPECIFIC RATIONALE:

This section is for illustrative purposes only, and does not impose specific orders upon the attending physician.

 

WRITTEN ORDER

RATIONALE FOR ORDER

3.1

Premedication (e.g., diazepam, IV); may continue stable infusions of hypnotics/narcotics.

Anxiolytic, amnestic but not an apnea-inducing dose. Maintain current comfort medication.

3.2

Infusions of vasoactive drugs and other pharmacologic or mechanical life support that do not contribute to patient comfort may be discontinued.

Withdrawal of life support has been decided by the attending physician and the patient. Comfort measures only has been decided by the attending physician and the patient (or surrogate). Comfort measures only are provided in accordance with the guidelines on Life-Sustaining Treatment (Policy No. 4007).

3.3

For a spontaneous breathing rate below 24 per minute and no distress, decrease respiratory support (ventilator rate, tidal volume, FiO2 or PEEP).

Ventilator weaning occurs only if no distress is present. No additional sedation is given because it is not needed.

3.4

For signs of discomfort (e.g., respiratory rate above 24 per minute, tachycardia, tachypnea, gasping or use of accessory respiratory muscles) give narcotics or sedation (e.g., morphine IV).

Weaning is on hold and sedation is given because of evidence of distress.

3.5

When ventilatory support is stopped, remove ventilator. Patient may be extubated.

Weaning completed.

3.6

Continue order 3.4 PRN after the ventilator has been removed and patient has been extubated.

Provides for continued patient comfort after weaning has been completed.

Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×

WASHINGTON HOSPITAL CENTER: PROTOCOL FOR THE RAPID ORGAN RECOVERY PROGRAM, TRANSPLANTATION SERVICES1

Overview

The single greatest factor limiting the number of renal transplants performed today is the size of the donor pool. The number of patients awaiting renal transplantation today is greater than ever, but the size of the donor pool has failed to increase to meet this demand, and in fact, has shrunk slightly in the last several years. We have proven that kidneys can be recovered from the NHBD and through utilization of unique pulsatile preservation methods verify viability of these organs prior to transplantation. Work in Europe suggests that, addition of the Non-Heart-Beating Donor (NHBD) to the pool could increase the number of available kidneys by at least 20%.

In the fall of 1993, under the sponsorship of the Medlantic Research Institute, we hosted a Consensus Conference on the Asystolic Trauma Donor. Expert panels addressed medical, legal, ethical, social, and community concerns raised by our proposed protocol for recovering organs from victims of fatal trauma in the MedSTAR. The conferees concurred with protocol implementation with a variety of recommendations.

We have implemented those recommendations and have undertaken the recovery of kidneys from the NHBD for transplantation. Successful kidney recovery has taken place. Steps have been taken to meet the recommended requirements for community education. However, a variety of research initiatives must continue to explore consent issues, community attitudes, experimental aspects of organ recovery, training and education. Our goal is to assure that the option of organ donation is available to all potential donor families, successfully recover transplantable organs and recover costs.

Design and Methods

Oversight

This protocol is subject to the oversight of an advisory committee, as recommended by the consensus conference participants. This committee is composed of community members who have an interest in seeing that the program is sensitive to community needs and concerns. The Community Oversight Committee is comprised of nurses, physicians, morticians, clergy, legal services representatives, D.C. Government officials, educators, and local transplant groups. The advisory committee is currently chaired by the Director of the Office of Decedent Affairs and reports directly to the office of Community Affairs of the

1  

Provided courtesy of Washington Hospital Center, Washington, D.C.

Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
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Medlantic Healthcare Group. This advisory committee meets at least on a quarterly basis and began in December 1993. All policies, protocols, and practices will be available for review by the Community Oversight Committee.

There will also be regular reports submitted to the IRB for continuing review. Although the Rapid Organ Recovery Program does not constitute a research program, we are requesting the same consideration under the existing internal review mechanisms. We feel that because of the nature of the program and the community that we serve, the internal review board must be kept apprised of the program’s progression and offer advice or direction as the board deems appropriate.

Donor Criteria

Potential Non-Heart-Beating cadaveric organ donors will include all patients pronounced cardiac dead in MedSTAR, an ICU or the Emergency Department at Washington Hospital Center. The potential donors will be limited to the following criteria of acceptability:

  • Patients should generally not be over 60 years of age or younger than 18 years of age (<18 with next-of-kin consent). Exceptions will be made on a case by case basis.

  • Patients D3 = have a known time of death.

  • Patients must not have active, untreated systemic bacterial sepsis at the time of death.

  • Patients must not have documented positive testing for HIV, HBsAg, or HTLV1.

  • Patients must not have cancer except primary brain tumors, lip/skin cancers, in-situ carcinomas.

  • Patients must not be among those classified high risk by the CDC, including homosexual/bisexual males, current I.V. drug abusers, or patients with hemophilia/coagulation disorders.

The identity of the patient must be known. In those cases where the identity of the patient is unknown, the Family Advocate will make an assessment of the known circumstance of death that will include discussions with the involved law enforcement agency. Line placement pursuant to the provisions of the Anatomical Gift Amendment Act of 1996 will not occur unless a high probability of patient and next-of-kin identification and notification can be accomplished within four hours after the known time of death.

Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×
ICU Donor Protocol (controlled donors)

There are several avenues to obtain organs from non-heart-beating donors in the Intensive Care Units. Any patient over 60 years old from whom withdrawal of support is anticipated and who is expected to suffer a cardiac death shortly after withdrawal (<48 hours) should be considered a potential donor. When such patients seem medically suitable according to the criteria in this document, a member of the primary or critical care team should notify the ODA. After the approval of the responsible intensivist the ODA will contact the Medical Examinees Office (if necessary) and WRTC to evaluate the patient. The WRTC coordinator will discuss the potential of organ acceptability with the intensivist. The patient’s attending along with the critical care team will discuss withdrawal of support with the family or person responsible for the patient’s health care decisions. If organs seem acceptable a member of the primary or critical care team will introduce the family to the WRTC coordinator who is generally the individual who will discuss the option of organ donation along with the ODA Family Advocate. The family member or other person responsible for the patient’s healthcare decisions may then elect to have organs donated. If consent for organ donation has been obtained, the primary medical team and critical care team will notify the ODA of the impending withdrawal of support. The ODA will communicate with the ROR team and WRTC to coordinate their efforts with the primary or critical care team which will direct the withdrawal process. If the patient dies during or after the withdrawal of support the ROR line placement and preservation protocol will be instituted. A patient will remain in the ICU during this time unless it is determined that the OR, MedSTAR or the PACU is the preferred setting.

To accomplish preservation, abdominal cooling lines will be inserted. Next the femoral artery and vein will be accessed and a catheter inserted within the 60 minute time allowance. The kidneys will be flushed with a perfusion solution designed to limit the amount of ischemic damage which the kidneys will sustain. Once cooled, the donor can be maintained up to four hours until an operating room is available and a standard operative recovery can be performed.

Fatal Trauma Victim Protocol (uncontrolled donors)

The second method for recovering organs from non-heart-beating donors is applicable to patients in MedSTAR or the Emergency Department who suffer uncontrolled cardiac arrest In this situation it is imperative that the respective unit physicians pronounce death prior to any intervention from the Transplantation Services Department and that there be a clear delineation of the time of death versus the initiation of organ preservation protocols. Based on recommendations made by the attendees of the “Trauma Victims as Organ Donors; Con-

Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×

sensus Conference,” numerous steps have been taken to educate the community about this program.

Since appropriate steps have been taken, and with concurrence from the Community Oversight Committee, it has been determined that line placement for the purpose of preserving the option of donation for the next-of-kin is both legal (Anatomical Gift Amendment Act of 1996) and appropriate in the event that the family is not present. If the family is present, the Family Advocate must obtain consent prior to the placement of the cold preservation lines. It has been documented that most of the potential ROR cases will arrive in MedSTAR without family present and this constraint has jeopardize the success of the ROR Program. However, data has been accumulated to show how families will respond to the placement of preservation lines.

When a potential donor is identified, the Trauma Fellow, Trauma team leader (R4), trauma nurse, or designee in MedSTAR shall page the in house Family Advocate through the in-house MedSTAR emergency page system. MedSTAR staff may participate in the ROR Protocol only in a support role to the line placement team. This type of support may include locating supplies and movement of the decedent to a more suitable location for line placement. They may not participate in direct hands-on donor preservation line placement.

Placement/Transfer of Potential Rapid Organ Donors

Potential ROR donors shall be cared for in MedSTAR, an ICU or the PACU until organ recovery occurs. Under no circumstance should these patients be transferred to a floor to await ROR unless specific arrangements are made between the ICU medical staff and the Nursing Supervisor covering the ICU.

Consent

A majority of deaths in MedSTAR or an ICU may fall under the jurisdiction of the Medical Examiner for the District of Columbia. The Family Advocate shall assist with notification and must obtain consent from the M.E.’s office prior to initiation of any procedure, should this death fall under their jurisdiction. Regardless of the next-of-kin’s wishes, the Medical Examiner has the right to object to donation of any organs or tissues, if such removal would have a potential impact on the determination of cause and manner of death. Under no circumstances will any procedure be initiated without the Medical Examiner’s approval. Once the Medical Examiner has agreed to allow intervention, the Family Advocate will immediately page the Line Placement Team.

The Family Advocate shall be responsible for responding to the MedSTAR unit immediately and determining whether a decedent is a possible Rapid Organ Recovery candidate. Tile determination will be made in consultation with the attending physician/intensivist. The Family Advocate will then immediately

Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×

page the Line Placement Team A search in conjunction with local authorities will be instituted if a family member cannot be located. The Family Advocate is responsible for offering the option of organ/tissue donation to the decedent’s next-of-kin. The consent will be obtained utilizing the standard Uniform Donor Form according to WHC Standard Practice # 583.20 and ODA SOP#C.300. Additionally, the decedent’s medical/social history must be obtained from the legal next-of-kin and documented utilizing the standard WRTC Medical History Form.

A Line Placement Team will be available in-house 24 hours a day to respond to preservation calls. If deemed necessary, the team member will draw 10 cc’s of blood and run a STAT viral screening. Should the potential donor show positive, efforts for organ preservation will be discontinued. Negative test results will continue the procedure. Two 10cc red top tubes and one lavender top tube of blood will be drawn and labeled. One red top tube will be held for the project coordinator to be sent for virology testing and the second sent by Med-STAR/ICU staff to the stat lab for ABO determination, BUN, Creatinine and Electrolyte levels. The lavender top will also be sent by MedSTAR staff for CBC evaluation. Aerobic and Anaerobic blood cultures will also be drawn and sent. The bladder will then be catheterized and a specimen sent for stat urinalysis and urine culture. An additional 3 red top tubes of blood must also be drawn for the Medical Examiners Office along with as many PVC test tubes of urine as possible. All tubes must be labeled with the donor’s name, social security number (if available), medical record number, and the date and time of death. A visual image will be recorded at the medical examiner’s request. WRTC will be advised as soon as possible as to the whereabouts of the blood samples. The WRTC Coordinator will notify the central donor lab so that arrangements can be made for the transport of the samples to that lab and serological testing can be initiated.

Line Placement Technique

A cooling blanket should be placed under or over the donor and set at the lowest possible setting. This is used as an adjunct to core cooling the donor. Supplies for the cannulation and flushing procedure will be provided by the Line Placement Team. A member of the Line Placement Team place the abdominal lavage lines and cannulate the femoral artery and vein in the following manner:

  1. PERITONEAL LAVAGE:

Two small incisions in the abdomen shall be made to insert the in-flow and outflow peritoneal lavage trocars. A sterile disposable trocar, Auto Suture, Surgiport, 1–1.5 mm, provided in the onsite donor kit) is then placed through the abdomen into the peritoneum, preferably in the patients right upper quadrant, to facilitate infusion of peritoneal lavage. An second modified trocar (with holes in

Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×

it) and pool suction cannula should be placed in a similar fashion into the left lower quadrant directed towards the pouch of Douglas for outflow. Cold 0.9% Saline solution is infused until abdominal distention is noted (usually 4 liters). This tubing will be connected to a sterile submersion pump. This ravage should be run continuously until stopped by the Transplant Recovery Surgeon. Documentation must be maintained according to Standard Operating Procedures regarding the amount, type and flow rates of fluid used in the lavage on the NHBD/MedSTAR Flow Sheet.

  1. PERFUSION CATHETER:

A femoral cut-down is performed. The femoral artery is isolated and controlled with a 0 Silk ligature. An arteriotomy is performed and a Porges Multiple Organ Recovery Balloon Catheter passed to the level of the xiphoid process and inflated with approximately 15cc of 50% hypaque solution. The Porges Catheter is placed in the femoral artery for the purpose of infusing the perfusate. The infusion tubing should be connected to the mixed perfusate I.V. solution and primed to expel any air in the line. The arterial access catheter is then connected to the primed infusion tubing. The tubing may be secured to the patient with a 0 Silk suture. The occlusion balloon is also inflated. IN SITU FLUSH SHOULD BEGIN NOW.

The flush solution shall consist of several liters of Viaspan solution, each augmented with:

4 mg Stelazine

40 units insulin

16 mg dexamethasone

20,000 units heparin

  1. EFFLUENT CANNULA:

In the same cut-down site utilized for placement of the perfusion catheter, the femoral vein is isolated and controlled with a 0 Silk ligature. A venotomy is performed and a marked 22 or 26 fr. Foley Catheter is inserted to the marking to allow venting for the perfusate solution. This 30cc balloon is to be inflated with approximately 20–30 cc of 50% hypaque catheter must be pulled taut to set the balloon at the femoral bifurcation. The catheter be secured with a 2-0 Silk ligature. The distal end of the venous catheter is connected in a sterile fashion to a 2000 cc urine collection bag. Drainage %*All be accomplished by gravity only, and riot with the assistance of suction.

ALL SUPPLIES NECESSARY FOR CANNULATION AND PERFUSION ARE SUPPLIED IN THE ON-SITE RAPID ORGAN RECOVERY CART

Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×

These solutions shall be maintained at 4°C until the time of infusion. (Refrigerated until the patient is included as a candidate for donation and then placed in the provided igloo cooler on ice.) Pre-mixed solutions shall be stored in the refrigerator located in MedSTAR and should be used only if there is no time to mix them in the lab under sterile conditions. To allow for optimal kidney flush and preservation, the solutions should be infused at 70 mm Hg of pressure.

The infusion pressure may be approximated by raising the I.V. pole and/or by providing pressure bags as an adjunct. The Line Placement Team will monitor of the flush solutions for continued inflow and outflow. Flow characteristics and other parameters to be measured are found on the ROR/MedSTAR Flow Sheet.

Organ Recovery

Organ recovery will not be initiated without consent of the legal next of kin, consistent with current practice. Once preservation attempts are completed, consent for organ/tissue retrieval is obtained, and the recovery surgeon and the WRTC coordinator are present, the body of the donor will be removed from either the MedSTAR unit or the ICU unit. It should be noted that this process will not be delayed if the WRTC Coordinator is not present when the recovery surgeon is ready to proceed with the recovery. The recovery will be performed using standard technique. Efforts to topically cool the kidneys by peritoneal lavage will be discontinued at the request of the surgeon.

  1. The body will be prepped from the neck to the pubis and draped in the usual fashion.

  2. A midline incision is made from the sternal notch (sternal saw required) to the symphysis pubis with bilateral supra umbilical transverse extensions through the skin, subcutaneous layer, fascia, and muscle. Hemostasis is obtained using the electrocautery.

  3. The right colon and small bowel mesentery are then reflected to expose the retro peritoneum from the aortic bifurcation to the renal veins. The abdominal organs will be visually inspected. If upon inspection the organs they appear well flushed and cool to the touch, a hepatectomy, pancreatectomy and/or a bilateral en-bloc nephrectomy (as approved by the M.E. and family consent), will be performed as described below. The abdominal cavity and kidneys are then packed with iced saline slush.

  4. The kidney, renal vessels, and ureter are carefully dissected with Metzenbaum scissors, DeBakey forceps, and Dean hemostatic forceps. One method of resection of en bloc resection, involves the removal of sections of the inferior vena cava and aorta with both kidneys in continuity. An incision is made along the route of the small bowel mesentery up to the esophageal hiatus. The entire gastrointestinal tract, spleen, and inferior portion of the pancreas are mobilized by dividing the celiac axis and the superior mesenteric artery, exposing the en-

Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×

tire retroperitoneal region. The inferior vena cava and aorta are clamped below the renal vessels with vascular clamps, and the vessels are divided.

Lumbar tributaries are secured with metal clips and are divided. The kidneys and ureters are freed from their surrounding soft tissues. The ureters are divided distally at the pelvic brim. The suprarenal aorta and inferior vena cava are clamped and divided superior to the diaphragm. The vessels and kidneys are severed from the surgical field, and the aorta and vena cava are ligated.

  1. After removal of the kidneys, the kidneys are moved to the back table and are placed in a container of cold saline solution and surrounded by saline slush where they are immediately flushed with cold (8°C) Viaspan solution. Careful inspection, dissection and measurement are carried out on the back table. Cultures of the abdominal fluid, the ureter tips and the organs and the basin containing sterile slush will be obtained and sent to the microbiology laboratory. A wedge biopsy will be obtained of the liver as well as each kidney and sent to surgical pathology for both a frozen and permanent section.

  2. The kidneys are then placed in the hypothermic pulsatile perfusion machine for transport to the MRI/HUH OPL for monitoring and evaluation.

  3. While kidney perfusion is begun, the abdominal lymph nodes and spleen are removed for use in tissue typing.

  4. The incision is closed with heavy running suture.

A video tape may be made at the request of the Medical Examiner of the initial incision and the recovery physician will verbally note any pertinent observations. This tape will be labeled with donor name and date and will be sent to the Medical Examinees Office. Finally, any other tissues donated (e.g., corneas, heart valves, skin, bone, etc.) by the next-of-kin will be procured by the appropriate tissue agencies. All relevant parameters and interventions will be recorded. The WRTC on site coordinator will observe the surgical recovery and record the anatomy of the kidneys. Photos of the recovered organs will be taken for documentation purposes.

Kidney Preservation

The kidneys will be placed on a hypothermic pulsatile perfusion machine in the Operating Room where they will then be transported to the Medlantic Research Institute/Howard University Hospital Organ Preservation Lab for perfusion and evaluation. The kidneys will be perfused with a modified commercially available solution used in standard ex-vivo kidney perfusion. Appropriate parameters for kidney function and status such as temperature, flow rates, ph and perfusion pressures will be measured and recorded over the next four to six hours, to determine organ viability as well as suitability for transplantation. Patient history prior to injury, hemodynamic parameters prior to death, warm ischemic time, cannulation and flush characteristics, biopsy and perfusion characteristics will be used to

Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×

determine the viability of the kidneys and to assess the potential suitability for transplant. Once the kidneys have been deemed suitable for transplantation by the MRI/HUH Organ Preservation Lab Co-Medical Directors and the WRTC Medical Director through a conference call initiated by the MRI/HUH Organ Preservation Lab staff, the WRTC Coordinator will be notified so that recipients may be located and the kidneys placed as per UNOS Standards. Placement will not take place until the kidneys are on pump for a minimum of 6 hours. In the event that one or both of the MRI/HUH Co-Medical Directors are unavailable for consultation, the organ recovery surgeon will be responsible for organ suitability evaluation and communications with the WRTC Medical Director.

Kidney preservation will be performed according the MRI/HUH Organ Preservation Lab’s Standard Operating Procedures, under licensure from the District of Columbia Department of Consumer and Regulatory Affairs. Post perfusion photos of the kidneys will be taken for documentation purposes.

Community Education

One of the most important factors in the success of the Rapid Organ Recovery Program is effective community education. The primary concern of the participants of the 1993 Consensus Conference was that of community education and awareness of the Rapid Organ Recovery Program. To this end, the Office of Decedent Affairs has planned and conducted more than 30 educational presentations. Media coverage of the program has been extensive. The Community Oversight Committee designed a survey which has also been utilized to assess public attitudes toward the Rapid Organ Recovery Program. Presentations have been made to key D.C. City Council Members as well as the mayor, all expressing support for the program. A program brochure will be made available to potential donor families and the community at large. The brochure has been developed through the efforts of the community oversight committee.

Facilities and Equipment

The placement of preservation lines will take place within the Washington Hospital Center. Potential donors will remain in MedSTAR/ICU until Operating Room time is coordinated. All necessary line placement equipment and supplies were purchased previously and are available. Organ recovery will take place in the WHC operating room. Kidneys will be placed in the Medlantic Organ Preservation Lab’s MOX perfusion pump while in the OR and transported to the MRI/HUH Organ Preservation Lab for preservation and evaluation. The MRI/HUH OPL is fully equipped and ready to perfuse and evaluate ROR organs. No additional equipment will be necessary.

Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
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Collaborators/Consultants

These costs are reimbursable and are outlined in the WRTC billing agreement when organs are recovered and transplanted.

Conclusion

The recovery of organs from this donor source will clearly be a major advance in increasing the supply of available organs for transplantation. It has been shown that the recently deceased cadaver is a medically acceptable source of organs for transplantation. By utilizing this donor source both the number of patients waiting for cadaveric transplantation, and the time these individuals must wait for such a transplant will be reduced. Further, a wider pool of potential matches for those patients with uncommon HLA antigens will be available. In addition, more patients and bereaved families will now have the unique opportunity to gain solace from organ donation.

We have, in the past year, shown that kidneys recovered from this donor source can be successfully recovered and transplanted by our program. Major steps have been taken to insure compliance with the recommendations made by the participants of the Consensus Conference. We have spent the past year crawling and it is now time to walk. Several other transplant centers are exploring the possibility of utilizing kidneys from non-heart-beating donors. However, only a handful of transplant centers in the U.S. have actually recovered and transplanted kidneys from this donor population.

All charges incurred in the evaluation and procurement of these kidneys for transplant will be paid through an agreement with WRTC either through standard billing mechanisms or direct WRTC billing from the Medlantic Research Institute Transplant Research Center.

Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
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Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
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Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
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Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
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Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
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Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
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Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
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Suggested Citation:"APPENDIX F Non-Heart-Beating Donation Protocols." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
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In 1997, the Institute of Medicine published a report entitled Non-Heart- Beating Organ Transplantation: Medical and Ethical Issues in Procurement. The findings and recommendations of that study defined the ethical and scientific basis for non-heart-beating organ donation and transplantation, and provided specific recommendations for practices that affirm patient welfare, promote patient and family choice, and avoid conflicts of interest.

Following the 1997 study, the Department of Health and Human Services requested a follow up study to promote such efforts. The central activity for this study was a workshop held in Washington, D.C., on May 24-25, 1999. The workshop provided the opportunity for extensive dialogue on non-heart-beating organ donation among hospitals and organ procurement organizations (OPOs) that are actively involved in non-heartbeating organ and tissue donation and those with concerns about whether and how to proceed.

The findings and recommendations of this report are based in large measure on the discussions and insights from that workshop. Non-Heart-Beating Organ Transplantation includes seven recommendations for developing and implementing non-heart-beating-donor protocols. These recommendations were based on the findings and recommendations from the 1997 IOM report and consensus achieved among participants at the national workshop. The committee developed these recommendations as steps towards an approach to non-heart-beating-donor organ donation and procurement consistent with underlying scientific and ethical guidelines, patient and family options and choices, and public trust in organ donation.

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