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Appendix F: Non-Heart-Beating Donation Protocols
Pages 112-156

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From page 112...
... APPENDIX F Non-Heart-Beating Donation Protocols ~2
From page 113...
... C A LifeCenter representative will discuss the possibility of procurement with the attending physician or his designee.
From page 114...
... to prepare the patient for organ donation.
From page 115...
... 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.
From page 116...
... HOSPITAL POLICY AND PROCEDURE NON HEART-BEATING ORGAN DONATION t ~;~ i1f tilCI.F Ntli (~;'§E~; ~ ]
From page 117...
... Ah. ~1~ ~7 It: ^ (~[~.I~1~> t~'<~l~:~<,; S>-1~13>s~ $~ 1~>'~ dig tall $~1]
From page 120...
... 120 I o o o o o - o o I_ .O i it's ~ ~ 2,=.o ° ~ a 0 ~ =~ '< ~ ~ ;~ .
From page 122...
... 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)
From page 123...
... Some of these patients from whom life support is withdrawn may be acceptable organ donors after death.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.
From page 124...
... 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.
From page 125...
... (node recovery for tissue typing permitted) · Organ recovery NEOB Model Protocol for NHBD (Elements for Center Review)
From page 126...
... · 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.
From page 127...
... 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.
From page 128...
... E 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.
From page 129...
... 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.
From page 130...
... 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: 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)
From page 131...
... 131 Femoral Artery and Vein Dissection To Be Done By: Transplant Staff Cannulate Femoral Artery with Organ Procurement Catheter or 22 Fr Baxter Fogarty Occlusion Catheter (60 cc sterile saline t250 cc bottle] to balloon)
From page 132...
... 132 NON-HEART-BEATING ORGAN TRANSPLANTATION 5. Proceed to the Operating Room for removal of liver and kidneys as soon as possible.
From page 133...
... 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.
From page 134...
... 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.
From page 135...
... 5. 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.
From page 136...
... 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, .
From page 137...
... b. The physician must have familiarity with the guidelines on lifesustaining treatment and the policy for removal of life-sustaining support in potential non-hear/beating organ donors.
From page 138...
... 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.
From page 139...
... PATIENTS UNDERGOING "BRAIN DEATH PROTOCOL" WHO ARE PRONOUNCED DEAD USING CARDIAC CRITERIA A Individuals who are in the process of having death declared using neurologic criteria may become non-hear/beating organ donors if: and/or adequate consent has been obtained from the patient or patient surrogate, 2.
From page 140...
... C 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-hear/beating organ donation.
From page 141...
... GUIDELINES FOR REMOVAL OF LIFE-SUSTAINING SUPPORT IN TERMINALLY ILL PATIENTS WHO MAY BECOME ORGAN DONORS AFTER DEATH I GOALS: 141 1.1 Humane removal of life support.
From page 144...
... 144 Go Go 3 E o ~ 'aim I ~ ~ ~ · X .S U)
From page 145...
... 145 ~ ~ ~ ~ ~ ~ , it ~ ~ ~ ~ .
From page 147...
... 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.
From page 148...
... 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)
From page 149...
... 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.
From page 150...
... 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.
From page 151...
... A member of the Line Placement Team place the abdominal ravage 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 ravage trocars.
From page 152...
... The femoral artery is isolated and controlled with a 0 Silk ligature. An arteriotomy is performed and a Forges Multiple Organ Recovery Balloon Catheter passed to the level of the xiphoid process and inflated with approximately 15cc of 50% hypaque solution.
From page 153...
... 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.
From page 154...
... 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.
From page 155...
... 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.
From page 156...
... 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.


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