APPENDIX F
Non-Heart-Beating Donation Protocols



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Non-Heart-Beating Organ Transplantation: Practice and Protocols APPENDIX F Non-Heart-Beating Donation Protocols

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Non-Heart-Beating Organ Transplantation: Practice and Protocols 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. Referral Donor hospitals are encouraged to contact LifeCenter before terminating ventilator or vasopressor support on a patient. 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. Consent Process 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. 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. 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. 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. 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. 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.

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Non-Heart-Beating Organ Transplantation: Practice and Protocols The family will be given the opportunity to spend time with the patient prior to discontinuation of support. Attention should be given to patient comfort measures. The family will be given the option to see the deceased patient after organ and/or tissue recovery surgery has been completed. Determining Death Before termination of support, it should be clear that the patient does not meet brain death criteria. LifeCenter will utilize the accepted method of terminating support as determined by the attending physician and/or hospital. The attending physician or his designee will pronounce death. LifeCenter will wait for five (5) minutes of pulselessness before proceeding with donation. Donor Management (Laboratory work will only be started after signed family consent is obtained and with a physicians order) 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. Stat serology tests should be done, after family consent is obtained. LifeCenter coordinator is responsible for arranging transportation to the serology lab. Blood specimens for tissue typing should be drawn at the same time as serology labs are drawn. Abnormal parameters to be treated (see LifeCenter Donor Management Protocol). Electrolyte abnormalities—change IV solutions, rates, and adjust additives. ABG abnormalities—alter ventilator settings Low hematocrit Coagulopathy—warm patient to 37 degrees, give FFP Low urine output—give fluids, mannitol, or lasix Preparing Patient and Operating Room for Organ Recovery. Per LifeCenter Donor Management Protocol, the patient will be given IV fluids, medications, blood products, etc. to prepare the patient for organ donation. All preparation related to equipment and supply set-up needed for surgical removal of the organs will be completed prior to withdrawing support.

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Non-Heart-Beating Organ Transplantation: Practice and Protocols The organ recovery surgeon will be in the donor hospital and available prior to withdrawing support. The attending physician or his/her designee will order for and orchestrate the termination of support. 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. Death Declared Once death has been declared: Under no circumstances will chest compression’s be performed after death has been declared. If not already in the operating room, the patient will be moved quickly to the operating room. A vertical, midline incision will be made and the abdomen entered. Lymph nodes and portions of the spleen will be removed for use in tissue typing. If consent has been obtained from the family, tissues will be recovered in the morgue. 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. 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. 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

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Non-Heart-Beating Organ Transplantation: Practice and Protocols GIFT OF LIFE DONOR PROGRAM1 1   Provided courtesy of Gift of Life Donor Program, Philadelphia.

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Non-Heart-Beating Organ Transplantation: Practice and Protocols

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Non-Heart-Beating Organ Transplantation: Practice and Protocols

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Non-Heart-Beating Organ Transplantation: Practice and Protocols 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: 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”). The OPO shall make the determination of medical suitability for donation. 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. 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.

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Non-Heart-Beating Organ Transplantation: Practice and Protocols SHANDS at the University of Florida Donation Protocols Continued SPECIAL INSTRUCTIONS Continued Medical suitability/unsuitability of the potential donor Should the patient be deemed medically unsuitable for donation: 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. 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. 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 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. Should the next of kin agree to donation: A written consent form shall be included in the patient’s medical record (see PM02-20, Appendix B). The OPO or hospital staff under the direction thereof, may perform any and all tasks to evaluate the patient as a potential donor. All additional expenses incurred in the procedures to preserve the donor’s organs or tissues shall be paid by the OPO. Medical Management and Recovery of the Organ Donor 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. 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.

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Non-Heart-Beating Organ Transplantation: Practice and Protocols 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. The OPO will be responsible for obtaining an informed consent using the hospital’s procedures consent form. 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. 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. Perfusion shall not begin until five (5) minutes after death has been pronounced by the Critical Care Medicine, Primary, or Anesthesiology Attending Physician. Removal of organs shall take place only in the operating room. No incision, for the purpose of removing organs, may be made until five (5) minutes after death is pronounced. Death shall be pronounced when the patient meets cardiopulmonary death criteria. 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: Confirm correct EKG lead placement, AND Confirm a pulse of zero (0) via the arterial catheter or EKG AND Confirm a zero (0) blood pressure via arterial catheter or NIBP monitor AND Confirm the patient is apneic, AND Confirm the patient is unresponsive to verbal stimuli. Provided courtesy of SHANDS at the University of Florida, Gainesville.

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Non-Heart-Beating Organ Transplantation: Practice and Protocols 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.

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Non-Heart-Beating Organ Transplantation: Practice and Protocols 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.

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Non-Heart-Beating Organ Transplantation: Practice and Protocols 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.

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Non-Heart-Beating Organ Transplantation: Practice and Protocols 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.

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Non-Heart-Beating Organ Transplantation: Practice and Protocols 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-

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Non-Heart-Beating Organ Transplantation: Practice and Protocols 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

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Non-Heart-Beating Organ Transplantation: Practice and Protocols 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: 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

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Non-Heart-Beating Organ Transplantation: Practice and Protocols 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. 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 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

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Non-Heart-Beating Organ Transplantation: Practice and Protocols 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. The body will be prepped from the neck to the pubis and draped in the usual fashion. 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. 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. 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-

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Non-Heart-Beating Organ Transplantation: Practice and Protocols 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. 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. The kidneys are then placed in the hypothermic pulsatile perfusion machine for transport to the MRI/HUH OPL for monitoring and evaluation. While kidney perfusion is begun, the abdominal lymph nodes and spleen are removed for use in tissue typing. 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

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Non-Heart-Beating Organ Transplantation: Practice and Protocols 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.

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Non-Heart-Beating Organ Transplantation: Practice and Protocols 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.