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PROCEDURE T18.02 TITLE: Organ, Tissue and Eye Donation General Nursing Issuing Department: Departments Involved: Effective Date: 11/98 Review Dates: 09/05, 04/12 Revision Dates: 03/04, 05/07, 12/08, 11/10, 09/14 This procedure rescinds any previous publication covering the same material I. PURPOSE A. To ensure that the family of each potential organ, tissue, and eye donor is informed of their option to donate. To encourage discretion and sensitivity with respect to circumstances, views, and beliefs of the patient and the patient’s family. B. To remain in accordance with the State of Ohio Revised Code Section 2108, Ohio Senate Bill 188, and Ohio Senate Bill 158, and all other regulatory agency regulations related to organ procurement. II. DEFINITIONS A. Next of Kin: 1. Hierarchy of Consent / Authorization: a. Donor designation per Ohio DMV or other legal document (i.e.: state ID card, donor card, etc.). b. Spouse (common law not recognized in Ohio) c. Adult son or daughter d. Parent e. Adult brother or sister f. Grandparent g. Guardian of the person h. Person authorized to dispose of the body Organ, Tissue and Eye Donation – page 2 T18.02 B. Potential Organ Donor: any person who has suffered a lethal, or potentially lethal, head injury or disease and is hemodynamically maintained with mechanical ventilation and is in the critical care setting. C. Potential Tissue Donor: Any person who expires in any unit of the hospital and is not maintained with mechanical ventilation. D. Organs: Heart, lungs, livers, pancreas, kidneys, and intestines. Can be recovered from organ donors only. E. Tissues: Heart valves, pericardium, saphenous veins, femoral vessels, bone, connective tissue, skin and eyes. F. Brain Death: An irreversible loss of function of all parts of the brain, including the brain stem. G. Cardiopulmonary Death: Cessation of the circulatory and pulmonary function. H. Imminent Death: Any patient who has a fatal head injury or disease process or brain death testing is anticipated. I. Early Referral: Call being made to Donor Referral Line prior to the declaration of brain death on ALL patients suffering from a lethal head injury or disease process with a Glasgow Coma Scale of 3-5. J. Donor Referral Coordinator: Triage coordinator who answers initial referral call. For potential organ donors, triages call to Procurement Transplant Coordinator. For potential eye/tissue donors, works further with the hospital caregiver to determine suitability and to facilitate donation process. They are the Designated Requestors for all tissue and eye donations. K. Procurement Transplant Coordinator: A LifeBanc coordinator who will evaluate donor suitability, discuss donation process and facilitate organ recovery in conjunction with hospital staff. III. PROCEDURE A. The patient’s nurse (or designated individual) will be responsible for placing a referral call to the One Call for Life (1-800-558-5433) donor referral line and documenting the referral upon a patient’s death or imminent brain death of any patient. 1. DO NOT approach the legal next of kin about the option of donation prior to calling the donor referral line. 2. The call to the Donor Referral Line will take place when: a. There is any patient death (call will be placed within 1 hour from time of death). b. A patient has a potentially life-threatening brain injury and: i. The patient suffered a lethal head injury or disease process and Organ, Tissue and Eye Donation – page 3 T18.02 ii. Glasgow Coma Scale Score of 3-5. c. Prior to discussing DNR status with the family on any mechanically ventilated patients with a neurological injury or insult. d. Prior to the discontinuation of any life support measure. e. A patient with a cardiac arrest of > 10 minutes with resumed circulation. B. Making the Call to the Donor Referral Line 1. Prior to making the call to the Donor Referral Line, have the patient’s chart available and be prepared to provide information. If the decedent does not meet the initial criteria, the Donor Referral Line will terminate the process and/or additional instructions will be given. This information is to be noted on the LifeBanc log and in the Medical Record under Nurse’s Notes. 2. If the patient is in the critical care setting and being hemodynamically maintained by mechanical ventilation and has suffered a potentially lethal head injury or brain death testing is anticipated, the LifeBanc Procurement Transplant Coordinator will discuss in detail the plan of action, and at the appropriate time, will come on site to further evaluate and assist with the consent/authorization process. 3. If the decedent meets donation criteria for tissue and/or eye donation provide by the Donor Referral Line with a number where the next of kin can be reached within one hour. The Donor Referral Line will contact the next of kin to discuss donation. a. If the family initiated the conversation about donation prior to leaving the hospital, notify the Donor Referral Line who will then discuss donation before they leave. b. If the family has not initiated this conversation – do not attempt to do so. The Donor Referral Line will talk with them and guide the family through these decisions. 4. Final determination of recovery of tissues and/or eyes will be made only after the Donor Referral Coordinator has obtained: a. A hospital course summary from hospital personnel b. A complete medical and social history from the legal next of kin c. The Donor Referral Coordinator will notify the hospital personnel when to release the body to the funeral home / coroner. d. LifeBanc must release the body (verify referral number) prior to releasing the body to the funeral home / coroner. IV. PROCESS Organ, Tissue and Eye Donation – page 4 T18.02 A. Upon a patient’s death or imminent death the patient’s primary caregiver will call the Donor Referral Line. B. The Referral Line will guide the primary caregiver on which steps to take. C. If the patient is not a candidate for donation please refer to Post-Mortem Care procedure. D. If patient is a candidate for donation please notify the Clinical Supervisor / Manager on-call immediately. E. After donation is decided, the Clinical Supervisor / Manager on-call will work with LifeBanc to schedule/plan retrieval. F. If more than eyes are being recovered, the Director of Surgery Services or designated personnel / surgical scrub will be called by the Clinical Supervisor. G. Consents must be obtained for each organ/tissue retrieved (obtained per LifeBanc). H. Upon retrieval, the Clinical Supervisor/Manager on-call (eyes) or Director of Surgical Services (tissue/organs) will obtain documentation (Operative Report and Tissue Recovery) from LifeBanc personnel of what was retrieved and fill out a charge sheet and list of supplies used during retrieval. Original forms to be given to the Clinical Supervisor/Manager on-call. The originals will be placed in the Medical Record. A copy will be made and sent to the Billing Office and the Pomerene LifeBanc Coordinator. 1. Please note the “TYPE” of donor to bill LifeBanc for: a. DCD Donor (Donation after Cardiac Death) b. Non-DCD Donor c. Unproductive Donor (donor that is not retrievable) d. Tissue Donor e. Eye Only donor 2. Note that each organ/tissue retrieved and all equipment and supplies used during the retrieval. V. DONOR SPECIFIC INFORMATION A. EYE DONATION 1. When Consent for the anatomical gift of the eye has been given, the following will be done to obtain a viable eye donation. a. Close the eyes gently b. Raise the donor’s head 30 degrees Organ, Tissue and Eye Donation – page 5 T18.02 c. Apply ice packs to the eyes (disposable gloves filled with ice, placed on closed eyes) d. Place body in morgue as soon as possible e. Document the donation on the LifeBanc log. 2. Retrieval will be done in the morgue or ED. B. DCD DONOR (DONATION AFTER CARDIAC DEATH) 1. Protocol for DCD will include patients that have been maintained in the Special Care Unit (SCU) on a ventilator and in which brain death cannot be established. A patient can be considered DCD if the family has elected to withdraw support and the DNR orders are placed after the decision to withdraw has been made. Potential donors will include head trauma by blunt or penetrating injury, anorexic event, or those expected to arrest within 1 hour from extubation but do not meet established brain death criteria. Exclusions would include, but are not limited to: a. Acute untreated systemic bacterial infection. b. Documentation positive testing for HIV, Hepatitis B Surface Antigen (HbsAg), or Human T-cell Lymphotropic Virus Type 1 (HTLV1). c. Cancer or active malignancy except primary brain tumors or lip/skin cancers. d. Potential Donors must be screened and, if necessary cleared by the Medical Examiner / Coroner prior to recovery. e. Age younger than 2 or older than 65. f. High risk as defined by the CDC. g. Uncontrolled Hypertension. h. Insulin Dependent Diabetic. i. BP: Adults with mean <60, Pediatrics: less than 10% for age. 2. When a potential donor is identified via clinical triggers, the physician or primary caregiver will contact LifeBanc. Pomerene staff will not discuss option with the potential donor’s family. (Clinical triggers: devastating neuro injury, mechanically vented, GCS<5, 2 or more brain reflexes absent) 3. LifeBanc checks the donor registry to verify donor status and will inform the Individual Legally Authorized to Consent to Organ Donation of the decedent’s wish to be a donor as indicated by the Bureau of Motor Vehicles. Alternatively, a decedent’s wish to be a donor may be expressed in a State of Ohio Living Will Declaration. Or a LifeBanc designated requestor, in conjunction with a member of the medical team, will discuss donation with the Individual Legally Authorized to Consent to Organ Donation if medical criteria are met as determined by the procurement agency. Organ, Tissue and Eye Donation – page 6 T18.02 4. If the decedent has expressed desire to consent to donation and the Individual Legally Authorized to Consent to Organ Donation is opposed to donation the Administrator on call will be notified immediately to assist as a facilitator in this event. a. LifeBanc staff will obtain information via phone and report to Pomerene Hospital. i. LifeBanc personnel will review the chart and discuss with the attending physician, or designee, the appropriateness for DCD protocol. ii. The physician or designee will inform the family that the patient’s condition is terminal and after the family has made an informed decision to terminate life support. LifeBanc staff will approach the family in regards to the opportunity for organ/tissue donation. iii. Aside from discussion of cost, incision, funeral, reconstruction, communication, etc. LifeBanc staff will also discuss: 1) Option for tissue/eye donation 2) Thorough medical/social history 3) Cannulation process 4) Options for family members to spend time with the donor prior to termination of life support and following recovery 5) Transportation of donor to the OR 6) Recovery of organs 7) Interest in family outcome letters iv. Once the decision to terminate life support has been given, care will be provided by the attending physician until pronouncement of death. v. A consent form will be placed in the patient’s medical record, giving permission for the discontinuation of life support, placement of the donor lines, administration of medications, and for each procedure/removal intended to be done by the LifeBanc team. vi. The LifeBanc staff will coordinate a time with the Director of Surgical Services, or designee for referral. vii. Any required laboratory testing will be ordered by the physician or designee in accordance with the United Network for Organ Sharing and coroners requirements. viii. The donor will be disconnected to life support by the attending physician, or designee, via hospital protocol. Withdrawal of life support will take place in Special Care. Organ, Tissue and Eye Donation – page 7 T18.02 ix. Monitoring will be continued until asystole. x. If after a three hour period, there is no 5-minute interval of asystole, the patient will not be considered a candidate, and will remain in the SCU under the care of the attending physician. 1) The patient’s family will be notified that the patient has not expired. 2) Care will be continued to be provided by the attending physician. 3) Medical tests and procedures requested by LifeBanc will be reimbursed by the same. 4) The process is stopped. 5) When a 5-minute interval of asystole is achieved, the attending physician will pronounce the donor dead. Documentation of time and date of death will be recorded in the progress notes of the patient’s chart. A cardiac strip will be printed at the start of asystole and at the end of the 5-minutes. The strips will be placed in the patient’s chart showing the period of asystole. 1. After death is announced and documented, LifeBanc recovery team will be notified. 2. The donor will be taken to the Operating Room where organ/tissue retrieval will begin in accordance with the informed consent. 3. An employee of Pomerene Hospital’s Surgical Team will remain in the OR and in attendance at all times during the procedure. A list of supplies used will be documented by the hospital staff and given to the Clinical Supervisor / Manager on-call. The Operating Room staff will not be a part of the retrieval team. Supply costs will be reimbursed by LifeBanc. 4. Following retrieval, the donor family will be given ample opportunity to spend time with the donor. The body will be released to the Funeral Director designated by the family per hospital protocol. 5. Occasionally, it may be necessary for LifeBanc to perform the retrieval at another location. The Clinical Supervisor / Manager oncall will work with LifeBanc and the family with these arrangements. 6. If the individual Legally Authorized to Consent to Organ Donation denies consent (in the case that the decedent has not already expressed consent via BMV or Living Will) the process is terminated. C. NON-DCD DONOR Organ, Tissue and Eye Donation – page 8 T18.02 1. A Protocol for Non-DCD donors will be patients that are being hemodynamically maintained by mechanical ventilation and death by neurological criteria is imminent or the patient is pronounced dead by neurological criteria, the LifeBanc Coordinator will discuss the case with the Clinical Supervisor / Manager on-call and determine suitability or the need for onsite evaluation. 2. If an onsite evaluation is completed, the LifeBanc representative will notify the Clinical Supervisor / Manager on-call of the potential for donation. A plan offering the option of donation with the Individual Legally authorized to Consent to Organ Donation will be discussed with the medical team members. 3. LifeBanc checks the donor registry to verify donor status and will inform the Individual Legally Authorized to Consent to Organ Donation of the decedent’s wish to be a donor as indicated by the Bureau of Motor Vehicles. Alternatively, a decedent’s wish to be a donor may be expressed in a State of Ohio Living Will Declaration. Or a LifeBanc designated requestor, in conjunction with a member of the medical team, will discuss donation with the Individual Legally Authorized to Consent to Organ Donation if medical criteria are met as determined by the procurement agency. 4. If the decedent has expressed desire to consent to donation and the Individual Legally Authorized to Consent to Organ Donation is opposed to donation the Administrator on call will be notified immediately to assist as a facilitator in this event. 5. A consent form will be completed by LifeBanc and a copy placed in the decedent’s medical record for documentation of consent. 6. Final determination of recovery of organs, tissues, and/or eyes will be made only after the following: a. LifeBanc staff has obtained a hospital course of summary from the hospital staff as needed. b. LifeBanc has obtained a complete medical and social history from the Individual Legally Authorized to Consent to Organ Donation. c. A thorough medical evaluation has been conducted. 7. If the Individual Legally Authorized to Consent to Organ Donation denies consent (in the case that the decedent has not already expressed consent via BMV or Living Will) the process is terminated. D. TISSUE DONOR 1. If the decedent is deemed a suitable donor, the One Call for Life Coordinator will obtain the phone number where the Individual Legally Authorized to Consent to Organ Donation can be reached at a later time (generally 1-2 hours after leaving the hospital). 2. A consent form will be completed by LifeBanc / Cleveland Eye Bank via the telephone and will be faxed to the hospital; a copy is to be placed in the decedent’s medical record Organ, Tissue and Eye Donation – page 9 T18.02 for documentation of consent – or – the consent will be brought with the procurement team upon arrival for the recovery. 3. Final determination of tissues and/or eyes will be made only after the following have occurred. a. LifeBanc or Cleveland Eye Bank has obtained a hospital course summary. b. A thorough evaluation has been conducted. c. A complete medical and social history has been obtained from the Individual Legally Authorized to Consent to Donation. d. Consent to Organ Donation has been obtained. 4. If the Individual Legally Authorized to Consent to Organ Donation denies consent (in the case that the decedent has not already expressed consent via BMV or Living Will) the process is terminated. II. REFERENCES A. OneCall for Life Routine Notification Administrative Policy. B. Health Care Financing Administration’s Hospital Conditions of Participation (42 CRF, part 482, Chapter IV. C. CIHQ. D. The State of Ohio Revised Code Chapter 2108. E. Ohio Senate Bill 188 and 158. F. LifeBanc. Patient Number: Patient Name: Date of Service: CDM 600022 Tissue Donation Tissue only Units Organ, Tissue and Eye Donation – page 10 CDM 601231 601232 601233 CDM 601234 601235 601236 601237 601238 601239 Use the below for Organ Donation ONLY Description Organ Donation Characteristics Unproductive Donor DCD Donor Non-DCD Donor Per Organ additional Charges to above Heart Pancreas Intestine Lungs (1 or 2) Kidneys (1 or 2) Liver T18.02 Units Units