Organ Recovery Services

Transcription

1 Title: Donation After Circulatory Death Associated Departments: Medical Director, VP Operations, Hospital Development Release Date: Approver: Alison Smith Revision History Revision Date Revision Description of Change Author 2 Added/changed language to include ASTS Recommended Practice Guidelines Evelyn Schultz and UNOS DCD Model Elements. 03/15/ Document Created Evelyn Schultz Definitions and Acronyms ABG AOC BP CCME CPA DBD DCD DNR DRC GOH Hg HR ICU IV Kg mm O2 Sat OPO OR ORC PCC PEA u/l UNOS WIT Arterial Blood Gas Administrator On-Call Blood pressure Cook County Medical Examiner Cardio-pulmonary Arrest Donation after brain death Donation After Circulatory Death Do Not Resuscitate Donor Resource Center Gift of Hope Chemical symbol for Mercury Heart Rate Intensive Care Unit Intravenous kilogram Millimeter Oxygen saturation Organ Procurement Organization Operating Room Organ Recovery Coordinator Patient Care Conference Pulseless Electrical Activity Medical symbol for units per liter United Network for Organ Sharing Warm Ischemia Time Required Documents and Tools - Criteria: The items listed in this section are required to be used or followed in executing this procedure. Each item either captures or provides essential information to ensure the quality and consistency of the work being done. Documents of external origin must include the revision status in the Title field. Title Control Location ORS008F Potential DCD Donor Information Internal MREC042F Consent for Donation After Circulatory Death Internal MREC008F Post Extubation Data Flowsheet Internal References and Optional Tools - Criteria: The items listed in this section are not required but may be used or followed in executing this procedure. Each item assists or provides relevant information with regard to the work being done. Documents of external origin must include the revision status in the Title field. Title Control Location Company Private Information Uncontrolled if Printed Page 1 of 6

2 Non-Heart-Beating Organ Transplantation Practice and Protocols: Committee on Non-Heart-Beating Transplantation II: The Scientific and Ethical Basis for Practice and Protocols. Institute of Medicine, Organ Donation-Opportunities for Action: Expanding the Population of Potential Donors Chapter 5, page Institute of Medicine, 2006 Donation after Cardiac Death: A Reference Guide. United Network for Organ Sharing:2003 Attachment III to Appendix B of the Organ Procurement and Transplant Network (OPTN) Bylaws; Model Elements for Controlled DCD Recovery Protocols; July, 2007 Organ Donation and Transplantation After Cardiac Death. Edited by David Talbot and Anthony M. D Allessandro Publisher: Oxford University, Press, 2009 Gift of Hope Medical Director Scope / Purpose It is the policy of Gift of Hope to recover organs from suitable candidates who do not meet brain death criteria, but who experience circulatory death upon the termination of medical treatment/support. Responsibilities Patient, family, or legal guardian in consultation with the primary care physician makes the decision to stop treatment and withdraw medical treatment/support. GOH Medical Director or designee/aoc Determines the suitability of a potential donor for DCD. AOC - Supervises all phases of the donation process. GOH staff - Coordinates all functions related to donation including, but not limited to the following: medical and social screening obtains authorization from the legal next-of-kin allocates available organs collaborates with patient s physician regarding medical management obtains authorization for release of organs/tissues from CCME or county coroner as applicable supports the donor family throughout the process provides all relevant information and timely updates to the respective recovery teams. Patient s physician or his/her designee - Responsible for the following: medical management of the patient withdrawal of life sustaining medical treatment/support ordering/administering comfort care measures determination of death Administer anti-coagulant at the time of extubation Transplant Centers Responsible for the following: reviewing donor data posted in Donor Net making timely decisions on organ offers arriving at donor hospitals on time participating in the PCC prior to extubation complying with OPO and hospital policies regarding their exclusion from donor management, patient extubation, and determination of death Required Skills Knowledge of DCD donation process and job responsibilities Knowledge of documentation requirements and working documents used on DCD cases Knowledge of DCD protocol and all associated organ donation policies and procedures Flowchart Company Private Information Uncontrolled if Printed Page 2 of 6

3 N/A Instructions 1.0 CRITERIA: Patients who meet the following criteria are eligible to be evaluated as potential DCD donors as determined by the GOH Medical Director, his designee and/or the AOC: kg (minimal consideration); generally, 2 years of age to 60 years of age; Children 2 years of age will be evaluated by the Medical Director or his/her designee on a case by case basis 1.2 The patient is dependent on ventilator or other mechanical support for survival (typical diagnoses: irreversible brain injuries, high spinal cord injuries). 1.3 The patient s identity is known 1.4 The patient, legal next-of-kin, or legal guardian, in consultation with the primary care physician, decide to withdraw life sustaining medical treatment/support from the patient in accordance with the hospital s established protocol. 2. Screening: 3. Authorization: 2.1 The DRC will process the initial referral call and preliminary medical screening with the AOC. 2.2 Upon completion of the initial evaluation, the ORC will confer with the Medical Director/AOC. 2.3 The ORC will consult with the patient s physician to determine the likelihood of CPA within GOH s required timeframe of 90 minutes or as otherwise required by the donor hospital s policy. 2.4 The order to withdraw life sustaining medical treatment/support will be documented in the patient s hospital chart by the patient s primary care physician or his/her designee. 3.1 The decision to stop treatment should be made prior to any discussion with next of kin about donation.the decision to withdraw life sustaining medical treatment/support will be made by the patient, family, or legal guardian in consultation with primary care physician. GOH will not be involved in making the decision to withdraw life-sustaining medical treatment/support. 3.2 In collaboration with the patient s health care providers, the designated GOH staff member will review the family s understanding of the patient s status, confirm the decision to withhold treatment and/or withdraw life sustaining medical treatment/support and discuss potential options for donation (DCD and potential for DBD). If BD appears imminent, the family will be given the opportunity to wait rather than pursue DCD. 3.3 In cases where progression to BD might occur, authorization should also be obtained for DBD in case progression may occur. 3.4 The GOH staff will further discuss with the family any special issues (ie: funeral requirements). 3.5 The family discussion will include obtaining authorization for DCD, modification of their DNR decision so that care is not decelerated, explanation of the donation process, options for determining when and where extubation will occur, recovery procedure, and the need to administer any medications prior to death, such as an anti-coagulant and/or vasodilator. 3.6 Invasive procedures for the purpose of DCD (such as arterial line insertion, femoral cannulation, bronchoscopy, etc.) requires authorization from the legal next-of-kin and order from the primary care physician or designee. 3.7 GOH staff will contact the CCME/Coroner to obtain release for donation and inform the family of the need for their approval before the donation can proceed. 3.8 The GOH staff will also discuss with the family and hospital staff steps to be taken, such as returning the patient to a designated bed/unit for continuation of comfort care measures as well as notifying the family if they are not present, if the patient does not expire within the allotted timeframe. 4. Transplant Center Communications: Company Private Information Uncontrolled if Printed Page 3 of 6

4 5. On-site Communications: 6. Management: 4.1 All organ offers will be made in accordance with all current UNOS and GOH policies. 4.2 Intended time and location of patient extubation, and other pertinent information reflected in donor hospital policies regarding DCD (allowable time for death after extubation, administration of an anticoagulant and/or vasodilator) will be communicated to the transplant center at the time of the offer. This information will also be documented in Donor Net, prior to any organ offers. 5.1 It is intended that the conduct of a DCD case will be based on the following sequences of communications: After the family expresses interest in pursuing DCD options, discussion with the ICU staff and the patient s physician will occur to discuss ventilator and hemodynamic support needed for optimizing organ perfusion until withdrawal of life sustaining medical treatment/support occurs After release by the CCME/Coroner (if applicable) is obtained in order to set an approximate operating room time that coincides with the family s wishes and organ recovery logistics Prior to the withdrawal of life sustaining medical treatment/support, the OPO and hospital healthcare team will verify patient s identification. The patient care team, organ recovery team(s), and GOH staff will meet to discuss roles and responsibilities. At this time, the declaring physician will be informed/reminded that a minimum of a two minute observation period following PEA/asystole is needed before death is declared, unless hospital policy requires a longer observation period Upon arrival of Recovery Team (s), GOH coordinator will arrange for a short communication between the Recovery surgeons and the O.R Team to ensure preparedness and smooth process. 6.1 To facilitate vital organ recovery, the patient must be maintained on a ventilator, have a functional arterial line and be supported hemodynamically for organ perfusion until the withdrawal of life sustaining medical treatment/support occurs. 6.2 Medical management will remain the responsibility of the patient s physician or designee. The ORC will collaborate with the patient s physician and discuss treatment options to maintain hemodynamic stability and ordering laboratory tests for determining organ suitability. 6.3 In an effort to minimize cold ischemic time, organs will be allocated pre-recovery if possible. 6.4 GOH will work collaboratively with ICU staff, OR staff, and transplant teams to set an approximate operating room time that takes into account organ placement requirements with the family s wishes. 6.5 The ORC will work with primary physician to determine who will pronounce patient death. The physician who is involved in the withdrawal of life sustaining medical treatment/support and pronouncement of death cannot be directly associated with the organ recovery staff or transplant teams. 7. Withdrawal of Life Sustaining Medical Treatment/Support: 7.1 To maximize outcomes of organ viability for transplantation, the withdrawal of life sustaining medical treatment/support will ideally take place in the operating room or adjacent peri-operative area. 7.2 The patient care team, recovery team, and GOH staff will meet to discuss roles and responsibilities prior to the withdrawl of life sustaining medical treatment/support. ( see 5.1.1) 7.3 When hospital policy allows, accommodations will be made for the family to be present from the time of withdrawal of life sustaining medical treatment/support until death occurs. 7.4 The patient will not be prepped and draped prior to pronouncement of death if extubation is taking place outside the O.R. suite. 7.5 Heparin, 300u/kg, will be given by IV bolus at the time of extubation and Heparin 2000u/L will be added to the first bag of organ preservation solution for the in-situ flush. Company Private Information Uncontrolled if Printed Page 4 of 6

5 8. Determination of Death: 9. Documentation 10. Financial Considerations: 7.6 At hospitals not allowing Heparin administration prior to declaration of death, GOH will notify the AOC so further discussion can take place with the Gift of Hope Medical Director to determine whether the case will be able to proceed. 7.7 Life sustaining medical treatment/support (extubation and the withdrawal of all devices/vasopressors) will be withdrawn by the patient s physician or his/her designee. Comfort measures can be provided by the hospital staff based on hospital protocol for the removal of life sustaining medical treatment/support. 7.8 If extubation will occur in the surgical suite, the transplant center s surgical recovery team(s ) may be present to prepare and drape, but shall not be present in the surgical suite prior to the withdrawal of life sustaining medical treatment/support and shall remain outside of the room until death has been declared. The designated hospital/goh staff shall provide the team(s) with periodic updates on the status of the donor. The surgical recovery team shall enter the surgical suite only after receiving notification that the primary physician (or his/her designee) has declared the patient dead. 7.9 If withdrawal of life sustaining medical treatment/support occurs in a room outside of the surgical suite, the transplant center recovery team must remain in the surgical suite until the donor is declared dead and brought into the surgical suite. The GOH staff shall provide the surgical recovery and hospital OR teams with periodic updates on the status of the donor, starting with extubation Neither members of the transplant center surgical recovery team nor GOH staff will provide recommendations or guidance related to the comfort care orders or administration thereof. All comfort care measures are ordered by the primary physician or his/her designee, and are administered by members of the patient s primary care team Depending on the donor hospital s policy, from the time of extubation until declaration of death, either designated hospital staff or GOH staff will be present in proximity to the patient to track vital signs on the Post Extubation Flowsheet and to support the family The patient s hemodynamic monitoring and pulse oximetry will be monitored and maintained prior to and after extubation. 8.1 Death will be pronounced by the primary physician or his/her designee. The physician certifying death may not be involved as part of a transplant team, procurement team, nor GOH. 8.2 The pronouncement of death will occur after a minimum of two minutes of asystole/pea, or as dictated per hospital policy. This will ordinarily be triggered by PEA as measured by electrical activity on monitor and arterial pressure monitoring (BP=Zero). The declaring physician will record the date and time of death in the medical record and complete any other necessary paperwork per hospital policy. 8.3 The procurement surgery may proceed at the end of the two minute interval required for declaration of death. Surgical incision is followed by rapid aortic cannulation with in-situ cooling of organs. 8.4 If the patient does not arrest within the designated timeframe, the patient will be returned to a predesignated area where comfort care measures will be maintained by the patient care team and. Patient s family will be notified immediately. 9.1 The Post Extubation Donor Data Form will be utilized to record the following data: Date and Time of Extubation BP, HR, O2 Sat, heart rhythm, MAP Date and Time of declaration of death Calculated WIT Medications given prior to asystole In-situ flush with organ preservation solution Urine output from vent DC to CPA Place of pronouncement Method of cannulation Incision date/time Recovery Surgeon(s) Company Private Information Uncontrolled if Printed Page 5 of 6

6 10.1 All donation-related costs will be the responsibility of Gift of Hope Key Metrics Organ Recovery Department metrics for organs/donor consent, etc. Records Record Retention Record Record Holder Title Requirement Location Organ Donor Chart Medical Records Dept Minimum of 10 years Medical Records Dept Standards Standard Section AOPO Standards CL 1.0 CL DO AS 7.1 Company Private Information Uncontrolled if Printed Page 6 of 6