First Person Consent Uniform Anatomical Gift Act of 1968

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Andrew Wilson, Medicolegal Death Investigator Not-for-profit Organ Procurement Organization (OPO) & Tissue Recovery Agency Regulated by Centers for Medicaid and Medicare Services (CMS) and FDA Offices in North Liberty, Altoona, & Sioux City Communication Center operates 24/7/365 2 dedicated tissue recovery suite locations with off-site recovery capabilities Partner with Iowa Lions Eye Bank First Person Consent Uniform Anatomical Gift Act of 1968 Chapter 1064. Sec. 4. Section 142C.3, subsection 8, Code 2001 Legalized the transplantation of human organs and tissues. Since 1972, all 50 states and the District of Columbia have adopted this act. Centers for Medicare & Medicaid Services (CMS) Requires CMS funded hospitals to refer ALL cardiac and imminent deaths to OPO Mandates that only trained personnel discuss opportunity of donation with potential donor families HIPAA Allows healthcare professionals to disclose protected patient information to OPOs Every 10 minutes, there is another name added to the national organ transplant waiting list Every day, 22 people die while waiting for a life saving transplant

As of February 1 st, 2016: ONE donor can save the lives of up to 8 people and enhance the lives of more than 300 people. 121,545 604 This number does not include those waiting for tissue transplants. Donation starts with ONE. 1. Timely Organ Donation Consult 2. Preserve Opportunity with CBIGs 3. Grave Prognosis & Timely Brain Death Testing 4. Planned donation conversation with family Provide aggressive and thorough treatment when there is hope for recovery Perform or consult for neuro assessment Preserve the Opportunity with CBIGs Huddle with IDN coordinator Declare brain death (circulatory death in DCD) Prepare family to speak with IDN Ensure consult with IDN made Keep IDN updated of changes in patient status Collaborate with physicians on implementing CBIGs Huddle with IDN coordinator Support family through grave prognosis Prepare family to speak with IDN Assist IDN coordinator with donor management Consult IDN if patient is on ventilator & meets one of the following criteria: 1. Has lost 2 or more brain stem reflexes 2. Has a GCS of 5 or less 3. Family asks about donation 4. Withdrawal of care conversation initiated by family or healthcare team

Pupils Corneals Cough Gag Motor response Oculocephalic (Doll s eyes) Oculovestibular (Ice Water Calorics) Spontaneous respirations Notify IDN that patient is on ventilator. Provide: Hospital Name/Unit/Phone number Your Name Patient s name and DOB Cause of Admission IDN Coordinator returns call. Provide: Medical history Brain stem reflexes Vital Signs/Labs Use of pressors/sedation Plan of Care Based on information, IDN may: 1. Come onsite for further assessment 2. IDN may follow by phone 3. IDN may notify you to call back with time of death Communicate to IDN: Changes in patient status Loss of additional brain stem reflexes or brain death testing planned Family making end-of-life decisions Patient cardiac arrests on ventilator Follow hospital policy for notification to medical examiner of patient death IDN obtains permission for organ donation for all donors regardless of cause of death

Cushing s Triad Hypertension followed by hypotension Bradycardia Respiratory irregularity Loss of all brain stem reflexes Many patients become unstable as brain stem herniates. Preserve opportunity for donation with Catastrophic Brain Injury Guidelines (CBIGSs) Catastrophic Brain Injury Guidelines 1. Maintain SBP > 100 2. Treat Diabetes Insipidus 3. Maintain PaO2 > 100 and ph 7.35-7.45 4. Maintain core temperature of 36 37.5 C 5. Monitor and treat electrolytes 6. Monitor and treat low Hgb & Hct Phase 1 Communicate seriousness of injury has suffered severe damage to his/her brain. We are doing everything we can to help him/her recover. Phase 2 Communicate grave prognosis Despite everything that we have done, is getting worse. He/she may not recover. Phase 3 Phase 4 Communicate Brain Death Testing As you know, has suffered a devastating brain injury. It appears that his/her brain has stopped working and cannot possibly recover. We will begin testing to be certain about this. Brain Death Discussion The testing is complete. has lost all brain function. This is permanent. This means that he/she is medically and legally dead. When all treatment options have been exhausted and despite best efforts the patient dies, the option of donation can provide a positive outcome to a tragic situation. Hope for Recovery can become Hope through Donation Aggressive Treatment Deteriorating condition Preparing family for negative outcome Grave prognosis Declaration of death & Support of family Life saving transplants Support of donation management Donation discussion Preserving the option

Death by Neurological Criteria (Brain death): Irreversible cessation of spontaneous brain functions. [2-3% of deaths] Death by Circulatory Criteria (DCD): Irreversible cessation of spontaneous respiratory and circulatory function. 1. Prerequisites 2. Clinical Examination 3. Apnea test 4. Ancillary test only if indicated Coma, irreversible, and cause known Neuroimaging explains coma No CNS depressant drug effect No evidence of residual paralytics or severe acid-base, electrolyte, endocrine abnormality Normothermia (> 36 C) Systolic Blood Pressure > 100 mmhg No spontaneous respirations Examination performed by 2 physicians (per Iowa Law) Pupils nonreactive to bright light Corneal reflex absent Oculocephalic reflex absent Oculovestibular reflex absent No facial movement to noxious stimuli at supraorbital nerve, temporomandibular joint Gag reflex absent Cough reflex absent to tracheal suctioning Absence of motor response to noxious stimuli in all 4 limbs Pupil Test Corneal Test

Oculocephalic Reflex Oculovestibular Reflex Gag Reflex Pain Response Hemodynamically stable Ventilator adjusted for PaCO 2 34-45 mmhg Preoxygenate with 100% FiO 2 for 10 min Baseline ABG PEEP of 5 cm of water Oxygenate via suction catheter 6 L/min or T piece Disconnect ventilator Observe for respirations ABG at 8 10 min Reconnect ventilator Positive Apnea Test 20 mmhg rise of CO 2 above baseline or increase CO 2 to 60 mmhg and no spontaneous respirations When to abort test: - Patient instability - Respirations observed

Completed if clinical exam inconclusive or apnea test not completed in its entirety Cerebral angiogram EEG Transcranial doppler 1 st exam performed at least 24 hours following CPR or brain injury Term newborns 37 weeks gestational age up to 30 days - 24 hour time interval between the 2 examinations 31 day to 18 year olds - 12 hour time interval between the 2 examinations Non-recoverable, irreversible neurological injury (or other end-stage disease process) resulting in ventilator dependency Family makes determination to withdraw lifesustaining measures Medically suitable (determined by IDN) Patient likely to expire within 60 minutes of extubation Attending physician continues to medically manage patient RN accompanies patient to the OR and stays during withdrawal of care process Withdraw of care occurs in the OR Recovery of organs occur only after patient pronounced dead by primary care team Donation Huddles 1. Determine next steps in plan of care 2. Determine registry status, legal NOK, family dynamics, & needs of family 3. Identify right time, right place, and right person to introduce donation to the family Goal is to ensure healthcare team & IDN work together to develop plan to discuss donation with family Iowa Donor Network serves as the hospital s designated requestor. CMS regulations require that a designated requestor approaches families with the opportunity for donation. IDN speaks directly to the family Family made aware of First Person Consent Family is aware of donation opportunity Family is provided information about the process Family makes the best donation decision for them after speaking to IDN

This is. He/She is part of our end-of-life care team. Conversation with family: 1. Introduced as member of health-care team 2. Expression of condolences & conversation about loved one 3. Meaningful transition from conversation about loved one and loss to the donation conversation 4. References to recipients & putting a face on those waiting 5. Use value-positive language 6. Utilize empowering offer of donation IDN assumes financial and medical responsibility for the patient once patient is declared & authorization for donation is obtained Full code Central venous access & arterial line placement ABO testing, serology testing, clinical labs Hourly vitals monitoring & I/O documentation Chest xray, bronchoscopy, EKG, Echocardiogram, Cath Antibiotic coverage NG/OG Height & Weight Brain Death Physiology: Brain Injury Loss of thyroid hormones (T3 & T 4) Catecholamine surge followed by depletion of catecholamines Decline in serum cortisol, antidiurectic hormone & insulin UNSTABLE High Doses PATIENT!! of Vasopressors Hormone Replacement Therapy: Helps to reduce vasopressors required to maintain hemodynamic stability May reverse metabolic & hemodynamic instability Stimulates aerobic metabolism Increases number of organs suitable for transplant Pre-medicate in rapid succession as follows: 1 amp 50% Dextrose IV push over 1-2 minutes 2 grams Solumedrol IV push over 4 minutes 20 units of regular insulin IV push 20 mcg T4 IV push Start Infusion: Start continuous infusion at 25 ml/hr or 10 mcg/hr See IDN coordinator for T4 titration orders

Allows continuous monitoring of hemodyamics (BP, CO, SV, SVV) by connecting to an arterial line Helps determine appropriate treatment Fluids versus pressors Protocol that involves adjusting the ventilator, managing fluids, and other activities to increase lung viability Criteria: P/F ratio < 400 Early bronchoscopy (no lavage) Pressure Control (total PIP of 40) PC 25 Peep 15 Adjust rate to keep PCO 2 normal After 2 hours: Volume Control VT 6-7 ml/kg (ideal body weight) Peep 5 Adjust rate to keep PCO 2 normal Chest Xray 30 min later; Calculate P/F ratio Organ recovery takes place at donor hospital Local and possibly out of state surgeons Normally 24-48 hours from consent to recovery What Happens in the OR In the final moment s of Jason s life, we were praying for a miracle. We didn t get the miracle we were hoping for, but we got another one that will bring so much joy to others. He will be helping save, enhance and benefit so many lives. That s the ultimate miracle. By his selfless decision, he can now live on in others, continuing to do the work he was created for. Anesthesia is present to manage and ventilate Recovering surgeon dissects to isolate each organ Cannula is placed in abdominal aorta & portal vein Aorta is clamped and preservation solution infused

Cross-Clamp Portal Vein Aortic Root Heart Liver Kidneys Lungs Pancreas Small Intestine Aorta distal to renal arteries Eye Heart Valve Bone Skin Adipose Tissue Fresh skin allograft Denovo cartlige Allostem bone graft Saphenous Veins & Femoral Veins Connective Tissue Structural bone grafts Humacyte vascular graft Spinal cervical grafts Initial Mailing at Time of Donation: Donor Medallion Program Donate Life lapel pins Donate Life bracelets Additional Correspondence: Donor/Recipient correspondence Notice of donor family events Hand-embossing Quilts After donation phone call 1 week letter 1 month phone call 6 month letter 1 year anniversary card 2 year Tissue Disposition

1. Refer all patients meeting clinical triggers within 2-4 hours to Iowa Donor Network 2. Collaborate with attending physician and IDN to preserve donation opportunities with CBIGs 3. Introduce family to end-of-life decisions with discretion and sensitivity, allowing IDN to discuss donation opportunities with family 4. Sign-up on the donor registry to make your wishes known and tell your family are the link between a potential donor, who can offer hope, and the recipients, who are waiting for a lifechanging gift. Andrew Wilson Medicolegal Death Investigator awilson@iadn.org Main Office: 550 Madison Ave North Liberty, IA Regional Office: 320 Adventureland Dr NW Altoona, IA 50009