Donor

Protocol

Manual

Updated

November 2010

Gift of Life Michigan

1

Organ, Tissue & Eye Donation: 1-800-482-4881

Customer Service Line: 1-866-500-5801, ext. 411

TABLE OF CONTENTS

Mission Statement 1

Goals and Objectives 2

DONOR CRITERIA

Organ Donation 3.1

Tissue Donation 3.2

Eye Donation 3.3

MANAGEMENT OF A POTENTIAL DONOR

Catastrophic Brain Injury Guidelines 4.1

Guidelines for Adult Potential Donor 4.2

Guidelines for Pediatric Potential Donor 4.3

OBTAINING CONSENT

Consent for Donation According to Best Practices 5.1

First Person Consent 5.2

Michigan’s Uniform Anatomical Gift Law 5.3

Michigan’s Medical Examiner Law 5.4

SURGICAL RECOVERY

OR Pack and Surgical Center 6.0

Instrument Requirements for Organ Recovery 6.1

Anesthesia Requirements for Organ Recovery 6.2

Instrument Requirements for Tissue Recovery 6.3

RESOURCES

Gift of Life Michigan Resources 7.1

Websites 7.2

WHOLE BODY DONATION

Whole Body Donation Resources 8.1

HOSPITAL POLICIES (Insert)

Updated

November 2010

Gift of Life Michigan

MISSION STATEMENT

To improve and extend the lives of the citizens of the state of Michigan byincreasing public and professional participation
in organ and tissue donation for transplantation.

1

Gift of Life Michigan

GOALS AND OBJECTIVES

Gift of Life Michigan is dedicated to improving the quality of life for all people in the state of Michigan awaiting an organ/tissue transplant.Gift of Life Michigan’s goal is to maximize the potential donor pool in the state to provide transplantable organs and tissues to all waiting recipients.

To achieve this goal, Gift of Life Michigan has established the following objectives:

  1. Facilitate organ/tissue transplantation by coordinating the retrieval, preservation, transportation and distribution of organs and tissues.
  2. Coordinate efforts by all healthcare facilities and healthcare personnel to provide maximum efficiency and optimal benefit to recipients of organ and tissue transplants.
  3. Disseminate information regarding all aspects of organ/tissue transplantation and associated diagnostic and therapeutic modalities to medical, paramedical and lay groups.
  4. Develop programs, public and professional, that promote organ and tissue donation and transplantation.

2

Gift of Life Michigan

DONOR CRITERIA

Organ Donation

Organs that can be donated:

  • Kidneys
  • Liver
  • Heart
  • Lungs
  • Pancreas
  • Intestine

Gift of Life should be contacted within one hour for every patient who meets the first three clinical triggers or either of the final two triggers:

Gift of Life MichiganStandard Clinical Triggers

  • Intact circulation on a ventilator
  • Glasgow Coma Scale 5
  • Severe neurological injury (e.g., GSW, CVA, MVA, Anoxia, etc.)
  • Deceleration of Care
  • Withdrawal of Support

Important note: Age, medical condition or Medical Examiner involvement do not preclude organ donation. You are always required to call if the above triggers are met.

These triggers are based on the CMS Conditions of Participation (Federal Register 482.75) for imminent deaths and are mutually agreed upon by each hospital. Please refer to your hospital’s policy on organ donation for your specific triggers.

Types of Organ Donation

  1. Brain Death—This type of organ donation occurs after a patient is declared legally brain dead per hospital policy. Please refer to your hospital’s policy on declaration of brain death.
  2. Donation after Cardiac Death (DCD)—This type of organ donation occurs after a patient reaches cardiac death. Please refer to your hospital’s policy on donation after cardiac death (DCD).

3.1

Tissue Donation

Tissues that can be donated include:

  • Whole Eyes/Cornea
  • Heart for Valves
  • Veins
  • Bone
  • Skin

Gift of Life Michigan should be contacted at 1-800-482-4881 within an hour of every patient death to assess for tissue donation eligibility.There are no absolute rule-outs for tissue or eye donation; Gift of Life will make that determination. Calling within one hour is a CMS Condition of Participation requirement (Federal Register 482.75).

If your hospital participates in the Life program, in which Gift of Life Michigan approaches families for tissue donation:

  1. Obtain two phone numbers where the family can be reached over the next few hours as part of ‘normal hospital routine,’ in case the hospital needs to contact them for any reason.
  2. Obtain a name and location of the funeral home, if known.

3.2

Eye Donation

Upon death, the hospital plays a vital role in the successful retrieval of viable eye tissue for transplantation. Gift of Life Michigan will instruct your hospital on how this process will occur when it is notified of the death.

The most important thing hospital staff can do is maintain the integrity of eye tissue through meticulous eye care. Follow your hospital’s eye care protocol for comatose or ventilator patients, maintaining corneal lubrication and keeping eye area clean. If possible, do not use oil-based ointments; instead, use water soluble ophthalmic ointments or drops.

The Michigan Eye-Bank clinical staff will notify your hospital of the approximate time when the eye tissue will be recovered. They may also need to review the donor’s medical record upon arriving at the hospital before carrying out the procedure.

The Michigan Eye-Bank staff will act as quickly as possible to recover the eye tissue from the donor to prevent any delays in funeral arrangements. Eye donation does not preclude any funeral arrangements, including having an open casket. Eye tissue recovery does not require an operating room.

Eye Donor Preparation

  • Elevate head and shoulders, if possible
  • Place sterile saline in each eye
  • Close lids and lightly tape shut with paper tape
  • Place ice packs over both lids, while protecting the skin (e.g., rubber gloves filled with ice over a wash cloth)
  • Refrigerate the body as soon as possible

3.3

Gift of Life Michigan

MANAGEMENT OF A POTENTIAL DONOR

Catastrophic Brain Injury Guidelines

These are general guidelines for caring for a neurologically devastated patient and are presented here as a reference for hospital staff.Consider obtaining a critical care consult, if one isnot already involved in the patient’s care. These guidelines will help sustain organ function while giving the family time to consider the opportunity for organ donation. This is important, because you are not just treating this patient; you are treating up to 8 potential recipients of these organs.

Maintain SBP > 100 (MAP > 60)

  1. Consider invasive hemodynamic monitoring.
  2. Ensure adequate hydration to maintain euvolemia.
  3. Vasopressor support:If hypotensive after adequate rehydration,use Dopamine as the first pressor of choice up to 20 mcg/kg/min, followed by Levophed if needed.

Maintain Urine Output > 0.5ml/kg/hr < 400ml/hr (consider DI if > 4cc/kg/hr x 2 hrs)

  1. Treat Diabetes Insipidus with Vasopressin drip 1-2.5u/hr, if UO still > 400ml/hr, give DDAVP 0.5 mcg IVP every 2-3 hours or replace UO cc for cc.
  2. If UO falls below 0.5ml/kg/hr, assess fluid status – patient may need rehydration or BP support.

Maintain PO2 > 100 & pH 7.35-7.45

  1. Adequate ventilation: 5.0-8.0 PEEP. Use aggressive respiratory hygiene if not contraindicated by patient’s condition (suction and turn every 2 hours). Utilize respiratory treatments to prevent bronchospasm.

Other orders to consider

  1. Monitor and treat electrolytes maintaining the following:

Sodium: 134 – 145 mmol/L

Potassium: 3.5 – 5.0 mmol/L

Magnesium: 1.8 – 2.4 meq/L

Phosphorus: 2.0 – 4.5 mg/dL

Ionized Calcium: 1.12 – 1.3 mmol/L

4.1

  1. Monitor glucose and treat with insulin drip if needed (keep 80-200) rather than SQ.
  1. Monitor and treat Hgb/Hct/coagulation factors (especially if GSW or other penetrating head injury).
  2. Maintain Hgb > 8.0 g/dL and Hct > 30%
  3. If PT > 18.0 give 2u FFP
  4. If Fibrinogen 70-100 give 2u FFP, if < 70 give cryoprecipitate
  5. If platelets < 50 give 6pk of platelets

Note: Remember to recheck labs after treatment

  1. Maintain temperature at 36-37.5 Celsius with Bair Hugger/warming-cooling blanket

4.1

Physician Guidelines for Potential Adult Organ Donor Management

These are management guidelines for a patient when brain death is pending and to sustain organ function while giving the family time to consider the opportunity for organ donation. Remember, you will be treating up to 8 potential recipients of these organs.Organ donation should not be mentioned to the family until the Physician has discussed the patient’s diagnosis and grave prognosis with them. The Gift of Life staff will be available for any discussions with the family regarding organ donation.

HYPOTENSION (sustained systolic BP less than 100 mmHg)

  • Maintenance IV Fluid: D5 ½ NS with 20 mEq KCL at 150 ml/hr. (Saline may need to be adjusted for Na+ greater than 148)
  • For hypovolemia: Bolus with 500 cc Lactated Ringers solution until SBP sustains > 100 mmHg.
  • Start Dopamine infusion and titrate to maintain SBP between 100 and 140mmHg, (maximum 20mcgs/kg/min)
  • If Dopamine is at 20 mcg/kg/min, CVP greater than 8 and SBP remains less than 100 mmHg consider Levophed infusion
  • Titrate to clinical effect (maximum 20 mcg/min).
  • In cases of extreme instability, where above measures have not had desired effect, consider giving Solu-medrol 15 mgs/kg IVPB.
  • If HCT less than 30%, recommend 1 unit of PRBC’s over 1 hour, repeat as necessary to maintain HCT greater than 30%.
  • HYPERTENSION
  • Use Hydralazine or Nipride. Avoid beta-blockers as they may cause some delayed function after transplant.
  • HYPOTHERMIA
  • Warming blanket to maintain core body temperature between 36.5 and 37.2 C.
  • DIABETES INSIPIDUS
  • For urinary output greater than 4 ml/kg/hr X 2 hours, recommend Vasopressin drip or replace urine output ml/mo.
  • HYPOXEMIA
  • Titrate FiO2 to maintain SaO2 greater than 98%.
  • Tidal Volume at 10 to 12 ml/kg.
  • Add PEEP of 5-8 cmH2O.
  • Rate adjusted to maintain normal pH (7.35-7.45).
  • Suction and turn patient q 1-2 hrs.
  • Initiate chest percussion q 2-4 hrs
  • CombiventAlbuterol Nebulizers: 2.5 mg q 4 hrs.

LABS

  • Daily: electrolytes, glucose, BUN, creatinine, and CBC. Correct abnormal values.
  • If serum K+ less than 3.5, give 20 mEq KCL IV over 1 hour.

OPTIMAL OUTCOMES

For best donation outcomes, notify Gift of Life when the patient meets clinical triggers as listed above, or when deceleration of care is going to be discussed with the family. A Gift of Life representative will respond on site to assess the situation. We will collaborate with critical care staff to establish a communication plan and management strategies at that time.

Additional donor management instructions you might anticipate once Gift of Life Michigan is on site and the patient has been evaluated as a suitable donor or potential donor:

  • Levothyroxine (T4) drip: protocol per donation coordinator on site.
  • Echocardiogram, EKG. cardiac catheterization
  • CXR, Bronchoscopy with BAL using minimal fluid instillation.
  • Arterial, pulmonary artery catheter, and central line placement if not yet present.
  • Labs: liver function, amylase, lipase, sputum culture/gram stain, electrolytes, CK, troponin, etc.

4.2

Physician Guidelines for Potential Pediatric Organ Donor Management

  • These are management guidelines for a patient when brain death is pending and to sustain organ function while giving the family time to consider the opportunity for organ donation. According to the American Heart Association guidelines a pediatric patient is younger than 8 years old. Remember you will be treating up to 8 potential recipients of these organs. Organ donation should not be mentioned to the family until the Physician has discussed the patient’s diagnosis and grave prognosis with them. The Gift of Life staff will be available for any discussions with the family regarding organ donation.
  • HYPOTENSION
  • Lowest acceptable systolic blood pressure = (2 x age in years) + 70.
  • Start Dopamine infusion to maintain normal systolic blood pressure for age.
  • For hypovolemia: Normal Saline 10-20ml/kg. If Sodium (Na) is elevated consider 0.25% NS 5-10ml/kg onsider Levophed infusion. Titrate to clinical effect.
  • In cases of extreme instability, where above measures have not had the desired effect, consider giving Solucortef 6mg/kg .
  • HYPERTENSION
  • Use Hydralazine or Nipride. Avoid beta-blockers as they may cause some delayed function after transplant.
  • HYPOTHERMIA
  • Warming blanket to maintain core body temperature between 36.5 and 37.2 C.
  • DIABETES INSIPIDUS
  • For urinary output greater than 4 ml/kg/hr X 2 hours, recommend Vasopressin drip or replace urine output ml/ml.
  • HYPOXEMIA
  • Titrate FiO2 to maintain SaO2 greater than 98%.
  • Tidal Volume at 10 to 12 ml/kg .
  • Add PEEP of 5 cmH2O.
  • Rate adjusted to maintain normal pH (7.35-7.45).
  • Suction and turn patient q 1-2 hrs.
  • Initiate chest percussion q 2-4hrs.
  • Albuterol Nebulizers: 2.5 mg q 4 hrs.
  • LABS
  • Daily: electrolytes, glucose, BUN, creatinine, and CBC. Correct abnormal values.
  • If serum K+ less than 3.5: give 1 mEq/kg IV over 2 hour
  • OPTIMAL OUTCOMES
  • For best donation outcomes, notify Gift of Life when the patient meets clinical triggers as listed above, or when deceleration of care is going to be discussed with the family. A Gift of Life representative will respond on site to assess the situation. We will collaborate with ICU staff to establish a communication plan and management strategies at that time.
  • Additional donor management instructions you might anticipate once Gift of Life Michigan is on site and the patient has been evaluated as a suitable donor or potential donor:
  • Levothyroxine (T4) drip: protocol per donation coordinator on site.
  • Echocardiogram, EKG.
  • CXR, Bronchoscopy with BAL using minimal fluid instillation.
  • Arterial, pulmonary artery catheter, and central line placement if not yet present.
  • Labs: liver function, amylase, lipase, sputum culture/gram stain, electrolytes, CK, troponin, etc.

4.3

Gift of Life Michigan

OBTAINING CONSENT
FOR DONATION

Best Practices for
Obtaining Consent for Donation

Organ Donation

CMS requires that the hospital, in collaboration with Gift of Life Michigan, ensure that the family of each potential donor be informed of its option to donate.The individual initiating the request to the family must be a Gift of Life representative, preferably in collaboration with the physician, nurse and others.A Gift of Life representative must be present for all donation discussions, including any mention of “Gift of Life” or “organ donation.”

Upon arrival at the hospital, the Gift of Life coordinator will:

  • Assess the patient’s suitability for organ donation.
  • Huddle with the hospital care team to assess the stage of the family’s grief and their understanding and acceptance of the patient’s imminent death.
  • Develop a communication plan with the hospital regarding an appropriate time to offer donation to the family in collaboration with the most appropriate hospital representative, e.g., physician, nurse, chaplain, social worker, etc.

If a family mentions or asks about donation prior to a donation coordinator arriving onsite, Gift of Life should be notified immediately by calling 800-482-4881.

Tissue Donation

If the hospital participates in the LIFE Program for tissue and eye donation:

  • Gift of Life and the Michigan Eye-Bank will provide the hospital with designated requestor services for tissue and eye donation.
  • When patient deaths are reported to Gift of Life, please provide telephone contact numbers for the patient’s family.Families will be contacted by Gift of Life or Michigan Eye-Bank to offer tissue and eye donation on behalf of your hospital. (See Section 3.2 for additional details.)
  • Gift of Life Condolence Cards are provided to hospitals. The Gift of Life representative will let you know whether or not to give the family the Condolence Card,which informs them that a Gift of Life or Eye-Bank representative may be contacting them about the option of tissue and eye donation.
  • Condolence Cards for your hospital are located in your patient care unit.Notify your Gift of Life Hospital Development Associate or call 800-482-4881 if more Condolence Cards are needed.

Additional Guidelines according to Best Practices

The Center for Medicare and Medicaid Services Conditions of Participation for Organ, Tissue and Eye Donation; Federal Register Notice, Section 482.45:

“A designated requestor is an individual who has completed a course offered or approved by the organ procurement organization (Gift of Life) for approaching families and requesting organ or tissue donations.”

“The individual designated by the hospital to initiate the request for donation to the family must be an organ procurement representative or a designated requestor.”

Gift of Life Michigan shall pursue documentation regarding the potential donor's wishes regarding anatomical donation or shall request consent of the highest priority Class who are reasonably available to make or object to making an anatomical gift, for each candidate referred for potential organ and tissue donation.

NOTE: See Section 5.2, regarding First Person Consent.

If first person consent documentation cannot be verified,determine the method of consent process to be used (e.g., written or electronically recorded) based upon the location of Gift of Life Michigan staff and the person in the highest priority Class, who is reasonably available:

A.Classes are to be identified in the following priority:

1. Patient advocate if applicable

2. Spouse

3. Adult son or daughter

4. Mother or father

5. Adult brother or sister

6. Adult grandson or granddaughter

7. Grandmother or grandfather

8. An adult who exhibited special care and concern for the decedent

9. Legal guardian

10. Persons assigned by the state of Michigan to authorize medical care for the decedent at the time of death, including public ward custodians, correctional or mental health facility personnel, or foster parents.

11. Any other person authorized or under obligation to dispose of the body, including unidentified bodies.

B.Consent shall be requested of the highest priority Class who are reasonably available to make or object to making an anatomical gift.

C.If there is more than one member of the highest priority Class entitled to make an anatomical gift, consent may be made by a member of the class, unless that member knows of an objection by another member of the same class. If an objection is known, consent may be made only by a majority of members of the class who are reasonably available.

D.If unusual family dynamics exist, Classes 1-10 are not readily identifiable or found by search, or a member of a Class may be mentally challenged, request the assistance of the referring hospital's legal counsel.

E.If the highest priority classes' primary language is not English, obtain the assistance of a qualified interpreter through the: