Organ and Tissue Donation Program | Gift of Life Michigan



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Donor

Protocol

Manual

Updated

November 2010

Gift of Life Michigan

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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 by increasing 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 Michigan Standard 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 is not 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

2. Monitor glucose and treat with insulin drip if needed (keep 80-200) rather than SQ.

3. Monitor and treat Hgb/Hct/coagulation factors (especially if GSW or other penetrating head injury).

• Maintain Hgb > 8.0 g/dL and Hct > 30%

• If PT > 18.0 give 2u FFP

• If Fibrinogen 70-100 give 2u FFP, if < 70 give cryoprecipitate

• If platelets < 50 give 6pk of platelets

Note: Remember to recheck labs after treatment

4. 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

o 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:

1. Gift of Life Michigan staff or Board member .

2. Donor hospital medical translation personnel

3. AT&T Language Line Services (800-528-5888; select menu option #3)

F. If the highest priority Class appears to be impaired by physical, mental, or substance related (alcohol or drug) influences, the consent process should be deferred until such time that the person subsequently appears to be in a rational frame of mind to provide an informed consent for anatomical donation, or consent may be obtained from the next priority Class who is reasonably available.

G. Review the contents of the Consent Form, or any appropriate hospital Anatomical Gift Donation Statement with the priority Class in the presence of a witness or with the aid of an electronic recording device.

H. Periodically clarify the priority Class's level of understanding of the consent form's contents. Items of clarification should include, but are not necessarily limited to:

1. Specific anatomical gifts can be donated.

2. Each type of anatomical gift may be used in the course of medical treatment.

3. Whether the person is the highest priority of Class reasonably available and if other persons from another Class exist that may be eligible to participate in the consent granting process.

4. If the donation of anatomical gifts is limited to transplantation and therapy, or to include research or medical education.

5. The release of the donor's remains for transport, if necessary, and the release of donor records.

6. The release of medical records and test results regarding the donor.

7. The release of Gift of Life Michigan and hospital from liability.

8. The Class’s responsibility for payment of patient and funeral-related expenses.

9. Disclosure of any significant past medical/social behaviors about the donor.

10. Consent may be rescinded up to the point that the donor goes to surgery, or if any patient undergoes treatment to receive an organ transplant.

NOTE: Gift of Life has additional policies related to the consent process. Please consult with your hospital development associate or call 1-800-482-4881 if you’d like more information.

5.1

First Person Consent

All notifications of death or imminent death received by Gift of Life will be investigated for documentation regarding the potential donor's wishes regarding anatomical donation.

A. Appropriate documentation of anatomical donation (first person consent) includes:

1. A registration (electronic or otherwise) in an organ and tissue donor registry from any state or country.

2. A statement or symbol regarding anatomical donation imprinted or displayed on a driver license or state identification card from any state or country. The statement or symbol may or may not be indicative of registration in an organ and tissue donor registry. Revocation, suspension, expiration or cancellation of the driver license or state identification card upon which the anatomical gift is indicated does not invalidate the gift.

3. Durable Power of Attorney for Health Care, patient advocate forms, a living will, a will or any legal document from any state or country. Anatomical gift by will takes effect whether or not the will is probated.

4. During a terminal illness or injury to the donor, any form of communication addressed to two adults, at least one of whom is a disinterested witness. The physician attending the potential donor cannot be the recipient of the communication. Family members and adults exhibiting special care of the donor, along with Gift of Life and other procurement organization personnel, cannot serve as the disinterested witness to the communication.

5. Any other form of documentation, (e.g., donor card) that indicates a desire to make an anatomical gift.

B. If first person consent is verified and the potential donor has an identifiable person in any Class for consent, a reasonable search will occur to inform the person(s) of the document. The involved coordinator will make every effort to obtain the priority classes' signature on an Acknowledgment of Anatomical Gift Donation Form after reviewing its content.

1. Gift of Life Michigan coordinator may sign the form on behalf

of the highest priority Class following an electronically recorded acceptance of the document.

2. If the highest priority Class refuses to sign the document, is not reasonably available, or cannot be located after a reasonable search, the donation may still be pursued, and Gift of Life executive management should be advised.

C. A copy of any documentation or record of communication regarding anatomical gifts is to be affixed to an Acknowledgment Form. The original is to be placed into the donor hospital medical record and a copy will be placed in the Gift of Life Michigan donor record. In the event that an amended gift was expanded to include additional body parts or purposes, consent is pursued with the highest priority Class, and a Consent Form would be used to document the expanded gift.

D. Gift of Life will pursue organs and tissues for transplant to the fullest extent possible. In Michigan, if the first person consent documentation does not identify the purpose of the anatomical gift, the gift may be used for transplantation, therapy, research or education, without additional consent from the priority Class. If the purposes are not set forth in any priority, the gift shall be used for transplantation or therapy, and, if not suitable for those purposes, for research and education. If a first person document is received from another state or country, and the purpose of the anatomical gift is not identified, Michigan law governs the purpose of the anatomical gift as outlined above.

5.2

Michigan’s Uniform Anatomical Gift Law

EXECUTIVE SUMMARY

Background

On March 13, 2008, Governor Jennifer Granholm signed the revised Uniform Anatomical Gift Law (UAGL). The new law enhances donor rights while clarifying all aspects of the donation process in Michigan. It stems from the original Uniform Anatomical Gift Law, which was enacted across the country in 1968 but had not seen any major changes in Michigan since 1987. Now, with passage of the revised UAGL, Michigan joins a nationwide movement to bring uniformity to organ and tissue donation laws from state to state. Michigan becomes the 22nd state to adopt the revised UAGL, with many other states also working on the updated measure. The revised UAGL takes effect May 1, 2008.

The revised UAGL is a straight-forward measure that brings the organ, tissue, and eye donation process into line with federal requirements. Still, questions may arise as it is implemented. Gift of Life Michigan is your source for addressing issues quickly and accurately. Please don’t hesitate to contact the Gift of Life or Michigan Eye-Bank hospital development associate assigned to your facility, or to call (800) 482-4881 if you have questions about the new law.

Overview

The revised UAGL:

• More accurately reflects the environment in which donation occurs.

• Gives Michigan conformity with the federal National Organ Transplant Act and Centers for Medicare and Medicaid (CMS) regulations.

• Supports the Michigan Organ Donor Registry.

• Upholds an individual’s autonomy to make a binding personal decision for or against organ, tissue or eye donation at the time of death.

• Still adheres to an “opt-in” principle as the default rule for donation.

• Still limits its scope to donations from deceased donors.

Specific Accomplishments of the Revised UAGL

• Reinforces an individual’s right to make an anatomical gift and prohibits others from changing the decision.

• Authorizes individuals to sign a refusal that bars anyone else from making an anatomical gift of the individual’s body or body parts.

• Establishes a priority order for each “class” that may make donation decisions (e.g., patient advocate, spouse, adult children, etc.), if they are reasonably available, and that a majority of the class can make the decision if there is more than one member of the class present (such as multiple adult children of an individual or multiple siblings).

Note: The revised UAGL defines “reasonably available” as “able to be contacted by a procurement agency without undue effort and willing and able to act in a timely manner consistent with existing medical criteria necessary for making an anatomical gift.”

• Allows for more classes of family relationship to have a say in donation decisions, by including grandchildren and grandparents to the list of people who may authorize donation, if no more closely related family is reasonably available.

• Allows for additional classes to have a say in donation decisions, including anyone who has medical authority to make a medical decision, public wards and adults who exhibited special care and concern for the individual.

• Supports a donation process that complies with the National Organ Transplant Act, CMS regulations, and accreditation requirements of The Joint Commission (formerly known as JCAHO) and American Osteopathic Association.

• Permits procurement organizations to assess medical suitability of a patient, including blood draws for serology and histocompatibility testing, prior to obtaining consent, as long as a written refusal does not exist.

• Interprets first-person consent to be for the recovery of organs, tissue and eyes for the purpose of transplantation, therapy, research and education, in that order.

• Maintains the right for a donor to name an individual recipient, a so-called “directed donation.” Additionally, the sale or purchase of body parts continues to be prohibited.

• Maintains the prohibition against physician participation in the transplantation process by either the physician who attends the decedent at death or the physician who determines the time of the decedent’s death.

• Maintains strong statutory immunity for persons who act in “good faith” in the facilitation of the donation process, as outlined in this act, and immunizes the donor’s estate from prosecution.

• Provides clarity on interpretation of advance directive, such that if the prospective donor has an advance health care directive, the measures necessary to ensure the medical suitability of an organ for transplantation will not be withdrawn while the examination is being conducted by the organ procurement organization.

April 7, 2008

For more on Michigan’s Uniform Anatomical Gift Law, look up Public Act 39 of 2008 at legislature.mileg.asp?page=PublicActs

5.3

Kyle Ray Horning’s Law

(formerly known as Michigan’s Medical Examiner Law)

On Oct. 20, 2005, Governor Jennifer Granholm signed into law Public Act 176. This amended the County Medical Examiner Code, by adding Section 9 to the chapter. On March 13, 2008, the governor signed Public Act 38 of 2008, which renamed the measure after Kyle Ray Horning, an infant who was the first organ donor under the law. This memorandum, provided by Gift of Life legal counsel, summarizes the law’s provisions.

1. For deaths that take place outside of a hospital, if a county medical examiner has charge of a body that he or she determines may be suitable for the donation of tissue or organs, the medical examiner is required to notify Gift of Life of the potential donor.

2. If a medical examiner becomes aware that the brain dead or deceased person is a tissue or organ donor, the medical examiner must conduct the examination of the body within a time period that permits organs, tissues, and eyes to remain viable for transplant. If the medical examiner cannot conduct the investigation within that time frame, a health care professional who is authorized to remove an anatomical gift from a donor may remove the donated tissues or organs, upon notice to the medical examiner. The medical examiner has the right to be present during the removal of organs and may request a biopsy of the organs, but may not prohibit the removal of transplantable organs.

3. When contacted by Gift of Life or the Midwest Eye-Bank, the county medical examiner is required to enter into an agreement with Gift of Life and the Midwest Eye-Bank that coordinates the recovery and allocation of anatomical donations in that county. That agreement will outline procedures and protocols that each party will follow to assure that transplantable organs, tissues, and eyes are obtained from potential donors. The agreement will provide that, if any extraordinary medical examinations or other expenses are necessary prior to the removal of organs, tissues or eyes, Gift of Life or the Midwest Eye-Bank will reimburse those costs to the county. Gift of Life will work through the Michigan Association of Medical Examiners to

develop a “boiler plate” agreement and will distribute the agreement to medical examiner offices statewide for signature.

4. The medical examiner may release to Gift of Life Michigan or the Midwest Eye-Bank information that is relevant to tissue and organ donation or that is relevant to the identification of potential organ, tissue, or eye donors so that those organizations may seek consent for such donations, as required by Michigan law.

5. Medical examiners are prohibited from discussing the option of donation with any individual with the authority to make a gift of organs, tissues, or eyes under the Michigan Uniform Anatomical Gift Act. Comment: This section was entered as a protection to medical examiners, and their designees. As a result of national standards established through the Medicare program for hospitals, only trained requestors may offer donation options to families. Untrained requestors have been sued for providing inaccurate donor information that resulted in a donation or a refused donation. The prohibition from discussing organ and tissue donation permits medical examiners to devote their attention to examinations and insulates them from the risks associated with involvement in the organ and tissue donation process.

For more on Michigan’s Medical Examiner Law, look up P.A. 38 of 2008 at legislature.mileg.asp?page=PublicActs

5.4

Gift of Life Michigan

SURGICAL RECOVERY

Gift of Life Michigan Surgical Center

For more than a decade, Gift of Life Michigan has transported tissue donors from southeast Michigan hospitals to our Surgical Center at Straith Hospital for tissue recovery and perfusion. Having one facility has eased the demand on Detroit-area medical centers for staff, space and equipment required to do our specialty work. It also has allowed Gift of Life the opportunity to work in a consistent surgical environment, which has reduced variation in our procedures, improved quality and lowered contamination and discard rates. Because of this, Gift of Life Michigan has begun to transfer organ donors from other Michigan hospitals to our Surgical Center for organ and tissue donation. We’re doing this on a case-by-case basis and will consider moving donors based on meeting the family’s needs, operating room availability and the availability of personnel to perform the recovery.

We believe that moving organ and tissue donors, when possible, benefits the donor hospital, donor family and ultimately will provide the best quality outcomes and help the thousands of organ and tissue recipients worldwide lead healthier, better lives.

Benefits to the Donor Hospital

• Eliminates moving scheduled surgeries for donor cases

• Allows the ICU bed to become available sooner for incoming patients

• Gift of Life Michigan handles the release and delivery of the body to the funeral home

Benefits to the Donor Family

• Decreases time from consent to completion of surgical recovery

• Body will be released and delivered to funeral home in a timely manner

Benefits to the Transplant Recipients

• Decreases transport time from donation surgical center to transplant center

o Decreases cold ischemia time

o Better organ function immediately following transplant

• Decreases variability results and better surgical outcome

For more information on the Gift of Life Surgical Center, please contact your hospital development associate or call 1-800-482-4881

Operating Room Supply Pack for Organ Donation

Gift of Life Michigan has developed a new process for set up in the operating room when preparing for an organ donation surgery. In order to increase efficiency and require less time of hospital staff, Gift of Life Michigan will bring an assembled sterilized supply pack to the Operating Room or Surgical Suite.

This Operating Room supply pack is provided to us through Avid Medical and it includes a variety of supplies necessary for an organ donation surgery. You will notice the list does not include any instruments. We will still have the same need for your hospital instruments to complete an organ donation surgery. The supply pack component detail is provided for your review. Please note that this package is sterile, disposable and for single use only. For more information on the Operating Room supply pack, please contact your hospital development associate or call 1-800-482-4881.

Component Detail

STERILE ~ DISPOSABLE ~ SINGLE USE ONLY

1.00 GOWN, KC400 MICROCOOL SURG, LG

1.00 TOWEL, ABSORB. WHITE

1.00 WRAP, 30 X 30 3PP

1.00 BASIN O.R. 6000CC ROUND

1.00 WRAP, 55 X 72 E-COAT

1.00 BASIN O.R. 6000CC ROUND

2.00 BOWL, 32/35 OZ

1.00 PITCHER, GRAD 12OOCC PLAS

4.00 CUP, SPECIMEN 5 OZ W/SCREW LID

1.00 TAPE, UMBILICAL 1/8” X 30 2’S

1.00 GAUZE, 4X8 12PLY XR 10’S

1.00 BASIN, EMESIS 700ML

2.00 BLADE, #10 S/S

1.00 SPONGE, PEANUT 5’S

1.00 MARKER, PERM W/RULER & 9 BLNK

1.00 BONE WAX, 2.5 GRAMS

4.00 LABEL, WHITE 1/2 X 1.75

2.00 SUTURE, 2 ETHILON BLK MONO 60”

2.00 YANKAUER HNDL, BULB TIP NON

2.00 YANKAUER, SUCTION POOLE

1.00 SYR, 50CC BULB

2.00 CAUTERY, ROCKER WITH HOLSTER

2.00 KIT, DURAPREP

1.00 COUNTER, NDL FOAM/MAG 40 CT

1.00 WRAP, BASIN 50 X 50

1.00 TRAY, FOAM 18 X 14 X 5/8

1.00 BAG, BEDSIDE SUTURE W/TAPE

6.00 SPONGE, LAP 18X18 PW 5’S LOOPS

2.00 SPONGE, LAP 18X18 PW 5’S LOOPS

12.00 TOWEL, OR BLUE 17” X 26”

2.00 TUBING, SUCT 1/4ID” X 12

1.00 SHEET POLY 66 X 44

1.00 DRAPE SYSTEM, UNIV HD CV ARTS

1.00 COVER, MAYO STAND 54” X 23”

1.00 COVER, TABLE 60 X 90 (STERILE) FF

2.00 GOWN, MICROCOOL XL SURG KC400

2.00 TOWEL, ABSORB. WHITE

1.00 GOWN, KC400 MICROCOOL SURG, LG

1.00 TOWEL, ABSORB. WHITE

1.00 COVER, TABLE 60 X 90 SF HD ECOAT

1.00 PAPER, FL. ORANGE 8.5 X 11

Instrument Requirements for

Organ Recovery

Below is a list of standard equipment and supplies required for organ recovery. Please inform the Gift of Life screener and donation coordinator prior to recovery if any of these supplies are not available. Note: Items that are absolute necessities are in bold-face type.

Personnel

• Surgical Tech/Scrub Nurse (one or two depending upon the length of procedure and availability)

• Circulating Nurse

Sterile Supplies

For kidney, liver and/or pancreas procedure

• Laparotomy instruments/tray

• Abdominal retractors

• Long fine tip right angels

• Vein hooks or Cushing retractors

• Potts or DeBakey forceps

• Bull dog clamps

• 2-Tonsil and 2-Poole suction tips - with two (2) sets of tubing*

• Hemoclip appliers

• Vascular instruments/tray with aortic/vascular clamps

• Sternal saw and/or Lebsche knife with mallet*

• Sterile slush machine

• Extra right angles – “fine tips”

For heart, lung or heart-lung procedure

• Thoracotomy instruments/tray

• Intrathoracic paddles and defibrillator available in room

Sutures

• Ask surgeon – silk ties 3-0, 2-0, 0

Prep

• Chin to pubis, bedside to bedside

6.1

Drapes

• Laparotomy pack (for any procedure)

• Laparotomy sheet (kidney and/or pancreas procedure)

• Cardiovascular sheet (liver and/or thoracic procedure)

Non-sterile supplies

• Blood/I.V. fluid warmers

• Two electrocautery*

• Sterile back table with large basin (one for each organ)

• Suction setups (2) with extra canisters*

• I.V. Poles (one for each surgical team)

• Sterile slush machine (if possible for extrarenal procedure)

• Room temperature at 75 degrees

• Non-sterile ice

NOTE: *Denotes “must have” items

6.1

Anesthesia Requirements for

Organ Recovery Following Brain Death

Below is a list of standard equipment and supplies needed for anesthesia for organ recovery after brain death. Note: Donation after Cardiac Death (DCD) typically does not require anesthesia.

Equipment

• Pressure bag for rapid I.V. infusion (2)

• Blood/I.V. fluid warmer

• PEEP valve

• Esophageal temperature probe

• Hemodynamic monitors

Supplies

• Albumin, 50 cc vials (6)

• Dopamine, 400 mg

• Heparin, 30,000 nits

• Lasix,. 200 mg

• Mannitol, 25 gm %2

• Pavulon, (or other muscle relaxer)

• Potassium Chloride, 40 mEq

• Solumedrol, 1 gm

• I.V. solution (lactated ringers or normal saline), 10 liters

• Colloidal plasma expanders (Hespan, Hetastarch or Dextran), 1 liter

• Packed Red Blood cells (for extrarenal donors only), 4-5 units on hold

6.2

Instrument Requirements for

Tissue Recovery

The tissue recovery team will need two (2) back tables.

If tissue recovery follows organ recovery, the team will need unsterile ice available.

Otherwise, the tissue recovery team brings all supplies they need.

6.3

Gift of Life Michigan

RESOURCES

Gift of Life Michigan Resources

For more information on:

• Organ and tissue donation, consult your Hospital Development Associate, call 1-800-482-4881 or visit .

• Physician to physician education, through Gift of Life’s Peer Physician Education Program, consult your Hospital Development Associate or go to hospitals.

• Family resources on organ and tissue donation, go to .

7.1

Useful Websites

Gift of Life Michigan……..…………………….

United Network for Organ Sharing……………….……….….

Organ Procurement & Transplant Network…………..……….

Hlth. Res. & Services Admin. Collaborative…..

Association of Organ Procurement Organizations……..……..

Michigan Health and Hospital Association……...…………….

Scientific Registry of Transplant Recipients……..…...

Michigan Eye-Bank…………………………….……………..

U.S. Dept. of Health and Human Services…………….

Minority Organ Tissue Transplant Education Program..…...

Organ Donation and Transp. Alliance……...

Donate Life America…………….………………………

Donate Life Coalition of Michigan………..…..

Musculoskeletal Transplant Foundation………..……………...

National Kidney Foundation……………………….………

American Liver Foundation………………………

American Medical Association……………….…………ama-

American Heart Association………….…….…....…

7.2

American Lung Association………………………………

American Association of Tissue Banks………………………

Michigan Public Acts (state law) ………………………………………….. ……………………….legislature.mileg.asp?page=PublicActs

Note: Relevant Acts are:

• Public Act 38 of 2008

• Public Act 39 of 2008

• Public Act 140-143 of 2005

• Public Act 67 of 2003

• Public Act 368 of 1978

• Public Act 90 of 1992

• Public Acts 62 and 63 of 2003

Federal Register (U.S. law)…….……fr/advanced.html

Note: Relevant sections are:

• Medicare Cond. of Participation…..1998 FR, Vol. 63 Search: 16490

• HIPAA ………………….………...2000 FR, Vol. 65 Search: 32678

• FDA Good Tissue Practices…..…...2004 FR, Vol. 69 Search: 68611

7.2

Gift of Life Michigan

WHOLE BODY DONATION

Whole Body Donation Resources

Body donation is an option to a family that has suffered a loss. In many cases, organ and tissue donation may occur prior to body donation. Please coordinate this through Gift of Life Michigan.

The donation of organs/tissues for transplantation takes precedence over whole body donation if both types of donations are made. Arrangements for whole body donation need to be made well in advance of death for most programs.

Gift of Life Michigan - Gift of Body Donation through the IIAM (International Institute for the Advancement of Medicine) - source



• arrangements do not need to be made in advance of death

• next of kin can make decision at time of death

• accepts whole bodies and after organ and/or tissue donation

• makes all arrangements for removal of the body & transportation to IIAM

• cremated remains buried, scattered at memorial site, or returned to family

For additional information, please contact:

Gift of Life Michigan 1-800-482-4881

3861 Research Park Drive

Ann Arbor, MI 48108

Michigan State University – Willed Body Program (source – MSU.edu)



• arrangement must be made in advance of death

• accepts whole bodies only, will accept bodies following eye/corneal donation

• provides transportation within the immediate Lansing area; other areas, family is responsible for transportation costs (usually through a funeral home)

• cremated remains buried at MSU or can be returned to family

For additional information, please contact:

Jacque Liles 517-353-5398

Michigan State University – Willed Body program

E206 East Fee Hall

East Lansing, MI 48824-1316

Wayne State University – Body Bequest Program (source – Wayne.edu)



• arrangement must be made in advance of death

• accepts whole bodies only, will accept bodies following eye/corneal donation

• makes all arrangements for removal of the body & transportation to Wayne State University School of Medicine

• can have funeral with viewing

• cremated remains buried at Wayne State or can be returned to family

8.1

For additional information, please contact:

Barb Rosso (313) 577-1188 or (313) 577-1198

E-mail: brosso@med.wayne.edu

Wayne State University School of Medicine

Department of Anatomy & Cell Biology

540 E. Canfield

Detroit, MI 48201

University of Michigan – Anatomical Donations Program (source umich.edu)



• arrangement must be made in advance of death

• accepts whole bodies; organ donation possible, dependent on case

• transportation costs to U of M are the responsibility of the family or donor’s estate

• cremated remains buried at U of M or can be returned to family

• can have funeral with viewing

For additional information, please contact:

Anatomical Donations Program 734- 764-4359

3767 Medical Science Building II

University of Michigan Medical School

Ann Arbor, MI 48109-0608

Email: donorinfo@umich.edu

8.1

HOSPITAL POLICIES

(Note: Please attach copies of your hospital’s policies on Brain Death, Donation After Cardiac Death-DCD, and any other policies relevant to organ, tissue and eye donation. Consult your Gift of Life Michigan Hospital Development Associate if you have questions, 1-800-482-4881.)

-----------------------

Gift of Life will request the following information:

1. Phone number to unit

2. Hospital name

3. Unit

4. Name and title of caller

5. Is patient on a vent (yes, previously or never); if previously, date and time of extubation

6. Patient name

7. Date of birth

8. Race, sex, weight

9. Medical Record number

10. Social Security number

11. Date and time of death

12. Date and time of admittance

13. Cause of death

Note: Keep chart on unit; Gift of Life requires additional information on all tissue donors.

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