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Are you curious about the process pf organ donation and transplantation? Look here for a compilation of all the best and most accurate information available on the web.

Learn More

Are you curious about the process pf organ donation and transplantation? Look here for a compilation of all the best and most accurate information available on the web.

Organizations and Regulations

The Uniform Anatomical Gift Act (UAGA)

Organ donations and recovery procedures adhere to national and state laws. The primary piece of legislation governing organ donation is the Uniform Anatomical Gift Act (UAGA). Before this, organ donation was handled on a state-by-state basis and systems varied widely [5a]. In 1968, the UAGA became a model legislation that formally recognized the power of individuals to donate organs and tissues as an immediate gift to any person in need. The Uniform Law Commission[1] developed the legislation to increase the number of available organs for transplant and unify organ procurement policies and procedures across states. In 1972, the UAGA mandated that donor cards be recognized as a legally binding document in all 50 states [5a].

By 1987, the science, technology, and knowledge behind organ procurement and transplantation had seen significant developments since the original 1968 law. The Uniform Law Commission approved the Revised Uniform Anatomical Gift Act (R-UAGA) to address changes in circumstance and practice since the 1968 law [6a]. However, the 1987 version was adopted by only 26 states, leading to variances and dissimilarities across the country between states which adopted the 1987 version and states which were still working with the 1968 version. Since organ transplants can have a donor in one state and a recipient in another, the variance in legislation could complicate the transplant process.

Addressing these inconsistencies was a 2006 version of the UAGA approved by the Uniform Law Commission approved to realign organ donation policies and procedures across states. The 2006 version of the UAGA also: reflected changes in the technology and practices of procurement and transplantation since earlier versions of the law; clarified the list of people who can make a donation decision on behalf of the deceased; and further strengthened a donor’s decision to donate by clarifying the finality of a donor’s anatomical gift [6a]. Previously, some procurement organizations sought additional approval from next-of-kin even when the donor left clear documentation of the decision to donate. This caused unnecessary delays in procuring organs and at times a reversal of the donor’s decision to donate. Under the 2006 version of the UAGA, organ donor designations on driver’s licenses, donor registration cards, and those listed in living wills are recognized as legally binding first-person authorizations.

At present, 46 states including West Virginia and New York have adopted the 2006 version of the UAGA [7a]. As of October 2012, the Act is under review for adoption in Pennsylvania [8a]. The version of the UAGA currently in effect in Pennsylvania is the 1987 version.



[1] The Uniform Law Commission http://www.uniformlaws.org/ has been in existence since 1892 and works “for the improvement of state laws by drafting uniform state laws on subjects where uniformity is desirable and practical,” and diversity “obstructs the interests of all the citizens of the United States.” Commissioners are mostly appointed by the state governors and serve for specific terms.

References
5a. Association of Organ Procurement Organizations: Legislative. Association of Organ Procurement Organizations [cited 2012; Available from: http://www.aopo.org/advocacy/legislative/.

6a. Anatomical Gift Act (2006) Summary. National Conference of Commissioners on Uniform State Laws; Available from: http://www.uniformlaws.org/ActSummary.aspx?title=Anatomical%20Gift%20Act%20%282006%29

7a. Legislative Fact Sheet–Anatomical Gift Act 2006. National Conference of Commissioners on Uniform State Laws; Available from: http://www.uniformlaws.org/LegislativeFactSheet.aspx?title=Anatomical%20Gift%20Act%20%282006%29

8a. Pennsylvania Bill Information, 2011-2012 Session. Pennsylvania House and Senate; Available from: http://www.legis.state.pa.us.

Organ Procurement and Transplantation Network (OPTN)

The Organ Procurement and Transplantation Network (OPTN) is the national network established under the National Organ Transplant Act (NOTA) of 1984 [11]. The network’s operation is facilitated by United Network for Organ Sharing under a federal contract with the U.S. Department of Health and Human Services.

The OPTN is a public-private partnership that enables all professionals involved in the donation and transplantation system to interact and coordinate organ sharing around the clock. The OPTN improves effectiveness, efficiency, and equity in organ sharing nationwide. In addition, the OPTN also increases the supply of donated organs [11]. The OPTN operates the national database of all U.S. patients waiting for a transplant, among other activities.



References
11. about optn. Human Resources and Services Administration, DHHS; Available from: https://optn.transplant.hrsa.gov.

United Network for Organ Sharing (UNOS)

The United Network for Organ Sharing (UNOS), based in Richmond, Virginia, is a private, not-for-profit organization. UNOS is under contract with the Health Resources and Services Administration of the U.S. Department of Health and Human Services to facilitate the operation of the OPTN [12]. UNOS uses an internet-based system called UNet to connect transplant hospitals and OPOs together in a real-time, secure, and confidential environment.

The UNet website allows transplant hospitals to list patients on the transplant waiting list, and complete and submit OPTN data forms, status justification forms and access reports. The OPOs use UNet to add donors and run donor-recipient matching lists. The OPO then contacts the hospital and the organ is offered for the matched patient [13].

In addition to operating the OPTN database, UNOS also supports the following efforts required by the OPTN contract awarded [12]:

  • Collecting medical data on all transplants nationwide;
  • Maintaining OPTN membership standards;
  • Providing information to the transplant community regarding organ-sharing policies;
  • Educating public and transplant professionals; and
  • Assisting patients and family members and friends.


References
12. About us. United Network for Organ Sharing; Available from: https://unos.org/about/.
13. UNet Goes Live: Internet_Based Technology in Transplant System. Organ Procurement and Transplantation Network 1999 [cited 2013; Available from: http://optn.transplant.hrsa.gov/news/newsDetail.asp?id=192.

The Organ Procurement Organization (OPO)

Organ procurement organizations (OPOs) are federally designated, not-for-profit organizations responsible for encouraging donor registration in their designated service areas, identification and care of organ donors, organ recovery, preservation, and facilitating allocation [9]. OPOs are responsible for procuring organs after death and with checking the registry for an individual with an authorized donation. Each of the 58 U.S. OPOs has a Designated Service Area based on population and geography. OPO staff works with donor families and educates medical staff and the general public about organ, tissue, and eye donation. They also procure and transport organs for transplantation. Primary OPO activities include [9]:

  1. Obtaining authorization for recovery.
  2. Screening for medical suitability.
  3. Coordinating organ recovery and allocation process.
  4. Data follow-up.
  5. Donor family support and bereavement services.
  6. Public education.

In addition, the OPOs’ professional services liaisons work closely with hospitals in identifying ways in which the opportunity for organ donation can be preserved.



References
9. About OPOs. Association of Organ Procurement Organizations; Available from: http://www.aopo.org/about-opos/.

The Center for Organ Recovery & Education (CORE)

The Center for Organ Recovery & Education (CORE) is the OPO for Western Pennsylvania and most of West Virginia. Its region encompasses 155 hospitals and almost six million people throughout western Pennsylvania (32 counties), West Virginia (50 counties) and Chemung County, NY [10]. Each hospital in CORE’s designated region serves as a referral site for potential donors. Five hospitals also perform organ transplants:

  • Children’s Hospital of Pittsburgh
  • UPMC Presbyterian
  • Veterans Administration Medical Center
  • West Penn Allegheny Health System-Allegheny General Hospital
  • Charleston Area Medical Center Hospital in West Virginia [10]

Other hospitals in CORE’s designated service area rely on corneas or tissue for transplantation.

Besides supporting families during the grieving process and discussing their opportunities to donate, the agency also notifies the organ transplant team and coordinates the surgical recovery of organs and tissues. CORE is also responsible for facilitating the computerized matching of donated organs and corneas. Finally, CORE provides: clerical support to hospitals; transportation for donated organs and tissues; and general awareness and public education.



References
10. What is CORE? Center for Organ Recovery & Education Available from: http://www.core.org.

Donation Logistics

Early Referral

When hospital staff determines that death is imminent, they are required by law to report the imminent death to their Organ Procurement Organization (OPO). When CORE, our local OPO, receives one of these calls, they initiate a set of standard procedures. First, they will establish and verify the identities of the referring organization and the potential donor. After confirming the identities of the referring organization and the potential donor, an Organ Procurement coordinator (OPC) is assigned to the case.

The OPC at CORE has an important role. The OPC is the person who obtains authorization to recover organs, and determines donor suitability.

Identification and Referral

In compliance with the Centers for Medicare and Medicaid Services (CMS) conditions of participation, all U.S. hospitals must identify patients whose death is imminent or have died and report them to the regional Organ Procurement Organization (OPO). This law and the associated state and federal regulations maximize success of organ transplantation by timely identification and referral of the potential donor to the OPO, which allows for optimum donor management until the organs are recovered. To facilitate timely referrals, CORE (the OPO for Western PA and West Virginia) maintains a referral call center that is staffed 24 hours.

People can die either from brain death or cardiac arrest. For patients expected to die of brain death, hospitals must notify the OPO within one hour of the patient meeting the imminent death criteria. For cardiac death patients, hospitals must notify the OPO within one hour of the patient meeting the imminent death criteria or within one hour of cardiac asystole. Brain death and cardiac death are discussed in detail in later resources.

Identifying Imminent Death

A diagnosis of imminent death involves fulfillment of any of the following criteria in a patient on mechanical ventilation. CORE emphasizes that the hospital staff should anticipate imminent death and should not hesitate when making a referral. CORE provides all hospitals in its designated service area with trigger cards listing the imminent death criteria. Meeting any of the following criteria will trigger referral to the OPO:

  • Death expected within 24 to 48 hours
  • Patient has suffered severe, irreversible brain injury. Injury to the brain may be traumatic or non-traumatic.
  • A Glasgow Coma Scale score of 5 or less.
  • Anoxia secondary to cardiac arrest.
  • Change in medical care protocol from active treatment to “Do Not Resuscitate” or “Comfort Only” or “De-escalation of Care” being considered.
  • Terminal wean or a planned withdrawal of support being considered allowing natural death to occur.
  • Brain death protocol being considered.
  • Loss of protective reflexes without sedation.

Authorization and the Organ Procurement Coordinator

People have the right to determine what happens to their body after they die. This includes their decision to donate their organs, tissues and eyes to help those who are in need. The decision to donate is a personal one and must be honored under all circumstances. No recovery of organs, tissues and eyes can take place in the absence of explicit authorization from the potential donor or next of kin. The organ procurement coordinator (OPC) has an important role to play in obtaining authorization for donation.

Watch the following video to learn more about the OPCs role.

First-person Authorization

First-person authorization for donation (authorization by the donor) proclaims an individual’s desire to donate and requires no further confirmation. An individual can authorize organ and tissue donation either through completing a donor card, registering online, designating on driver’s license or state ID, or by executing a living will. The most common method is to join a state donor registry when renewing a driver’s license. A symbol is placed on the driver’s license, but the actual registration is in a secure database.

People who designate their wish to be donors using a donor card or living will can use the online registry to add their name to the database, or they can send a copy to be processed by the OPO. Those who authorize donation in their should also register with the state online donor registry or indicate donor designation status on their driver’s license. This is because a donor designation written in a living will or a donor card alone may not be discovered until it is too late for organ donation.

When a patient whose death is imminent is referred to the OPO, the OPO checks for the patient’s donor designation status in the database. If the patient is a designated donor, the OPO is legally obligated to honor the donor’s wish. The OPC talks to the next-of-kin and addresses any concerns that the family may have. Accordingly, it is important that whenever someone registers as an organ donor, they communicate their wishes with their family.

In some cases, donors may be eligible for research rather than transplantation. In these situations the administrator-on-call at CORE makes the final decision on organ recovery.

Next-of-kin Authorization

In the absence of individual authorization, OPC approaches the next-of-kin to discuss a donation opportunity. Next-of-kin authorization can be on-site or via a recorded telephone call. The timing and setting for organ donation discussion is crucial. Most importantly, the discussion about organ donation should be separate from discussion about the patient’s death. Typically, the OPC is responsible for initiating the organ donation conversation.

The Uniform Anatomical Gift Act (UAGA) establishes the order of priority in which the next-of-kin are approached for organ donation conversation [6]. Institutional support personnel including social workers, a chaplain and nursing staff are involved as appropriate.

Essential elements of organ donation conversation include:

  1. Introducing oneself to the next-of-kin.
  2. Confirmation of patient’s identity and his/her clinical terminal condition.
  3. Use of language conversant to the next-of-kin.
  4. Providing all possible donation options.
  5. Discussing the impact of organ donation on funeral arrangements.
  6. Explaining the need for social/medical history taking and relevant lab tests.
  7. General description of the organ recovery process.
  8. Statement that the cost of organ recovery and transplantation are not to be borne by the family.

As per the UAGA, if someone considered to be a “lower priority” next-of-kin is approached for authorization, the choice is documented with a justification of why a higher priority next-of-kin was not contacted. If authorization is by telephone, the time of call is documented.

CORE has a standard protocol that must be followed by OPC when requesting authorization from next-of-kin. When next-of-kin authorizes a donation, the OPC uses CORE’s authorization form, signed by next-of-kin with hospital staff as witness. One copy of this form is given to the hospital and one to the next-of-kin. The original is retained by CORE. Appropriate contact information is provided to next-of-kin if they need more information on the donation process. If next-of-kin declines the request for organ donation, the family is thanked for their time and their decision is documented. Appropriate contact information is still provided for further information on organ donation. In addition, CORE has stringent quality control measures including authorization review and telephone audits in place to ensure adherence to CORE protocol. If any deviation from the protocol is identified during review/audit, immediate corrective measures are taken.



References
10. 6. Anatomical Gift Act (2006) Summary. National Conference of Commissioners on Uniform State Laws; Available from: http://www.uniformlaws.org/ActSummary.aspx?title=Anatomical%20Gift%20Act%20%282006%29.

Authorization for Donation and Religious Beliefs

The influence of religious beliefs on an individual or a family’s decision to donate cannot be overemphasized. Religion can play a crucial role in the decisions one makes on a day-to-day basis. The influence of religious beliefs on a life-changing crisis situation can be especially complex and profound.

People from different religious denominations often believe that organ donation is prohibited. However, most major religions support organ and tissue donation (see table below) [14]. The left column lists religions that actively support donation, and the right column lists those that consider a donation decision an individual choice. None of the religions explicitly forbids it.

Actively Support Donation View Donation as Individual Decision

African Methodist Episcopal (AME) & AME Zion

Amish1

Catholicism

Assembly of God

Christian Church (Disciples of Christ)

Buddhism

Episcopal Church

Church of Christ, Scientist

Greek Orthodox

Independent Conservative Evangelicals

Islam

Hinduism

Judaism

Jehovah’s Witnesses2

Lutheran Church

Mennonite

Mormonism

Moravian

Presbyterian

Pentecostals

Protestantism

Southern Baptist Convention

Seventh-Day Adventist

Society of Friends (Quakers)

Unitarian Universalist

 

United Church of Christ

 

United Methodist Church

 


1 The Amish consent to donation if they know it is for the health and welfare of the transplant recipient. They believe that since God created the human body, it is God who heals. However, they are not forbidden from using modern medical services, including surgery, hospitalization, dental work, anesthesia, blood transfusions, or immunization.

2 Jehovah’s Witnesses are often mistakenly assumed to be opposed to organ donation because of their belief against blood transfusion. The fact is that any organ or tissue transplanted must be cleared of the donor’s blood. Jehovah’s witnesses believe that the decision to donate and receive an organ or tissue is an individual one.

References
14. Religious Views on Organ Donation. Health Resources and Services Administration; Available from: http://organdonor.gov/about/religiousviews.html.

Authorization for Donation and Funeral Arrangements

Sometimes people are reluctant to become organ donors or consent to donating a deceased family member’s organs because they worry about potential disfigurement or losing the ability to have an open-casket funeral. Organ donation does not affect the appearance of the body for open-casket viewings and funerals.

The OPC and recovery team also work within a family’s time constraints regarding funeral services. For example, if the family needs to have a funeral service quickly, the OPO can coordinate recovery of a few key organs and forgo tissue recovery processes so the body is available more quickly.

Medical Details

General Screening and Organ-specific Testing

General screening involves establishing potential donor’s eligibility to donate, a body exam, a review of medical record, blood transfusion and fluid infusion evaluation, and serology tests [15]

  • Children’s Hospital of Pittsburgh
  • UPMC Presbyterian
  • Veterans Administration Medical Center
  • West Penn Allegheny Health System-Allegheny General Hospital
  • Charleston Area Medical Center Hospital in West Virginia [10]

It is the role of the OPC along with the transplant surgeon to make the final suitability determination. As a PCP, you can express this important fact to interested patients. Educating those interested in being a potential organ donor is an important role you can fulfill.

Lay people often presume that they are ineligible to donate because of age or medical condition. No age restrictions exist for organ donation. People who have had a history of health issues–including cancer, diabetes, cardiovascular disease, pulmonary conditions, or drug and alcohol abuse–can still be organ and tissue donors. Some people may be ineligible as donors because of the conditions above, while others will not. It is important for potential donors not to “rule themselves out.” In essence, there is no absolute rule-out for an organ donor.

Donor eligibility is determined on a case by case basis by trained medical professionals. It depends on a person’s medical and social history at the time of death. The OPC carefully screens potential donors to ensure any organs recovered will not introduce any new infections or diseases.

Donors may be classified as ‘high risk’ if they carry certain infections and transplanting their organs may lead to transmission of the infection. To prevent inadvertent transmission of infection, potential donors believed or confirmed to be at high risk of certain infections may be excluded from being a donor. However, if a potential recipient is already exposed to a certain infection, an organ transplant from a high-risk donor may be possible.

High risk donors are identified through medical/social history taking. An individual who knows the donor’s medical/social history best is the most appropriate interviewee. It may be also necessary to interview other significant life partners, distant relatives and the family physician to obtain accurate medical/social history. For donors less than 18 months old, medical/social history of the potential donor and the mother is recorded. Interviewing for medical/social history follows OPO protocol serving the healthcare organization where the potential donor is admitted. Obtaining parental consent is necessary for donors less than 18 years old, even if the person listed themselves on a donor registry.

Body Exam

Once initial suitability is determined, the donor referral coordinator examines the donor’s body. In presence of hospital staff, the body is examined for patient personal effects. All patient personal effects are documented and then removed, bagged and handed over to a hospital designee. The body exam also involves examining the body for overall appearance, noting markings that may help identify the body, and checking for evidence of IV drug abuse (that may have been missed in medical/social history). This procedure is followed by physical inspection of all body regions and cardiovascular, respiratory, and musculoskeletal system. All findings are documented concurrently with each step in the medical record.

Medical Record Review

The OPC reviews the patient’s medical records including current and previous records. This involves verifying information obtained by the donor referral coordinator including patient identification information, physical characteristics (height, weight, etc.) and next of kin. The OPC also verifies that the medical/social history is complete. The OPC also looks for information that may help determine the health of the organs and likelihood of success of transplantation. For instance, long duration of ventilator support may compromise the donor’s defense mechanisms leading to secondary infections. Information obtained through medical record review (such as electrolyte, glucose and arterial blood gas levels) also facilitates donor management.

Blood Transfusion and Fluid Infusion Evaluation

Reviewing transfusion/infusion history is critical because many serology test results may be altered due to hemodilution. For example, hemodiltuion may lead to false negative results for HIV tests. The extent of hemodilution is determined using the medical record. If the extent of dilution crosses the defined threshold, then a pre-infusion blood sample is used for serology testing. For infants younger than 3 months old with diluted blood, serology testing can be done using the blood from the biological mother.

Serology Testing [16]

CORE performs all serological and ABO testing at their in-house laboratory using FDA-approved screening kits for eye, tissue, and organ donors and for cadaveric specimens when available. All blood, urine, and bile samples are transported from the hospital to CORE’s laboratory with proper documentation and packaging following CORE’s standard protocol. A number of tests are conducted to ensure infection free transplantation and prevent blood group mismatch.

If any screening process or other information result in the donor not meeting criteria, the Administrator-on-call (AOC) at CORE will be notified. The AOC will make the final determination if the donor should be deferred.

Organ-specific Testing

CORE uses a battery of tests for organ-specific testing but the exact set of laboratory and diagnostic tests used vary from center to center (see Appendix B). The results of these tests determine which organs are suitable for recovery.



References
15. Donor Screening, in CORE Policies and Procedures 2011. Center for Organ Recovery & Education.
16. Donor Serology Testing, in CORE Policies and Procedures 2011. Center for Organ Recovery & Education.

Brain Death

Determination of Death by Neurologic Criteria

Determination of death by neurologic criteria, or brain death, is death. It is defined as the irreversible cessation of all brain functions including brain stem reflexes [18]. Because heart and lung function can be maintained in a dead patient using artificial means, sometimes people confuse “brain death” with other non-responsive states, such as coma, or persistent vegetative state (PVS). However, brain death determined using the 1995 American Academy of Neurology practice parameter means that there is no possibility of recovery of cognitive function or the ability of the brain to regulate and maintain bodily functions [19]. Brain death most typically occurs due to head trauma (traumatic brain injury), stroke or lack of oxygen to the brain.

In the United States, the diagnosis of brain death is guided by the Uniform Determination of Death Act [20]. This document sets the general legal standard for determination of brain death but does not establish the clinical criteria. The clinical criteria for determination of brain death are detailed in the 1995 American Academy of Neurology practice parameters [18].

Watch what the leading medical experts in the field have to say.

Brain death testing requires performing at least one neurologic examination (legally sufficient in most US states) if a certain period of time has elapsed since the injury to exclude any possibility of neurologic recovery. However some states including Pennsylvania and West Virginia require a second neurologic exam. The two exams may be conducted by the same physician but some hospitals may require two different physicians. The importance of the second neurologic exam lies in establishing the irreversibility of the condition determined in the first exam. An intervening observation period of 6 hours is recommended [18] but the supporting evidence is insufficient [19]. In children (37 weeks to 18 years), the recommended observation period is longer (12 hours for 1 year or older to 48 hours for 7 days to 2 months old) [21]. The diagnostic criteria for brain death are listed in Appendix A.



References
18. Practice Parameters: Determining Brain Death in Adults. Neurology, 1995. 45: p. 1012-14
19. Wijdicks, E.F., et al., Evidence-based guideline update: Determining brain death in adults: report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology, 2010. 74(23): p. 1911-8.
20. Defining Death: A Report on the Medical, Legal and Ethical Issues in the Determination of Death, in President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research1981.
21. Nakagawa, T.A., et al., Clinical report-Guidelines for the determination of brain death in infants and children: an update of the 1987 task force recommendations.Pediatrics, 2011. 128(3): p. e720-40.

Cardiac Death

Donation after cardiac death (DCD) is an alternative to donation after brain death when the latter is not feasible, such as: a) when brain death is not imminent or the brain death criteria cannot be met in spite of the presence of catastrophic brain injury and there is a request for withdrawal of life support.; and b) when brain death testing cannot be conducted due to severe hemodynamic instability [22, 23].

Donation after cardiac death is considered only after the patient’s treating physician has determined that there is no expectation of meaningful survival and after the family has made the decision to withdraw ventilator and oxygen perfusion support [24-26]. At this time, the OPC talks to the family about the process of withdrawing life-support and the opportunity for organ donation. The family is explained that there is a possibility that the patient may not die or may not provide transplantable organs [27]. Prior to withdrawing life-support, the patient is evaluated for the likelihood of passing away within 60 minutes. This involves several different respiratory evaluations including a ‘T-piece trial.’ The T-piece trial involves removing the patient from the ventilator and providing passive oxygen. The OPC explains to the family that patient is at risk of decompensating and experiencing a respiratory arrest during T-piece trial. The patient is monitored closely to see if he/she experiences a decrease in oxygen saturations and either 1) a decrease in respiratory rate or effectiveness of the breaths, or 2) a decrease or increase in the blood pressure. If the patient’s condition remains stable past the 30 minute mark, there is a high likelihood that the patient would not die within 60 minutes. Conversely, if the patient’s peak inspiratory pressure (PIP) is greater than 30 mm Hg, the patient is highly likely to pass away within 60 minutes.

Once it is deemed that the patient will pass away within 60 minutes, the T-piece trial is discontinued. The patient is taken to the operating room and -if the family has authorized organ donation- prepared for organ recovery. The family is then allowed to be present. Comfort measures are provided to the patient. The attending physician from the hospital is in charge of withdrawal of support. Once the physician deems that the patient is comfortable, ventilator and oxygen perfusion support is withdrawn. After the cessation of the cardiorespiratory function, a waiting period is observed before cardiac death is declared in case patients auto-resuscitate. The Society of Critical Care Medicine recommends a waiting period of 2 minutes [25] while the Institute of Medicine recommends a waiting period of 5 minutes [23, 24, 26]. Since there is no evidence that patients can auto-resuscitate after 2 minutes [23, 28], the American Society of Transplant Surgeons (ASTS) recommends a waiting period of 2 minutes to minimize warm ischemic injury to the organs and maximize their transplant potential [22]. Until the attending physician declares the patient dead, patient management continues to be under the control of the hospital and the recovery surgeon or team has no contact with the patient. When conflicting interests arise, as when a member of the transplant team shares patient care duties, the ASTS recommends that the transplant team member in such cases shall cede patient care responsibilities to someone who is not involved in the organ recovery/transplant process [22]. The recovery team comes only after the donor has been declared dead and after the family has had a moment with their deceased loved one. If the patient does not pass away in the expected time period, the donation process is aborted and the patient is returned to the intensive care unit or the ward and made comfortable [24, 29].



References
22. Reich, D.J., et al., ASTS recommended practice guidelines for controlled donation after cardiac death organ procurement and transplantation. Am J Transplant, 2009. 9(9): p. 2004-11.
23. Organ donation: Opportunities for action, 2006, Institute of Medicine: Washington, DC.
24. Non-heart beating organ transplantation: Medical and ethical issues in procurement, 1997, Institute of Medicine: Washington, DC.
25. Recommendations for nonheartbeating organ donation. A position paper by the Ethics Committee, American College of Critical Care Medicine, Society of Critical Care Medicine. Crit Care Med, 2001. 29(9): p. 1826-31.
26. Non-heart beating organ transplantation: Practice and Protocols, 2000, Institute of Medicine: Washington, DC.
27. Donation after cardiac death: A reference guide, 2004, United Network of Organ Sharing: Richmond, VA: UNOS.
28. Bernat, J.L., et al., Report of a National Conference on Donation after cardiac death. Am J Transplant, 2006. 6(2): p. 281-91.
29. Critical Pathway for Donation After Cardiac Death, United Network of Organ Sharing.

Recovery Process

Organ Recovery

Organs are recovered only after the donor has been declared dead and the family has had sufficient time to spend with the deceased, which is typically less for donation after cardiac death. This is because the donor is not on life support and quick recovery of organs is crucial for transplantation success. The organ recovery team can enter only after the family has left the operating room.

Dignity and respect for the donor are foremost considerations when recovery takes place. Before recovery can begin, the recovery team pauses to pay tribute to the donor whose gift of life will help someone in need. Organ recovery is a surgical procedure that is carried out in an aseptic environment. The recovery team prepares like any surgical team would prepare for surgery, following standard scrubbing and gowning protocols [31].

Organs are recovered en bloc and tissues are recovered as per established surgical protocols. Recovery is also conducted in accordance with any specific requests of the authorization. For example, if the donor had specific requests about which organs and tissues they would like to give, these requests will be honored by the recovery team, which will not remove any unauthorized organs or tissues.

Specific processes for recovery procedures and documentation may vary by OPO. CORE maintains detailed operative notes on the recovery procedure [6]. The organs are placed in sterile packaging and transported to the recipient’s transplant hospital. Time is critical at this point. Hearts and lungs can only be outside of a human body for 4-6 hours. Other organs can remain viable for slightly longer periods, but time is critical for all organ transplant surgeries. This is also why timely identification and referral of dying patients is so important.

Tissue Recovery

While organs must be recovered quickly after death and withdrawal of ventilator support, tissue recovery can take place up to 24 hours after a patient’s heart stops. Tissue recovery involves the procurement of bone, skin, veins, heart valves, corneas, tendons, and other gifts for transplantation. As with organ donation, tissue recovery is a surgical procedure conducted in an operating room under sterile conditions.

In cases of organ donation with subsequent tissue donation, tissue recovery usually takes place shortly after the organ recovery at the treating hospital. In cases where a patient cannot donate organs but is a tissue donor, arrangements may be made for recovery at a designated tissue recovery site outside the hospital. Depending on the tissues recovered, the surgical procedure can take 4-8 hours. CORE will work with the donor’s family to meet time expectations for funeral arrangements.

After tissue is recovered, it is packaged in sterile containers and sent to cold storage to a tissue processor. The tissue processing facility will review the donor’s medical records and administer additional lab tests to ensure that the tissue is safe for transplantation. Finally, the tissue processing facility will portion the tissues into bone, skin, tendon, valve and other types of tissue grafts to be used in surgical procedures for patients in need. Much of the tissue donated to CORE will be used in procedures for patients in Western Pennsylvania and West Virginia.



References
6. Operative Notes, in CORE Policies and Procedures, 2011.
31. General Recovery Procedures, in CORE Policies and Procedures, 2011.

Appendix A: Diagnostic Criteria for Determination of Neurologic Death

Prerequisites
  • Presence of Central Nervous System (CNS) catastrophe that is compatible with brain death
  • Absence of complications that may confound assessment of brain death including hypotension and acid-base imbalance
  • Absence of drug intoxication or poisoning, absence of sedation and neuromuscular blockage
  • Core temperature > 32oC (90oF)
Cardinal signs of neurologic death (Clinical Examination of Neurologic Death)

Coma

Coma is defined as having no cerebrally mediated motor response to noxious stimuli i.e. to nail-bed pressure in all extremities or no response in the head (e.g. supraorbital or temporo-mandibular joint pressure).

Absence of brainstem reflexes

Pupils

  • No response to bright light
  • Size: from mid-position (4 mm) to dilated (9 mm) (May also be pin-point)

Ocular movement

  • Occulocephalic relex (doll’s eyes) is absent1
  • Occulovestibular reflex is absent2
  • Facial sensation and facial motor response
  • No corneal reflex to touch with a cotton swab or gauze

Pharyngeal and tracheal reflexes

  • No response to stimulation of posterior pharynx with tongue blade
  • No cough response to bronchial suctioning

Apnea.

Apnea is defined as he absence of respiratory movement and exchange of gases.

Following conditions must be met prior to performing the apnea test.

  • Core temperature ≥ 36.5°C or 97.7°F
  • Arterial PCO2 ≥ 40 mm Hg
  • Arterial PO2 ≥ 100 mm Hg

Testing and confirmatory testing procedures for brain death:

A pre-test blood gas is drawn to ensure that above PO2 and PCO2 requirements have been met.

The patient is pre-oxygenated for 10 minutes with 100% oxygen via the ventilator. Apnea testing is done with pre-oxygenation[3] to eliminate respiratory nitrogen stores, accelerate oxygen transportation, and decreases the risk of hypoxic complications during apnea testing.

The ventilator is removed and the patient receives 100% oxygen via a passive means.

The patient is monitored for any signs of chest movement.

Arterial blood gases are drawn every two minutes until the following occurs:

  • PCO2 is greater than or equal to 60 mm of Hg
  • PCO2 is 20 mm Hg greater than pre-test level
  • The patient becomes unstable
  • At the end of the apnea testing the patient is placed back on the ventilator at the previous settings.

    Confirmatory testing

    Sometimes the patient is unstable before apnea testing or may become unstable during the test compelling the physician-on-call to abort the test. In such cases, alternative tests may be performed to determine brain death although some hospitals may require both apnea testing and confirmatory testing where both can be carried out. Tests that may be used for alternative testing include Cerebral Flow Scan, Transcranial Doppler Ultrasonography, Electroencephalography, and Cerebral Scintigraphy [33]. Electroencephalography was once the gold standard for determining brain death. However, EEG frequently gives false positive results and is therefore less accurate. The general trend across the country today is to use the cerebral flow scan.

    Cerebral Flow Scan

    This test provides unequivocal evidence of brain death. The test involves intravenous injection of radioactive isotope and taking static images at several time intervals including immediately after isotope injection, and between 30 and 60 minutes. To confirm that the isotope was injected into the blood stream, additional liver images may be taken to demonstrate uptake. If the images do not reveal blood perfusion in the brain, the patient is brain dead. Many hospitals however do not perform cerebral flow scans and therefore the radiology technicians and the radiologist may be unfamiliar with the procedure. A limitation of this test is that it may be false positive for patients who have undergone craniotomy or in children as they have a well perfused scalp.


    1Must assure that the spinal cord is intact prior to performing this examination.

    2Occulovestibular reflex is the deviation of the eyes to irrigation in each ear with 30-50 ml of ice water. Observe for 1 minute after irrigation and wait at least 5 minutes before testing on the opposite side.

    References
    33. Dixon, T.D. and D. Malinoski, Devastating Brain Injuries: Assessment and Management, Part I: Overview of Brain Death. Western Journal of Emergency Medicine, 2009. 10(1): p. 11-17.

    Appendix B: Tests used by CORE for organ-specific testing

    Heart donor
    • ECG
    • Chest radiograph
    • Echocardiogram
    • Cardiac catheterization if the potential donor is 50 years or older
    • Creatine kinase (CK), isoenzyme of CK with muscle and brain subunits (CK-MB), and troponin levels
    Lung donor
    • ABG on 100% FiO2; then, serial ABGs
    • Chest radiograph
    • Bronchoscopy
    • Chest CT Scan considered if potential donor is 50 years or older with smoking history of 20 pack years or more
    Pancreas donor
    • Serial blood glucose determinations
    • Amylase and lipase levels
    Liver donor
    • Liver function tests (LFTs)
    • Prothrombin time (PT)
    • Activated partial thromboplastin time (aPTT)
    Kidney donor
    • Electrolytes
    • Blood urea nitrogen (BUN)
    • Creatinine (Cr)
    • Glomerular Filtration Rate

    Appendix C: Donor Management in CORE’s designated service area

    In general, the goals of donor management are to achieve a set of specific critical care end points. The exact donor management guidelines and critical care endpoints vary by the OPO, the hospital as well as the specific organs being recovered [30]. These endpoints include:

    • Mean arterial pressure between 60 and 100 mm Hg
    • Central venous pressure between 4 and 10 mm Hg
    • Ejection fraction greater than 50%
    • Arterial blood gas pH between 7.3 and 7.45
    • PAO2:FIO2 >300 on PEEP = 5 cm H20
    • Serum Sodium level between 135 and 160 mEq/L
    • Blood glucose level less than 150 mg/dL
    • Hemoglobin level greater than 10mg/dL
    • Urine output between 1 and 3mL/kg/hr. for preceding 4 hrs

    In CORE’s designated service area, a potential organ donor is managed by the recovery team using the following protocol.

    Blood Pressure

    Systolic blood pressure is maintained above 100 mm of Hg. Alternatively, mean arterial pressure is maintained between 60 and 65 mm of Hg. Fluids (crystalloids, colloids and blood products) are infused to maintain adequate blood volume. Pressor drugs including Dopamine, Neosynephrine (Phenylephrine), Levophed (Norepinephrine), Epinephrine, Dobutamine and Vasopressin are administered to maintain blood pressure.
    The brain dead organ donor undergoes a number of metabolic changes. T3 & T4 is limited resulting in decreased glucose metabolism. Anaerobic metabolism occurs leading to metabolic acidosis, decreased muscle contractility, and decreased cardiac output.

    This is also responsible for myocardial irritability, and responsiveness to inotropic drugs, leading to further vasodilation, and variations in heart rate and rhythm. T3 and T4 (converted to T3) reverses this process [34,35]. Aerobic metabolism is once again established. T3 also replenishes myocardial energy stores, decreases serum lactate, and reduces inotropic support. This improves and stabilizes myocardial function. After 30 – 90 minutes, the donor will mostly likely become tachycardic, temperature and BP will rise. Titration of other pressors can then begin. CORE has developed its own hormone replacement regime for donor management in its designated service area.

    Electrolyte Balance

    All electrolytes (Na, K, Ca, Mg, PO4) are maintained at optimal level. Maintenance fluids are adjusted to balance for excess or depleted sodium and potassium. Central Venous Pressure is maintained between 6 to 8 mm of Hg. Urine output is maintained above 100 ml/hr.

    Diabetes Insipidus

    Diabetes Insipidus appears due to lack of Antidiuretic Hormone (vasopressin) and is characterized by urine output that is greater than 7 ml/kg/hr or 300 ml/hr with specific gravity of urine less than 1.005 and rising sodium levels. Diabetes Insipidus can be managed by Desmopressin infusion and replacing all urine in excess of 250 ml/hr with 0.2 NaCl.

    CORE uses following guidelines to ensure that the donor is adequately oxygenated:

    • Pa(O2)1> 100 mm Hg
    • Aspiration Precautions: over-inflate cuff, kerlex
    • Titrate Fi(O2)2to maintain Sa(O2)3> 98%
    • Tidal Volume between 10 to 12 ml/kg
    • Maintain PEEP4at 5-8 cm H2O
    • Rate adjusted to maintain normal pH (7.35-7.45)
    • Suction airway as indicated.

    If the patient meets the criteria for lung donation, these additional requirements are followed:

    •Recruit lungs to maximize functionality

    •Ventilator settings: Tidal Volume 12ml/kg ideal body wt, rate 10, PEEP at 5 cm H2O, Fi(O­2)

    1.0 (02 Challenge)

    •Mucomyst & Albuterol q3 hrs

    •Solumedrol 15 mg/kg IV

    •Chest physiotherapy

    •P(O2) > 300 & PAP < 30= Donor

    •P(O2) < 300 & PAP > 30 =further evaluation with bronch

    Warming and cooling blankets are used to maintain body temperature above 32oC.

    In a brain dead donor, the body is no longer able to control insulin regulation. Blood sugar is closely monitored (every 2 hrs. or every hour if necessary). Insulin drip may be used after consulting with the OPC.


    1Partial pressure of oxygen in arterial blood.

    2Fraction of inspired oxygen maintained in a mechanically ventilated patient.

    3Arterial oxygen saturation as measured by pulse oxymetry. Measures tissue perfusion of oxygen.

    4Positive End Expiratory Pressure. Positive pressure ventilation keeps the alveoli patent.

    References
    30. Malinoski, D.J., et al., Achieving Donor Management Goals Before Deceased Donor Procurement Is Associated With More Organs Transplanted Per Donor. The Journal of TRAUMA Injury, Infection, and Critical Care, 2011. 20(30): p. 1-6.
    34. Novitzky, D., D. Cooper, and B. Reichert, Hemodynamic and metabolic responses to hormonal therapy in brain-dead potential organ donors. Transplantation, 1987. 43: p. 852-54.
    35. Jeevanandam, V., B. Todd, and T. Regillo, Reversal of donor myocardial dysfunction by triiodothyronine replacement therapy. Journal of Heart Lung Transplant, 1994. 13: p. 681-87.