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More than 28,000 organ transplants occurred in the United States in 2010, and as of November 2011, approximately 110,000 candidates were waiting to receive one or more organs from a willing donor.1,2 Many nurses and nurse managers are familiar with the organ donation protocols used in their medical facility, but most are unaware of the legal framework under which organ donation is conducted and the complex network of government and private agencies that support organ procurement and transplantation.
We detail the regulations and organ network structure for organ, tissue, and eye donation, issues of consent and liability, and myths surrounding this often misunderstood process.
The National Organ Transplant Act (NOTA) of 1984 established the Organ Procurement and Transplantation Network (OPTN) with the intent of creating a unified public-private partnership of organizations involved with the donation and transplantation process.3 Under federal law, all U.S. transplant centers and organ procurement organizations (OPOs) are required to be members of the OPTN to receive Medicare funding.4
The United Network for Organ Sharing (UNOS) is responsible for administering the OPTN under a federal contract awarded through the Health Resources and Services Administration of the U.S. Department of Health and Human Services.5 This private, non-profit organization is charged with managing the national transplant waiting list and database of all organ transplant data, matching donors through a secure web-based system, and developing standardized policies and procedures for the OPTN.6 Its board of directors consists of 41 elected members that include regional UNOS counselors, transplant surgeons, physicians and coordinators, other medical experts, and members of the general public such as transplant candidates and recipients.6
The OPTN consists of 58 OPOs responsible for the coordination of the organ donation process on a state or regional level, including checking the state donor registry to confirm a potential donor's status, matching the organ donor's information with the OPTN national waiting list of potential recipients, providing a medical evaluation of the potential donors, and discussing donation with family members.7 OPOs are non-profit organizations governed by a board of directors and have a medical director on staff who's typically a transplant surgeon or physician.8 OPOs are also actively engaged in direct marketing and community outreach activities designed to educate the public about the benefits of organ donation and increase the number of registered potential donors.
The state or regional registries contain information on a potential donor's legal consent given during his or her lifetime. Most registries allow persons wishing to give their legal consent to be a donor (or conversely, their desire not to be a donor) to complete an online application that allows them to specify which organs and human tissue they're willing to donate and whether such donations can be used for transplant and/or research purposes.
Tissue donation is strictly regulated by the FDA. The American Association of Tissue Banks (AATB) is an accreditation program established to provide assurance that tissue banks understand and comply with standards for tissue banking, which are published and amended when necessary. The FDA is also the regulatory agency that oversees ocular tissue. The Eye Bank Association of America (EBAA) is the nationally recognized accrediting body for eye banks. A team of professionals with extensive experience in eye banking and/or corneal transplantation conduct site inspections of eye banks at least every 3 years to evaluate adherence to EBAA medical standards and procedures.
Who can donate? The Revised Uniform Anatomical Gift Act (UAGA) sets forth who may donate, consent, revoke, and receive anatomical gifts, along with prohibited acts, permitted acts, and required documentation with regard to anatomical gift donations. In accordance with the UAGA, any adult (over age 18 or an emancipated minor) may make an anatomical gift of his or her body or body parts.9
In the event a deceased person didn't make his or her wishes known before death, the UAGA outlines certain individuals that may make an anatomical gift on the deceased's behalf in writing or in an oral communication that's electronically recorded or contemporaneously put into writing and signed by the individual receiving the oral consent.10 Generally, an anatomical gift may be made for the purpose of transplantation, therapy, research, or education by the following persons in this order of priority:
1. agent of the deceased at the time of death
2. spouse of the deceased
3. adult children of the deceased
4. parents of the deceased
5. adult siblings of the deceased
6. adult grandchildren of the deceased
7. grandparents of the deceased
8. an adult who exhibited special care and concern for the deceased
9. persons who were acting as the guardians of the deceased at the time of death
10. any other person having the authority to dispose of the deceased's body.11
The UAGA also addresses the priority of the medical examiner and the cooperation between the medical examiner and the OPO. It's advisable to check your state law regarding statutes addressing who can donate and order of priority, including the priority of the coroner or medical examiner.
Consent and revocation of consent. Nearly all states have a mechanism by which drivers can give their consent to donate through the Department of Motor Vehicles (DMV) and their status as a donor will be delineated on their driver's license. A donor may make the intent of the anatomical gift known by authorizing a statement that will be printed on the donor's driver's license or identification card, in a will, in a living will or advance directive, or during a terminal illness or injury (with certain qualifications).12 As aforementioned, they may also give their legal consent by directly contacting their state donor registry and completing a donor application form online. Many state donor registries receive electronic data transfers containing donor status information from their respective DMV so that it can be compiled and accessed in the future by the OPO.
If an individual no longer wants to be a donor, he or she can amend or revoke the anatomical gift any time before death by a signed record or a document that amends or revokes the previous anatomical gift or a portion of the gift signed by another person acting on behalf of the donor if the donor is physically unable to sign, or by amending or revocation of a will (if the donation was made in a will).13
Effect of a valid consent to donate. Unless otherwise indicated by the donor, any person other than the donor is barred from making, amending, or revoking an anatomical gift of the donor's body or body part.14 Note, however, that this section of the UAGA is based more on premise than in practice. On premise, the express wishes of the donor are to be honored upon death based on the UAGA guidelines; however, in practice, healthcare providers are often reluctant to proceed with donation without a family member's consent because of lack of medical history or because of the fear of conflict, a lawsuit, controversy, or bad publicity.
The decision and valid consent of the individual to donate should be the most important factor in determining if a donation is or isn't permissible. A few well-known lawsuits have emphasized the importance of respecting an individual's decision, privacy, and autonomy, even when the individual is unconscious or incapacitated. Despite well-established UAGA guidelines, blocked organ donations based on family refusals-even in light of the individual's wish to donate-constitute a major source of lost donations.15 In some cases, concern that removing or accepting an organ surrounded by controversy or negative publicity might decrease the possibility of future donations or create an ethical dilemma for the provider, hospital, or OPO may result in organs remaining with the intended donor after death, despite the donor's expressed intent during his or her lifetime.15
After the landmark 1976 Karen Ann Quinlan case that pioneered the Right to Die Movement, many states began enacting advance directive legislation, giving individuals the right to direct treatment in the event they should become incapacitated.16 An advance directive, or living will, may contain documentation of an individual's desire and intent to donate. In some states, penalties may be imposed if the advance directive or advance directive legislation isn't followed. Although each state has its own penalties, they can generally be grouped into four categories:
1. financial liability
2. charges of unprofessional conduct
3. licensure-related consequences
4. charges of criminal (misdemeanor) activity.16
It's important for providers, hospitals, and OPOs to know if there are penalties in their state for failure to follow an advance directive or advance directive legislation.
Limitation on liability. Hospitals and critical access hospitals (CAHs) that receive funds from Medicare or Medicaid must have written protocols and policies for the identification of potential organ donors.17 The protocol or policy must ensure that families of potential donors are made aware of the option to donate organs or tissue and the option to decline donation.18 Also, the protocol or policy must encourage discretion and sensitivity with respect to potential donation and family values, views, and beliefs.19 Finally, the protocol or policy must ensure that the hospital notifies the designated organ procurement agency of the potential organ donor.20 For hospitals and CAHs to limit their liability, they must write, implement, and follow protocols or policies in accordance with federal law, as well as demonstrate discretion and sensitivity in dealing with the deceased person's family members and adhere to the deceased person's wishes in accordance with the policy, protocol, and state law.
The UAGA also sets forth immunity or limitations on civil, criminal, and administrative liability for persons that act in good faith. Generally, if the procurement and use of the body or part was done in good faith, it means it was done in an honest and sincere manner and without any intent to seek an unfair advantage. Therefore, in the event a lawsuit is filed, the provider, hospital, or OPO can show that it acted in good faith with regard to the organ or tissue procurement, decreasing its liability.
Despite public education efforts among medical professions and the public, many myths and misconceptions persist regarding organ donation. Anyone can be a potential donor regardless of age, race, or medical history.21 The gift of transplantation is started with initial notification from a federally designated third party to the organ procurement agency, tissue recovery agency, or eye bank that an individual has died or met preliminary criteria for donation.21 The notifying third party is most likely a hospital, medical examiner, funeral home, or family member. At that time, an initial determination of donor eligibility is made based on predefined criteria and the donor information that's available at the time (age, medical diagnosis, cause of death, immediate evidence of infection, and so on).
If it's determined that the deceased individual is a candidate for donation, the state donor registry is searched for a match. If the candidate is a registered donor, the registration document serves as legal and binding consent. A thorough medical evaluation will be performed, along with a detailed medical and social history interview from an individual who knew the deceased. If the potential donor isn't found on the registry, his or her legally authorized representative is offered the opportunity to authorize the donation.
The type of donation offered to the family depends on the criteria set forth by the OPO, tissue agency, or eye bank regarding the type of donation: organs, tissues, and ocular tissue, respectively. Organ donation is considered life saving and can occur with:
* a deceased donor, who can give kidneys, pancreas, liver, lungs, heart, or intestinal organs.
* a living donor, who can give a kidney, or a portion of the liver, lung, intestine, or pancreas.22
Tissue donation, however, is considered life enhancing. This includes long bones of the arms and legs, connective tissue, skin, and heart for valves and veins. Tissue donation must be initiated within 24 hours of death. Unlike organs, tissue can be processed and stored for an extended period of time for use in burn cases, ligament repair, or bone replacement.23
Ocular tissue is necessary for the preservation and restoration of sight and often dramatically improves the quality of life for recipients. Recovery of ocular tissue must be initiated within 12 hours after death. However, this time frame may vary depending upon the eye bank. Corneal tissue can be transplanted up to 14 days after recovery.24
It's the goal of the OPO, tissue recovery agency, and eye bank to work with the medical examiner and funeral home to ensure the families' wishes are respected and followed with compassion and dignity.
Healthcare professionals are taught the skills to deal with incurable diseases and medical and surgical emergencies, but often aren't taught about organ donation after a person succumbs to those injuries or diseases. Every day, healthcare professionals must make phone calls informing family members that a loved one has died. Conversely, many people in this country are waiting for the call that will save their lives: they've been matched with a donor. Healthcare professionals have the responsibility to educate bereaved family members on the process and importance of organ donation during this critical window of time. Key leadership is needed within healthcare organizations to ensure policies and procedures are implemented that align with the legal and organizational framework of organ donation on local, state, and federal levels.
* NOTA: This Act, created in 1984, established the OPTN.
* OPTN: A unified public-private partnership of organizations involved with the donation and transplantation process. Under federal law, all U.S. transplant centers and OPOs are required to be members of the OPTN to receive Medicare funding.
* UNOS: A private, non-profit organization charged with managing the national transplant waiting list and database of all organ transplant data, matching donors through a secure web-based system, and developing standardized policies and procedures for the OPTN.
* OPOs: Organ procurement organizations
* AATB: An accreditation program established to ensure that tissue banks understand and comply with standards for tissue banking.
* EBAA: The nationally recognized accrediting body for eye banks.
* UAGA: This Act, revised in 2006, sets forth who may donate, consent, revoke, and receive anatomical gifts, along with prohibited acts, permitted acts, and required documentation with regard to anatomical gift donations.
1. Organ Procurement and Transplantation Network. Data reports: Transplants in the U.S. by state. http://optn.transplant.hrsa.gov/latestData/rptData.asp. [Context Link]
2. Organ Procurement and Transplantation Network. Data reports: Current U.S. waiting list. http://optn.transplant.hrsa.gov/latestData/rptData.asp. [Context Link]
3. Organ Procurement and Transplantation Network. About OPTN. http://optn.transplant.hrsa.gov/optn. [Context Link]
4. Organ Procurement and Transplantation Network. About OPTN-Profile. http://optn.transplant.hrsa.gov/optn/profile.asp. [Context Link]
5. United Network for Organ Sharing. About us. http://www.unos.org/about/index.php. [Context Link]
6. Organ Procurement and Transplantation Network. Members-Board Q&A. http://optn.transplant.hrsa.gov/members/bodQA.asp. [Context Link]
7. Organdonor.gov. Organ procurement organizations. http://www.organdonor.gov/materialsOpoList.asp. [Context Link]
8. Organ Procurement and Transplantation Network. Donation and transplantation-Donor matching system. http://optn.transplant.hrsa.gov/about/transplantation/matchingProcess.asp. [Context Link]
9. UAGA Sections 1 and 4. http://www.law.upenn.edu/bll/ulc/uaga/2006final.htm. [Context Link]
10. UAGA Section 10. http://www.law.upenn.edu/bll/ulc/uaga/2006final.htm. [Context Link]
11. UAGA Section 9. http://www.law.upenn.edu/bll/ulc/uaga/2006final.htm. [Context Link]
12. UAGA Section 5. http://www.law.upenn.edu/bll/ulc/uaga/2006final.htm. [Context Link]
13. UAGA Section 6. http://www.law.upenn.edu/bll/ulc/uaga/2006final.htm. [Context Link]
14. UAGA Section 8. http://www.law.upenn.edu/bll/ulc/uaga/2006final.htm. [Context Link]
15. Reeves RR, Agin WS, Rose ES, Reynolds MD, Beazley AR, Douglas SP. When is an organ donor not an organ donor? South Med J. 2004;97(12):1259-1261. [Context Link]
16. Iltis AS, Rie MA, Wall A. Organ donation, patient's rights, and medical responsibilities at the end of life. Crit Care Med. 2009;37(1):310-315. [Context Link]
17. 42 U.S.C. [S]1320b-8 et.seq. [Context Link]
18. 42 U.S.C. [S] 1320b-8 (a)(1)(A)(i) [Context Link]
19. 42 U.S.C. [S] 1320b-8 (a)(1)(A)(ii) [Context Link]
20. 42 U.S.C. [S] 1320b-8 (a)(1)(A)(iii) [Context Link]
21. Donate Life America. http://www.donatelife.net. [Context Link]
22. http://Organdonor.gov. About donation and transplantation. http://www.organdonor.gov/about. [Context Link]
23. American Association of Tissue Banks. http://www.aatb.org. [Context Link]
24. Eye Bank Association of American. http://www.restorsight.org. [Context Link]
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