End of Life Care Manual
Section 7: State and Federal Law on Organ Procurement
Washington state law governing organ procurement is encompassed in the revised Uniform Anatomical Gift Act. (1) Among other things, the Act delineates who may donate organs, who may receive a donated organ, and the obligations placed on hospitals and physicians to facilitate donations. Organ donation is generally referred to in the Act as an "anatomical gift". The Act is concerned with increasing organ donation and reducing the ratio between available organs and individuals needing a transplant.
In addition to the revised Uniform Anatomical Gift Act, the Centers for Medicare and Medicaid Services (CMS) Conditions of Participation and the Joint Commission standards on organ procurement set out requirements hospitals must meet. The Medicare Conditions of Participation are comprehensive and require specific hospital procedures and protocol, including collaboration with organ and tissue procurement organizations. The Joint Commission standards closely conform to those set forth by CMS.
The revised Uniform Anatomical Gift Act, the Medicare Conditions of Participation, and Joint Commission standards are discussed below.
Relevant law and regulations are discussed in this section. At the end of this section is a list of resources, including a resource guide from the Department of Health and Human Services prepared to assist hospitals in complying with the law. This information provides program suggestions, a resource list of government agencies and advocacy organizations, and general information on organ procurement.
To summarize, the law on organ procurement for hospitals in Washington state requires:
- Any adult, emancipated minor, or minor aged 15½ or older may donate all or part of his or her body for transplantation, therapy, research, or education. Donations may be rescinded or revoked in some circumstances.
- Family consent is not needed if an adult has expressed the desire to be an organ or tissue donor upon death.
- Hospitals and medical personnel are required to ask any deceased individual's next of kin, at or near the time of death, whether the deceased is an organ donor.
- Hospitals must enter into agreements or affiliations with organ procurement organizations to coordinate the procurement and use of anatomical gifts.
The information presented in this section outlines the legal obligations of hospitals that do not perform organ, tissue, or eye transplantations in their facilities. This information is not comprehensive for hospitals that have transplant centers or facilities.
The Revised Uniform Anatomical Gift Act
The revised Uniform Anatomical Gift Act (UAGA) is contained in RCW 68.64.010 through 68.64.903. The UAGA was revised in 2008 to generally comply with the federal revised Uniform Anatomical Gift Act. Uniformity among state laws was sought in order to facilitate speed and efficiency in donations and transplantations across state boundaries. In addition to increasing uniformity, the revised UAGA allows individuals as young as 15½ to donate, sets up new rules addressing decision-making by next of kin, and dictates a process hospitals and physicians must follow in the event of a conflict between an advance directive and a document addressing organ donation. The revised UAGA also allows the Department of Licensing to transfer all information relating to organ and tissue donors to any Washington state organ procurement organization that intends to establish a statewide organ and tissue donor registry. (2)
Hospitals should be aware that under the new Act:
- Hospitals must enter into agreements or affiliations with at least one procurement organization to facilitate coordination of procurement and use of anatomical gifts. (3)
- Neither the physician who attends a decedent at death, nor the physician who determines time of death, may participate in procuring the decedent's organs. (4)
- Unless the individual expressed contrary intent, a hospital must take measures to ensure the medical suitability of an individual at or near death while a procurement organization examines the patient for suitability as a donor. (5)
- If there is a conflict between an advance directive and the measures necessary to ensure suitability to donate under the terms of an anatomical gift donation, measures must be taken to ensure the medical suitability of the prospective donor while the conflict is resolved. Measures may only be withheld if they are contraindicated by appropriate end-of-life care. (6)
Hospitals are still obligated to take specific steps to inquire about organ donation, document the inquiry, and designate a hospital representative to discuss organ donation with patients near death. While the revised UAGA no longer imposes these obligations on hospitals, they are still required by both CMS and the Joint Commission.
The following is an overview of the revised UAGA:
The Act defines an anatomical gift as "a donation of all or part of a human body to take effect after the donor's death for the purpose of transplantation, therapy, research, or education." (7) While all four purposes are valid, if a donation is made for more than one purpose, transplantation or therapy is given priority over research or education. (8)
Who may donate
The donor may make an anatomical gift during his or her lifetime if the donor is an adult, an emancipated minor, or 15½ (the age at which a minor may apply for a driver's license). An individual other than the donor may make an anatomical gift if:
- the person is expressly authorized to make health care decisions on the donor's behalf via power of health care attorney or expressly authorized to make an anatomical gift by the donor.
- the person is the parent of an unemancipated minor donor (however, this donation expires once the donor is emancipated or reaches adulthood).
- the person is the donor's guardian. (9)
With the exception of unemancipated minors, once a donor has made an anatomical gift, all other persons are prohibited from making, amending, or revoking the gift. (10)
If a person has not documented a preference with respect to donation of organs or body parts, the statute allows other interested persons to consent to donation. Absent a deceased person's instructions not to donate, RCW 68.64.070 lists seven classes of persons authorized to consent to donation on behalf of the deceased person. Consent must be obtained in the following order of priority:
- the agent of the decedent (holder of power of attorney for health care or expressly authorized to make an anatomical gift by a signed record;
- the spouse or state registered domestic partner of the decedent;
- the adult child of the decedent;
- the parents of the decedent;
- adult siblings of the decedent;
- adult grandchildren of the decedent;
- grandparents of the decedent;
- any person acting as the guardian of the person of the decedent at the time of death;
- any other person having authority under applicable law to dispose of the decedent's remains. (11)
If a member of a higher class is reasonably available to make a donation decision, individuals in lower classes may not make the decision. (12) Any anatomical gift made by an authorized person may be revoked or amended by any member of a prior class, orally or in writing. (13) However, revocation is only effective if the procurement organization, transplant hospital, physician, or technician knows of the revocation before an incision is made to remove the donated body part or before the transplant procedures have begun on the recipient. (14) Once these procedures have begun, any revocation is moot.
If there is more than one person in any of the above classes, any member may make the decision to donate all or part of the decedent's body, unless the person or the entity who will receive the organ knows that another member of the class objects. If so, the donation may only be made if by a majority of the members who are reasonably available. Reasonably available is defined as "able to be contacted by a procurement organization without undue effort" and willing and able to give timely consent. (15)
Instruments of donation
A donor may make an anatomical gift via a "document of gift", a will, or a communication addressed to one adult and one disinterested witness during a terminal illness or injury. A "document of gift" is "a donor card or other record used to make an anatomical gift. The term includes a statement or symbol on a driver's license, identification card, or donor registry." (16) Note that revocation, suspension, expiration, or cancellation of a driver's license or identification card does not void the donation.
An authorized person may make an anatomical gift for a decedent via a document of gift signed by the person or by oral communication contemporaneously recorded and signed. (17)
Refusal, revocation, and amendment of gift
A donor may, during his or her lifetime, amend or revoke an anatomical gift via a signed record or a later-executed document of gift. An authorized person (an agent, parent, or guardian) may revoke or amend a gift via a signed record witnessed by two adults, one of whom is a disinterested witness. (18)
An individual may also execute a refusal to donate. This may be done in the same manner as amendment or revocation, in a will, or any form of communication to two witnesses during a terminal injury or accident. (19) An individual's unrevoked refusal to donate bars any donation by any other persons.
A donor or authorized person may also revoke an anatomical gift by destroying or cancelling the document of the gift with the intent to revoke. (20)
Any donation made by an authorized person on behalf of a decedent may be amended or revoked by a person of a prior class. If multiple members of a class are reasonably available, the gift can be amended only if the majority of the available members agree. (21) Similarly, the gift can only be revoked if a majority of the available members agree or are equally divided. (22)
The revised UAGA makes it clear that, absent express action by the donor, organ donation should be encouraged and facilitated. Thus, under the Act, revocation by a donor of an anatomical gift is not a refusal and does not bar an authorized person from making an anatomical gift. (23) Refusal to donate by an individual other than the donor does not stop another authorized person from making a donation. (24) Absent an express, contrary indication, an anatomical gift of a specific body part is not a refusal to donate another part and does not limit donation of another part by the donor or another. (25) Similarly, absent an express, contrary indication, an anatomical gift made for a specific purpose (transplantation, therapy, research, or education) does not limit making a gift for another purpose.
An individual who acts in accordance with the UAGA, or attempts to do so in good faith, is not liable for the act in a civil action, criminal prosecution, or administrative proceeding. (26)
Advance Directives and Organ Donation
The revised Uniform Anatomical Gift Act specifically addresses the possibility of a conflict between an advance directive and measures necessary to ensure medical suitability for organ donation. If a prospective donor's advance directive or declaration and the terms of a potential anatomical gift are in conflict regarding the measures necessary to ensure medical suitability of a donated organ or body part, the donor's attending physician and donor (or agent or authorized person if donor is incapacitated) must confer to resolve the conflict. (27) Conflicts are to be resolved expeditiously. While the conflict exists, measures must be taken to ensure the medical suitability of the prospective donor while the conflict is resolved. Measures may only be withheld if they are contraindicated by appropriate end-of-life care. (28)
Nursing Homes and Organ Donation
Nursing homes are regulated under WAC 388-97-065, entitled Advance Directives, which refers specifically to organ and tissue donation. The term "advance directive" in the section specifically encompasses organ donation. This regulation is discussed in Section One of this manual and the text appears in Section Three.
Medicare and Medicaid Conditions of Participation on Organ Procurement
The Centers for Medicare and Medicaid Services (CMS) issued Conditions of Participation on organ procurement designed to increase organ donation. (29) The regulations impose several requirements a hospital must meet. They became effective August 21, 1998.
The CMS Conditions of Participation are the requirements hospitals must meet to participate in the Medicare and Medicaid programs. They are intended to protect patient health and safety and to assure that high quality care is provided.
These requirements apply to all Medicare and Medicaid participating hospitals including: short term, psychiatric, rehabilitation, long-term, children's, and alcohol-drug hospitals, whether or not they are accredited. This rule does not apply to Critical Access Hospitals (see Social Security Act, Section 1861(e)). However, the Conditions of Participation for Critical Access Hospitals include requirements for organ, tissue, and eye procurement that mirror the written protocols that hospitals must have. (30) The obligations regarding written protocols apply to both hospitals and Critical Access Hospitals, but the portion on organ transplantation responsibilities does not apply to Critical Access Hospitals.
The CMS organ procurement regulations codified in 42 C.F.R., Section 482, Conditions of Participation: organ, tissue, and eye procurement, require hospitals to:
- Have and implement written protocols that:
- Establish an agreement with an organ procurement organization (OPO) under which the hospital will notify the OPO, in a timely manner, of every individual whose death is imminent or who has died in the hospital ? this step is taken prior to approaching the family to determine patient suitability. (31) Notification must be made for every individual who has died at the hospital, or whose death is imminent, regardless of medical suitability. The organ procurement organization will determine suitability after notification. (32) CMS interpretive guidelines direct that these written protocols must define "imminent death" and "timely notification," specify notification methods and triggers, and permit regular access to the hospital's death record information.
- The OPO must be one designated by the Secretary of the Department of Health and Human Services.
- The OPO may designate a third party to receive the notifications of patient death.
- The OPO determines the patient's medical suitability for organ donation.
- The OPO determines medical suitability for tissue and eye donation, absent an alternative arrangement by the hospital.
- When death is imminent, the hospital must notify the OPO both before a potential donor is removed from a ventilator and while the potential donor's organs are still viable.
- Establish an agreement with at least one tissue bank and at least one eye bank to cooperate in the retrieval, processing, preservation, storage, and distribution of tissues and eyes, as may be appropriate to assure that all usable tissue and eyes are obtained from potential donors. (33)
- The agreement must not interfere with organ procurement.
- The tissue bank and eye bank define "usable tissue" and "usable eyes."
- Ensure, in collaboration with an OPO, that the family of each potential donor is informed of the options to donate organs, tissue, or eyes, or to decline to donate. (34) If possible, the OPO and hospital representatives should approach the family together.
- The individual designated to approach family members must be either an organ procurement representative or a designated requestor.
- A designated requestor is an individual who has completed a course offered or approved by the OPO and designated in conjunction with the tissue and eye bank community on how to approach families and request organ or tissue donation. The designated person may also be a representative of the organ procurement organization. (35)
- Encourage discretion and sensitivity with respect to the circumstances, views, and beliefs of the families of potential donors. (36)
- Using discretion does not mean a judgment can be made by the hospitals that certain families should not be approached. Hospitals should approach all families with the belief that a donation is possible, treating family members with care and respect. The hospital staff's perception that a family's grief, race, ethnicity, religion, or socioeconomic background would prevent donation should never be used as a reason not to approach a family.
- Ensure that the hospital works cooperatively with the designated OPO and at least one tissue bank and one eye bank in educating staff on donation issues, reviewing death records to improve identification of potential donors, and maintain potential donors with necessary testing and ensure that placement of organs and tissues takes place. (37)
- Comply with organ transplantation responsibilities:
- A hospital that performs transplants must be a member of the Organ Procurement and Transplantation Network (OPTN) and abide by its rules. (38)
- The OPTN is established and operated under the Public Health Service Act. (39)
- If a hospital performs any type of transplant, it must provide organ-transplant-related data, as requested by the OPTN, the Scientific Registry, and the organ procurement organization. (40)
- The hospital must also supply this data to the Secretary of HHS when requested to do so.
- The term "organ" in these standards means a human kidney, liver, heart, lung, or pancreas. (41)
When the CMS regulations were published, they referenced a study demonstrating that family members of a deceased individual are much more likely to consent to organ donation when the following three elements are in place at the time of request:
- First, family members must be given time to understand and accept their relative's death before the donation request is made.
- Second, consent rates are higher when the request is made by the OPO in conjunction with the hospital staff. In the study, either their requests were made at the same time, or the OPO made a formal request after the designated hospital staff mentioned organ donation.
- Third, the setting in which the request is made should be quiet and private, such as a conference room or family meeting room. (42)
The Joint Commission Accreditation
The Joint Commission's 2007 Comprehensive Accreditation Manual for Hospitals contains standards that are very similar to the CMS Conditions of Participation. Organ procurement is addressed in Leadership (LD) standard 3.110 and the companion elements of performance, which was newly amended in January of 2007. Any Joint Commission-accredited facility, including hospitals, outpatient clinics, and nursing homes, must adhere to the Joint Commission standards in order to retain accreditation.
The Joint Commission does not require hospitals to ask patients about their organ donation wishes unless required by law, regulation, organization policy or procedure, or by agreement with an Organ Procurement Organization. If organ donation is specified in a patient's advance directive or verbally expressed by the patient, the hospital should approach this wish as it would all other portions of an advance directive. This includes honoring the patient's wishes within the limits of the facility's capacity. (43) (See Section One for Joint Commission standards regarding advance directives.)
The following Joint Commission standards address organ procurement:
Leaders implement policies and procedures developed with the medical staff's participation for procuring and donating organs and other tissues.
- Organ procurement policies and procedures apply to all potential organ donors.
- Hospitals must:
- Have an agreement with an appropriate organ procurement organization (OPO) and follows its rules and regulations.
- Have an agreement with at least one tissue bank and at least one eye bank (so long as the process does not interfere with organ procurement) to cooperate in retrieving, processing, preserving, storing, and distributing tissues and eyes.
- Belong to the organ procurement and transplantation network (OPTN) and follow its rules and regulations if the hospital transplants organs.
- Provide all organ transplant-related data upon request of the OPTN, the Scientific Registry, or the hospital's designated OPO.
- The hospital must have policies and procedures for organ and tissue procurement and donation, including the following elements:
- the OPO with which the hospital is affiliated;
- the OPO is notified of a patient who has died or whose death is imminent prior to the withdrawal of life-sustaining therapies, within the time jointly agreed upon by the hospital and OPO, and according to the triggers mutually agreed upon;
- the OPO determines medical suitability for organ donation and, in the absence of alternative arrangements by the hospital, for tissue and eye donation;
- procedures, mutually developed with the OPO, for notifying the family of each potential donor of the option to donate ? or decline to donate ? organs, tissues, or eyes;
- written documentation by the hospital's designated requestor showing that a patient or family accepts or declines the opportunity to donate organs or tissues;
- staff education includes training in the use of discretion and sensitivity to the circumstances, beliefs, and desires of the families of potential donors;
- the hospital maintains records of potential donors whose names have been sent to the OPO and tissue and eye banks; and
- the hospital works cooperatively with the OPO, tissue, and eye banks in order to:
- review death records to improve identification of potential donors;
- ensure the necessary testing and placement of potentially donated organs, tissues, and eyes takes place to maximize viability;
- educate staff about donation issues; and
- develop a donation policy that addresses opportunities for asystolic recovery, based on an organ potential for donation that is mutually agreeable by the OPO, hospital, and medical staff.
The hospital addresses the wishes of the patient relating to end-of-life decisions.
- The hospital documents and honors the patient's wishes concerning organ donation within the limits of the law or hospital capacity.
The hospital provides initial orientation.
Training should include:
- Hospital-wide policies and procedures (including safety and infection control) and relevant unit, setting, or program-specific policies and procedures.
- Specific job duties and responsibilities and service, setting, or program-specific job duties and responsibilities related to safety and infection control.
- Cultural diversity and sensitivity.
- Education about patient safety and ethical aspects of care, treatment, and services and the process used to address ethical issues.
Ongoing education, including in-services, training, and other activities, maintains and improves competence.
Ongoing education must be documented and ought to:
- Increase staff knowledge of work-related issues, laws, regulations, and the needs of the patient population.
- Occur when job responsibilities or duties change.
- Emphasize specific job-related aspects of safety and infection prevention and control.
- In 2008, the Washington state legislature adopted the revised Uniform Anatomical Gift Act, issued by the National Conference of Commissioners on Uniform State Laws (NCCUSL) in 2006. Second Engrossed Substitute H.B. 1637, 60th Leg. Sess., Reg. Sess. (Wash. 2008).
- RCW 68.64.200.
- RCW 68.64.140.
- RCW 68.64.120(9).
- RCW 68.64.120(3).
- RCW 68.64.180(2).
- RCW 68.64.010(3).
- RCW 68.64.100(4).
- RCW 68.64.030.
- RCW 68.64.070(1).
- A hospital or physician may rely on the representations made by individuals regarding their status as a member of a class authorized to make donation decisions, unless the hospital or physician knows the representation is false. RCW 68.64.170.
- RCW 68.64.080(3).
- RCW 68.64.090(2).
- RCW 68.64.090(3).
- RCW 68.65.010(24).
- RCW 68.64.010.
- RCW 68.64.090(1).
- RCW 68.64.050(1)(b).
- RCW 68.64.060(1) & (2).
- RCW 68.64.050(3).
- RCW 68.64.090(2)(a).
- RCW 68.64.090(2)(b).
- RCW 68.64.070(2).
- RCW 68.64.070(3).
- RCW 68.64.070(5).
- RCW 68.64.170(1).
- RCW 68.64.180(2).
- RCW 68.64.180(2).
- The statutory authority for the Conditions of Participation for organ donation is derived in part from section 1138 of the Social Security Act, entitled "Hospital protocols for organ procurement and standards for organ procurement agencies."
- 42 C.F.R. § 485.643.
- 42 C.F.R. § 482.45(a)(1) and 42 C.F.R. § 485.643(a).
- CMS Interpretive Guidelines, State Operations Manual, Appendix A ? Survey Protocol, Regulations and Interpretive Guidelines for Hospitals, www.cms.hhs.gov/GuidanceForLawsAndRegulations/08_Hospitals.asp.
- 42 C.F.R. § 482.45(a)(2) and 42 C.F.R. § 485.643(b).
- 42 C.F.R. § 482.45(a)(3). Under 42 C.F.R. § 485.643(c) the individual designated by Critical Access Hospitals to approach families must be a designated requestor.
- See the Medicare Conditions of Participation section for further information.
- 42 C.F.R. § 482.45(a)(4) and 42 C.F.R. § 485.643(d).
- 42 C.F.R. § 482.45(a)(5) and 42 C.F.R. § 485.643(e).
- 42 C.F.R. § 482.45(b)(1).
- 42 U.S.C. § 274.
- 42 C.F.R. § 482.45(b)(3).
- 42 C.F.R. § 482.45(b)(2).
- Medicare and Medicaid Programs Hospital Conditions of Participation for Identification of Potential Organ, Tissue, and Eye Donors and Transplant Hospitals' Provision of Transplant-Related Data, 63 Federal Register 33856 (June 22, 1998) (to be codified at 42 C.F.R. pt. 482).
- The Joint Commission website http://www.jointcommission.org/AccreditationPrograms/
Hospitals/Standards/09_FAQs/RI/Organ_Donation.htm, accessed August 30, 2007.