Section 5 - Organ Procurement Under State and Federal Law

The Uniform Anatomical Gift Act is the bulk of Washington state law governing organ procurement. The Act regulates how and by whom organs may be donated and outlines procedures hospitals must follow to facilitate and encourage organ donation. The Act is concerned with increasing organ donation and lessening the ratio between available organs and individuals needing a transplant. Currently, the number of individuals needing an organ or body part far exceeds the number available for transplant.

In addition to the Uniform Anatomical Gift Act, the Medicare Conditions of Participation (CoP) and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) standards on organ procurement set out requirements hospitals must meet. The Medicare CoP are comprehensive and require specific hospital procedures and protocol, including collaboration with organ and tissue procurement organizations. JCAHO has adopted the donation provisions of the CoP rule in its standards for hospitals.

The Uniform Anatomical Gift Act, the Medicare CoP and JCAHO standards are discussed below.

The text of relevant law and regulations is included at the end of this section, along with a Resource Guide 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.

Washington state law on organ procurement can be summarized as follows:

• Any adult may donate all or part of her or his body for transplantation, medical research, or education.
• 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.
• Family consent is not needed if an adult has expressed the desire to be an organ or tissue donor upon death.

The Uniform Anatomical Gift Act and Related RCWs

Washington state's Uniform Anatomical Gift Act covers RCW 68.50.520 through 68.50.630 and 68.50.901 through 68.50.903. In addition, RCW 68.50.500 and 68.50.510 require hospital procedures for procuring organs.

Congress promulgated the Uniform Anatomical Gift Act in 1968, which has since been adopted by all 50 states and the District of Columbia. Washington state's Uniform Anatomical Gift Act is intended to complement federal law. In particular, the state's Act references the federal law on advance directives, which is discussed in sections one and two of this manual. An advance directive facilitates organ donation because it gives an individual the opportunity to express in writing the desire to be an organ donor.

A "document of gift" may also be used to indicate a deceased person's desire to donate organs. The statutory definition of a document of gift is "a card, a statement attached to or imprinted on a motor vehicle operator's license, a will, or other writing used to make an anatomical gift." RCW 68.50.530.

However, if a deceased person has not documented the desire to donate (or the desire to not donate) organs or body parts, the statute allows other interested persons to consent to donation. Absent a deceased person's instructions to not donate, RCW 68.50.550 lists seven classes of persons authorized to consent to donation on behalf of the deceased person. The statute contains certain restrictions regarding when someone on the list may consent, but generally, consent must be obtained in the following order of priority:

• the appointed guardian of the decedent at the time of death;
• an individual named as a Durable Power of Attorney for Health Care decisions;
• the spouse of the decedent;
• a son or daughter of the decedent who is 18 years of age or older;
• either parent of the decedent;
• a sibling of the decedent who is 18 years of age or older; or
• a grandparent of the decedent.

The Uniform Anatomical Gift Act also outlines requirements a hospital must follow for developing organ donation procedures and identifying potential organ and tissue donors. (RCWs 68.50.500, 68.50.560 and 68.50.600.) These provisions are summarized below. Please refer to the full text of the statutes included at the end of this section for the statutes' original language.

The Act defines an anatomical gift as "a donation of all or part of a human body to take effect upon or after death." RCW 68.50.530.

Hospitals must develop procedures for identifying potential donors that include the following elements (RCW 68.50.500):

• If a deceased patient's medical records do not state whether the patient is an organ donor, a designated person must ask the patient's next of kin or someone else authorized to consent to donation (refer to the list in RCW 68.50.550, outlined above) about whether the deceased person's organs or tissue may be donated.
• If the hospital participates in the Medicare program, Medicare Conditions of Participation require the hospital's designated person to approach families of deceased patients about organ donation to have taken a course on donation requests authorized by the organ procurement organization. The designated person may also be a representative from the organ procurement organization - see the Medicare CoP section below.
• When the hospital gains approval to donate a patient's organs, it must notify an established organ procurement organization (as defined in RCW 68.50.570) and cooperate in the procurement of the organs.
• The procedures hospitals use to approach families about organ donation must be discrete and sensitive.
• The procedures may take into account the deceased individual's religion or obvious nonsuitability for organ donation.

The statute shields hospitals from liability for any act or omission in developing or implementing these procedures, as long as the hospital has acted in good faith. RCW 68.50.510.

Hospitals must develop policies and procedures to document and carry out a patient's wishes to donate, or not to donate, organs or tissue. The polices and procedures must include the following efforts (RCW 68.50.560):

• On or before admission to a hospital, or as soon as possible thereafter, a person designated by the hospital shall ask each patient who is at least eighteen years of age: "Are you an organ or tissue donor?"
• If the answer is yes, the hospital must request copies of the documented instructions;
• If the answer is no or there is no answer, the hospital must provide the patient information about the right to make a tissue or organ donation and then ask the patient if he or she wishes to become a donor;
• o If the patient wants to become a donor, the hospital must provide the patient with materials to write these instructions down; and
• o The hospital must place in the patient's medical records a copy of the materials stating the patient wishes to donate (or not to donate).
• If, at or near the time of death of a patient, there is no medical record that the patient wants to be an organ or tissue donor or refuses to be one, the hospital administrator or a representative designated by the administrator must:
• Discuss the option of organ donation with the persons allowed to consent to donation on behalf of the patient (listed in RCW 68.50.550, outlined above);
• Make the request for donation with reasonable discretion and sensitivity to the circumstances of the family;
• Keep in mind the statute states a request is not required if the organ or tissue is not medically suitable, however, the Medicare Conditions of Participation require hospitals to notify the organ procurement organization of every individual who has died at the hospital, or whose death is imminent, regardless of medical suitability, which the OPO will determine after notification (see Medicare section below);
• In the patient's medical record, write down who made the donation request, the name of the individual to whom the request was made, the individual's relationship to the patient, and the individual's response.
• When an individual is admitted to a hospital at or near the time of death, the hospital must make a reasonable search of the individual (and the individual's "personal effects") for information identifying the person as a donor or someone who does not want to be a donor.
• If, at or near the time of death of a patient, a hospital knows the patient is a donor, the hospital must notify the donee; if no donee is named, the hospital must notify an organ procurement organization.
• The hospital must cooperate in the procurement of the anatomical gift or release and removal of a part.
  

• Every hospital in the state, after consultation with other hospitals and procurement organizations, must establish agreements or affiliations for coordination of procurement and use of organs and body parts.

Nursing Homes and Organ Donation

Nursing homes are regulated under WAC 388-97-065, entitled advance directives, which refers specifically to organ tissue donation. This regulation is discussed in section one of this manual.

Medicare Conditions of Participation on Organ Procurement

The Centers for Medicare and Medicaid (formerly the Health Care Financing Administration) issued Medicare Conditions of Participation (CoP) on organ procurement designed to increase organ donation. The regulations impose several requirements a hospital must meet. They became effective August 21, 1998.

Medicare CoP for hospitals 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)).

The organ procurement regulations (482.45 Conditions of Participation of Medicare: 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 family approach to determine patient suitability.
• 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.
• 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 deaths.
• 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.
• The agreement must not interfere with organ procurement.
• Ensure, in collaboration with the OPO, that the family of each potential donor is informed of its options to donate organs, tissues, or eyes, or to decline to donate.
• The individual designated to approach the family members about organ donation 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 designed in conjunction with the tissue and eye bank community on how to approach families and request organ or tissue donation.
• Encourage discretion and sensitivity with respect to the circumstances, views, and beliefs of the families of potential donors.
• Ensure the hospital works with the 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 maintaining potential donors while necessary testing and placement of organs and tissues take place.
• 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.
• The OPTN is established and operated under the Public Health Service Act (42 U.S.C. 274).
• 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 OPOs.
• 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.

These standards, while more specific in that they require written hospital protocol and hospital cooperation with the OPO and OPTN, largely mirror the state's Uniform Anatomical Gift Act.

The Medicare regulations cite a study demonstrating 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 the request:

• First, family members must be given time to understand and accept their relative's death before the donation request is made.
• Secondly, 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 following the designated hospital staff's mention of organ donation).
• Thirdly, the setting in which the request is made should be quiet and private, such as a conference room or family meeting room.

Following this section you will find the law and regulations covering organ procurement, and a useful question and answer sheet the Centers for Medicare and Medicaid prepared to assist hospitals with understanding these regulations, along with its Interpretive Guidelines.

The Joint Commission on Accreditation of Healthcare Organizations (JCAHO)

JCAHO has adopted the donation provisions of the Medicare Conditions of Participation rule in its standards for hospitals. Any JCAHO-accredited-facility, including hospitals, outpatient clinics and nursing homes must adhere to JCAHO standards in order to retain its accreditation.

The following JCAHO standards address organ procurement:

RI.1.2.4 - A hospital must address advance directives.

• The hospital must determine whether a patient has or wishes to make an advance directive and that it is honored to the best of the hospital's capabilities and within the limits of the law.
• For example, if a patient elects to donate organs at the end of life, the hospital must have a process to honor that directive.

RI.2 - A hospital must implement policies and procedures, developed with the medical staff's participation, for the procuring and donation of organs and other tissues.

• Any hospital procuring human organs must be a member of the appropriate organ procurement organization (OPO) and follow its rules and regulations.
• For nonfederal hospitals, this organization is the Organ Procurement and Transplantation Network.
• Hospitals must have 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 tissue and eyes.
• Policies and procedures for organ and tissue procurement and donation must be written and implemented, and include the following elements:
• the OPO with which the hospital is affiliated;
• the hospital procedures for notifying the OPO in a timely manner of individuals who have died in the hospital or whose death is imminent;
• the OPO determines an individual's suitability for organ donation;
• the hospital procedures, developed in collaboration with the OPO, for notifying the family of each potential donor of the option to donate, or decline to donate, organs, tissues, or eyes. The notification must be made by an OPO representative or a hospital's designated requestor;
• written documentation by the hospital's designated requestor showing that a patient or family accepts or declines the opportunity to donate organs or tissue.
• the hospital staff acts with 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, as well as to tissue and eye banks;
• the hospital works cooperatively with the OPO, tissue, and eye banks in reviewing death records to improve identification of potential donors and to maintain potential donors while the necessary testing and placement of potential donated organs, tissues, and eyes take place; and
• the hospital works cooperatively with the OPO, tissue, and eye banks in educating staff on donation issues.

IM.3.2.1 - A hospital must review medical records on an ongoing basis for completeness and timeliness of information.

• Action must be taken to improve the quality and timeliness of documentation that impacts patient care, including records of donation and receipt of transplants.

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