End of Life Care Manual
Section 1: Federal and State Law on Advance Directives
The federal Patient Self-Determination Act (PSDA), enacted in 1991, dictates that health care institutions certified by Medicare and/or Medicaid must take steps to educate all adult patients and the larger community on their right to accept or refuse medical care.(1) This law also directs facilities to inquire on admission whether a patient has made an advance directive, maintain policies and procedures on advance directives, and provide this information to patients upon admission. Organizations must comply with the PSDA in order to receive reimbursement through the Medicare and Medicaid programs. (The federal and state regulations implementing the Patient Self-Determination Act, along with the relevant state statutes and regulations mentioned in this section, can be found in Section Three.)
Specifically, the PSDA requires providers to inform patients of their rights, under state law, to make decisions about their medical care and the right to formulate advance directives. The PSDA defines an advance directive as a, "written instrument, such as a living will or durable power of attorney for health care, recognized under state law? relating to the provision of such care when the individual is incapacitated." (2)
In Washington State, an individual's right to control decisions involving their health care and to make an advance directive is codified in two places:
- An individual's right to control decisions involving health care via an advance directive is codified in the Natural Death Act in chapter 70.122 of the Revised Code of Washington.(3)
- An individual's right to control decisions involving mental health care by making a mental health advance directive is codified in chapter 71.32 RCW, concerning mental health advance directives.(4)
Both types of advance directives fit the definition in the PSDA as written instruments, recognized under state law, relating to the provision of care when the individual is incapacitated.
To ensure compliance with the PSDA, hospitals, including rural primary care hospitals, nursing facilities, providers of home health care, health maintenance organizations, competitive medical plans, and hospice programs certified by Medicare and/or Medicaid must:
- maintain written policies and procedures on advance directives with respect to all adult individuals receiving medical care by or through the provider or organization;
- provide written information to each such individual concerning the individual's rights under state law (whether statutory or recognized by the state's courts) to make decisions concerning medical care including: the right to accept or refuse medical or surgical treatment, the right to formulate advance directives, and the hospital's policies respecting the implementation of such rights;
- document in the individual's medical record whether or not the person has executed an advance directive;
- not condition the provision of care or otherwise discriminate against an individual based upon whether or not the individual has executed an advance directive;
- ensure their written policies on advance directives include a clear and precise statement of limitation if the provider cannot implement an advance directive based on moral or ethical objections, including the legal authority for such objection (see the Natural Death Act or the Mental Health Advance Directive chapter) and whether the objection is institution-wide or may be raised by an individual provider;
- inform individuals that complaints concerning the advance directives requirements may be filed with the state survey and certification agency;
- ensure that the facility complies with state law concerning advance directives (see the Natural Death Act and the Mental Health Advance Directive chapter);
- educate staff on the facility's policies and procedures concerning advance directives; and
- provide for community education. The educational materials must inform the public of their rights under state law to make decisions about their medical care, the right to formulate advance directives, and the facility's implementation policies concerning an individual's advance directive.
The written information concerning advance directives must be provided to an adult individual by:
- hospitals, at the time of inpatient admission;
- nursing facilities, at the time of admission;
- home health care or personal care services, in advance of the individual coming under the care of the provider;
- hospices, at the time of initial receipt of hospice care; and
- HMOs, at the time of enrollment.
If an individual is incapacitated at the time of admission or is otherwise unable to articulate whether or not he or she has executed an advance directive, information about advance directives may be given to an individual's family or surrogate.
Questions & Answers Regarding the Patient Self-Determination Act (PSDA)
(The information below has been extracted from the comment and answer section of the PSDA regulations.)
Q: If an individual is admitted to the hospital incapacitated, must the hospital meet the PSDA requirement that it give each individual admitted to the hospital written information about advance directives?
A: If an individual is incapacitated at the time of admission and is unable to receive information or articulate whether or not she or he has an advance directive, the facility should give advance directive information to the patient's family or surrogate to the extent that it gives other materials about policies and procedures to an incapacitated person's family, surrogate, or other concerned person in compliance with state law.
Q: When an individual is first admitted as an inpatient to a hospital and later transferred to a nursing home, are both facilities responsible for providing information on advance directives to the individual?
A: Yes, both the hospital and the nursing home would be required to provide information on advance directives to the individual. The hospital discharge planner may provide the information on behalf of the nursing home, including the nursing home's policies regarding advance directives, in the course of coordinating the transfer, but the nursing home would still be responsible for ensuring the individual received the information and to mark in the individual's medical record whether or not she or he has an advance directive.
Q: Are individuals required to execute an advance directive?
A: No. In fact, the PSDA specifically prohibits providers from conditioning care on whether or not an individual has executed an advance directive. The regulations make clear that the PSDA's main intent is to ensure patients receive information about the right to accept or refuse medical or surgical treatment and about the right to formulate an advance directive.
Q: What constitutes minimally sufficient educational efforts in meeting the PSDA's community education requirements?
A: The PSDA allows great flexibility in the level of community education it requires. At a minimum, a provider must be able to document its community education efforts. For example, photocopying a brochure or pamphlet that meets the community education requirements and was distributed to the public may be sufficient to show the community education requirement was met. Community education does not necessarily require the distribution of written materials and may be carried out in a variety of formats at the provider's discretion (workshops, seminars, etc.).
Q: May a provider exempt itself from the community education requirement based on conscience?
A: No. A provider must meet it obligation to provide community education on advance directives. Under state law, a provider may conscientiously object to implementing an advance directive. However, a provider's conscientious objection must be included in the provider's policy and mentioned in both its community education materials and the materials distributed to individuals upon their admission to the facility.
The Washington State Living Will Registry
In 2006 the legislature passed a statute directing the Department of Health to establish and maintain a statewide online health care declarations registry.(5) A person can upload directives onto a secure website and these directives will then be accessible to patients, personal representatives, and health care providers. Individuals may submit a health care directive, durable power of attorney for health care, mental health advance directive, or a POLST form.(6) The Department of Health's website for the registry is located at http://www.doh.wa.gov/livingwill. A power point presentation for hospitals describing the website and how it works can be found at: http://wsha-archive.seattlewebgroup.com/page.cfm?ID=webcasts.
Submitting or failing to submit a directive to the registry does not affect the validity of the directive, alter the laws regarding the requirements necessary to make a document legal, or create a presumption regarding the validity of the document.(7) Revocation of a directive stored in the registry must conform to the standard statutory method. Failure to notify the Department of Health of a valid revocation does not affect the validity of the revocation.(8)
According the enacting legislation, the legislature intends the registry be consulted by providers in instances where there may be a question about the patient's wishes and the existence of an advance directive might clarify the patient's intentions. The registry does not create any new or distinct obligations for a provider or facility to ascertain the existence of a directive.(9) A provider is not subject to criminal or civil liability or sanctions for unprofessional conduct if the provider provides, does not provide, withdraws, or withholds treatment:
- to a patient in the absence of actual knowledge of the existence of a health care declaration stored on the health care declarations registry;
- pursuant to a health care declaration stored in the registry in the absence of actual knowledge of the revocation of the declaration;
- according to a health care declaration stored in the registry in good faith reliance upon the validity of the declaration that is subsequently found to be invalid; or
- according to a patient's health care declaration stored in the registry.(10)
Medicare and Medicaid Conditions of Participation
Medicare and Medicaid Conditions of Participation for hospitals are the minimum requirements that hospitals must meet to participate in the Medicare and Medicaid programs. Conditions of Participation are intended to protect patient health and safety and to assure that high quality care is provided.
These requirements apply to all Medicare or Medicaid participating hospitals. This includes: short-term, acute care, surgical, specialty, psychiatric, rehabilitation, long-term, children's, and alcohol/drug treatment facilities, whether or not they are accredited. This rule does not apply to Critical Access Hospitals (see Social Security Act Section 1861(e)). Critical Access Hospitals and long-term care facilities are addressed later in this section.
The Conditions of Participation for advance directives have been in effect since 1991 and are largely a product of the Patient Self-Determination Act (PSDA). Therefore, their requirements mirror those of the PSDA outlined in the Federal and State Law on Advance Directives portion above and will not be duplicated here.(11)
In 1999 an interim final rule, called the "Patients' Rights" Conditions of Participation for hospitals, became effective.(12) The Conditions of Participation for patients' rights address hospitals' obligations regarding advance directives and end-of-life care. The Centers for Medicare and Medicaid Services (CMS) finalized changes to the Conditions of Participation for Patients' Rights standards in January 2007. The sections pertaining to advance directives, end-of-life care, and right to participation in treatment decisions are unaltered from the 1999 language.
The Conditions of Participation for Patients' Rights relevant to end-of-life care and advance directives state that:
- patients have the right to participate in the development and implementation of their plan of care;
- patients (or their representatives under state law) have the right to make informed decisions regarding their care, know their health status, be involved in their care planning and treatment, and be able to refuse or request treatments;
- patients have the right to formulate advance directives and to have hospital staff and practitioners comply with these directives (in accordance with the conditions of participation on advance directives).(13)
The CMS issued interpretive guidelines regarding the Conditions of Participation for Patients' Rights.(14) These guidelines stress that, whenever possible, the hospital should inform a patient of her or his rights in a language the patient understands. The interpretive guidelines also state that hospitals must be sensitive to the communication needs of its patients. Hospitals must also comply with Civil Rights laws that ensure it will provide alternative communication techniques or aides for those who are deaf or blind, or take other steps as needed to effectively communicate with the patient. To comply with these guidelines hospitals may need to use large print materials, specialized programs to inform those who are deaf or blind, or utilize interpreters.
The CMS interpretive guidelines specifically include mental health advance directives (referred to as psychiatric advance directives). In accordance with state law, a mental health advance directive should be given the same respect and consideration that traditional advance directives for health care are given. As discussed, Washington law allows for the creation of mental health advance directives. The interpretive guidelines note that hospitals should carefully coordinate how the choices a patient expresses in a mental health advance directive balance against the rights and safety of staff, patients, and other individuals in the event a dangerous situation arises.
The interpretive guidelines stipulate that hospitals must take specific action if moral or ethical objections may hamper compliance with an advance directive. The policies the facility disseminates regarding advance directives must include a clear and precise statement of limitation if the hospital cannot implement an advance directive based on moral or ethical objections. These policies should clarify any differences between institution-wide and individual practitioner objections, reference state law that allows objections, and describe the range of procedures affected by the objections.(15)
Long-Term Care Facilities
The CMS established separate Conditions of Participation to address the use of advance directives in nursing facilities, skilled nursing facilities, and Critical Access Hospitals that provide long-term services.(16) This does not include facilities for the mentally retarded. The requirements that mirror the Patient Self-Determination Act apply equally to hospitals and long-term care facilities. The Conditions of Participation for long-term care facilities relevant to advance directives and end-of-life care state that:
- unless adjudged incompetent or found to be incapacitated under state law, residents have the right to participate in planning care and treatment or changes in care and treatment;
- residents (or representatives under state law) have the right to be fully informed of their total status, including medical condition, in a language that they can understand; and
- residents (or representatives under state law) have the right to refuse treatment, to refuse to participate in experimental research, and to formulate an advance directive.
The CMS issued interpretive guidelines to accompany these Conditions of Participation for long-term care facilities.(17) Facilities must promote these rights, and the exercise thereof, to each resident, including those who face barriers (such as communication problems, hearing problems, and cognition limits) in exercising those rights. Information should be presented in language that residents can understand ? this includes the use of translators for foreign and sign language, or other aides as necessary, while minimizing the use of technical jargon. If a resident has an advance directive, facilities are not required to provide care that conflicts with an advance directive. As with hospitals, long-term care facilities are not required to implement an advance directive if the provider has an objection, but must inform residents of these objections.
Joint Commission Accreditation
The Joint Commission (formerly the Joint Commission on Accreditation of Healthcare Organizations or JCAHO) addresses advance directives, end-of-life care, and surrogate decision-making standards in the 2006 Comprehensive Accreditation Manual for Hospitals. All Joint Commission accredited facilities, including hospitals, outpatient clinics, and nursing homes, must adhere to Joint Commission standards in order to retain accreditation.
The Joint Commission addresses advance directives, end-of-life care, and surrogate decision-making in its Ethics, Rights, and Responsibilities Standards (RI). End-of-life care is also addressed in the Provision of Care, Treatment, and Services Standards (PC). The elements of performance that accompany the standards direct hospitals to provide patients with information about their right to accept or refuse medical treatment, including forgoing or withdrawing life-sustaining treatment or withholding resuscitative services. Specifically, information must be provided upon admission on the extent to which the hospital is able, unable, or unwilling to honor advance directives. Information should be conveyed in a way that is appropriate to the patient's age, understanding, and language.
The Joint Commission defines an advance directive to include living wills, durable powers of attorney, do-not-resuscitate orders, right to die, or similar documents listed in the Patient Self-Determination Act which express the patient's preferences. Though the Joint Commission's accreditation standards do not specifically address mental health advance directives, these directives fall under the obligations laid out in the Patient Self-Determination Act.
The following is a list of section numbers and titles from the Comprehensive Accreditation Manual for Hospitals 2007 edition that address advance directives, end-of-life care, and surrogate decision-making.
The hospital respects the rights of patients.
Hospital policies and procedures must address the rights of each patient to:
- care, treatment, and services within the capability and mission of the hospital and in compliance with law and regulation;
- cultural, psychosocial, spiritual, and personal values, beliefs, and preferences respected;
- hospital support of the right to personal dignity; and
- accommodations for pastoral or other spiritual services.
Patients receive information about their rights.
- Information is provided upon admission to each patient regarding patient rights and the extent to which the hospital is able, unable, or unwilling to honor advance directives.
Patients have the right to refuse care, treatment, and services in accordance with law and regulation.
The hospital respects the patient's right to and need for effective communication.
The hospital must provide:
- written information in a manner that is appropriate to the age, understanding, and language of the patient;
- interpretation services, including translation, as necessary; and
- services to address the needs of those with vision, speech, hearing, language, and cognitive impairments.
IM.6.10 and IM.6.20
The hospital has a complete and accurate medical record for patients assessed, cared for, treated, or served and the records contain patient specific information, as appropriate, to the care, treatment, and services provided.
Patients are involved in decisions about care, treatment, and services provided.
The hospital addresses the rights and wishes of patients relating to end-of-life decisions.
Hospitals must comply with the following elements:
- have policies, in accordance with law and regulations, that address advance directives and the framework for forgoing or withdrawing life-sustaining treatment and withholding resuscitative services and consistently implement them;
- provide adult patients with written information about their rights to accept or refuse treatment and hospital policies addressing these rights;
- document the existence or absence of a patient's signed advance directive;
- document and honor, within the limits of the law or hospital capacity, a patients' wishes concerning organ donation;
- upon request, help or refer patients for assistance in formulating advance directives, including reviewing and revising existing directives; and
- have a mechanism for health care professionals and designated representatives to honor advance directives within in limits of the law or hospital capabilities.
In outpatient hospital settings, the hospital must:
- develop and implement policies addressing advance directives, specifying whether the hospital will honor the directives;
- inform patients and families of these policies upon request or as appropriate for care, treatment, and services provided; and
- help patients formulate advance directives or refer them to other entities for assistance.
Patients have the right to pain management.
Hospitals must plan, support, and coordinate activities and resources to:
- assess for pain;
- educate all relevant providers about assessing and managing pain; and
- educate patients and families about their roles in managing pain, including the potential limitations and side effects of pain treatments.
Development of a plan for care, treatment, and services is individualized and appropriate to the patient's needs, strengths, limitations, and goals.
Pain is assessed in all patients.
Comfort and dignity are optimized during end-of-life care.
- Hospital educate staff about the unique needs of dying patients and their families and caregivers.
Surrogate Decision-Making (18)
Patients are involved in decisions about care, treatment, and services provided.
Patients have the right to refuse care, treatment, and services in accordance with law and regulations.
Regulations on Nursing Homes in Washington
Washington state has regulations specifically applicable to nursing homes. Nursing homes must adhere to these requirements in addition to the federal and state law on advance directives discussed previously.
Washington Administrative Code 388-97-065, entitled "Advance Directives," outlines requirements for nursing homes. These requirements are similar to those under the Patient Self-Determination Act, discussed at the beginning of this section. The term "advance directive" in this chapter of the WAC refers to any document indicating a resident's choice with regard to a specific service, treatment, medication, or medical procedure option that may be implemented in the future. Examples of advance directives include a durable power of attorney for health care, a health care directive, a limited or restricted treatment order, and a DNR. Though mental health advance directives are not specifically referenced, nursing homes are directed to carry out the WAC in accordance with applicable state law. As mental health advance directives are state law, they are probably included in nursing homes' obligations regarding advance directives.
Similar to the Patient Self-Determination Act requirements, under WAC 388-97-065, a nursing home must:
- inquire whether a resident has an advance directive and the nature of the directive;
- document in the clinical record whether or not the resident has an advance directive;
- not require that the resident have an advance directive;
- inform the resident in writing and orally, at the time of admission and as necessary thereafter, in language and words the resident understands, of the resident's right to make health care decisions and the nursing homes policies and procedures concerning implementation of advance directives;
- inform the resident of the right to change his or her mind regarding previous decisions; and
- review the resident's advance directive at the resident's request, when the resident's condition warrants review, and when there is a change in condition.
A resident's advance directive might conflict with nursing home procedures and policies (which must be consistent with state and federal law). If this occurs, WAC 388-97-065 requires the nursing home to inform the resident of the procedures or policies that would preclude the home from implementing the resident's advance directive. The resident must be provided with written policies and procedures that explain the circumstances under which the resident's directive will or will not be implemented by the nursing home. The nursing home should meet with the resident, discuss the conflict, and implement a plan to carry out the resident's wishes to the fullest extent possible. This plan should be attached to the advance directive and placed in the resident's chart. If the resident chooses to seek care elsewhere where his or her directive will be fully honored, the nursing home must assist the resident in locating other appropriate services.
In addition to advance directives, the regulations pertaining to nursing homes cover patient rights, informed consent, and guardianship. These regulations dictate that a nursing home must:
- protect and promote the right of residents, including the right to accept or refuse treatment;
- fully inform residents in advance, in language and words they understand, about care and treatment and of any changes in care or treatment that may affect residents' well-being; and
- document any refusal of care in the resident's comprehensive plan of care.
Nursing home regulations covering advance directives, patient rights, informed consent, and guardianship can be found in the following sections of the Washington Administrative Code:
- WAC 388-97-051 Residents Rights
- WAC 388-97-052 Free Choice
- WAC 388-97-055 Residential Decision-Making
- WAC 388-97-060 Informed Consent
- WAC 388-97-065 Advance Directives
- WAC 388-97-07005 Notice of Rights and Services
- WAC 388-97-090 Comprehensive Plan of Care
See Section Three for the full text of the federal and state regulations implementing the Patient Self-Determination Act, along with the relevant state statutes and regulations mentioned in this section.
- Patient Self-Determination Act, 42 U.S.C. § 1395cc (2000).
- 42 U.S.C § 1395cc(f)(3).
- A health care advance directive (aka a living will) expresses a competent individual's preferences regarding the withholding or withdrawal of life-sustaining treatment if terminally ill or permanently unconscious, see RCW 70.122. A durable power of attorney for health care appoints an agent to provide informed consent for health care decisions on behalf of the individual who executed the directive, see RCW 11.94.
- A mental health advance directive expresses a competent individual's preferences and instructions regarding his or her mental health treatment in the event of incapacitation. The directive may also appoint an agent to make decisions on behalf of the person who executed the directive.
- RCW 70.122.130.
- RCW 70.122.130(2)(a).
- RCW 70.122.130(2)(b).
- RCW 70.122.130(c).
- RCW 70.122.051(3).
- RCW 70.122.051(4)(a-d).
- Refer to 42 C.F.R § 489.102 for details regarding hospitals' obligations to educate patients and the community, have written policies, ensure compliance with state law, make timely inquiries regarding whether a patient has an advance directive.
- 42 C.F.R § 482.13(b).
- "For the purpose of this part, advance directive means a written instruction, such as a living will or durable power of attorney for health care, recognized under State law (whether statutory or as recognized by the courts of the State), relating to the provision of health care when the individual is incapacitated." 42 C.F.R § 489.100.
- CMS State Operations Manual, Appendix A - Survey Protocol, Regulations and Interpretive Guidelines for Hospitals (Rev. 1, 05-21-04) A-0038 - A-0052.
- Washington's Natural Death Act allows health care facilities or personnel to refuse to participate in the withholding or withdrawing of life-sustaining treatment due to moral or ethical objections. Patients must be informed of this policy or practice when the provider or facility becomes aware of the existence of a directive. RCW 70.122.060(2) & (4). Washington's Mental Health Advance Directive law also allows providers and facilities to decline to follow a patient's directive, but this must be clearly conveyed at the time the provider or facility receives the directive. RCW 71.32.150(5)(a). Refer to Section Two on Mental Health Advance Directives for further information.
- 42 C.F.R § 483.10.
- CMS State Operations Manual, Appendix PP - Guidance to Surveyors for Long-Term Care Facilities (Rev. 22, 12-15-06) and Appendix W - Survey Protocol, Regulations and Interpretive Guidelines for Critical Access Hospitals (CAHs) Swing-Beds in CAHs (Rev. 02-21-04).
- See Section Five, Surrogate Decision-Making, for further information.