Informed Consent

Key:

USC – United States Code

CFR – Code of Federal Regulations

H&S – Code California Health and Safety Code

Laws on informed consent:

  • California Code of Regulations (CCR), Title 22, §§ 72527(a)(3), (4) & (5), 72527(e) & 72528
  • California Health and Safety (H&S) Code §§ 1418.8 & 1418.9;
  • United States Code (USC), Title 42, §§ 1395i-3(c)(1)(A)(i) & 1396r(c)(1)(A)(i);
  • Code of Federal Regulation (CFR), Title 42, §§ 483.10(d) & 483.10(b)
  • Note: The excerpt of the following regulation contains pertinent provisions on the right to informed consent but excludes other parts of the regulation.

    California Code of Regulations, Title 22, Section 72527(a)(3), (4) & (5), 72527(e)

    (a) Patients have the rights enumerated in this section and the facility shall ensure that these rights are not violated. The facility shall establish and implement written policies and procedures which include these rights and shall make a copy of these policies available to the patient and to any representative of the patient. The policies shall be accessible to the public upon request. Patients shall have the right:

    (3) To be fully informed by a physician of his or her total health status and to be afforded the opportunity to participate on an immediate and ongoing basis in the total plan of care including the identification of medical, nursing and psychosocial needs and the planning of related services.

    (4) To consent to or to refuse any treatment or procedure or participation in experimental research.

    (5) To receive all information that is material to an individual patient’s decision concerning whether to accept or refuse any proposed treatment or procedure. The disclosure of material information for administration of psychotherapeutic drugs or physical restraints or the prolonged use of a device that may lead to the inability to regain use of a normal bodily function shall include the disclosure of information listed in Section 72528(b).

    (e) Patients’ rights policies and procedures established under this section concerning consent, informed consent and refusal of treatments or procedures shall include, but not be limited to the following:

    (1) How the facility will verify that informed consent was obtained or a treatment or procedure was refused pertaining to the administration of psychotherapeutic drugs or physical restraints or the prolonged use of a device that may lead to the inability of the patient to regain the use of a normal bodily function.

    (2) How the facility, in consultation with the patient’s physician, will identify consistent with current statutory case law, who may serve as a patient’s representative when an incapacitated patient has no conservator or attorney in fact under a valid Durable Power of Attorney for Health Care.

    California Code of Regulations, Title 22, Section 72528

    (a) It is the responsibility of the attending licensed healthcare practitioner acting within the scope of his or her professional licensure to determine what information a reasonable person in the patient’s condition and circumstances would consider material to a decision to accept or refuse a proposed treatment or procedure. Information that is commonly appreciated need not be disclosed. The disclosure of the material information and obtaining informed consent shall be the responsibility of the licensed healthcare practitioner who, acting within the scope of his or her professional licensure, performs or orders the procedure or treatment for which informed consent is required.

    (b) The information material to a decision concerning the administration of a psychotherapeutic drug or physical restraint, or the prolonged use of a device that may lead to the inability of the patient to regain use of a normal bodily function shall include at least the following:

    (1) The reason for the treatment and the nature and seriousness of the patient’s illness.

    (2) The nature of the procedures to be used in the proposed treatment including their probable frequency and duration.

    (3) The probable degree and duration (temporary or permanent) of improvement or remission, expected with or without such treatment.

    (4) The nature, degree, duration and probability of the side effects and significant risks, commonly known by the health professions.

    (5) The reasonable alternative treatments and risks, and why the health professional is recommending this particular treatment.

    (6) That the patient has the right to accept or refuse the proposed treatment, and if he or she consents, has the right to revoke his or her consent for any reason at any time.

    (c) Before initiating the administration of psychotherapeutic drugs, or physical restraints, or the prolonged use of a device that may lead to the inability to regain use of a normal bodily function, facility staff shall verify that the patient’s health record contains documentation that the patient has given informed consent to the proposed treatment or procedure. The facility shall also ensure that all decisions concerning the withdrawal or withholding of life sustaining treatment are documented in the patient’s health record.

    (d) This section shall not be construed to require obtaining informed consent each time a treatment or procedure is administered unless material circumstances or risks change.

    (e) There shall be no violation for initiating treatment without informed consent if there is documentation within the patient’s health record that an emergency exists where there is an unanticipated condition in which immediate action is necessary for preservation of life or the prevention of serious bodily harm to the patient or others or to alleviate severe physical pain, and it is impracticable to obtain the required consent, and provided that the action taken is within the customary practice of licensed healthcare practitioners of good standing acting within the scope of their professional licensure in similar circumstances.

    (f) Notwithstanding Sections 72527(a)(5) and 72528(b)(4), disclosure of the risks of a proposed treatment or procedure may be withheld if there is documentation of one of the following in the patient’s health record:

    (1) That the patient or patient’s representative specifically requested that he or she not be informed of the risk of the recommended treatment or procedure. This request does not waive the requirement for providing the other material information concerning the treatment or procedure.

    (2) That the licensed healthcare practitioner acting within the scope of his or her professional licensure relied upon objective facts, as documented in the health record, that would demonstrate to a reasonable person that the disclosure would have so seriously upset the patient that the patient would not have been able to rationally weigh the risks of refusing to undergo the recommended treatment and that, unless inappropriate, a patient’s representative gave informed consent as set forth herein.

    (g) A general consent provision in a contract for admission shall only encompass consent for routine nursing care or emergency care. Routine nursing care, as used in this section, means a treatment or procedure that does not require informed consent as specified in Section 72528(b)(1) through (6) or that is determined by the licensed healthcare practitioner acting within the scope of his or her professional licensure not to require the disclosure of information material to the individual patient. Routine nursing care includes, but is not limited to, care that does not require the order of a licensed healthcare practitioner acting within the scope of his or her professional licensure. This section does not preclude the use of informed consent forms for any specific treatment or procedure at the time of admission or at any other time. All consent provisions or forms shall indicate that the patient or incapacitated patient’s representative may revoke his or her consent at any time.

    (h) If a patient or his or her representative cannot communicate with the licensed healthcare practitioner acting within the scope of his or her professional licensure because of language or communication barriers, the facility shall arrange for an interpreter.

    (1) An interpreter shall be someone who is fluent in both English and the language used by the patient and his or her legal representative, or who can communicate with a deaf person, if deafness is the communication barrier.

    (2) When interpreters are used, documentation shall be placed in the patient’s health record indicating the name of the person who acted as the interpreter and his or her relationship to the patient and to the facility.

    California Health and Safety Code Section 1418.8

    1418.8. (a) If the attending physician and surgeon of a resident in a skilled nursing facility or intermediate care facility prescribes or orders a medical intervention that requires that informed consent be obtained prior to administration of the medical intervention, but is unable to obtain informed consent because the physician and surgeon determines that the resident lacks capacity to make decisions concerning his or her health care and that there is no person with legal authority to make those decisions on behalf of the resident, the physician and surgeon shall inform the skilled nursing facility or intermediate care facility.

    (b) For purposes of subdivision (a), a resident lacks capacity to make a decision regarding his or her health care if the resident is unable to understand the nature and consequences of the proposed medical intervention, including its risks and benefits, or is unable to express a preference regarding the intervention. To make the determination regarding capacity, the physician shall interview the patient, review the patient’s medical records, and consult with

    skilled nursing or intermediate care facility staff, as appropriate, and family members and friends of the resident, if any have been identified.

    (c) For purposes of subdivision (a), a person with legal authority to make medical treatment decisions on behalf of a patient is a person designated under a valid Durable Power of Attorney for Health Care, a guardian, a conservator, or next of kin. To determine the existence of a person with legal authority, the physician shall interview the patient, review the medical records of the patient, and consult with skilled nursing or intermediate care facility staff, as appropriate, and with family members and friends of the resident, if any have been identified.

    (d) The attending physician and the skilled nursing facility or intermediate care facility may initiate a medical intervention that requires informed consent pursuant to subdivision (e) in accordance with acceptable standards of practice.

    (e) Where a resident of a skilled nursing facility or intermediate care facility has been prescribed a medical intervention by a physician and surgeon that requires informed consent and the physician has determined that the resident lacks capacity to make health care decisions and there is no person with legal authority to make those decisions on behalf of the resident, the facility shall, except as provided in subdivision (h), conduct an interdisciplinary team review of the prescribed medical intervention prior to the administration of the medical intervention. The interdisciplinary team shall oversee the care of the resident utilizing a team approach to assessment and care planning, and shall include the resident’s attending physician, a registered professional nurse with responsibility for the resident, other appropriate staff in disciplines as determined by the resident’s needs, and, where practicable, a patient representative, in accordance with applicable federal and state requirements. The review shall include all of the

    following:

    (1) A review of the physician’s assessment of the resident’s condition.

    (2) The reason for the proposed use of the medical intervention.

    (3) A discussion of the desires of the patient, where known. To determine the desires of the resident, the interdisciplinary team shall interview the patient, review the patient’s medical records, and consult with family members or friends, if any have been identified.

    (4) The type of medical intervention to be used in the resident’s care, including its probable frequency and duration.

    (5) The probable impact on the resident’s condition, with and without the use of the medical intervention.

    (6) Reasonable alternative medical interventions considered or utilized and reasons for their discontinuance or inappropriateness.

    (f) A patient representative may include a family member or friend of the resident who is unable to take full responsibility for the health care decisions of the resident, but who has agreed to serve on the interdisciplinary team, or other person authorized by state or federal law.

    (g) The interdisciplinary team shall periodically evaluate the use of the prescribed medical intervention at least quarterly or upon a significant change in the resident’s medical condition.

    (h) In case of an emergency, after obtaining a physician and surgeon’s order as necessary, a skilled nursing or intermediate care facility may administer a medical intervention that requires informed consent prior to the facility convening an interdisciplinary team review. If the emergency results in the application of physical or chemical restraints, the interdisciplinary team shall meet within one week of the emergency for an evaluation of the medical intervention.

    (i) Physicians and surgeons and skilled nursing facilities and intermediate care facilities shall not be required to obtain a court order pursuant to Section 3201 of the Probate Code prior to

    administering a medical intervention which requires informed consent if the requirements of this section are met.

    (j) Nothing in this section shall in any way affect the right of a resident of a skilled nursing facility or intermediate care facility for whom medical intervention has been prescribed, ordered, or administered pursuant to this section to seek appropriate judicial relief to review the decision to provide the medical intervention.

    (k) No physician or other health care provider, whose action under this section is in accordance with reasonable medical standards, is subject to administrative sanction if the physician or health care provider believes in good faith that the action is consistent with this section and the desires of the resident, or if unknown, the best interests of the resident.

    (l) The determinations required to be made pursuant to subdivisions (a), (e), and (g), and the basis for those determinations shall be documented in the patient’s medical record and shall be made available to the patient’s representative for review.

    California Health and Safety Code Section 1418.9

    1418.9. (a) If the attending physician and surgeon of a resident in a skilled nursing facility prescribes, orders, or increases an order for an antipsychotic medication for the resident, the physician and surgeon shall do both of the following:

    (1) Obtain the informed consent of the resident for purposes of prescribing, ordering, or increasing an order for the medication.

    (2) Seek the consent of the resident to notify the resident’s interested family member, as designated in the medical record. If the resident consents to the notice, the physician and surgeon shall make reasonable attempts, either personally or through a designee, to notify the interested family member, as designated in the medical record, within 48 hours of the prescription, order, or increase of an order.

    (b) Notification of an interested family member is not required under paragraph (2) of subdivision (a) if any of the following circumstances exist:

    (1) There is no interested family member designated in the medical record.

    (2) The resident has been diagnosed as terminally ill by his or her physician and surgeon and is receiving hospice services from a licensed, certified hospice agency in the facility.

    (3) The resident has not consented to the notification.

    (c) As used in this section, the following definitions shall apply:

    (1) “Resident” means a patient of a skilled nursing facility who has the capacity to consent to make decisions concerning his or her health care, including medications.

    (2) “Designee” means a person who has agreed with the physician and surgeon to provide the notice required by this section.

    (3) “Antipsychotic medication” means a medication approved by the United States Food and Drug Administration for the treatment of psychosis.

    (4) “Increase of an order” means an increase of the dosage of the medication above the dosage range stated in a prior consent from the resident.

    (d) This section shall not be construed to require consent from an interested family member for an attending physician and surgeon of a resident to prescribe, order, or increase an order for antipsychotic medication.

    United States Code, Title 42, Section 1395i-3(c)(1)(A)(i)

    Requirements relating to residents’ rights

    (1) General rights

    (A) Specified rights

    A skilled nursing facility must protect and promote the rights of each resident, including each of the following rights:

    (i) Free choice: The right to choose a personal attending physician, to be fully informed in advance about care and treatment, to be fully informed in advance of any changes in care or treatment that may affect the resident’s well-being, and (except with respect to a resident adjudged incompetent) to participate in planning care and treatment or changes in care and treatment.

    United States Code, Title 42, Section 1396r(c)(1)(A)(i)

    Requirements relating to residents’ rights

    (1) General rights

    (A) Specified rights

    A nursing facility must protect and promote the rights of each resident, including each of the following rights:

    (i) Free choice: The right to choose a personal attending physician, to be fully informed in advance about care and treatment, to be fully informed in advance of any changes in care or treatment that may affect the resident’s well-being, and (except with respect to a resident adjudged incompetent) to participate in planning care and treatment or changes in care and treatment.

    Code of Federal Regulations, Title 42, Section 483.10(d)

    Resident rights.

    The resident has a right to a dignified existence, self-determination, and communication with and access to persons and services inside and outside the facility. A facility must protect and promote the rights of each resident, including each of the following rights:

    (d) Free choice. The resident has the right to–

    (1) Choose a personal attending physician;

    (2) Be fully informed in advance about care and treatment and of any changes in that care or treatment that may affect the resident’s well-being; and

    (3) Unless adjudged incompetent or otherwise found to be incapacitated under the laws of the State, participate in planning care and treatment or changes in care and treatment.

    Code of Federal Regulations, Title 42, Section 483.10(b)

    Resident rights.

    The resident has a right to a dignified existence, self-determination, and communication with and access to persons and services inside and outside the facility. A facility must protect and promote the rights of each resident, including each of the following rights:

    (b) Notice of rights and services. (1) The facility must inform the resident both orally and in writing in a language that the resident understands of his or her rights and all rules and regulations governing resident conduct and responsibilities during the stay in the facility.

    The facility must also provide the resident with the notice (if any) of the State developed under section 1919(e)(6) of the Act. Such notification must be made prior to or upon admission and during the resident’s stay. Receipt of such information, and any amendments to it, must be acknowledged in writing;

    (2) The resident or his or her legal representative has the right–

    (i) Upon an oral or written request, to access all records pertaining to himself or herself including current clinical records within 24 hours (excluding weekends and holidays); and

    (ii) After receipt of his or her records for inspection, to purchase at a cost not to exceed the community standard photocopies of the records or any portions of them upon request and 2 working days advance notice to the facility.

    (3) The resident has the right to be fully informed in language that he or she can understand of his or her total health status, including but not limited to, his or her medical condition;

    (4) The resident has the right to refuse treatment, to refuse to participate in experimental research, and to formulate an advance directive as specified in paragraph (8) of this section;

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