(a)As used in this section, the following definitions shall apply:
(1)“Informed consent” means the voluntary agreement of a resident or a resident’s representative to accept a treatment or procedure after receiving information in accordance with subdivisions (b) to (e), inclusive, of this section, subdivision (j) of Section 1599.1, and in accordance with Section 1418.8, if applicable.
(2)“Psychotherapeutic drug” means a
drug to control behavior or to treat thought disorder processes, excluding antidepressants.
(3)“Representative” means an individual who has authority to act on behalf of the resident, including, but not limited to, a conservator, guardian, person authorized as agent in the resident’s valid advance health care directive, the resident’s spouse, registered domestic p
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(a)
As used in this section, the following definitions shall apply:
(1)
“Informed consent” means the voluntary agreement of a resident or a resident’s representative to accept a treatment or procedure after receiving information in accordance with subdivisions (b) to (e), inclusive, of this section, subdivision (j) of Section 1599.1, and in accordance with Section 1418.8, if applicable.
(2)
“Psychotherapeutic drug” means a
drug to control behavior or to treat thought disorder processes, excluding antidepressants.
(3)
“Representative” means an individual who has authority to act on behalf of the resident, including, but not limited to, a conservator, guardian, person authorized as agent in the resident’s valid advance health care directive, the resident’s spouse, registered domestic partner, or family member, a person designated by the resident, or other legally designated individual.
(4)
“Resident” means a person who is receiving care at a skilled nursing facility or an intermediate care facility, as those facilities are defined in Section 1250.
(b)
(1)
Prior to prescribing a psychotherapeutic drug for a resident, the
prescriber shall personally examine and obtain the informed written consent of the resident or the resident’s representative.
(2)
The prescriber shall communicate, and the written consent form shall contain, in a language the resident understands, the information a reasonable person in the resident’s condition and circumstances would consider material to a decision to accept or refuse the drug. However, if written translation services are not timely available, the written consent form may be provided in
English with oral interpretation in a language that the resident understands. If the resident is hearing impaired or vision impaired, the material information and written consent form shall be provided in an accessible format.
(3)
The form shall be signed by the resident or the resident’s representative. The form shall also be signed by a health care professional who declares the resident or resident representative has been provided the material information. If the signature of the resident or resident’s representative cannot be obtained, a licensed nurse shall sign the form and
verify that they confirmed informed consent with the resident or resident’s representative and state the name of the person with whom they verified informed consent and the date. Copies of the signed consent form shall be given to the resident and their representative.
(4)
Within six months after the consent form is signed, and every six months thereafter during which the resident receives a psychotherapeutic drug, the facility shall provide a written notice to the resident and, if applicable, the resident’s representative, of any recommended dosage adjustments and the resident’s right to revoke
consent and to receive gradual dose reductions and behavioral interventions in an effort to discontinue the psychotherapeutic drug.
(5)
For purposes of obtaining informed written consent pursuant to this subdivision, the use of remote technology, including, but not limited to, telehealth, to allow a prescriber to examine and obtain informed written consent, and for the prescriber, the resident or the
resident’s representative to use electronic signatures, shall be permitted.
(c)
In addition to the information required by subdivision (j) of Section 1599.1, the prescriber shall provide the following information material to an informed consent decision concerning the administration of a psychotherapeutic drug:
(1)
Possible nonpharmacologic approaches that could address the resident’s needs.
(2)
Whether the drug has a current boxed warning label along with a summary
of, and information about how to find, the contraindications, warnings, and precautions required by the United States Food and Drug Administration.
(3)
Whether a proposed drug is being prescribed for a purpose that has or has not been approved by the United States Food and Drug Administration.
(4)
Possible interactions with other drugs the resident is receiving.
(5)
How the facility and prescriber will monitor and respond to any adverse side effects and inform the resident of side effects.
(d)
Before initiating treatment with psychotherapeutic drugs, facility staff shall verify that the resident’s health record contains a written consent form with the signatures required under subdivision (b), except as specified in subdivision (j). For a prescription written prior to the admission and encompassing the admission of the resident, the facility staff shall verify that the resident or the resident’s representative gave informed consent and make a notation in the resident’s records.
(e)
Residents’ rights policies and procedures established pursuant to this section and Section 1599.1 concerning informed consent shall specify how the facility will verify that the resident provided informed consent or refused treatment or a procedure pertaining to the administration of psychotherapeutic drugs.
(f)
This section shall not be construed to require a facility to obtain informed consent each time a drug is administered unless material circumstances or risks change.
(g)
A violation of subdivision (c) shall be presumed to have caused the affected residents harm, which may be rebutted, and shall be classified as a class “B,” “A,” or “AA” violation, according to the nature of the violation pursuant to the standards established in Section 1424, and cited accordingly by the State Department of Public Health.
(h)
In addition to any other penalties set forth in this section, the willful or repeated violation of this section is punishable as a misdemeanor unless there is an emergency as described in subdivision (e) of
Section 72528 of, or subdivision (e) of Section 73524 of, Title 22 of the California Code of Regulations.
(i)
The State Department of Public Health shall, in consultation with interested stakeholders, develop a standardized informed consent form.
(j)
Skilled nursing facilities and intermediate care facilities shall not be required to
include the written consent form in the resident’s health record until the informed consent form is available as developed by the department. The department shall have a final informed consent form available to skilled nursing facilities and intermediate care facilities by December 31, 2025. Nothing in this section negates existing informed consent requirements in law or regulations.
(k)
This section shall not apply to an individual under the care of the State Department of State Hospitals.
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l
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Notwithstanding any other law, the department may, without taking any regulatory actions pursuant to Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, implement, interpret, or make specific this section by means of an All Facilities Letter (AFL) or similar instruction.