Cal. Code Regs. Tit. 22, § 72528 - Informed Consent Requirements
(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.
Notes
2. Amendment of subsections (a), (e) and (f)(2)-(h) and amendment of NOTE filed 3-3-2010; operative 4-2-2010 (Register 2010, No. 10).
Note: Authority cited: Sections 1275, 100275 and 131200, Health and Safety Code. Reference: Sections 1276, 1316.5, 1599.72, 131050, 131051 and 131052, Health and Safety Code; and Cobbs v. Grant (1972) 8 Cal.3d 229.
2. Amendment of subsections (a), (e) and (f)(2)-(h) and amendment of Note filed 3-3-2010; operative 4-2-2010 (Register 2010, No. 10).
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