0940-01-02-.06
Procedures For Obtaining Informed Consent
Cite as Tenn. Comp. R. & Regs. 0940-01-02-.06
(1)
Any staff member may encourage a patient to give informed consent for psychotropic
medication, physical treatment, and/or release of information. A consent is not voluntary if it
is given in response to force or to the threat of force, discharge, involuntary commitment,
transfer to a more restrictive environment, or loss of privileges. Providing information about
the benefits of psychotropic medication, physical treatment, and/or release of information and
the potential adverse consequences of consenting or not consenting is permitted.
(2)
Informed consent shall be obtained only after determining that there are no indicators (e.g.,
actions, statements, behavior) that the patient lacks capacity to give informed consent or, if
indicators are present, after a physician, licensed practitioner, or qualified mental health
professional has determined that the patient does not lack capacity. If the patient has
provided a current Declaration for Mental Health Treatment that addresses the issue for
which informed consent is needed, then the patient’s capacity must be assessed by:
(a)
Two (2) physicians; or
(b)
One (1) physician with expertise in psychiatry by training, education, or experience and
one (1) psychologist with health service provider designation.
(3)
A staff member who has been trained in obtaining informed consent must discuss the
proposed psychotropic medication, physical treatment, and/or release of information with the
patient as follows:
PROCEDURES FOR PRESCRIPTION AND ADMINISTRATION OF
CHAPTER 0940-01-02
PSYCHOTROPIC MEDICATIONS AT MENTAL HEALTH INSTITUTES
(a)
For psychotropic medication: A member of the RMHI Medical Staff, a registered nurse,
or a pharmacist must discuss the psychotropic medication(s) to be prescribed and its
type and purpose; the dosage and route of administration; the potential risks and side
effects of the psychotropic medication(s); the advantages and risks of alternative
treatments, if available; and the prognosis if the psychotropic medication(s) is not
given. This discussion shall be tailored to the patient’s level of understanding.
(b)
For physical treatment: A member of the RMHI Medical Staff or a registered nurse
must discuss the physical treatment(s) to be prescribed and its purpose; the potential
risks of the physical treatment(s); the advantages and risks of alternative treatments, if
available; and the prognosis if the physical treatment is not provided. This discussion
shall be tailored to the patient’s level of understanding.
(c)
For release of information: A clinical professional or a staff member supervised by a
clinical professional must discuss the proposed release, including the name of the
person or organization the information is to be released to/from; the information to be
released; the purpose of the release; and the potential risks if the information is not
released. This discussion shall be tailored to the patient’s level of understanding.
(4)
A staff member who has been trained in obtaining informed consent must discuss the content
of the consent form(s) and/or the release of information form with the patient, patient’s
conservator or other legal representative, offered to answer questions, and advised the
patient that they may revoke informed consent at any time.
(5)
Informed consent for psychotropic medication and/or physical treatment shall be documented
on a state-approved form and maintained in the patient’s medical record.
Consent forms shall include notice of:
(a)
The rights of a voluntary patient who does not lack capacity to refuse psychotropic
medication and/or physical treatment, except in emergency situations;
(b)
The rights of an involuntary patient who does not lack capacity to refuse psychotropic
medication and/or physical treatment, except in emergency situations, unless the
Treatment Review Committee authorizes psychotropic medication and/or physical
treatment over the patient’s objection in accordance with Rule 0940-01-02-.10;
(c)
The definition of emergency and the duration of psychotropic medication and/or
physical treatment allowed in emergency situations;
(d)
The right of revocation and procedures for revocation;
(e)
The consent form shall state the class of psychotropic medication and/or physical
treatment prescribed and shall contain an acknowledgment that the person who
obtained the consent has fully discussed the psychotropic medication and/or physical
treatment with the patient, including the information specified in subparagraphs 0940-
01-02-.06(3)(a) and (b); and
(f)
The consent form shall contain an acknowledgment that the person who obtained the
consent has fully discussed the contents of the consent form with the patient, offered to
answer questions, and advised the patient of their right to refuse psychotropic
medication and/or physical treatment.
(6)
Informed consent for release of information shall be documented on the release of
information form.
PROCEDURES FOR PRESCRIPTION AND ADMINISTRATION OF
CHAPTER 0940-01-02
PSYCHOTROPIC MEDICATIONS AT MENTAL HEALTH INSTITUTES
(7)
The consent form and/or the release of information form shall be signed, dated, and time-
stamped by the person giving informed consent and by the staff member who obtained the
consent. The completed form must be maintained in the patient’s medical record.
(a)
If a patient, conservator or other legal representative gives oral consent to psychotropic
medication, physical treatment, and/or release of information, but is unable or unwilling
to sign the consent form and/or the release of information form, oral consent shall be
noted on the consent form and/or the release of information form and witnessed by two
(2) staff members.
(b)
Informed consent may be obtained from a conservator or other legal representative by
phone, video-conference, or other electronic means that allow the required information
to be provided to the conservator or other legal representative. The consent form
and/or the release of information form is to be explained to the conservator or other
legal representative, and the conservator or other legal representative is to be given
the opportunity to discuss the psychotropic medication, physical treatment, and/or
release of information with a staff member in accordance with Rules 0940-01-02-.04
and 0940-01-02-.06.