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Public Act 102-0646 |
SB2265 Enrolled | LRB102 13807 CPF 19157 b |
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AN ACT concerning regulation.
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Be it enacted by the People of the State of Illinois,
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represented in the General Assembly:
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Section 5. The Nursing Home Care Act is amended by |
changing Section 2-106.1 as follows: |
(210 ILCS 45/2-106.1)
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Sec. 2-106.1. Drug treatment.
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(a) A resident shall not be given unnecessary drugs. An
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unnecessary drug is any drug used in an excessive dose, |
including in
duplicative therapy; for excessive duration; |
without adequate
monitoring; without adequate indications for |
its use; or in the
presence of adverse consequences that |
indicate the drugs should be reduced or
discontinued. The |
Department shall adopt, by rule, the standards
for unnecessary
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drugs
contained in interpretive guidelines issued by the |
United States Department of
Health and Human Services for the |
purposes of administering Titles XVIII and XIX of
the Social |
Security Act.
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(b) Except in the case of an emergency, psychotropic |
medication shall not be administered without the informed
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consent of the resident or the resident's surrogate decision |
maker. "Psychotropic medication"
means medication that
is used |
for or listed as used for psychotropic, antidepressant, |
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antimanic, or
antianxiety behavior modification or behavior |
management purposes in the latest
editions of the AMA Drug |
Evaluations or the Physician's Desk Reference. "Emergency" has |
the same meaning as in Section 1-112 of the Nursing Home Care |
Act. A facility shall (i) document the alleged emergency in |
detail, including the facts surrounding the medication's need, |
and (ii) present this documentation to the resident and the |
resident's representative. The No later than January 1, 2021, |
the Department shall adopt, by rule, a protocol specifying how |
informed consent for psychotropic medication may be obtained |
or refused. The protocol shall require, at a minimum, a |
discussion between (i) the resident or the resident's |
surrogate decision maker and (ii) the resident's physician, a |
registered pharmacist (who is not a dispensing pharmacist for |
the facility where the resident lives) , or a licensed nurse |
about the possible risks and benefits of a recommended |
medication and the use of standardized consent forms |
designated by the Department. The protocol shall include |
informing the resident, surrogate decision maker, or both of |
the existence of a copy of: the resident's care plan; the |
facility policies and procedures adopted in compliance with |
subsection (b-15) of this Section; and a notification that the |
most recent of the resident's care plans and the facility's |
policies are available to the resident or surrogate decision |
maker upon request. Each form designated or developed by the |
Department (i) shall be written in plain language, (ii) shall |
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be able to be downloaded from the Department's official |
website or another website designated by the Department , (iii) |
shall include information specific to the psychotropic |
medication for which consent is being sought, and (iv) shall |
be used for every resident for whom psychotropic drugs are |
prescribed. The Department shall utilize the rules, protocols, |
and forms developed and implemented under the Specialized |
Mental Health Rehabilitation Act of 2013 in effect on the |
effective date of this amendatory Act of the 101st General |
Assembly, except to the extent that this Act requires a |
different procedure, and except that the maximum possible |
period for informed consent shall be until: (1) a change in the |
prescription occurs, either as to type of psychotropic |
medication or an increase or decrease in dosage , dosage range, |
or titration schedule of the prescribed medication that was |
not included in the original informed consent ; or (2) a |
resident's care plan changes. The Department may further amend |
the rules after January 1, 2021 pursuant to existing |
rulemaking authority. In addition to creating those forms, the |
Department shall approve the use of any other informed consent |
forms that meet criteria developed by the Department. At the |
discretion of the Department, informed consent forms may |
include side effects that the Department reasonably believes |
are more common, with a direction that more complete |
information can be found via a link on the Department's |
website to third-party websites with more complete |
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information, such as the United States Food and Drug |
Administration's website. The Department or a facility shall |
incur no liability for information provided on a consent form |
so long as the consent form is substantially accurate based |
upon generally accepted medical principles and if the form |
includes the website links. |
Informed consent shall be sought from the resident. For |
the purposes of this Section, "surrogate decision maker" means |
an individual representing the resident's interests as |
permitted by this Section. Informed consent shall be sought by |
the resident's guardian of the person if one has been named by |
a court of competent jurisdiction. In the absence of a |
court-ordered guardian, informed consent shall be sought from |
a health care agent under the Illinois Power of Attorney Act |
who has authority to give consent. If neither a court-ordered |
guardian of the person nor a health care agent under the |
Illinois Power of Attorney Act is available and the attending |
physician determines that the resident lacks capacity to make |
decisions, informed consent shall be sought from the |
resident's attorney-in-fact designated under the Mental Health |
Treatment Preference Declaration Act, if applicable, or the |
resident's representative. |
In addition to any other penalty prescribed by law, a |
facility that is found to have violated this subsection, or |
the federal certification requirement that informed consent be |
obtained before administering a psychotropic medication, shall |
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thereafter be required to obtain the signatures of 2 licensed |
health care professionals on every form purporting to give |
informed consent for the administration of a psychotropic |
medication, certifying the personal knowledge of each health |
care professional that the consent was obtained in compliance |
with the requirements of this subsection.
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(b-5) A facility must obtain voluntary informed consent, |
in writing, from a resident or the resident's surrogate |
decision maker before administering or dispensing a |
psychotropic medication to that resident. When informed |
consent is not required for a change in dosage, the facility |
shall note in the resident's file that the resident was |
informed of the dosage change prior to the administration of |
the medication or that verbal, written, or electronic notice |
has been communicated to the resident's surrogate decision |
maker that a change in dosage has occurred. |
(b-10) No facility shall deny continued residency to a |
person on the basis of the person's or resident's, or the |
person's or resident's surrogate decision maker's, refusal of |
the administration of psychotropic medication, unless the |
facility can demonstrate that the resident's refusal would |
place the health and safety of the resident, the facility |
staff, other residents, or visitors at risk. |
A facility that alleges that the resident's refusal to |
consent to the administration of psychotropic medication will |
place the health and safety of the resident, the facility |
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staff, other residents, or visitors at risk must: (1) document |
the alleged risk in detail; (2) present this documentation to |
the resident or the resident's surrogate decision maker, to |
the Department, and to the Office of the State Long Term Care |
Ombudsman; and (3) inform the resident or his or her surrogate |
decision maker of his or her right to appeal to the Department. |
The documentation of the alleged risk shall include a |
description of all nonpharmacological or alternative care |
options attempted and why they were unsuccessful. |
(b-15) Within 100 days after the effective date of any |
rules adopted by the Department under subsection (b) of this |
Section, all facilities shall implement written policies and |
procedures for compliance with this Section. When the |
Department conducts its annual survey of a facility, the |
surveyor may review these written policies and procedures and |
either: |
(1) give written notice to the facility that the |
policies or procedures are sufficient to demonstrate the |
facility's intent to comply with this Section; or |
(2) provide written notice to the facility that the |
proposed policies and procedures are deficient, identify |
the areas that are deficient, and provide 30 days for the |
facility to submit amended policies and procedures that |
demonstrate its intent to comply with this Section. |
A facility's failure to submit the documentation required |
under this subsection is sufficient to demonstrate its intent |
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to not comply with this Section and shall be grounds for review |
by the Department. |
All facilities must provide training and education on the |
requirements of this Section to all personnel involved in |
providing care to residents and train and educate such |
personnel on the methods and procedures to effectively |
implement the facility's policies. Training and education |
provided under this Section must be documented in each |
personnel file. |
(b-20) Upon the receipt of a report of any violation of |
this Section, the Department shall investigate and, upon |
finding sufficient evidence of a violation of this Section, |
may proceed with disciplinary action against the licensee of |
the facility. In any administrative disciplinary action under |
this subsection, the Department shall have the discretion to |
determine the gravity of the violation and, taking into |
account mitigating and aggravating circumstances and facts, |
may adjust the disciplinary action accordingly. |
(b-25) A violation of informed consent that, for an |
individual resident, lasts for 7 days or more under this |
Section is, at a minimum, a Type "B" violation. A second |
violation of informed consent within a year from a previous |
violation in the same facility regardless of the duration of |
the second violation is, at a minimum, a Type "B" violation. |
(b-30) Any violation of this Section by a facility may be |
enforced by an action brought by the Department in the name of |
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the People of Illinois for injunctive relief, civil penalties, |
or both injunctive relief and civil penalties. The Department |
may initiate the action upon its own complaint or the |
complaint of any other interested party. |
(b-35) Any resident who has been administered a |
psychotropic medication in violation of this Section may bring |
an action for injunctive relief, civil damages, and costs and |
attorney's fees against any facility responsible for the |
violation. |
(b-40) An action under this Section must be filed within 2 |
years of either the date of discovery of the violation that |
gave rise to the claim or the last date of an instance of a |
noncompliant administration of psychotropic medication to the |
resident, whichever is later. |
(b-45) A facility subject to action under this Section |
shall be liable for damages of up to $500 for each day after |
discovery of a violation that the facility violates the |
requirements of this Section. |
(b-55) The rights provided for in this Section are |
cumulative to existing resident rights. No part of this |
Section shall be interpreted as abridging, abrogating, or |
otherwise diminishing existing resident rights or causes of |
action at law or equity. |
(c) The requirements of
this Section are intended to |
control in a conflict
with the requirements of Sections 2-102 |
and 2-107.2
of the Mental Health and Developmental |