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Public Act 102-0646 | ||||
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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, |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
Disabilities Code with respect to the
administration of | ||
psychotropic medication.
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(d) In this Section only, "licensed nurse" means an | ||
advanced practice registered nurse, a registered nurse, or a | ||
licensed practical nurse. | ||
(Source: P.A. 101-10, eff. 6-5-19.)
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Section 99. Effective date. This Act takes effect upon | ||
becoming law.
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