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1 | | purposes of administering Titles XVIII and XIX of
the Social |
2 | | Security Act.
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3 | | (b) Except in the case of an emergency, psychotropic |
4 | | medication shall not be administered without the informed
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5 | | consent of the resident or the resident's surrogate decision |
6 | | maker. "Psychotropic medication"
means medication that
is used |
7 | | for or listed as used for psychotropic, antidepressant, |
8 | | antimanic, or
antianxiety behavior modification or behavior |
9 | | management purposes in the latest
editions of the AMA Drug |
10 | | Evaluations or the Physician's Desk Reference. "Emergency" has |
11 | | the same meaning as in Section 1-112 of the Nursing Home Care |
12 | | Act. A facility shall (i) document the alleged emergency in |
13 | | detail, including the facts surrounding the medication's need, |
14 | | and (ii) present this documentation to the resident and the |
15 | | resident's representative. The No later than January 1, 2021, |
16 | | the Department shall adopt, by rule, a protocol specifying how |
17 | | informed consent for psychotropic medication may be obtained |
18 | | or refused. The protocol shall require, at a minimum, a |
19 | | discussion between (i) the resident or the resident's |
20 | | surrogate decision maker and (ii) the resident's physician, a |
21 | | registered pharmacist (who is not a dispensing pharmacist for |
22 | | the facility where the resident lives) , or a licensed nurse , |
23 | | including, but not limited to, a licensed practical nurse, |
24 | | about the possible risks and benefits of a recommended |
25 | | medication and the use of standardized consent forms |
26 | | designated by the Department. The protocol shall include |
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1 | | informing the resident, surrogate decision maker, or both of |
2 | | the existence of a copy of: the resident's care plan; the |
3 | | facility policies and procedures adopted in compliance with |
4 | | subsection (b-15) of this Section; and a notification that the |
5 | | most recent of the resident's care plans and the facility's |
6 | | policies are available to the resident or surrogate decision |
7 | | maker upon request. Each form designated or developed by the |
8 | | Department (i) shall be written in plain language, (ii) shall |
9 | | be able to be downloaded from the Department's official |
10 | | website or another website designated by the Department , (iii) |
11 | | shall include information specific to the psychotropic |
12 | | medication for which consent is being sought, and (iv) shall |
13 | | be used for every resident for whom psychotropic drugs are |
14 | | prescribed. The Department shall utilize the rules, protocols, |
15 | | and forms developed and implemented under the Specialized |
16 | | Mental Health Rehabilitation Act of 2013 in effect on the |
17 | | effective date of this amendatory Act of the 101st General |
18 | | Assembly, except to the extent that this Act requires a |
19 | | different procedure, and except that the maximum possible |
20 | | period for informed consent shall be until: (1) a change in the |
21 | | prescription occurs, either as to type of psychotropic |
22 | | medication or an increase or decrease in dosage , dosage range, |
23 | | or titration schedule of the prescribed medication that was |
24 | | not included in the original informed consent ; or (2) a |
25 | | resident's care plan changes. The Department may further amend |
26 | | the rules after January 1, 2021 pursuant to existing |
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1 | | rulemaking authority. In addition to creating those forms, the |
2 | | Department shall approve the use of any other informed consent |
3 | | forms that meet criteria developed by the Department. At the |
4 | | discretion of the Department, informed consent forms may |
5 | | include side effects that the Department reasonably believes |
6 | | are more common, with a direction that more complete |
7 | | information can be found via a link on the Department's |
8 | | website to third-party websites with more complete |
9 | | information, such as the United States Food and Drug |
10 | | Administration's website. The Department or a facility shall |
11 | | incur no liability for information provided on a consent form |
12 | | so long as the consent form is substantially accurate based |
13 | | upon generally accepted medical principles and if the form |
14 | | includes the website links. |
15 | | Informed consent shall be sought from the resident. For |
16 | | the purposes of this Section, "surrogate decision maker" means |
17 | | an individual representing the resident's interests as |
18 | | permitted by this Section. Informed consent shall be sought by |
19 | | the resident's guardian of the person if one has been named by |
20 | | a court of competent jurisdiction. In the absence of a |
21 | | court-ordered guardian, informed consent shall be sought from |
22 | | a health care agent under the Illinois Power of Attorney Act |
23 | | who has authority to give consent. If neither a court-ordered |
24 | | guardian of the person nor a health care agent under the |
25 | | Illinois Power of Attorney Act is available and the attending |
26 | | physician determines that the resident lacks capacity to make |
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1 | | decisions, informed consent shall be sought from the |
2 | | resident's attorney-in-fact designated under the Mental Health |
3 | | Treatment Preference Declaration Act, if applicable, or the |
4 | | resident's representative. |
5 | | In addition to any other penalty prescribed by law, a |
6 | | facility that is found to have violated this subsection, or |
7 | | the federal certification requirement that informed consent be |
8 | | obtained before administering a psychotropic medication, shall |
9 | | thereafter be required to obtain the signatures of 2 licensed |
10 | | health care professionals on every form purporting to give |
11 | | informed consent for the administration of a psychotropic |
12 | | medication, certifying the personal knowledge of each health |
13 | | care professional that the consent was obtained in compliance |
14 | | with the requirements of this subsection.
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15 | | (b-5) A facility must obtain voluntary informed consent, |
16 | | in writing, from a resident or the resident's surrogate |
17 | | decision maker before administering or dispensing a |
18 | | psychotropic medication to that resident. When informed |
19 | | consent is not required for a change in dosage, the facility |
20 | | shall note in the resident's file that the resident was |
21 | | informed of the dosage change prior to the administration of |
22 | | the medication or that verbal, written, or electronic notice |
23 | | has been communicated to the resident's surrogate decision |
24 | | maker that a change in dosage has occurred. |
25 | | (b-10) No facility shall deny continued residency to a |
26 | | person on the basis of the person's or resident's, or the |
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1 | | person's or resident's surrogate decision maker's, refusal of |
2 | | the administration of psychotropic medication, unless the |
3 | | facility can demonstrate that the resident's refusal would |
4 | | place the health and safety of the resident, the facility |
5 | | staff, other residents, or visitors at risk. |
6 | | A facility that alleges that the resident's refusal to |
7 | | consent to the administration of psychotropic medication will |
8 | | place the health and safety of the resident, the facility |
9 | | staff, other residents, or visitors at risk must: (1) document |
10 | | the alleged risk in detail; (2) present this documentation to |
11 | | the resident or the resident's surrogate decision maker, to |
12 | | the Department, and to the Office of the State Long Term Care |
13 | | Ombudsman; and (3) inform the resident or his or her surrogate |
14 | | decision maker of his or her right to appeal to the Department. |
15 | | The documentation of the alleged risk shall include a |
16 | | description of all nonpharmacological or alternative care |
17 | | options attempted and why they were unsuccessful. |
18 | | (b-15) Within 100 days after the effective date of any |
19 | | rules adopted by the Department under subsection (b) of this |
20 | | Section, all facilities shall implement written policies and |
21 | | procedures for compliance with this Section. When the |
22 | | Department conducts its annual survey of a facility, the |
23 | | surveyor may review these written policies and procedures and |
24 | | either: |
25 | | (1) give written notice to the facility that the |
26 | | policies or procedures are sufficient to demonstrate the |
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1 | | facility's intent to comply with this Section; or |
2 | | (2) provide written notice to the facility that the |
3 | | proposed policies and procedures are deficient, identify |
4 | | the areas that are deficient, and provide 30 days for the |
5 | | facility to submit amended policies and procedures that |
6 | | demonstrate its intent to comply with this Section. |
7 | | A facility's failure to submit the documentation required |
8 | | under this subsection is sufficient to demonstrate its intent |
9 | | to not comply with this Section and shall be grounds for review |
10 | | by the Department. |
11 | | All facilities must provide training and education on the |
12 | | requirements of this Section to all personnel involved in |
13 | | providing care to residents and train and educate such |
14 | | personnel on the methods and procedures to effectively |
15 | | implement the facility's policies. Training and education |
16 | | provided under this Section must be documented in each |
17 | | personnel file. |
18 | | (b-20) Upon the receipt of a report of any violation of |
19 | | this Section, the Department shall investigate and, upon |
20 | | finding sufficient evidence of a violation of this Section, |
21 | | may proceed with disciplinary action against the licensee of |
22 | | the facility. In any administrative disciplinary action under |
23 | | this subsection, the Department shall have the discretion to |
24 | | determine the gravity of the violation and, taking into |
25 | | account mitigating and aggravating circumstances and facts, |
26 | | may adjust the disciplinary action accordingly. |
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1 | | (b-25) A violation of informed consent that, for an |
2 | | individual resident, lasts for 7 days or more under this |
3 | | Section is, at a minimum, a Type "B" violation. A second |
4 | | violation of informed consent within a year from a previous |
5 | | violation in the same facility regardless of the duration of |
6 | | the second violation is, at a minimum, a Type "B" violation. |
7 | | (b-30) Any violation of this Section by a facility may be |
8 | | enforced by an action brought by the Department in the name of |
9 | | the People of Illinois for injunctive relief, civil penalties, |
10 | | or both injunctive relief and civil penalties. The Department |
11 | | may initiate the action upon its own complaint or the |
12 | | complaint of any other interested party. |
13 | | (b-35) Any resident who has been administered a |
14 | | psychotropic medication in violation of this Section may bring |
15 | | an action for injunctive relief, civil damages, and costs and |
16 | | attorney's fees against any facility responsible for the |
17 | | violation. |
18 | | (b-40) An action under this Section must be filed within 2 |
19 | | years of either the date of discovery of the violation that |
20 | | gave rise to the claim or the last date of an instance of a |
21 | | noncompliant administration of psychotropic medication to the |
22 | | resident, whichever is later. |
23 | | (b-45) A facility subject to action under this Section |
24 | | shall be liable for damages of up to $500 for each day after |
25 | | discovery of a violation that the facility violates the |
26 | | requirements of this Section. |
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1 | | (b-55) The rights provided for in this Section are |
2 | | cumulative to existing resident rights. No part of this |
3 | | Section shall be interpreted as abridging, abrogating, or |
4 | | otherwise diminishing existing resident rights or causes of |
5 | | action at law or equity. |
6 | | (c) The requirements of
this Section are intended to |
7 | | control in a conflict
with the requirements of Sections 2-102 |
8 | | and 2-107.2
of the Mental Health and Developmental |
9 | | Disabilities Code with respect to the
administration of |
10 | | psychotropic medication.
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11 | | (Source: P.A. 101-10, eff. 6-5-19.)
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12 | | Section 99. Effective date. This Act takes effect upon |
13 | | becoming law.".
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