Failure to Obtain and Document Informed Consent for Psychotropic Medications
Summary
The deficiency involves the facility’s failure to obtain and document informed consent for psychotropic medications prior to administration, thereby failing to ensure residents or their representatives were informed in advance of the risks, benefits, alternatives, and options for treatment. For Resident #1, who had severe dementia with psychotic disturbance, anxiety disorder, and depressive disorder, the record showed extensive use of multiple psychotropic medications, including divalproex, lorazepam, olanzapine, quetiapine, sertraline, and trazodone over a defined period. The resident had an Office of Public Advocacy (OPA) guardian as medical decision-maker, yet there was no documented informed consent for any of these medications. Emails to the guardian referenced that Depakote and other psychotropics had been ordered or adjusted, but did not include information on risks, benefits, alternatives, or options, nor did they document that the guardian was given an opportunity to choose a preferred option. The guardian later stated the facility had never reviewed risks, benefits, alternatives, or options for any medications and that such information would have guided decision-making. For Resident #3, who had vascular dementia and cerebrovascular disease and also had an OPA guardian, the medical record showed long-term administration of valproic acid and a period of mirtazapine use, totaling hundreds of psychotropic medication administrations. The record contained no documented informed consent for these medications. A progress note indicated that a licensed nurse was unable to reach the resident’s representative and mailed a copy of notes, including the addition of mirtazapine, but there was no further documentation of efforts to contact the representative to discuss medications or obtain informed consent. The facility was unable to provide any proof of informed consent for Resident #3’s psychotropic medications, and the guardian similarly stated that information on risks and benefits would have guided decision-making. For Resident #4, who had Parkinson’s disease with dyskinesia, dementia due to Parkinson’s disease with behavioral disturbance, hallucinations, and Lewy body dementia with psychotic disturbance, the record showed an order and ongoing administration of pimavanserin, an antipsychotic, over approximately 90 days. The resident had a representative who made medical decisions, but there was no documented informed consent for this psychotropic medication, and the facility could not provide any proof when requested. For Resident #5, diagnosed with dementia with behavioral disturbance and Parkinson’s disease, quetiapine was ordered and first administered before the facility obtained a signed Psychotropic Risk/Benefits Verification of Informed Consent form; the consent was dated one day after the first dose was given. This demonstrated that consent was not obtained prior to initial administration. Interviews with nursing staff and leadership revealed confusion and inconsistency regarding responsibility for obtaining informed consent, when it should be obtained, and where it was documented. One licensed nurse believed physicians were ultimately responsible for obtaining consent and was unsure where signed consents were stored. Another nurse did not know who was responsible, when to obtain consent, or how to verify its presence before administering a new medication, and believed only antipsychotics required consent. A third nurse assumed that if a physician wrote an order, informed consent had already been obtained, and identified psychotropics and antipsychotics as requiring consent that included discussion of risks and benefits. The DON and LTC nurse manager stated that bedside nurses were trained to obtain informed consent before the first dose of medications needing consent and that the facility did not obtain new informed consent for psychotropics if a resident was already taking the same medication on admission, assuming the resident already knew the risks and benefits. The LTC nurse manager also stated that consents were sometimes obtained via email to representatives or guardians, but copies of those emails were not placed in the medical record, and audits of consents had not been done regularly. These practices conflicted with the facility’s resident rights document and its psychopharmacological drug use policy, both of which required that residents or their representatives be advised of potential risks and benefits of psychotropic medications and that this be documented.
Penalty
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Informed consent was not documented before a psychotropic med was started for one resident with dementia and anxiety, and it was not documented before another resident's Vraylar dose was increased for aggression. The DON stated the consent form should be completed before initiation or dose increase, and the facility policy required informed consent before starting or increasing a psychotropic med.
Missing Informed Consent for Psychotropic Medications: Five residents received psychotropic meds, including antidepressants and antianxiety agents, without signed consent forms in the chart. The residents included individuals with intact cognition as well as residents with dementia or severe cognitive impairment. The DON stated the consents had not been signed, and the ADM said she was unaware the forms were missing until the day of the interview. The facility’s psychotropic medication policy did not address medication consents, and no informed consent policy was provided.
Surveyors found that the facility did not ensure residents or their representatives were informed of and able to participate in decisions about psychotropic medications. Several residents with conditions such as dementia, early-onset Alzheimer’s disease, major depressive disorder, psychotic disorder, and Parkinson’s disease were started on drugs including haloperidol, donepezil, buspirone, quetiapine, zaleplon, and sertraline without documentation that risks, benefits, or alternative treatments were discussed in advance. The DON reported that staff notify families when medications are started or changed but do not review risks and benefits, offer alternative options, or obtain signed consent, resulting in no evidence of informed decision-making for these psychotropic treatments.
A resident with moderate dementia and severe cognitive impairment was started on Zyprexa after a MH NP changed her medication regimen, and physician orders documented its use for depression and later unspecified psychosis. Progress notes showed that the responsible party (RP) was informed of psychiatric recommendations and was later contacted multiple times regarding a pending consent form, and also requested discontinuation of Zyprexa while the consent remained unsigned. Despite this, the MAR showed that Zyprexa was administered on two occasions before any written consent was obtained, contrary to staff statements and facility policy requiring a signed antipsychotic consent from the resident or RP and the prescriber, and prior disclosure of risks, benefits, and alternatives.
A resident with schizophrenia, HTN, and MDD with psychotic features, and documented severe cognitive impairment requiring substantial/maximal assistance with ADLs, was receiving Quetiapine (Seroquel) 100 mg PO daily without documented informed consent. The ADON reported that antipsychotic consents are required on admission and with new orders and must include the medication name, dose, route, and frequency, but confirmed there was no consent on file for this antipsychotic. Facility policy on informed consent for psychotropic drugs required disclosure of reasons for use, benefits, risks (including black box warnings), and alternatives to the resident or RP, yet this process was not completed for the resident’s Seroquel order.
Surveyors found that the facility did not complete psychotherapeutic medication disclosure/consent forms for four residents before administering multiple psychotropic drugs, including antipsychotics, sedatives, antidepressants, and anxiolytics for conditions such as dementia with behavioral disturbance, MDD, anxiety, panic disorder, and psychosis. Record reviews showed that medications like Lorazepam, Seroquel, Clonazepam, Haldol, Hydroxyzine, Ramelteon, Risperidone, Mirtazapine, Caplyta, and Olanzapine were ordered and given without corresponding signed consent forms in the EHR. In an interview, the DON acknowledged that these residents should have had completed and signed consents and stated her expectation that residents or their representatives be informed about treatments and medications, including risks and benefits, before use.
Informed Consent Not Documented Before Psychotropic Medication Start or Increase
Penalty
Summary
The facility failed to ensure informed consent was obtained and documented before starting or increasing psychotropic medications for 2 residents reviewed for unnecessary medications. One resident with diagnoses including dementia with psychotic behaviors and anxiety had Rexulti 1 mg initiated for dementia with agitation, with the medication started the next day, but the Psychoactive Medication Consent and Management Agreement dated after the start lacked documentation from the resident's representative giving consent for the new psychotropic medication. Another resident with diagnoses including Alzheimer's disease, major depressive disorder, psychotic disorder, and anxiety had Vraylar increased from 1.5 mg to 3 mg for aggression, with the higher dose started the next day. The Psychoactive Medication Consent and Management Agreement was dated after the increase and documented telephone consent on that later date. The DON stated the consent form should be completed prior to initiation or increase of a new psychotropic medication, and the facility policy required informed consent to be obtained and documented before initiation or an increase in dosage, including discussion of risks, benefits, and alternatives.
Missing Informed Consent for Psychotropic Medications
Penalty
Summary
The facility failed to ensure that five residents were fully informed and had signed informed consent for psychotropic medications before those medications were administered. Residents #30, #32, #93, #127, and #130 were each receiving antidepressant and/or antianxiety medications, and record review showed no signed consent documents in their electronic medical records for the ordered psychotropic drugs. Resident #30 was admitted with diagnoses including cerebral infarction and depression, had a BIMS score of 13, and was receiving duloxetine and mirtazapine. Resident #32 had dementia, depression, and anxiety, had a BIMS score of 03, and was receiving Paxil. Resident #93 had cerebral infarction, depression, and anxiety, had a BIMS score of 05, and was receiving buspirone and citalopram. Resident #127 was admitted with depression and anxiety, had no completed MDS assessment in the record reviewed, and was receiving duloxetine. Resident #130 was admitted with depression and anxiety, had a BIMS score of 14, and was receiving clonazepam, escitalopram, and Wellbutrin XL. During interview, the DON stated the consents had not been signed and that nursing staff were responsible for obtaining consent when the order was received. The ADM stated she was not aware the consents were not signed until the day of the interview and that staff had been trained to obtain consent when medication was ordered. The facility’s psychotropic medication policy did not include information related to medication consents, and no informed consent policy was provided when requested.
Failure to Inform Residents of Risks, Benefits, and Alternatives Before Starting Psychotropic Medications
Penalty
Summary
The deficiency involves the facility’s failure to ensure that residents, or their representatives, were informed of and allowed to participate in decisions regarding psychotropic medication treatment, including being informed in advance of the risks, benefits, and treatment alternatives. For four sampled residents, medical record review showed new orders for multiple psychotropic medications without any documentation that the resident or representative had been informed of these elements prior to initiation. Resident 8, with diagnoses including hemiplegia and hemiparesis following cerebral infarction, psychotic disorder with delusions, dementia, and major depressive disorder, was started on haloperidol lactate, donepezil, buspirone, quetiapine, and sertraline on various dates, with no documentation of informed discussion or consent. Resident 4, with unspecified dementia and anxiety disorder, was started on zaleplon, quetiapine, and buspirone, again with no record that risks, benefits, or alternatives were discussed in advance. Resident 54, diagnosed with early-onset Alzheimer’s disease and dementia in other diseases classified elsewhere, was started on sertraline and quetiapine, and Resident 6, diagnosed with Parkinson’s disease without dyskinesia, was started on buspirone, quetiapine (Seroquel), and sertraline, with no documentation that either resident or their representative had been informed of the risks and benefits or treatment options before these psychotropic medications were initiated. During an interview, the DON stated that the facility notifies families when medications are started or doses are changed but does not discuss risks and benefits, provide alternative options, or obtain signed consent. This practice contributed to the lack of documented evidence that residents or their representatives were fully informed and able to participate in treatment decisions regarding psychotropic medications.
Antipsychotic Administered Without Prior Informed Consent
Penalty
Summary
The deficiency involves the facility’s failure to obtain and document informed consent for an antipsychotic medication prior to administration. A female resident with moderate dementia, anxiety, and depression, and a BIMS score of 02 indicating severe cognitive impairment, was admitted with no documented psychiatric or mood disorders, no indicators of psychosis, and no behavioral symptoms. Her care plan, however, included a focus on the use of the antipsychotic medication Zyprexa related to psychosis, initiated and revised in mid-April 2026. On 03/18/2026, a mental health nurse practitioner evaluated the resident and ordered discontinuation of Keppra, Buspar, and melatonin, and initiation of Zyprexa 10 mg at bedtime and Topamax 100 mg twice daily. Physician orders documented Zyprexa 10 mg at bedtime first for depression and then for unspecified psychosis. Progress notes indicated that the resident’s responsible party (RP) understood the psychiatric recommendations, and later notes documented calls to the RP regarding a pending signature for consent and that discontinuation of Zyprexa was requested by the RP while the consent signature was still pending. The MAR showed that Zyprexa 10 mg was administered on two evenings in early April without a signed consent from the RP. Interviews with nursing staff confirmed that facility practice and policy required a signed consent form from the resident or RP and the physician/NP before administering antipsychotic medications, and that verbal consent alone was not sufficient. Staff acknowledged that administering an antipsychotic without a signed consent could mean the RP or resident was not informed of side effects or other information about the medication. The DON confirmed that the resident received Zyprexa on two occasions without a consent form signed by the RP, despite the facility’s written policy stating that, prior to initiating or increasing psychotropic medications, the resident or representative must be informed of benefits, risks, alternatives, and have the opportunity to accept or decline, with documentation of this information in a format chosen by the facility.
Failure to Obtain Informed Consent for Antipsychotic Medication
Penalty
Summary
Facility staff failed to ensure that a resident and/or the resident’s responsible party were informed in advance of the risks and benefits of the antipsychotic medication Quetiapine (Seroquel), thereby not obtaining informed consent prior to its use. The resident was admitted with diagnoses including schizophrenia, hypertension, and major depressive disorder with psychotic features, and had a physician’s order dated 3/11/2026 for Quetiapine Fumarate 100 mg by mouth once daily for major depressive disorder with psychotic features. The resident’s Minimum Data Set dated 3/6/2026 documented severe cognitive impairment and a need for substantial/maximal assistance with most ADLs, indicating that the resident was not independently managing daily tasks. During an interview and concurrent record review with the ADON, it was stated that consents for antipsychotic medications are to be completed upon admission and whenever there is a new order, and that such consents must include the medication name, dosage, route, and frequency. The ADON confirmed there was no consent on file for Seroquel 100 mg for this resident, despite the existing order. The facility’s policy and procedure titled “Informed Consent for Psychotropic Drugs,” reviewed 2/2026, defined informed consent as disclosure of material information, including reasons for use, benefits, risks (including black box warnings), and alternatives, to allow the resident or representative to accept, refuse, or revoke consent. The absence of a documented consent for Seroquel showed that this process was not followed for the resident.
Failure to Obtain Psychotropic Medication Consents for Multiple Residents
Penalty
Summary
The deficiency involves the facility’s failure to obtain and complete psychotropic medication consent forms for multiple residents before initiating or continuing psychotropic medications. For one resident with senile degeneration of the brain, severe vascular dementia with behavioral disturbance, sequelae of cerebral infarction, adult failure to thrive, and generalized muscle weakness, physician orders included multiple Lorazepam and Seroquel regimens for anxiety and agitation over several dates. Review of this resident’s electronic health record on 04/27/26 showed that a Psychotherapeutic Medication Administration Disclosure/Consent form had not been completed prior to the use of Lorazepam or Seroquel. Another resident, admitted with dementia with behavior disturbance, anxiety disorder, moderate cognitive communication deficit, and mild cognitive impairment, had numerous psychotropic and related medications ordered, including several Clonazepam regimens, Haldol Decanoate IM, Haloperidol, Hydroxyzine, Ramelteon, and Risperidone for anxiety, agitation, combativeness, and insomnia. Record review on 04/27/26 revealed that no Psychotherapeutic Medication Administration Disclosure/Consent form was completed before the use of any of these medications. A third resident with Parkinsonism, dementia with behavioral disturbance, cognitive communication deficit, major depressive disorder, and hallucinations had orders for Caplyta and Mirtazapine for major depressive disorder, with changes and discontinuations over time. The electronic health record review showed that a psychotherapeutic consent form was not completed prior to the use of Mirtazapine or Caplyta. A fourth resident, admitted with depression and panic disorder, had physician orders for Clonazepam for anxiety and Olanzapine for psychosis. Review of this resident’s electronic health record on 04/27/26 also showed that a Psychotherapeutic Medication Administration Disclosure/Consent form was not completed before these medications were used. During an interview on 04/27/26 at 2:33 p.m., the DON stated that these residents should have had completed and signed consent forms for any psychotropic medications and that her expectation is that all residents or their representatives receive information on all treatments and medications prior to use so they are aware of the risks and benefits.
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