Failure to Obtain Informed Consent for Psychotropic Medication
Summary
A deficiency was identified when the facility failed to obtain informed consent for the administration of Celexa, an antidepressant medication, to a resident diagnosed with depression. The resident, who was cognitively intact and had a history of paroxysmal atrial fibrillation, coronary artery disease, and congestive heart failure, was admitted to the facility and subsequently prescribed Celexa for depression manifested by low interest and motivation with activities of daily living. Review of the resident's records confirmed that informed consent was not documented prior to starting the medication. During an interview, the Quality Assurance Nurse acknowledged that informed consent had not been obtained before initiating the psychotropic medication, despite facility policy requiring that residents, families, or representatives be informed of the risks and benefits of such medications and that this information be documented in the resident's chart. The facility's policy specifically included antidepressants as psychotropic medications for which informed consent is required.
Plan Of Correction
F552 - Right to be informed/ Make Treatment Decisions How Corrective Action(s) will be accomplished for those residents found to have been affected by the deficient practice: - On 5/30/25, the Quality Assurance Nurse (QAN) offered and secured the consent from Resident 45 regarding the Celexa medication. (Exhibit #1) How the facility will identify other residents having the potential to be affected by the same deficient practice and what corrective action will be taken: - On 6/2/25, the Social Service Director (SSD) and QAN reviewed the list of residents with psychoactive medications orders to ensure that informed consents were signed and obtained. (Exhibit #2) - No other resident was affected of the same deficient practice. What measures were put into place or what systematic changes the facility will make to ensure that the deficient practice does not recur: - On 6/17/25 and 6/18/25, the Director of Nursing (DON) provided in services to the licensed nurses regarding the facility's policy and procedure (P&P) titled "Use of Psychotropic Medications" dated 3/17/2025. (Exhibit #3) - Starting on 6/16/25, the SSD will conduct a weekly review for three months of the informed consents for those residents who will be receiving psychoactive medications orders. In addition, the SSD will review the informed consents of the newly admitted residents. (Exhibit #4) - Starting on 6/16/25, the SSD will report to the administrator any non-compliance. How the facility plans to monitor its performance to make sure that solutions are sustained. The facility must develop a plan for ensuring that correction is achieved and sustained. This plan must be implemented and the corrective action evaluated for its effectiveness. The POC is integrated into the quality assurance system: - The SSD will discuss any trends or patterns during the monthly QA committee meeting for three months for review and recommendation and will re-evaluate if any further concerns are identified after. Date of completion: June 20, 2025
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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