Failure to Obtain Psychotropic Medication Consent: The facility administered psychotropic medications to several residents, including antidepressants, an antipsychotic, and an antianxiety medication, without documented proof that the residents or their representatives were informed in advance of the risks and benefits or signed consent forms. Interviews with residents, the DON, Unit Manager, Psychiatric NP, Medical Director, and Consulting Pharmacist confirmed that consent was required when psychotropic medications were started or increased, but the records for the affected residents did not show that this occurred.
Failure to Obtain Consent for Psychotropic Medications: The facility administered psychotropic meds to multiple residents, including antipsychotics, antidepressants, and antianxiety agents, without documented consent or evidence that the resident or representative was informed in advance of the risks and benefits. Records showed orders for medications such as quetiapine, Seroquel, duloxetine, sertraline, mirtazapine, trazodone, diazepam, fluoxetine, buspirone, escitalopram, and Risperdal Consta, while interviews confirmed that consent was sometimes not obtained before administration.
Failure to obtain medication-specific informed consent for psychotropic drugs: The facility administered antipsychotic medications to four residents with diagnoses including dementia, Parkinson’s disease, and psychotic disorders, but the EMR lacked documentation that the residents or their RRs/Guardian were informed in advance of the risks, benefits, and treatment alternatives. The only consents in the records were general psychotropic medication forms signed on admission, and interviews showed the DON, Administrator, Medical Director, and Psychiatric NP had differing understandings of who was responsible for obtaining informed consent.
Failure to obtain informed consent for psychotropic medications: Two residents with dementia, anxiety, and depression received antianxiety, antidepressant, and antipsychotic medications without documentation that they or their Responsible Parties were informed in advance of the risks and benefits or consented to treatment. The MARs showed the medications were administered as ordered, while interviews with the DON, Social Services, Psychiatric NP, and Administrator confirmed the facility was not obtaining or auditing informed consents for psychotropic medications.
The facility failed to obtain and document informed consent for psychotropic medications for three residents. One resident with dementia and behavioral symptoms received quetiapine and divalproex, including a dose increase, without documented evidence that the responsible party was informed of risks and benefits or consented. Another resident with anxiety and depression, severe cognitive impairment, and disruptive behaviors was started on duloxetine and given multiple doses of PRN lorazepam, again without documentation that the responsible party was informed or consent obtained. A third cognitively intact resident with depression and anxiety received escitalopram 20 mg daily with no record that she was informed of the medication’s risks and benefits or that she consented. The Nurse Team Lead, identified as responsible for obtaining psychotropic consents, and the DON both confirmed that the expected notifications and consent documentation were not present in the medical records.
The facility failed to obtain and document informed consent, including discussion of risks and benefits, before initiating or increasing psychotropic medications for three residents receiving antianxiety and antidepressant drugs. Cognitively intact residents reported that no provider or staff discussed side effects or risks and benefits when their alprazolam, sertraline, Xanax, or Zoloft were started or increased, and a responsible party for a severely cognitively impaired resident did not recall any discussion when buspirone was initiated. Records lacked documentation of informed consent, while interviews with the NP, Medical Director, Rounding Nurse, DON, Informatics Nurse, and Consulting Pharmacist revealed that nursing staff were expected to handle psychotropic consents, but consents were only being obtained for new antipsychotic orders and not for residents admitted on psychotropics or for antidepressant and antianxiety medications, despite policy defining these as psychotropics.
A resident with Lewy Body Dementia and severe cognitive impairment was started on risperidone 0.5 mg twice daily for a mood disorder without documented informed consent from the responsible party regarding the risks and benefits of the psychotropic medication. Record review showed no consent documentation in the electronic medical record, and interviews with the social services staff and the NP revealed that the prior process for obtaining psychotropic consents had lapsed after a former social worker left. The DON confirmed that the system for notifying the NP to obtain informed consent for new psychotropic medications had failed, resulting in the medication being initiated without proper informed consent.
The facility failed to obtain and document informed consent before initiating psychotropic antidepressant medications for seven cognitively intact or mildly impaired residents with conditions such as depression, anxiety, stroke, dementia, insomnia, and falls. Physician orders and MARs showed that medications including duloxetine, sertraline, amitriptyline, trazodone, bupropion, and Prozac were administered as ordered, but EMRs lacked evidence that residents or responsible parties were informed of the medication names, purposes, risks, benefits, alternatives, or their right to refuse, and there were no signed consent forms or progress notes reflecting consent discussions. In interviews, the Case Manager and DON reported they were unaware that consent was required for psychotropic medications and acknowledged the facility had not been obtaining informed consent, while the Physician stated she was unaware consent had not been obtained and affirmed that informed consent prior to starting psychotropic medications is essential.
Surveyors found that the facility repeatedly failed to obtain and document informed consent before initiating psychotropic medications for several residents with dementia, mood disorders, psychosis, and anxiety. Multiple residents with severe cognitive impairment were receiving antipsychotics, antidepressants, antianxiety agents, and mood stabilizers such as olanzapine, haloperidol, quetiapine, lorazepam, trazodone, duloxetine, venlafaxine, lamotrigine, mirtazapine, and fluoxetine without any record that they or their representatives had been informed of the risks and benefits or had consented. Interviews with the Administrator, DON, ADON, MDS nurse, and SW showed that responsibility for obtaining psychotropic consents was shared between the MDS nurse and SW, but they were not consistently notified of new or changed orders, were unclear that consents were required for all psychotropics (not just antipsychotics), and acknowledged that frequent staff turnover and process gaps led to consents "slipping through the cracks."
The facility failed to obtain and document informed consent, including discussion of risks and benefits, before initiating and escalating the psychotropic medication divalproex sodium for three severely cognitively impaired residents with dementia and related psychiatric diagnoses. A psychiatric NP recommended divalproex for behaviors such as aggression, agitation, hallucinations, and evening agitation, and physicians ordered progressive dose increases that were administered as recorded on the MAR. However, the medical records for each resident contained no evidence that a representative had been informed in advance of the risks versus benefits or had consented, and both the unit manager and DON acknowledged in interviews that psychotropic consents were their responsibility and had been overlooked, despite the administrator’s stated expectation that such consents be obtained prior to starting or changing psychotropic medications.
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