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.
A resident admitted with bipolar disorder, dementia, and anxiety was started on multiple psychotropic medications, including an antipsychotic, an anticonvulsant/mood stabilizer, and an antidepressant, which were administered as ordered. The admission MDS showed the resident was cognitively intact and receiving these medications, but review of the electronic record found no completed psychotropic consent form and no documentation that risks versus benefits of the medications had been reviewed with the resident or a representative. The unit manager, NP, and DON all confirmed that the psychotropic consent form should have been completed by the admitting nurse at admission, with a discussion of risks versus benefits prior to medication administration, but this did not occur or was not documented.
A resident with stroke and non-Alzheimer’s dementia, assessed as severely cognitively impaired and without behaviors, was started on mirtazapine and trazodone for depression and received these medications daily without documented informed consent from the responsible party regarding risks, benefits, or alternatives. The medical record lacked any evidence of such consent, and attempts to reach the responsible party were unsuccessful. Interviews with the ADON, DON, SW, NP, and Administrator showed confusion and inconsistent practices about who was responsible for obtaining psychotropic consents and how new psychotropic orders were communicated, leading to missed consents.
A resident with multiple psychiatric and medical diagnoses was started on antianxiety and antidepressant medications without documented informed consent or advance discussion of risks and benefits. Staff interviews revealed inconsistent practices for obtaining consent, and the DON acknowledged that consents for psychotropic medications were not consistently obtained.
A resident with dementia and anxiety disorder had the frequency of a psychotropic medication increased without the responsible party being informed of the change or the associated risks and benefits. The responsible party was unaware of the medication and the change in frequency, and staff interviews confirmed that consent was not obtained prior to the medication adjustment.
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