Incomplete informed consent for psychotropic medications
Summary
The facility failed to ensure valid informed consent for psychotropic medications and treatments for multiple residents. Review of the facility’s policies showed that written informed consent was required for psychoactive drugs, with renewal every six months, and that the licensed nurse was to verify informed consent before the first dose or first increased dose. The facility also had an instruction sheet for the Psychotherapeutic Drug Informed Consent Form requiring the Caution and Warning Summary section to identify whether the medication was off-label use, FDA-approved use, and whether it carried a black box warning label. For Resident 2, the record showed diagnoses of dementia and inability to understand and make treatment decisions. The resident had orders for quetiapine for psychosis manifested by sudden angry outburst and trazodone for depression manifested by inability to sleep. The quetiapine informed consent was documented as given by the resident, but the resident did not sign the form and only one licensed nurse verified it. The trazodone consent was given by the resident’s representative via telephone, but only one licensed nurse verified the consent. For Resident 6, who had no decision-making capacity, the physician ordered quetiapine for schizoaffective disorder manifested by striking out. The informed consent form for quetiapine did not include the diagnosis, the behavior manifestation related to the medication, or the duration for use as ordered. For Resident 11, who had no capacity to understand and make decisions, the alprazolam consent form showed the resident gave consent but did not sign, and only one licensed nurse verified it. For Resident 13, the trazodone consent form did not show the resident’s signature, and the clonazepam consent form did not complete the Caution and Warning Summary to show whether the medication was off-label use and FDA-approved use. For Resident 3 and Resident 61, the consent forms for duloxetine, escitalopram, and trazodone did not complete the Caution and Warning Summary to show off-label use, FDA-approved use, and, where applicable, black box warning information.
Penalty
Resources
Below are regulatory guidelines relevant to this citation:
Failure to Obtain Informed Consent Before Starting Duloxetine: The facility failed to obtain and document informed consent before starting Duloxetine for a resident with anxiety, depression, and chronic pain. The DON confirmed there was no informed consent for the medication, and the facility policy required informed consent before initiating psychotropic meds, including discussion of the target symptom, intended benefit, risks/side effects, and alternatives.
Failure to Obtain Informed Consent for Psychotropic Medications: Two residents receiving psychotropic medications, including antidepressants, antipsychotics, and mood stabilizers, did not have documented informed consent in their records before the medications were administered. One resident had diagnoses including depression, bipolar disorder, and schizophrenia, and the other had traumatic brain injury, schizoaffective disorder-bipolar type, major depressive disorder, and paraplegia. The DON could not provide consent documentation for one resident, and the other resident's record lacked consent explaining the risks and benefits of the medications. The NP stated the facility is responsible for obtaining medication consents when residents are admitted on psychotropics or when doses or medications change.
A resident with diabetes, dementia, and CHF was started on Diazepam for anxiety, but the clinical record lacked evidence that the resident and/or representative were informed in advance of the medication’s risks, benefits, and alternative treatments. The DON confirmed the missing documentation, and the facility policy required RN-obtained consent and notification of the resident’s representative regarding desired effects and potential side effects.
A resident with intact cognition and diagnoses including renal dialysis dependence, type 2 DM, and insomnia was prescribed clonazepam and temazepam, but the medical record lacked evidence of informed consent for either psychotropic medication. The DON was unable to locate signed consent, and stated that residents admitted on psychotropic meds needed a consent form signed on admission day.
The facility failed to document and offer nonpharmacological treatment options when obtaining consent for psychotropic medications for several residents. A resident with PTSD, anxiety, and depression; a resident with severe cognitive impairment and dementia; and two residents with dementia-related behaviors received antipsychotic, antianxiety, and/or antidepressant medications, and consent forms were completed, but the records did not show that alternate treatment interventions were presented. The DON confirmed the facility had no evidence that these options were provided with the psychotropic medication consents.
Failure to obtain informed consent for psychotropic medications: two residents were prescribed medications for mental health-related conditions, but the EMR did not show education or consent for all ordered drugs. One resident with intact cognition had orders for Depakote and gabapentin without documented education on risks, benefits, side effects, or alternatives. Another resident with severe cognitive impairment had consent for Celexa, but not for hydroxyzine or risperidone; the DON stated residents and/or families should know the risks and side effects before deciding to take the medication.
Failure to Obtain Informed Consent Before Starting Duloxetine
Penalty
Summary
The facility failed to ensure that Resident #7 was informed in advance, by the physician or other professional, of the risks and benefits of proposed care, treatment alternatives, and the option to choose the preferred treatment before Duloxetine was started. Resident #7 was admitted with diagnoses including unspecified anxiety disorder, unspecified depression, and chronic pain. Record review showed an order for Duloxetine HCl 30 mg, and the medication record indicated that Duloxetine was initiated on 4/15/26, later discontinued and reordered, and remained active as of 7/8/26. During interview on 8/13/26, the DON stated there was no informed consent for Resident #7’s Duloxetine and said, “We are working on it now.” The facility’s Informed Consent policy stated that no treatment, procedure, or service requiring informed consent is to be initiated without informed consent from the resident or representative, and that psychotropic medications require documented informed consent before initiation. The policy also required discussion of the target symptom or condition, intended benefit, potential risks and side effects, and available alternatives before starting a psychotropic medication.
Failure to Obtain Informed Consent for Psychotropic Medications
Penalty
Summary
The facility failed to ensure informed consent was obtained before psychotropic medications were administered to Resident #4. A record review on 8/12/26 showed physician orders for Paroxetine 40 mg daily for depression, Trazodone 100 mg daily for depression, Divalproex 500 mg twice daily for bipolar disorder, and Risperidone 2 mg three times daily for schizophrenia. Resident #4 was admitted with diagnoses including major depressive disorder, depression, bipolar disorder with manic severe psychotic features, and paranoid schizophrenia. When the DON was asked to provide documentation of informed consent for these psychotropic medications, she was unable to provide evidence that the resident or resident representative had been informed of and consented to their use prior to administration. The same issue was identified for Resident #11, who was admitted with diagnoses including traumatic brain injury, schizoaffective disorder-bipolar type, major depressive disorder, and paraplegia. The resident was receiving Haldol 10 mg three times daily, Olanzapine 10 mg at bedtime, and Divalproex sodium 500 mg every 12 hours for schizoaffective disorder and bipolar disorder, but the record did not contain consent for psychotropic medication use explaining the risks and benefits prior to administration. During interview, the DON stated the NP obtains medication and treatment consents when she visits residents, while the NP stated it is the facility's responsibility to obtain medication consents when a resident is admitted on psychotropic medications and when there is a dosage increase, decrease, or medication change. The facility policy stated residents receiving psychotropic medication are to have the risks and benefits reviewed and consent completed prior to initiation of the medication.
Failure to Inform Resident/Representative Before Diazepam Use
Penalty
Summary
The facility failed to inform Resident R11 and/or the resident’s representative in advance of the risks, benefits, and treatment alternatives before starting Diazepam, a psychotropic medication. The facility policy on Psychotropic Medications stated that the resident’s representative would be informed of the need for the desired effects and potential side effects of the medication, and that the RN would obtain consent verbally or in person and complete a Psychotropic Medication Consent form. Resident R11 was admitted with diagnoses including diabetes, dementia, and CHF. The clinical record showed physician orders for Diazepam 5 mg by mouth twice daily for 90 days, followed by a later order for Diazepam 5 mg by mouth daily and 10 mg at bedtime. The record lacked evidence that the resident and/or representative were informed in advance of the risks, benefits, and alternative treatments prior to administration of Diazepam. During interview, the DON confirmed that the record lacked evidence of this notification.
Failure to Obtain Informed Consent for Psychotropic Medications
Penalty
Summary
The facility failed to obtain informed consent, including risk and benefit information, for one resident who was reviewed for psychotropic medications. The resident had intact cognition on the comprehensive MDS, was admitted with diagnoses including dependence on renal dialysis, type 2 diabetes, and insomnia, and was prescribed clonazepam 1 mg by mouth daily on Monday, Wednesday, and Friday for dialysis days, as well as temazepam 30 mg by mouth at bedtime. The medical record did not contain evidence of informed consents for either medication, and the DON attempted to locate signed consent without success. During interview, the DON stated that any resident admitted with a psychotropic medication in use needed a consent form signed for that medication on admission day. The facility policy stated that a consent form must be signed for use of an antipsychotic medication and that the Permission for use of Psychotropic Medications form would be used to obtain consent.
Failure to Inform Residents of Nonpharmacological Options for Psychotropic Medications
Penalty
Summary
The facility failed to fully inform residents and/or their resident representatives by not documenting and offering nonpharmacological treatment options when obtaining consent for psychotropic medications. The deficiency involved 4 of 5 sampled residents, including residents with diagnoses such as dementia, anxiety, depression, PTSD, stroke, and severe cognitive impairment. Facility policies stated that residents and/or representatives would be educated on medications and that consent forms would be completed with new psychotropic orders and dose increases, but the records reviewed did not show alternative nonpharmacological interventions were presented with the consents. Resident 4 was cognitively intact, independent with several activities of daily living, and had diagnoses including diabetes, stroke, anxiety, depression, and PTSD. The resident received aripiprazole, buspirone, fluoxetine, and trazodone, and consent forms were completed for each medication. Resident 25 had severe cognitive impairment, required staff assistance with dressing, toileting, transfers, and hygiene, and had diagnoses of dementia, anxiety, and depression. The resident received bupropion and venlafaxine, and consent forms were completed for both medications. For both residents, the record contained no evidence that nonpharmacological treatment options were documented and offered. Resident 21 had severe cognitive impairment, delusions, and other behaviors 1-3 days weekly, with diagnoses of dementia, anxiety, and depression, and received mirtazapine, citalopram, quetiapine, and lorazepam. Resident 1 had severe cognitive impairment, rejected care, wandered 1-3 days in the prior 7 days, required assistance with hygiene, dressing, and bathing, and received lorazepam and quetiapine for anxiety and behavior disturbance associated with dementia. For both residents, consent forms were present for the psychotropic medications, but there was no evidence that alternative nonpharmacological treatment intervention options were documented and offered. The DON confirmed during interview that the facility did not have evidence that such alternatives were provided when obtaining consent.
Failure to Obtain Informed Consent for Psychotropic Medications
Penalty
Summary
The facility failed to ensure residents were informed of and consented to medications prescribed and given for mental health intervention for 2 of 5 residents reviewed for unnecessary medications. One resident had a significant change assessment showing intact cognition and diagnoses of Parkinson’s disease, anxiety, insomnia, and bipolar disorder. That resident’s care plan addressed behavior related to bipolar disorder and anxiety, and provider orders included Depakote 250 mg by mouth twice daily for bipolar disorder and gabapentin 300 mg by mouth three times daily for anxiety. The resident’s EMR did not contain evidence that the resident had been educated on the risks, benefits, side effects, and alternatives for either medication. A second resident had diagnoses including Parkinson’s disease, polyneuropathy, depression, and anxiety, and the MDS identified severe cognitive impairment, dependence on staff for activities of daily living, and receipt of antianxiety medications, opioids, and anticonvulsants. The resident’s order summary included Celexa 20 mg daily for major depressive disorder, hydroxyzine 10 mg twice daily for hallucinations/delusions related to Parkinson’s disease, and risperidone 0.25 mg at bedtime for hallucinations related to major depressive disorder. The EMR showed consent for Celexa, but not for hydroxyzine or risperidone. The DON stated that residents and/or their families should know the side effects and risks of the medication to decide if the risk was worth taking the medication.
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