F0552

E

Failure to Obtain and Document Informed Consent for Psychotropic Medications

Brevard, North Carolina Survey Completed on 03-05-2026

Penalty

No penalty information released

Summary

The deficiency involves the facility’s failure to obtain and document informed consent for psychotropic medications prior to initiation for multiple residents. For one resident with generalized anxiety disorder and severe cognitive impairment, the record showed an active PRN lorazepam order with no documentation that the responsible party was informed in advance of the risks and benefits or that consent was obtained. Another resident with major depressive disorder, anxiety disorder, borderline personality disorder, hallucinations, and unspecified psychosis, who had intact cognition and no documented behaviors, was receiving risperidone, duloxetine, and lamotrigine without any record that she or her guardian had been informed of the risks and benefits or had consented to these treatments. A third resident with schizophrenia, anxiety disorder, bipolar disorder, and schizoaffective disorder, with moderate cognitive impairment and no behavioral symptoms, was receiving trazodone, venlafaxine, quetiapine, and haloperidol, again with no documentation that the responsible party had been informed in advance or had consented.

Another resident with Alzheimer’s disease, major depressive disorder, anxiety disorder, and insomnia, who was severely cognitively impaired and wandering, was receiving mirtazapine, fluoxetine, lamotrigine, and lorazepam on a routine basis. The electronic medical record contained no documentation that the responsible party had been informed in advance of the risks and benefits of these medications or had consented. A resident with dementia, major depressive disorder, and hallucinations was receiving daily olanzapine for hallucinations, with MDS documentation of severe cognitive impairment and daily antipsychotic use, but there was no record that the responsible party had been informed of the risks and benefits or had consented. Another resident with unspecified dementia, generalized anxiety disorder, major depressive disorder, and cognitive communication deficit, who was severely cognitively impaired and receiving antidepressant, antipsychotic, and anticonvulsant medications routinely, was administered olanzapine, lamotrigine, and trazodone without documentation that the representative had been informed in advance of the risks versus benefits or had consented.

Interviews with facility staff revealed systemic process issues contributing to the lack of psychotropic consents. The Administrator stated that the Social Worker (SW) and MDS Coordinator were responsible for obtaining psychotropic medication consents but acknowledged that no consent forms could be found for the identified residents and was unsure where the breakdown occurred. The MDS Coordinator and SW both confirmed they shared responsibility for obtaining consents when new psychotropic medications were ordered or existing orders were changed, but reported they were not always informed of new orders or changes, and that providers sometimes added or changed psychiatric medications without notifying them. The Assistant DON/Interim DON and DON stated they believed consents were required for antipsychotics but were not aware of the need for consents for all psychotropic medications, and both cited frequent position changes and acknowledged that obtaining psychotropic consents had “slipped through the cracks.”

Psychiatric Nurse Practitioners documented ongoing psychotropic regimens and stability for some residents, including notes that one resident was stable on olanzapine with no indication for gradual dose reduction, and another was stable on olanzapine, lamotrigine, and trazodone with no medication changes needed. However, despite these ongoing psychotropic treatments and routine administration documented on the MARs, the facility’s records lacked corresponding informed consent documentation for each of the psychotropic medications identified in the survey. Staff interviews consistently confirmed the absence of psychotropic consent forms for the affected residents and an inability to explain precisely where in the process the failure to obtain and document consent had occurred.