Failure to Obtain and Document Informed Consent for Psychotropic Medications
Penalty
Summary
Surveyors identified a deficiency in the facility’s management of psychotropic medications related to informed consent and documentation of risks and benefits for three residents. For one resident with dementia with behavioral disturbances and adjustment disorder, the EMR showed an order for Depakote ER 250 mg at bedtime for mood stabilization and episodic agitation, but there was no signed consent or documentation of risks versus benefits for psychoactive medications in the resident’s miscellaneous documents. Another resident with schizoaffective disorder, bipolar type, bipolar disorder, adjustment disorder with mixed anxiety and depression, and psychosis had intact cognition and was receiving multiple psychoactive medications, including Klonopin, Abilify, Sertraline, and Quetiapine. The consent form for psychoactive medication for this resident was signed and witnessed by facility social workers because the resident had no hands or arms and verbally gave permission, but the form did not list any of the required medication details such as drug name, dosage, frequency, targeted behavior, or potential side effects for any of the four medications. A third resident with dementia with behavioral disturbances, personality disorder, major depressive disorder, and psychosis, and who was severely cognitively impaired with a BIMS score of 0, had a physician order for Valproate Sodium oral solution 250 mg/5 ml, 2.5 ml twice daily for behaviors. Review of this resident’s miscellaneous documents also showed no signed consent or documentation of risks versus benefits for psychoactive medications. During an interview, the DON confirmed she was unable to locate signed psychoactive medication consents for these three residents. The facility’s own policy on the use of psychotropic medications, revised in May 2025, requires that prior to initiating or increasing psychotropic medications, the resident, family, and/or representative be informed of benefits, risks, alternatives, and any black box warnings, and that this information be documented in a format such as a written consent form or narrative note, which was not done in these cases.
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