Failure to Obtain Informed Consent Before Initiating Psychotropic Medications
Penalty
Summary
The facility failed to follow its own psychotropic medication policy requiring residents or their representatives to be informed of risks and benefits and to provide informed consent before psychotropic medications are initiated. For one resident, an adult female with multiple diagnoses including type II DM, cellulitis of the face, multiple fractures, sleep apnea, hyperlipidemia, sciatica, alcohol abuse, schizoaffective disorder, and cocaine abuse, the Physician Order Summary Report showed that Quetiapine Fumarate, an antipsychotic, was started on 10/8/2025. However, the corresponding psychotropic consent form was not signed until 10/15/2025, meaning the resident received the antipsychotic medication for seven days prior to documented consent. For another resident, an adult female with diagnoses including toxic encephalopathy, dysphagia, cognitive communication deficit, need for assistance with personal care, multiple fractures, paranoid schizophrenia, and dementia, the Physician Order Summary Report showed that Clozapine was started on 9/9/2025. The psychotropic consent form for this resident was signed and dated 9/17/2025, indicating she received the antipsychotic medication for eight days before consent was obtained. During an interview, the Interim DON stated that orders for psychotropic medications should not be entered prior to obtaining consent and explained that she obtained consents for these residents at their care plan meetings, which are usually held 3–7 days after admission. The facility’s written policy states that once informed consent is obtained, the order will be entered into the medical record, which did not occur in these two cases.
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