Failure to Obtain and Document Informed Consent for Psychotropic Medications
Penalty
Summary
The facility failed to obtain and document informed consent, including an explanation of risks and benefits, prior to administering psychotropic medications to two residents. One resident, who had severe cognitive impairment and multiple medical conditions including heart failure, dementia, and a history of stroke, was admitted from an acute care hospital and was prescribed duloxetine, haloperidol, and mirtazapine. The resident's family member, who was actively involved in care decisions, reported not being informed about the antidepressant medications or their side effects. Review of the medical record confirmed the absence of signed or verbal consent forms for these medications, and staff interviews verified that the required documentation was missing. A second resident, also with severely impaired cognitive skills and multiple diagnoses such as aphasia, traumatic brain injury, epilepsy, anxiety disorder, and depression, was prescribed risperidone for severe, recurrent major depressive disorder with psychotic symptoms. The medical record for this resident similarly lacked evidence of informed consent for the antipsychotic medication. Staff interviews indicated that the admitting nurse was responsible for obtaining consents, but the required documentation was not found in the resident's record at the time of review. The facility's policy on antipsychotic medication use directed staff to gather and document information regarding the resident's condition and symptoms but did not specifically address the process for obtaining informed consent or educating residents or their representatives about the risks and benefits of psychotropic medications. Multiple staff members, including the DON, acknowledged that obtaining and documenting informed consent for these medications was expected but had not been completed for the residents in question.