Failure to Obtain and Document Informed Consent for Psychotropic Medications
Penalty
Summary
The facility failed to ensure that residents and/or their representatives were fully informed and provided consent regarding the risks and benefits of newly ordered antipsychotic and opioid medications for three residents. For one resident with Alzheimer's disease and dementia with psychosis, multiple orders for Seroquel were initiated and adjusted over time, but there was no documentation that the risks and benefits were reviewed or that consent was obtained at the time of the medication changes. Similarly, another resident with diagnoses including depression, psychosis, schizoaffective disorder, anxiety, vascular dementia, insomnia, and hemiplegia was started on Seroquel and Sertraline, but the clinical record did not show that the risks and benefits were discussed or that consent was obtained from the responsible party at the time of initiation. A third resident with psychotic disorder and vascular dementia was prescribed Seroquel, but there was no documentation that the resident or their representative was informed of the risks and benefits of the antipsychotic medication. Interviews with the Nursing Home Administrator confirmed that the facility did not have a formal consent and risk/benefit form in place at the time and relied on phone calls to inform representatives, but these discussions were not documented in the clinical records. The lack of documentation and formal process led to the deficiency under resident rights.