Failure to Obtain Informed Consent for Psychotropic Medications
Penalty
Summary
The facility failed to ensure that a resident and/or their responsible party was fully informed and provided consent prior to the administration of psychotropic medications. Record reviews showed that a resident with diagnoses including metabolic encephalopathy, unspecified dementia, and major depressive disorder was prescribed and administered mirtazapine and trazodone. The Minimum Data Set indicated the resident had severely impaired cognitive skills and required maximal to total assistance with activities of daily living. Despite these conditions, the required informed consent documentation for both medications was either incomplete or missing, lacking signatures and confirmation that the resident or responsible party had been informed and had consented to the treatment. Interviews with facility staff, including a registered nurse and the Director of Nursing, confirmed that informed consent forms for the psychotropic medications were not properly completed prior to administration. The facility's own policy requires that informed written consent be obtained and documented in the resident's medical record before initiating psychotherapeutic drug treatment. However, the resident's health record did not contain the necessary signed consents, and both medications were administered without this documentation.