Failure to Obtain Valid Informed Consent for Psychotropic Medications
Penalty
Summary
The facility failed to obtain valid informed consent for the administration of psychotropic medications, specifically Quetiapine and Divalproex, for a resident with diagnoses including dementia, psychotic disorder, and mood disorder. The resident was assessed as having severely impaired cognitive status and required varying levels of assistance with daily activities. Physician orders for these medications were present in the resident's records, but a review of the electronic health record and facility documentation revealed that informed consent forms for these drugs were either incomplete or missing the prescriber's signature, rendering them invalid. Interviews with facility staff, including a registered nurse, the medical record director, and the director of nursing, confirmed that the required informed consent process was not properly completed. Facility policy mandates that the prescriber must obtain and sign the informed consent form when psychotropic medications are ordered, ensuring that the resident or their representative is fully informed and agrees to the treatment. The lack of a valid, signed informed consent for these medications constituted a violation of the resident's rights to be informed and to participate in decisions regarding their care and treatment.