Failure to Obtain Informed Consent for Psychotropic Medications
Penalty
Summary
The facility failed to ensure that residents were fully informed and provided consent prior to the administration of psychotropic medications. Specifically, for two residents reviewed, required consent forms for antipsychotic and antidepressant medications were either incomplete or missing at the time the medications were administered. Documentation for both residents lacked necessary information and signatures from the prescribing practitioner and the resident or their representative. One resident, an older female with diagnoses including major depressive disorder, bipolar disorder, and adjustment insomnia, was administered Seroquel and Cymbalta without completed consent forms. The forms for both medications were missing critical information such as the prescriber's details, clinical indications, and signatures from both the prescriber and the resident or representative. The resident's care plan indicated use of high-risk drugs and risk for side effects, but the required informed consent process was not documented. Another resident, also an older female with major depressive disorder and severely impaired cognition, received Seroquel without a completed consent form. The form lacked the resident or representative's acknowledgment and signature. Interviews with facility leadership revealed a lack of awareness regarding the incomplete consent forms, and the facility's policy required that residents or their representatives be informed of the risks, benefits, and alternatives to psychotropic medications prior to administration, with documentation of this process.