Failure to Obtain and Document Informed Consent for Psychotropic Medications
Penalty
Summary
The facility failed to ensure proper informed consent procedures for psychotropic medication administration for two residents. For one resident with diagnoses including anxiety disorder, psychotic disorder, and unspecified mood affective disorder, the informed consent form for Mirtazapine was signed by the resident's representative but not by the physician prior to medication administration. The Assistant Director of Nursing confirmed that the physician's signature and date were required on the informed consent form. In another instance, a resident receiving Buspirone for anxiety did not have a signed informed consent form, and only verbal consent was documented. The resident reported that the physician had not discussed informed consent for Buspirone and that she had neither signed nor given verbal consent for the medication. The Assistant Regional Director acknowledged that the physician should have explained the risks, benefits, and alternatives to the resident and that a signature was required if the resident was able to sign. The facility's policy indicated that informed consent, including discussion of risks and benefits, must be obtained and documented prior to initiating or changing psychotropic medications.