Failure to Obtain Informed Consent for Psychoactive Medication
Penalty
Summary
Facility staff failed to implement their policy and procedure regarding psychoactive medication informed consent for a resident who was prescribed Olanzapine and Lorazepam. The resident, who was cognitively intact and had the capacity to make medical decisions, was admitted with multiple diagnoses including end stage renal disease, Type 1 diabetes mellitus, and non-ST elevation myocardial infarction. Despite being prescribed antipsychotic medication for schizoaffective disorder manifested by verbal aggression, there was no documented informed consent signed by the resident for the administration of these medications. During interviews, the resident stated that they had not signed any consent forms related to the medication and expressed that they did not have schizophrenia or need the medication. Review of the facility's policy confirmed that written informed consent, including signatures from both the resident and the healthcare professional, was required before initiating psychotherapeutic drugs. Staff interviews confirmed that the required consent was not obtained, and the resident's health record lacked the necessary documentation prior to administration of the medications.
Plan Of Correction
CORRECTIVE ACTION On 3/21/25, the SSD validated that the informed consent for Resident 5 for the use of Olanzapine and Lorazepam has been obtained. The informed consent verification was done on 3/21/25. The DON/Designee initiated education to licensed staff on 3/21/25 to ensure that any residents receiving psychotropic medications shall have an informed consent verified. OTHER RESIDENTS AFFECTED IDENTIFICATION The DON/Designee audited all residents from 3/21/25 to 3/28/25 receiving psychotropic medications to verify if a valid informed consent has been obtained. There are 72 residents receiving psychotropic medications — all informed consents for residents on psychotropics have been verified from 3/21/25 to 3/28/25. MEASURES AND SYSTEMIC CHANGES On 3/21/25, the DON/Designee provided reeducation to licensed staff and the IDT regarding residents' rights to have an informed consent prior to the initiation of antipsychotics and to ensure that informed consent is available for all residents with orders for psychotropic medications. Upon admission, any residents receiving antipsychotics shall be audited by Medical Records to confirm if the verification of the informed consent has been completed. During weekly Behavior Management Meetings, the IDT shall monitor and audit the compliance of informed consent verification, and the copy of the audit will be provided to the administrator, DON, and the IDT. Findings on the audit will be addressed by the SSD and IDT immediately. MONITORING PERFORMANCE Medical Records will audit psychotropic medications once weekly for 3 months or until substantial compliance is achieved, with nursing follow-up and reporting of any deficits to the DON for follow-up. Issues and trends, along with a copy of the report, will be forwarded to the DON/Administrator for further review and immediate corrective action as necessary. MONITORING PERFORMANCE (CONTINUED) The DON/Designee will present the results to the QA Committee for monthly review for the next 3 months and quarterly thereafter or until substantial compliance is achieved.