F0552

E

Failure to Obtain and Document Informed Consent for Psychotropic Medications

Seward, Alaska Survey Completed on 02-11-2026

Penalty

No penalty information released

Summary

The deficiency involves the facility’s failure to obtain and document informed consent for psychotropic medications prior to administration, thereby failing to ensure residents or their representatives were informed in advance of the risks, benefits, alternatives, and options for treatment. For Resident #1, who had severe dementia with psychotic disturbance, anxiety disorder, and depressive disorder, the record showed extensive use of multiple psychotropic medications, including divalproex, lorazepam, olanzapine, quetiapine, sertraline, and trazodone over a defined period. The resident had an Office of Public Advocacy (OPA) guardian as medical decision-maker, yet there was no documented informed consent for any of these medications. Emails to the guardian referenced that Depakote and other psychotropics had been ordered or adjusted, but did not include information on risks, benefits, alternatives, or options, nor did they document that the guardian was given an opportunity to choose a preferred option. The guardian later stated the facility had never reviewed risks, benefits, alternatives, or options for any medications and that such information would have guided decision-making.

For Resident #3, who had vascular dementia and cerebrovascular disease and also had an OPA guardian, the medical record showed long-term administration of valproic acid and a period of mirtazapine use, totaling hundreds of psychotropic medication administrations. The record contained no documented informed consent for these medications. A progress note indicated that a licensed nurse was unable to reach the resident’s representative and mailed a copy of notes, including the addition of mirtazapine, but there was no further documentation of efforts to contact the representative to discuss medications or obtain informed consent. The facility was unable to provide any proof of informed consent for Resident #3’s psychotropic medications, and the guardian similarly stated that information on risks and benefits would have guided decision-making.

For Resident #4, who had Parkinson’s disease with dyskinesia, dementia due to Parkinson’s disease with behavioral disturbance, hallucinations, and Lewy body dementia with psychotic disturbance, the record showed an order and ongoing administration of pimavanserin, an antipsychotic, over approximately 90 days. The resident had a representative who made medical decisions, but there was no documented informed consent for this psychotropic medication, and the facility could not provide any proof when requested. For Resident #5, diagnosed with dementia with behavioral disturbance and Parkinson’s disease, quetiapine was ordered and first administered before the facility obtained a signed Psychotropic Risk/Benefits Verification of Informed Consent form; the consent was dated one day after the first dose was given. This demonstrated that consent was not obtained prior to initial administration.

Interviews with nursing staff and leadership revealed confusion and inconsistency regarding responsibility for obtaining informed consent, when it should be obtained, and where it was documented. One licensed nurse believed physicians were ultimately responsible for obtaining consent and was unsure where signed consents were stored. Another nurse did not know who was responsible, when to obtain consent, or how to verify its presence before administering a new medication, and believed only antipsychotics required consent. A third nurse assumed that if a physician wrote an order, informed consent had already been obtained, and identified psychotropics and antipsychotics as requiring consent that included discussion of risks and benefits. The DON and LTC nurse manager stated that bedside nurses were trained to obtain informed consent before the first dose of medications needing consent and that the facility did not obtain new informed consent for psychotropics if a resident was already taking the same medication on admission, assuming the resident already knew the risks and benefits. The LTC nurse manager also stated that consents were sometimes obtained via email to representatives or guardians, but copies of those emails were not placed in the medical record, and audits of consents had not been done regularly. These practices conflicted with the facility’s resident rights document and its psychopharmacological drug use policy, both of which required that residents or their representatives be advised of potential risks and benefits of psychotropic medications and that this be documented.