Failure to Monitor Antipsychotic Side Effects and Obtain Valid Informed Consent
Penalty
Summary
The deficiency involves the facility’s failure to prevent unnecessary chemical restraint and to adequately monitor and obtain informed consent for the use of the antipsychotic medication quetiapine for one resident. The resident was admitted with diagnoses including orthopedic aftercare, unspecified psychosis, and a history of falls. The admission History and Physical dated 12/19/2025 documented that the resident did not have the capacity to understand and make decisions, while a subsequent MDS dated 12/25/2025 indicated intact cognitive skills for daily decisions and that the resident was receiving an antipsychotic. On 12/22/2025, the physician ordered quetiapine 100 mg by mouth at bedtime for psychosis manifested by delusions. The facility failed to follow physician orders for monitoring orthostatic blood pressure related to quetiapine use. An order dated 1/15/2026 required orthostatic blood pressure checks (lying and then sitting within three minutes) every Sunday, with instructions to call the physician if the systolic blood pressure changed by more than 20 mmHg or the diastolic by more than 10 mmHg. Review of the January 2026 MAR showed that on 1/18/2026 and 1/25/2026, the assigned LVN documented orthostatic blood pressure as “not applicable” for both lying and sitting positions, meaning the ordered monitoring was not performed. The ADON and DON both stated that quetiapine can cause orthostatic hypotension, that the order required weekly orthostatic blood pressure monitoring, and that failure to complete and document these assessments could delay physician notification and delay care. Facility policies on Adverse Consequences and Medication Errors and on Psychotropic Medication Use required monitoring residents for adverse consequences and documenting responses to psychotropic medications. The facility also failed to obtain appropriate informed consent for the initiation and subsequent dose increase of quetiapine. An informed consent form dated 12/19/2025 documented that the resident verbally consented to quetiapine 50 mg twice a day for agitation and aggression, verified by an RN. However, the H&P from the same date indicated the resident lacked capacity to understand and make decisions. The ADON stated the facility should have followed the H&P and clarified with the physician and informed the responsible party. On 12/22/2025, the order was clarified to quetiapine 100 mg at bedtime, and on 12/28/2025, an additional order for quetiapine 50 mg in the evening was added, resulting in a total daily dose of 150 mg from 12/28/2025 to 1/4/2026. The ADON and DON stated that when the dose of a psychotropic medication is increased, a new informed consent is required, and acknowledged that no new consent was obtained when the dose was increased to a total of 150 mg. The DON further stated that, because the resident did not have capacity, the responsible party should have provided consent, and that without valid informed consent, the responsible party’s rights were violated. Review of the facility’s Psychotropic Medication Use and Antipsychotic Medication Use policies showed requirements to inform residents or representatives of the recommendation, risks, benefits, purpose, and potential adverse consequences of antipsychotic use and to obtain documented consent prior to initiating or increasing psychotropic medications, which the DON stated were not followed.
