Failure to Obtain and Document Informed Consent for Psychotropic Medications
Summary
Surveyors identified a deficiency in the facility’s management of psychotropic medications related to informed consent and documentation of risks and benefits for three residents. For one resident with dementia with behavioral disturbances and adjustment disorder, the EMR showed an order for Depakote ER 250 mg at bedtime for mood stabilization and episodic agitation, but there was no signed consent or documentation of risks versus benefits for psychoactive medications in the resident’s miscellaneous documents. Another resident with schizoaffective disorder, bipolar type, bipolar disorder, adjustment disorder with mixed anxiety and depression, and psychosis had intact cognition and was receiving multiple psychoactive medications, including Klonopin, Abilify, Sertraline, and Quetiapine. The consent form for psychoactive medication for this resident was signed and witnessed by facility social workers because the resident had no hands or arms and verbally gave permission, but the form did not list any of the required medication details such as drug name, dosage, frequency, targeted behavior, or potential side effects for any of the four medications. A third resident with dementia with behavioral disturbances, personality disorder, major depressive disorder, and psychosis, and who was severely cognitively impaired with a BIMS score of 0, had a physician order for Valproate Sodium oral solution 250 mg/5 ml, 2.5 ml twice daily for behaviors. Review of this resident’s miscellaneous documents also showed no signed consent or documentation of risks versus benefits for psychoactive medications. During an interview, the DON confirmed she was unable to locate signed psychoactive medication consents for these three residents. The facility’s own policy on the use of psychotropic medications, revised in May 2025, requires that prior to initiating or increasing psychotropic medications, the resident, family, and/or representative be informed of benefits, risks, alternatives, and any black box warnings, and that this information be documented in a format such as a written consent form or narrative note, which was not done in these cases.
Penalty
Resources
Below are regulatory guidelines relevant to this citation:
PRN Antipsychotic Order Not Limited or Reassessed: A resident with advanced dementia, Alzheimer’s disease, agitation, and hospice services received PRN haloperidol for agitation and delirium under an open-ended order rather than a 14-day limit. Physician documentation continued the medication but did not show an evaluation of its ongoing need or an adequate rationale for renewal, and nursing notes did not document non-pharmacological interventions before one PRN dose was given.
A resident with depression and delusional disorders was prescribed Olanzapine for delusions, but the MAR and care plan showed no targeted behavior monitoring or other behavioral documentation to support the medication’s use or effectiveness. The SS Director and DNS both confirmed the resident was not on behavior monitoring, despite the facility stating residents on antipsychotics were placed on it.
A resident with severe dementia and behavioral symptoms received Seroquel with multiple dose increases, but the orders did not include a documented diagnosis to justify use or escalation. The chart showed dementia, agitation, and later psychosis documentation, while staff described the resident as generally directable and pleasant with more evening behaviors. The resident also had falls during the stay, including one that led to ER transfer.
A resident with anxiety, restlessness, agitation, and moderately impaired cognition received PRN lorazepam for anxiety, but the order had no stop date and the EHR lacked a documented duration with physician rationale for continued use. The psychotropic care plan did not address the PRN lorazepam, and an RN verified the facility had not obtained the required 14-day stop date or documentation for ongoing use.
Incomplete Psychotropic Monitoring Documentation: The facility did not complete or accurately document monthly behavior summaries for a resident receiving Ativan, quetiapine, risperidone, and sertraline, and another resident’s behavior summary for lurasidone HCl and fluoxetine HCl was inaccurate compared with the MAR. The same resident also lacked complete orthostatic BP monitoring documentation, as the required sitting readings were not recorded within the appropriate time frame. The SSD and DON verified the missing and incorrect documentation.
A resident with CVA and dementia, and severe cognitive impairment, received trazodone for depression without a completed medication consent form before the medication was administered. The record also showed a pharmacist-recommended GDR was declined with documentation that family routinely declines GDRs, but the rationale did not state that a further dose reduction would likely impair function or cause psychiatric instability, as required.
PRN Antipsychotic Order Not Limited or Reassessed
Penalty
Summary
The facility failed to ensure a PRN antipsychotic medication was limited to 14 days and that continued use of the medication was evaluated by the attending physician or prescribing practitioner for one resident. The resident had severe cognitive impairment, Alzheimer’s disease, dementia, and received hospice services. The resident’s care plan addressed behavioral problems including refusing care and wandering, and staff were directed to administer medications as ordered, monitor for side effects, explain care before starting, and use calming and diversion techniques as needed. The resident’s medication orders showed haloperidol solution ordered PRN for agitation and delirium, with an order written on 7/10/26 as open-ended rather than limited to 14 days. The resident received PRN haloperidol multiple times in July and once in August. A physician progress note described advanced dementia, disorientation, inability to make needs known, a history of agitation, and continued use of haloperidol PRN along with structured environment and safety precautions, but the note did not document an evaluation of the appropriateness or continued need for the PRN antipsychotic medication or an adequate rationale for renewal. Nursing documentation showed a PRN dose was given for restlessness and was effective, but the note did not identify non-pharmacological interventions attempted before administration. The DON stated the resident should have had a 14-day face-to-face evaluation to ensure the ongoing need for the PRN antipsychotic medication. The pharmacist stated the medication had been reviewed and that PRN antipsychotic medications required a face-to-face medical provider evaluation every 14 days, and also noted the indication was not appropriate and that the medication was later discontinued.
Lack of Behavior Monitoring for Antipsychotic Use
Penalty
Summary
The facility failed to ensure behavior monitoring was in place related to the use of an antipsychotic medication for one resident reviewed for unnecessary medications. Resident 8 was admitted with diagnoses including depression and delusional disorders and had a physician order for Olanzapine 5 mg once daily for delusions. Review of the resident’s July 2026 MAR and May 2026 care plan showed no identification or monitoring of targeted behaviors related to antipsychotic use, and the record did not include other behavioral documentation to support the use or effectiveness of the medication. Staff interviews confirmed that the resident was not on behavior monitoring, and the DNS stated that residents receiving antipsychotic medications were placed on behavior monitoring and confirmed this resident did not have it in place.
Antipsychotic Use Lacked Documented Diagnosis Support
Penalty
Summary
The facility failed to ensure that one resident receiving antipsychotic medication had diagnoses documented to support the use of Seroquel and the medication’s ongoing dose increases. Resident #19 had severe cognitive impairment on the MDS, with disorganized thinking, fluctuating behavior, delusions, and intermittent verbal and nonverbal behavioral symptoms. The resident’s documented active diagnoses included non-Alzheimer’s dementia, atrial fibrillation, and COPD, but the MDS did not list any psychiatric or mood disorder diagnoses, and the physician’s orders for Seroquel 25 mg at 3:00 PM and 100 mg at supper did not include a diagnosis for use. The record showed that the resident’s psychotropic consent form listed dementia with psychotic behavior and irritability as the reason for Seroquel, along with expected benefits and potential adverse effects. Later documentation showed repeated requests for gradual dose reduction were declined because the resident continued to have increased agitation. The physician then ordered additional Seroquel doses, including 12.5 mg in the morning and 25 mg at noon for increased afternoon and evening behaviors, and later increased the afternoon dose to 50 mg for anxiety and agitation, but these orders also did not include a diagnosis supporting the medication changes. The resident experienced falls during the stay, including an unwitnessed morning fall and a later fall with possible left hip external rotation and increased pain that resulted in transfer to the emergency room. Staff interviews described the resident as confused but fairly functional, directable, pleasant, and sometimes upset or yelling, with behaviors more noticeable in the evening. The EHR later added a diagnosis of unspecified psychosis, and the physician’s final report documented psychosis and stated the resident did not experience hallucinations currently due to medication control, but the deficiency cited that the facility had not ensured the antipsychotic use and dose escalation were supported by documented diagnoses at the time of the orders.
PRN Lorazepam Lacked Required Stop Date and Rationale
Penalty
Summary
The facility failed to ensure a 14-day stop date or a documented specified duration with rationale for Resident 47’s ongoing PRN lorazepam order. Resident 47 had diagnoses of anxiety, restlessness, and agitation, and her Quarterly MDS documented moderately impaired cognition and dependence on staff for all ADLs. Her psychotropic medication care plan stated staff would administer medications as ordered and monitor side effects and effectiveness, but it did not include directions related to her PRN lorazepam use for anxiety. Resident 47’s physician order dated 06/01/2026 directed lorazepam 0.5 mg every six hours as needed for anxiety, but the order did not include a stop date. The EHR also lacked documentation of a specified duration with a physician-documented rationale for extended use. On 08/05/2026, Administrative Nurse D verified the resident had received PRN lorazepam and confirmed the facility had not obtained the required 14-day stop date or documented rationale for continued use. The facility policy stated PRN psychotropics required a 14-day stop date and, for continued use, documented rationale and indication of duration in the medical record.
Incomplete Psychotropic Behavior Monitoring and Orthostatic BP Documentation
Penalty
Summary
The facility failed to ensure that two sampled residents receiving psychotropic medications had accurate behavioral monitoring documentation and required monitoring completed. One resident was prescribed lurasidone HCl and fluoxetine HCl for bipolar disorder and depression, and another resident was prescribed Ativan, quetiapine, risperidone, and sertraline for anxiety, bipolar disorder, psychosis, and depression. The facility’s policy required behavioral monitoring for residents receiving psychotropic medications, including documentation of behavioral triggers, episodes, symptoms, and the resident’s response to interventions. For the resident receiving Ativan, quetiapine, risperidone, and sertraline, the medical record showed physician orders for monthly behavioral summaries tied to the target behaviors for each medication. Although the MAR showed the resident was being monitored for the related behaviors, the record did not contain the monthly behavioral summaries for those medications, and the SSD confirmed the documentation could not be located. For the resident receiving lurasidone HCl and fluoxetine HCl, the June 2026 MAR showed five episodes of mood swings and five episodes of verbalized sadness. However, the OBRA Chemical Reduction and Behavior Management Meeting form dated 7/17/26 recorded zero episodes for both behaviors and listed the month as July instead of June. The SSD verified that the form presented to the IDT was incorrect based on the MAR. In addition, the resident had an order for weekly orthostatic blood pressure monitoring while lying and sitting, but the MAR and blood pressure log did not show the required sitting blood pressures were obtained within the appropriate time frame, and the DON verified the orthostatic monitoring documentation was incomplete.
Psychotropic Medication Consent and GDR Documentation Failure
Penalty
Summary
The facility failed to ensure a resident was free from unnecessary psychotropic medication use when trazodone was administered without a completed medication consent form before the medication was given. The resident had been admitted with diagnoses of CVA and dementia, and the MDS showed severe cognitive impairment with a BIMS score of 02. The record showed trazodone 50 mg was ordered for depression beginning on 09/20/24, but the medication consent form was not obtained until 03/03/25, after the medication had already been in use. The record also showed that a pharmacist recommended a gradual dose reduction for trazodone on 04/23/26, but the provider declined and documented the reason as "Family routinely declines GDRs." The report stated this rationale did not document that an additional dose reduction would likely impair the resident's function or increase distressed behavior, as required. A later pharmacist recommendation for a GDR on 06/30/26 was accepted. Interviews with the POA, RN, LPN, pharmacist, and DON confirmed that medication consent was required before administering psychotropic medication and that the documented reason for not attempting the GDR did not meet the required standard.
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