Failure to Ensure Proper Informed Consent and PRN Psychotropic Medication Documentation
Summary
The facility failed to ensure that a resident with severe cognitive impairment and a documented inability to make medical decisions was not permitted to sign informed consent forms for psychotropic medications. Specifically, the resident, who had diagnoses including schizophrenia, unspecified intellectual disabilities, and a cognitive communication deficit, was found to have signed his own consent for both antipsychotic and antidepressant medications. The Director of Nursing confirmed that the resident did not have the capacity to provide informed consent, as indicated in the resident's history and physical, and that the consent obtained was therefore invalid. Additionally, the facility did not ensure that another resident's PRN psychotropic medication order included a specific duration or stop date, nor did it document a clinical reason for extending the order beyond 14 days. The resident, who had diagnoses of unspecified dementia, anxiety disorder, and depression, was not capable of making medical decisions. The order for clonazepam was written as PRN with an indefinite end date and lacked documentation of a specific treatment duration or rationale for continuation beyond the standard 14-day limit. Both the LVN and the consultant pharmacist acknowledged that the order should have included a stop date or specified duration, and the facility's policy required such documentation. The facility's own policy stated that PRN orders for psychotropic drugs are limited to 14 days unless the prescriber documents a rationale for extension and indicates the duration. The policy also required verification of informed consent prior to administration of psychotropic medications. In both cases, the facility failed to follow its own procedures and regulatory requirements, resulting in deficiencies related to the use and documentation of psychotropic medications.
Penalty
Resources
Below are regulatory guidelines relevant to this citation:
Failure to Assess and Monitor Antipsychotic Use: A resident with severe cognitive impairment, dementia, anxiety, and mood disorder received Risperidone for agitation and paranoia, but the EMR did not show an AIMS assessment on admission or timely target behavior monitoring. The RN case manager and DON confirmed that baseline AIMS and ongoing behavior monitoring should have been in place when the antipsychotic was started, but the resident’s record lacked measurable target behaviors and documentation of medication effectiveness.
Two residents receiving PRN anti‑anxiety medications were not protected from potential chemical restraints when PRN lorazepam/Ativan orders lacked required 14‑day stop dates and physician re‑evaluation. One resident with schizoaffective disorder, dementia, and anxiety had a PRN Ativan order without a stop date that was administered multiple times over several months. Another resident with metabolic encephalopathy, heart failure, and peripheral vascular disease had a PRN lorazepam order without a stop date that was still being administered weeks later, with no documented physician reassessment. The DON confirmed that these PRN psychotropic orders should have included 14‑day limitations but did not.
Surveyors determined that the facility failed to consistently manage psychotropic medications for three residents. Two residents with dementia and psychiatric conditions had only one documented psychotropic medication review and gradual dose reduction (GDR) attempt, completed in January, with no evidence of quarterly reviews or additional GDR efforts. Another resident with hemiplegia, psychotic disorder, dementia, and major depressive disorder had a PRN IM haloperidol order written without an end date, which remained active and was administered on multiple occasions beyond 14 days, and the DON confirmed there was no physician documentation justifying the extended PRN antipsychotic order.
A resident with moderate dementia and severe cognitive impairment, but no documented psychosis or behavioral symptoms, was started on Zyprexa (olanzapine) 10 mg at bedtime after a mental health NP changed her medication regimen. Physician orders listed varying indications for the antipsychotic, including depression, unspecified psychosis, anxiety, and bipolar disorder, despite the clinical record and MDS lacking corresponding documented diagnoses at the time. Nursing staff reported that they were responsible for entering and clarifying antipsychotic orders and recognized that inappropriate indications for dementia residents could constitute a chemical restraint. The DON could not locate documentation supporting a stated history of schizophrenia, and the facility’s own psychotropic drug policy required a specific, diagnosed, and documented condition for such medications, leading surveyors to find that the antipsychotic was used without an adequate indication.
Two residents received PRN Lorazepam orders without the required 14-day stop date, and the record did not show a documented diagnosed specific condition supporting PRN psychotropic use. One resident had dementia, moderate cognitive impairment, and hospice care with Lorazepam administered on multiple occasions, while the other had dementia with severe cognitive impairment and hospice care with a long-standing PRN Lorazepam order for anxiety and restlessness. The DON and ADM acknowledged PRN psychotropics required review for stop dates, and the facility policy stated PRN psychotropic use must be tied to a documented specific diagnosis and limited to 14 days.
A resident with a history of stroke, aphasia, and anxiety, and with severely impaired cognition per BIMS, had a PRN Lorazepam 0.5 mg G-tube order written without a stop date and used for more than 14 days without documented prescriber re-evaluation. The clinical record lacked evidence that the physician or other prescribing practitioner assessed the ongoing appropriateness of this psychotropic medication, even though the care plan identified anti-anxiety drug use and outlined monitoring for adverse reactions.
Failure to Assess and Monitor Antipsychotic Use
Penalty
Summary
The facility failed to ensure that a resident receiving psychotropic medications was adequately assessed and monitored. R3’s admission MDS identified severe cognitive impairment and the need for assistance with ADLs, with diagnoses including non-traumatic brain dysfunction, unspecified dementia without behavioral, psychological, mood, or anxiety disturbances, non-Alzheimer’s dementia, anxiety disorder, and mood affective disorder. The resident’s physician orders included Risperidone 0.25 mg, two tablets by mouth every four hours PRN for agitation and paranoia, with a maximum of three PRN doses in 24 hours, and Risperidone 0.5 mg, one tablet by mouth three times daily for paranoia/agitation. R3’s EMR did not show that an AIMS assessment was completed upon admission despite the resident receiving antipsychotic medication, and the assessment was only completed after surveyor request. The record also lacked evidence that target behavior monitoring had been initiated for the antipsychotic use, with no measurable target behaviors documented, including frequency, duration, severity, precipitating factors, or response to interventions for agitation and paranoia. Interviews with the RN case manager and DON confirmed that AIMS assessment and behavior monitoring should have been completed upon admission or initiation of antipsychotic medications, and both acknowledged that target behavior monitoring had not been initiated.
Failure to Limit and Re‑Evaluate PRN Psychotropic Medications
Penalty
Summary
The deficiency involves the facility’s failure to ensure that residents were free from potential chemical restraints by not complying with federal requirements for PRN psychotropic medications. For one resident with schizoaffective disorder bipolar type, dementia, and anxiety disorder, the MDS showed cognitive impairment and the care plan identified mood problems, yelling out, and anxiety/restlessness. A physician ordered PRN Ativan for anxiety with no stop date specified. The MAR showed the PRN Ativan was administered multiple times over several months, including in January, March, and April 2026, without a 14‑day limitation or documented stop date. The DON stated that the PRN order was supposed to have a 14‑day stop date, confirming that the order did not meet regulatory requirements. For another resident with metabolic encephalopathy, heart failure, and peripheral vascular disease, a physician ordered PRN lorazepam every four hours for anxiety, again without a specified stop date. The MAR documented administration of lorazepam nearly a month after the order was written, with no evidence that the physician had re‑evaluated the continued use of the PRN anti‑anxiety medication beyond 14 days. The DON confirmed that no stop date had been added to this order. These omissions resulted in PRN psychotropic medications being available and used beyond 14 days without required time limitations or documented physician re‑evaluation, constituting a failure to ensure residents were free from potential chemical restraints and unnecessary drugs.
Plan Of Correction
Pharmacist will send out a re-education to all the providers regarding PRN psychotropics and end dates by May 4, 2026. Resident records for all residents receiving psychotropics were checked on April 30, 2026- no other orders were missing stop dates. New psychotropic orders added to Point Click Care dashboard on May 1, 2026- listing shows new orders and stop dates. Interdisciplinary team will review dashboard during clinical meeting for stop dates- any missing stop dates will be added. Charge nurses will audit order listing report for new psychotropic orders- 5 residents will be audited x 4 weeks, then 2 residents per week for 4 weeks, then random residents monthly. Audits will be added to quality indicators and reviewed at QAPI.
Failure to Perform Regular GDR and Limit PRN Antipsychotic Orders
Penalty
Summary
Surveyors found that the facility did not ensure appropriate management of psychotropic medications for three sampled residents. For two residents with dementia and related psychiatric diagnoses, the medical records from late April 2026 showed only one documented psychotropic medication review and gradual dose reduction (GDR) attempt, completed in January 2026. There was no documentation of any GDR attempts or psychotropic reviews prior to January 2026, despite the DON stating that such reviews and GDRs should be completed quarterly. The records for these residents did not contain additional GDR attempts beyond the January 2026 review. For a third resident with hemiplegia following cerebral infarction, psychotic disorder with delusions, dementia, and major depressive disorder, a physician’s order dated February 8, 2026, prescribed PRN intramuscular haloperidol lactate every 12 hours for delusions, hallucinations, paranoia, and agitation, without an end date. Review of the MARs for February through April 2026 showed that this PRN antipsychotic was administered on two occasions, and no end date was documented on the MAR. In an interview, the DON acknowledged that the PRN haloperidol order extended beyond 14 days and that the physician had not documented a reason for continuing the order beyond that period.
Inadequate Indication for Antipsychotic Use Resulting in Chemical Restraint
Penalty
Summary
Surveyors identified a deficiency related to the facility’s failure to prevent the use of unnecessary psychotropic medications and chemical restraints for one resident. The resident was an elderly female with moderate dementia, anxiety, and depression, admitted with severe cognitive impairment as evidenced by a BIMS score of 02. Her MDS showed no psychiatric or mood disorders, no indicators of psychosis such as hallucinations or delusions, and no behavioral symptoms. She required extensive assistance with ADLs, including showers, toileting, and personal hygiene. Her routine medications included antidepressants, an antibiotic, hypoglycemics (including insulin), and anticonvulsants. The clinical record showed that on a specific date, a mental health NP evaluated the resident and issued new orders to discontinue Keppra, Buspar, and melatonin, and to start Zyprexa (olanzapine) 10 mg at bedtime and Topamax 100 mg twice daily. Progress notes documented that these orders were carried out and the responsible party was notified. Subsequent physician orders listed multiple and changing indications for Zyprexa 10 mg at bedtime, including depression, unspecified psychosis, anxiety, and bipolar disorder, despite the resident’s MDS and record lacking documented psychosis, mood disorder, or bipolar diagnosis at that time. The Zyprexa order also carried a black box warning for increased mortality in elderly patients with dementia-related psychosis, and the medication was administered on multiple days during the month per the MAR. Interviews with nursing staff and the DON revealed that nurses were responsible for entering NP or physician antipsychotic orders into the computer and were expected to clarify any unclear or inappropriate indications, particularly for residents with Alzheimer’s or dementia. LVNs interviewed acknowledged that antipsychotics for dementia residents required a specific, accurate indication and that vague indications such as altered mental status would be inappropriate, potentially constituting a chemical restraint. The DON stated that the NP had written the Zyprexa order for psychosis and later referenced a history of schizophrenia and bipolar disorder, but the DON could not locate documentation of schizophrenia in the record. The facility’s psychotropic drug use policy required that psychotropic medications only be used to treat a specific, diagnosed, and documented condition and not as a chemical restraint, and defined chemical restraint as any drug used for discipline or staff convenience and not required to treat medical symptoms. The lack of an adequate, documented indication for Zyprexa prior to its administration constituted the identified deficiency.
PRN Lorazepam Orders Lacked Required Limits and Documentation
Penalty
Summary
The facility failed to ensure that two residents did not receive PRN psychotropic medication without a documented diagnosed specific condition in the clinical record and failed to ensure PRN orders for Lorazepam were limited to 14 days. Resident #21 had a history of unspecified dementia without behavioral disturbance, type 1 diabetes with nephropathy, cerebral infarction, and hospice care. Her quarterly MDS showed moderate cognitive impairment with a BIMS score of 8, and the active diagnoses section did not list anxiety disorder, depression, bipolar disorder, psychotic disorder, schizophrenia, or PTSD. Her care plan included PRN Lorazepam for restlessness and anxiousness, and physician orders dated 9/19/2025 included Lorazepam Intensol oral concentrate every 4 hours as needed for mild to moderate anxiety or agitation. Resident #21’s MAR showed Lorazepam was administered in March and April 2026, but the order did not have a stop date and extended beyond 14 days. Resident #40 had shortness of breath, delirium due to known physiological conditions, dementia with mood disturbance, and hospice care. Her quarterly MDS showed severe cognitive impairment with a BIMS score of 6, and the active diagnoses section did not list anxiety disorder, depression, bipolar disorder, psychotic disorder, schizophrenia, or PTSD. Her care plan included PRN Lorazepam for psychotropic medication use, and physician orders dated 10/01/2024 included multiple PRN Lorazepam concentrate doses every 2 hours as needed for anxiety and restlessness. Resident #40’s MAR for February, March, and April 2026 did not show any administered Lorazepam doses, but the PRN order also lacked a stop date and remained beyond 14 days. During interviews, the DON stated PRN psychotropic medication should not go past 14 days except, in her belief, for hospice residents, and the ADM stated the DON was responsible for ensuring PRN psychotropics were reviewed for stop dates. The facility policy stated PRN psychotropic medications are not to be prescribed or administered unless necessary to treat a diagnosed specific condition documented in the clinical record, and PRN orders are limited to 14 days.
Failure to Re-Evaluate Prolonged PRN Lorazepam Order
Penalty
Summary
The deficiency involves the facility’s failure to prevent the prolonged use of an as-needed psychotropic medication without appropriate time limits or documented re-evaluation. One resident with diagnoses including stroke with aphasia and anxiety had a Significant Change MDS assessment showing a BIMS score of 4/15, indicating severely impaired cognitive abilities for daily decision-making. A physician order dated 4/06/2026 directed Lorazepam 0.5 mg via G-tube every 4 hours as needed for anxiety, but the order did not include a stop date. Review of the clinical record showed no documentation by the physician or prescribing practitioner that the resident had been evaluated regarding the appropriateness of continued PRN Lorazepam use. As of 4/28/2026, the resident had been continuously prescribed this PRN Lorazepam for 22 days without a documented reassessment of its ongoing necessity. The resident’s care plan, dated 01/19/2026, identified the use of anti-anxiety medications and listed goals and interventions focused on monitoring and reporting adverse reactions and side effects such as drowsiness, confusion, impaired thinking, and unexpected behavioral changes. However, despite this care plan, there was no evidence in the record that the prescriber had reviewed or justified the continued PRN psychotropic therapy beyond 14 days, and facility leadership acknowledged that the medication should have been re-evaluated or the ongoing need documented.
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