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:
A resident with COPD, anxiety, and PTSD had a PRN lorazepam order entered for palliative care related to COPD without an appropriate clinical indication documented. The care plan directed staff to give meds as ordered by the physician, and the CNO later stated the lorazepam indication should have been shortness of breath or anxiety.
Failure to document GDR or rationale for psychotropic use: A resident with dementia, TBI, anxiety, and depression was receiving escitalopram and quetiapine, with no behaviors noted during the assessment period. Pharmacy recommended review of continued use and a clinical rationale if doses were maintained, but the record did not show a GDR attempt or documented rationale for not completing one; the DON stated that documenting the resident as stable was not an appropriate rationale.
PRN antipsychotic order lacked required stop date. A resident with severe cognitive impairment, dementia, anxiety, depression, wandering, and behavioral symptoms received PRN Haloperidol repeatedly, but the order was entered as indefinite even though it was written for 14 days. Staff said the medication was used when redirection failed and behaviors disturbed others, and the LPN, RN, and DON confirmed PRN psychotropic meds should have an end date and be re-evaluated after 14 days.
A resident with depression, anxiety, and moderate cognitive impairment received PRN Hydroxyzine on multiple occasions, but the record did not show that individualized non-pharmacological interventions were tried or ineffective before administration. The chart also lacked the prescriber’s clinical rationale and duration for continuing the PRN psychotropic order beyond the 14-day limit.
A resident with anxiety and depression was prescribed Buspirone for anxiety as manifested by restlessness/inability to relax, but the order did not identify the resident’s specific behaviors. Staff described the resident’s restlessness differently, the CNA did not know the signs and symptoms, and the RN noted the MAR did not reflect the resident’s anxiety level. The DON stated the documentation was not accurate because staff had different ideas of what restlessness meant, and the facility policy required psychotropic use only for a specific, diagnosed, and documented condition.
A resident had an active PRN order for Lorazepam for agitation that exceeded the 14-day limit for psychotropic medications. The DON confirmed the order was over 14 days, and the PA stated there was no documented rationale for the medication in the clinical record.
Inappropriate Indication for PRN Lorazepam
Penalty
Summary
The facility failed to ensure medications were administered with an appropriate clinical indication for Resident #23, who was admitted with diagnoses including COPD, anxiety, and PTSD. The resident’s care plan, revised 5/27/26, directed staff to give medications as ordered by the physician. Physician orders showed lorazepam 2 mg/mL, 0.5 mL by mouth every 4 hours as needed, ordered for palliative care related to COPD and initiated on 6/29/26. During review on 7/9/26 at 2:45 PM, the CNO reviewed the lorazepam order and stated the indication should be shortness of breath or anxiety.
Failure to Document GDR or Rationale for Psychotropic Use
Penalty
Summary
The facility failed to ensure a gradual dose reduction (GDR) was attempted, or that a clinical rationale was documented for continued psychotropic use for one resident. The resident’s MDS assessment identified mildly impaired cognition, dependence on staff for ADLs, and diagnoses of dementia, traumatic brain injury, anxiety, and depression. The resident reported feeling down, depressed, or hopeless several days over the prior 2 weeks, and no behaviors were noted during the assessment period. The resident was receiving escitalopram 5 mg daily for generalized anxiety and quetiapine 100 mg at bedtime for unspecified dementia with agitation. The pharmacy medication review recommended that the physician assess continued use of both medications and provide a clinical rationale if the current doses remained appropriate. The physician reviewed and accepted the report, and the NP later documented that the medications were to continue as is, with the resident’s mood stable and no changes recommended. However, the record did not contain documentation that a GDR had been completed or that a rationale for not completing a GDR had been documented. The DON stated that documenting stable was not an appropriate rationale for continued use.
PRN Antipsychotic Order Lacked Required Stop Date
Penalty
Summary
The facility failed to ensure that a PRN psychotropic medication order had a defined stop date and was limited to 14 days without a documented rationale for extension for one resident. The resident had severe cognitive impairment and diagnoses including non-traumatic brain dysfunction, Alzheimer's disease, non-Alzheimer's dementia, anxiety, and depression, and exhibited verbal behavioral symptoms, behavioral symptoms not directed at others, and wandering. The resident's mood/behavior care plan directed staff to administer medications per MD/NP orders, monitor for side effects, notify the provider with concerns, and refer to behavioral services as needed. The resident's order review history showed Haloperidol 1 mg by mouth every 4 hours as needed for 14 days starting 4/28/26, but the order lacked an end date and was entered as indefinite. The resident received PRN Haloperidol 16 times in June and once during the first six days of July. Staff interviews confirmed the medication was being used when redirection did not work and when behaviors disturbed other residents, and the LPN verified the order had been mistakenly given beyond the 14-day end date. The RN and DON also confirmed PRN psychotropic medications should have an end date and be re-evaluated after 14 days, and the facility policy stated PRN antipsychotic medications are only effective for 14 days.
Failure to Document Non-Pharmacological Interventions and PRN Psychotropic Order Extension
Penalty
Summary
The facility failed to document that individualized non-pharmacological interventions were attempted or found ineffective before administering PRN Hydroxyzine to Resident 35, and it also failed to document the prescribing practitioner’s clinical rationale and specified duration for continuing the PRN psychotropic medication beyond the federal 14-day limit. Resident 35 was admitted with diagnoses including depression and anxiety and was assessed as moderately cognitively impaired on the Quarterly MDS with a BIMS score of 12. Physician orders showed Hydroxyzine 25 mg was ordered PRN at bedtime for anxiety for 14 days, then later changed to PRN twice daily. The MAR showed the medication was administered on multiple occasions, but the clinical record did not identify documentation that non-pharmacological interventions were attempted before any of the administrations. The record also did not contain documentation from the prescribing practitioner supporting continuation of the PRN Hydroxyzine order beyond 14 days or specifying the duration of the extension.
Unclear indication documented for Buspirone use
Penalty
Summary
The facility failed to ensure that one sampled resident reviewed for unnecessary medications had a specific indication documented for the use of Buspirone. The resident was admitted with diagnoses including anxiety and depression, and the physician order dated 6/2/2026 directed Buspirone HCL 15 mg by mouth twice daily for anxiety as manifested by restlessness/inability to relax, but the order did not identify the resident’s specific behavior associated with restlessness or inability to relax. The resident’s MDS dated 6/5/2026 indicated moderate cognitive impairment and need for partial/moderate assistance with several activities of daily living, and also noted anxiety and depression. During interviews, staff gave different descriptions of the resident’s restlessness, including pacing, asking about appointments, complaining of pain, inability to sleep, walking around, and asking for pain medication. One CNA stated she did not know the resident’s signs and symptoms of restlessness. RN 2 stated the MAR for 6/30/2026 should have reflected the resident’s anxiety level but did not. The resident’s RP stated the resident’s sign of restlessness was isolating himself and reported that the resident texted her about having anxiety from 10:30 AM until 7 PM on 6/30/2026. The DON reviewed the MAR and stated it was not accurate because staff had different ideas of what restlessness was, and stated the resident should have the correct manifestation of anxiety reflected in the physician order and MAR. The facility policy stated psychotropic medications are to be used only when a practitioner determines the medication is appropriate to treat the resident’s specific, diagnosed, and documented condition.
PRN Psychotropic Order Exceeded 14-Day Limit
Penalty
Summary
The facility failed to ensure that a PRN order for a psychotropic medication was limited to 14 days for Resident #5. Review of the resident’s MAR showed an active order for Lorazepam 0.5 mg by mouth every 4 hours as needed for agitation, with a start date of 6/12/26. During interview, the DON confirmed that the Lorazepam order was greater than 14 days, and the PA stated that no rationale for the Lorazepam had been documented in the clinical record. The facility policy reviewed by surveyors stated that psychotropic medications are not to be prescribed or given on a PRN basis unless necessary to treat a diagnosed specific condition documented in the clinical record, and that PRN orders for psychotropic medications are limited to 14 days.
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