Failure to Ensure Appropriate CMS-Approved Indication for Antipsychotic Therapy
Summary
Surveyors identified a deficiency in the facility’s drug regimen review process related to the use of an antipsychotic medication for a resident with dementia. The resident’s EMR listed diagnoses of Alzheimer’s disease, cerebral infarction, insomnia, and major depressive disorder, with a BIMS score indicating severe cognitive impairment. The MDS showed the resident was independent in activities of daily living and did not exhibit behaviors during the assessment period, though it documented antipsychotic use. The CAA noted antipsychotic use and risk for adverse effects from Seroquel. The care plan, initiated earlier, described behaviors of resisting care and yelling out related to depression, anxiety, and dementia, and stated that Quetiapine (Seroquel) was used for these behaviors, but it lacked a clear psychiatric indication for the medication. The EMR contained a renewed order for Quetiapine 12.5 mg daily with an indication of unspecified dementia with psychotic disturbances, and there was no behavioral monitoring documented related to the antipsychotic use. Review of the consultant pharmacist’s monthly recommendations from May through February showed that the pharmacist recommended a gradual dose reduction of Quetiapine to the lowest effective dose, which the medical provider declined, citing risk of decompensation. The pharmacist’s recommendations did not address the use of the antipsychotic with the indication of dementia, and the facility could not provide documentation supporting a CMS-approved indication for the continued use of Quetiapine despite a request for such rationale. Observations showed the resident calm and engaged in group activity without behaviors. Interviews revealed that the consultant pharmacist stated the resident was admitted on the antipsychotic and that the representative refused changes or discontinuation, and that the medication was believed to be needed for dementia-related hallucinations and delusions. A nurse and an administrative nurse both stated that antipsychotics were not indicated for dementia alone and required a psychiatric diagnosis, and that the resident had been admitted with the medication and dementia diagnosis. This sequence of actions and inactions demonstrated a failure to ensure the consultant pharmacist addressed the lack of an appropriate CMS indication for the antipsychotic during the monthly drug regimen review, contrary to the facility’s drug regimen review policy.
Penalty
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Below are regulatory guidelines relevant to this citation:
A resident with colon cancer, seizures, hypotension, muscle weakness, and impaired cognition had a Depakote dose and frequency documented below usual dosing guidance, along with repeated severe and moderate drug-to-drug interaction alerts involving Ativan, Depakote, phenytoin, and lorazepam. An LVN and the ADON confirmed the nurse acknowledged the alerts but did not notify the MD, and the pharmacy consultant stated the facility had not reported the medication irregularities or interactions.
Failure to process a pharmacy recommendation led to a resident continuing Zinc Sulfate despite the pharmacist’s documented recommendation to discontinue it. The resident had diabetes and neuropathy, intact cognition, and the NP signed the recommendation, but no stop order was entered and nursing continued documenting administration on the MAR. The DON stated the signed recommendation was not provided to nursing, and the Administrator was unaware the order change had not been processed.
MRR documentation for a resident with anemia, atrial fibrillation, and HTN was not signed by the physician as required. The consultant pharmacist's monthly MRRs were instead signed by a PA, and the DON confirmed this during interview.
A pharmacist review failed to identify and follow up on medication irregularities for two residents. One resident receiving montelukast had a BBW monitoring need noted in the MRR, but no care plan was in place for the required monitoring. Another resident with dementia had a donepezil order written for cognitive impairment instead of dementia, and the consultant pharmacist made no recommendation to clarify the indication despite staff confirming the diagnosis was incorrect.
Failure to monitor psychotropic medication use: A resident with PLS, DM, and psychotropic orders for duloxetine, lorazepam, and quetiapine had hospice notes showing decreased behaviors and hallucinations, yet pharmacy psychotropic reviews continued to question whether a GDR was indicated and the provider deferred to hospice. The resident’s TAR later documented ongoing anxiety/hallucination episodes, and the DON stated she needed to speak with the Medical Director and Hospice MD about the resident’s psychotropic meds.
A resident with severe cognitive impairment, dementia, insomnia, and other diagnoses was prescribed trazodone for insomnia, and the consulting pharmacist recommended psychotropic consent and sleep monitoring. The resident’s record lacked evidence that consent was obtained or that sleep monitoring was completed, and RN and DON interviews confirmed the recommendations were not carried out timely.
Failure to Report Medication Irregularities and Drug Interactions
Penalty
Summary
The facility failed to ensure safe medication management for one resident with colon cancer, muscle weakness, seizures, hypotension, and impaired cognition who was unable to make decisions. During review of the resident’s record, a nursing progress note documented Depakote 250 mg by mouth in the afternoon for anticonvulsant use, and the dose and frequency were below the usual dosing regimen noted in the record. The facility also documented multiple drug-to-drug interaction alerts involving Ativan, Depakote, phenytoin sodium extended capsule, and lorazepam, including severe and moderate interactions. Interviews with an LVN and the ADON confirmed that when these interaction alerts and the out-of-recommendation dose occurred, the nurse acknowledged the alerts but did not notify the physician, and no progress notes were found showing physician notification for the events. The pharmacy consultant stated the facility had not reported any drug-to-drug interactions or medication orders outside of recommendation guidelines, and the facility policy required the physician to be immediately informed when treatment needed to be altered significantly.
Failure to Process Pharmacy Recommendation to Discontinue Medication
Penalty
Summary
The facility failed to follow a pharmacy recommendation to discontinue Zinc Sulfate 220 mg daily for one resident with diabetes and neuropathy who had intact cognition on the quarterly MDS. The monthly pharmacy review dated 5/21/26 documented the pharmacist’s recommendation to stop the zinc because the resident’s skin was intact and the zinc was no longer needed. The recommendation was signed and approved by the NP on 6/1/26, but there was no corresponding order to discontinue the medication in the resident’s chart. A review of the MAR showed nursing initials documenting administration of Zinc Sulfate daily from 6/1/26 through 6/24/26. During interview, the DON stated the signed pharmacy recommendation was not provided to nursing by the NP and that the NP was required to give any signed recommendation to nursing for the order change. The DON also stated the NP had given the zinc pharmacy order change to be scanned into the resident’s chart rather than to nursing, and the DON was not aware of the discontinuation until it was discussed on 6/24/26. The Administrator later stated he was not aware that the signed pharmacy recommendation to discontinue the zinc had not been provided to nursing for processing.
MRR Not Reviewed by Physician
Penalty
Summary
The facility failed to provide documentation that medication regimen reviews were completed and reviewed by the resident's attending physician monthly for one of five residents, Resident R3. The facility policy on Medication Regimen Review stated that the consultant pharmacist performs a comprehensive MRR at least monthly and provides a written report to the attending physicians within 24 hours for each resident identified as having a non-life threatening medication irregularity. Resident R3 was admitted to the facility with diagnoses of anemia, atrial fibrillation, and high blood pressure. Review of Resident R3's MRRs showed that the reviews dated 1/9/26, 2/25/26, 3/29/26, 5/14/26, and 5/27/26 were signed by a Physician Assistant rather than the physician as required. During interview on 6/24/26 at 1:19 p.m., the DON confirmed that the Physician Assistant signed Resident R3's MRRs instead of the physician.
Pharmacist Review Failed to Identify Medication Monitoring and Indication Issues
Penalty
Summary
The facility failed to ensure a licensed pharmacist completed and followed up on medication regimen review irregularities for two sampled residents. The report states that the facility’s Medication Regimen Review process was intended to identify medication-related problems, including inadequate monitoring and medications without adequate indication, and that the Black Box Warning policy required safe drug prescribing and administration. During record review and interviews, the Director of Nursing confirmed that pharmacist recommendations related to black box warning monitoring were expected to be followed. For one resident with COPD, CHF, and cardiomegaly, the order summary showed montelukast was prescribed, and the pharmacist’s medication regimen review identified that the resident required monitoring for a black box warning and that this monitoring should be addressed in the care plan. However, during review of the resident’s care plans with the Registered Nurse Supervisor, no care plan was found for monitoring the black box warning side effects of montelukast. The RN stated the resident should have had a care plan for black box warning monitoring. For another resident with dementia, schizoaffective disorder, and anxiety disorder, the order summary showed donepezil HCL was ordered for cognitive impairment. The resident’s MDS identified dementia, and staff confirmed the diagnosis listed for donepezil was incorrect because it should have been dementia rather than cognitive impairment. The consultant pharmacist reviewed the resident’s medications but made no recommendation to clarify the order, and both nursing staff and the pharmacist stated that the order should have been clarified to reflect dementia as the indication.
Failure to Monitor Psychotropic Medication Use
Penalty
Summary
The facility failed to ensure residents were monitored appropriately for medication, specifically for 1 of 2 residents reviewed for unnecessary medications. The facility’s Unnecessary Drugs policy dated 12/30/25 stated that documentation would be provided in the resident’s medical record to show adequate indications for the medication’s use and the diagnosed condition for which it was prescribed. Resident #4 was admitted with multiple diagnoses including post-laminectomy syndrome and diabetes, and had physician orders for duloxetine 60 mg daily for major depressive disorder, lorazepam 0.5 mg every 4 hours as needed for anxiety/agitation, and quetiapine 25 mg at bedtime for brief psychotic disorder. Resident #4’s hospice outside agency resident reports documented decreased behaviors on 12/1/25 and decreased behaviors and hallucinations on 1/2/26. A pharmacy psychotropic review dated 12/16/25 listed duloxetine, lorazepam, and quetiapine and asked whether a gradual dose reduction would be clinically indicated; the provider declined and documented “defer to hospice.” A later pharmacy psychotropic review dated 3/17/26 again listed psychotropic medications, including ativan PRN for hallucinations, duloxetine, lorazepam, and quetiapine, and again the provider declined with the same documentation. Resident #4’s TAR for May 2026 and June 2026 documented four occurrences of anxiety/hallucinations in May and two in June, and on 6/23/26 at 3:40 PM the DON stated she would need to visit with the Medical Director and the Hospice MD about Resident #4’s psychotropic medication.
Failure to Act on Pharmacist Recommendations for Psychotropic Medication
Penalty
Summary
The facility failed to ensure that recommendations from the consulting pharmacist were acted upon timely for 1 of 5 residents reviewed for unnecessary medication use, R9. R9’s admission MDS dated [DATE] indicated severe cognitive impairment, need for assistance with ADLs, and diagnoses of edema, dementia, hypertension, insomnia, and encephalopathy. A Pharmacy Consultation Report dated 5/19/26 stated the facility needed to obtain psychotropic consent for a new order of trazodone for insomnia and to monitor R9’s sleep while receiving trazodone. R9’s medical record lacked evidence that psychotropic consent was obtained for trazodone, and it also lacked evidence that the recommended sleep monitoring was completed. During interview, RN-H stated nurses obtained consent for a psychotropic medication when a resident was admitted or when a new psychotropic medication was ordered, and she verified the record lacked psychotropic consent for trazodone. RN-H also acknowledged sleep monitoring had not been initiated for R9. DON stated nurse managers were responsible for completing nursing department pharmacy recommendations and were expected to complete them within a week. A policy for follow up and review of consulting pharmacist recommendations was requested but not received.
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