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:
Failure to address pharmacist recommendations for melatonin: A resident with moderately impaired cognition and diagnoses including DM, Alzheimer’s disease, and anxiety remained on 6 mg of melatonin at bedtime despite repeated pharmacist recommendations to taper and discontinue it. The provider declined the recommendations and deferred to psychiatry, but the psych note continued the medication without a documented rationale for not following the pharmacist’s advice; the resident also had a fall and was noted to be difficult to wake during a later psych eval.
A resident’s monthly medication regimen reviews (MRRs) were not properly documented, as the facility could not produce the MRR that contained a pharmacist’s recommendation about fluid restriction, and there was no evidence that the attending physician reviewed or responded to pharmacist recommendations for gradual dose reductions of Abilify, Trazodone, and Vilazodone. The pharmacist repeated the same recommendations in a subsequent MRR, and the DON in training confirmed both the missing MRR and the lack of physician documentation, contrary to facility policy requiring timely review and response to pharmacist-reported irregularities.
Surveyors found that the facility failed to ensure monthly pharmacist drug regimen reviews were completed and documented for several residents with conditions such as Parkinson’s disease, dementia, and Alzheimer’s disease, with no pharmacist notes present for at least two consecutive months. Additionally, a pharmacist’s recommendation to add a low-dose daytime antipsychotic for a resident with dementia, psychotic disorder, and behavioral symptoms was not communicated to the physician or implemented for several months, despite documented behavioral concerns. An LPN reported not relaying the pharmacist’s recommendation because PRN Haldol had not been needed at that time, and the DON confirmed that the pharmacist reviews for the missing months were not done and that she did not have time to monitor follow-through on such recommendations.
Facility staff did not ensure timely completion and implementation of pharmacy medication regimen review recommendations for a resident. The DON reported that the pharmacy coordinator notifies her when reviews are ready, she forwards them to the physician for signature, and then to unit managers for implementation, with copies kept in a binder and originals scanned into the chart. Review of one resident’s record showed repeated delays of several weeks between pharmacist recommendations for gradual dose reductions of quetiapine, duloxetine, and pantoprazole, as well as completion of an AIMS assessment, and the physician’s review and signature, contrary to the facility’s medication regimen review policy.
Surveyors found that the facility did not ensure monthly drug regimen reviews by a licensed pharmacist were documented or acted upon for multiple residents with complex medical and psychiatric conditions. Records for several residents showed no monthly pharmacy reviews for extended periods and no documentation of staff responses to pharmacist-identified irregularities, even when PRN psychotropic and opioid medications were frequently administered. The DON reported that she did not know the location of the monthly reviews, that the facility could not provide them, and that no process or system was in place to respond to pharmacist-identified irregularities, including those requiring urgent action.
The facility failed to timely review and act on consultant pharmacist MRR recommendations for two residents. One resident with dementia, anxiety, depression, HTN, orthostatic hypotension, and failure to thrive had a missed monthly pharmacist review after a unit transfer, and another resident with cognitive impairment, dementia, anxiety, and COPD had pharmacist recommendations for monitoring with citalopram, olanzapine, and trazodone that were not documented as reviewed, communicated, or implemented in the EMR or order records.
Failure to Address Pharmacist Recommendations for Melatonin
Penalty
Summary
The facility failed to ensure that the consulting pharmacist’s recommendations from the monthly drug regimen review were fully addressed for one resident with moderately impaired cognition who had diagnoses of diabetes, Alzheimer’s disease, and anxiety. The resident had been receiving 6 mg of melatonin at bedtime since 7/21/23 for insomnia. In the pharmacist’s 11/5/25 consultation report, melatonin was identified as not recommended for sleep onset or sleep maintenance insomnia in adults, with adverse reactions including confusion, daytime drowsiness, dizziness, vivid dreams or nightmares, and increased bed wetting. The pharmacist recommended tapering the melatonin to 3 mg at bedtime for seven days and then discontinuing it, but the provider signed the report on 11/10/25 and declined the recommendation with a handwritten rationale stating the need to review with psychiatry. A second pharmacist consultation report dated 12/2/25 again noted the resident was receiving 6 mg of melatonin at bedtime and had experienced a fall on 11/22/25. The pharmacist again recommended discontinuing melatonin, but the provider signed on 12/11/25 and declined the recommendation, writing that psychiatry was following. A psychiatric evaluation note dated 1/12/26 documented the resident lying in bed sleeping and being difficult to wake, with the note stating to continue melatonin 6 mg at bedtime but without a rationale for not following the pharmacist’s recommendation. During interviews, the consultant pharmacist stated he believed the psychiatry note was a response to his recommendation, and the DON stated she did not believe the medical director had been notified regarding the melatonin recommendations.
Failure to Document Physician Response to Pharmacist Medication Regimen Review
Penalty
Summary
The facility failed to ensure that the attending physician documented review of the consultant pharmacist’s monthly medication regimen review (MRR) recommendations and actions taken in response for one resident reviewed for unnecessary medications. Review of the resident’s MRR notes from April 2025 through April 2026 showed the pharmacist documented completion of the MRRs and noted on 07/09/25 that a recommendation regarding fluid restriction was being sent. When surveyors requested the July 2025 MRR containing the specific fluid restriction recommendation and the physician’s response, the facility was unable to provide this document for review. The DON in training confirmed the July 2025 MRR for this resident could not be located. Further review of the December 2025 MRR for the same resident revealed the consultant pharmacist recommended a gradual dose reduction trial for Abilify, Trazodone, and Vilazodone. There was no documentation that the attending physician reviewed this MRR or responded to the pharmacist’s recommendations, and the January 2026 MRR showed the pharmacist repeated the same recommendation. The DON in training confirmed there was no documentation that the attending physician addressed the pharmacist’s December 2025 recommendations. This was inconsistent with the facility’s Medication Regimen Review policy, which states that pharmacist-reported irregularities are to be reviewed and a response provided in a timely manner, and that pharmacist recommendations are considered part of the medical record.
Failure to Complete Monthly Pharmacist Reviews and Timely Act on Medication Recommendations
Penalty
Summary
The deficiency involves the facility’s failure to ensure that a licensed pharmacist conducted and documented monthly drug regimen reviews for multiple residents and to ensure that identified medication irregularities were acted upon by the attending physician. For four sampled residents, the medical records lacked monthly pharmacist medication regimen review notes for at least two consecutive months. Specifically, residents with diagnoses including Parkinson’s disease, unspecified dementia, Alzheimer’s disease with early onset, and dementia related to other diseases had no documented pharmacist review notes for March and April 2026. The DON confirmed that the pharmacist had not completed pharmacy reviews for those months and that the notes, which should have been uploaded into each resident’s electronic medical record, were absent. In addition, the facility failed to act promptly on a pharmacist’s recommendation for a resident receiving psychotropic medications. One resident with hemiplegia following cerebral infarction, psychotic disorder with delusions, dementia, and major depressive disorder had a pharmacist recommendation in November 2025 to add a low-dose daytime Seroquel due to behavioral issues and afternoon anxiety. Nursing documentation showed that the pharmacist discussed the resident’s response to Seroquel versus Abilify and suggested a low-dose daytime Seroquel, but this recommendation was not communicated to the physician at that time. The LPN later stated she did not speak to the physician about the pharmacist’s recommendation because the resident had not needed PRN Haldol around that time. The physician did not write the order for daytime Seroquel until early February 2026, after a nurse raised concerns about the resident’s behaviors and reminded the physician of the prior pharmacist recommendation. The DON acknowledged that the pharmacist’s November 2025 recommendation was not completed until February 2026 and stated she did not have time to stay on top of such issues.
Delayed Implementation of Pharmacy Medication Regimen Review Recommendations
Penalty
Summary
Facility staff failed to ensure that monthly medication regimen reviews by the consultant pharmacist were completed and implemented in a timely manner for one resident in the survey sample. The DON described the facility’s process, stating that the pharmacy coordinator notifies her when reviews are ready, she then reviews them and forwards them to the physician for review and signature, and once signed, she gives them to unit managers to ensure recommendations are implemented. The DON also stated she keeps copies of all reviews in a binder in her office and sends the originals to medical records to be scanned into the resident’s chart. The facility’s policy, titled “Medication Regimen Review,” states that each resident’s drug regimen is reviewed at least monthly by a licensed pharmacist and includes a review of the resident’s medical chart. Record review for one resident showed multiple delays between the pharmacist’s recommendations and physician review/signature. A pharmacy review dated 2/18/25 recommended a gradual dose reduction of the antipsychotic quetiapine from 100 mg to 75 mg, but this was not reviewed and signed by the physician until 3/25/25. On 2/18/25, a recommendation for a current AIMS assessment was made and was not signed and completed until 3/27/25. On 7/29/25, a recommendation for a gradual dose reduction of the antidepressant duloxetine 60 mg twice daily was not addressed by the physician until 9/5/25. On 11/26/25, a recommendation to reduce pantoprazole from 40 mg daily to 20 mg was not reviewed and signed by the physician until 12/24/25. These findings demonstrate that pharmacy regimen review recommendations for this resident were not acted upon in a timely manner, contrary to facility policy.
Failure to Conduct and Act on Monthly Pharmacist Drug Regimen Reviews
Penalty
Summary
The deficiency involves the facility’s failure to ensure that a licensed pharmacist conducted and documented monthly drug regimen reviews (DRRs) for multiple residents and the facility’s failure to respond to pharmacist-identified irregularities according to established policies and procedures. For several residents, surveyors found no documentation in the clinical record of monthly pharmacist reviews or of the facility’s response to any identified irregularities. The Director of Nursing (DON) repeatedly stated that she did not know where the monthly DRRs were located, did not have them, and that the facility was unable to provide this information during the survey period. For one resident with diagnoses including a right femur neck fracture, alcoholic cirrhosis, hypertension, and depression, the quarterly MDS showed moderately impaired cognition. Review of this resident’s clinical record from late April revealed no documentation of the facility responding to irregularities identified by the pharmacist during monthly DRRs. When interviewed, the DON stated she did not know where the monthly DRRs were and could not provide them, and no additional information was produced by the end of the survey. Another resident with type 2 diabetes, chronic kidney disease, muscle weakness, and hypertension, and with severely impaired cognition per the admission MDS, also had no documented facility response to pharmacist-identified irregularities in the progress notes, and the DON again reported that the monthly DRRs could not be located or provided. For two additional residents, one with a stroke and aphasia and another with cataracts and anxiety, surveyors found that no monthly pharmacy reviews were documented in their clinical records over a 12‑month period. In the first of these cases, the resident had severely impaired cognition and active orders for PRN lorazepam via G‑tube and multiple PRN morphine doses for varying levels of pain or distress, which were frequently administered without documented pharmacy reviews or recommendations. The last pharmacy review in this resident’s record was dated more than a year earlier, and the last recommendation several months earlier. For the resident with cataracts and anxiety, no monthly pharmacy reviews were documented for the same 12‑month period, with the last review and recommendation both dated in the prior year. The DON acknowledged that she had only recently started a pharmacy review and recommendation binder and could not provide further information. The facility also failed to implement and follow policies and procedures for responding to pharmacist-identified irregularities, including those requiring urgent action, for two other residents. One resident with severe cognitive impairment and multiple psychiatric and neurologic diagnoses, including non‑Alzheimer’s dementia, seizure disorder, bipolar disorder, schizophrenia, and psychotic disorder, had no documentation in the progress notes of the facility responding to irregularities identified by the pharmacist during monthly DRRs. Another resident with extensive medical conditions, including chronic respiratory failure with hypoxia, diabetes with autonomic polyneuropathy, lymphedema, cirrhosis, NASH, hepatic fibrosis, COPD, morbid obesity, ventral hernia with obstruction, gastroparesis, panic disorder, chronic kidney disease, major depressive disorder, and anxiety disorder, similarly had no documentation of facility responses to pharmacist-identified irregularities. In both cases, the DON stated she did not have a process for responding to pharmacist-identified irregularities and had not developed a system since beginning employment, and the facility was unable to provide the missing DRRs or additional information before the survey concluded.
Delayed Review of Consultant Pharmacist Medication Recommendations
Penalty
Summary
The facility failed to ensure that recommendations from the consultant pharmacist’s monthly medication regimen review were reviewed and acted upon in a timely manner for 2 of 6 residents reviewed for unnecessary medications, including R9 and R65. The facility’s Pharmacy Recommendations policy required monthly pharmacist review of resident medication regimens, communication of recommendations to nursing and physicians, documentation in the medical record, and timely resolution of recommendations. The policy also required unresolved recommendations to be tracked, re-reviewed the following month, and escalated if non-response continued. For R65, whose diagnoses included Alzheimer’s disease, non-Alzheimer’s dementia, anxiety, depression, hypertension, orthostatic hypotension, and adult failure to thrive, the consultant pharmacist’s reviews were present for several months after admission, but no review was present for December 2025 after the resident changed units. The DON stated the monthly review was missed because of the unit transfer, and the consultant pharmacist confirmed no record review was completed that month. For R9, who had moderate cognitive impairment and diagnoses including Alzheimer’s disease with late onset, non-Alzheimer’s dementia, anxiety disorder, and COPD, the consultant pharmacist identified medication regimen recommendations related to citalopram, olanzapine, and trazodone, including patient-specific target behavior monitoring, side effect monitoring, and orthostatic blood pressure monitoring. Review of the EMR and physician order records showed no evidence that the facility reviewed, acknowledged, communicated, or acted on these recommendations in a timely manner, and no rationale was documented for not implementing them.
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