Failure to Obtain Timely Informed Consent for Medication
Summary
The facility failed to adhere to the consultant pharmacist's recommendations regarding the medication regimen for a resident, identified as Resident 16. The facility's policy required a monthly Medication Regimen Review (MRR) by a consultant pharmacist, who would report any irregularities to the relevant staff, including the Administrator, Director of Nursing, attending physicians, and the Medical Director. Despite these procedures, the facility did not act on the pharmacist's repeated recommendations to obtain informed consent for the antidepressant medication Remeron prescribed to Resident 16. The pharmacist noted the need for consent on four separate occasions over a seven-month period, but the consent was not obtained until March 18, 2025. Resident 16's records indicated that they were receiving Mirtazapine (Remeron) for appetite and insomnia. The consultant pharmacist's MRR highlighted the absence of informed consent for this medication starting from August 2024. The deficiency was confirmed during an interview with the Director of Nursing, a Registered Nurse, and the Social Services Director, who acknowledged that the facility did not address the MRR request in a timely manner, contrary to the facility's policy. This oversight was part of a broader review involving a sample size of six residents, with the facility census at 33.
Penalty
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The facility failed to provide evidence that MRRs were reviewed by the attending physician for three residents. One resident with HTN, Parkinson's disease, and anxiety had an MRR recommending a GDR of quetiapine, but the record only showed a CRNP note without physician response. Another resident with DM, MS, and depression had multiple MRRs citing missing PRN details, stop dates, and pain reassessment, and a third resident with HTN, anxiety, and arthritis had an MRR noting multiple antidepressants and recommending evaluation for a single agent; in both cases, staff confirmed there was no evidence the attending physician reviewed the MRRs.
Consultant Pharmacist Failed to Identify Missing Medication Parameter Checks: A resident with DM, HTN, and schizophrenia had repeated Novolog administrations when BG was below the ordered hold parameter, but the CP’s MRRs did not identify all of the missed holds. Another resident with HTN, major depressive disorder, and schizoaffective disorder had orders for propranolol and amlodipine with BP/pulse hold parameters, yet the MAR lacked documented BP and/or pulse readings before administration, and the CP did not report the missing parameter checks during MRRs.
A resident had a consultant pharmacist recommendation for lab monitoring, including A1C, FBS, TSH, and a lipid panel, to assess the safety and efficacy of medication therapy. The physician signed the recommendation, but the clinical record showed no evidence that the ordered lab monitoring was completed, and the NHA confirmed the finding.
Failure to Address Pharmacy Medication Review Recommendations: The facility did not respond to pharmacy MRR recommendations for two residents. One resident had a pharmacist note to clarify an ergocalciferol order, but there was no documentation that the order was clarified. Another resident, who was on a pureed/mechanical soft diet and had multiple chronic conditions including HTN, HF, kidney failure, and diabetes, had several meds that required a "do not crush" order, but the chart did not reflect this and an LPN said the meds were being crushed because no such order existed. The same resident also had an AIMS recommendation that was not documented as completed until later, and the DON confirmed the recommendations were not appropriately addressed.
Failure to Act on Pharmacist Medication Review Recommendations: A resident with CHF, dementia, anxiety, psychosis, and MDD had orders for Quetiapine, Escitalopram, Melatonin, and PRN Sudafed. Multiple MRRs identified the need for physician review, including GDR assessment for psychotropic meds, discontinuation of unused Sudafed, and annual review of Melatonin, but no physician response or signature was documented.
The facility failed to maintain separate written pharmacist MRR irregularity reports and failed to show physician review and response for pharmacist-identified issues for two residents. For one resident, the consultant pharmacist’s EHR notes referenced irregularities and recommendations, but the facility could not produce the separate written reports or verify physician acknowledgment. For another resident, the MRR identified medication irregularities, but the facility could not provide documentation of the physician’s response to one of the pharmacist’s recommendations.
MRRs Not Reviewed by Attending Physician
Penalty
Summary
The facility failed to provide evidence that medication regimen reviews (MRRs) were reviewed by the resident's attending physician for three residents. Facility policy stated the consultant pharmacist would provide MRRs to identified facility personnel so the attending physician, medical director, DON, and other necessary staff would receive the recommendations. Review of the clinical record for Resident R2 showed diagnoses of high blood pressure, Parkinson's disease, and anxiety, and an MRR dated 1/23/26 recommended a gradual dose reduction of quetiapine fumarate. The record did not include a response from the attending physician, and a CRNP note stated, "Already being done," without indicating whether the recommendation was accepted or declined. Medical Records staff confirmed the MRR was addressed by the CRNP and that there was no evidence the attending physician reviewed it. Resident R4's record showed diagnoses of diabetes, multiple sclerosis, and depression. Multiple MRRs dated 9/12/25, 11/18/25, 1/2/26, and 7/29/26 included pharmacist recommendations regarding missing PRN pain severity, missing stop dates, PRN orders not used in the previous 30 days, and reevaluation of pain status. The record did not include a response from the attending physician for these recommendations, and Medical Records staff confirmed there was no evidence the attending physician reviewed the MRRs. Resident R7's record showed diagnoses of high blood pressure, anxiety, and arthritis, and an MRR dated 1/27/26 identified concomitant use of multiple antidepressants and recommended evaluation for a single agent. The record lacked a response from the attending physician, and a CRNP note stated, "accepted and decreased the duloxetine to 40mg," with Medical Records staff confirming there was no evidence the attending physician reviewed the MRR.
Consultant Pharmacist Failed to Identify Missing Medication Parameter Checks
Penalty
Summary
The facility failed to ensure the Consultant Pharmacist identified and reported medication administration issues during the monthly drug regimen review for two residents. One resident had diagnoses of type 2 DM, HTN, and schizophrenia, was cognitively intact on the MDS, and had an order for Novolog insulin 10 units before meals with instructions to hold the dose when blood sugar was below 120 mg/dL and to call the provider for blood sugar below 60 mg/dL or above 400 mg/dL. The resident’s care plan directed staff to administer diabetes medications as ordered and to monitor, document, and report signs and symptoms of hypoglycemia as needed. Review of the Consultant Pharmacist’s monthly regimen reviews from January 2026 through July 2026 showed that the pharmacist reported on one occasion that the resident’s Novolog was not held when blood sugar was below 120 mg/dL, but the reviews did not identify or report additional instances in May and June 2026 when Novolog should have been held. Review of the April, May, and June 2026 MARs showed multiple administrations of Novolog when blood sugar was below the ordered parameter. A licensed nurse and an administrative nurse stated that the physician’s insulin parameters should be followed and that insulin should be held when below the ordered threshold. A second resident had diagnoses of HTN, major depressive disorder, and schizoaffective disorder, with moderately impaired cognition and hospice services. This resident had orders for propranolol 120 mg daily to be held if BP was below 110/60 mm/Hg and amlodipine 10 mg daily to be held if SBP was below 100 mm/Hg or pulse was below 60 mm/Hg. Review of the Consultant Pharmacist’s monthly regimen reviews from January 2026 through July 2026 showed the pharmacist failed to identify and report that BP and/or pulse were not recorded before administration of propranolol and amlodipine. Review of the MARs showed no documented BP or pulse readings with amlodipine administration and no documented BP obtained with propranolol administration. Staff interviews confirmed that physician parameters should be followed and that BP and pulse should be documented when required.
Failure to Complete Ordered Pharmacist-Recommended Lab Monitoring
Penalty
Summary
The facility failed to ensure that the resident's attending physician addressed and responded appropriately to consultant pharmacy recommendations for one of five residents reviewed, Resident 17. The facility policy for Consultant Pharmacist Reports stated that the consultant pharmacist performs a comprehensive monthly review of each resident's medication regimen, identifies irregularities from sources including the MAR, prescriber orders, progress notes, the RAI, laboratory and diagnostic test results, behavior monitoring information, staff input, and resident assessment or observation, and reports findings and recommendations to the DON, Medical Director, and attending physician. For Resident 17, a consultant pharmacist recommendation dated February 16, 2026, requested lab monitoring including A1C, FBS, TSH, and a lipid panel to ensure safety and efficacy of medication therapy. The physician signed the recommendation on February 17, 2026, but review of the clinical record showed no evidence that the facility completed the recommended lab monitoring. The Nursing Home Administrator confirmed these findings during interview on July 31, 2026, at 11:02 AM.
Failure to Address Pharmacy Medication Review Recommendations
Penalty
Summary
The facility failed to respond to pharmacy medication regimen review recommendations for two residents. For one resident, who was cognitively impaired, required maximum assistance, received insulin, and had diagnoses of hypertension, heart failure, kidney failure, and diabetes, a pharmacy review noted that the physician order for ergocalciferol 200 micrograms/milliliter to give 2 drops by mouth at bedtime needed clarification to reflect 2 dropperfuls = 2 milliliters = 400 micrograms. There was no documented evidence in the clinical record that the order was clarified. For another resident, who was cognitively impaired, had diagnoses of high blood pressure, heart failure, kidney failure, and diabetes, received antipsychotic medications, and was on a pureed or mechanical soft diet with pills crushed in applesauce, a pharmacy review stated that "do not crush" should be added to orders for divalproex DR 125 mg, Protonix 20 mg, metoprolol ER 50 mg, and tamsulosin. There was no documented evidence that these orders were updated, and an LPN stated that all medication for this resident was being crushed because there was no do not crush order in place. A separate pharmacy review also indicated the resident needed an AIMS assessment, and there was no documented evidence that it was completed until about one month later. The DON confirmed that the recommendation was not appropriately addressed for the residents.
Failure to Act on Pharmacist Medication Review Recommendations
Penalty
Summary
Medication irregularities were not appropriately acted upon by a physician for one resident whose diagnoses included chronic diastolic congestive heart failure, dementia, anxiety disorder, psychosis not due to a substance or known physiological condition, and major depressive disorder. The resident had physician orders for Quetiapine 25 mg daily for psychosis, Escitalopram 20 mg daily for major depressive disorder, Melatonin 5 mg at bedtime for insomnia, and Sudafed 12 hr extended release as needed for cough and congestion. Review of the resident’s Medication Management Reviews showed repeated pharmacist recommendations that required physician review or response, including a September 2025 recommendation that Lexapro 20 mg was due for assessment for a gradual dose reduction, a February 2026 recommendation to discontinue the as-needed Sudafed due to non-usage, a March 2026 recommendation again noting Lexapro 20 mg was due for assessment for GDR, an April 2026 recommendation that Melatonin 5 mg was due for annual assessment, and a July 2026 recommendation that Quetiapine 25 mg was due for assessment for GDR. No physician response or signature was observed on any of these forms.
Missing pharmacist irregularity reports and physician responses
Penalty
Summary
The facility failed to consistently maintain separate written reports of medication regimen review irregularities and failed to ensure documentation was available showing that pharmacist-identified irregularities were reviewed by the physician and that the physician responded to them. This deficiency was identified during the recertification survey for 2 of 5 residents reviewed for Medication Regimen Review, Residents #2 and #5. For Resident #2, the consulting pharmacist’s monthly MRR tracking showed irregularities identified on multiple dates, including 08/28/2025 and 05/18/2026. The electronic medical record contained pharmacy review progress notes stating that the pharmacy order was reviewed and that a report would identify any irregularities and recommendations, including a recommendation for psychiatric consultation to assess progress and gradual dose reduction. However, the facility could not provide the separate written pharmacist reports for the identified irregularities, and the progress notes did not verify the specific irregularities or recommendations referenced by the pharmacist. The consultant pharmacist stated he completed monthly reviews, documented irregularities in the EHR, and did not always prepare a written report for the attending physician, sometimes contacting the physician by telephone and documenting the outcome in the EHR. For Resident #5, monthly MRRs from February through July 2026 identified medication irregularities in February and March. The DON provided documentation related to the March irregularity and a pharmacist progress note for the February irregularity, which stated the pharmacist would request review for continued need and benefit from nystatin treatment and ketoconazole shampoo. The facility was unable to provide documentation of the physician’s response to the February irregularity. The Medical Director stated there was a process for acknowledging recommendations and that the physician was responsible for agreeing or disagreeing with them, but he acknowledged the concern when informed that physician responses were not consistently documented.
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