Systemic Failure to Monitor and Document Black Box Warning Medications
Summary
Surveyors identified a systemic failure in the facility's management of medications with FDA Black Box Warnings (BBW), specifically Levaquin (levofloxacin) and Metformin, affecting all residents who received these drugs. For 54 residents who received Levaquin and 19 residents who received Metformin, there was no documentation that BBW monitoring was performed, and no care plans were developed addressing the BBW risks associated with these medications. Additionally, 30 residents who received Levaquin did not have an appropriate indication or diagnosis documented for its use. Six residents received both Levaquin and Metformin without proper BBW monitoring or care plans. These failures were confirmed through record reviews, interviews with staff, and examination of the facility's policies and procedures. Interviews with nursing staff, the Infection Preventionist (IP), and the Director of Nursing (DON) revealed inconsistencies and gaps in understanding and implementing BBW monitoring. While the facility's policy required nursing progress notes to reflect monitoring and resident response to BBW medications, staff interviews indicated that only the day shift nurse administering the medication would see the BBW alert, and documentation in progress notes was inconsistent or absent. Evening and night shift nurses were not consistently alerted or documenting BBW monitoring. Multiple resident records reviewed showed no evidence of BBW monitoring in either the Medication Administration Record (MAR) or nursing progress notes, despite ongoing or recent administration of Levaquin or Metformin. The facility's Infection Preventionist and Consultant Pharmacist failed to identify and report irregularities related to frequent Levaquin use, missed BBW monitoring, inappropriate antibiotic indications, and lack of care plans during their respective reviews. The deficiency was observed across all shifts and affected all residents prescribed these medications during the review period. The lack of monitoring and documentation was confirmed for multiple residents with complex medical histories, including those with kidney disease, diabetes, infections, and other serious conditions, as evidenced by detailed record reviews and staff interviews.
Penalty
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Inadequate monitoring was identified for a resident receiving furosemide, a high-risk diuretic. The resident had CAD with angina, HTN, hyperlipidemia, cognitive impairment, and dementia, but the record lacked orders for weights or edema monitoring and did not include clear provider-notification parameters for changes in weight or edema. Although the care plan referenced monitoring edema and weight, weights were done monthly instead of weekly, and an eight-pound weight fluctuation was not documented as reported to the provider. Staff and the DON stated they expected weekly weights and regular edema checks for residents on diuretics.
Failure to follow ordered medication parameters led to unnecessary drug administration. One resident with DM, HTN, and schizophrenia received rapid-acting insulin even when BS was below the ordered hold parameter on multiple occasions, and another resident with HTN, major depressive disorder, and schizoaffective disorder received antihypertensive meds without documented BP or pulse readings despite hold parameters. A third resident with DM had an insulin order without BS parameters, and a nurse later updated the EMR with parameters.
Failure to Follow BP Hold Parameters for Antihypertensive Medications: A resident with hypertensive heart disease received ordered BP medications despite BP readings below the physician's hold parameter of systolic BP less than 100. The MAR showed Isosorbide Mononitrate ER, Losartan, and Atenolol were administered when BP was 86/54, 94/57, and 77/52, and the DON confirmed the medications were given when the ordered parameters were not met.
A hospice resident with COPD, opioid dependence, chronic pain, and anxiety received Narcan nasal spray from staff without a physician order or standing order after being found unresponsive. After the dose, the resident developed flailing and jerking movements, respiratory distress, and signs consistent with opioid withdrawal, and was transported to the hospital where she received lorazepam and morphine and was admitted.
Two residents receiving insulin did not have ordered blood glucose checks completed, including missed checks when one resident was sleeping and a documented shortage of test strips. One resident with type 2 DM had multiple missed BG checks and no documentation that the provider was contacted when BG exceeded the ordered threshold, while another resident with type 2 DM, CHF, chronic respiratory failure, and obesity also had missed q4h BG checks and no provider notification documented for BG readings over 400 mg/dL.
A facility failed to follow provider parameters for an antihypertensive medication when a resident’s metoprolol was given even though SBP was below the hold threshold on multiple occasions. The facility also allowed two active PRN ondansetron orders for another resident, and both orders were available in the EHR and used. RNs and the DON confirmed the medication parameters and duplicate-order review process were not followed.
Inadequate Monitoring for Resident on Furosemide
Penalty
Summary
The facility failed to ensure adequate monitoring was in place for a resident receiving furosemide, a high-risk diuretic, as part of the resident’s drug regimen. The resident’s quarterly MDS listed coronary artery disease with angina pectoris, hypertension, hyperlipidemia, moderate cognitive deficit, and unspecified dementia with impaired decision making and poor short-term memory. The medical record included orders for compression bandages, weekly orthostatic blood pressure checks, a 2-gram sodium diet, daily furosemide 40 mg, and shortness of breath assessments three times per day, but it lacked orders for weights or edema monitoring. The care plan identified diuretic therapy related to excess fluid and included monitoring for side effects, effectiveness, edema, and weight, but it did not include specific parameters for provider notification related to changes in edema or weight. The resident’s weights were documented monthly, showing 227 pounds on 6/6/26, 235 pounds on 7/13/26, and 227 pounds on 8/6/26, and there was no evidence that the provider was notified of the eight-pound weight fluctuation. During interviews, nursing staff and the DON stated they expected residents on furosemide to be monitored for edema and weighed weekly, and the NP stated she expected weekly weights and notification for a weight gain of greater than five pounds in a week. The DON confirmed the resident was being weighed monthly, there were no edema monitoring orders, and no parameters were listed for provider notification when weight or edema changed.
Failure to Follow Ordered Medication Parameters
Penalty
Summary
The facility failed to ensure a resident’s insulin was held when blood glucose was below the physician’s ordered parameter. The resident had diagnoses including type 2 DM, HTN, and schizophrenia, and his EMR documented intact cognition on the annual MDS. His physician ordered Novolog 10 units subcutaneously before meals with instructions to hold the dose when blood sugar was less than 120 mg/dL and to call the provider for blood sugar less than 60 mg/dL or over 400 mg/dL. Review of the resident’s MAR showed multiple instances in April, May, and June 2026 when Novolog was administered even though blood sugar was below 120 mg/dL. The report states the insulin was not held on three of 90 opportunities in April, three of 93 opportunities in May, and three of 90 opportunities in June. During observation and interview, a licensed nurse and an administrative nurse stated that the physician’s insulin parameters should be followed and that insulin should be held when blood sugar was below the ordered parameter. The facility also failed to ensure physician-ordered parameters were obtained and recorded before administering antihypertensive medications to another resident. That resident had HTN, major depressive disorder, and schizoaffective disorder, with moderately impaired cognition on the annual MDS and hospice services. His orders for propranolol and amlodipine included blood pressure and pulse hold parameters, but review of the MAR from January 2026 through July 2026 showed no documented blood pressure or pulse with amlodipine administration, and propranolol was administered without blood pressure being obtained and documented. A certified medication aide and licensed nurse stated the parameters should be followed, and an administrative nurse stated blood pressure and pulse should be documented when physician parameters are present. The report also identified a third resident with DM whose insulin order lacked blood sugar parameters, and a nurse stated she updated the EMR with blood sugar parameters after noting the issue.
Failure to Follow BP Hold Parameters for Antihypertensive Medications
Penalty
Summary
The facility failed to keep a resident's drug regimen free from unnecessary drugs by not following physician-ordered blood pressure parameters for administering blood pressure medications. During review of Complaint 3031582, surveyors reviewed the medical record of Resident #11, who had been in the facility for 18 days in 2026 and had a diagnosis of hypertensive heart disease. The April 2026 MAR showed the resident received Isosorbide Mononitrate ER 30 mg in the evening, Losartan Potassium 25 mg in the evening, and Atenolol 25 mg twice daily even when the resident's blood pressure was below the ordered hold parameter of systolic blood pressure less than 100. The record showed these medications were administered on 4/9/26 and 4/10/26 when blood pressure readings were 86/54 and 94/57, and Atenolol was also administered on 4/16/26 when the blood pressure was 77/52. The Surveyor reviewed the April 2026 MAR with the DON, and the DON confirmed that the resident was given blood pressure medications on 4/9, 4/10, and 4/16/26 when the blood pressure did not meet the physician-ordered parameters.
Unordered Narcan Administration to Hospice Resident
Penalty
Summary
The facility failed to ensure a resident’s drug regimen was free from unnecessary drugs when staff administered Narcan (naloxone) to a hospice resident without a physician order or documented clinical indication. Resident #4 had diagnoses including COPD, opioid dependence, anxiety disorder, chronic pain, and polyneuropathy, and was receiving hospice services for COPD with comfort-focused symptom management. The resident’s orders included oxycodone PRN, a fentanyl patch that was increased from 50 mcg/hr to 75 mcg/hr, and morphine sulfate for pain and shortness of breath. The resident’s electronic record did not show an order authorizing Narcan or any standing order for its use. According to staff interviews and records, the resident was found unresponsive and a staff member, believing it looked like an overdose, retrieved Narcan nasal spray from the medication cabinet and administered it without a physician order. After the Narcan, the resident became more active, flailed, and had jerking movements of the upper extremities, appeared in respiratory distress, pushed away the oxygen mask, and was not following commands. EMS documented findings consistent with opioid withdrawal following Narcan administration, and hospice records stated the Narcan was administered inappropriately. The resident was transported to the hospital, where she received multiple doses of lorazepam and morphine, was admitted, and a morphine infusion was started.
Missed Blood Glucose Monitoring for Residents Receiving Insulin
Penalty
Summary
The facility failed to ensure that residents' drug regimens were free from unnecessary drugs by not completing ordered blood glucose monitoring for two residents receiving insulin. One resident with type 2 diabetes mellitus had a physician order for insulin lispro before meals and at bedtime, with blood glucose checks to guide treatment, but the July 2026 MAR documented 25 instances where the resident was sleeping and the blood glucose was not drawn. The MAR also documented that no glucose test strips were in the building on July 28, 2026, and it did not show blood glucose checks at 4:00 PM on July 2, 4, 5, 11, 17, and 18, 2026. The resident stated that the facility had run out of glucose test strips, so staff could not test blood sugar or administer insulin that day. A second resident with type 2 diabetes mellitus and other diagnoses including chronic diastolic heart failure, chronic respiratory failure, and obesity had a physician order for blood sugar checks every 4 hours, with instructions to contact the provider if blood sugar exceeded 400 mg/dL. The May 2026 MAR showed missed blood glucose checks at 12:00 AM on May 13, 12:00 PM on May 15, and 12:00 AM and 4:00 AM on May 16. The MAR and progress notes also did not show that the physician was contacted when blood glucose levels exceeded 400 mg/dL on May 13 at 8:00 PM and May 14 at 4:00 PM. Staff interviews confirmed that sleeping residents were expected to be awakened for ordered blood glucose testing and that the facility should not run out of strips or insulin.
Unnecessary Medication Use and Duplicate PRN Orders
Penalty
Summary
The facility failed to ensure that antihypertensive medication was administered according to provider-ordered parameters for one resident with intact cognition who had diagnoses including heart failure and diabetes. The resident had an order for metoprolol 50 mg twice daily with instructions to hold the medication if systolic blood pressure was below 120 or heart rate was below 60. The MAR showed multiple instances in which metoprolol was documented as given even though the resident’s systolic blood pressure was below the ordered hold parameter, including readings of 116, 115, 112, and 106. The resident’s care plan identified hypertension and use of antihypertensive medication, with instructions for blood pressure checks per provider order and monitoring for side effects such as orthostatic hypotension and increased heart rate. The medical record did not contain consent from the provider to give metoprolol outside the written parameters. During interview, the RN overseeing the resident’s care confirmed the medication should have been held when the blood pressure was below the ordered threshold and acknowledged it had been administered outside the parameters. The facility also failed to prevent duplicate active medication orders for another resident with intact cognition and diagnoses including kidney disease, diabetes, and dementia. That resident had an active PRN ondansetron order for nausea and vomiting, and a second PRN ondansetron order was entered later, resulting in two active orders available in the EHR. The resident received ondansetron under both orders on multiple occasions. The record also showed the resident had signed onto hospice, and the order summary in the certification and plan of care reflected only one ondansetron order.
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