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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Failure to document NPI before PRN oxycodone was given to a resident with bipolar disorder and dementia. The resident had an order for PRN oxycodone and a separate order for NPI, but MAR review showed the medication was administered nine times and the progress notes did not show NPI was used first. The UM and DON stated NPI should be attempted before PRN pain meds are given.
A resident’s midodrine was administered multiple times despite MAR-documented BPs above the prescriber’s hold parameter of SBP > 120. The RN stated a check mark means the med was given and was unsure why the resident’s midodrine was marked that way, while the DON confirmed the med should not have been administered when BP was outside parameters and that the MAR check mark indicates administration.
Failure to hold antihypertensive meds as ordered occurred when staff administered Amlodipine and Carvedilol to a resident with HTN despite BP readings below the ordered diastolic parameters. The MAR showed multiple doses were given when DBP was under 60, and the DON confirmed the meds should have been held per the physician's orders and facility policy.
A resident who was not a smoker received a nicotine patch for smoking cessation after returning from a hospital stay, even though staff confirmed she had no smoking history. The resident reported the patch made her feel sick, caused diarrhea, and left her upset and stressed. Interviews showed the charge nurse did not investigate the hospital order, the resident refused the patch on multiple days, and the pharmacist’s MRR did not note the inappropriate order.
A resident with paranoid schizophrenia, CKD, and severe cognitive impairment received Metformin for 8 days even though no DM diagnosis was supported by the record. An NP note added type 2 DM and started Metformin based on an HgbA1c that was not consistent with the resident’s prior normal HgbA1c results, and later staff found no lab evidence to support the diagnosis or order. The guardian questioned the order, and staff could not provide evidence of incident-specific education.
A resident with dementia, HTN, and edema had an order for daily amlodipine with hold parameters for low systolic BP or HR. The MAR showed the medication was given regularly without evidence that BP and HR were checked before administration, and vital signs records showed they were not being monitored daily. The DON confirmed the findings.
Failure to Document Nonpharmacological Interventions Before PRN Pain Medication
Penalty
Summary
The facility failed to provide nonpharmacological interventions before administering PRN oxycodone for Resident 16, who was admitted with diagnoses including bipolar disorder and dementia and was able to make needs known. The resident had a provider order for PRN oxycodone and a separate order to document non-pharmacological interventions such as heat, repositioning, relaxation breathing, food or fluid, massage, exercise, immobilization of a joint, or other interventions in the progress note. Review of the medication administration record for May 2026 showed the resident received PRN oxycodone on nine occasions, and review of the progress notes for that month did not show documentation that nonpharmacological interventions were used before the medication was given. During interviews, the Unit Manager stated the facility ensured PRN pain medications were necessary by providing NPI first, and the DON stated NPI should be attempted prior to giving PRN pain medications and that the resident’s lack of NPI prior to receiving PRN oxycodone did not meet expectations.
Medication Administered Outside Ordered BP Parameters
Penalty
Summary
The facility failed to ensure Resident #108’s medication regimen remained free from unnecessary drugs by administering midodrine outside of the prescriber’s ordered parameters. The physician orders dated 03/13/2026 and 05/20/2026 directed midodrine 5 mg by mouth three times daily for hypotension and to hold the medication for systolic blood pressure greater than 120. Review of the May 2026 MAR showed multiple administrations of midodrine when the resident’s documented blood pressure was above the hold parameter, including readings such as 132/84, 130/81, 130/72, 140/72, 132/70, 121/61, 126/74, 122/70, 129/68, 122/75, 131/73, 136/69, 134/72, 130/70, 145/78, 145/65, 126/62, 121/66, and 124/62. During interview, Staff K, RN stated that a check mark on the MAR means a medication was administered and that if a medication is held, a number should be documented in the MAR along with a nursing note, but she was not sure what happened with the resident’s midodrine. The DON stated that the check mark means the medication was given and that nurses should not have administered midodrine if the blood pressure was outside of parameters. The facility policy required medications to be administered as prescribed in accordance with written prescriber orders.
Failure to Hold Antihypertensive Medications for Low Blood Pressure
Penalty
Summary
Ensure each resident's drug regimen was free from unnecessary drugs was not met when the facility failed to hold a resident's antihypertensive medications as ordered based on blood pressure parameters. Resident 23 had diagnoses including hypertension, and the care plan for ineffective tissue perfusion directed staff to administer medications as ordered and monitor vital signs. The physician's orders for May 2026 directed staff to give Amlodipine 10 mg daily only if systolic blood pressure was at least 100 and diastolic blood pressure was at least 60, and to give Carvedilol 25 mg twice daily only if systolic blood pressure was at least 110 and diastolic blood pressure was at least 60. Review of the MAR showed Amlodipine was administered on multiple days when the resident's diastolic blood pressure was below 60, including readings of 54 and 59. Carvedilol was also administered on multiple occasions when the diastolic blood pressure was below 60, including readings of 54, 58, 59, 50, and 57. The DON reviewed the MAR and confirmed that Amlodipine and Carvedilol were administered on those dates when they should have been held. The facility policy stated staff should verify the correct medication, dose, route, rate, time, and resident, and obtain vital signs if necessary.
Unnecessary Nicotine Patch Given to Non-Smoker
Penalty
Summary
The facility failed to ensure that one resident’s drug regimen was free from unnecessary drugs when the resident received a nicotine patch despite being a non-smoker. The resident was admitted with diagnoses including long-term use of antibiotics due to infection of her knees, and her MDS BIMS score was 15, indicating good decision-making ability. The resident later reported that after returning from a hospital stay, she was given a nicotine patch without any explanation, even though she was not a smoker. The resident stated that the nicotine patch made her feel sick, caused diarrhea, and left her very unhappy and stressed. During record review and interview, the charge nurse confirmed that the resident had orders for nicotine patches for smoking cessation and had refused them on multiple days. The charge nurse also confirmed that the resident was not a smoker, had not been a smoker before going to the hospital, and that no investigation was done at the time the resident returned with a hospital order for nicotine patches. Additional interviews confirmed that the resident was not a smoker. The social services assistant verified records showing the resident was not a smoker, and the activities director stated she had no reason to complete a smoking assessment because the resident was not a smoker. The pharmacist stated that a nicotine patch given to a non-smoker can cause stomach upset, nausea, and/or diarrhea, and that a non-smoker should not receive one. The pharmacist’s medication regimen review did not reference the nicotine patch order or the resident’s non-smoking status.
Unnecessary Metformin Given Without Supported Diabetes Diagnosis
Penalty
Summary
The facility did not ensure that a resident’s drug regimen was free from unnecessary drugs when R2 received Metformin for 8 days despite having no diagnosis of diabetes. R2 was admitted with diagnoses including paranoid schizophrenia and chronic kidney disease, had a BIMS score of 7/15 indicating severe cognitive impairment, and had a legal representative for health care decisions. The care plan identified R2 as at risk for impaired cognitive function and included reviewing medications and causes of cognitive deficit, including new medications. Record review showed an NP progress note documented a diagnosis of type 2 diabetes mellitus and started Metformin ER 1000 mg daily based on an HgbA1c of 12.1%, but later nursing review found no recent HgbA1c results to support the diagnosis or order. R2’s prior HgbA1c values were 5.5 and 5.6, both within normal range. Staff documented that the NP stated the diagnosis had been dictated incorrectly, and Metformin was discontinued. The resident’s guardian was informed of the medication initiation and later questioned the diagnosis and order. Surveyor interviews also found staff could not provide evidence of education specific to the medication error incident, and facility leadership confirmed they could not provide evidence that such education had been given.
Blood Pressure Medication Given Without Required Vital Sign Monitoring
Penalty
Summary
The facility failed to ensure that parameters for Resident #49’s blood pressure medication were monitored before administration. Resident #49 was admitted with diagnoses including dementia, hypertension, and edema, and had an order dated 05/06/25 for amlodipine daily with instructions to hold the medication if systolic blood pressure was under 110 or heart rate was under 60. Review of the medication administration record showed the amlodipine was given regularly without evidence that blood pressure and heart rate were assessed before administration, and review of vital signs assessments showed the heart rate and blood pressure were not being checked daily. The Director of Nursing confirmed these findings during interview on 05/20/26 at 5:05 P.M.
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