Systemic Failure to Monitor and Document Black Box Warning Medications
Penalty
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.