Controlled Medication Reconciliation Failure
Summary
The facility failed to have an effective medication reconciliation system in place for controlled medications for 3 residents. Resident 8 had diagnoses including dementia and adhesive capsulitis of the right shoulder, and the MDS indicated moderately impaired cognition and impaired ROM in both upper and lower extremities. Resident 48 had diagnoses including dementia and a wedge compression fracture of the fourth lumbar vertebra, and the MDS indicated a short-term memory problem, moderately impaired cognitive skills for daily decision making, and dependence with all ADLs. Resident 49 had diagnoses including dementia and breast cancer, and the MDS indicated moderately impaired cognition. For Resident 8, the narcotic record showed lorazepam 1 mg was removed from controlled storage for administration, but the MAR for that same dose was not signed-marked as administered. For Resident 48, the narcotic record showed acetaminophen with codeine 300-30 mg was removed for administration, but the MAR for that dose was not signed-marked as administered. For Resident 49, the narcotic record showed alprazolam 0.25 mg was removed for administration, but the MAR for that dose was not signed-marked as administered. During interview, the DON stated the facility did not have a system in place where the MARs were reconciled with the narcotic records and had not investigated the controlled medications that were not accounted for. The DON also stated that signing the MAR indicated the resident received the medication and described the process for controlled medications as requiring licensed nurses to remove the medication, sign the narcotic record, and then sign the MAR once the medication was administered. The facility policy required an accurate reconciliation of controlled drugs and documentation of administration on the accountability record and MAR.
Plan Of Correction
F0755 CFR(s): 483.45(a)(b)(1)-(3) Pharmacy Services/Procedures/Pharmacist/Records Root Cause: The root cause of the deficient practice was inconsistent adherence to controlled substance documentation and reconciliation processes, including failure to consistently verify Narcotic Records (NR), Medication Administration Records (MAR), and physical counts, along with lack of a standardized discrepancy resolution process and oversight. The corrective action(s) will be accomplished for those residents found to have been affected by the deficient practice: On 3/13/2026, for Residents #8, #48, and #49, the Director of Nursing (DON) and designee completed a full reconciliation of Narcotic Records (NR), Medication Administration Records (MAR), and physical controlled substance counts. Documentation was reviewed, staff were interviewed, and all narcotic counts were verified to ensure accuracy. Any discrepancies identified were immediately investigated and resolved. No adverse resident outcomes were identified. How the facility will identify other residents having the potential to be affected by the same deficient practice and what corrective action will be taken: On 3/31/2026, the DON and designee conducted a 100% audit of all residents receiving controlled medications over the past 30 days, verifying: NR documentation accuracyMAR documentation accuracyPhysical count reconciliationCompletion of required signaturesNo additional unresolved discrepancies were identified. Any discrepancies, if identified, would be immediately investigated, reconciled, and documented, with staff re-education provided. What measures will be put into place or what systemic changes the facility will make to ensure that the deficient practice does not recur: To prevent recurrence, the facility implemented the following systemic controls:Standardized Reconciliation Process: Controlled substance counts will be completed at every shift change by two licensed nurses, verifying: Narcotic Record (NR) Medication Administration Record (MAR) Physical count of controlled medications Both nurses must sign and verify accuracy at each shift change. Real-Time Documentation Requirements: All controlled medications must be documented immediately at the time of removal, administration, waste, or return. Documentation must include date, time, dose, balance remaining, and two licensed nurse signatures for waste. Discrepancy Process: Any discrepancy will be identified immediately and investigated at the time of discovery. The licensed nurse will notify the DON/designee immediately. A discrepancy report will be completed, including documentation of findings and resolution. If diversion is suspected, the facility will initiate escalation procedures, including Administrator notification, Consultant Pharmacist involvement, and reporting per facility policy and regulatory requirements. Education & Oversight: On 3/30/2026, the DON conducted mandatory in-service training for licensed nurses on controlled substance procedures, reconciliation, and documentation requirements. The Consultant Pharmacist will provide ongoing monthly review and oversight of controlled substance practices. How the facility plans to monitor its performance to ensure that solutions are sustained: The facility will maintain a 100% compliance threshold for controlled substance reconciliation and documentation. Monitoring Plan: The DON or designee will conduct weekly audits of a minimum of 5 residents receiving controlled medications for 4 weeks, followed by monthly audits for 2 months. Audits will include: NR vs MAR vs physical count reconciliation Completion of shift-to-shift narcotic count documentation Presence of required signatures Review of discrepancy identification, documentation, and resolution Corrective Action Loop: Any identified noncompliance will be corrected immediately, including reconciliation of counts and documentation updates. The responsible staff member will receive re-education prior to the end of the shift. A follow-up audit within 24 hours will be conducted to ensure compliance. Repeated noncompliance will be addressed through progressive discipline per facility policy. Reporting & Oversight: Audit findings will be reported weekly to the Administrator and DON during the monitoring period. The Consultant Pharmacist will review findings during monthly pharmacy reviews. Results will be presented at the monthly Quality Assurance (QA) Committee Meeting. The QA Committee will monitor compliance monthly until sustained 100% compliance is achieved. Responsible Parties: Licensed Nurses: Shift-to-shift narcotic counts, real-time documentation, discrepancy identification Director of Nursing (DON)/Designee: Oversight, audits, investigation of discrepancies Consultant Pharmacist: Monthly review and compliance oversight Administrator: Oversight and escalation if needed Completion Date: 4/13/2026
Penalty
Resources
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