Misappropriation of Controlled Narcotics
Summary
The facility failed to ensure residents' rights to be free from misappropriation of controlled narcotics for seven residents. Specifically, the facility did not account for a significant number of narcotic tablets, including Oxycodone and Hydrocodone, for these residents. The missing medications were discovered through a review of pharmacy delivery records, controlled substance count sheets, and controlled drug record sheets. Interviews with staff revealed inconsistencies and lapses in the proper documentation and verification processes for controlled substances. Resident #1 had 48 tablets of Oxycodone 10 mg missing, and the DON could not explain discrepancies in the controlled substance count sheet. Resident #2 had 61 tablets of Oxycodone 5 mg missing, and the controlled drug record sheet for this resident was removed and could not be located. Interviews with staff indicated that proper procedures for witnessing and documenting the removal of controlled substances were not followed. Similar issues were found for Residents #5, #6, #7, #8, and #9, with varying amounts of Hydrocodone and Oxycodone tablets unaccounted for. The facility's failure to properly handle, store, and document controlled medications resulted in Immediate Jeopardy for the affected residents. The DON confirmed that the missing narcotic tablets for these residents could not be accounted for due to missing narcotic sheets and medication cards that were improperly removed from the medication cart. This deficiency highlights significant lapses in the facility's controlled medication management and documentation processes.
Removal Plan
- Resident #6 discharged from the facility. Charges to his insurance was reversed and charged to the facility.
- Resident #1 was assessed for pain, no pain was noted and current residents #1, #5, #8 and #9 were assessed for pain by the DON. No pain was noted.
- Controlled medications were reconciled on every medication cart by the DON.
- The pharmacy was informed of the missing medications for residents #1, #5, #8, and #9. The charges to their insurance for their medications were reversed and charged to the facility.
- The DON and SCC conducted interviews with licensed staff to inquire if they had knowledge of controlled medication unaccounted for or if they had suspicion of anyone working while impaired.
- The DON and SCC began auditing the Controlled Medication delivery logs for Resident #1 to ensure all deliveries were added to carts #1 and #2 on Hall #3.
- The DON and SCC began auditing the Controlled Drug Records for residents that were recently discharged or deceased from Hall #3. An audit of controlled medication logs was conducted for every resident in the facility with an order for a controlled medication to determine if other nurses/residents were involved. This was performed by the DON and SCC. Hall #3 was the only hall identified with controlled medications unaccounted for. Any findings were reported to the legal and regulatory authorities: Health Facilities Commission, TN Regional Office; TN Bureau of Investigation; Police Department, Ombudsman and APS.
- The affected residents with a BIMS of 8 or greater were interviewed by the DON, and all stated they received their pain medications, and all denied pain.
- The affected resident with a BIMS less than 8 was assessed for pain by the DON, there was no complaint or signs of pain.
- Pain assessments were completed for all residents on Hall #3 by the nurse managers to determine if any had uncontrolled pain. There were no residents experiencing uncontrolled pain.
- The nurse managers interviewed residents on Hall #3 with a BIMS equal or greater than 8 to determine if their pain is controlled and as needed (PRN) medications had been administered when requested. All stated their pain is controlled and they receive their PRN medications when requested.
- The DON reviewed documented pain levels for uncontrolled pain. No one had uncontrolled pain levels.
- One nurse was suspended due to reasonable suspicion and remains suspended. This nurse was reported to the Tennessee (TN) Board of Nursing. The TN Bureau of Investigation is continuing the investigation.
- A root cause analysis was conducted. It was determined that the nurse did not follow the process for removing controlled medications; obtaining a witness to verify the removal of controlled medications. The process was changed to prevent the nurses/medication aides from removing completed medication cards or discontinued medication cards. The DON or Unit Managers will remove controlled medications from the medication cart; completed medication cards/sheets and discontinued medication cards/sheets.
- A root cause analysis was conducted. It was determined the excess controlled medication cards/sheets did not need to be on the medication cart. A cabinet with 2 locks was secured in the medication room for overflow-controlled medications and a new form was developed, Controlled Substance Overflow Sheet, to record the addition and removal of controlled medication to that cabinet.
- Education was conducted by the Director of Nursing (DON) and Staff Development Coordinator (SDC) with all staff on the Abuse and Misappropriation Policy. Any staff/agency staff who were not educated will be before working their next shift.
- Education was conducted by the DON and SDC with all licensed staff and Medication Aides on the Controlled Medication Policy and process changes for counting/receiving/removing controlled medication. Any staff/agency staff who were not educated will be educated prior to working their next shift.
- Two nurses will verify the pharmacy delivery manifests for controlled medications in the presence of the driver. Once the quantity has been verified, they will sign the pharmacy delivery manifest. Two nurses will sign the Controlled Drug Record sheet and indicate the total quantity for the prescription (RX) number and the number of medication units, i.e. tablets, on the Controlled Drug Record sheet. Once the quantities are verified the two nurses will add the controlled medications to the medication cart and sign them into the Controlled Substance Record sheet.
- The Unit Managers will audit the pharmacy delivery manifests, daily, to verify controlled medications and Controlled Drug Record Sheets were added to the Controlled Substance Count Sheet and for count accuracy.
- The DON/UM will remove all controlled medications with a witness (empty and discontinued) from the medication cart, reconcile the Controlled Substance Count Sheets and compare the Controlled Substance Count Sheets to the Controlled Drug Records as they are removed from the cart to be secured for destruction. No one will remove controlled medication card/sheets without the DON/UM witnessing. This process, along with the process in #5 above, will prevent the ability to remove a count sheet and medication card without being discovered.
- A secured cabinet with 2 locks was placed in the Four Seasons (hall #2) medication storage room. Overflow of controlled medications will be stored in the secured cabinet. The cabinet has 2 locks with 2 separate keys that are assigned to 2 different licensed nurses (the DON and SDC). The DON and SDC will access the controlled medication cabinet as needed: when multiple cards/sheets are delivered and as the nurses need medications due to running out on the cart. The carts will be checked at the end of the day and before the weekend to ensure the residents will not miss a dose of their controlled medication. The transaction will be recorded on the Controlled Substance Overflow sheet. There will not be a key to this cabinet on any other key ring. In the event the DON or SDC are not in the facility, the DON will designate a Clinical Manager to hold one key.
- The licensed nurses/medication aides were educated by the DON, SDC or UM. Any licensed staff including agency nurses that were not educated will be before their next shift.
- An Ad Hoc QAPI was held via phone, with Corporate Leadership, SCC, Pharmacy President (VP) Strategic Accounts, and the Medical Director to discuss new findings and ongoing investigation.
- An Ad Hoc QAPI was held with Corporate Leaders to discuss audit findings, via phone.
- An Ad HOC QAPI was held with the Medical Director to discuss the event and plan of correction.
- An Ad HOC QAPI was held with the Medical Director, to discuss implementation of a secured overflow cabinet for controlled medications, the process for accessing the cabinet and the recording of adding/removing controlled medications. This new process will be discussed in QAPI meetings to ensure compliance and determine any changes that may be warranted.
- The Clinical Interdisciplinary Team (IDT) will audit every scheduled nurse at shift change for accuracy of the count process daily for two weeks then, weekly times (x) 2 weeks, then monthly x 2 months, then quarterly thereafter.
- The DON/Unit Manager (UM) will audit the medication carts to ensure discontinued/completed controlled medications have been removed from the cart and the Controlled Medication Count Sheet accurately records the removal 5 times per week x 2 weeks then, 3 times per week x 2 weeks then, 2 times monthly x 2 months.
- The DON will conduct random audits of the Pharmacy Delivery Report to ensure the delivered controlled medications were accurately added to the medication carts and Controlled Substance Count Sheets; 5 deliveries per week x 2 weeks then, 3 deliveries per week x 2 weeks then, 3 deliveries per month x 2 months.
- The Quality Assurance (QA) Team will review staff education and QA audits for completion and accuracy. Findings of audits will be reported to the QAPI Committee which includes the Administrator, DON, Unit Managers, SDC, Social Services Director, Maintenance Director, Dietary Manager, Life Enrichment Director, Rehab Manager, and Medical Director. The QAPI meetings will be held weekly for 4 weeks then, 2 times per month for the next 30 days then, monthly thereafter or until the QAPI Committee determines substantial compliance has been achieved. The QAPI Committee reserves the right to modify or extend monitoring times according to outcomes.
- Regional oversite has been in place daily. The Senior (Sr.) Signature State Care Consultant has been in the facility assisting with interviews, education, audits, process changes, attending Ad Hoc QAPI meetings and oversight of compliance with process changes. Regional oversite has occurred onsite or by phone from the Sr. Signature State Care Consultant, the Regional VP of Clinical Operations, or the Regional VP of Operations. The Regional team has collaborated with the facility team on process changes and attended Ad HOC QAPI meetings via phone to discuss audit findings and develop a plan of correction.
Penalty
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