Failure to Safely Manage and Reconcile Controlled Substances, Including Oxycodone
Penalty
Summary
The deficiency involves the facility’s failure to maintain a safe and effective medication system for controlled substances, specifically oxycodone, by not following its own policies and procedures for counting, documenting, and removing narcotic medications. The facility’s written policy required controlled substances to be counted upon delivery, jointly verified and signed by the receiving nurse and the delivery person, stored in separately locked compartments, and reconciled at each shift change by the oncoming and offgoing nurses. The policy also required that only one dose at a time be removed from the emergency medication kit as needed, with proper documentation and reconciliation of all controlled substances, including waste and destruction. Surveyor review showed that these procedures were not consistently followed, leading to an unaccounted-for card of oxycodone and undocumented doses removed from the emergency medication kit. The resident involved had multiple medical conditions, including a fracture of the lower end of the right femur, cognitive communication deficit, major depressive disorder, osteoarthritis of the knee, seizure disorder, chronic pain, and severe cognitive impairment as indicated by a BIMS score of 7. The resident used a wheelchair, had limitations in both arms and legs, was dependent on staff for ADLs, and reported moderately rated pain. Hospital discharge orders included oxycodone 5 mg every eight hours as needed for moderate to severe pain, and the facility’s physician orders later reflected oxycodone 5 mg every four hours as needed for pain. On one occasion, an RN documented that after giving scheduled pain medication, the resident continued to experience significant pain, including yelling and screaming during care and dressing changes, and the RN removed three oxycodone 5 mg tablets from the emergency kit, administering one dose but not documenting the disposition of the remaining two tablets. Record review and staff interviews revealed systemic failures in controlled substance handling and documentation. The facility’s investigation showed that nurses could not consistently recall how many oxycodone cards were present for the resident, and the DON found that none of the interviewed nurses had signed the Controlled Drug Count sheet for the relevant dates, despite their statements that counts were done at shift change. The Daily Controlled Substances Audit form showed nurses were signing to verify card counts without actually performing the required counts. When medication cards were destroyed, nurses documented changes such as +1 or -2 without initials or clear indication of which card was added or subtracted. One LPN reported that on a later date he/she observed that a previously present third card of oxycodone was missing, with the corresponding narcotic count sheet page folded over as if for destruction or return, but with no documentation. Multiple nurses, including LPNs and RNs, stated they routinely removed multiple doses (e.g., several tablets at once) from the emergency medication kit, sometimes eight or nine tablets, and then included any unused tablets in the narcotic count, explaining that they had been trained by other nurses to do this, even though the DON and Administrator stated staff were expected to remove and document only one dose at a time from the emergency kit. These actions and inactions resulted in an unaccounted-for card of oxycodone and undocumented controlled substance doses, in violation of the facility’s controlled substance policy. Additional interviews with leadership confirmed the expectations that were not met. The DON stated that controlled substances should be counted at each shift change by both oncoming and offgoing nurses, that each medication cart and each card’s pill count should match the narcotic count sheets, and that staff should sign the narcotic count book and count medications each time the medication room keys changed hands. The DON also stated that staff should remove only one dose at a time from the emergency medication kit and document removals in the emergency kit carbon notebook for communication with the pharmacy. The Administrator similarly stated that staff were expected to follow the facility’s policy on counting controlled substances and to remove only one dose at a time from the emergency medication kit. Despite these stated expectations, the documented practices and staff interviews showed that counts were not reliably performed or reconciled, documentation was incomplete or inaccurate, and multiple doses were removed from the emergency kit at once without proper tracking, leading to the identified deficiency in the facility’s medication management system for controlled substances.
