Systemic Failures in Controlled Substance Accountability and Availability
Penalty
Summary
The facility failed to maintain accurate control, accountability, and reconciliation of controlled substances for multiple residents over several months. One resident with a PRN order for oxycodone 30 mg was sent to the hospital after becoming unresponsive, hypotensive, and hypoxic. After the resident left the facility, two doses of this resident’s oxycodone were signed out on the controlled medication utilization record, including one dose documented by a nurse and another with an unreadable signature and time, even though the resident was no longer in the building. The resident’s MAR showed the last oxycodone dose administered earlier that afternoon, and there was no documentation supporting administration of the two later doses. The facility’s internal investigation could not determine who signed out the second dose, and the nurse identified as signing out at least one dose did not cooperate with inquiries. The facility also failed to ensure that physician‑ordered narcotic pain medications were available and properly supplied for two other residents, leading staff to repeatedly “borrow” controlled substances from other residents’ supplies. One resident with a scheduled oxycodone 15 mg order received doses documented on the MAR using another resident’s oxycodone 15 mg supply over several days, with at least 20 tablets signed out as borrowed by multiple nurses and the Unit Manager. Staff reported that it was common practice to borrow controlled medications when a resident’s supply ran out, often without notifying the DON, and they were unclear how borrowed medications were replaced or reimbursed. The DON acknowledged there was no policy for borrowing controlled substances, stated that nurses were not supposed to borrow medications, and could not produce records showing that the resident’s oxycodone had been reordered, delivered, or that the supplying resident had been reimbursed. Another resident with an order for oxycodone 10 mg PRN for pain had doses administered using two 5 mg tablets taken from a different resident’s oxycodone 5 mg supply, with documentation on that resident’s controlled substance accountability record indicating at least 12 tablets were borrowed by several nurses and the Unit Manager. The Unit Manager stated that the resident’s own oxycodone supply had been exhausted and that borrowing from another resident was common when medications ran out, despite the availability of a backup oxycodone 5 mg supply and without obtaining DON approval. The DON again reported no policy for borrowing controlled substances, was unaware of the frequency of borrowing, and could not provide documentation that the resident’s oxycodone had been reordered or that the supplying resident’s medication had been replaced. Over a five‑month period, monthly pharmacy storage audits conducted by the Consultant Pharmacist repeatedly identified systemic deficiencies in controlled substance management. These included missing nurse signatures on shift‑change controlled substance counts on multiple medication carts and halls, discrepancies between the number of doses signed out on controlled substance accountability records and the doses documented as administered on MARs for several residents receiving opioids and lorazepam, incorrect or unclear card counts, PRN controlled substances administered earlier than ordered intervals, and controlled substances wasted without a second nurse witness signature. The Consultant Pharmacist documented these findings on multiple monthly audit forms, noting ongoing issues with controlled substance documentation and reconciliation. The DON stated she was not aware of the specific controlled substance concerns cited in the audits, had not reviewed the monthly storage audit reports, did not perform full reconciliations of controlled substance records against MARs, and was unaware that nurses were wasting controlled substances without a second signature. The Administrator reported she was not aware of the audit‑identified controlled substance issues and stated that any such concerns should have been addressed by nursing leadership.
