What Happened
Tufts Medical Center in Boston agreed to pay $100,000 to settle allegations that negligent recordkeeping of its controlled substances violated the Controlled Substances Act, in a settlement tied to losses associated with three former nurses.
The government alleged that the hospital failed to maintain accurate inventories of controlled substances and associated records, failed to keep tight control of prescription pads, and failed to make the required reports to DEA about thefts or significant losses of controlled substances connected to three former nurses. The settlement, announced September 20, 2016 during National Prescription Opioid and Heroin Epidemic Awareness Week, resolved those allegations without a finding of criminal wrongdoing.
Tufts cooperated fully with the federal investigation once the violations came to light, agreed to permit DEA to perform warrantless administrative inspections of the hospital for three years, and implemented new recordkeeping procedures and physical security measures — including cameras and lockboxes — to prevent further diversion.
What Went Wrong
Recordkeeping and reporting gaps around three former nurses' access to controlled substances went unaddressed long enough to draw a federal settlement. Key failures included:
- Inaccurate controlled-substance inventories meant the hospital could not reliably reconcile what had been received, dispensed, and remaining on hand.
- Prescription pads were not tightly controlled, creating an avenue for diversion outside the pharmacy's direct custody.
- Suspected theft or significant loss of controlled substances tied to three former nurses was not reported to DEA within the required timeframe.
- Physical security measures such as camera coverage and lockboxes for controlled substances were not yet in place before the violations occurred.
How It Could Have Been Prevented
- Maintain accurate, continuously reconciled controlled-substance inventories rather than relying on periodic counts to surface discrepancies.
- Secure and log access to prescription pads with the same rigor applied to physical controlled-substance storage.
- Build a documented, time-bound process for reporting suspected theft or significant loss of controlled substances to DEA as required by the CSA.
- Install camera coverage and lockboxes for controlled-substance storage areas as a baseline control, not a post-settlement remedy.
- Audit departures of staff with controlled-substance access for outstanding discrepancies before their access is closed out.
Related Guidance
- Hospital Diversion Prevention Checklist — Hospital self-assessment, 8 sections 63 items, including inventory, recordkeeping, and DEA reporting controls.
- Camera & Surveillance Guide — Video retention and coverage practices for controlled-substance areas.
- DEA Form 106 Guide — Theft and significant-loss reporting obligations and timelines.
- Controlled Substance Inventory Requirements — Biennial inventory requirements and recordkeeping practices that surface losses.