Northeast Hospital Corp., part of Cambridge, Mass.-based Beth Israel Lahey Health, has agreed to pay $1.9 million to resolve allegations that it violated the Controlled Substance Act by failing to keep accurate records of opioids.
The Drug Enforcement Agency began investigating Northeast after it reported on March 22, 2018, that a staff member stole 17,846 dosage units of controlled substances, including fentanyl, Percocet and oxycodone, over more than a year, the Justice Department said in a Dec. 5 news release. Northeast discovered the diversion while updating its pharmacy operations and suspended the employee.
The settlement resolves allegations that Northeast's bookkeeping was not in compliance with the CSA. According to the settlement, Northeast ordered controlled substances under Beverly (Mass.) Hospital's DEA registration but transferred the drugs to other locations without notifying the DEA, which requires healthcare facilities to inform it about the transfer of controlled substances, even when transfers are among affiliated entities.
Northeast does business as Beverly Hospital, Lahey Outpatient Center Danvers, BayRidge Hospital in Lynn, and Addison Gilbert Hospital in Gloucester. All four of these Massachusetts locations are separately registered with the DEA to handle controlled substances.
The settlement also resolves allegations that Northeast's controlled substances inventory differed from what its records showed. In addition to voluntary improvements undertaken by Northeast — before and after the DEA investigation — Northeast agreed to further security and recordkeeping measures, according to the Justice Department.
The CSA requires accurate inventorying and tracking of controlled substances from the manufacturer to the end user. Recordkeeping requirements are designed to prevent the misuse of controlled substances and avoid overdoses or other harms.
"We are committed to ensuring the strongest possible safeguards for the handling of controlled substances and have robust policies and procedures in place, including anti-diversion software and strong audit and monitoring practices," a Northeast spokesperson said in a statement shared with Becker's Hospital Review. "After identifying concerning signs that pointed to drug diversion by an employee in 2018, we immediately notified the appropriate authorities and terminated the employee. We are grateful for the diligence and professionalism of federal law enforcement in this case."