Hospitals Pays $2M for Controlled Substance Recordkeeping

Northeast Hospital Corporation (Northeast), part of Beth Israel Lahey Health, has agreed to pay $1.9 million in civil penalties to resolve allegations that Northeast violated the Controlled Substance Act (the CSA) by failing to keep accurate records of controlled substances, including opioids.

The CSA requires accurate inventorying and tracking of each controlled substance in circulation, from the manufacturer to the ultimate user. The recordkeeping requirements are intended, in part, to prevent misuse of controlled substances and avoid overdoses or other harms.

Northeast does business as Beverly Hospital in Beverly, Mass.; Lahey Outpatient Center Danvers in Danvers, Mass.; BayRidge Hospital in Lynn, Mass.; and Addison Gilbert Hospital in Gloucester, Mass. Each of these four locations is separately registered with the Drug Enforcement Agency (DEA) to handle controlled substances.

The DEA began investigating Northeast after it reported on March 22, 2018, that an employee had stolen 17,846 dosage units of controlled substances, including fentanyl, Percocet, oxycodone, dextroamphetamine and MS Contin, over more than a year. Northeast discovered the diversion in the course of implementing improvements to its pharmacy operations and controlled substances accountability procedures, and promptly suspended the employee.

The settlement resolves allegations that Northeast’s recordkeeping was not in compliance with the CSA and its regulations. According to the admissions in the settlement, Northeast ordered controlled substances under Beverly Hospital’s DEA registration but subsequently transferred the location of those drugs to other Northeast locations, without notifying the DEA of such inter-registrant transfers. DEA requires that registrants notify the agency of transfers of controlled substances between registrants through filings with the DEA, even when transfers are among affiliated entities. The settlement also resolves allegations that, based on DEA’s audit of the controlled substances that Northeast had on site, Northeast’s actual controlled substances inventory differed from what its records showed should be present.

As part of the settlement, in addition to the improvements undertaken by Northeast voluntarily, both before and after the DEA investigation, Northeast has agreed to additional security and recordkeeping measures.