Yale University, Controlled Substances Act Violations, Connecticut 2023

Yale University Agrees to Pay $308,250 to Resolve Allegations of Controlled Substances Act Violations

Yale University, on behalf of Yale Medicine and the Yale Fertility Center, has entered into a civil settlement agreement with the federal government in which it will pay a total of $308,250 to resolve allegations that it violated civil provisions of the Controlled Substances Act.

The Yale Fertility Center, a fertility medical practice located on Yale University's West Campus, in Orange, Connecticut, is operated by Yale Medicine, the clinical practice for the Yale School of Medicine, and a component of Yale University.

The settlement resolves allegations that Yale failed to maintain complete and accurate records concerning the controlled substances it purchased and dispensed at the Yale Fertility Center, and failed to provide effective controls and procedures to guard against theft and diversion of controlled substances.

In November 2020, Donna Monticone, a nurse responsible for ordering and inventorying controlled substances at the Yale Fertility Center, was discovered to have tampered with vials of fentanyl. The fentanyl was kept at the Yale Fertility Center for patient use during out-patient surgical fertility procedures.

A criminal investigation revealed that Monticone stole the fentanyl for her own use. She withdrew the fentanyl from the vials, reinjected saline into the vials and reintroduced the vials into the stock of the Yale Fertility Center to be used during surgical procedures.

In March 2021, Monticone pleaded guilty in federal court to tampering with a consumer product. A related civil investigation identified 685 separate occasions in which the record-keeping requirements of the Controlled Substances Act were allegedly violated by Yale.

The DEA's audit of the Yale Fertility Center's inventory of controlled substances revealed discrepancies of 665 units of controlled substances, including vials of fentanyl 100mcg, ketamine 10mg, and midazolam 2mg. The investigation also found that Yale failed to maintain an initial inventory, failed to keep a record of destruction of controlled substances, and was unable to readily produce DEA e222 forms, which are required records for purchase and sale of Schedule II controlled substances.

Source: https://www.justice.gov/usao-ct/pr/yale-agrees-pay-308k-resolve-allegations-violations-controlled-substances-act