NEW HAVEN, Conn. (WTNH) — Yale University, on behalf of Yale Medicine and the Yale Fertility Center, will pay the federal government $308,250 to resolve allegations that the fertility center violated the Controlled Substances Act, according to Connecticut U.S. States Attorney Vanessa Roberts Avery.
The fertility center, located on the university’s Orange campus, faced allegations that it did not maintain “complete and accurate records” about the controlled substances it purchased and dispersed, and also failed to have effective controls and procedures to prevent theft, according to the announcement.
“This settlement highlights our efforts to ensure compliance with the Controlled Substances Act,” Avery wrote in the announcement. “Healthcare providers’ obligations to keep accurate records and safeguard access to controlled substances are key to prevent diversion of these powerful drugs, and to ensure the safety of our community.”
The allegations came after a nurse, Donna Monticone, who was responsible for ordering and inventorying substances, was accused in 2020 of tampering with fentanyl when she stole the drug for her own use, according to the announcement.
She pleaded guilty in March 2021 of tampering with a consumer product.
An investigation uncovered 685 times that Yale violated the Controlled Substances Act, according to the announcement. An additional audit of the fertility center also found discrepancies of 665 units of controlled substances. Those included fentanyl, ketamine and midazolam.
The center did not maintain an initial inventory, didn’t keep a record of the destruction of controlled substances and wasn’t able to immediate produce required forms.
“Yale deeply regrets the distress suffered by some of its patients when a former nurse at the Yale Fertility Center diverted pain medication intended for patient procedures,” a statement from the university reads. “After Yale discovered the nurse’s misconduct, it removed her from the Center, alerted law enforcement agencies, and notified patients who might have been affected. The Center also reviewed its procedures and made changes to further oversight of pain control and controlled substances.”