Yale University has agreed to pay a $308,250 settlement to resolve allegations that Yale failed to maintain complete and accurate records of the controlled substances it purchased and dispensed at the Yale Fertility Center. Additionally, according to the U.S. Attorney’s Office for the District of Connecticut, Yale allegedly failed to put in place effective controls and procedures to guard against theft and diversion of controlled substances.
The allegations arose after a nurse responsible for ordering and keeping a proper inventory of controlled substances at the Yale Fertility Center was found to have been tampering with vials of fentanyl in November 2020. A criminal investigation revealed that the nurse was extracting fentanyl from the vials and refilling them with saline and putting them back in stock to be used during surgical procedures.
A related civil investigation found 685 separate occasions where Yale allegedly violated federally mandated record-keeping requirements. An audit of the Yale Fertility Center’s inventory of controlled substances by the Drug Enforcement Administration (DEA) found discrepancies of 665 units of controlled substances, including vials of fentanyl, ketamine and midazolam.
The investigation also found that Yale did not maintain an initial inventory, failed to keep a record of the destruction of controlled substances and was unable to produce records for the purchase and sale of Schedule II controlled substances.
“This settlement highlights our office’s efforts to ensure compliance with the Controlled Substances Act,” U.S. Attorney Vanessa Roberts Avery said. “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.”
A Yale spokesperson said in a statement that the Fertility Center has since reviewed and updated its procedures to further the oversight of controlled substances.