DALLAS — The University of Texas Southwestern Medical Center will pay $4.5 million to resolve allegations that it failed to properly monitor controlled substances, including fentanyl, resulting in the fatal overdoses of two of its nurses in 2016 and 2018, the Department of Justice announced in a news release Tuesday.
This civil settlement for drug diversion is the largest sum paid in Texas and the second-largest in the country, the DOJ said.
Tuesday's news comes after a three-year-long joint DEA and U.S. Attorney's Office investigation following news of the two overdoses at UTSW's Clements University Hospital. The investigation was triggered after a 2018 Dallas Morning News report found the nurses overdosed on fentanyl likely intended for patients.
The DOJ alleges that over the course of five years UTSW violated multiple provisions of the Controlled Substances Act (CSA). These violations resulted in UTSW employees diverting controlled substances — including fentanyl — from UTSW’s Clements University Hospital and Zale Lipshy Pavilion. The DOJ says that the hospital failed to record the theft or significant loss of the drugs in a timely manner, a violation of the CSA and a violation of the hospital's obligations as a DEA registrant.
This resulted in the deaths of two UTSW nurses, one in 2016 and another in 2018, the DOJ claims. On Dec. 15, 2016, a UTSW nurse overdosed on fentanyl from UTSW’s Clements University Hospital and was later found dead in a hospital bathroom. On April 16, 2018, another UTSW nurse overdosed on opioids, including fentanyl, from the same hospital, and was later found dead in a different Clements Hospital bathroom, the DOJ says.
In addition to failing to report the loss of the controlled substances to the DEA in a timely manner, the DOJ says UTSW failed to properly report the the "dispensing and 'wasting' of controlled substances" and also made errors in forms documenting the ordering, receipt and distribution of controlled substances, which are all violations of the CSA.
UTSW's settlement agreement does not constitute an admission of liability, the DOJ says, but the medical center did publicly admit that theft and significant loss of controlled substances occurred at the two hospitals mentioned above and that they failed to notify the DEA of those losses in a timely manner and that some of the hospital center's policies were not in accordance with the CSA. UTSW cooperated with the investigation, the DOJ said.
UTSW cooperated with the DEA’s investigation, and started instituting changes before the settlement was reached, the DOJ said.
In a Tuesday news release, UTSW said that two of its nurses died from opioid overdoses at Clements University Hospital. After those deaths, the hospital center said it started reviewing its policies and procedures with consultants before the DEA investigation. UTSW said it fully cooperated with the investigation.
"As a leading health care institution, we are committed to meeting all legal and ethical obligations in every aspect of our operations, and specifically to following best practices in opioid stewardship, consistent with our broad commitment to maintaining a safe clinical care and workplace environment," UTSW said in the news release.
Tuesday's settlement includes the following steps for UTSW:
- The hospital center will hire an external auditor to conduct unannounced audits of controlled substances, with a focus on fentanyl, and must provide that data to the DEA
- The hospital center will institute a training center designed to help employees identify symptoms of addiction and signs of drug diversion
- The hospital center will start an employee compliance hotline for anonymous reporting of suspected drug theft or loss
- The hospital center will install security cameras at drug dispensing machines and will provide footage to the DEA upon request
- the hospital center will create a database of employees who have been discharged or have resigned because of drug diversion and will disclose relevant information upon request
- The hospital center will permit the DEA to enter UTSW facilities at any time without prior notice and without a warrant in order to guarantee compliance.
"We felt that the serial compliance failures we uncovered warranted a multi-million-dollar penalty and a stringent corrective action plan,” U.S. Attorney Chad Meacham said in the news release. “In this settlement agreement, we’re doing everything in our power to mitigate the threat of opioid diversion by outlining protocols above and beyond what’s required by law.”