The University of Texas Southwestern Medical Center has agreed to a $4.5 million settlement to resolve claims that the medical center failed to properly secure controlled substances including fentanyl.

The settlement comes after a three-year-long joint investigation by the DEA and the US attorney's office. The investigation was prompted after two nurses were found dead at UTSW’s Clements University Hospital. One nurse was found dead in a University Hospital bathroom on December 15th, 2016, after having overdosed on Fentanyl. On April 16th, 2018, another UTSW nurse was found dead in the same hospital after having overdosed on opioids.

According to the Department of Justice, over a five-year period, UTSW violated several provisions of the Controlled Substance Act. Because of these violations, employees were able to get a hold of the controlled substances including fentanyl.

The Department of Justice details that some of the violations of the Controlled Substance Act included a failure to report the stolen opioids to the DEA in a timely manner. UTSW also failed to report the “dispensing and ‘wasting’ of controlled substances.” The University Medical Center was also careless in ordering, documenting, and distributing the controlled substances according to investigators.

U.S. attorney Chad Meacham shared, “For years prior to our investigation, U.T. Southwestern exhibited an almost shocking disregard for its obligations under the Controlled Substance Act, enabling some employees to steal and abuse prescription narcotics – including powerful synthetic opioids such as fentanyl. We felt that the serial compliance failures we uncovered warranted a multi-million-dollar penalty and a stringent corrective action plan.”

Although the settlement does not serve as an admission of guilt on the part of the University, UTSW has taken it upon themselves to admit that they were careless and negligent in adhering to the Controlled Substance Act. Following the news of the settlement, the University Medical Center shared a statement that read in part, “The DOJ/DEA investigation has now concluded with a settlement agreement in which UTSW acknowledges our failure to comply with regulatory requirements and the payment of a fine based on the government’s findings. We have implemented improvements to address identified deficiencies and ensure we comply with all relevant regulatory responsibilities.” UTSW adds, “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.”

Following the death of the nurses, UTSW conducted their own investigation into how their controlled substances were stored and accessed. Their findings concluded that UTSW did not fully comply with opioid-related recordkeeping requirements. As a result of their investigation, the medical center explained that they hired additional staff, implemented stronger security measures, and even updated technology and software to remedy the situation.

In addition to the $4.5 million fine, the University Medical Center will adhere to the following requirements as well:

• Hiring a third-party auditor to conduct regular random audits
• Implementing a training program that would help employees have greater knowledge of symptoms related to addiction. The training programs will also help workers know the signs of diversion and what the threat of diversion means to personal care and professional reputation.
• Install additional security cameras.
• Implement a database that details employees who had resigned or were discharged because of drug diversions.
• Allowing DEA agents to enter a UTSW facility at any time without a warrant or prior approval or notice.