UT Southwestern to Pay $4.5M For Opioid ‘Compliance Failures': DOJ

UT Southwestern Medical Center in Dallas will pay $4.5 million in penalties for failing to have adequate safeguards in place to prevent the diversion of dangerous drugs, including fentanyl, federal prosecutors say.

The settlement, announced Tuesday by the Department of Justice, comes after a three-year investigation into the medical center's handling of controlled substances and the overdose deaths of two nurses.

The UT Southwestern nurses died of overdoses of the painkiller fentanyl on the hospital's campus in December 2016 and April 2018, respectively, according to a 2018 investigation by NBC 5's media partner The Dallas Morning News.

The settlement is the largest ever for drug diversion in Texas and the second-largest in the nation, the Department of Justice said.

The investigation found that controlled substances were taken from UT Southwestern's Clements University Hospital and Zale Lipshy Pavilion.

"For years prior to our investigation, UT 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," U.S. Attorney Chad Meacham said in a statement. "We felt that the serial compliance failures we uncovered warranted a multi-million-dollar penalty and a stringent corrective action plan."

The action plan includes steps the medical center must take to improve the handling of potentially dangerous medications, including the hiring of an external auditor to conduct unannounced audits of controlled substances, instituting an employee training program and installing security cameras, among other measures.

"The University of Texas Southwestern Hospital has an obligation to keep the highest standard of care for their patients. They also have an obligation of internal safeguards to keep controlled substances from being diverted,” DEA Dallas Special Agent in Charge Eduardo A. Chávez said in a statement. "Opioids, like fentanyl, do not discriminate in its addictive properties when diverted or taken outside the direction and supervision of medical professionals."

UT Southwestern said it conducted its own investigation after the overdose deaths on its campus and came to similar conclusions to those of the Department of Justice.

Its own findings revealed UTSW did not fully comply with recordkeeping and reporting requirements when it came to opioids. The medical center said it hired additional staff, improved its technology and software, implemented stronger physical security measures and formed a team to investigate controlled substances.

"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," UT Southwestern said in a statement.

UT Southwestern Medical Center's full statement is below.

The national epidemic of opioid abuse and its tragic consequences manifested on the UTSW campus in 2016 and 2018, when in separate incidents, two nurses succumbed to opioid overdoses at Clements University Hospital. After losing these two members of our campus community, UT Southwestern engaged outside consultants to help review UT Southwestern policies and practices. This review identified opportunities to improve oversight of controlled substances in our health care facilities. In particular, it became clear that we had not fully complied with our recordkeeping and reporting obligations in dispensing opioid medication in our inpatient facilities as required by regulatory authorities. Similar findings were found in the course of an investigation subsequently launched and now completed by the U.S. Department of Justice and Drug Enforcement Administration (DOJ/DEA), with which UTSW fully cooperated.

As noted in today’s settlement agreement with the DOJ/DEA, prior to learning about their investigation, UTSW conducted a comprehensive compliance review of its controlled substances safeguards and procedures and invested significant resources to enhance these processes, including hiring additional staff, acquiring advanced technology and software, and implementing physical security controls like lockboxes and tamper-resistant IV tubing. In response to, and in collaboration with the DOJ/DEA’s investigation, UTSW has continued to strengthen its handling of controlled substances, including the formation of a Controlled Substance Investigation Team and the installation of security cameras to deter diversion of these substances within its facilities.

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.

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.