UT Southwestern to pay millions for lax opioid oversight

UT Southwestern Medical Center must pay $4.5 million for failing to properly guard dangerous medications, including fentanyl that two nurses overdosed on inside one of its hospitals.

The penalty, imposed by federal law enforcement officials, is the second-highest of its kind against a hospital nationwide and the biggest in Texas, the U.S. Department of Justice said.

A Dallas Morning News investigation in 2018 found the nurses died from fentanyl likely intended for patients. Our reporting triggered a federal hospital inspection and a separate probe by the U.S. Drug Enforcement Administration and the U.S. Attorney’s Office for the Northern District of Texas.

“For years prior to our investigation, UT Southwestern exhibited an almost shocking disregard for its obligations under the Controlled Substance Act,” U.S. Attorney Chad Meacham said in a statement Tuesday. “The serial compliance failures we uncovered warranted a multi-million-dollar penalty and a stringent corrective action plan.”

Drug thefts at hospitals are typically met with requirements to improve record-keeping, DEA Dallas Special Agent in Charge Eduardo Chávez said in an interview. High-dollar penalties are rare, he said, and reflect the scope of UT Southwestern’s failures.

Investigators reviewed more than five years of records at UT Southwestern and found thefts of opioids such as fentanyl at Clements University Hospital, where the nurses died, and Zale Lipshy University Hospital, a smaller facility on campus. Some employees stole the medications for significant periods of time, investigators found.

Officials also found that UT Southwestern failed to keep thorough and accurate records of controlled substances and report thefts to the DEA.

As part of a settlement agreement, UT Southwestern admitted no legal liability, but acknowledged that its policies to keep track of controlled substances and report thefts fell short of federal standards.

UT Southwestern had made some security improvements before the DEA began its review of records, officials said. Even so, federal officials say more precautions are needed.

For three years, the school will undergo random audits of its drug inventory and must permit the DEA to inspect its facilities without notice or a warrant. UT Southwestern also agreed to install security cameras near cabinets that store controlled substances, share the footage with the DEA and improve training. It also must create a confidential hotline to report possible drug thefts and investigate physicians suspected of diverting controlled substances.

UT Southwestern declined an interview request Tuesday.

“UTSW acknowledges our failure to comply with regulatory requirements,” the school said in a statement. “We have implemented improvements to address identified deficiencies and ensure we comply with all relevant regulatory responsibilities.”

Two overdose deaths

The News’ investigation found that the two nurses, who worked at Clements, had overdosed in hospital bathrooms. At the time, UT Southwestern said it could not determine where the drugs came from.

Experts told The News that the deaths, just a year and a half apart, were alarming and suggested the hospital was not paying enough attention to its dangerous drugs.

Although government rules require hospitals to closely track and report missing drugs, hospitals can devise their own security measures. They are not required to report whether missing drugs are connected to an overdose or a death.

The hospital inspection prompted by The News found 31 instances of missing drugs that UT Southwestern had never reported to the DEA.

Inspectors found that nurse Patricia Norman, who died in 2016, had signed out medication for patients several times without fully accounting for how the drugs were used. Experts say that pattern can signal a caregiver is stealing the drugs and could have a substance abuse problem.

Although UT Southwestern reported that fentanyl had disappeared on the day Norman died, the school did not tell the DEA about the other missing drugs connected to her until early 2019 — after the hospital inspection. The university told The News it had not previously detected those medications. Norman also had been rushed to the emergency room at Clements for a suspected overdose about six months before she died.

Hospital inspectors also found UT Southwestern failed to report any missing fentanyl after nurse Iyisha Keller overdosed and died, even though her patient’s fentanyl IV bag didn’t contain the drug. An expert told The News that the lack of fentanyl suggested tampering, such as replacing the drug with another liquid.

Drugs came from hospital

Despite UT Southwestern’s contention that it could not determine where the drugs used by the nurses came from, the DEA and U.S. attorney’s office found that the medications had been taken from the hospital.

Meacham, the U.S. attorney, declined to say how investigators reached that conclusion. The DEA also found that after Norman was brought to the emergency room for an apparent drug overdose, UT Southwestern failed to fully investigate and didn’t refer her to drug counseling, restrict her access to controlled substances, or report her to the state nursing board.

The nurses are not named in the settlement agreement, but The News determined their identities based on details surrounding their cases.

While the DEA was investigating, UT Southwestern reduced the number of storage cabinets containing fentanyl, bought new computer software to track controlled substances and created a team to investigate missing drugs.

The only penalty higher than the one levied on UT Southwestern was $7.7 million, against a hospital company in Michigan this year.

Meacham said he was pleased with the $4.5 million payment.

“But we’re more happy with the compliance measures that are in place at UT Southwestern,” he said. “We hope other hospitals model their compliance programs after what’s being put in place there. And that everybody that has a vested interest in this problem continues to do all they can to address this horrible opioid epidemic we have in this country.”

Keller’s mother, Denise Keller, said she was pleased with the penalty but resents UT Southwestern’s lapses in securing dangerous drugs. Given the stress of working as a nurse, hospitals should take extra care to prevent easy access, she said.

UT Southwestern should have known better, Keller said.

“They did not protect the nurses and their staff from the drugs,” she said.