UT Southwestern to pay millions for lax opioid oversight

UT Southwestern Medical Center has to pay $ 4.5 million for failing to properly monitor dangerous drugs, including fentanyl, which two nurses overdosed in one of its hospitals.

The sentence imposed by federal law enforcement is the second highest of its kind against a hospital in the country and the highest in Texas, the US Department of Justice said.

A 2018 Dallas Morning News investigation found the nurses died from fentanyl, which was likely intended for patients. Our coverage sparked a federal hospital inspection and separate investigation by the US Drug Enforcement Administration and the US Attorney’s Office for the Northern District of Texas.

“For years prior to our investigation, UT Southwestern showed an almost shocking disregard for its Controlled Substance Act obligations,” US Attorney Chad Meacham said in a statement Tuesday. “The serial compliance errors we uncovered warranted a multi-million dollar fine and a rigorous corrective action plan.”

Drug thefts in hospitals are usually faced with requirements to improve records, said Eduardo Chávez, the special agent in charge of the DEA Dallas, in an interview. Large fines are rare, he said, and reflect the extent of UT Southwestern’s mistakes.

Investigators checked records at UT Southwestern more than five years old and found thefts of opioids like fentanyl at Clements University Hospital, where the nurses died, and at Zale Lipshy University Hospital, a smaller facility on campus. Some employees stole the drugs for long periods of time, investigators found.

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

As part of a settlement agreement, UT did not admit legal liability to Southwestern, but did acknowledge that its policies on tracking controlled substances and reporting theft did not meet federal standards.

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

The school will undergo random drug inventory reviews for three years and must allow the DEA to inspect its facilities without notice or warrant. UT Southwestern also agreed to install security cameras near closets that hold controlled substances, share footage with the DEA, and improve education. It also needs to set up a confidential hotline to report potential drug thefts and investigate doctors suspected of removing controlled substances.

UT Southwestern declined an interview request on Tuesday.

“UTSW recognizes that we have failed to meet regulatory requirements,” the school said in a statement. “We have implemented improvements to address any deficiencies we have identified and to ensure that we adhere to all relevant regulatory responsibilities.”

Two overdose deaths

Investigation of the news revealed that the two nurses who worked at Clements had overdosed in hospital toilets. At the time, UT said Southwestern had no way of knowing where the drugs were coming from.

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

Nurse Patricia Norman(Courtesy Jeri Van)

Although government regulations require hospitals to closely track and report missing medications, hospitals can develop their own security measures. You don’t need to report whether a missing medication is related to an overdose or death.

The News-sponsored hospital inspection found 31 missing drug cases that UT Southwestern never reported to the DEA.

Inspectors found that nurse Patricia Norman, who died in 2016, had issued medications to patients multiple times without fully considering how the medication was used. Experts say patterns can signal that a caregiver is stealing the drugs and may have a substance abuse problem.

Although UT Southwestern reported that fentanyl was gone the day Norman died, the school didn’t inform the DEA of the other missing drugs associated with it until early 2019 – after the hospital inspection. The university told The News that it had not previously discovered these drugs. Norman had been admitted to Clements emergency room about six months before her death on suspected overdose.

Nurse Iyisha Keller(Courtesy of the Keller family)

Hospital inspectors also found that UT Southwestern did not report a lack of fentanyl after Nurse Iyisha Keller overdose and died despite her patient’s fentanyl IV bag missing the drug. An expert told The News that the lack of fentanyl indicated tampering, such as replacing the drug with a different liquid.

Medicines came from the hospital

Despite UT Southwestern’s claims that it could not determine where the drugs the nurses were using came from, the DEA and US Attorneys found that the drugs came from the hospital.

Meacham, the US attorney, did not want to tell how investigators came to this conclusion. The DEA also noted that after being rushed to the emergency room for an apparent drug overdose, UT Southwestern failed to conduct a full investigation, refer her to drug counseling, restrict her access to controlled substances, or report her to the State Nursing Department.

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

During the DEA investigation, UT Southwestern reduced the number of storage cabinets of fentanyl, bought new computer software to track controlled substances, and assembled a team to investigate missing drugs.

The only penalty higher than that imposed on UT Southwestern this year was $ 7.7 million against a Michigan hospital company.

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

“But we’re happier with the compliance measures at UT Southwestern,” he said. “We hope that other hospitals will base their compliance programs on what is being introduced there. And that everyone with a legitimate interest in this problem continues to do everything possible to combat this terrible opioid epidemic that we have in this country. “

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