Springfield, Ga.-based Effingham Health System has agreed to pay $4.1 million to resolve allegations that it failed to provide procedures to protect against theft and loss of controlled substances, leading to opioid diversion, according to a statement released from the health system May 16.
The health system also allegedly failed to report the suspected diversion to the Drug Enforcement Administration in a timely manner. It is the country's largest penalty settlement of its kind, according to WTOC-TV.
The DEA began investigating Effingham Health System in 2017 after receiving reports of diversion.
"DEA determined that tens of thousands of oxycodone 30mg tablets were unaccounted for and were believed to have been diverted over more than a four-year period, in violation of the hospital's responsibilities under the Controlled Substances Act," a release from the U.S. Attorney's Office obtained by WTOC-TV stated.
"DEA also determined that Effingham Health System failed to notify DEA of the suspected diversion within the time required by federal law," the statement reads.
Effingham's statement said the health system "cooperated with the DEA's investigation and, prior to this investigation, overhauled its pharmacy operations to help ensure that it will avoid diversions in the future."
The statement said Effingham cooperated with DEA and the U.S. Attorney's Office to develop a plan to address the deficiencies in how the health system handled controlled substances.
The components of the plan include quarterly internal accountability audits and requirements to keep detailed records that track all controlled substances within the hospital, according to the statement.
"We appreciate the cooperative nature of the United States Attorney's Office and Drug Enforcement Agency, for recognizing the efforts put forth since 2016 to improve pharmacy operations," said Fran Baker-Witt, RN, CEO of Effingham Health System. "We were dismayed to find, through this investigation, vulnerabilities in our prior record- keeping and reporting systems."
"This settlement is not an admission of liability, but in the spirit of cooperation, it has allowed us to avoid extensive legal expenses and costs related to an ongoing investigation," the statement reads. "It assures that an ongoing investigation will not interrupt, or compromise, the care we provide our patients."
Over the last two years, the health system has been transforming protocols, including hiring new pharmacy leadership and implementing electronic inventory systems that protect order integrity, track inventory and dispense medications.