SOVAH Health will pay millions to resolve Controlled Substances Act violation claims

ABINGDON, Virginia (WDBJ) – A hospital system in southern Virginia has agreed to pay the United States $ 4.36 million to resolve complaints related to violations of the Controlled Substances Act.

According to the U.S. Attorney’s Office for the Western District of Virginia, SOVAH Health has also agreed to be subjected to a four-year period of increased compliance and oversight during which any failure to comply with its obligations may result in contempt for the findings of the court. These results could lead to further financial penalties and injunctive relief.

SOVAH Health operates a hospital with two campuses, one in Danville and another in Martinsville. SOVAH Health was formed in 2017 when the campuses of what were then known as the Danville Regional Medical Center and Memorial Hospital in Martinsville and Henry County merged.

Representatives from the US Attorney’s Office say claims that SOVAH is paying to address the regional health system’s inability to prevent the diversion of prescription pain relievers opioids. In a press release, the office said that from 2017 to 2019 a SOVAH pharmaceutical technician in Danville diverted more than 11,000 controlled substances in Schedule II. From January to May of 2020, the office said a second employee, a nurse from Danville, tampered with fentanyl and injectable hydromorphone vials, replacing them with saline and diverting the controlled substance.

In a statement from the U.S. Attorney’s Office, representatives said the U.S. said that SOVAH Health has not provided effective controls and procedures to protect itself from diversion of controlled substances, fulfilled orders for controlled substances without a system in acted to reveal suspicious orders for controlled substances, and failed to maintain readily recoverable records of controlled substances.

“As opioid overdose deaths skyrocket, it is critical that healthcare companies are held accountable when they fail to effectively safeguard these powerful prescriptions within their facilities,” said US Attorney Christopher R. Kavanaugh for the Western District of Virginia. “The oversight provided by this resolution will ensure future compliance involving these important but potentially deadly substances, and the US Attorney’s Office for the Western District of Virginia will continue to vigorously pursue these cases with our federal and local partners in order to protect the communities of Virginia. “

“Today’s agreement sends a clear message to all registrants that it is essential to maintain effective controls to prevent diversion of controlled substances,” said Jarod Forget, DEA Washington Special Agent in charge. “DEA is committed to fighting the problem of prescription drug abuse in Virginia and across the country and to holding all DEA registrants accountable.”

“The FDA oversees drug delivery in the United States to ensure patients receive safe and effective drugs,” said Acting Special Agent George A. Scavdis of the FDA’s Office of Criminal Investigations Metro Washington Field Office. “We will continue to protect public health by holding healthcare companies accountable for failing to safeguard their prescription drug inventory and thereby compromising the health and comfort of their patients.”

“With opioid deaths and overdoses at record levels, especially throughout Southside Virginia, there must be zero tolerance for trusted health care professionals engaged in drug diversion,” said Colonel Gary T. Settle, Superintendent of Police. of the state of Virginia. “For the safety and security of Virginia’s communities, our Virginia State Police Special Drug Diversion Agents, in conjunction with our local and federal public safety partners, will continue to aggressively pursue investigations relating to the illegal distribution of fentanyl and other prescription drugs. “

According to the US Attorney’s Office, this settlement resolves SOVAH’s potential civil and criminal liability based on the investigation. As part of the resolution, the SOVAH also undertakes to make changes to maintain compliance with the Controlled Substances Act. Include, but are not limited to, having cameras in all automated dispensing machines to capture controlled substance entry / removal activity; timely reporting of leaks and diversion of controlled substances; adopt and report the disciplinary measures adopted against employees held responsible for the theft, diversion or loss of controlled substances; maintain a mandatory program of random drug testing for employees; and conduct a complete physical inventory of all federally scheduled II-V controlled substances more frequently than required by law.

US Assistant Attorneys Justin Lugar and Randy Ramseyer have represented the United States in this matter. The investigation was conducted by the Food and Drug Administration – Office of Criminal Investigations, the Drug Enforcement Administration – Roanoke Resident Office Diversion Group and the Virginia State Police.

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