Hospital’s Failure to Keep Proper Records Results In $2 Million Civil Fine
JUL 26 -- (Indianapolis) St.Vincent Hospital of Indianapolis has agreed to pay the United States $2 million to settle alleged record keeping deficiencies regarding its receipt and storage of controlled substances at its clinic pharmacy. According to United States Attorney Susan W. Brooks, St. Vincent Hospital will pay $1,200,000.00 within 30 days of entry of the consent decree, and $800,000.00 will be deferred pending the hospital’s compliance with federal regulations within the next year.
The records discrepancy was uncovered during an investigation conducted by the Indianapolis DEA District Office. The investigation revealed that St. Vincent Hospital failed to keep accurate records and make accurate reports under the laws designed to safeguard the public against diversion of the most abused classes of legally manufactured and prescribed drugs. St. Vincent was unable to account for thousands of Hydrocodone tablets, a Schedule III opioid analgesic narcotic sold in tablet form. The narcotic is highly addictive and often diverted to the black market from legitimate sources.
The DEA’s investigation began in October 2005 when it was alleged that Hydrocodone was being stolen from the hospital pharmacy by a pharmacy technician, Dianne Hauss. An audit conducted by the DEA at St. Vincent Hospital pharmacy, as well as their offsite clinic pharmacy in May 2006 revealed a shortage of 623,861 Hydrocodone/Apap tablets. The audit also revealed numerous record keeping and security violations. The investigation subsequently led to the arrest and conviction of Dianne Hauss and her son Mark Hauss, and both were sentenced in February 2007. A third defendant, Mark Cook, has been charged federally with one count of conspiracy to distribute a Schedule III controlled substance, and is currently awaiting trial.
“The diversion of legitimate drugs for non-medical use is no laughing matter,” stated Gary G. Olenkiewicz, the Special Agent in Charge of DEA’s Chicago Field Division which covers Indianapolis. “It is the responsibility of any DEA registrant to maintain accurate records and safeguard controlled substances. It is DEA’s responsibility to investigate and bring to justice anyone not in compliance with the Controlled Substances Act. We will continue working with our law enforcement partners as well as the US Attorney’s Office to investigate and prosecute these cases.”
In 1970, Congress enacted the Controlled Substances Act (CSA), Title 21, United States Code, Section 801 et seq., to create a “closed system” of distribution for controlled substances in which every facet of the handling of the substances – from manufacture to consumption by the ultimate user – was to be subject to pervasive government controls. The law is designed to prevent the diversion and abuse of legitimate controlled substances, while at the same time ensuring an adequate supply of those substances needed to meet the medical and scientific needs of the United States. DEA Diversion Investigators (DIs) are responsible for addressing the problem of diverted controlled pharmaceuticals and regulated chemicals from the legitimate channels in which they are manufactured, distributed and dispensed. The mission of a DI is to aid the pharmaceutical and chemical industries in complying with the CSA and other pertinent acts, as well as international treaties and conventions. DIs conduct investigations to uncover and investigate suspected sources of diversion and take appropriate criminal, civil and/or administrative actions.
The St. Vincent Hospital investigation was conducted by investigators from the Indianapolis DEA, the United Drug Task Force, and the Hamilton/Boone County Drug Task Force. The prosecution was lead by Assistant U.S. Attorney Thomas E. Kieper for the Southern District of Indiana.