Extraordinary Compliance Requirements

Sovah Health has agreed to pay $4.36 million to settle claims that the hospital system violated the Controlled Substance Act. The violations occurred between 2017 and 2020 with two employees, in separate independent schemes, diverting controlled substances. Both plead guilty and are being sentenced to time in federal prison. By now, we are used to hearing about these cases and the resulting fines. We are also used to seeing resolutions that include putting in place additional security measures such as cameras, promptly reporting controlled substances losses, permitting the DEA to enter the facility at any time without warrant or prior notice, and additional physical controlled substance inventories or audits. Here is an agreement obligation I have not heard before, “..shall maintain a mandatory random testing program applicable to any Sovah Health employee with access to controlled substances. Each such employee shall be tested at least once every six months.” WOW!

If your facility lacks a comprehensive drug diversion mitigation and monitoring program, you leave yourself open to large-scale diversion which can translate into extensive fines, stringent obligations being imposed on your facility by the Court, costs associated with meeting those obligations, and potential harm to your patients and staff. Take action now to assess your program and close the gaps, or start a program if you don’t currently have one. Rxpert Solutions can assist you with an outside audit, developing a comprehensive audit, and we also provide Diversion Monitoring as a Service (DMaaS) for those of you who have a software surveillance program but don’t have the expertise or resources to maximize its use. Set up a consultation today.

Terri Vidals
Terri Vidals

Terri has been a pharmacist for over 30 years and is a drug diversion mitigation and monitoring subject matter expert. Her years of experience in various roles within hospital pharmacy have given her real-world insight into risk, compliance, and regulatory requirements, as well as best practices for medication and patient safety.

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