DSCSA lot level requirements took full effect for dispensers on July 1. Like many other facilities, Cheyenne Regional Medical Center realized months before the deadline that they would need a streamlined way to manage compliance requirements and data.
Director of Pharmacy Timothy Steffen sums up their perspective when they first started thinking about this in January: “I wanted one solution to make it easy so my team isn’t wasting time, and I’m not getting constant phone calls from confused staff.” Sound familiar? If your organization is still evaluating how you’ll approach DSCSA, read on to find out why Steffen and this 222-bed facility choose a third-party compliance solution.
For some operational needs, Cheyenne Regional Medical Center relies on internal solutions. For instance, Steffen was brought in three years ago when Cheyenne chose to bring their pharmacy management in-house.
Cheyenne Regional briefly explored a homegrown solution when it came to compliance, also. As Steffen explains, “I contacted our IT department and had concerns about whether we had enough storage space to accommodate all the compliance data.” And resource factors went beyond just data storage. “We knew that we would need more staff to handle compliance data ourselves. That’s when we realized we couldn’t manage it in-house,” says Steffen.
Easy access to data
The biggest concern for Cheyenne Regional was having easy, reliable access to required information when they are receiving product or sending compliance documentation as part of a product loan.
The medical center purchases from 15 suppliers. Much of their product comes from one of the three major wholesale distributors, which provides portal access to compliance data. Steffen says that website is easy to use but goes down quite frequently, making it challenging to get information whenever you need it.
A reliable third-party solution can help prevent a negative impact on operations. “If your department constantly has to reach out to get and manage compliance documentation, then it could absolutely impact patient care. With the right tools where data is automatically captured, downloaded and searchable, that isn’t a concern,” explains Steffen.
It’s no surprise that
Plus, adhering to compliance raises a complex checklist of priorities, including:
- Is all documentation correct, and does it match the actual shipment?
- How do we store all this documentation for the required six years?
- For inquiries or inspections, how do we pull out the required documents in a timely fashion?
With so much to consider and so many procedures to adjust, it’s easy to see why Cheyenne Regional Medical Center wanted a compliance solution that streamlines processes and provides some built-in guidance.
While it can be tempting to go it alone or avoid compliance altogether, those aren’t really options with so much at stake. Failure to comply with DSCSA can lead to fines, suspension or revocation of license, and even potential imprisonment or civil penalties.
According to Steffen, “I don’t want that risk. No matter how much you think you know, there always seems to be some little nuance that will cause a surprise. Everyone is still trying to fully comprehend DSCSA and all the implications.”
In fact, Steffen wishes they’d started figuring out their compliance solution sooner. “There were a lot of people scrambling in June. We wanted a solution for the July