Hospitals and health systems are dealing with a new pharmacy reality – a steadily rising level of scrutiny coupled with stricter state and federal safety requirements related to sterile compounding. That's because the healthcare industry continues to raise the bar on USP 797 compliance as a result of several high-profile cases that caused preventable harm to patients in recent years.
For Sarasota Memorial Hospital, the risks associated with non-compliance are quite high since the Florida Board of Pharmacy has adopted USP 797 standards as requirements. As one of the largest health systems in Florida and the only hospital in the state to earn a five-star quality and safety rating from CMS, Sarasota Memorial has long focused on delivering high quality care that extends to the pharmacy.
As Sandra Prenosil, manager of pharmacy services at Sarasota Memorial, puts it: "Sterile compounding processes are a critical component of patient care as well as a top patient safety concern. It's very important that we achieve this higher standard of practice across all of our operations to avoid adverse patient events and provide the best care for our patients."
With 30 staffers involved in sterile compounding functions across multiple sites and facilities, Prenosil needed a streamlined method for standardizing processes across all operations. Because the state board conducts compliance inspections without notice, she has to be ready at a moment's notice to provide documentation and evidence of USP 797 compliance. And she needed a way to ensure that the required level of monitoring and staff competency is always achieved.
As an early adopter of USP 797, SMH used Simplifi 797 from Wolters Kluwer until 2013 when it was replaced as part of a bundled contract arrangement with another vendor. But the health system returned to Simplify 797 due to its comprehensive, superior functionality and customer service. The ease of documentation retrieval to support inspections was a key element in the decision to bring back Simplifi 797. Prenosil stresses both the importance of meeting USP 797 standards for patient safety and the need for a quality management system like Simplifi 797 to meet the goal: "The most important outcome is that a quality product is compounded and delivered," she says.
With the help of a quality management system, Sarasota Memorial Hospital has improved its sterile compounding practices and achieved compliance with USP 797 – a feat only 38 percent of US hospitals have managed so far.
