Sterile compounding, a critical component of hospital care delivery, has come under greater scrutiny in recent years following high-profile mishaps causing preventable patient injury. In response, the industry continues to up the ante on compliance with the United States Pharmacopeia (USP) 797 guidelines—the accepted standard that defines minimum practice standards for compounded sterile preparations.In truth, sterile compounding is one the pharmacy’s riskiest functions and must rank high within any hospital’s quality management and patient safety strategy. Today, more than ever, healthcare organizations must exemplify a strong sense of strategic direction to comply with state and federal compounding mandates and achieve higher standards of practice.
State of Industry Compliance
USP 797 compliance is a key focus of most state board inspections and accreditation surveys. Despite the significant financial and reputational consequences that can occur from nonadherence, overall USP 797 compliance remains elusive with only 38 percent of facilities reporting full compliance, according to Pharmacy Purchasing & Products’ 10th annual survey of compounding practice. Further, three out of 10 facilities reported that a patient incident involving a compounding error had occurred in their institution over the past five years. Larger facilities reported a higher rate of these incidences.
The Business Case for Investing in USP Quality Management Solutions
To align high standards of practice with an organization’s strategic direction, healthcare executives must overcome barriers preventing USP 797 compliance. Typical challenges include a lack of resources, competency, time and leadership support, and the prevalence of manual, paper-based workflows exacerbates the situation. For these reasons, the business case for investing in a web-based quality management solution, like Simplifi 797®, is an easy one to make. The system’s comprehensive approach to USP compliance addresses standard operating procedures, training needs, processes and documentation.
Staff can seamlessly comply with mandates through the availability of expert consultations and policy and procedures pre-configured for program use. Plus, continual system updates give managers confidence that activities reflect changing regulations. In particular, Simplifi 797 documents the completion of essential tasks noted in USP guidelines. These compliance tracking capabilities generate trend reports and analysis by activity, compounding area or facility. Managers can then evaluate and identify potential risks and initiate timely responses to deviations from quality assurance plans.
Improving Staff Competencies
Empowering compounding staff with continuing education opportunities is an essential component to maintaining an effective strategic direction. Written by industry experts, Simplifi 797 provides users with unlimited access to CriticalPoint, a comprehensive eLearning platform for USP 797 and USP 800 adherence. The training is approved by Accreditation Council for Pharmacy Education (ACPE) and includes 22 hours of sterile compounding continuing education credit. The platform can report site-specific recommendations for additional staff training, ensuring staff competencies align with high performance.
Achieving Reduction in Required Resources
As healthcare costs continue to rise, organizations must also integrate innovative resource-saving solutions to achieve higher standards of practice. By investing in web-hosted quality management solutions, pharmacies realize significant savings by reducing expenditures associated with ownership and updating. Additionally, Simplifi797 provides a 10-year data storage plan, eliminating the need for paper-based storage and ensuring efficient, hassle-free access to needed information when undergoing accreditation and regulatory inspections. Notably, facilities that have implemented Simplifi 797 have realized a 50 percent reduction in resources required to achieve USP guidelines.