Hospital and health systems are facing an influx of increasingly rigorous and complex state and federal requirements related to United States Pharmacopeia (USP) Chapters 797 and 800. Accrediting and governing agencies regularly inspect compounding sites to ensure quality control, training and documentation practices are appropriately met. While resource-strapped pharmacies face challenges to complying with these standards, noncompliance places them at risk for significant financial impacts and reputational losses.
As such, healthcare providers must prepare ahead of time before errors in compounding processes occur. Quality management systems, such as Simplifi 797, provide the comprehensive framework needed to address the complexities of USP requirements as well as assist pharmacy directors with regulatory inspections.
Many factors are converging to bring USP compliance front and center as a priority. Here’s are six reasons why pharmacies need to invest in a quality management system now to improve the outlook:
1. Regulatory scrutiny
Introduced in 2004, USP 797 was the first enforceable sterile preparation compounding requirement. Due to various high-profile compounding discrepancies, multiple states are upping the ante on compliance with this standard. In addition, USP 800 was recently introduced to improve interactions with hazardous compounded drugs (HCDs), as well as provide guidelines on facility design, protective equipment, disinfection and administration. Hospitals leveraging Simplifi 797 can seamlessly address both USP regulations with compliance tracking functionality. The solution also equips pharmacy staff with easily accessible reports on trends and issues, ensuring proactive response and ongoing process improvement.
2. Patient safety
Compounding presents high potential for human error and a low rate of detection. Quality management systems like Simplifi 797 improve the outlook on patient safety by providing expert-based guidance and monitoring for potential risks. Real-time alerts equip staff at the point of care for any facility or system-level deviations from best practices. This ensures rapid response, elevating patient safety and lending to better outcomes.
3. Financial and Reputational Consequences
No hospital pharmacy wants to be tomorrow’s negative front-page headline. Recent high-profile incidents resulting in preventable patient harm and death have placed a spotlight on compounding operations. In fact, these high-profile events were the catalyst for greater scrutiny and regulation by national healthcare governing bodies and state boards of pharmacy. By leveraging the functionalities of a quality management system, facilities can navigate through compounding practices with ease to avoid the fallout of failed inspections or compounding errors.
4. Lack of Resources
Most pharmacies face budgetary constraints and increasingly demanding workflows, which makes compliance with complex USP requirements challenging at best. Often, facilities lack the necessary staff resources, time and leadership commitment needed to implement high-performing, sustainable compliance programs. Simplifi 797 streamlines these efforts by providing an automated framework for comprehensive quality management oversight and training. In fact, the solution typically reduces resources required for USP compliance by 50 percent.
5. Need for Standardized Best-Practices
Standardization of practice is critical for compliance. Hospital pharmacies often need expert guidance to establish standard operating procedures that inform the actions of staff. Simplifi 797 provides 31 policies and procedures written by industry experts that are continually updated to reflect changing regulations and best practices. The platform provides procedures as well as automated documentation that ensures all USP guidelines and tasks are efficiently completed. Along with this offering, pharmacies also receive a facility-specific quality assurance plan developed by Eric Kastango, MBA, BSPharm, FASHP, the leading expert in the field of sterile compounding.
6. Ongoing Competency Training
To address risk mitigation and provide optimal outcomes during state inspections, it is essential that staff is kept up to date through ongoing training. Pharmacy directors are often tasked with developing these training programs from scratch and maintaining them. Simplifi 797 alleviates this burden by providing access to CriticalPoint, a web-based comprehensive educational platform that includes 30 hours of sterile compounding continuing education. This ensures that staff members are empowered and equipped with the necessary tools to effectively perform tasks.
Simplifi 797 is a turnkey web-based quality management solution that provides policies, procedures, staff trainings and competency evaluations to simplify and automate the USP 797 and 800 compliance process. Based on the expert rules of trusted industry leader, Eric S. Kastango, the solution:
- enables 50% reduction in pharmacy resources needed to comply with USP standards
- identifies and helps mitigate ongoing risks
- eliminates hours of stressful pre-inspection preparation through immediate access to facility and system level data needed for accreditation and regulatory inspections
- ensures quality assurance and industry best practices
- standardizes training to make sure staff is integrating policies into practice
- provides easy access to reports on compliance trends
- ensures regular and consistent documentation of activities across all compounding sites and locations