Pharmacy OneSource Blog

The USP Gold Standard: How do your compliance initiatives stack up?

Posted on 03/30/17

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Value is the name of the game in healthcare today. At Wolters Kluwer, we pride ourselves on forward-looking innovation that keeps our clients one step ahead of industry movements. That’s why hospitals and health systems increasingly look to our Pharmacy OneSource solutions to help them respond to increased regulatory scrutiny and achieve performance improvement.

Specifically, state pharmacy boards, in tandem with national efforts by The Joint Commission, are placing heavier scrutiny on the sterile compounding processes—a critical component of care delivery in today’s hospitals. Yet, resource-strapped pharmacies often lack the staff expertise, leadership and training needed to comply with United States Pharmacopeia (USP) Chapter 797 and the recently published USP Chapter 800—the industry gold standards for quality performance in compounding.

Simplifi 797 is a comprehensive web-based quality management system that helps pharmacies address USP complexities and create sustainable quality management programs. Developed to address patient risk mitigation and USP compliance concerns, Simplifi 797 provides ongoing training, procedures and documentation to ensure pharmacy directors have confidence in the compounding process throughout regulatory inspections.

Advanced features and functionality differentiate Simplifi 797:

Customized Expert Guidance

A facility-specific quality assurance plan developed by Eric Kastango, MBA, BSPharm, FASHP, the leading expert in the field of sterile compounding, is provided that includes a complete set of 31 expert-based policies and procedures compliant with USP 797 and 800 as well as 25 well-tested forms. Batch-processing templates are available for storing recipes, compounding records and labeling.

Resource and Time Savings

Time-consuming manual workflows found in many pharmacies are replaced by an automated, electronic platform. This enables pharmacy staff to reduce the time spent on USP compliance processes, such as searching through paper-based batch logs if drug recalls occur. Many pharmacies using Simplifi 797 achieve a 50 percent reduction in the resources needed for USP compliance.

Staff Training 

The availability of CriticalPoint sterile compounding training increases staff competency and eliminates the need for pharmacy directors to design and maintain their own education programs. CriticalPoint partners with leading pharmacy boards, national organizations and subject matter experts to deliver the most comprehensive, ACPE-approved sterile compounding eLearning platform available. The training provides staff members with 33 hours of CE credit, directly linked to USP 797 and 800 standards, as well as the opportunity to demonstrate training validation through observational competency documentation.

Lengthy Data Storage and Reduced Cost of Ownership

Facilities that rely on paper-based logs are limited in the storage of vital documents that are required during regulatory inspections. Our ten-year data storage plan provides pharmacies immediate access to data required for accreditation and regulatory inspections. Healthcare facilities also realize a significant decrease in cost of ownership through the system’s Web-hosted platform, maintenance and updates.

Contact us today to learn how the Simplifi 797 quality management system can readily improve your compliance to both Chapter USP 797 and USP 800.

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Topics: Sterile Compounding

About the Author

Deb Oroszlan is the Marketing Director for Pharmacy OneSource - Wolters Kluwer.