Category: Professional Posters
Purpose: In 2017 as part of the preparation for the new USP 800 and revised USP 797, a large multi hospital health system completed a USP 797 and 800 gap analysis for all pharmacy sterile compounding areas. The information collected in this activity was used to determine the level of adherence to the USP standards, identify next steps, and develop action plans necessary to create a compliant sterile compounding pharmacy enterprise with the goal of 100% compliance by the enforceability date of December 1st, 2019.
Methods: Information collected from the gap analysis activity was compiled into system level trend documents and presented to the health system board of directors to gain capital budget approvals for construction necessary to address the facility design deficits. Entity specific finding were distributed to site level pharmacy managers for review and action. Construction prototypes were developed for cleanroom design with input from the pharmacy leadership group and USP content experts. A multidisciplinary system level USP steering committee was created to guide action, vet solutions, and promote standardization in practice throughout the system pharmacies. System level policies were enacted to support the standardized compliance expectations. Subcommittees; the Assessment of Risk Workgroup and the USP 800 Taskforce, were created to approve and standardize the new processes and work practices the USP 800 Chapter will require. Continuous readiness surveys were developed and completed to review local entity USP 797 and 800 related practices. Action plans are created for each site from these surveys. The surveys are completed for all sterile compounded product preparation areas at least annually and reported out to the USP Steering Committee.
Results: In 2018 a survey tool was developed and executed to assess compliance rates, overall USP 797 compliance at UH was 85.2%. We reassessed compliance in the first quarter of 2019 and showed an 8.5% increase in compliance, the overall 2019 average USP 797 compliance rate for UH is 93.9%.
In 2018 the overall compliance for USP 800 practices was 66%, while USP 800 facility requirements was 64%. The 2019 survey for USP 800 practices will be redone one year after the initial assessment, in September 2019. The 2019 USP 800 facilities survey shows 100% compliance for areas that have construction complete.
Conclusion: The initial gap assessment was completed in 2017. A number of pharmacy sites require the construction project completion before they will be able to achieve 100% compliance with either USP 797 or USP 800 chapters. The system construction project in on track and set to complete in November 2019. With the conclusion of the system level construction project and the standardization work completed within the multi-hospital multidisciplinary USP committees, the health system is on track to demonstrate 100% compliant pharmacies.