Pharmacy OneSource Blog

A Case Study of USP 797 Compliance

Posted on 05/12/15

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Every facility involved in the sterile compounding process strives to maintain compliance with USP Chapter 797. Yet, because USP 797 is so comprehensive in its scope and detailed in its compliance rules, achieving a state of control and compliance poses a greater challenge than many compounding pharmacies expect. These pharmacies have discovered that trying to make their manual compliance process more efficient produces unsatisfactory results and many have turned instead to an electronic solution that streamlines processes and promotes greater compliance. One recent case study illuminates the value of such an approach to USP 797.

The magnitude of changes required to become compliant with USP 797's 60 pages of regulations daunted a Virginia-based medical center serving a seven-county area. In addition, the detailed regulations needed to be applied to job sites that had unique workflows. Pharmacy leadership formed a team to streamline the compliance processes and customize the technology to fit each location’s specific workflow needs. As a result, compliance, personnel competencies and accountability all improved.

Compliance gains

The team first deployed a web-based quality compliance solution to address compliance gaps. They found that the 25 forms and more than 30 expert-based policies built into the solution allowed staff to manage tasks and schedules through a user-friendly dashboard interface. Technology task automation reduced staff time associated with compliance by eliminating the need for manual tracking and paper-based documentation. Furthermore, because the system automatically sends notifications of overdue tasks, exceptions and out-of-range measurements, compliance improved.

Enhanced competency

The training program provided with the compliance package produced a degree of competency among personnel that would have been hard to achieve otherwise. Many organizations have only one person who is knowledgeable about the requirements of USP 797; this system provided all involved staff with unlimited, on-demand access to training, leading to a higher level of team competency.

Web-based training also relieved leadership of the need to continuously conduct training, as staff could access the training tools at a time and pace that suited their schedules and knowledge levels.

Mutual accountability

As the team developed the necessary skills to become USP 797 compliant, they also created a culture that values maintenance of compliance as the actively engaged employees hold each other accountable for performance and task competency. Staff now understand that compliance is not an endpoint, but an ongoing process.

After integrating the automated compliance solution into the medical center's operations, the team standardized compounding practices to ensure each identical production of each item, no matter who performed the compounding. This ensured both accuracy and compliance, but most importantly, it made the institution and its staff better patient-safety advocates.

What steps have you taken to improve USP 797 control and compliance?

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Topics: Sterile Compounding

About the Author

Tim McMenamin has more than 30 years of experience in the Hospital Information Technology (HIT) industry and has been an active member of HIMSS, ASHP, HFMA and other healthcare communities for many years. Leveraging emerging technologies to deliver clinical content to the point-of-care has been an area of special interest and research.