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USP 797 Training Requirements: A Case Study A summary of the process used by Swedish Medical Center (Seattle, WA) to meet the personnel training and evaluation requirements for USP 797. |
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Abstract This paper summarizes the process used by Swedish Medical Center in Seattle, WA to comply with the personnel training and evaluation in aseptic manipulation skills required by the United States Pharmacopeia (USP) Chapter <797>. Given the multiple requirements for USP 797 compliance, Swedish pharmacy management quickly made the decision not to build a new process from scratch. Instead, they enhanced their existing program by purchasing the commercially available Valiteq products. The conclusion through the Swedish experience is that a quality USP 797-compliant training and evaluation program can be implemented with minimal effort when built around commercially available products. Introduction USP Chapter <797> was released in January 2004, creating a new (US) national standard for sterile preparation. This standard is intended to describe the current best practice for quality assurance in sterile compounding in an effort to improve patient safety and reduce the number of adverse events related to sterile compounding activities. The Joint Commission for Accreditation of Healthcare Organizations (JCAHO) has adopted these standards for use after July 1, 2004. Individual State Pharmacy Boards are also including the standards in their inspections. USP 797 is an evolving document that is subject to continuous refinement and updates. Refer to the USP Web site1 and the JCAHO Perspectives newsletter2 for current guidance on the regulations. Facility Overview The Swedish System3 in Seattle, WA includes 697 licensed beds on the main First Hill campus, 163 beds at its Ballard campus and 436 beds on the Medical Center’s Providence campus, as well as a large Home Care Services division. Internationally recognized specialties at the Medical Center include many types of surgery, cancer treatment through the Swedish Cancer Institute, and cardiac care at the Seattle Heart and Vascular Institute. Swedish is affiliated with more than 2,000 physicians representing every medical and surgical specialty and sub-specialty. Last year, more than 39,000 surgical procedures were completed at Swedish Medical Center. |
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STAR Center for Pharmacy and Cleanroom Skills Training Now Open Baxa Corporation recently launched its state-of-the-art STAR (Skills Training, Academics and Resources) Center for pharmacy and cleanroom skills training. Baxa designed and built the STAR Center as a fully USP 797-compliant pharmacy cleanroom to provide professional education on pharmacy practice, cleanroom principles and compliance to regulatory requirements. The STAR Center, the only dedicated facility of its kind in the world for hands-on cleanroom experience and training in environmental monitoring and aseptic technique, provides a unique opportunity for industry professionals to learn best practice from subject-matter expert trainers. |
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Baxa, a customer-focused medical device company, provides innovative, solution-based technologies for fluid handling and delivery. Its systems and devices promote the safe and efficient preparation, handling, packaging, and administration of fluid medications. Key products include Rapid-Fill™ Automated Syringe Fillers, Exacta-Med® Oral Dispensers, MicroFuse® Syringe Infusers, Repeater™ Pharmacy Pumps, and Exacta-Mix™ and MicroMacro™ Multi-Source Compounders; used worldwide in hospitals and healthcare facilities. Privately held, Baxa Corporation has subsidiaries and sales offices in Canada and the United Kingdom; direct representation in Austria,Belgium, Denmark, Finland, France, Germany, Luxembourg and The Netherlands; and distribution partners worldwide. Link to ASHP Guidelines on Handling Hazardous Drugs Link to details about Baxa Corporation's CD: 'What’s Next For USP 797?' Link to the Baxa Corporation website |