Session Information
2013 Summer Meeting
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What Has the Compounding Tragedy Taught Us?
Track:
Education Sessions (CE)
Program Code: 136-L05
Date: Sunday, June 2, 2013
Time: 8:00 AM to 9:45 AM EST
Location:
200 D, Level 2
PROGRAM CHAIR:
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Description
USP <797> is approaching ten years as a standard, yet compliance with all aspects is still not universal. Many health systems struggle with issues involving facilities, personnel, and monitoring. The recent quality issues with sterile compounding outsourcers have exposed the licensure and oversight weaknesses of these vendors and the significant reliance that hospitals and other healthcare providers have for their CSPs from outsource providers. There is a need for healthcare leaders to fully understand the pros and cons of outsourcing vendors and how to ensure the patient safety aspects of sterile compounding are in place.
LEARNER OUTCOMES:
- Develop plans to modify your clean rooms and segregated compounding areas and personnel testing programs per USP <797> requirements and list the resources available that should be used to support planning and service decisions.
- Differentiate viable and non-viable monitoring.
- Evaluate gaps in certification and quality reports that need to be investigated.
- Interpret the state and federal licensure challenges and how they apply to your setting.
- Review the findings of the FDA 483s issued to prominent outsource providers and how to use those findings in developing an audit program for outsource vendors.
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