2012 USP 797 Compliance Study results have been released
The 2012 USP Compliance Study results have been released. To read the full article click here
The 2012 USP Compliance Study was completed in June 2012 and the results have just been published. Originally performed in 2011, the study was the largest and most comprehensive investigation of compliance ever undertaken. The ongoing USP Compliance Study is led by sterile compounding experts Eric Kastango, RPh, MBA, FASHP, and Kate Douglass, MS, RN, APN,C, CRNI. We believe that the information gathered and the insights gained from the data will be valuable to the industry, will inform compounding decision-making and will facilitate ongoing improvements to patient safety.
The 2012 USP Compliance Study used a sophisticated web-based Gap Analysis Tool which Eric and Kate developed and have been using in their assessments of sterile compounding practice at industry locations for several years. This tool was made available at no charge to all study participants. It should also be noted that ALL INDIVIDUAL FACILITY RESULTS ARE CONFIDENITAL - ONLY AGGREGATE DATA WAS USED IN THE STUDY REPORT.
In return for their participation, each participant received a highly-detailed Action Plan for Compliance with the Chapter that was automatically generated based on their answers to the survey items. The Action Plan provided can be used to begin or continue sterile compounding practice improvements at participants’ locations.
To participate in the 2013 USP Compliance Study send an e-mail to
and you will be notified in May 2013 when the Study cycle begins again. If you prefer, you can access the Gap Tool now by visiting www.797study.com and following the directions for registration.
USP <797> states “Personnel who prepare Compounded Sterile Preparations (CSPs) shall be trained conscientiously and skillfully . . . . . . . . before they begin to prepare CSPs. Compounding personnel shall perform didactic review and pass written . . . . testing . . . .initially, at least annually thereafter . . . . and semi-annually for high-risk compounding”
CriticalPoint is the only training company that meets or exceeds all of the training (and testing) standards specified in USP <797>. Our flagship Course in Sterile Compounding plus The Virtual CompounderTM contain 42 lessons designed specifically to teach and reinforce the necessary skills.
All of our courses are written by leading industry experts (including members of the <797> and NIOSH expert committees), and our courses always include the latest updates to the standards.
CriticalPoint courses are delivered over the Internet, offering convenient anytime/anywhere training. Our engaging, self-paced format makes it easy for your staff to learn and means that new hires don’t have to wait to get up and running. Plus, the testing after each lesson and our unique Virtual Compounder assure that your staff has mastered the required skills. Also, all of our courses are ACPE-approved, so your staff members receive the added benefit of earning up to 42 Continuing Education Credit Hours.
Our robust Learning Management System (LMS) takes the administrative burden off of you. Our comprehensive and flexible reporting system makes compliance tracking and audit preparation as simple as 1-2-3!
That’s why in an independent survey of 260 pharmacy directors, 100% of users rated CriticalPoint as Excellent or Good compared to 77% for the next highest-rated provider. (State of Pharmacy Compounding – 2009, Pharmacy Purchasing & Products, April, 2009). And why more than 800 sites in 15 countries, and over 6000 pharmacy personnel have used CriticalPoint for their training needs.
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CriticalPoint’s unique The Virtual Compounder® modules supplement key areas of your USP Chapter <797> training program. Expert authors have identified ten compounding skills that require specific process steps to be performed properly for effectiveness. Each module includes one hour of ACPE-approved CE credit.
The topics include:
- Personnel Garbing
- Cleaning Solution Preparation
- Cleaning the Primary Engineering Controls (Laminar Flow Workbench, Compounding Aseptic Isolator, Compounding Aseptic Containment Isolator, and Biological Safety Cabinet) (4 modules)
- Monthly and Daily Cleaning (2 modules)
- Hazardous Drug Spill Cleanup
- Volumetric Air Sampling
The Virtual Compounder® engages users to direct pharmacy personnel on the screen to perform process steps, learning and building competency in a simulated environment. This approach improves subject retention versus a single-method learning approach. See it in action.
For a complete list of lessons and learning objectives in The Virtual Compounder, CLICK HERE.
Our Flagship Program: The Course in Sterile Compounding
This program delivers the required training specified in USP <797>, along with testing to document learning. This didactic curriculum covers every topic in the USP Chapter <797> in five course modules:
- Basic Compounding Skills
- Environmental Sampling
- Compounding Practices
- Engineering Controls
- Hazardous Drugs
The entire program is completely up to date with the current revisions to USP <797>. Up to 32 hours of ACPE approved CE are available, and can be site-licensed or purchased on a per-seat basis.
The following screen shots give you an idea of what our modules look like:
1. Cleaning and Disinfection
2. Pre-Test with Feedback
3. Word Quiz
CLICK HERE for a complete list of lessons and learning objectives in The Course in Sterile Compounding.