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Administrator
Posts: 578
Registered: ‎02-22-2010
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Join the 2012 USP 797 Compliance Survey

The 2012 USP <797> Compliance Study is now open, led by sterile compounding experts and Study Co-Directors, Eric Kastango, RPh, MBA, FASHP, and Kate Douglass, MS, RN, APN,C, CRNI.

First conducted in 2011, the study is the largest and most comprehensive study of USP 797 compliance ever undertaken in the United States. The study uses a sophisticated web-based <797> Gap Analysis Tool that Eric and Kate developed and have been using for the last several years. This tool is being made available at no charge to all study participants.

Participants in the study will receive a highly detailed Action Plan that is automatically generated based on the participant's answers to the survey. This Action Plan provides documentation that can be used to begin or continue sterile compounding practice improvements at your location.

The survey takes 60 to 90 minutes to complete but does not need to be completed at one sitting. All individual facility results are confidential - only aggregate data will be used in the study report. 

You can register for the study by going to www.797study.com and use Survey Code B797J. The survey closes June 30th.

Established Member
Posts: 4
Registered: ‎07-27-2010
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Re: Join the 2012 USP 797 Compliance Survey

I have a question concerning the gaptool study. Questions state:

1. At a minimum written competency evaluations on Hand Hygiene and Garbing (including gloved
fingertip/thumb sampling); Cleaning and Disinfecting, and Aseptic Technique as well as personnel
media-fill testing are successfully completed by all compounding staff (and supervising pharmacists)
initially and semi-annually thereafter.

1. There is evidence in the form of employee-specific documentation that media fill units have been
successfully completed initially (before compounding CSPs) and at least semi-annually thereafter.

 

<797> states:

Media-fill testing of aseptic work skills shall be performed initially before beginning to prepare CSPs and at least annually thereafter for low- and
medium-risk level compounding and semiannually for high-risk level compounding.

If we are in compliance with annual testing for low and medium risk compounding, we must answer no to the survey question as we do not test semi-annually. This is a failure point in the gaptool study. Or am I misinterpreting the survey question?

 

Thank you for your time,

Linda Ashley

Expert
Posts: 1,174
Registered: ‎02-23-2010
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Re: Join the 2012 USP 797 Compliance Survey

Linda,

 

Thanks from the question.  When you started the using the tool, there were a series of questions in the General Compounding Section that you were asked that helps the tool turn questions on and off.  The reasons that you are being asked if you are doing these activities twice a year is because the tool thinks you are doing high-risk level compounding. If you go back to the general compounding section of the tool, make sure you didn't check off that you perform high-risk compounding or any other activity that could be considered high-risk within the context of USP 797.   

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
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Established Member
Posts: 4
Registered: ‎07-27-2010
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Re: Join the 2012 USP 797 Compliance Survey

Thank you. I checked the High-risk as we have done that. We have a few people who take high -risk media fill tests semi-annually, and they are the only ones who would compound these preparations. The majority of our people only compound low and medium risk and are tested annually. I did not think I could answer yes for testing semi-annually when it did not include everyone. It might be less confusing to separate this question for low and medium risk vs. high risk as the rules differ. 

Linda Ashley