Pharmacy OneSource Blog

The CriticalPoint USP 797 Compliance Study: Looking Backward and Forward

Posted on 10/18/17

CriticalPoint’s 2017 USP 797 Study Results: Why Don’t We Embrace Better Practice

Wednesday, November 1, 2017
12:00 noon Eastern

It happens every fall – CriticalPoint releases the results of their annual USP 797 compliance study. Once again this year, the results paint a picture that’s at once both hopeful and concerning. Considering the continued high profile of sterile compounding in the wake of incidents of preventable patient harm, and much closer inspection scrutiny, anything less than full USP 797 compliance should be unacceptable. But the data this year tells us once again that’s not the case.  USP 797 represents the minimum acceptable standard and still the industry falls short.

Last year, the USP 797 compliance study report began by noting the industry has shown slow but measureable improvement in some specific areas of sterile compounding practice since 2011. But it further notes that after ten years of USP 7979, several disturbing compliance gaps still exist. Last year’s study pointed to some specific areas of concern that hospitals should be addressing – personnel and environmental sampling, high risk level compounding, sterility testing, and staff training and competency. These four areas shared both lower levels of compliance coupled with increasing risk of harm from non-compliance.

Personnel and Environmental Sampling
Sampling was a key area from last year where hospital pharmacies clearly needed to improve. What progress the industry has demonstrated is slow, at a rate that won’t lead to 100% compliance in gloved fingertip sampling for another five years. While compliance has improved notably since 2011, it has slowed or flattened in the past few years in nearly all domains related to personnel and environmental sampling.

High Risk Level Compounding
While only about 10-15% of pharmacies perform nonsterile to sterile compounding, those that do showed a troubling lack of compliance. The 2016 study rates for bacterial endotoxin testing, steam sterilization and sterilization by filtration were not only lower than those reported in 2015, but lower than 2011 levels as well.

Sterility Testing
The data from 2016 showed that continued poor compliance, and gaps in even understanding what conditions require sterility testing at locations, seems to be an unresolved issue. In fact, sterility testing rates in the 2016 study were nine points lower than the previous year. Of those hospitals that do perform sterility testing, many have no procedures to notify doctors or patients of a sterility failure, nor a written procedure for recall of CSPs in the event of sterility failure.

Staff Training and Competency Verification
While data from last year shows 78% of hospitals comply with staff training and competency measurement, that represents just 4% improvement over the past five years. Considering that the major cause of harm to patients is variation in how procedures and processes are performed, the value of a highly educated, engage, and disciplined pharmacy staff should be clear.

We hope you’ll join us for our webinar unveiling the results of this year’s study. Eric Kastango, RPh, MBA and Kate Douglass, MS, RN, CRNI, will deliver an overview of the data and how it compares to compliance insights from the past two years.

View Webinar Recording

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