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Are USP <797> Compliance Rates Good Enough?

October 2015 : Cleanrooms & Compounding - Vol.12 No. 10 - Page #2

With the completion of this year’s study, we can now reflect on 5 years of compliance data—and the results are mixed. Certainly there has been real and measurable improvement in USP Chapter <797> scores in this study, but is it enough? We do not think it is, not nearly so. As such, we would like to take this opportunity to share our perspectives on compliance. Our thoughts are drawn from this and previous years’ study results; in addition, they are informed from the hundreds of emails, telephone calls, and visits we have conducted with sterile compounding personnel and regulators over the same time period.

Following the NECC compounding tragedy that killed 64 people and permanently injured hundreds more, we expected the response would be an enduring sense of urgency driving the implementation of improved sterile compounding practices. More recently, a federal grand jury handed down a 131-count indictment in the NECC case that encompasses crimes ranging from racketeering to mail fraud, as well as 25 counts of second-degree murder. One might expect this would bolster any fading sense of complacency; however, that does not seem to be the case. As Michael Cohen of ISMP has oft been quoted, “Unfortunately, there are too many in health care who feel that if it hasn’t happened to them directly, the adverse experiences of others do not apply.”

The lessons learned from this preventable tragedy (including the necessity of disciplined facility cleaning and environmental and personnel sampling and the imperative to take actions based upon those results) have yet to translate into change at the rate that we had hoped. In comparing this year’s compliance scores for hospitals (the largest cohort in this study) against the scores from 5 years ago, we see an overall improvement in compliance, with only a few exceptions (see Figure 1). Nevertheless, the 2015 data demonstrate that despite significantly greater regulatory and enforcement action (see Table 1), progress remains slow. Lagging compliance in what we believe are essential activities—such as aseptic technique, cleaning and disinfection, environmental sampling, staff training/competency, and quality metrics such as sterility testing, bacterial endotoxin testing, and filter integrity testing—is troubling.

Survey Bias
Though valuable, it is important to note that the data from the CriticalPoint USP <797> study contains an inherent bias. Those who participate are likely motivated to do so because they are either interested in benchmarking their organization’s performance or are incentivized by the Action Plan for Compliance they receive upon completing the survey. As such, the participating locations are likely to be committed to and engaged in the pursuit of improvement in sterile compounding practice. In addition, since this is a self-report study, we are certain that respondents’ answers do not always reflect their actual practice. On many occasions, we have asked pharmacies to complete a gap analysis in preparation for a visit or telephone consultation. When we follow up, we typically discover that the staff did not fully understand the gap analysis items or they indicated compliance in areas where their actual practices did not fully comply. In every single case, when we objectively verify scores with observation, the resulting scores are lower than originally reported.

Understanding the Data
It is important to look at these data with an understanding that the scores are likely to reflect higher rates of compliance versus actual practice. Overall, hospital pharmacies report a compliance rate of 80%. Considering that this translates into a B-: we need to decide whether we should accept this as good enough. Note that the items with the lowest or lagging compliance often are practice areas that may engender the most risk to patients.

USP Chapter <797> provides minimum practice and quality standards for compounded sterile preparations of drugs and nutrients based on current scientific information and best sterile compounding practices. When the American Society of Health-System Pharmacists published its Sterile Compounding Technical Assistance Bulletin in 1993, Kenneth E. Avis, often considered to be the father of good compounding practices in pharmacy, asserted, “This is not new science, but rather old news that few bothered to heed.” Similarly, many of the  <797> requirements have been in place for over a decade. Even the newest requirements of the chapter have been official for 8 years. Since 2001, the Sterile Compounding Expert Committee has been hard at work revising the chapter and the resulting updates are expected to be released for public comment in late 2015 or early 2016. Our hope is that you will join us in pushing for full compliance with the current version of the chapter. We need you to actively participate in the revision process and provide thoughtful feedback to the Expert Committee once the revised chapter is available for public comment. Your participation is imperative because what we are doing now is not good enough to ensure patient safety.

Kate Douglass, MS, RN, APN,C, CRNI, is the vice president of CriticalPoint, LLC, and serves as the codirector of the annual USP <797> Compliance Survey.

Eric S. Kastango, MBA, RPh, FASHP, is the president, CEO, and principal of Clinical IQ, LLC, and CriticalPoint, LLC. He also serves as the codirector for the annual USP <797> Compliance Survey.

Peter Cantor (COO and managing partner of CriticalPoint, LLC) is the study coordinator.


Address all correspondence to Kate Douglass at


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