Let This Be Your Wake-up Call

October 2014 : Cleanrooms & Compounding - Vol.11 No. 10 - Page #2

Since 2011, the National USP <797> Compliance Survey has measured the degree of self-reported compliance by pharmacies performing sterile compounding. Given that USP Chapter <797> is now 10 years old and enforceable by 22 state boards of pharmacy, the study investigators hoped this year would bring significant compliance improvements in all areas. The study results do indeed demonstrate an upward trend in overall compliance for both the overall population and the hospital cohort; however, many important, individual compliance requirements realized little or no progress. We worry that a phenomenon known as normalization of deviance is at work (an in-depth discussion follows below).

This year we opted to present the data in a slightly different format with selected results depicted through either tables or graphs with commentary explaining developing trends and practice impacts. Readers of 2011 and 2012 study findings were provided with free resources, including forms and policies and procedures, along with detailed recommendations on how to address those areas of non-compliance that posed significant risks to both patients and employees. Based on this year’s survey results, these resources continue to be applicable and remain available to assist facilities in implementing compliant sterile compounding practices (see Table 1). 

Resources Provided

Hazardous Drug Risk Acknowledgement Form

Sample Gloved Fingertip/Thumb Sampling P&P 

2011 USP <797> Compliance Survey Results 

2012 USP <797> Compliance Survey Results 

2013 USP <797> Compliance Survey Results 

Compliance Challenges
Despite the good news that these data, however inflated through the self-report mechanism, do show gradual improvement in overall compliance scores, the number of items for which hospitals have achieved at least 90% compliance is not increasing. There are also many individual items where improved compliance has not been achieved (see page S14). Now 10 years on, a revision to USP Chapter <797> is expected to be available for public comment later this year. Pharmacy’s hesitance to adopt voluntary standards of practice has been well documented.1-3 Since 2004, pharmacists have had a federal standard and yet most of the requirements outlined in USP <797> establishing minimum sterile compounding practice have yet to be fully adopted by the hospital community. 

Normalization of Deviance
In her book, The Challenger Launch Decision: Risky Technology, Culture, and Deviance at NASA,4 Diane Vaughan investigates the series of events that led up to the ill-fated decision to launch the Challenger space shuttle. As part of her explanation of the event, she describes a phenomenon called normalization of deviance, or the gradual acceptance of performance results that are outside normal acceptance criteria. An examination of how normalization of deviance occurs and what can be done about it are concepts that are useful to explore in today’s safety culture. 

As Mike Mullane, a former astronaut and recipient of the NASA Space Flight Medal explains on his website (http://mikemullane.com/stopping-normalization-of-deviance/), when a burn-damaged O-ring (a criticality 1 deviance) was first observed following the second shuttle mission, NASA was under enormous schedule pressure. They convinced themselves the problem could be fixed without grounding the fleet, as is normally required for a criticality 1 deviance. Several subsequent missions flew without O-ring issues so NASA let that stand as validation of their decision not to ground the fleet. Over the next several years, more cases of O-ring sealing problems were observed in the returned boosters, but as each flight was deemed successful, the false feedback reinforced that it was safe to continue flight operations. To put it plainly, since nothing bad happened, this was incorrectly interpreted as an indication that the team’s actions were safe. In truth, it was pure luck that a disaster had not occurred. Since the NASA team had not experienced any repercussions after accepting the criticality 1 deviance many times, the deviance was normalized into the team’s decision-making process. 

The sterile compounding community would do well to ask themselves if the same issue is occurring in their sterile compounding practice. Remember that NECC was performing environmental sampling at intervals more frequent than required by chapter <797>; however, they failed to examine, analyze, and act upon those results. The 2014 USP <797> Compliance Study data show that only 61.8% of hospital locations state that they have a logical plan to re-evaluate the adequacy of personnel work practices, cleaning procedures, operational procedures, as well as air filtration efficiency until resolution of air or surface sampling action level results are achieved. The good news is that the 61.8% reflects a 20.4% improvement since 2011. But, how long will it take for all sterile compounding practices to comply with all aspects of the minimum standard of practice? Do the other 38% of locations feel a lack of urgency to implement such procedures since—as far as they are aware—nothing bad has happened yet?

NECC’s lack of response to clearly out-of-limit surface and air sampling findings was one of the critical mistakes that led directly to the deaths of 64 people and the ongoing suffering of over 687 more.5 Nonetheless, fewer than three-quarters of hospitals are performing viable air and surface sampling, and of those that do, many do not have any defined method of analyzing the results and then taking effective steps to remediate and resample. Something is not right.

The data from the study seem to bear out a sentiment often expressed to the study directors when talking with sterile compounders: “We are mostly there” or “We are good enough” is commonly shared. Perhaps the phenomenon of normalization of deviance is at work here. Understand that the NECC event was a wake-up call for pharmacy. The FDA continues to be uncomfortable with many aspects of pharmacy compounding; in addition, the FDA believes that <797> does not impose sufficient quality standards. It is time for all sterile compounding operations to become 100% compliant with this minimum standard of practice now—before we have other NECCs and the future of pharmacy compounding is put unretrievably at risk.

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

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

Address correspondence to Kate Douglass at kdouglass@criticalpointce.com


  1. Kastango ES, Bradshaw BD. USP chapter <797>: Establishing a practice standard for compounding sterile preparations in pharmacy. Am J Health Syst Pharm. 2004;61:1928-1938. 
  2. Morris AM, Schneider PJ, Pedersen CA, et al. National survey of quality assurance activities for pharmacy-compounded sterile preparations. Am J Health Syst Pharm. 2003; 60:2567-2576.
  3. Santell JP, Kamalich RF. National survey of pharmacy-prepared sterile products in hospitals and home infusion facilities-1995. Am J Health Syst Pharm. 1996.53:2591-2605.
  4. Vaughan D. The Challenger Launch Decision: Risky Technology, Culture and Deviance at NASA. University of Chicago Press; London and Chicago, 1996.
  5. Centers for Disease Control and Prevention. Multistate Outbreak of Fungal Meningitis and Other Infections-Case Count. http://www.cdc.gov/hai/outbreaks/meningitis-map-large.html. Accessed on September 4, 2014.


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