In reviewing the summary findings of the 2016 USP <797> Compliance Study, it is clear that over the 6 years since this study began, there has been slow but measurable improvement in some specific areas of sterile compounding practice. Nonetheless, Chapter <797> has been in existence for over a decade and disturbing gaps in compliance still exist. The chapter sets the minimum standard for sterile compounding practice in the United States. It was, and still is, our belief that pharmacies would aspire at first to meet the requirements and then work to exceed the requirements. That has yet to happen for many facilities.
The current version of Chapter <797> will be replaced over the next year or two by an updated version with even more stringent requirements. This is concerning, as compliance efforts with the current version of the chapter in some important areas—such as high-risk level compounding, personnel and environmental sampling, sterility testing, and training—have demonstrated little or slow progress toward improvement. We believe that most pharmacies want to be better than average—better than a “C” operation—but how can we help you get there? What will it take?
The commentary that follows focuses on a few important areas from the 2016 USP <797> Compliance Study. We hope you will review the entire supplement and consider what practices your pharmacy can enact to ensure compliance with these minimum standards of practice.
Personnel and Environmental Sampling
Over the past 5 years, certainly there has been improvement in the domains that measure compliance with personnel and environmental sampling in hospitals (see TABLE 1). While we commend this progress, it has occurred at a rather sluggish pace. At this rate, it will take another 5 or 6 years before there is 100% compliance in gloved fingertip sampling and many years before we see full compliance in the other areas.
Under the current version of Chapter <797>, personnel sampling is only required upon initial hire and then every 6 or 12 months, depending on the type of risk level compounding that a pharmacy performs. Viable air sampling is required just every 6 months and surface sampling is required only periodically. These frequencies were considered a starting point by the expert committee when they were first included in the chapter. We believe that these frequencies are insufficient if the goal is to develop a quality system that effectively detects a drift away from a state of control, which can be identified and remedied before it causes patient harm. Proposed Chapter <797> increases the required frequency of these activities. In the proposed chapter, viable air sampling and surface sampling must be performed monthly, and gloved fingertip sampling must be performed initially and then quarterly during media fill testing.
Underscoring the importance of increased testing frequency, the CriticalPoint Center for Training and Research recently detected a serious microbial growth issue in our HVAC ductwork, which would have gone undetected had it not been for the weekly viable air and surface sampling that we conduct—a much higher frequency than required by Chapter <797>. We conducted our own investigation and added additional sampling, which ultimately facilitated a full-facility decontamination (this will be the subject of a future Webinar). Had we not committed to conducting more frequent sampling, it would have been at least 6 months before the growth became evident. Imagine the possible contamination issues should such an event occur in your facility.
Compliance with the current minimum requirements for environmental and personnel sampling of Chapter <797> cannot wait—nor can your patients.
High Risk Level Compounding
Although nonsterile to sterile compounding is performed in only 10% to 15% of pharmacies, the continued poor compliance with the items in each of the domains in TABLE 2 is troubling. This type of compounding is designated as high risk level because it requires focus and discipline to take nonsterile components and make them sterile. High risk level compounding is complex and requires specialized knowledge, equipment, and quality systems. Patients receiving high risk level CSPs may be at a higher risk of receiving CSPs with microbial contamination or content errors, especially if pharmacies dispensing these formulations are making them without the proper expertise and work practices.
It is disturbing that in every year since 2011, the hospitals that report performing high risk level compounding are a significantly smaller number than those that report using a 0.22 micron filter for the purposes of sterilization (see TABLE 3). The data should reflect opposite numbers. Sterilization by filtration is but a subset of high risk level compounding. Since these data have been consistent, it seems the only explanation is that pharmacies do not perceive sterilization by filtration to be a high risk level compounding activity.
These findings become even more troubling when examining the number of pharmacies that perform a filter integrity test after they have used the filter to sterilize a solution. The filter integrity test, also called a bubble point, is required to be performed each time a filter is used to sterilize a CSP (or batch). CSPs (or batches) sterilized by filtration may not be released and dispensed to patients until this test has been performed and the filter has passed. A filter integrity (or bubble point) test determines if the filter has maintained its integrity during the compounding process. Often a filter may be “blown” if there is too much pressure applied during the filtration process (eg, this can happen if the compounding staff member is in a hurry or if a pump is used on too high a pressure to push the solution through the filter). When the filter integrity test is not performed, then blown or defective filters go undetected. A filter that has been damaged during the process of filtration has no chance of actually sterilizing the solution. Despite the fact we have discussed this finding each year, the progress made in this domain has been negligible.
TABLE 2 summarizes the overall compliance for high risk content domains. Though the number of pharmacies answering these questions represents only about 10% of the total hospitals, these hospitals are performing high risk level compounding and, based on the responses, do not have the requisite knowledge to do so safely.
Compliance with the items in the Sterility Testing domain (see TABLE 4) continues to be poor, and the number of pharmacies performing sterility testing as required remains problematic. Since it is clear that not all pharmacies understand the conditions that require sterility testing, a survey question was developed to identify the existence of conditions that would require sterility testing (see FIGURE 1). Based on the data presented in FIGURE 1, 135 hospitals stated that at least one of the three conditions that requires sterility testing existed at their location. Most of those 135 hospitals (119) stated that there are times when the beyond-use dates assigned to CSPs exceeded the storage times published in Chapter <797>, whereas a smaller number stated they prepare high risk CSPs in groups larger than 25 or that they expose the CSPs to longer wait periods before sterilization than required.
It seems that hospitals do not understand that they are required to perform sterility testing, regardless of risk level, if the storage limits defined in Chapter <797> are exceeded. The entirety of Chapter <797> should be viewed as a quality management system. Technically, the storage limits allowed by the chapter are only permitted for pharmacies in compliance with all of the requirements of the chapter.
Only 37 of 135 hospitals perform sterility testing as required. The 37 that said they did perform sterility testing were asked some additional items (see TABLE 5) that were not asked of those locations that said they did not perform sterility testing. Of those who do perform sterility testing, it appears many do not have procedures in place to notify the physician or patient in the event of a sterility failure, nor do they have a written procedure for immediate recall of dispensed CSPs in the event of a sterility failure (whether or not they dispense “at risk”). This not acceptable.
Whether it is personnel sampling, environmental sampling, sterility testing, or other operational variances, it is not acceptable for pharmacies performing sterility testing to fail to take the required follow-up actions. On a larger scale, only 63% of hospitals report that there would be evidence of a consistent process that is triggered any time a desired patient outcome is not achieved, an Action Limit is exceeded, or other operational variance is noted, and appropriate follow up occurs to ascertain the effectiveness of actions taken to eliminate the problem. That finding has also remained consistent across the years. What is the point of conducting sampling and testing, or recognizing variances, if we are not using the information to improve practice and patient safety?
Staff Training and Competency Verification
Sterile compounding requires significant expertise and consistent work practices in order to achieve and maintain a microbial and operational state of control. The key component to accomplishing this is a knowledgeable and engaged workforce. The people who do the work every day require both a theoretical education and vocational training focused on the science behind the design and maintenance of primary and secondary engineering controls, proper aseptic technique and conduct in controlled cleanroom environments, and all work practices related to the operation. After staff receives education in the scientific rationale, they require guidance from detailed, written standard operating procedures, opportunities to practice those procedures, as well as initial and ongoing competency verification. One of the most frequent complaints we hear from both practitioners and inspectors is that there is a lack of meaningful and effective education for those performing and supervising the work of sterile compounding.
In addition to quality concerns, there are important economic reasons to train workers. Companies with poor staff training programs tend to have more negative findings and penalties from regulators.1 Conversely, companies with effective training are 66% more likely to report increased productivity, 150% more likely to improve the quality of their products and services, and three times more likely to report increased profit.1
A Louis Harris and Associates poll reported that among employees that identified poor training opportunities, 41% of those employees planned to leave their employer; among those who considered their company’s training opportunities to be excellent, only 12% planned to leave.2
If pharmacies want quality outcomes for their patients, they have to establish consistency in work practice. This does not happen by chance. Rather, it is the result of planned, disciplined work practices carried out by a highly educated and engaged workforce. That only occurs after the careful development of detailed policies and procedures, which are used to train staff. Furthermore, the outcome of the training must be objectively documented through testing and selected observational competencies.
The major cause of harm to all patients in health care is variation in how procedures and processes are carried out.3 When there is a lack of standardization, then by definition, the practice is not based on the best available evidence. So, please evaluate the data in TABLES 6 and 7 and ask yourself, are we doing the best we can?
Pharmacy-prepared sterile preparations continue to provide specialized care for patients. Entire industries, such as home infusion, are founded upon pharmacy sterile compounding. Recent events have demonstrated that the United States Food and Drug Administration has, and will continue to step into what was once the purview of the state boards of pharmacy. If pharmacy fails to meet accepted standards and regulations, it may lose control of its own practice. It is time to step up to the plate. A “C” is not good enough. Your patients deserve more and so does the profession.
Kate Douglass, MS, RN, 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 co-director for the annual USP <797> Compliance Survey.
Peter Cantor, who serves as the COO and managing partner of CriticalPoint, LLC, is the study coordinator.
CriticalPoint gratefully acknowledges the assistance of Nick Kastango, whose expertise using Tableau facilitated our ability to obtain and analyze the survey data in a much more efficient manner.
Address any questions to Kate Douglass at email@example.com.
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