The 2018 CriticalPoint
USP <797> Compliance Study Results
Filter Integrity Testing (Bubble Point)
High Risk Compliance Subset - Primarily Hospital Data
Deeper Dives into Selected Domains and Items
Image retrieved on October 16, 2018 from Updates on Compounding Standards.
Table of Contents
High Risk Domain Data
Bacterial Endotoxin Testing
Domain Compliance Data
High Risk Gloved Fingertip and Media Fill
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High Risk General Data
Overall <797> Compliance
Environmental Monitoring and Personnel Sampling
This is the eighth and final year of the current CriticalPoint compliance reporting on the 2008 version of USP Chapter <797> Pharmaceutical Compounding – Sterile Preparations. The proposed revisions to the chapter were published in 2015 and again this year after a second round of public comment. It is expected that the final version of the revised Chapter <797> is to be published in its final format on June 1, 2019 and enforceable as of December 1, 2019 (at the same time USP Chapters <795> and <800> are also expected to be official and enforceable).
Note to CriticalPoint Compliance Study Participants:
CriticalPoint is currently working on a revised gap analysis and resultant action plan items that will reflect the final version of the revised chapter which USP expects to publish in its final format in June 2019. The revised CriticalPoint gap analysis will go live in August of 2019 so pharmacies and other entities can make objective measurements of their compliance with the revised chapter and take actions resulting in compliance by December 2019.
Figure 1: Previous Participation in Compliance Study by All Participants (N=640)
The number of locations participating in the study was down this year. There were 686 locations that completed at least 90% of the 797 items which is roughly 50% less than prior years. This is not an unexpected finding. Since the first proposed revision to <797> was published in 2015, we have found that the existence of a proposed version seems to divert concentration away from compliance with the current and enforceable (2008) chapter. Though this phenomenon has been observed before, we believe this last three-year period during which three versions of USP <797> have been in the public domain has resulted in confusion, uncertainty and a lack of focus on complying with the current version of the chapter. Not only do the data support this, but we have observed this with conversations with consulting and live training customers. Despite this, we were happy to see that about half of the participants in this year’s study were doing so for the first time (Figure 1).
All demographic and non scored findings can be found elsewhere in this paper
It is important to remember that the USP Chapters on Compounding, including USP <797> are intended as the minimum level of acceptable practice. Yet a decade later there are continuing areas of significant noncompliance. Has there been improvement? Yes, there has, and we will highlight some of those areas however there continue to be troubling areas where progress is slow. Most of the compliance lags relate to work practices that require a deeper level of understanding and integration of USP <797> as a sterile compounding quality system. Compliance is not just “checking a box” or adding specific activities because the chapter says so. All the requirements in the chapter serve a purpose, and USP 797 is intended as an integrated and formal quality system where processes, procedures and responsibilities for achieving quality objectives are completed and documented. The quality system “helps coordinate and direct an organization’s activities to meet customer and regulatory requirements (patient safety and compliance) and improve its effectiveness and efficiency on a continuous basis.”[i]
[i] American Society of Quality. What is a Quality Management System (QMS)? Retrieved 10/16/2018.
[i] American Society of Quality. What is a Quality Management System (QMS)? Retrieved 10/16/2018.
Selected General Demographics and Non Scored Findings of Interest
As in all other study years, the largest cohort in the study were hospitals with Home Infusion providers as the second largest cohort (Figure 3). Three locations were identified as FDA registered entities and it is difficult to understand why these locations would participate in this study since USP <797> is not relevant to 503B or other FDA registered operations. They are governed by draft FDA guidance documents and Current Good Manufacturing Practices (CGMPs).
This report focuses on hospital group findings since they are the largest cohort and therefore these data may have better validity than other groups. Since this is a self-report study, it is biased toward higher compliance scores. Those who chose to participate are assumed to be those who are actively engaged in complying with <797>. Self-report studies can present other disadvantages. Image management can skew answers as locations answer the way they are supposed to answer especially when these are used as report cards and shown to upper management. Any self-report study is limited by the extent to which participants understand the self-evaluation items as well as their ability to objectively evaluate their operation’s compliance. CriticalPoint attempted to minimize these issues by rewarding those who answered that they are not in full compliance with each item, with a detailed Action Plan intended to provide specific and focused recommendation to assist their organization in achieving compliance. Locations who fully disclosed areas of noncompliance therefore got more detailed and complete action plans for remediation.
It seems too that increased scrutiny of <797> compliance from regulatory authorities and accreditation bodies may be driving continued improvement. Though both hospitals and non-hospitals report that the single most influential factor driving their pursuit of compliance with USP <797> is that it is a standard of practice that should be implemented, forty-six percent (46%) of participants reported that concern about State Board of Pharmacy or other regulatory or accreditation sanctions were most influential in driving their sterile compounding compliance (Figure 2). Over the years the percentage of hospital locations reporting that some “entity had negative findings about their sterile compounding” has risen from 14% in 2011 to 29% in 2016 and has increased annually to 32% and 36% in 2017 and 2018. Figures 3 and 4 show selected domain compliance scores for all participants based on whether they reported negative findings by regulatory and accreditation entities versus no negative findings. It appears that negative findings from these types of organizations may prompt improvement in work practices which translate to higher compliance scores.
Figure 2: Respondents by Practice Settings (N=684)
Figure 3: Most Influential Factor in Hospital Pursuit of USP Sterile Compounding Compliance (n=485)
Figure 4: USP <797> Overall High-Risk Domain Compliance by Presence of Negative or No Negative Findings
Figure 5: USP <797> Overall Selected Domain Compliance by Presence of Negative and No Negative Findings
Figure 7: Work Practices Fall Below the Requirements of <797> (N=505)
Two new non scored items were added to the study this year to try to get an overall sense of where participants felt they were relative to meeting the core requirements of <797>. Figures 6 and 7 summarize these data. Most respondents (58%) reported that they do not exceed <797> requirements in any of the areas listed and this is consistent with what we have observed at client locations and through feedback in live training classes. Similarly, only thirty-nine percent (39%) of participants report their location does not fall below <797> requirements in any area. Nineteen percent (19%) said they exceed chapter requirements in hand hygiene and garbing which is not consistent with our observations. We have noticed many facilities opting for “bunny suits” instead of gowns thinking they exceed the chapter only to learn that the bunny suits may not be donned correctly and that other aspects of garbing are not in compliance. In consulting and live training observations, we have noted consistently that the way sterile gloves are donned is problematic and/or is performed using highly error-prone methods. As a result, CriticalPoint is modifying its Sterile Compounding Boot Camp curriculum to address this and other garbing shortcomings to allow attendees more time to practice these critical skills.
Figure 6: Work Practices Exceed the Requirements of <797> (N=505)
Figure 8: USP <797> Compliance by Year
There has been significant improvement over the last 10 years, however the pace of improvement to achieve compliance with minimum practice standards is slower than expected. Though the current version of USP <797> is not as specific as most in the profession would like, there are many great articles, presentations and tools available for free in the public domain to help achieve compliance. Listed below are the 10 domains in which hospitals had the highest compliance scores in 2018, but only the first 6 listed have compliance scores in the 90th percentile or more.
Figure 9: Overall Self-Reported USP <797> Hospital Compliance by State
Quality Management: Non-Viable Particle Testing (performed by certifiers)
Single and Multiple-Dose Vials
Final Release Checks
Temperature and Humidity Monitoring
Viable Air Sampling (most often performed by certifiers)
Beyond Use Dating
Personnel Media-Fill Challenge Testing
Hand Hygiene and Garbing Cleaning and Disinfection
Cleaning and Disinfection
General Compliance Improvement Trends
Though improvement in overall USP <797> has increased for all providers and specifically for hospitals each year (as shown in Figure 8), at this rate it would take until 2023 to achieve 100% compliance by those participating in the study (and remember that those who choose to participate are more likely to be highly engaged in compliance with <797> than those who don’t and therefore reflect higher than average scores). CriticalPoint hopes that the rate of compliance improvement may increase with the improved clarity and specificity demonstrated in the 2018 Proposed Revision to Chapter <797>. Figure 9 depicts overall <797> hospital compliance by state but these data are limited in generalizability based on the number of participants in each state.
These data can be reviewed in detail in individual charts and graphs later in this publication, but Figure 10 depicts non high risk hospital domain compliance by year. Interestingly, even though these domains have realized the most improvement over the last 8 years of CriticalPoint compliance data, 5 of the 10 remain in the 10 lowest non high risk domains for hospital compliance. How do we work toward better compliance with the key concepts of contamination control (hand hygiene and garbing, material handling and conduct in cleanrooms), cleaning and disinfection, environmental monitoring and personnel sampling? All these requirements are directly tied to patient safety.
· Gloved Fingertip Sampling
· Airflow and Pressure Differentials
· General Viable Air and Surface Sampling Considerations
· Surface Sampling
· Environmental Sampling Program
The other five domains demonstrating the lowest compliance for hospitals include:
· Quality Management General
· Equipment Calibration
· General Facility Design
· Training and Competency Measurement
· Low Risk with 12-hour BUD (this will be eliminated in next year’s study)
Listed below are domains that have realized the greatest improvement in percentage of hospital compliance based on CriticalPoint data from 2011 through 2018. It is interesting to note that of these, though there has been significant compliance improvement, the overall compliance scores for many of these critical work practices is still well below 90 or 95% after 10 years that the chapter has existed (2008 version):
1. Gloved Fingertip Sampling (improved 41% but is at 83% hospital compliance)
2. Viable Air Sampling (improved 32% and achieved 90% hospital compliance)
3. Airflows and Pressure Differentials (improved 30% but is at 80% hospital compliance)
4. Incubation (improved 25% but is at 84% hospital compliance)
5. General Viable Air and Surface Sampling Considerations (improved 24% but is at 80% hospital compliance)
6. Surface Sampling (improved 24% but is at 81% hospital compliance)
7. Environmental Sampling Program (improved 19% but is at 82% hospital compliance)
8. Primary and Secondary Engineering Controls (improved 15% and has achieved 92% hospital compliance)
9. Cleaning and Disinfecting (improved 12% but is at 80% hospital compliance)
10. Hand Hygiene and Garbing (improved 11% but is at 86% hospital compliance)
Figure 11: Hospital Item Compliance for Quality Management General Domain
*2019 USP <797> will address and significantly change these domains
The Heart of the Matter…
So, the previous information highlighted the significant improvements made in some sterile compounding work practices in the last decade. The authors believe that despite these improvements the profession seems to have reached a plateau. We need to take a step back and re-evaluate how we change our mindset and oversight of sterile compounding. Figures 11 through 16 highlight some examples of the continued challenges to compliance. They illustrate a common thread which is the failure to surrender (or some would say the active resistance) to fundamentally change the way we operate our sterile compounding operations. It’s time to strip the isolated work practices that have been layered on top of our existing system and establish a truly integrated quality system that achieves compliance during the natural completion of the activity required by <797>.
The General Quality Domain remains the lowest non high risk compounding domain for hospitals. Figure 11 explores individual domain elements of compliance further. These and other activities in the figures that follow demonstrate that compliance lags in the areas where systematic implementation of the sterile compounding quality system has not occurred. We need to integrate operational-wide sterile compounding quality systems rather than implementing isolated work practice changes, thus building quality into the CSP and not inspecting into the CSP.
Figure 10: Non High Risk Hospital Domain Compliance by Year
Figure 14: Hospital Compliance by State with Item from Figure 13
Figure 13: Hospital Item Compliance for QA/PI Plan that includes specific monitoring and evaluation activities, details on how results are reported and delineation of persons responsible.
Figure 12: Hospital Item with Requirement for a Written QA/PI Plan that considers all aspects of sterile compounding including but not limited to environmental sampling and testing
Figure 16: Hospital Compliance by Year for Item in Figure 15
 American Society of Quality. What is a Quality Management System (QMS)? Retrieved 10/16/2018.
So, what next?
So, are those performing sterile compounding doing better? Yes, absolutely. But are we doing enough to protect the patient? We need to understand that the chapter has identified the core activities designed to achieve a minimally safe operating system. We know that the chapter is here to stay and is about to be improved. The forthcoming chapter will be easier to read, clearer and more specific in many areas that were ambiguous or confusing. The future of compounding practices demands real, meaningful implementation of an integrated quality system where responsibilities for practice and outcomes are delegated and communicated through written standard operating procedures. We need to do more than just “check the box.” We need to understand that compliance ensures a consistent and stable environment and work practices that minimizes the patient harm risk associated with compounded sterile preparations. Physical plants and work practices need to be crafted with efficiency, contamination control and accuracy as outcomes. It can be done but only by embracing the importance of this aspect of pharmacy practice which includes sterile compounding that integrates the concepts of quality control and quality assurance activities in the routine day-to-day activities. The data and information generated by compliance can be used, trended, and analyzed to continually improve sterile compounding quality and therefore patient safety. Providing our most important assets (sterile compounding staff) with dynamic, specific and meaningful training based on evidence-based, written, and detailed standard operating procedures will help them be successful and promote ever-improving patient care. Staff must know the “why behind the what” of the chapter and additional best practice recommendations. We know that our understanding of science changes over time and we learn after analyzing adverse patient events. Let’s learn from the past, understand where we are today, but pledge to move forward by fully embracing all the elements of the chapter so we can fulfill our promise to patients.
Figure 15: Hospital Item Compliance for Evidence of a Consistent Process any time a desired patient outcome is not achieved, Action Level exceeded, or other variance is noted. Appropriate follow up occurs to evaluate effectiveness of actions taken to eliminate the problem.
2018 Compliance Study Facts
995 locations registered to take one or both compliance studies
470 locations took both 797 and 800 items
236 limited responses to 797 items only
194 limited responses to 800 items only
95 answered non-chapter questions only
As in previous years, CriticalPoint limits reportable respondents to those who completed at least 90% of the questions they were required to answer (respondents are presented with differing items based upon how they answer demographic, general compounding and other non scorable items)
There were 686 locations that completed at least 90% of the required 797 items (roughly 50% less participation than in 2016 when there were 1185 total surveys completed at least 90%). We believe that focus on compliance with the current chapter is waning since the 2015 Proposed Revision and the 2018 Proposed Revision have been published.
Deeper Dive into Selected Domains and Items
High Risk Compliance Subset
Primary Hospital Data
High Risk Gloved Fingertip and Media Fill Compliance
Filter Integrity Testing
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