Initiated in 2011, the United States Pharmacopeia (USP) Chapter <797> Compliance Survey was developed to evaluate the degree of compliance in the United States to the sterile compounding requirements in USP Chapter <797>. It was hoped that by asking pharmacists and technicians to measure their facility’s performance objectively against the requirements of the chapter, a definitive operational baseline would be established and thus create a known state from which to measure progress and change in practices nationwide.
The survey was repeated in the second quarter of 2012 and results from both surveys were compared to quantify the change in compliance rates between the initial survey and this year’s survey. In addition, new questions were added in 2012 to obtain attitudinal data about the chapter and challenges to compliance. The results demonstrate that although there was some incremental compliance improvement in several areas, it was less than anticipated. 2011 survey participants received targeted information and resources based on their survey responses in an effort to address specific areas of non-compliance that posed significant risks to employee and patient safety. These areas were work practice-related for which practice improvements could be implemented without significant financial impact. These resources provided in PP&P’s October 2011 issue (ie, Gloved Fingertip Sampling Form and HD Acknowledgement of Risk Form) appear to have increased compliance for those activities, particularly among the facilities that participated in both the 2011 and 2012 surveys.
Despite the incremental improvements in a few of the key chapter requirements, there continue to be many opportunities to achieve improved compliance with the chapter. Financial constraints/budgetary limitations and physical plant challenges were cited as barriers to compliance in both 2011 and 2012. The good news is that many of the lowest scoring compliance elements can be remedied without requiring a significant financial investment or renovation of the physical plant; they simply require focusing on and changing employee work practices. The outstanding compliance issues appear to be related to convincing the pharmacy and/or hospital leadership to embrace the fact that consistent and dependable employee work practices are the single most important determinant to ensuring the production of safe CSPs in an efficient manner. Too many facilities report that they are waiting until they get a new cleanroom or upgraded facility before making the fundamental changes in staff work practices. As the following results demonstrate, there is no reason to wait; rather, focus on the opportunities immediately at hand to change attitudes and improve work practices. The change you embrace today will improve current sterile compounding practices and reduce patient risk.
Purpose, Methodology, and Limitations
For the 2012 survey, approximately 13,000 unique invitations were sent out, including invitations sent to last year’s survey participants as well as those sent from the study supporters’ and sponsors’ lists. Pharmacy Purchasing & Products magazine also ran print ads soliciting participation in the survey. Recruitment was not limited to hospitals, but also included home infusion and ambulatory infusion providers; pharmacy outsourcing providers; prescriber office settings; radiopharmaceutical/nuclear medicine providers; community pharmacy; and others. In total, 950 locations registered for the survey, which represents approximately a 7.3% response rate. The study population for data analysis was limited to those participants from the United States who completed 95% or more of the questions in study tool (412).
The survey was opened on May 1, 2012 and data was collected through June 30, 2012. The 412 participants in this year’s survey represented a 64% drop over last year’s survey, which had 1,184 respondents. It was encouraging to note that there were 262 new locations participating for the first time in 2012; however, only 150 of the 1184 (12.6%) locations that participated in the 2011 survey chose to participate in 2012. For a comprehensive discussion of the purpose, methodology, and limitations of this survey, refer to the discussion published in Pharmacy Purchasing & Product’s October 2011 Supplement: The 2011 USP <797> Study.
Changes to the 2012 Survey
Several questions in the survey were reworded based on feedback from survey users and the expert panel review. Logic changes were made in five questions in the Patient/Caregiver Training domain that were previously asked of all respondents, but which only applied to the home infusion/alternate care providers. Twelve new non-scored items (Table 1) were added in an attempt to measure attitudes and beliefs about the chapter, motivation for participation in the study and challenges to successful compliance with chapter elements. Other changes to the tool involved the resizing of graphics to improve the loading speed in locations with less bandwidth and to improve the display on small monitors.
Description of Study Population
Hospital pharmacies (325) represented the overwhelming majority of the total sample population of survey respondents (412) with home infusion/ambulatory infusion suites comprising the next largest group (50). Though there was representation from all other settings, their sample size was significantly smaller; therefore, this article will be limited to the results from hospital-based participants only.
Similar to last year’s results, the 2012 survey had geographic representation from every state and the District of Columbia. There was a range of participants per state from one (District of Columbia, Alaska, Hawaii, and Idaho) to 41 (California) with a mean of 8 and a median of 6 respondents per state respectively (details available at www.pppmag.com/respondentsbystate).
Attitudinal and Belief Scores
Motivation for Participation in the Study
The vast majority of respondents (79%) indicated that they participated in the survey to objectively measure their compliance to the chapter and use the resultant action plan to work toward improved compliance. There was no difference in motivation between those who had or had not previously participated in the survey. When asked to identify a secondary motivation for participating, 64% of participants left the item blank. The factor most often cited by those who did answer this question was that they would use the results to acknowledge and motivate staff (15%), share with superiors (8%), contribute to the database of the sterile compounding community (6%), and three locations (1%) planned to use their results as a marketing tool.
Patient Safety & Influences to Pursue Compliance (Table 2)
Ninety-five percent (95%), or 391 locations, indicated that they believe that Chapter <797> has had a positive influence on patient safety. The most influential factors in both the initial and present day pursuit of compliance with the chapter are shown in Table 2. Most locations report that they are pursuing compliance with Chapter <797> because it is the right thing to do rather than out of fear of their state board of pharmacy or other regulatory authority or accreditation organization.
Challenges to Achieving Compliance (Figure 1)
Financial and budgetary restrictions, as well as limitations to the sterile compounding physical plant, remain the primary barriers to achieving compliance. In 2011, just 10% of participants cited the time required to implement changes as their biggest initial challenge; in 2012 that number increased to 20% of the participants. This is likely due to the fact that time is less of a consideration in the initial planning period when pharmacy leadership is investing resources in learning about, rather than implementing, the chapter. Supporting this theory, 19% of the locations now identify the availability of training and competency resources available to assist them as the second most pressing challenge.
Compliance Scores (Figure 2)
This year the overall compliance score for the entire study population was 77.7%, up from 73.9% in 2011. The average hospital compliance score increased from 72.4% to 76.3%. Notably, those who participated in the 2011 survey had a higher compliance score than those who did not. This finding was true for the overall population as well as for the hospital and alternate site groups.
These data suggest there is truth to the idea that focus delivers results: those locations maintaining a focus and emphasis on compliance with the chapter make better progress than those who do not make compliance a priority.
Hospital Data (Figures 3 and 4)
Comparing the distribution of compliance scores among participating hospitals in 2011 versus 2012 demonstrates that there were fewer scores below 50 percent in 2012 (see Figure 3). Of note, there was no difference in compliance scores based upon the number of CSPs compounded per week in the 2012 survey population. The distribution of the 2012 hospital sample based on bed size is similar to that of 2011, as seen in Figure 4. Hospitals under 300 beds accounted for the most improvement in overall hospital compliance scores. Scores for hospitals with less than 100 beds improved the most of any group, increasing by 7.9% year over year.
Specific Compliance Findings
Although compliance was analyzed by participant group, this article is limited to reporting results of the hospital survey participants only. Core compliance data are presented in the following tables.
- 2012 Hospital Compliance by Domains (Table 3)
- 2012 Domains with Compliance ≥ 80% for Hospitals Compared with 2011 (Table 4)
- 2012 10 Top Scoring Individual Items that apply to ALL Hospital Locations (Table 5)
- 2012 Domains with Compliance ≤ 70% for Hospitals Compared with 2011 (Table 6)
- 2012 Items that apply to ALL Hospital Locations with Compliance Less than 60% (Table 7)
- 2012 Items that apply to a Smaller Subset of Hospitals with Compliance Less than 50% (data available online at www.pppmag.com/USPcompliance)
Areas Requiring Improvement
Overall compliance scores have improved slightly across the board in the past year, with those locations demonstrating an increased focus on compliance reaping the greatest improvements. Nonetheless, the overall compliance for many items is lower than expected. While progress is being made, it is slow and some compliance elements experienced no improvement at all. The discussion that follows reviews particular activities required by the chapter where significant focus is still needed.
Quality Management and Environmental Sampling Plan (Figure 5)
In 2011, about half (49%) of hospital pharmacies reported that their quality assurance/performance improvement program included specific monitoring and evaluation activities, with details on how those results are reported and who is responsible for managing those results. This low number was surprising given that most state boards of pharmacy and national accrediting organizations have this same requirement in place. In 2012, compliance with this item improved slightly to 52% of hospital pharmacies.
A written environmental sampling plan and associated policies and procedures (P&Ps) are also fundamental to ensuring an effective environmental sampling program; however, only 49% of hospitals in 2011 reported that they had written P&Ps. In 2012, compliance with this requirement marginally improved to 53%.
Quality Management: Gloved Fingertip/Thumb Sampling (GFS) (Figures 6 and 7)
In 2011, 30% of hospitals complied with the requirement for all compounding personnel (including supervising pharmacists) to successfully complete at least three gloved fingertip/thumb sampling procedures (success is 0 CFUs for both hands) before being allowed to compound CSPs. This requirement is designed to verify that compounding personnel can properly don sterile gloves without contaminating them. Figure 6 shows that in 2012, compliance with this requirement has increased to 36%.
Since the GFS requirement was added in the 2008 revision of the chapter, the survey team provided a detailed P&P and a form that participants and readers of the PP&P article could use as a template to develop their own policies. To determine if this resource was used by 2011 participants to improve their practices, we looked at compliance data for this requirement comparing results for those who participated in 2011 and 2012 against those who participated in 2012 alone. The results are summarized in Figure 7. Compliance for this requirement was only 28% for those participating in the survey for the first time in 2012, compared to 51% for those who participated in both 2011 and 2012. Since contamination of CSPs is linked directly to the aseptic skills of compounding personnel, the microbiological quality of their gloved hands can have direct impact on the quality of CSPs. This requirement of the chapter needs to be a cornerstone of any quality sterile compounding program and still requires attention.
Surface Sampling: A Personnel and Environmental Metric (Table 9)
Overall compliance with the requirements of the chapter for surface sampling remained unchanged this year. While 70% of hospitals report that surface sampling is performed using the contact plate or swab method, only 57% state they use a TSApl plate when collecting each specimen (regardless of collection method). It is important to emphasize that those ingredients (polysorbate 80 and lecithin) are added to neutralize the effect of any cleaning agents that may be present on the surface being sampled.
Viable Air Sampling (Table 10)
Another change in the 2008 revision required viable air sampling be performed using two different types of media (a general growth media and another that supports the growth of fungus) for those hospitals performing high-risk compounding. In the 2011 Compliance Survey, the survey tool incorrectly posed this question to all pharmacies, regardless of their compounding risk level. The study team thought that the low 2011 compliance for this item (43%) was due to the error in constructing this question. For 2012, the logic in the survey tool was changed so that the question was asked only to those pharmacies who indicated that they performed high-risk level compounding. The compliance to this requirement remains at 43% for those performing high-risk level compounding though the sample size for this item is only 30 hospitals.
Any location reporting that they conducted no high-risk level compounding was asked if viable air sampling was performed using a general (TSB) growth medium. This new item had a much higher compliance score of 68%. There was a 5% improvement in those reporting that their viable air sampling volume was of 400-1000 liters of air. This year also saw an 8% improvement in the overall Viable Air Sampling Domain score; however, significant improvements in compliance remain necessary for this important requirement.
Facility Metrics: Airflow/Pressure Monitoring and Line of Demarcation (Figures 8 and 9)
Participants who indicated that they had both an ante and buffer area were asked if they measured their pressure differential or airflow velocities daily. Figure 8 compares the compliance for this item in 2011 with 2012 and demonstrates no improvement. Chapter <797> states a “pressure gauge or velocity meter shall be installed to monitor the pressure differential or airﬂow between the buffer area and ante-area and the ante-area and the general environment outside the compounding area. The results shall be reviewed and documented on a log at least every work shift (minimum frequency shall be at least daily) or by a continuous recording device. The pressure between the ISO Class 7 and general pharmacy area shall not be less than 5 Pa (0.02 inch water column (w.c.)). In facilities where low- and medium-risk level CSPs are prepared, differential airﬂow shall maintain a minimum velocity of 0.2 meter/second (40 fpm) between buffer area and ante-area.” Last year we thought one potential barrier to compliance might be related to older compounding suites that did not have a magnehelic gauge installed when built. This is a fairly easy, inexpensive and quick fix and a review of last year’s article will provide this information. There was no difference in compliance between those participating in the study for the first time and those who participated last year.
All participants were again asked if their location had a line of demarcation in the ante-area or segregated compounding space that separates the dirty area from the clean area. In 2011, only 48% of hospitals reported the use of a line of demarcation. The requirement for a line of demarcation was not included in the 2008 Chapter <797> revisions. It was proposed in 2010 in the Pharmacopeial Forum, but is not yet required. While hospital implementation of this item has increased to 53% (see Figure 9), this remains an important and easily implemented change. (For further details on this topic, see the 2011 USP <797> Compliance Study, available at pppmag.com).
Filter Integrity Testing (Figure 10)
Figure 10 summarizes data for the item with the lowest compliance in both 2011 (10.8%) and 2012 (9.9%), which asked if filter integrity testing was performed after the use of a 0.22 micron filter. Respondents were only asked this question if they indicated they used a 0.22 micron filter in their compounding processes. The study team considered that the low 2011 compliance score might be due to ambiguity within the question itself since the 2011 question did not specifically ask if they used a filter to sterilize solutions. To address this concern, the item was reworded in 2012 to reflect filter use specifically for sterilizing solutions, however, the clarification did not result in any significant change in compliance. It is interesting to note that although 177 locations claim to use filters to sterilize solutions (indicating they may perform high risk level compounding), only 57 locations report they are performing high risk compounding. Those locations using a 0.22 micron filter without conducting any high risk compounding may be doing so to compound intrathecal injections or neonate CSPs.
This question was also asked by another method. Hospitals that self-identified as performing high-risk compounding (n=26) were asked if they performed filter integrity at the conclusion of sterilization by filtration, and just 31% did so (8 of 26). This finding is troubling for two reasons. First, it seems that the definition of high-risk compounding may not be well understood by those locations performing sterile compounding, and secondly, it indicates that the requirement to perform (or the process of how to perform) bubble point testing is poorly understood. Sterilizing grade filters must be used according to Chapter <797> and a filter integrity test is to be performed after use per manufacturer specifications. Filter integrity testing is a critical quality assurance component and required by USP <797> when solutions are terminally sterilized via filtration.
Hazardous Drug Requirements (Figures 11-14)
In 2012, 251 (77%) of hospitals reported that they perform hazardous drug (HD) compounding (data available at www.pppmag.com/HDdata). These facilities are required to obtain written confirmation from employees of reproductive age who compound HDs stating that they understand the associated risks that apply to the compounding of HDs. In 2011, just 24% of hospitals complied with this item. The study team postulated that this low rate of compliance may have been due to the requirement being added in the 2008 update to Chapter <797>. To aid in compliance with this requirement, the study team provided the 2011 survey participants with a template that could be used to develop a form of their own. In 2012, hospital compliance for this item increased to 31%, a net change of 7 percent (Figure 11). The study team also examined the differences in compliance for this item between hospitals that participated in both years’ studies (and therefore received the template) versus those who only participated in 2012 (Figure 12). The results showed that those who participated both years had a 10% higher compliance rate (37%) compared to those who participated for the first time in 2012 (27%).
Though overall compliance for certain HD compounding requirements (Figure 13) fell slightly or remained the same, when the data is sorted for those who participated in the study in both 2011 and 2012 compared with those who participated in 2012 alone, the group that participated both years had higher compliance scores (Figure 14).
Clearly, USP Chapter <797> has had a positive impact on sterile compounding practices, thus aiding pharmacy’s goal of reducing the risk of injury to patients who receive sterile drugs. To continue to reduce this risk to our patients, we need a clear understanding of the limitations in our abilities to prevent errors.
Without a robust sterile compounding program as described in USP Chapter <797>, we risk preventable patient injury. In the past three years alone, there have been several significant events where administered CSPs were either contaminated or contained grossly incorrect amounts of ingredients and resulted in serious preventable infections, loss of sight, and death to patients. Nationwide drug shortages will continue to put pressure on healthcare professionals to use their limited supplies of drugs with great vigilance. Recently, both the CDC and CMS extolled the importance of complying with USP Chapter <797> so that the use of single-dose vials could be maximized. To meet these challenges while ensuring patient safety, compliance with Chapter <797> can no longer be viewed as optional and partial compliance is simply not sufficient.
The study team wants to extend their appreciation to those who participated in this 2012 survey and hope that they will find value and motivation to continue improving their compliance to the requirements within USP Chapter <797>.
Kate Douglass, MS, RN, APN,C, CRNI (president of Performance Strategies, LLC) and Eric S. Kastango, MBA, RPh, FASHP (president, CEO, and owner of Clinical IQ, LLC) are the Study Directors for the USP <797> Compliance Survey. Peter Cantor is the Study Coordinator. Address correspondence to Kate Douglass at firstname.lastname@example.org.
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