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The 2011 USP <797> Compliance Study
October 2011 : Cleanrooms & Compounding - Vol. 8 No. 10 - Page #8
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Seven years after the initial publication of USP Chapter <797> and three years after the first revision, many facilities have made significant improvements to their sterile compounding safety. Nonetheless, all too often we operate without clear data to properly evaluate our practice. Because the risks to patients from receiving tainted CSPs can be significant indeed, it is imperative that the profession regularly measures its success in complying with sterile compounding requirements. Equally important is ensuring access to the right tools to assist us in continually improving our sterile compounding practices. With this in mind, we bring you the results from the inaugural USP Chapter <797> Compliance Study.

We are exceedingly grateful to all the survey participants whose candid responses make this study a valuable resource for assessing current compliance to <797>, and perhaps more importantly, for identifying areas that require further attention and resource development. While this article is limited to an overview of the findings, readers can expect further articles that focus on specific findings and include detailed discussions of the best steps to take to improve sterile compounding safety. 

Purpose
This study was designed to evaluate current sterile compounding practices in the United States related to USP <797> compliance. Since the chapter became the standard of practice, significant progress has been made in ensuring quality sterile compounding practices. Nonetheless, by systematically evaluating compliance to each specific requirement in the chapter, we can pinpoint those sterile practices that remain a challenge and identify resources to address them. The goal of this study is to not only identify existing areas of non-compliance, but to use the resulting data to drive corrective actions, either through the identification of existing resources that pharmacies can use to improve their practice or through the design of additional resources as needed. To this end, every study participant received a detailed, individualized <797> Action Plan to assist in the continuous improvement of sterile compounding practice. Finally, the survey results will be used to identify areas within sterile compounding practice that require further study and will provide detailed data to the USP <797> Expert Committee as they evaluate potential revisions to the chapter in their next session. 

Methods
Survey Design
The Web-based, self-report survey tool (the Gap Tool) contains 236 items reflecting the required elements within USP <797>, and the logic used in the survey determined which questions each facility would answer based on the types and operational practices of their sterile compounding facility. Each question presented a required element in <797> with respondents answering “yes” if they were fully compliant and “no” if their facility was not fully compliant with the requirement. Survey items were grouped into domains (a complete list of the Gap Tool domains is available online at www.pppmag.com/GapToolDomains) with 36 scorable and three non-scorable domains. The initial questions were non-scorable items designed to determine the participants’ demographic information and type of compounding performed. These questions serve as gating items, meaning the answers determined whether to present certain domain-specific questions to participants later in the survey. 


In return for their participation in the study, each participant received a highly detailed Action Plan specific to their work practice to assist them in complying with USP <797> requirements. The Action Plan is derived from each participant’s responses; any answer that indicates non-compliance triggers the creation of a detailed set of practical steps that, upon implementation, will ensure compliance with that item. The resultant Action Plan provides documentation that may be used to begin or continue sterile compounding practice improvements

The tool was beta tested by 20 facilities and additional gating was added or refined and a number of items were reworded for clarity, based on the beta testers’ feedback. All 20 beta test sites agreed that the Action Plan provided to each participant made it worthwhile to spend the required 60-90 minutes completing the survey. During the beta test, participants completed an average of 152 questions. 

Sampling Methodology 
In order to achieve the study goals and maximize the number of participating facilities, the study team approached a variety of organizations to support the study. Study Supporters assisted by encouraging participation among their constituents through email and print campaigns. Industry Sponsors assisted by providing grants to underwrite the costs associated with the study. Publicly available lists of sterile compounding facilities were also used to recruit volunteers. Participants were asked to complete the Gap Analysis for the busiest compounding location at their physical work mailing address.

Approximately 7400 requests for participation were sent out via email and some of those received personal telephone calls. Print ads also appeared in Pharmacy Purchasing & Products magazine soliciting participation. Recruitment was not limited to hospitals, rather it included home infusion and ambulatory infusion providers; pharmacy outsourcing providers; prescriber office settings; radiopharmaceutical and nuclear medicine providers; community pharmacies and others. In total, 1700 persons registered for the study representing approximately a 23% response rate. The Study Directors determined they would limit the study population for data analysis to those who completed 99% or more of the questions in the study tool (N=1148). 

The study was open on the Internet from May 3, 2011 through June 30, 2011. Compounding locations with multiple responses were contacted to eliminate duplicate data and those individuals whose responses represented the top and bottom 10% of all scores were contacted to verify their submissions. Data were validated and all identifying information was blinded before the analysis process began. For the purposes of this report, only US hospital pharmacy data was analyzed (n=894). 

Survey Limitations
Given the objective nature of the survey content, the tool has not been tested for reliability and validity; nonetheless, a high degree of validity can be assumed since the content is based solely on USP <797> requirements and does not include additional best practice recommendations. All data gathered through the Gap Tool is self-reported and was not verified through onsite independent assessments. With self-reported data, there is always a potential for exaggeration or overly positive reporting. There is also a risk for social desirability bias, wherein subjects may answer questions based on how they think they should be answered. It is also possible that subjects may guess on survey items they do not know the answers to, so to help offset this, participants were encouraged to pause the survey to obtain accurate answers to such questions. Because each participant was motivated to complete the survey, at least in part, by the fact that they would receive a highly detailed, practical Action Plan for <797> compliance upon completion of the survey, our expectation is that this further encourages the submission of accurate data. In order to realize the full value of the Action Plan, it was necessary for each respondent to answer the items in a manner that closely matched actual practices so that the resulting Action Plan would be applicable to their specific practice setting. Furthermore, as the intent is to repeat this survey annually, it is our hope that participants will complete the tool each year in part as a mechanism to document their improvement in compliance relative to the standard.

Since participation in the study was voluntary, it is also possible that there is inherent bias in the self-selection process in that those who chose to participate are pharmacies with particular motivations, such as:

  • Interest in <797> and therefore may represent pharmacies that have adopted the changes in <797> earlier or more completely
  • Perception that they are behind in their <797> compliance and therefore want to participate to obtain the detailed <797> Action Plan generated by completion of the Gap Tool

Finally, this is a descriptive study and although the findings are interesting, no cause and effect can be attributed to the data. 



Study Results: Compliance Findings
Overall Compliance Scores
The overall compliance scores for the entire study population broken out by provider type is depicted in Figure 1. Note that the range is extremely wide from a single respondent (FDA-registered provider) to 894 (hospitals). Only hospitals and home infusion/ambulatory infusion suite providers had sample populations that numbered greater than 100. Regardless, the results are not surprising. Although the chapter applies to all provider types and settings where sterile drugs are compounded, many veterinary and prescriber office practices have been slow to embrace the requirements. The radiopharmaceutical community was not specifically addressed until the 2008 revision, thus, it is expected that these scores might lag behind other populations. Furthermore, central fill and FDA-registered compounders were expected to achieve higher compliance scores given typical regulatory requirements; however, these population sizes were small. Given the wide variability in sample size for each provider type, these data are interesting but not compelling. Additional data on the study findings are available at www.ppmag.com/USPComplianceScores.

Compliance Challenges for Hospital Pharmacy
The survey results clearly delineate the broader areas, or domains, where hospital pharmacy has had the most success meeting compliance standards (see Table 1) as well as those domains where compliance remains elusive (see Table 2). The sophistication of the Gap Tool provides insights to the specific items within these domains that pose the greatest obstacles to compliance (see Table 3). As might be expected, some of the newer requirements added in the 2008 revision, such as gloved fingertip sampling and radiopharmaceuticals, have lower compliance scores. Notwithstanding, it is surprising to see some areas of non-compliance reflect easy-to-fix issues, such as surface sampling policies and procedures and filter integrity testing. Of the 36 scorable domains in the Gap Tool, hospital pharmacies scored below 70% compliance on 15 of them. Hospital pharmacies were also below 50% compliance on 93 of the possible 236 individual items in the Gap Tool. 





Click here to view a larger version of this Table.


Solutions to Hospital Pharmacy Challenges
Filter Integrity Testing 
The survey item with the dubious distinction of having the lowest compliance rate (10.8%) was one that questioned whether filter integrity testing was performed following the use of a 0.22 micron-filter. This low compliance score may be due in part to some ambiguity within the question itself, as participants were only asked this question if they indicated the use of a 0.22 micron filter in any of their compounding processes because the study team assumed that 0.22 micron filters were used solely for the purpose of sterilization. The survey also asked about filter integrity testing by a different mechanism. Only 25.6% of those performing high risk compounding and sterilizing by filtration (n=78) currently perform a filter integrity test (eg, bubble-point test) at the conclusion of the compounding procedure. This finding is indeed troubling. In observation of compounding practice, proper filter use in general appears to be misunderstood. Filters must be used per manufacturer specifications and too often those specifications are not followed. Integrity testing of sterilizing filters is a critical quality assurance component and required by USP <797>, which states “Filter units used to sterilize CSPs shall also be subjected to manufacturers’ recommended integrity test, such as the bubble point test.”1 

Employee Acknowledgement of Hazardous Drug Risk 
As part of the 2008 chapter revisions, hospitals that perform hazardous drug (HD) compounding are required to obtain written confirmation from all compounding staff of reproductive age stating that they understand the risks of handling HD. This confirmation must be kept on file for every compounding staff member of reproductive age regardless of HD compounding volume. Only 23.9% of hospital pharmacies are in compliance with this requirement (see Figure 2). Compliance may be low as this requirement is relatively new and there is little available guidance on how to create such a form. To facilitate compliance with this area, a sample Hazardous Drug Risk Acknowledgement Form is available at www.pppmag.com/HDRiskForm.


Labeling of Reusable Cleaning Supplies
Only 37.6% of hospital participants label reusable cleaning items with the allowed location of their use and have policies and procedures reflecting that repeated use of these items will not adversely affect the bioburden in those locations (see Figure 3). This low compliance rate may reflect the common misperception that pharmacists have to prove that their stated practice does not increase bioburden. Rather, it is sufficient for policy and procedures to indicate which, if any, items may be reused and how they may they be reused. For example, if buckets are reused (which is permissible since they are made of impervious materials and are readily cleaned and dried), those buckets must be labeled (eg, floors vs walls/ceilings) and kept inverted in a designated area such that no standing water remains inside. A clear and detailed policy and procedure will provide the rationale as to why those items will not negatively affect the bioburden in the room.



Patient/Caregiver Training
The chapter requires that a formal training program be in place to ensure patients or caregivers understand the sometimes complex storage, handling, and administration requirements for CSPs so that homecare responsibilities are clear and specified in terms of patient or caregiver competencies. 

Hospitals are responsible to teach patients and their families about the drugs they are receiving during their hospital stay, whether pharmacy provides the training directly or works with other departments such as nursing and discharge planning to coordinate and verify that patients receive information about their CSPs during their hospital admission. Only 49.4% of hospitals (n=894) indicate that written materials are provided to patients. Hospitals scored low on another training item that asked if patients/caregivers had to demonstrate specific competencies before being allowed to administer CSPs independent of healthcare professionals. Although some hospital pharmacies do perform this training for their home infusion/home health agencies, this practice is not the norm and the study team should have only presented that question to participants representing home infusion companies.

Personnel Sampling 
Another new chapter inclusion from 2008, gloved fingertip/thumb sampling (GFS), poses challenges to more than half of the hospital pharmacy participants. Three items within this domain scored particularly low. Only 29.6% of hospitals reported that all compounding personnel (including supervising pharmacists) successfully complete at least three GFS procedures before being permitted to compound (see Figure 4). In 2008, the USP Expert Committee added this requirement stating “all compounding personnel shall successfully complete an initial competency evaluation and gloved fingertip/thumb sampling procedure (zero cfu) no less than three times before initially being allowed to compound CSPs for human use.”1 The rationale behind this requirement is to test whether the compounder is able to don sterile gloves without contaminating them. This survey purposely included supervising pharmacists in the query, as we strongly believe that pharmacists supervising sterile compounding should be competent to perform all of the duties they are responsible to supervise. 

During the initial GFS, 48.9% of hospitals took samples from both gloved hands onto media plates immediately after compounders perform hand hygiene and garbing but before their gloves are cleaned with sterile 70% IPA. These data suggest: 

  1. Compliance with initial GFS performance may be higher than the reported 29.6%.However, those performing GFS may not require its completion three times, may not require supervising pharmacists to complete it, and/or may not require completion before operators are allowed to compound.
  2. The procedure for correctly performing GFS is unclear and the study team has observed this finding in practice. It is important to realize that the sample needs to be taken before the compounders’ gloves would normally be cleaned with sterile 70% IPA to preclude false negatives. It is also important to change sterile gloves after the sample is taken and before compounding begins.


Hospitals whose compounding is limited to low and medium risk levels (n=801) reported a slightly higher compliance rate of 48.2% for performing GFS annually on both hands at the time of media-fill testing for both compounding staff and supervising pharmacists. Of those hospitals performing high-risk compounding (n=93), just one-third report that they perform GFS of both hands during their (at least semi-annual) media-fill testing. GFS is an important personnel metric that validates whether compounders can keep their gloves clean and it is most easily performed during employee media-fill testing. It is key that a thorough, compliant policy and procedure is developed to ensure compliance to the GFS requirements. A sample GFS policy and procedure is available at www.pppmag.com/GFSPolicy.

Surface Sampling
About half the hospital pharmacies (49.6%) indicate that they perform surface sampling regularly and that the frequency, location, and action levels of surface sampling are detailed within the Environmental Sampling Plan (ESP) and written policies and procedures. About the same number (48%) indicate that surface sampling is performed at the conclusion of compounding and before the area is cleaned with an appropriate disinfectant. When surface sampling is performed, it must occur at the conclusion of the compounding day or shift to capture the worst-case scenario and be performed according to the locations detailed in the ESP.  The chapter does not specify exactly how often to perform surface sampling but states it is to be “performed in all ISO classified areas on a periodic basis… and shall be done at the conclusion of compounding. Locations to be sampled shall be defined in a sample plan or on a form.”1 

Surface sampling should be performed when it makes sense based on your compounding scenarios. The frequency and timing can be determined based on the following:

  • Compounding risk level (more frequently for high-risk compounding)
  • Environmental sampling results history (more frequently at compounding facilities with no environmental sampling history)
  • Tenure of compounding staff (more frequently if compounding staff are new, inexperienced, or have not established a sampled history associated with environmental sampling, GFS, or media-fill testing)
  • Consider other factors that may impact work practices (ie, more frequently during periods of short staffing; more frequently if custodial staff assume cleaning activities)
  • Recommend that specific compounders be associated with each sample so that results may be tracked back to specific staff members that require retraining
  • Consider performing surface sampling randomly (ie, sampling occurring monthly should not take place at the same time of the month and optimally, employees should be sampled without warning)
  • Consider noting the name of the compounding personnel working inside of a particular PEC at the time of the sample. By including the employee’s name on the plate/swab, an opportunity for reteaching that individual is captured should surface sampling exceed designated action levels. 

Those who perform high risk compounding must perform surface sampling with two different types of media. In addition to tryptic soy agar medium (with polysorbate and lecithin added to neutralize cleaning agents— TSApl), high-risk level compounders are required to use an additional media that supports fungal growth, particularly yeasts and mold such as malt extract agar (MEA). Only 16.1% of the 93 hospital pharmacies conducting high-risk compounding comply with this requirement.

Viable Air Sampling
Another change in the 2008 revision requires viable air sampling to be performed using two different types of media—a general growth media and one that supports the growth of fungus. Only 42.5% of hospital pharmacies reported compliance with this item. Since viable air sampling is required at the time of room evaluation and certification, it is most often completed by a clean room certification company. In this case, review your last viable air sampling report, as it is possible both were performed but the results were not clearly communicated. If not, contact your certification provider to ensure they are aware of the requirement. Most certifiers are aware and have purchased active air samplers to provide this service to their clients. Thus, there is no reason to assume the expense of purchasing an active air sampler, but note that policies and procedures on viable air sampling, including size and location of samples and coordination of sampling and results, must be in place.

Quality Management and Environmental Sampling Plan
About half (49.1%) of hospital pharmacies reported that their Quality Assurance/Performance Improvement Program includes specific monitoring and evaluation activities with details on how results are reported and a delineation of the persons responsible. This low number was surprising as most state boards of pharmacy and accrediting organizations have this same requirement. A written environmental sampling plan and policies and procedures for environmental sampling are fundamental to effective implementation of environmental sampling; however, only 41.5% of hospitals report that they have written policy and procedures covering all aspects of surface sampling and viable air sampling. Just 45.6% had a written environmental sampling plan that included sample locations, methods of collection, frequency of sampling and volume of air sampled (for viable air sampling), and time of day for collection in relation to compounding and action levels. Be sure to integrate all critical sterile compounding quality metrics (whether they are related to the facility or personnel) into the organization’s quality assurance plan.

Recommendations for Future Study 
This study will be conducted annually to provide a continual measure of changes in sterile compounding practice in the United States. Those who participated this year are urged to continue their yearly participation as a means of tracking their organization’s achievements relative to USP <797> compliance. We hope to have increased success in recruiting participants from the other sterile compounding populations who were underrepresented in this year’s sample.Some items in the tool will be revised next year, including questions related to patient/caregiver training. In addition, new questions will be incorporated to sample participants’ attitudes regarding resources, time constraints, biggest achievements, and largest frustrations. 

Conclusion
USP Chapter <797> has clearly had a positive impact on sterile compounding practices, thus reducing the risk of injury to patients receiving sterile drugs. The preliminary results of this survey indicate that significantmisunderstanding continues to surround some of the chapter requirements and there is a need for guidance in how to best implement compliant practices in a variety of settings. Although the chapter has been an enforceable national standard for seven years, it is clear that we must continue to look for better ways to communicate the requirements, educate managers and administrators, and train staff to efficiently implement the practices required to ensure ever-safer sterile compounding practices. Our goal is to continue to identify those areas that need closer attention and to provide the guidance and tools necessary to achieve full compliance.

Reference

  1. United States Pharmacopeial Convention, Inc. <797> Pharmaceutical Compounding—Sterile Preparations. United States Pharmacopeia 34–National Formulary 29. Rockville, MD: US Pharmacopeial Convention, Inc; 2011.

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 2011 USP <797> Compliance Survey. Peter Cantor and Max Shevitz of Clinical IQ, LLC, are the Study Coordinators. Address correspondence to Kate Douglass at kdouglass@performancestrategies.info.


Coming in November

Watch for additional data from the 2011 USP <797> Compliance Survey on:

  • Monitoring Airflow
  • Line of Demarcation
  • Sterility Testing
  • Additional Compounding Resources
What is the size of your Facility?
  • 1 - 100
  • 101 - 200
  • 201 - 300
  • 301 - 400
  • 400+

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