Prioritize a Sterile Compounding Training Program

July 2022 - Vol.19 No. 7 - Page #6
Category: USP Training Programs

Implementing a comprehensive training and competency program for staff that performs or oversees sterile compounding is both challenging and rewarding. Despite the time, effort, and complexity of creating a training and competency program, the opportunity to watch new staff learn and perfect their compounding craft makes these efforts worthwhile. Key to maximizing payoffs and minimizing challenges is a program rooted in the regulations with responsibilities and competencies clearly delineated and documented.

At Brigham and Women’s Hospital (BWH), the training and competency assessment process is critical to the sterile compounding program. Located in Boston, Massachusetts, the BWH pharmacy department has 350 employees including pharmacists, pharmacy technicians, and pharmacy interns with approximately 50 pharmacy technicians and interns, and 50 pharmacists working in sterile compounding. Strong program leadership, competencies, and documentation are key to training and maintaining staff to ensure the pharmacy department compounds safely and efficiently.

Rooted in Regulation

BWH follows the current version of USP <797>, along with guidance in anticipation of the proposed <797> drafts and new regulations that will be promulgated by the Massachusetts Board of Pharmacy. To accommodate these anticipated regulations, BWH has incorporated semi-annual testing (every 6 months) for observed gowning, garbing, fingertip, and aseptic technique media fills for all staff that actively perform sterile compounding. Staff who only oversee compounding do the full observed testing annually; however, they also take an independent media fill test 6 months after the observed competency. BWH uses multiple training platforms to house the training modules.

Designating Responsibilities

Managing a training and competency program requires coordination between multiple departments, maintenance and updating of training materials and schedules, and consistent oversight of the overall program. To meet these needs, the BWH pharmacy department dedicates three roles to support the training competency of the pharmacy sterile products staff:

  • Quality Assurance Coordinator (QAC)
  • Technical Operators Coordinator
  • Professional Development Manager

The role of the QAC is to develop, implement, and oversee training programs and competency assessments to ensure a high level of expertise in the compounding of sterile admixtures. The QAC advises the Chief Pharmacy Officer and Director of Pharmacy Regulatory Compliance, Quality, and Safety on all quality matters related to the preparation of sterile compounded products (CSPs) and evaluates pharmacy staff members’ understanding of and compliance with pharmacy standard operating procedures. This staff member has expert knowledge of the USP chapters and other regulations pertaining to the preparation of CSPs. The requirements for the QAC role and additional responsibilities are listed in TABLE 1.

Working in tangent with the QAC, as well as the sterile products room manger, are the pharmacy department technical operations coordinator and the professional development manager. The technical operations coordinator assists with onboarding new pharmacy technicians and interns to the pharmacy department and provides direction and guidance to technical staff in following policy and procedure while promoting professional behaviors and attitudes. This role also creates, maintains, and deploys training and mentoring material, builds training schedules, and provides feedback to pharmacy leadership about the efficiency of the department workflows. The technical operations coordinator continually updates training log policies, assists the professional development manager with continuing educational programs, and participates in departmental quality improvement and group research projects. For requirements of the technical operations coordinator role and additional responsibilities, see TABLE 2.

The professional development manager oversees department education initiatives. For new staff, this entails organizing recruiting and onboarding efforts, acting as a liaison with human resources talent acquisition, developing pharmacist training schedules, and coordinating department specific orientations. Additional overarching responsibilities include daily staff scheduling, developing continuing educational programs, and executive oversight for the pharmacy residency training programs.

Training Checklists

While competencies and modules are housed digitally, area and role specific training checklists developed by departmental leadership are paper-based. These checklists are extensive, covering standard expectations per role, topics, and procedures required to complete the tasks and overarching principles of requirements. For example, the elements of a compounding staff’s training check list include gowning and garbing, cleaning and disinfection, aseptic technique, compounding/preparation procedures, restocking, and coverage (ie breaks/meals). The details in each section are specific to our facility’s policies and procedures. Both senior staff acting as trainers and new staff trainees have the opportunity to provide feedback on the checklist workflow and patient care.

The sterile products room is one area that utilizes these checklists, as it has several unique positions for the movement of medications throughout the preparation process. Each position has a specific checklist and training log. At various points of training, the technical operations coordinator will review the checklist and expectations of each role and allow the trainee the opportunity to provide feedback. Once a training checklist is completed and signed by the trainee, it is then scanned to the area manager and placed in the individual’s personnel file.

Most training takes up to 5 days but will vary depending on the individual’s previous experience and the ongoing assessments of skill. To accommodate the need for results to be back before independent staffing can take place and account for training lead time, the QAC is notified of all new individuals entering the sterile products room. Continuous, regularly scheduled communication between the technical operations coordinator and QAC ensures these goals and deadlines are met.

Sterile Compounding Competencies

The evaluation of aseptic technique and sterile compounding competency consists of media-fill testing, gloved fingertip and thumb sampling, observed aseptic manipulations, and observed gowning and garbing.1 The competencies are evaluated initially in triplicate and every 6 months for personnel compounding low- or medium-risk CSPs. Didactic training is completed annually, using both an attestation of sterile products compounding policies and procedures and the learning management system. The QAC performs all observed testing. Of note, the QAC must also go through the same testing with the sterile products room manager acting as the observer.

Personnel that compound sterile products perform semiannual observed gloved fingertip and media fill competencies. Those who oversee the compounding of sterile products are assigned annual competency testing that includes one observed gloved fingertip and observed media fill competency and annual media fill competency. These competencies are spaced every six months apart. A passing test for on-going fingertip testing is no more than 3 colony forming units (CFUs) combined on both hands.

Fingertip and Thumb Sampling

Any new staff member training in the SPR must complete an initial fingertip testing in triplicate. Sterile product compounding personnel include pharmacy technicians, pharmacy interns, and several pharmacists. Pharmacists verify and oversee sterile compounding. A passing test for an initial fingertip test must be zero CFU on both hands.

The QAC observes the following aspects of the competency: gowning and garbing, handwashing, movement in the buffer room, and aseptic technique during compounding. The competency begins with the staff member entering the anteroom and donning the appropriate personal protective equipment (PPE) prior to washing their hands. After donning the required PPE, the staff member is then escorted to the buffer room where the QAC takes the first set of fingertip and thumb samples. The fingertips and thumbs on both hands are to touch plates that are made of microbial growth agar, Trypticase soy agar (TSA), supplemented with neutralizing additives that support both bacterial and fungal growth. The plate samples are labeled with identifiers such as the initials of the staff member, date, time, left hand, and right hand, and that these are pre-media fill samples. A separate plate is used with each hand. Also, 70% sterile isopropyl alcohol cannot be used on the hands immediately prior to the staff member touching the plates. The staff member is reminded not to touch anything as that could compromise the goal of the test, which is checking the individual’s gowning and gloving technique. Staff must ensure that the sterile gloves do not touch anything nonsterile such as the individual’s hands or other items.

The control plate is treated the same as the sample plate but contains no fingertip samples to ensure there is no contamination with the plates themselves. If the control plate has growth after incubation, it could be because the entire set of plates were contaminated or only the control plate was contaminated. The latter would be likely true if the sample plates resulted in no growth. In either case, the test would be invalid, and the staff member would need to be retested.

Media Fill Test

Following the initial fingertip and thumb sampling, the staff member takes the media fill test. Media fill is a sterile broth solution used to qualify both the processes and personnel doing sterile compounding. The staff member is required to puncture a vial 20 times and aseptically transfer the broth from the vial into the media fill bag. The broth promotes microbial growth so any exposure to bacterial or fungal contamination will yield growth within a 14-day incubation period. After incubation, a clear bag with no turbidity, particulate, or other foreign bodies present in the solution indicates a passing test. Once the media fill test is completed, the QAC takes a second set of fingertip and thumb samples as described above. Once again, the staff member cannot use 70% sterile isopropyl alcohol on the hands immediately prior to the staff member touching the plates.

Documentation

Personnel Competency Checklist

In addition to training checklists, the QAC uses the personnel competency checklist during the observations. It includes sections on gowning and garbing, hand hygiene, aseptic technique, and related practices. The personnel competency checklist is used as a guideline for compliance, ensures staff knows steps listed in the section, and is used as a benchmark for continuous improvement.

Training Records

Training records are documented in an Excel spreadsheet and in our pharmacy compliance software. To simplify competency follow up, each staff member is listed twice on the spreadsheet under the months their competencies are due. When staff completes their competencies, the staff member’s name is listed on another spreadsheet designating which individuals have been tested, along with the date of the tests and when to read the plates and the media fill bag. Our compliance software provides an electronic documentation of the competencies. All the pertinent information of the competency and results are included such as:

  • Manufacturer
  • Lot and expiration of the media fill bag and vial
  • Quantity of CFUs on the plates
  • Testing dates
  • Result read dates

Each staff member’s completed personal competency checklist is sent to them to allow for tracking and personal development.

Competency Evaluation

The competency evaluation is a series of 30+ training modules with pre- and post-testing within each module provided through our training software. These modules are completed by each staff member on a biannual basis. These modules are designed to keep the staff up to date on the latest training that is established under USP <797>, <800>, and <71>. Specific modules are assigned to be completed annually and must be done by December 31st. Completion of these modules is manually documented in our pharmacy compliance software.

Scheduling of staff competencies occurs every month. Coordination is required to ensure staff is present during the date and time of the scheduled tests and that patient care will not be impeded. Once the testing date is determined, staff are informed, and Outlook calendars are utilized to schedule assessments. If there is a change of plans, communication occurs between the individual and the QAC for rescheduling the test. More individuals are scheduled for testing at the beginning of the month to ensure all staff members due that month are tested. This allows changes of test dates and retests to occur due to unforeseen circumstances. Careful planning is needed to ensure all staff members due for the month are tested during that month.

If a staff member should fail any part of the competency, be it the gloved fingertip sample or media fill test, the individual must be retested for both tests. First, they must go over what they might or might not have done to cause the failure with the QAC. Following counseling, the staff member can be scheduled for a retest. Per policy, the staff member has two additional opportunities to pass the competencies. If a failure occurs after the third attempt, the staff member is suspended from compounding sterile products or checking compounded sterile products for 6 months. After 6 months, the staff member is allowed to retest using the initial competencies criteria. Any failure for initial testing of a new employee results in that employee being barred from compounding sterile products or checking compounded sterile products prior to passing the initial sterile compounding competencies. The time between retests varies between individuals, and documentation occurs throughout this process.

Overcome Implementation Challenges

Coordinating sterile compounding training comes with some challenges. It takes time and effort to set up the training and to ensure new staff will be ready to take the competencies and will be able to complete the training modules within their training timeframe. Even with advanced scheduling, some individuals require more time than initially allotted to master and pass the competencies and feel comfortable working independently. This can have downstream effects on staff schedules when these pieces do not fall into place. As individuals move from the training period and begin working independently, they are then staffed in the SPR to gain confidence and build on their skill set. However, this creates challenges when staffing additional trainees, as it is not ideal to have staff with minimal experience training new staff members.

The ongoing staff competency program poses additional challenges. With over 100 staff members requiring competency assessments twice a year, scheduling can be difficult between full-time, part-time, or per diem, pharmacists, pharmacy technicians, and interns. The testing schedule must fit into the QAC availability while simultaneously maintaining workflows in the SPR and other areas within the pharmacy. Planning of the competencies also needs to consider when the test will be read; for example, gloved fingertip plates are read in 72 hours. Tests are scheduled so that the reading of results does not fall on the weekend or a holiday when there is no one available to evaluate the results.

Competency rescheduling occurs often and can wreak havoc on a carefully planned testing schedule. For example, if a staff member calls in sick on the day of the scheduled competency, then the rescheduling process would have to begin again.

It is important to plan for competency failures. This can occur during initial testing in the training period or during an ongoing competency for a current staff member. As soon as a failure is discovered, a root cause analysis is undertaken between the staff member and the QAC to determine what could have occurred during the test. The QAC then reviews the personnel competency checklist for any items or noncompliance during the fingertip and media fill competencies. Often, sterile compounding training plays a role in the failures. Most failures occur when staff are rushing to finish the competencies to return to their work, or because trainees have not had sufficient time to train in the skills needed to pass the competencies.

Best Practices

To determine training schedules, set up a template for standard days and shifts to allow exposure to a variety of workflows. Templated schedules should be tweaked over time based on feedback from trainees and trainers to provide the most efficient and comprehensive training period. Also, include pharmaceutical calculations practicum exams for new staff training in sterile compounding. While the focus is often on gowning/garbing and aseptic technique, fundamental knowledge of pharmaceutical calculations must be emphasized and demonstrated.

Another best practice is to have experienced sterile compounding technicians mentor pharmacists. Typically, the pharmacy technician does the compounding, whereas a pharmacist may not get that type of training in pharmacy school. Additionally, create a frontline staff survey to gather responses about your current training and competency program. This allows the frontline staff to describe what they think is successful in the program while also identifying improvement opportunities.

Consider scheduling “competency days” to focus on didactic education—this allows protected time for staff to absorb the information, though it does need to be balanced against staffing restraints.

Lastly, it is always best to try to stay ahead of regulations. Training program leadership should be aware of the new drafts of USP <797> and other pertinent USP chapters, as well as local and federal requirements that might be coming down the pipeline.

Conclusion

Developing a comprehensive training and competency program for sterile compounding is a time-consuming and thought-provoking process. It takes a team of leaders and experts to work together to both develop and maintain the program. Clear and open communication between the scheduling, training, and quality teams is a must for a successful program. An electronic platform to manage documentation is critical for ease of access to this information, and is helpful during regulatory audits, as one can easily run a report with all pertinent employee training and competency documentation. Also, push-type reminders to staff are helpful to ensure that staff and program leaders complete tasks and competencies on time. Finally, relying on frontline staff for feedback is of the utmost importance for making continued improvements to any training and competency program.


References

  1. Pharmaceutical compounding—sterile preparations (general information chapter 797). In: The United States Pharmacopeia, 36th rev., and the National Formulary, 31 ed. Rockville, MD: The United States Pharmacopeial Convention; 2013: 361–98.

 


Caryn Belisle, RPh, MBA, is the director of pharmacy regulatory compliance, quality and safety at Brigham and Women’s Hospital, Boston Massachusetts. She currently serves as president-elect on the Massachusetts Board of Pharmacy in the hospital pharmacist seat. Caryn has also served as president of the Massachusetts Society of Health System Pharmacists and is a member of the ASHP Council on Public Policy.

Josephine H. Leung, PharmD, MBA, is the pharmacy manager of sterile compounding services and ambulatory infusion services at BWH. She received a PharmD from the University of Maryland, School of Pharmacy and an MBA from the University of Baltimore, Merrick School of Business.

Megan Rocchio, PharmD, BCPS, is a pharmacy supervisor and PGY1 residency coordinator at BWH. From 2015 through 2020, she oversaw sterile compounding operations in the pharmacy department.

Nakkisha K. Stephens is the pharmacy technical operations coordinator at BWH. She has been with the institution since 1999 and has advanced pharmacy technician practice as a leader in inpatient and ambulatory operations.

Jennifer C. Vaughan-Copeland is the quality assurance coordinator at BWH. She has been with the institution since 1997 and has advanced pharmacy technician practice as a specialist in the investigational drug service.

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