By Lou Diorio, RPh, and Dave Thomas, RPh, MBA
According to USP <797>, “compounding personnel are responsible for ensuring that compounded sterile preparations (CSPs) are accurately identified, measured, diluted and mixed, and are correctly purified, sterilized, packaged, sealed, labeled, stored, dispensed, and distributed.”1 Given this, you need to be certain your sterile compounding personnel have the requisite knowledge and resources. It is untenable to assume your staff can conform to these strict guidelines simply because they have the proper academic credentials.
In 1991, the results of an ASHP study recommended that more formal education be provided in sterile preparation and quality assurance requirements to those expected to perform these tasks. In fact, as part of this study, the results of a survey sent directly to the deans of colleges of pharmacy found that only about one-sixth of respondents believed their students were adequately trained in compounding CSPs before graduation.2 So, it is critical that you take steps to assess and close these potentially dangerous gaps in the education of your compounding personnel, and furthermore, assure the “working knowledge” some employees bring to their jobs is adequate to meet the challenges they will face inside the modern cleanroom.
The first challenge in tackling this issue is to determine and qualify your personnel’s existing experience with, and knowledge of, sterile compounding. In the March 2010 issue of Pharmacy Purchasing & Products, Eric Kastango provided a simple but effective blueprint for this task.3 His listing of the requisite competencies to determine your employee’s skill levels is a good starting place, and together with your facility’s policies and procedures manual, you can take steps to ensure that educational gaps are minimized or eliminated.
Developing an Effective Training Program
In order to develop a comprehensive program for your employees, start with your policies and procedures manual. Although USP <797> describes suggested standard operating procedures (SOPs), the list of the 23 areas described therein is neither complete nor comprehensive. It is merely a starting point for your staff’s educational development.
Although many sources for generic cleanroom policy and procedure manuals exist, these must be tailored to your specific practice and a periodic review schedule must be established. Having a clear, up-to-date, and comprehensive policy manual containing documented best practices to train and work from is the cornerstone of any solid CSP operation.4 Full review of your training materials should be performed when considering any new or augmented practices. It is also a good idea to maintain a library of professional publications that regularly run articles related to compounding sterile preparations, as all the national pharmacy associations have training resources available; it is just a matter of finding what works best for your needs and your staff. Remember that training is a dynamic process, and your training program must be reviewed and maintained to assure it is up to date.
The most successful programs will be interesting and interactive; engaging participants rather than simply having them sit through long lecture sessions on proper technique. The best programs bring together hands-on practice sessions, one-on-one tutorials, as well as interactive virtual lessons, all geared to teach the required material and at the same time make the lessons fun. One of the most important goals of your training program should be to create within your staff the culture and attitude that all employees are responsible for the quality of the preparations produced, no matter how limited their involvement. Any employee witnessing breaks in technique or deviations from standard policies and procedures should feel comfortable correcting even the most tenured staff member or trainer.
Creating an Ongoing Training Environment
With the advent of computer- and web-based learning modules, employees can not only learn at their own pace, but also have some flexibility regarding when they learn. Some employees prefer to engage in training after work hours, away from the rush of daily operations. Keep in mind that flexibility also requires discipline, so be sure to clearly communicate the deadlines outlined in your policy and procedures manual for both intermittent and annual training.
Whatever training format you choose, providing your employees with the latest and best information available will make your operation more successful. Your biggest challenge in this area will be choosing materials that allow you to monitor employees’ progress and assist them if needed. Several good educational resources exist with this capability, and as with any important decision, it is best to review and consider several before making a final decision.
Incorporating Return Demonstration
Throughout the training process, employees must have a clear understanding of their job responsibilities. This will assist them in understanding how they fit into the mission of your operation. Before you begin training, make sure all personnel have a copy of their job description, as well as background information about the organization and information on the CSPs they will be preparing. Remember, documentation of training only assures personnel attended the training activity, it does not guarantee they absorbed the information. Therefore, it is critical that verification of the employee’s ability to perform the duties required is demonstrated during training. Return demonstration over time is a simple way to assure what has been taught to the employee during training will translate to the actual compounding process, in perpetuity.
The Costs of Training, Documentation, and Compliance
In reviewing the literature it is no secret that compliance to USP <797> will increase spending in the cleanroom. Direct increases can be expected in the following areas:5
When either reviewing an existing training program or developing a new one to meet USP <797> requirements, the subject of cost is always a concern. Rather than hold onto a program that is either inadequate for your operation’s needs or is simply ineffective, we would ask the larger question—can you afford not to be compliant? Regardless of the risk level of an individual compounded CSP, all sterile compounding comes with inherent risks and dangers. Training employees is an investment in your operation and only through constant staff development can you hope to foster a culture of continuous awareness.
Managers and administrators of CSP operations must create and maintain opportunities for staff to learn by introducing tools and programs that use a multi-faceted approach for the highest level of possible success. Competency-based learning is at the bedrock of all successful staff development activities. Vigilance by cleanroom supervisory personnel will help assure that your policies and procedures are in sync with your educational programming, thereby controlling the quality and safety of the final products delivered to your patients.
Lou Diorio, RPh, is a principal of LDT Health Solutions, Inc, a quality management consulting company specializing in compounded sterile preparations and regional compounding solutions. Lou is a graduate of Long Island University’s Schwartz College of Pharmacy and can be reached at LSDiorio@LDTRx.com
David L. Thomas, RPh, MBA, is a principal of LDT Health Solutions, Inc. Dave is a graduate of St. Louis College of Pharmacy and can be reached at DThomas@ldtrx.com
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