Though there are many tools available to pharmacies to facilitate best practice in sterile compounding, an empowered and knowledgeable workforce is by far the bedrock of any truly successful operation. Sterile compounding is a complex process where many smaller steps, each performed correctly, culminate to reduce the risk of error and contamination. There is no amount of managerial oversight that can make up for a staff that has not been adequately trained. Only a staff that embraces the rationale behind policy and procedure decisions and understands the impact that each member has on every compounded sterile preparation (CSP) can ensure consistent, high-quality output.    

USP Chapter <797> and the standards of the Pharmacy Compounding Accreditation Board have both addressed requirements relative to personnel training, competency assessment, and verification. Dedicating the time to plan and execute effective staff training and development is challenging, but has been reported to pay obvious dividends.1 Money spent to build the best cleanrooms and provide the compounding equipment is wasted if your staff cannot use these tools correctly. Staff must be knowledgeable of the fundamental principles of compounding and familiar with pharmacy-specific policies that have been developed using credible literature to reflect the activities performed in the pharmacy. The time spent developing an effective orientation and ongoing staff development program, including meaningful and objective competency verification, is the key to achieving an operation that is in control and consistently provides CSPs that are safe for your patients.

Organization-Specific Policies and Procedures:
The Foundation of Training
Before training can even be developed, well-defined, detailed policies and procedures must be in place, and training must be consistent with those procedures. Though policy and procedures templates are available for purchase, use them only as a foundation for a customized set of policies and procedures that make sense for your facility’s operations and business model.

Each pharmacy’s policies and procedures should be unique and based on its operations, goals, deliverables, applicable requirements of law, and standards from relevant accrediting and professional groups. Policies should not merely sit on a shelf in your office; a detailed set of policies and procedures that reflects how activities should be performed at your pharmacy can form the basis of an effective training program. In fact, employees can be trained directly from the policies, and competency assessment and verification forms can be created from your policies and procedures. Policy-based training can ensure that your staff knows the “why, who, what, and when” of compounding-related activities. You should also establish a policy that addresses the orientation and training of new staff members, as well as ongoing staff development, in order to consistently cover all required generic knowledge, as well as verify the compounding knowledge and behaviors specific to each defined role within the pharmacy. Figure 1 represents a proposed process flow for the design of sterile compounding orientation, training, and competency verification programs.

Training Methods
In order to make learning experiences more valuable for your staff, consider the following key characteristics of adult learning2 as they relate to your staff:

• Your staff will want to know why they need to know information.
• Your staff may only be ready to learn once they decide they need the information to help them with real-life situations.
•  A practical application of information to everyday situations is more likely to elicit a positive response from your staff.

Fortunately, technology is currently available to aid pharmacies in providing cost-effective and high-impact compounding education. With the advent of distance and e-learning applications, providing adult-oriented education is easier than ever. Computer networks, learning management systems, and software have made it possible for every pharmacy, large or small, to provide training that is consistent with adult learning models. Computer-assisted learning (CAL) presents the following advantages:

• Staff can use downtime more effectively.
• Staff can review the material at their own pace, so it accommodates high performers as well as novice learners.
• Staff may feel “safer” and consequently learn more, because there is less pressure to perform.
• Staff may find it more “fun” than paper-based learning.
• Staff may take the opportunity to view the learning modules at home on their own time.
• Depending on the application used, recordkeeping is automated.
• Time is saved because objective testing is automated.
• Managers can run learning activity reports, and e-mail functions may remind learners of required modules.
• Material is presented in a consistent manner, eliminating differences attributable to the teacher.

Whether you create your own computer-based training program or you purchase a commercially available program, by utilizing the computer, you have the opportunity to increase the quality and efficiency of staff training.

Training Resources
Excellent resources have been developed to specifically address sterile compounding in a variety of formats, including on-site training, hands-on classes, CAL, DVD/VHS/workbooks, and computer applications. One example of a hands-on course is the “Compliance Tools and Certification Training Program for USP <797>” held at Baxa Corporation’s Star Center. This comprehensive program is held at a state-of-the-art facility designed for cleanroom and pharmacy practice demonstrations, and combines both didactic and practicum experiences. These courses are excellent for those with little cleanroom background and can serve as a review for a pharmacy’s “master” compounders.

Computer-based training modules have also recently been made available by CriticalPoint, LLC. Their Web-based offering includes 32 one-hour segments covering all aspects of sterile compounding with content that is updated as the USP Chapter <797> evolves. It is housed in a learning management system that provides automated documentation of learning activities to improve administrative oversight of personnel training.

Computer-based quality management system applications such as Simplifi <797> from Pharmacy OneSource and the Valiteq Data Management System software are also available. These applications provide template policies/procedures, core competencies, and automated management tracking and documentation of all cleanroom quality assurance activities. Though all of these training resources require some capital expenditure, they quickly pay for themselves. Instead of spending time developing training programs, pharmacy directors and managers can direct their efforts towards reviewing quality assurance data, routinely mentoring staff, and refining organization-specific policies and procedures.

Pharmacies can also develop their own training materials. However, this takes time and, given the availability of high-quality training resources, a combination of internal and external course material is often the best choice, so long as the education provided is consistent with your pharmacy’s policies and procedures. A combination of classroom, computer-based training, and hands-on learning, as well as on-the-job mentorship, can ensure that your staff learns the material effectively.

Competency Assessment
It is necessary to develop objective measurements for the competency of each staff member’s compounding skills, as well as to document the outcomes of competency assessments. An individual competency checklist, such as the one illustrated in Figure 2, can identify processes that are critical to sterile compounding. These checklists should reflect both knowledge and psychomotor skills, and should be developed directly from your pharmacy’s policy, reflecting any specific procedures.

Remember that competency assessment, as well as knowledge and performance development, are ongoing processes. Desired competencies will change as your staff members and your organization evolves. Therefore, you should measure your new employee’s technical skills and develop ways to measure expert-level competencies for more seasoned staff members as well.

Summary
A thorough CSP training and competency program should be developed in an organized and consistent manner and be based on organization-specific policies and procedures. Furthermore, a consistent staff education and development program, involving the entire pharmacy team, can provide excellent feedback for the continual development of policies and procedures and targeted training and development3. By using high-quality training resources supplemented with internal course material, you can ensure that your staff members learn and excel at compounding practices and that your patients receive the highest quality CSPs possible.

Kate Douglass, MS, RN, APN,C, CRNI is the president of Performance Strategies, LLC, a consulting company assisting the pharmacy, nursing, and health care markets. Douglass served as a reviewer for ASHP’s Sterile Product Preparation CD-ROM: A Multimedia Learning Program; is a module author for CriticalPoint’s sterile compounding e-learning offering and has written several articles on aseptic compounding quality and training. During her tenure as COO of SoluNet LLC, she personally supervised the design, engineering, and build of four pharmacy compounding complexes that met or exceeded USP <797> requirements.