Cleanrooms no matter how they are constructed or configured—all must serve the same purpose, which is to provide atmospheric conditions that will protect compounded sterile preparations and compounding personnel.1 This is also true of compounding operations that forgo the “traditional” configuration of a primary engineering control (PEC) surrounded by a secondary engineering control (SEC), opting instead for a compounding aseptic isolator (CAI) in a non-ISO classed location (i.e., segregated compounding area).

However, even the best-designed cleanroom will not be effective unless the compounding personnel are properly trained. Making sure your compounding personnel receive proper training ensures the safety of both the patient receiving the CSP and the personnel preparing it.
The robust Responsibility of Compounding Personnel section of USP highlights the importance of proper personnel training and maintaining complete training documentation. In fact, the chapter states, “personnel who prepare CSPs shall be trained conscientiously and skillfully by expert personnel and through audio-video instructional sources and professional publications in the theoretical principles and practical skills of aseptic manipulations and in achieving and maintaining ISO Class 5 ... environmental conditions before they begin to prepare CSPs.

Compounding personnel shall perform didactic review and pass written and media-fill testing of aseptic manipulative skills initially, at least annually thereafter for low- and medium-risk level compounding, and semiannually for high-risk level compounding. Compounding personnel who fail written tests or whose media-fill test vials result in gross microbial colonization shall be immediately re-instructed and re-evaluated by expert compounding personnel to ensure correction of all aseptic practice deficiencies.”2

Responsibilities of Compounding Personnel
According to USP , “Compounding personnel are responsible for ensuring that CSPs are accurately identified, measured, diluted, and mixed and are correctly purified, sterilized, packaged, sealed, labeled, stored, dispensed, and distributed. These performance responsibilities include maintaining appropriate cleanliness conditions and providing labeling and supplementary instructions for the proper clinical administration of CSPs."  Beyond this, compounding personnel are responsible for understanding why specific compounding procedures are in place, the importance of following these procedures, and why deviations from them are unacceptable.

The responsibilities of compounding supervisors are also outlined in the chapter. Supervisors must ensure their compounding personnel are adequately trained to perform and document their duties, including antiseptic hand cleansing and disinfection of non-sterile surfaces; properly selecting and donning protective garb; maintaining or achieving sterility; properly managing ingredients using aseptic technique; and properly labeling and inspecting finished products. Furthermore, supervisors are responsible for protecting both the worker and environment from any contamination from hazardous drugs.

Every step in the compounding process, from proper gowning to the packaging and delivery of the CSP to the patient, has an effect on the final CSP, therefore, all personnel must be vigilant and willing to speak up when compounding personnel, regardless of position or title, are not following proper procedures or when a particular procedure does not seem to make sense. Compounding personnel must take pride in what they are doing and fully understand the importance of their contributions in the compounding process.

Developing an Effective Training Program

To develop a comprehensive program for your employees, start with your policy and procedure manual. Although USP describes suggested standard operating procedures (SOPs) within its text, the list of the 23 areas put forth is neither complete nor comprehensive.

While policy and procedure manuals of varying prices and completeness are available from many sources, it is important to note that these are generic manuals that must be tailored to your specific pharmacy practice. Having a clear, up-to-date, and comprehensive policy manual containing best practices to train and work from is the cornerstone of any solid CSP operation.

Designing the Policy Manual
A solid policy and procedure manual should contain, but not be limited to, the following areas of CSP preparation:

Orientation, Training, and Competency Evaluation covers how to train compounding staff to correctly perform and document the critical activities in their sterile compounding duties, and should reflect initial training for new employees, on-going training (review), and new skills training for new automation, devices, or products.

Good Documentation Practices details how to properly sign, document, and record critical records. It also highlights the consequences of improper documentation.

Universal Precautions for the Healthcare Worker contains definitions of the terms referred to in the CDC and other federal guidelines related to universal precautions, and gives an overview of the type of precautionary measures that are needed to protect health care workers from harm.

Cleaning and Disinfecting the Compounding Areas describes, standardizes, and defines the processes by which the controlled environments (ISO Class 5, 7, and 8) and the general preparation area are cleaned, disinfected, and maintained in a manner that ensures an environment suitable for CSPs.

Aseptic Technique Overview provides the general principles and techniques of asepsis for properly compounding sterile preparations. Aseptic technique refers to procedures performed under controlled conditions in an effort to minimize the risk of contamination and is the foundation of product integrity. At a minimum, this section should cover aseptic technique, hand hygiene and garbing, and cleaning and disinfecting.
This section should also contain a written description of specific training and a performance evaluation program for individuals involved in the use of aseptic techniques for the preparations of sterile product.

Conduct of Personnel in the Compounding Areas outlines the appropriate conduct of personnel in controlled areas, including the cleanroom, ante-room, pharmacy preparation areas, and pharmacy storage/warehouse areas.

Personnel Aseptic Media Fill Verification describes the methods used to verify and continuously monitor the quality of the aseptic technique of all individuals involved in compounding of sterile preparations. It describes methods to verify and continuously monitor the capability of the compounding environment and processes used to produce CSPs for patients.
Gloved Fingertip Sampling discusses the procedures used to monitor and quantify possible viable contaminants (i.e., living microorganisms) on personnel glove fingertip/thumb surfaces.

Environmental Quality Management Overview is designed to ensure that the compounding environment and personnel work practices reflect relevant regulatory requirements, current pharmacy practice standards, and result in a compounding environment with sufficiently low viable and non-viable particles. It also provides basic information about educating compounding staff on the principles of environmental control and the operation of the devices used to achieve this.

Building a Robust and Effective Training Program
If you have not scrutinized your training materials in a while, a comprehensive review is probably in order. Along with maintaining a solid library of professional publications, you should review the training resources available to determine what works best for your needs and your staff. Because training is a dynamic process, your training program must be reviewed regularly to assure it is up to date.

The most successful programs will be interactive, interesting, and engage participants rather than simply having them sit through long didactic sessions on proper technique. Blending various forms of training materials together can produce extraordinary results. Programs that bring together hands-on practice sessions, one-on-one tutorials, as well as video- and computer-based lessons, can cover the required material while making the lessons fun and memorable. One of the most important goals of your training program should be to create a culture where all employees are responsible for the quality of the preparations produced. Any employee witnessing breaks in technique or deviations from standard policies and procedures should feel comfortable to correct even the most tenured staff member or trainer.

With the advent of computer- and internet-based learning modules, employees can learn at their own pace, and also have some flexibility as to when they learn. Some employees prefer to engage in training after work hours, away from the rush of daily operations.

Whatever format you choose, providing your employees the best and most up-to-date information will make your operation more successful. Your biggest challenge will be choosing materials that allow you to monitor employee progress and assist them if needed. Several good educational resources exist with this capability; it is suggested that you demo several before making your final decision.

The key to any program you choose is that it must be competency-based. Throughout the training process, it is important that employees 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 any of the information. Therefore, it is critical that verification of an employee’s ability to perform the duties required is demonstrated during training. Return demonstration is a simple and successful way to assure what has been taught to the employee during training will make it to the actual compounding process.

Training and Documentation Costs
When developing a new program to meet USP requirements for training and documentation, there are often concerns about cost. The most important question to ask is: Can you afford to not be compliant? Regardless of the risk level of the CSP, all sterile compounding comes with inherent risks and dangers, thus, training and employee development are an investment in the continuous awareness culture you are attempting to establish.

Conclusion

Management must develop and execute the most appropriate and dynamic staff training program possible. Programs that stress “continuous awareness” are key to maintaining a safe and efficient CSP operation.1 Management must participate daily in the operations of the CSP area and emphasize that  nonperformance or short-cuts are not acceptable. Proper cleanroom protocols, proper aseptic technique, and strict attention to SOPs are all part of a properly functioning cleanroom operation, which must begin with the “day-one” training of all employees who compound sterile preparations.

Lou Diorio, RPh, is a principal of LDT Health Solutions, Inc, a quality management consulting firm specializing in compounded sterile preparations and regional compounding solutions and can be reached at: LSDiorio@LDTRx.com.

David L. Thomas, RPh, MBA, is a principal of LDT Health Solutions, Inc.  and previously served as the director of information technology operations for SoluNet, LLC. Dave can be reached at: DThomas@LDTRx.com.

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