As health care professionals, embracing the need for continuous training and education is not always intuitive. I know the skills I used as a post-graduate pharmacist in 1983 are quite different from the skills I now use in pharmacy. Like most of us, my understanding of sterile compounding was formed during pharmacy school. While school provided me with a solid foundation, my sterile compounding knowledge has evolved with each subsequent employment opportunity. This evolution was crystallized when I worked for Baxter Healthcare under current Good Manufacturing Practices (cGMPs) and Baxter’s Quality System. I entered the position confident of my sterile compounding and quality practices knowledge, but eventually had to accept that much of my working knowledge was not adequate to meet the challenges of managing a cGMP operation. My experiences at Baxter are likely very similar to those many pharmacists encounter today in their journey to comply with the principles and requirements of USP Chapter.
The Exemplar Approach
To complement the available resources that detail the structure and subtleties of proper training and education programs, the use of an exemplar can provide clarity by demonstrating a model of a successful approach. The following exemplar outlines a blueprint for a robust employee-training program at a hypothetical, Level 1 trauma center hospital in a major metropolitan city.
In this scenario, the hospital pharmacy department has approximately 70 staff members that need to be qualified to work in the sterile compounding area. On a daily basis, the staff prepares up to 25 bags of adult and neonate parenteral nutrition (PN) and several hundred compounded sterile preparations (CSPs). A limited number of hazardous drugs are compounded on a weekly basis—approximately four doses per week. The hospital pharmacy has six primary engineering controls in the sterile compounding area, with the following equipment routinely in use:
- Five laminar airflow workbenches (LAFWs)
- One Class II, Type B2 biological safety cabinet (BSC)
- One Baxa EM2400 parenteral nutrition compounder
Assessment and Level Setting
The first challenge in establishing an assessment program for 70 sterile-compounding employees is to determine and qualify their existing experience with, and knowledge of, sterile compounding. A didactic approach is the easiest and most effective way to evaluate this. Some of the key skills to focus on include, but are not limited to, the proficiencies and competencies listed in Table 1.
These skills will be evaluated through the hospital’s didactic learning management system using commercially available sterile compounding modules. Upon completion of the didactic and written testing assessments, several psychomotor and media test skills will be evaluated (see Table 2).
When a significant number of employees must complete the annual training requirements, the challenge of scheduling can be quite daunting. Some hospitals take a blitz approach and schedule every employee to complete the process in the first two months of each year. There are many reasons that a blitz approach is not ideal, including:
- Employees are rushed to complete activities
- Important detail-oriented activities become bothersome tasks
- Managing the requisite paperwork for a group this size can be overwhelming
- The volume of media fill units and environmental sampling plates may exceed the capacity of available incubators
The recommended approach is to spread training activities over time and coordinate the support resources necessary to properly evaluate the proficiency of such a large group. In our exemplar, annual testing will be conducted for one employee every five days so that by year’s end, all 70 will have completed their testing. During the testing process, each of the six primary engineering controls will be used on a rotating basis. To simplify each employee’s proficiency evaluation, a customized visual assessment form will be created based on the sample appendices III-V in USP . In addition, staff will be required to complete a media fill designed to mimic a challenging but routine compounding process, immediately followed by a gloved fingertip sample and surface sample of the work area. For additional information about the requirements in the chapter, a training and competency matrix is available at: www.pppmag.com/criticalpoint/trainingmatrix.
Employees responsible for evaluating personnel or performing the visual assessments and environmental sampling will require advanced training and their competency at these tasks also must be evaluated. Designate a mentor/expert to manage this process.
At year’s end, each of the 70 people will have been properly evaluated. Their testing and proficiency data will be documented and maintained within an electronic quality management software program. Data from the media fill units, gloved fingertip sampling, and surface sampling will provide objective feedback to the employee on their skills in the sterile compounding area. Employees will take pride in being able to perform at a specific skill level and having qualitative and quantitative data will foster their craftsmanship. Those employees without the necessary psychomotor skills or knowledge to safely prepare or check CSPs without additional training and mentorship will be identified. This data along with data from the semi-annual air testing and engineering control certification activities will provide the necessary information for pharmacy leadership to ensure operational control and identify any deviations.
Getting Full Value from Your Certification Provider
The goal of certification is to help ensure that your primary engineering controls and cleanroom facility are working properly and can maintain a state of control. To that end, your certifier should be using the testing and certification procedures outlined in the Controlled Environment Testing Association (CETA) document: Certification Guide for Sterile Compounding Facilities (CAG-003-2006), revised December 8, 2008. If they are not, find out why.
Among the growing number of outsourced services available to hospital pharmacies, many certification companies now offer viable air and surface testing on an outsourced basis. In choosing an outsourcer for these services, it is important to verify that the vendor understands how to properly collect, handle, incubate, and report the results of sampling. To ensure that their personnel are properly trained, request a copy of the vendor’s training program and training records. Regardless of how samples are managed, the vendor must include a competent microbiologist, infection control professional, or industrial hygienist in the process.
With a comprehensive plan and supportive leadership, the training and evaluation requirements of pharmacy personnel working within the sterile compounding area can be met. To ensure that training and proficiency testing is well managed, assign one person to lead this process. By focusing on sterile compounding craftsmanship, you can create and encourage a culture of quality. Your tenured personnel can then foster and enforce this culture.
Eric S. Kastango, MBA, RPh, FASHP, is the president, CEO, and owner of Clinical IQ LLC, a provider of customized process and educational strategies for the pharmaceutical, medical device, and health care industries. A member of USP’s Sterile Compounding Committee, he has practiced in the field of both hospital and home care pharmacy since 1980.
Additional Training Resources
- Attentus Medical Sales, Inc
- Berkshire Corporation
- Critical Point, LLC
- Pharmaconomics, Inc
- USP797.org, Inc
- Valiteq Lab Safety Corporation
- Clinical IQ, LLC
- Hardy Diagnostics
- Lasco Services
- Micronova Manufacturing, Inc
- Pharmacy OneSource, Inc
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