Pharmacy Cleanroom Staff Education and Development
Dr. Elaine Strauss, PharmD, MS / WB | Clinical / Jan 3, 2019
You’ve been asked to oversee the training program for your cleanroom staff and the annual training and refreshers are coming up. How do you approach it? What needs to be done? Can you continue to train as you’ve done in the past?
In light of upcoming USP <797> and <800> revisions due to be published later in 2019, there are some new requirements regarding staff training and education.
First, who is responsible for overseeing your staff training program? The revised USP <800> specifies that each site have a “…designated person who is qualified and trained...” and someone who ensures “…the competency of personnel1…” This individual can be the pharmacy manager/supervisor, a lead pharmacist, or a lead or senior pharmacy technician. Regardless of who this person is, they should complete additional training such as an advanced compounding certification and have the necessary experience to oversee training.
Next, how should you structure the training program? Research shows that learners retain about 90% of what they see, hear, and do. Therefore the development of a multi-modal learning program is key for adult learners2.
Initial training for a newly hired staff member should include:
- Didactic training (training videos, reading articles, guidelines, USP chapters, entity SOP)
- Observational learning
- Written testing
- Visual demonstration of proficiency: hand hygiene, garbing, gloving; cleaning and disinfecting; aseptic technique
- Objective demonstration of proficiency: media fill testing, gloved fingertip test
Ongoing training for existing staff members should include:
- Annual written test
- Every six month evaluation/demonstration of skills via gloved fingertip test and media fill sample
- Any staff member with a pause in compounding of six months or more are required to complete training
Training programs should include the following core competency areas:
- Hand hygiene and garbing
- Cleaning and disinfection of PEC and SEC spaces
- Aseptic manipulation
- Proper clean room behavior, movement
- Proper use of PECs and HEPA filtered unidirectional airflow
- Measuring and mixing
- Compounding calculations and pharmaceutical math
- Methods of sterilization and depyrogenation, if your compounding entity uses these techniques
- Use, calibration, cleaning, and maintenance of all related compounding equipment
- Documentation, compounding records, and, master formulary records
- Cleanroom certification and environmental monitoring
Finally, now that you’ve mastered the development of your training program, here are some additional best practices and tips to consider:
- Ensure that you are providing frequent review and feedback to both new and existing staff whenever deficiencies are noted
- Any staff or supervisors overseeing the training program should complete an advanced compounding certificate program
- Watch out for practice drift! A study published in AJHP3 initiated a training program where video footage is used to validate compounding technique after staff completed initial competencies. They found that practice drift occurs overtime and continuous vigilance is necessary to ensure staff approach all compounding tasks with the same level of diligence as they did during initial training and evaluation.
- Experienced pharmacists and technicians may bring with them a wealth of compounding knowledge. Make sure that any bad habits from previous compounding workplaces are quickly identified and discontinued.
References:
- Hazardous drugs—handling in healthcare settings (general information chapter 800). In: The United States Pharmacopeia, 40th rev., and the National Formulary, 35 ed. Rockville, MD: The United States Pharmacopeial Convention; 2017.
- https://www.nhi.fhwa.dot.gov/downloads/freebies/172/pr%20pre-course%20reading%20assignment.pdf
- Connor TK et al. Am J Health Syst Pharm. 2017; 74(16):1218-19.