The Importance of Proper Aseptic Technique
By Holly Simmons, R.Ph., President, Impact Solutions Group, Inc.
The US Pharmacopeia’s USP General Chapter <797>: Pharmaceutical Compounding – Sterile Preparations was released in January 2004. These guidelines apply to all healthcare professionals who prepare sterile medications and the ultimate goal of the requirements is to increase patient safety. There have been numerous unexpected patient deaths over the years as a direct result of contaminated compounded sterile medications. Also, it is likely that many more deaths were the result of contaminated medications. Either the chance of a contaminated medication was not investigated at the time of death, or could not be definitively traced back to the point of medication preparation.
The approach of USP General Chapter <797> is multifaceted, providing recommendations for physical facility improvements, written policies and procedures, proper operational processes, and suggestions for quality assurance methods and standards. In future articles, I’ll take various sections of USP General Chapter <797> (Often abbreviated to “USP <797>”), and the current proposed revisions, break them down into small sections and give an overview of the purpose and intent of each section. The discussion in this article will primarily refer to pharmacy-prepared compounded sterile preparations (CSPs), although the guidelines do apply to all healthcare professionals and organizations that compound sterile medications, including physician offices, and ambulatory clinics. It is important that those facilities follow all facets of these guidelines as well.
Each of the recommendations and requirements in USP <797> is equally important in increasing patient safety to the highest levels possible. The physical facility improvements can easily cost upwards of $100,000, since there are stringent requirements for the sterile airflow that is provided to cleanrooms, as well as the actual layout of the facility. To meet the air handling portion of the guidelines, a new HVAC system is often required, which will increase costs significantly. Some pharmacies have already performed a remodel, while others are still in the planning stages. During site visits to many hospital and home infusion pharmacies over the past two years, I have been amazed that many have taken a “wait and see” attitude and are waiting to implement ALL operational process until after the physical facility remodel is complete, While physical facility changes are essential, I cannot emphasize enough, the point that pharmacies can begin to increase quality NOW, just by becoming more diligent in staff supervision and quality assurance monitoring activities. Specifically, I’d like to focus on the importance of proper aseptic technique while preparing CSPs. You can build a beautiful facility, but if the people that work in the facility do not follow correct processes for materials movement and proper aseptic technique, it can minimize the value of the money that you spend to build or
improve your facility.
You can begin to make positive changes to your processes TODAY! The use of proper aseptic technique, when preparing sterile products, is sorely missing in many pharmacies across the country. My definition of aseptic technique encompasses not only the manual manipulation of equipment, vials, and syringes in the sterile cleanroom environment, but also proper hand hygiene, garbing, and movement within the compounding area. When proper hand hygiene is used, the hands still harbor microorganisms and a gloved hand is only sterile until it touches a non-sterile surface. Therefore, even when garbed, touch contamination is a likely potential source for CSP contamination. Proper aseptic technique can reduce the possibility of touch contamination. There also appears to be a great lack of appropriate training within many facilities that prepare CSPs. From NO training to IMPROPER training for staff, the deficiencies can negatively affect the sterility of pharmacy-prepared CSPs. Sure, there are videos and written tests available. Maybe employees are made to watch these videos yearly, but does that really enforce proper technique? I think it’s good to review the videos regularly and to be tested on the content, but that should not be the only way that you impart and review aseptic technique. Reviews should be ongoing; and not just annually. The review should minimally include observation of the whole process:
- Proper hand hygiene
- Proper donning of garb, including shoe covers, beard covers (where applicable), head covers, face mask, non-shedding gown, and sterile gloves
- Proper movement of materials and medications to be used while compounding: how do they get to the laminar airflow work-center (LAFW) or Biological Safety Cabinet (BSC)? Are the exterior portions of container wiped down with suitable disinfectant prior to compounding? Does the employee use correct manual manipulations and always avoid blocking the HEPA-filtered air?
Managers and supervisors should observe movements of all staff (including pharmacists and technicians) regularly to assure that the proper technique is maintained. The cleanroom work environment should foster a collaborative work atmosphere, where employees can critique each others’ technique without fear of retribution.
Upon hire, all pharmacists and technicians should be made to go through an intensive orientation program regarding aseptic technique. I have visited some facilities that do not require pharmacists, and sometimes technicians, to go through aseptic technique orientation, if they have prepared sterile products at another facility. Do not assume that they know CORRECT aseptic technique, just because they may have prepared CSPs elsewhere! All employees who compound should be comfortable with the observation process and should know that they will be assessed on a regular basis. After all, this is not about protecting egos, but is about Patient Safety! I often ask groups of pharmacists or technicians that I work with if they would want to be a patient in their own facility, or have a loved-one receive compounded sterile preparations that have been mixed in their facility. Many have to pause before answering, because there are some doubts. How would you answer regarding your facility? For those of you that are pharmacy directors, managers, or supervisors, start REALLY watching your staff that prepare CSPs. Let them know that you are involved. If you personally do not prepare CSPs as part of your job, consider doing it on an occasional basis; at least for the critique by others of your aseptic skills. Pharmacists that directly supervise compounding employees should adhere to the same requirements that ALL compounding staff are required to meet, even if they do not staff the cleanroom on a regular basis. This involvement will garner respect from employees and will also ensure that the supervisor is “kept in the loop” regarding compounding activities. Sometimes, when employees are in full compounding garb, they develop a false sense of security and may not realize that the way they move and touch materials while compounding has a huge effect on the sterility of the end-product.
The old adage “you don’t know what you don’t know” can be aptly applied to pharmacists and technicians who prepare CSPs regarding their knowledge of aseptic technique. Many pharmacy schools and educational programs lack “hands-on” training in aseptic technique, therefore, many pharmacists do not even recognize that they may be lacking
the proper skills to maintain sterile airflow to the critical sites of vials, syringes, tubing, etc. that are being used to mix CSPs. The next time you compound medication (or observe your staff), take great care to observe where the hands and gloves touch after handwashing, all the way to the point of compounding medications. Are the gloved hands disinfected (with 70% isopropyl alcohol) on a regular basis? Do vial and syringe manipulations in the sterile environment ever block the “First Air” (HEPA-filtered) within the
LAFW or BSC? For example, it is a common misconception when working in a horizontal LAFW, that the mechanics of the manipulations made with hands and arms are not as important if working within the area that begins 6 inches inside the hood. While it is true that the manipulations should be made at least six inches from the outer edge in a horizontal LAFW, it is essential that NOTHING pass between the critical sites of vials and syringes and the HEPA filter. I often see compounding staff leaning into the work area
of the hood with the head, or laying their arms and elbows on the compounding work surface. Additionally, they manipulate the vials and syringes in a manner that does NOT maintain consistent airflow to critical sites. When corrected, they often did not even realize that they were not following proper aseptic technique, or “knew better” and just were
not aware that it was happening. This is just one example, but we are humans, which means we will occasionally make MISTAKES and can easily fall into BAD HABITS, if we are not constantly diligent. The concepts presented here, may seem simple at first glance, but are the first line of defense in preparing CSPs that are free from contamination. Do not misinterpret the fact that the physical facility changes (and the other areas of USP Chapter <797>) are extremely important and necessary. BUT, the way that staff uses
the new facility is equally important!
In future articles, we’ll take a look at carved-out sections of USP <797>, since it is much easier to digest and understand in “small bites.” Keep in mind that proper technique is the first “building block” to reducing the possibility of contaminated products being dispensed from your pharmacy and therefore reducing the potential for patient harm or death.