Process Improvement: Keep It Simple by Staging (KISS)

For years we have heard the acronym “KISS” which stands for “keep it simple, stupid.” There is also a more positive spin of “keep it simple, smarty” and “keep it short and simple.” The acronym has an interesting historical perspective, as it was originally coined by the US Navy as an engineering design principle. “The KISS principle states that most systems work best if they are kept simple rather than made complicated; therefore simplicity should be a key goal in design, and that unnecessary complexity should be avoided.”[1] Encore’s lead consultant on compounding workflow has come up with a KISS principle that is very applicable to our industry, especially as it relates to hazardous drug handling, which is “keep it simple, by staging.”

Since 2012 Bryan Prince has taught some basic principles for keeping technicians safe during the compounding formulation process. Bryan has had the distinct honor of speaking at industry conferences like Compounders on Capitol Hill hosted by the IACP, the American College of Apothecaries Annual Conference and Expo, and more recently the Accreditation University’s USP <800> Education Workshop, each talk with the same goal of keeping it simple by staging. He starts the speaking session on workflow process improvement with this statement, “I want to give you real solutions that you can take back to your pharmacies right now and implement for little to no extra cost, and that will dramatically clean up your compounding rooms.”

The process of “staging” is really the main central point to minimizing personnel exposure and environmental exposure because once everything needed for a formulation is staged inside the containment primary engineering control (C-PEC) prior to compounding, then the technician really has no need to breach containment. Breaching containment is bringing contaminated gloves (or other soiled materials) outside the C-PEC, where micronized particles aerosolize into the lab environment, creating the exposure. “It’s somewhat of a culture change” Bryan tells his audience. “We actually have to think through the entire compounding process from beginning to end prior to engaging in compounding.”

Here’s how staging starts for a hypothetical encapsulation process… The master formulation record, or compounding record, identifies three chemicals. The technician would stage three weigh boats of appropriate size, three weighing utensils, a mixing vessel, capsule plates (pre-loaded with capsules), the scraper and tamper, an electronic balance (already present inside the C-PEC), a number of wipes (for post-production cleaning protocol), and feasibly additional materials such as a bag for disposable items. The goal of this exercise is to think through the process and stage whatever is necessary to complete the formulation inside the C-PEC before any powder handling beings. Therefore, a four-foot wide C-PEC is really the minimum size “hood” to consider purchasing for a non-sterile compounding room, especially when additional equipment is required for the formulation.

With any process there are obstacles to overcome, especially with non-sterile compounding. There are typically two verification processes prevalent: paper-based compounding records or formulation software. In the paper-based scenario a technician has to manually record each of the chemicals weights by writing on the formulation record. Typically, the paper record is located outside the hood and so the technician has no choice but remove their soiled gloves to record the weights in-between each chemical. The other verification process is when the pharmacy is using a formulation software and has to constantly interact with the computer’s mouse, usually located outside the C-PEC on the counter, just to proceed to the next screen. In both the paper-based system and the software system, the technician has a legitimate reason to remove their hands from inside the C-PEC, which is counterintuitive to the entire purpose behind this staging theory.

How do you keep the technician from bringing their contaminated gloves in and out of the face of the C-PEC? If a pharmacy wants to continue to use paper-based records, then we suggest adding a printer to the electronic balance. The printer is located outside the hood and connected to the electronic balance via a compatible cord. We do not recommend putting the paper record inside the hood because then it is considered contaminated and there is no way to clean paper prior to removal. We also do not recommend taping the paper record to the front face of the C-PEC because then the contaminated paper is in the technician’s breathing zone. The real solution is recording the chemical’s lot numbers, expiration dates, etc. prior to compounding and investing in a printer so the printed ticker-tape is the appropriate verification record. This methodology should prevent the technician from breaching containment.

If the pharmacy is using a software-based platform then the answer is putting a wireless mouse inside the C-PEC. To keep the electronic device from getting dirty and having to be sprayed with cleaning solutions, it is best to utilize a dental supply product called sticky wrap barrier film sheets, which price out about a penny or two a sheet. The sticky sheets should be disposed of between each formulation so as not to create a surface for cross contamination.  Keeping a wireless mouse inside the hood should prevent the technician from breaching containment.

In those situations where it is absolutely necessary for the technician to pull their hands out of the hood, three solutions will minimize environmental exposure. A spray or squeeze bottle of isopropyl alcohol (IPA) should be placed in the back corner of the C-PEC and the technician can apply the IPA directly to a wiper (away from powders already weighed). The partially saturated wiper is then used to remove bulk residue from the technician’s gloves. The technician can then remove their hands briefly before coming back in. The second solution is for the technicians to doff (remove) their outer set of gloves and leave the inside the C-PEC. A new set of gloves will have to donned prior to hands back into the C-PEC. The third solution is for the technician to ask another technician for assistance with whatever the need is. All of these simple solutions will greatly minimize environmental and/or personnel exposure to chemicals.

The simple goal of staging is a sound process improvement that will minimize the potential for environmental and/or personnel exposure, and it saves time. Time spent unnecessarily walking around the compounding room is not an efficient use of the pharmacy’s resources. The final advice on this topic is to train compounding technicians to spend a few minutes thinking through the entire process prior to engaging in the process. If you have any questions or comments about this blog, feel free to send an email to bryan.prince@encoresci.com or call Encore’s Customer Service team at 800-454-2304.

[1] Wikipedia contributors. “KISS principle.” Wikipedia, The Free Encyclopedia. Wikipedia, The Free Encyclopedia, 4 Oct. 2018. Web. 7 Oct. 2018.