I have had many people ask about USP Chapter <797>’s “new” Competency Testing in Aseptic Manipulation. Why do I put “new” in quotes? The truth is, this actually isn’t necessarily new. It is the way this should have been performed all along. USP has done a much better job of spelling this out for sure. But I’m also going to add something else to the standard way of performing this, which is going to save you time, and most likely money (plata!).

If I explain all of this in one post, it might take a while. So, I’m going to break this down into 4 posts. In the first, this post, we’re going to explore the difference between the competency in aseptic manipulation and the hand hygiene assessment, or I should say, the initial hand hygiene assessment. There seems to be confusion about this, but I’ll clarify the standard.

In the second, I’m going to explain how to design a media fill. This is actually a very simple thing to do when you think about it, you just need to be asked the right questions in order to design this yourself. Because honestly, NO ONE but YOU knows exactly what your media fill should look like. And if you’re currently buying a kit of some kind to accomplish your media fill, save your money! There’s a less expensive, more realistic and better way to design and perform your own custom media fills.

In part 3 I’m going to talk about something the standard doesn’t necessarily include in the competency assessment section, but if you connect the dots, you’d eventually come to this conclusion too. Performing a smoke study DURING the competency assessment. Usually, this task is left to the company that certifies your engineering controls. I’m not sure if everyone is paying money for this task or not, either way, after I show you exactly how to do one of these and what a smoke study should look like (with an accompanying report!), you’ll see that it isn’t complicated and all you really need is an iPhone and a nice air visualization smoke generator (I will clue you into the one I have and would use – and no, I receive no money for endorsing or pointing you in this device’s direction).

In the final part, I’m going to discuss the last 2 tasks someone needs to perform during the aseptic manipulation competency: ANOTHER glove fingertip thumb sample and surface sample. Let me just say, like I said at the beginning, this really isn’t, or shouldn’t be, new to anyone. Rather, this is how it always should have been done. The compounding committee has just now put it in extremely clear and simple terms. And while in the chapter it is only explained in a few paragraphs, to fully understand the reasoning behind why everything is done this way and exactly how to perform this, NOT just for checking a compliance checkbox, but to potentially reveal issues, problems in someone’s process in order to make corrections and IMPROVE QUALITY…THIS is the point of this exercise in reality. Welcome to quality assurance/quality controls 101 (QA/QC 101)!

Okay, my explanation of this series was long, so I’ll keep the actual subject of this first post short. It doesn’t need much explanation honestly anyway…

Hand Hygiene/Garging Competency Assessment (INITIAL) vs Competency Testing in Aseptic Manipulation

Okay, this is very simple: EVERYONE who is going to be compounding MUST do an initial garbing competency 3 times from beginning to end. This means that the person must, under observation, enter the cleanroom, wash their hands, don their garb, apply waterless surgical scrub to their hands, don their gloves and do a glove fingertip thumb sample. THEN, leave the cleanroom, take everything off and repeat TWO MORE TIMES. EVERYTHING, from the very beginning. This is to say, do not just take off your gloves and do the GFTT again. NO. Because the garbing competency is to assess the entire process, not just donning gloves.

This only needs to be done once. Period. It is an initial competency for any new personnel. After this is done, it never needs to be performed again. Maybe with one exception. I suppose if you built a new cleanroom, it might be a good idea to do these again because it would be a slightly different process given the environment has changed. I don’t know, I’ll leave that to you.

The Competency…no, I’m going to abbreviate this: CTAM…the CTAM is meant to be an ongoing, depending on which category (1, 2 or 3) you’ll be compounding, every 3 or 6 months. I will say this, I feel like the chapter explains these things as if they are separate activities, but make no mistake…everything I will explain in this series is meant to be done as a single activity with multiple tasks within. For whatever reason, the chapter explains the garbing competency as a separate subject altogether as if it couldn’t be performed WITH the rest of the aseptic manipulation competency. I am not sure why. BUT, if you do ALL of these tasks as a single activity, you’re able to consolidate a couple things into one task and saving time. BUT, I will say, the way I am going to explain it, you will be performing a glove fingertip sample TWICE, once after you don your sterile gloves (then perform media fill, WHILE conducting and filming the smoke study – but I would change my gloves after the initial glove fingertip sample and before I start the media fill), then you’re going to do ANOTHER glove fingertip sample after the media fill.

Sound scary? It isn’t. And this is why: if you’re doing the appropriate procedure for sanitizing your gloves (and I’ll explain what the “appropriate” procedure is), your gloves should be fairly “clean.” Sterile? I don’t know about that. But they don’t need to be. For the Aseptic competency manipulation, you’re allowed “some” growth (3 CFU between both hands). But for the INITIAL garbing competency, NO. The person must demonstrate the initial competency with ZERO CFU. But remember, the person isn’t doing all of these other tasks. They’re literally just donning gloves and putting their fingertips on media, then repeating the whole process. Easy. It SHOULD be super easy, if you’re donning gloves correctly, to get zero CFU 10 times out of 10.

Okay, that’s all I got for now, I will meet you again here in a few days to go over the next part – media fill. And if anyone has any questions about how exactly to properly don sterile gloves, let me know and I can easily show you this as well – I have a video that demonstrates how to properly wash your hands AND don your gloves (and sanitize them as well!). FUN!

Thanks for reading…see you soon!