04-28-2015 02:18 PM
The order of garbing in an ante room seemed simple enough until we saw our State Drug Control Inspection checklist for Sterile Compounding.
Our state checklist states that shoe covers are donned FIRST while crossing over the line of demarcation and THEN head/hair and face masks are donned.
We have been donning our head/hair and face masks FIRST and THEN donning shoes while stepping over the LOD. I also attended a seminar where this exact order of garbing was recommended.
In USP 797 it is a bit ambiguous as to the order of hair/face/shoes and they almost seem bundled together.
If we change our PnPs I really need to be able to explain WHY to our staff. Is the state checklist order of garbing now the new and only accepted order of garbing?
04-29-2015 07:21 AM - edited 04-29-2015 10:15 AM
USP <797> Personnel Cleansing and Garbing
Personnel shall don the following PPE in an order that proceeds freom those activites considered the dirtiest to those considered the cleanest. Garbing activites considered the dirtiest include donning of dedicated shoes or shoe covers, head and facial hair covers (e.g. beard covers in addition to face masks), and face masks/eye shields.
You are correct in that shoe covers, hair covers, and facial covers are referred to in the same sentence. However it does list shoe covers first.
As for an explanation to your staff, I don't think it is too out of the way to establish a new garbing sequence simply because your state inspectors are looking for this order. Your state board of pharmacy, or overseeing agency, is your final authority on USP <797> interpretation and if they see it as shoe covers being required first then, in your state at least, that is what comes first. If another state thinks face masks should be donned first then that is the correct method as well. Each state is going to have slight variations in compliance, at least until more exact wording is placed into <797>
Here in Florida, our state inspectors are looking for customers to comply with things that go above and beyond the requirements set forth in <797>. We all realize that there is quite a bit of gray area in <797> and if certain state's inspectors are trying to better define these areas, I welcome it. It helps to lessen the confusion of compliance for customers.
04-29-2015 11:34 AM
It is sometimes difficult to comply with the state however when what they are requiring us to do does not make clinical or practical sense.
I do NOT want to touch my head cover and face mask AFTER touching my dirty shoes and shoe covers. The way we were instructed - and it was quite clear - at our state wide USP 797 seminar just last month was to don your head and face covers THEN don the shoe covers (which are the dirtiest) as you cross the LOD and then continue on with washing your hands. This is the most aseptic procedure.
I actually think they should remove "Personnel shall don the following PPE in an order that proceeds from those activites considered the dirtiest to those considered the cleanest." Up until washing your hands on the clean side of the ante room, garb should be donned cleanest to dirtiest. This is part of aseptic technique and theory - similar to cleaning your hoods properly: from cleanest to the dirtiest areas of the hood.
04-29-2015 03:02 PM - edited 04-29-2015 03:02 PM
"It is sometimes difficult to comply with the state however when what they are requiring us to do does not make clinical or practical sense."
You could not have said this any better.
As a compliance officer for a certification company, I swim in the inconsistencies between federal and state regulations, and it can be illogical and impractical, however when the people with power to shut down pharmacies say to do things in a certain way, your options are limited. You could write to your Board of Pharmacy, or again the overseeing agency responsible for your inspections, and explain to them why you feel that the order of garbing required by the state is not proper.
04-30-2015 11:11 AM - edited 04-30-2015 11:14 AM
I will also add in, that during the 2014 CETA Conference in Austin, TX, there was an extensive demonstration and practice of the proper USP <797> garbing method, and we were instructed to don shoe covers, step over the LOD, don head covers, don facial covers (beard if necessary), then perform 30 seconds of hand washing with a soapy solution, after which you would don your gown, disinfect hands using waterless alcohol-based surgical hand scrub, then don sterile gloves.
The order you presented is intriguing to me, because it does seem to be the most aseptic method of performing this test. However, when I am performing the Gowning and Garbing Test on my customers, failure to perform the test in the proper sequence, as detailed in Appendix III of USP <797>, results in a failure.
I would really like to hear what Eric thinks of your order of gowning/garbing. It seems sound, but we must comply with regulations, until a revision is made, shoe covers first is the proper method.
04-30-2015 06:45 PM
The order in the chapter was not intended to prescriptive in order that the garb starts with shoe covers, hair cover and mask. I teach head, face and then feet because I don't want to touch my hair or face after my shoes. It really doesn’t matter as to the precision order. I don’t think that pharmacists should be cited for having a slightly different order as long as all of the garb (hair net, face mask and shoe covers) are donned prior to washing the hands. Hope this helps.
05-01-2015 08:52 AM
Ahhh, see now this is eye opening. As I said, shoe covers first didn't make much sense because you wouldn't want to touch your face and head covers after touching your shoe covers. This will take some convincing on my part to get my company to stop citing pharmacy workers for improper garb order. Thank you for weighing in on this discussion, Eric.