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KL
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Posts: 8
Registered: ‎06-15-2011
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Garbing in Ante Room

Our clean room consists of a buffer room and an ante room.  They are separated by a door.  Another door separates the ante room from the main pharmacy.  Can the donning of PPE occur entirely in the ante room prior to entering the buffer area?  Or, is a line of demarcation mandatory within the ante room, with the donning of PPE to occur only on 1 side?

VIP
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Posts: 44
Registered: ‎06-30-2011
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Re: Garbing in Ante Room

To the best of my knowledge, all donning of PPE occurs in the ante room.  After washing their hands and being  fully garbed, personnel are allowed in the buffer room. At our institution, the line of demarcation in the ante room is located immediately before the doors entering the buffer and negative pressure rooms.  The washing of their hands and putting on their nonshedding gowns occurs immediately before the line of demarcation in the ante room. The staff is taught that passing this line of demarcation within the ante room signifies that they are fully garbed and have already washed their hands and are ready to enter the buffer rooms.

 

 At our institution, the shoe covers are donned immediately before entering the ante room so that we do not enter the ante room with dirty shoes.  We also use two tacky mats; one at the entrance to the prep room (computers and IV room supplies and drug inventory are housed here--it is not an ante room*) and;  the other in front of the ante room door.  This has dramatically reduced the amount of dirt from shoes that is brought into the ante room.  We then enter the ante room where we don on the hair cover and face mask before we wash our hands. Before entering the buffer room, the staff in the ante room can wipe down the supplies that are going to be placed within the PEC.

 

*At our institution we technically have four rooms; a prep room (houses supplies for the cleanroom(s)); and three certified clean rooms:  ante room; buffer and a negative pressure buffer room.

Carlos M Marin, RPh
Lead Pharmacist/IV Room/Oncology
Overlook Medical Center
99 Beauvoir Ave
Summit, NJ 07901
MailBox #277
O: (908) 522-2294
F: (908) 908-522-2583
carlos.marin@atlantichealth.org

It is not a case we are treating; it is a living, palpitating, alas, too often suffering fellow creature. ~John Brown
Expert
Posts: 1,142
Registered: ‎02-23-2010
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Re: Garbing in Ante Room

Krista,

 

In the 2008 revision of USP Chapter <797>,  the definition of line of demarcation was missed but it was added the proposed revisions of the chapter in the May/June 2010 Pharmacopeial Forum that included the following language: 

 

Line of Demarcation - a visible line or a color separation on the floor that separates the room into areas for different purposes.  For example, in the ante-area, the line separates the cleaner from the clean area of the room.  When the line of demarcation separates two different ISO classification areas, it must be accompanies by a minimum air velocity of 40 fpm from the cleaner area to the less clean area.  There are references to a line of demarcation in the current chapter.  The following sequence is my recommended order that should clarify your question.  Thanks. 

 

The ante area will have a sink to accommodate hand washing.  The sink should be located on the clean side of the line of demarcation. 

Employees will don Shoe Covers upon entering the Ante Area before crossing over the line of demarcation. The general order after donning shoe covers is as follows:

1.         Don hair net, then don beard cover (if required), and then don face mask;

2.         Clean finger tips with a pick, wash hands and forearms (up to the elbow) with warm water and soap for at least 30 seconds, followed with a warm water rinse and drying;

3.         Don gown, closed at the neck and with elastic cuffs;

4.         Apply hand scrub with persistent activity (e.g., Avagard® by 3M or equivalent); and

5.         Don sterile gloves and routinely disinfect them with sterile 70% isopropyl alcohol or equivalent agent during the compounding process.

 

This hand-washing procedure is consistent with the Guideline for Hand Hygiene in Healthcare Settings published by the Centers for Disease Control (CDC). 

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
Senior Member
Posts: 3
Registered: ‎02-03-2011
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Re: Garbing in Ante Room

Erik,

 

Can you give me some guidance on the garb that is recommended in the IV prep room? There is no specific detail in the USP 797 chapter..are the associates that are in the IV prep room required to wear scrubs from the hospital, wear scrubs that they wear in from home, wear "moon suits"...I know the intent is to be as clean/sterile

as possible but information to clarify this would help me

 

Thank you,

John

 

John Dougherty

Director of Pharmacy

Nemours Children's Hospital

Expert
Posts: 1,142
Registered: ‎02-23-2010
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Re: Garbing in Ante Room

John,

 

I am attaching an article that links garb with the reduction of S. aures. Changing into scubs at work would be in my opinion the best practice to follow. 

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
Senior Member
Posts: 3
Registered: ‎02-03-2011
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Re: Garbing in Ante Room

Eric,

 

Perfect...is there an supplement to the USP 797 that direct the users how to meet the expectations...I agree with your suggestion and have been following this approach but it is difficult to explain to administration..

 

Thank you,

John

 

 

John Dougherty, MBA, PharmD, BCPS

Director of Pharmacy

Nemours Children's Hospital

Expert
Posts: 1,142
Registered: ‎02-23-2010
0

Re: Garbing in Ante Room

John,

 

Im' not sure what you are looking for when you say "supplement to the USP 797 that direct the users how to meet the expectations."  If you are a Simplifi user, then the software is your roadmap.  Let me know what specifically you are looking for.  Thanks 

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
Senior Member
Posts: 3
Registered: ‎02-03-2011
0

Re: Garbing in Ante Room

Eric,

 

Administration is looking for the specifics that the IV room personnel are requrested to wear scrubs laundered from the hospital or a certain coverall..I have communicating it is about making the environment sterile and clean..there are different ways to get to this end point..I have choosen to use hospital provided scrubs with gowns..it has worked..they have been asking why the document is not more directive.

 

Thank you,

John

Expert
Posts: 1,142
Registered: ‎02-23-2010
0

Re: Garbing in Ante Room

John,

 

This requirement [for scrubs] is not in the chapter and I am not sure if it will be in the next revision (although you can suggest it during the public comment period).  I'm not sure why administration is being so literally in their requirement that scrubs be required in the chapter (other than cost-->it is the right thing to do).  As you know, the chapter defines the minimum standards required for sterile compounding.  The importance of wearing proper garb in a compounding environment is no less important than in the OR.  Ideally it is a best practice and I personally would like to see it a requirement in the chapter.  I don't have a good explanation on why the requirement for scrubs is not in the chapter.  Hope this helps. 

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
Senior Member
Posts: 3
Registered: ‎02-24-2013
0

Re: Garbing in Ante Room

 I just read in the  PP&P Periodical on line an article by Kate Douglass, about compliant garbing practice for sterile compounding.  First, let me say at our facility we are garbing per Eric's recommendations below. This is how we set up our clean areas that we moved in to in January of 2015 per the state making <797> law retroactive to January 2014.  Our facility is small and we did a lot of research prior to our build as this is an expensvie build and we wanted to get it right.  We have been donning our shoe covers per below, and actually this is per the <797> revision too.    Now it looks like we are to don hair cover, face cover and  shoe cover, then cross the LOD.  Currently we are doning shoe covers and crossing the LOD. Our dirty area is small.  Are we now going to have to cram the additional items into the dirty area?  Is this the expectation?  Why has this changed?    Also, we follow the donning procedure through to nail cleaning, handwashing, donning gown, surgical hand scrub with persistent activity then gloves, sIPA 70%, then enter the buffer area and use the sIPA 70% then on.  Our rooms are set up with the surgical hand scrub with persistent activity dispenser in the anteroom.    Per Critial Point Personnel Hand Hygiene, Garbing, and Gloved Fingertip Sampling Lesson:  "You may don sterile gloves before or after entering the buffer area."   We don the gloves before entering the buffer areas.  Are we now supposed to apply the surgical hand scrub with persistent activity in the buffer area?  And then don the sterile gloves in the buffer area?    Exposed skin in the buffer area?  Opening the gloves in the buffer area?  Are we not creating additional particles in the buffer area?   Is the expectation that there are dispensers for the surgical hand scrub with persistent activity in the buffer areas?  We want to perform the donning practice correctly and we thought we were.  One other thing, when the state board investigator makes a visit, we are subject to their interpretations as well.  How are other institutions handling the variations in interpretation of the chapter?  This is a perfect example of various interpretations.  I have a lot of questions.  It would be great to hear what others are doing. 

 

Regards,

 

Linda Elias

 

 

 

 

 

Registered: ‎02-23-2010

 

Re: Garbing in Ante Room

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‎10-09-201110:39 PM

Krista,

In the 2008 revision of USP Chapter <797>, the definition of line of demarcation was missed but it was added the proposed revisions of the chapter in the May/June 2010 Pharmacopeial Forum that included the following language:

Line of Demarcation - a visible line or a color separation on the floor that separates the room into areas for different purposes. For example, in the ante-area, the line separates the cleaner from the clean area of the room. When the line of demarcation separates two different ISO classification areas, it must be accompanies by a minimum air velocity of 40 fpm from the cleaner area to the less clean area. There are references to a line of demarcation in the current chapter. The following sequence is my recommended order that should clarify your question. Thanks.

The ante area will have a sink to accommodate hand washing. The sink should be located on the clean side of the line of demarcation.

Employees will don Shoe Covers upon entering the Ante Area before crossing over the line of demarcation. The general order after donning shoe covers is as follows:

  1. Don hair net, then don beard cover (if required), and then don face mask;
  2. Clean finger tips with a pick, wash hands and forearms (up to the elbow) with warm water and soap for at least 30 seconds, followed with a warm water rinse and drying;
  3. Don gown, closed at the neck and with elastic cuffs;
  4. Apply hand scrub with persistent activity (e.g., Avagard® by 3M or equivalent); and
  5. Don sterile gloves and routinely disinfect them with sterile 70% isopropyl alcohol or equivalent agent during the compounding process.

This hand-washing procedure is consistent with the Guideline for Hand Hygiene in Healthcare Settings published by the Centers for Disease Control (CDC).

Eric S. Kastango, MBA, RPh, FASHP
It's all about the patient.