Showing results for 
Search instead for 
Do you mean 

Reply
Expert
Posts: 1,167
Registered: ‎02-23-2010
0

Re: IV Room Flow Webinar

Julie,

 

Thanks for your kind words.  Re: door swings.  If the buffer area is a positive-pressure room, then a door that swings both ways would be OK assuming as Robert mentioned that there isn't a hood within 4-6 feet of the door.  If it is a negative-pressure room, I would prefer a door that only opens one way.  There is a lot of debate about which direction the door should swing.  Typically, the direction will be dictated by life safety codes so your architect should know how to comply with that set of regulations.  Any door into a buffer area should be opened slowly since there will be changes in room pressure.  Re: line of demarcation, I am having difficulty imagining three areas.  If you can post a sketch or plan to the forum, I will look at it  and be able to give you an accurate answer.  Thanks.

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
Expert
Posts: 1,167
Registered: ‎02-23-2010
0

Re: IV Room Flow Webinar

 

Q: Are wipes used to clean off HD supplies going into the negative pressure room considered HD (since there are traces amount of chemo contamination on the outside packaging form the manufacturer)?

 

A:  I would consider any wipes used on HDs to be contaminated.  What I have seen is that HDs are being delivered from wholesalers in a dedicated HD tote and in a plastic ziplock bag.  I would recommend that you take the plastic ziplock bag directly into the negative-pressure buffer area where you can handle and unpack the vials.

 

Q: Can you comment on the new Compounding regulations in California SB1735 and how they differ from USP 797?

 

A:  I have not compared the two documents side by side but I am aware of the new recordkeeping regulations in the California reg.  USP 797 requires batch records and documentation but it is not explicit.  I am working with a client who was cited by the CDPH for non-compliance to USP 797 and NOT the California State Board of Pharmacy regulation.  It would be important to be intimately familiar and compliant with both USP 797 and California BOP regulations if you practice in California.

 

Q: Can you describe the gowning and garbing procedures when using a mobile isolation chamber that is not in a clean room?

 

A: The chapter says "When CAIs and CACIs are the source of the ISO Class 5 environment,  the garbing and gloving requirements for compounding personnel should be as described above (for LAFWs and BSCs), unless the isolator manufacturer can provide written documentation based on validated environmental testing that any component(s) of PPE or personnel cleansing are not required. The onus is on the manufacturer. Some manufacturers aren't willing to say what to garb and others are a little more brazen (in my opinion).  If you are handling HDs, I would garb since you can be exposed to HD residue from vials and packages.  The HD buffer area will most likely be contaminated so the bottom of your shoes will be contaminated.  I have attached an article that will address the challenges we still have when dealing with HDs.  If you are working in a positive-pressure isolator, I believe you should wear gloves and wipe all components and supplies down as you move them into the antechamber of the isolator. 

 

Q: Do you still need this on the floor if the areas are defined by doorway closures?

 

A: Not sure I understand your question.  If you are saying do you need a line of demarcation because they are doorway closures, I'm not sure where the dirty and clean of the ante area would be.  If it is clearly defined and I would know where your LOD is if I visited your pharmacy and I could perform my garbing procedure properly, then you are good to go. 

 

Q: During the monthly deep cleaning, should all products be re-wiped down or is it sufficient to wipe down the bins they are in?

 

A: I would try to limit the amount inventory I have in the bins so they won't have to be wiped down.  How do you know how fast your inventory turns over?  I would wipe everything down in the bins along with the bins. 

 

Q: What are your thoughts on the sticky mats?

 

A: Sticky mats can be helpful if you need to make your line of demarcation at the door going into the ante area because the sink is next to this door.  I would put the tacky mat on the door going into the ante area.  Generally,  I am not a fan of them because they are part of the floor and floors need to be washed daily and if you get them wet and water gets under them (if they are stuck to the floor) then the glue will become loose and the expensive tacky mat becomes useless. 

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
Expert
Posts: 1,167
Registered: ‎02-23-2010
0

Re: IV Room Flow Webinar

Have you checked with your Infection Preventionist in your institution?  They might be able to directly you to a reference for the general pharmacy.  I will see if I can find something on this.

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
Pharmacy OneSource
Posts: 5
Registered: ‎08-16-2010
0

Re: IV Room Flow Webinar

Ellsworth,

 

If you are still looking for the slides, you can get them by clicking on this link:  http://www.pharmacyonesource.com/news/article.asp?article_id=12344

 

Scroll down to "Past Webinars" and you will have the option to download the slides on the right side of the screen.

**** If you find this post helpful, please mark it as a solution ****
Administrator
Posts: 578
Registered: ‎02-22-2010
0

Re: IV Room Flow Webinar

Here are some more questions from our live presentation:

 

Q: How strict should policy be regarding staff that are sick? If they are not feverish, but have a slight cough is it recommended they are not in the clean room?

 

Q: How far (minimum and maximum) should the refrigerator be from the low wall exhaust vent?

 

Q: I noticed in your slide, you kept the chemo meds in plastic bin. Is it not required to have the chemo meds in a plastic spill proof bag before placing in a plastic bin?

 

Q: Is a return air vent required to be behind a refrigerator in the Buffer area?

 

Q: Does the line of demarcation definition not allow negative pressure from buffer to clean areas?

 

Q: Should vials be taken out of their packaging before being placed in the chemo fridge if the fridge is located in the clean room?

Expert
Posts: 1,167
Registered: ‎02-23-2010
0

Re: IV Room Flow Webinar

Q: How strict should policy be regarding staff that are sick? If they are not feverish, but have a slight cough is it recommended they are not in the clean room?

 

A:Not sure how to answer this question.  If this person had to compound something for you or a loved one, would you let them?  In the chapter you will find specific recommendations on excluding personnel with active respiratory infections.

 

Q: How far (minimum and maximum) should the refrigerator be from the low wall exhaust vent?

 

A: The low wall exhaust should be located immediately behind or adjacent to the refrigerator to be effective.

 

Q: I noticed in your slide, you kept the chemo meds in plastic bin. Is it not required to have the chemo meds in a plastic spill proof bag before placing in a plastic bin?

 

A: Not sure who requires chemo meds to be stored in a plastic spill proof bag.  It isn't a bad idea but in a restricted low-traffic area, I don't see any problem with storing chemo in bins.

 

Q: Is a return air vent required to be behind a refrigerator in the Buffer area?

 

A: The chapter says: Placement of devices (e.g., computers, printers) and objects (e.g., carts, cabinets) that are not essential to compounding in buffer areas is dictated by their effect on the required environmental quality of air atmospheres and surfaces, which shall be verified by monitoring (see Viable and Nonviable Environmental Sampling (ES) Testing).   If you can demonstrate that your buffer area can handle the particle load generated by a refrigerator, then one isn't required.  It has been my experience that planning for and installing an air return will mitigate the particles generated from a refrigerator. 

 

Q: Does the line of demarcation definition not allow negative pressure from buffer to clean areas?

 

A: Not sure I understand your question.  The ante area needs to be physically separated from the HD buffer area to achieve the pressure and air change requirements.

 

Q: Should vials be taken out of their packaging before being placed in the chemo fridge if the fridge is located in the clean room?

 

A: I would keep the HD vials in their boxes as a means of containing any spill should the vial get dropped.  Most individual drug packaging boxes are made of plastic coated clay board so as long as you aren't tearing them open, then you won't generate a lot of particles.  Remember that there are of lots of other particle generating objects in the buffer area.  To minimize the accumulation of particles in buffer area, the air changes per hour are required.

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
Administrator
Posts: 578
Registered: ‎02-22-2010
0

Re: IV Room Flow Webinar

Here are our final questions from our live presentation:

 

Q: We use Febreeze wet pads to clean the room. Is that acceptable? Can we keep them in the room even if we don't have a specific segregated area to keep cleaning material?

 

Q: Our IV room is an small area where we have mobile cabinet isolation, with a sink, work bench  and a cart for supplies. We work with low and medium risk level CSP. How could we use the line of demarcation in order to diminish the bio burden?

 

Q: What about anti-fatigue floor mats in the buffer area. Are they permitted?

 

Q: What about the gown a pharmacist wears when entering the buffer room (chemo) to check final product of chemo but does not compound.  Where should the gown be removed when leaving the buffer (chemo) room?

 

Q: What about eye guards? If a compounding technician is not wearing any glasses, should they be wearing some type of eye guard?

 

Q: Will a closed system device (like PhaSeal) be recommended in the guidelines and potentially eliminate the need for a BSC? Company is now advocating for sterility as well as non aspiration.

Q: Do hazardous drugs need to be kept in a negative pressure area? Can I negative pressure my PYXIS cabinet for HD storage?

Expert
Posts: 1,167
Registered: ‎02-23-2010

Re: IV Room Flow Webinar

Q: We use Febreeze wet pads to clean the room. Is that acceptable? Can we keep them in the room even if we don't have a specific segregated area to keep cleaning material?

 

A: I don't believe Febreeze wet pads have the same disinfectants that are listed on Appendix II of the current USP chapter. Not sure which room you are storing your cleaning supplies, the Buffer area or Ante area.  Cleaning supplies should not be stored in the Buffer Area.

 

Q: Our IV room is an small area where we have mobile cabinet isolation, with a sink, work bench  and a cart for supplies. We work with low and medium risk level CSP. How could we use the line of demarcation in order to diminish the bio burden?

 

A: If you have an isolator, the line of demarcation is not as critical as if you are working in a LAFW or BSC.  You can don shoe covers, minimize the amount of paper, keep corrugated cardboard out of the area and clean the floor on a daily basis.

 

Q: What about anti-fatigue floor mats in the buffer area. Are they permitted?

 

A: I have answered this question in past webinars but as long as they don't shed particles (break apart) and can be cleaned on a daily basis (they are part of the floor), then you can use them.

 

Q: What about the gown a pharmacist wears when entering the buffer room (chemo) to check final product of chemo but does not compound.  Where should the gown be removed when leaving the buffer (chemo) room?

 

A: I would keep this gown in the negative-pressure buffer area until it is disposed of at the end of the day.  You should assume that it is contaminated to some degree.

 

Q: What about eye guards? If a compounding technician is not wearing any glasses, should they be wearing some type of eye guard?

 

A: Eye shields or goggles are NOT typically worn when compounding but when cleaning or when cleaning up a HD spill. 

 

Q: Will a closed system device (like PhaSeal) be recommended in the guidelines and potentially eliminate the need for a BSC? Company is now advocating for sterility as well as non aspiration.

 

A: There is no scientific data demonstrating that a closed system transfer device (CSTDs) can used in lieu of BSC or can extend the BUD of single-dose vials.  The one poster that I have seen published on this topic (extending BUD) had a contamination of almost 2%.   That is not an acceptable rate of contamination.  I would be very careful in using this data/claim from the manufacturer since it has not been peer-reviewed.  CSTDs are required when preparing HDs under the low-volume exemption.  They are not required otherwise.

 

Q: Do hazardous drugs need to be kept in a negative pressure area? Can I negative pressure my PYXIS cabinet for HD storage?

 

A: If you place your Pyxis cabinet in your negative-pressure room, they you are meeting the requirements of the chapter.  You should contact the manufacturer of the cabinet to ask them if they can make your cabinet negative-pressure.

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
Occasional Visitor
Posts: 1
Registered: ‎02-15-2011
0

Re: IV Room Flow Webinar

Later this year we will be moving into a new pharmacy at our hospital.

 

One of the questions that we have is regarding the placement of the refrigerator in the clean room.

 

We are considering a pass-thru refrigerator and would like to know where it should be placed.  Can it be placed in the clean room adjoining the ante room?

 

Can you please give me some guidelines?

 

Thanks

Highlighted
Expert
Posts: 1,167
Registered: ‎02-23-2010
0

Re: IV Room Flow Webinar

Larry,

 

The answers to your questions can be gotten from listening to the IV Flow webinar and reviewing  the FAQs in this forum.

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.