There has been a challenge thrown out by an NSF qualified certifier in our area that pharmacy staff should NEVER lift and clean the area under the BSC work surface of BSC's that are used primarily to prepare hazardous drugs. We have referred to ASHP and ISOPP guidelines and practice standards to reinforce our case for decontamination underneath the BSC work surface, once weekly. Unfortunately - to our horror- some managers are choosing to hold onto the word of this BSC certifier and have issued instructions to their staff to NEVER lift the BSC work surface and clean underneath it.
In my work experience, I am tasked with performing site visits to certify that pharmacy staff are performing their responsibilities while observing safe handling practices. So I have seen the result - several times over- when this area of the BSC used for HD preparation is left alone and not ever cleaned. I have seen mud caked onto the surface underneath the work surface of a cabinet that is used to prepare sterile HDs. I ask you - how can this be OK?
The BSC certifier states that it is dangerous for the pharmacy staff member (and he has scared them with this statement) to decontaminate the area under the BSC work surface. He also claims that the product is prepared in a safer environment because less dirt is disturbed and released into the HEPA filter by just leaving the area underneath alone!
I should also mention that our safe practice standard for decontamination of the HD BSC includes the donning of full PPE including a NIOSH N95 or better respirator (fit tested) plus safety goggles or glasses with side shields and the requirement that no one else be present in the room during the process unless they are also appropriately garbed.
We have looked at CETA resources that we could access on the net and there is not much information about decontaminating the BSC. Also USP <797> does not go into specifics about cleaning this part of the BSC - used for HDs. As I stated already, ASHP and ISOPP documents are the only resources that we are aware of that mention this. We were told that the information in ASHP is Expert Opinion.
Can someone help us with this?! Has anyone else experienced this dilemma? We are not experts on the operation of the BSC as the NSF certifier is, but we can surmise that if we should be regularly cleaning the walls and ceilings in the Clean Room, surely we should also regularly clean/decontaminate the area underneath the BSC work surface where we have seen dirt buildup and accumulate if left alone! Does anyone know of any more references to show the necessity for regular decontamination of this area?
