10-21-2015 12:50 PM
Hoping to get feedback on best practice for handling a situation that seem to have divided our department.
Our facility has a modular IV room with three distinct areas: cleanroom, anteroom, and chemo room (negative pressure). Each room is separated by a door and all rooms meet ISO class 7 classification. We have a LAFW in our anteroom that is intended for compounding medications needed for emergency situations (e.g. codes and RN forgot to request a replacement gtt for cardiac agent and it's about to run out). Garbing process when using STAT hood is different, involves wearing head cover, face mask, handwashing, then gloves (no foot covers or gowns). Since we are not wearing gowns, anything compounded in the STAT hood is considered immediate use as defined under immediate use risk level stratification. Meaning that the infusion must be started within an hour of compounding time and end by the recommended BUD. Products compounded in the STAT hood are not reusable and marked accordingly.
Where we seem to have really strong regarding the utilization of our STAT hood is for non-life threatening situations, for example:
My current assumptions are that medications should be compounded in the cleanroom any time we have an opportunity unless there's a life threatening situation. Based on current USP guidelines that suggest medications should be compounded under ISO 5 conditions whenever there's a chance. In our case, the medications are all being compounded under ISO 5, but the only difference is the current risk level stratification: immediate (no gown) vs low or medium risk (gown). With the proposed changes, category 1 vs category 2, I don’t see that it make much difference. Ultimately are we just getting into the weeds or my initial assumptions are correct? We are trying to be practical but ensure that we keep patients safe!
Mike Sonuga, PharmD
10-21-2015 01:26 PM
The immediate use provision is intended for CSPs where delaying the treatment will acuse more harm then making it in an ISO 5 environment.
If you are making any CSP in a "hood" all garbing procedures must be followed.
An immediate use csp would be made in the ED or OR on a flat surface OUTSIDE of an ISO 5 environment using aseptic technique. These CSPs shall be started within an hour or discarded.
If you have CSPs being compounded in an LAFW located in your ante room you should 1) only be compounding low risk CSPs, and 2) they must only get a max of a 12 hour BUD and they must be started within the 12 hours but can run to completeion up to 24 hours once hung.
I hope this helps.