Leaderboard

We got the same song and dance from our infection department some years ago. Our manager told them the instruments would not work correctly if the saline/reagents were not in the manufacturer's container, the interior plastic bag would droop and possibly break without the cardboard support to contain it. The solution/compromise was to make a notebook of "acceptable" cardboard containers, e.g. saline/reagent cubes. If an inspector questioned, we would show them the book with pictures of what had to be in cardboard to maintain lot numbers or integrity of the reagent. I agree, the rule is to reduce incoming exterior dirt and insect infestation for patient areas but the lab is not a patient care area. Some committees make a mountain out of a molehill and go too far.

The sand doesn't react to temp changes as quickly, like a door open too long, which causes a false alarm, especially on an ultra low freezer. It provides a bit of a buffer, better than ethylene glycol or glycerol.

There was a FAQ on the CAP site a few years ago that basically said BB did not have to do lot to lot testing, that our regular QC was sufficient. I know the exception was fetal kits or other kits that had positive and negative controls as part of the kit. I was concerned about this standard regarding our regular reagents after it was revised so I wrote to CAP so I could get an understanding if things had changed so we did have to start doing lot to lot. This was my answer for my question about COM.30450 The way I read this we do not have to do lot to lot except for something like a fetal kit. You can perform QC on the day of use. Part of our QC is to check the shipment upon arrival, is the appearance normal, did it arrive at the proper temp, was the shipping container damaged, etc. I like having an answer in writing with the CAP logo if an inspector seems like they are going to site me. I can whip the email out and show them. Might help, also might make them mad.

I have never used plasma to validate a freezer. I have validated that alarms work, temp is accurate, plugged into proper receptacle, chart works, door seals properly, unit maintains temp etc.