For any of you who uses only the high alarm setting on your BB plasma freezers, how are you going to "meet" this "revised" standard for the low alarm setting? 

 

Our -40 freezer did not come from the manufacturer with the low alarm pre-set.  We can set it, but to what temperature & how do you simulate the alarm activation at such a cold temperature. 

 

 

 

TRM.42750 reads -

All component storage units are equipped with an alarm system that is monitored 24 hours/day (in laboratory or remote), with documented alarm checks (for both low and high settings) performed at least quarterly.

 

Thanks.

We had a policy approved stating that we would not be testing the low alarm value.

We are also unable to monitor low alarm for -80 C deep freezer. Would like to have feedback from anyone who is monitoring such low temp.

 

@lph does having a policy of not monitoring low temp alarm, not cause a problem with FDA??

I don't know of anyone who monitors the "low" temp of a freezer. The standard for frozen blood components is < -18C (I am not talking about tissue storage here). There is no low outlier temperature so why should it be monitored? I think a policy statement that freezers are not checked for the low temp would satisfy CAP - I don't think the FDA has concerns as long as the temp does not exceed -18C.

We monitor the low temp on our freezer where we keep tissues, but the alarm testing on that is really easy. It's on the program menu and you just select low alarm test and it runs and then it's done. On our freezer that we keep just plasma in, we only do the high alarm test and we have in our procedure that just plasma and cryo are kept in there.

Same as everyone else, no low alarm temp.

I only monitor high alarm. We store tissue and plasma in the same ultralow. I've never had anyone question it.

I interpret the standard to say that the alarm system check documents that it functions as expected.  Since we have not set a low alarm for the freezer there is no requirement to check one.

we do the same, no low alarm.

No low temp alarm for our freezers.