freezers and continous monitoring

[armymt2002]

I just got home after an interesting meeting with my boss. We had been having some problems with the chart recorder of our freezer that we store FFP and CRYO in. It was running a bit slow--we have since figured out the problem but we taking 4 hour temp in conjunction with daily temp and still having the chart going. Over the Memorial day weekend the temps were not taken every 4 hours but the daily temps were. My boss is saying because the chart recorder was running two hours behind the real time that the FFP and CRYO needed to be quarantined. We did and one of my techs said he checked the units and there was not any evidence of thawing and refreezing. The temp and chart both indicate that the temperature did not go above -18C. We have an alarm on the freezer (it is a Jewett Freezer) and there is someone in the vicinity of the blood bank (currently we are renovating the lab so the blood bank was moved into a big cubicle type space). My question is since someone is always near the blood bank and would be able to hear the alarm go off is that considered 24 hour monitoring or does the chart recorder have to be used. If someone can point out any references that would be awesome.

Thanks.

[Lcsmrz]

This is one of those "risk assessment" type of question where the Medical Director gets to make the final decision after reviewing the evidence.

Technically, anytime you can't prove by continuous monitoring that you've stored frozen plasma products at <-18 C, you're out of compliance and quarantining is warranted. Just showing that the products never thawed isn't good enough. But being able to show that the chart pen never travelled above -18 C, that the calibrated alarms never activated, and that every documented temp check was <-18 C is good evidence that the temp was always within range.

But it's still his call -- he has to sleep at night!

[John C. Staley]

Correct me if I get this wrong but the only problem was the chart was running a little slow? If that is the case then docment that the chart was running a little slow, the temp never exceeded -18oC, and the alarms didn't go off and move on. As long as the chart was working and the temp recorded was accurate and no reason to suspect otherwise that would be documentation of constant monitoring. I personally think this is one of those mole hill / mountain things.

[armymt2002]

My boss is mountain/mole hill type of guy and it is really frustrating. I would like to move on but he won't.