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How do you confirm the accuracy or quality of material before use when temps are out of range?   2 scenarios:


1.  Reagent range temp is 2-8C.   Fridge temp increases to 10 C for 30 minutes during inventory before returning to acceptable range.

2.  Reagent range temp is 2-8C.   Fridge temp increases to 22 C for 2 hours before discovery and reagents moved to another fridge.


Temperature Corrective Action



There is evidence of corrective action taken if acceptable temperature ranges for temperature-dependent equipment and environmental temperatures are exceeded, including evaluation of contents of refrigerators and freezers for adverse effects.

NOTE:  If acceptable temperature ranges are exceeded, stored reagents, controls, calibrators, etc. must be checked to confirm the accuracy or quality of the material before use and records maintained. The check should follow a defined procedure.


Edited by R1R2
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On ‎3‎/‎14‎/‎2017 at 6:44 AM, goodchild said:

Are these materials that are often taken out of the fridge and left at room temperature for lengths of time for testing purposes? I would focus my corrective action on why it took two hours to discover.

Quality Guy,


Scenario 1 happens frequently after reagent inventory or after new shipments are added to the fridge.   I would imagine that a lot of labs have these types of temp issues.  Sometimes they are unavoidable.   Scenario 2 hasn't happened since we installed an electronic temp monitoring system but for hospitals that still take manual temps, this could be a possibility.   What does your policy say about checking reagents after unacceptable storage conditions?   Do you perform a visual check or do you qc all the reagents stored in the fridge or do you do something else?  Thanks for your input.

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I agree with Dansket. Change your process.

We used to have lots of spike son our charts and documentation inventory?

We have electronic system now and everytime the temp. goes to 5C, we get a call and tech is required to check all temperatures and add comment in computer.....guess what the ref. does not alarm at all...the tech changed the process ...they closed the door early enough to the temperature does not even go to 5C!


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