We have a both a teperature chart and digttal readout on our refrigerators, platelet storage and freezers. Both readings are recorded daily and the SOPs state that not only must they be within range, but the difference between the 2 must be less than or equal to 2.  This is no problem for the fridges and platelet storage but the chart and digital readouts for the freezers sometimes differ by slightly more than 2.  With the wide temperature range (-18 t0 -30), I'd like to change the difference to 5 for just the freezers.  Would this violate any regulations?  I cant find anything...we are inspected by CAP, CAP-ISO, and FDA.  thanks 

We have our freezer ranges set to +/- 5 degrees. We've had it that way for so long, I don't remember where I got the idea, but at our last CAP inspection it was challenged. However, while I couldn't find any references for the 5 degree range at the time, the inspector couldn't find any references or regs that stated it had to be 2, or that 5 was not acceptable. We did not get cited and we kept the +/- 5 range.

Without a reference, you will have to check directly with CAP and FDA.  In general, they usually go with AABB recommendations.  For plasma, you need to be able to show that FFP, for instance, is stored -18 or below.  If you have freezer set at -20 and you have a variance documented from daily records of plus or minus 5, you are going to be in trouble.

 

I would think that at the minimum, you need to have freezers (or whatever) set a a temp (and alarmed) to accomidate whatever variance you have documented. 

 

For example, we need to store our packed cells at 1 to 6.  We document daily that our fridge's temps vary between the thermometers, recorder and readouts by no more than 1 degree -- so we have the alarms set at 2 and 5.

 

Scott

We use the 1 degree variance for both ref and freezers.  I think it used to be 2 degrees for freezers but the latest data I could find only allows for a 1 degree difference.

thanks for your replies.  the problem is the graph readings.  the lines are quite close together and go by 1 degree increments so the chart reading is subjective. plus its in an awkward position near the floor requiring techs to bend way over or get down on the floor to read it....other charts are near the top of the freezers and are difficult for the height challenged techs to see...  the digital readout records to the tenth of a degree.  so we have people recording temps as, ie.   chart -25.5  digital 27.9......  the freezer is well within proper temp range, but the temp difference is out...not sure how to remedy this...

I once did a CAP inspection in a very large hospital that had a dozen or so fridges that all had the temperature scribes on the bottom and wondered why on earth anyone would design them that way. Who wants to get down on a skeavy lab floor to work on those? We have the high ones, and keep a little plastic footstool next to the fridge and freezer so the height challenged can read and change the discs easily. Works fine.

The charts also do not need to be attached to the boxes.  They can be ordered so that they can be placed on the wall at a convenient height for all staff.

For our BB freezer, 2 degree variance is acceptable.  We record daily temps in BB, but I am trying to help OR set up their protocol for thier new tissue freezer.  It has a date logger, but my instincts tell me that they should check the temp daily.  Help please!

 

 

I think if you have a data logger you do not need to record temps daily as long as they have it set up to document at a specific time (or some such).    Wherre did you find the reg that allows a 2 degree (C?) variance?  I was unable to find one.

I have not found any standard or checklist item that requires daily readings of graph/digital/thermometer to agree within any variance.   As long as all temp readings are acceptable then you are good to go.  Quarterly, all temps are compared and should agree within +/- 1 C.

We have chart recorder and the digital readout for our fridges and freezers - but we also have external digital thermometers in place at the top and bottom so we can check the temperatures inside are okay overall. Are the external digital thermometers really necessary?

There is no regulation that requires this but we have always used 2 degrees for refrigerators and 5 for freezers.

Borocliff:  In our case, regulators need to see that any digital thermometer records match certified thermometer readings on a regular basis (at least quarterly if I am not mistaken).

 

Scott

We use the 1 degree variance for both ref and freezers.  I think it used to be 2 degrees for freezers but the latest data I could find only allows for a 1 degree difference.

David,

Would you kindly let me know the source of this data?  I was not able to find any references myself.  Thank you.

We have chart recorder and the digital readout for our fridges and freezers - but we also have external digital thermometers in place at the top and bottom so we can check the temperatures inside are okay overall. Are the external digital thermometers really necessary?

If your digital read outs compare favorably to NIST then you don't need any other thermometer, liquid in glass or digital.   In most blood banks you don't need both top and bottom thermometer either.  

Edited April 2, 201510 yr by R1R2

Just remember, at a minimum, you have to follow manufacturer's recomendations.