Temperature Mapping your Fridges

[RR1]

Please could you vote for whether you temperature map your storage equipment ( for annual mapping only) in-house, using your own data-loggers and producing reports etc, or you contract an external company to perform this.

many thanks!

Edited March 7, 2011 by RR1

[pluto]

Also seen some feedback on transfusion guideline website that mhra want temp mapping of the lab area as well not just the equipment

[RR1]

Thanks Pluto- I forgot that bit!

The Orange Guide states that refrigerators and walk-in cold rooms should be mapped annually, and controlled room temperature storage should be mapped every 2-3 years and after any significant modification to the premises, layout or heating system.

[Malcolm Needs ☆]

I really don't know why we bother putting up positive and negative controls with our tests these days. The MHRA have solved all of the problems for us by temperature mapping! I do wish we had asked these experts how to do things many years ago. We waste so many reagents with all these controls.

[RR1]

Good point Malcolm. So why do we run so many controls, might it be that so many of our tests are manual and subject to human error rather than to do with the reagent storage conditions? Could it be that we all go over the top with these things...probably??

You know I REALLY LIKE the MHRA, especially after our last inspection, and will defend them forever (possibly)!!!!

[Malcolm Needs ☆]

My point is, Rashmi, that because we use positive and negative controls for all methods, we will know immediately if the reagents are not working. We may not know why. It could be storage problems, it could be washing problems, it could be incubation problems; at this stage we don't know, but we do know that the tests have not worked.

I was joking, but if we do not perform these controls, because we know that the laboratory has been temperature mapped (once a year, maximum), can we rely on negative and positive results?

If I were to be the recipient of a transfusion, I know that I would rather have positive and negative controls included in the testing, rather than relying on temperature mapping; which begs the question, what is the point of temperature mapping the laboratory (or the incubators come to that)? It is just an extra piece of beaurocracy brought in my our new masters, the MHRA, for no added value.

[RR1]

I see what you mean- thanks. After having a look at the Orange Book, mapping is only required in areas where blood products/ blood components are stored. Laboratory areas where critical supplies such as reagents are stored should be monitored but not necessarily mapped annually; this can be done every 2-3years.

I certainly don't map our small incubators or plasma thawers, though this would be different for the Blood service where much larger equipment is used and there is a greater potential for hot/cold spots.

Are you sure it isn't your quality folk going OTT with measuring/mapping etc too often, rather than MHRA stating that you have to do this?

[Malcolm Needs ☆]

1) After having a look at the Orange Book, mapping is only required in areas where blood products/ blood components are stored. Laboratory areas where critical supplies such as reagents are stored should be monitored but not necessarily mapped annually; this can be done every 2-3years.

2) Are you sure it isn't your quality folk going OTT with measuring/mapping etc too often, rather than MHRA stating that you have to do this?

1) Okay, so it is every 2-3 years - but what is the added value if you are using positive and negative controls? Fine, if you abandon controls, but would you?????????

2) Absolutely certain! In fact, they wanted to know how we checked the temperature loggers and the thermometers when they were looking at one of our smallest 37oC incubators. They spent some 20 minutes over this, out of about an hour and a half!!!!!!!!!!

:boo::boo:

[RR1]

1) Okay, so it is every 2-3 years - but what is the added value if you are using positive and negative controls? Fine, if you abandon controls, but would you?????????

2) Absolutely certain! In fact, they wanted to know how we checked the temperature loggers and the thermometers when they were looking at one of our smallest 37oC incubators. They spent some 20 minutes over this, out of about an hour and a half!!!!!!!!!!

:

1.OK, so not a mega value adding activity unless this is just to check suitable environmental conditions to prevent any wastage if reagents were not optimally stored.

2. But this was just questioning what you do- or was this actually cited as a non-conformance? In any case a straight forward answer if the small incubator didn't have a logger or separate thermometer, would be to provide evidence of annual temperature calibration.

[Malcolm Needs ☆]

1.OK, so not a mega value adding activity unless this is just to check suitable environmental conditions to prevent any wastage if reagents were not optimally stored.

2. But this was just questioning what you do- or was this actually cited as a non-conformance? In any case a straight forward answer if the small incubator didn't have a logger or separate thermometer, would be to provide evidence of annual temperature calibration.

1) No Rashmi, no added value whatsoever - you would detect unsuitable environmental conditions preventing wastage if reagents were not stored optimally IMMEDIATELY if your controls did not work, whereas if you were relying on temperature mapping, you would not detect it until the next time you temperature mapped (IF YOU WERE NOT USING CONTROLS - and if you were, where is there ANY added value)? Please tell me; I am interested.

2. No, of course it wasn't, because we had done everything that the MHRA expected, despite the fact that it was a total waste of time and money, and YES, because we always did this kind of thing - but, much more importantly from the patients' point of view, we kept records of ALL results, including our controls.

You CANNOT convince me that such criteria add anything to patient safety; all they do is add to beaurocracy. I suggest, with all due respect and without being insulting, that you (but, more importantly, the MHRA) read some of Nevin Hughes-Jones' papers on the way antibodies work - and as the Cambridge University don who did most of the work on this, I am not going to argue with him.

:angered::angered:

[pluto]

Very useful info

will be mapping plasma thawer this year for first time and unsure of frequency after that probably every 2-3 years , cost is factor as mapping is £250 each and we have 2

Have never mapped room temp storage areas so will have to address that this year , had mhra inspection recently and though mapping not raised did ask how we were going to maintain a reasonable working temp in the lab as we had documented some high temps during summer ie 29oC .

He did look at the Diamed 37oc incubator but seemed happy that we recorded temp daily from display and that it was calibrated twice a year

[RR1]

1) No Rashmi, no added value whatsoever - you would detect unsuitable environmental conditions preventing wastage if reagents were not stored optimally IMMEDIATELY if your controls did not work, whereas if you were relying on temperature mapping, you would not detect it until the next time you temperature mapped (IF YOU WERE NOT USING CONTROLS - and if you were, where is there ANY added value)? Please tell me; I am interested.

2. No, of course it wasn't, because we had done everything that the MHRA expected, despite the fact that it was a total waste of time and money, and YES, because we always did this kind of thing - but, much more importantly from the patients' point of view, we kept records of ALL results, including our controls.

:angered::angered:

Hi Malcolm,

Do you think then that temperature mapping is only really significant for lab areas where blood products (albumin) are being stored? Regardless of controls being run with tests, isn't it useful to know that you are not storing reagents directly in hot/cold spots ie under air con units or warm lab areas. I know the controls would show if these reagents had deteriorated, but surely you want to prevent this happening in the first place and minimise wastage?

Regarding mapping small incubators, I suggest your quality folk reviews their risk asessment of the process and comes to the conclusion that as this equipment is calibrated according to manufacturers recommendations, that over/ under temp alarms are working and that controls are run routinely, this is very low risk and mapping is not required. Some of this stuff is just common sense- we all just all seem to be going over the top .

[RR1]

Very useful info

will be mapping plasma thawer this year for first time and unsure of frequency after that probably every 2-3 years , cost is factor as mapping is £250 each and we have 2

Have never mapped room temp storage areas so will have to address that this year , had mhra inspection recently and though mapping not raised did ask how we were going to maintain a reasonable working temp in the lab as we had documented some high temps during summer ie 29oC .

He did look at the Diamed 37oc incubator but seemed happy that we recorded temp daily from display and that it was calibrated twice a year

Hi Pluto,

We use 2 bag thermogenesis thawers and have never mapped these. Our validation plan/ data was reviewed by the inspectors and no comments were made, though we had stated in the validation that there was no purpose in doing this. The water circulates and the temperature is monitored by in-built calibrated equipment and over-temp alarms in place. It may be useful to map much larger thawers (e.g 10 bag ones), but this would be to check that water circulation was adequate in all areas.

If you are using a dry air thawer this may require mapping, but only because some of these thawers have rapid thaw programs that brings the internal temp to around 50'C (though these are not meant to affect the internal component temp- but I suppose these could be open to abuse).

Regarding daily recording of Diamed incubators-we stopped daily recording of these as there seemed little purpose in taking a one point temperature. If your SOPs state that it is procedural to place your cards into the incubator, with the appropriate serological controls, when it is at the required temp- I personally think this is sufficient.