AABB Standards - temperature monitoring

[lwomaha]

Could someone post the section of the AABB standards discussing temperature monitoring? I think it is section 3.6... Thanks!

[David Saikin]

Do you have a particular question regarding temperature monitoring?

[Lcsmrz]

There seems to be several "standards" for temp monitoring: one for storage of blood products, one for reagents, one for coolers, etc.

Personally, I think there is only one -- you must be able to prove that you stored any critical material within the temp range specified by the mfr, the FDA, or your own SOP/QP, from receipt to final use.

[rcollins]

Am I understanding 26th ed. standard 3.6 right...reagents need to be stored in a device with an alarm? Or temp recorded every 4 hours? Right now we just do daily temp recording but I don't think that's gonna cut it.

[L106]

Standard 3.6.1 states that Standard 5.1.8.1.2 applies. When you look at Standard 5.1.8.1.2, it does not include "reagents."

Standard 3.7 addresses alarm systems, and it does not include "reagents."

So, no, I don't think reagents need to be stored in a device with an alarm or temp recorded every 4 hours. (But....I could be wrong.......it's happened before!)

[rcollins]

Check out the summary of significant changes on the AABB website. There were some comments made on the standard and the committee's response stated daily recording does not meet the intent of the standard. confused!

3.6.2 Public comment received, no change made

Comment: Please clarify the meaning of the word “monitored.” Does recording the temperature each day fulfill that direction?

Outcome: Daily recording of temperature does not meet the intent of the standard.

3.6.2 Public comment received, no change made

Comment: Our facility currently stores reagents in 2 refrigerators that are not equipped with alarms. We question the requirement that all refrigerators used to store reagents must be equipped with alarms, specifically refrigerators used to store test reagents. Unlike blood components, for which we often must depend on visual inspection as evidence of contamination prior to distribution, we can perform quality control testing of test reagents to verify that the reagent is performing as expected prior to release of any test result.

Outcome: The Standards now explicitly requires that reagents be stored in accordance with manufacturer’s instructions (see also standard 5.1.8.) Some reagents require storage within relatively narrow temperature ranges. In order to comply with the manufacturer’s instructions for the storage and use of those reagents, storage must occur inside a controlled device.

[L106]

Thanks, Becky. This info is very helpful!

[kmh76]

I e mailed AABB accreditation and was told "Reagents" are not included in with alarms for storage. A reagent refrigerator should have a chart on it but does not need an alarm according to AABB accreditation department.

[rcollins]

I e mailed AABB accreditation and was told "Reagents" are not included in with alarms for storage. A reagent refrigerator should have a chart on it but does not need an alarm according to AABB accreditation department.

I wonder if a "max/min" or "hi/low" thermometer would cover this. Thoughts, anyone?

[Lcsmrz]

We use a Max/Min thermometer to show that our reagent storage refrigerator stays within mfr stated range.

Interestingly, it was the use of this thermometer that caused us to change refrigerators, when the old one was found to repeatedly go in- and out-of-range throughout the day through cycling and use. Once a day was giving us a false reading of the cabinet's temperature.

We also use them in refrigerators that are not monitored over weekends, to show that the temperature was maintained while we were gone.

[Alternatives]

Hello,

I am questioning about something...All your hospitals probably have monitoring systems already in place to monitor 24/7 some of your fridges, freezer...etc. Why don't you add some sensors into your reagent fridge to monitor it in real time? That's probably not a huge investment as solution has already been installed.

Taking twice a day does not show you what happened where you were not here, and does not prove you did not have any excursion. A Min Max only tell you that you have been out of range, and I don't think it's proactive, as if you see you were below or over your limit, I suppose you can't use your products anymore. And there is a cost involved for cold chain failure.

Every fridges have some defrost cycle. Some of them are higher than others. Placing some data loggers inside during 24 or more, will show you all these cycles and temperature homogeneity inside your fridge: for example, solution is sometimes to readjust your set point to be back within your allowed range.

Regulation could not be requesting you alarms, but will request you actions case of excursions.

I think the cost of cold chain failure (in term of $, but also quality, time...etc) is higher than having a good knowledge of your equipment and be proactive. You want to manage exception, not excursions. And many vendors of monitoring systems have highly increased their technology and decrease their costs too.

What do you think?

Benoît

[Deny Morlino]

We have alarms and chart recorders on both the reagent refrigerator and the unit refrigerator. Our reagent refrigerator is set up this way in case of failure of the primary unit fridge. we can transfer the units to the reagent fridge, move the reagents to another fridge and are able to continue "business as usual" until repairs / replacement can be made.

[L106]

We do the same.

[ANORRIS]

What is done if the temp went out of range? Are all reagents thrown away?

[adiescast]

That depends on the situation. If the temperature goes out of range and is detected and quickly remedied, the reagents are retained. If the temperature goes out of range and is not detected (some institutions do not alarm their reagent storage devices), then you have to evaluate the tolerance of those reagents for the temperatures they were exposed to and how long they were exposed. Often in the latter case, you do have to discard the reagents. Remember that your blood typing reagents and screening cells are often exposed to room temperature for hours at a time before they are placed back in refrigeration.