As expected, I was recently cited by AABB/CAP for not being able to change the alarm activation setting on my 20 year old BB Refrigerator to 2.5C (from 1.5C) because of the storage of RhIG. The alarm temperatures are factory set and cannot be changed.

Does anyone know where I can I can purchase a separate alarm system, to augment what I currently have, that will satisfy the citation??? 

 

thanks,

Susan

Dickson Data has some nice blood bank external chart recorder/alarms that will do the job for you. The alarm is a very nasty sound that will definitely get your attention when it goes off. I have one in a freezer whose chart recorder is deceased. The wire is very thin, should go through the door no problem. You can get a probe with a looooong wire so the recorder can be put somewhere out of the way. No very expensive.

Edited March 11, 201411 yr by AMcCord

Did you have any actual temperatures below 2C?  It is certainly a good quality idea to have an alarm on a refrigerator that maintains reagents and medications  such as Rhogam or RhIg Immunoglobulin (obviously it's required for storing red cells or plasma) and also maybe a written procedure on what to do if the temp is observed to fall below 2C. However I'm not aware of a regulation that requires medication refrigerators to have an alarm system.  As long as you can show you are recording the temp once per day and the temps are staying in range (2-8C), I don't understand the basis of  CAP/AABB surveyor's objection?      John V  

John V, AABB Standard 3.7 for Alarm Systems reads "Storage devices for blood, blood components, tissue, and derivatives shall have alarms...". RhIG is a derivative, so this is a valid finding.

This is definitely an AABB citing because RhIG is a derivative (manufactured product).

It does not matter if you have never had temperature go below 2C and have statements on the refrig....The alarm settings do not "match" the recommendations of the products. I understand what the citation is about....

I am looking into a NIST certified small and inexpensive min/max digital thermometer with an alarm. This is generally used in micro labs.  The probe can be placed in a small bottle of liquid (approximately the amount of volume in an RhIG syringe). There is a wire attached to the probe that can fit "between" the door jamb (without compromising anything) and the thermometer can "stick" on the side of the refrigerator.  Should be able to write protocols and also alarm testing procedures for this.

I stand corrected.  I'd better adjust up the lower alarm settings on our refrigerator storing Rhogam too.

There are some cheap min max thermometers out there that now have an alarm feature.  If your fridge is close enough so that staff could hear an alarm you could probably get away with that. 

 

I also saw this recently and thought is was "nifty":  http://www.thermoscientific.com/en/products/wireless-monitoring-solutions-cold-storage.html  Smart-Vue wireless temp monitoring

Thanks Susan for posting.  I just changed the alarm setting on my refrig that holds my Rhophylac too.

 

I feel your pain with having old equipment.  We had an ancient refrig once; it even went on fire once and we would have lost our whole blood supply if not for a couple very brave techs.  They still didn't get us a new one; they had that one repaired.

I thank you as well for posting. I had a spare alarm already in place from when my built-in got fried a few years ago (I never removed them after fixing the built-in). So I changed it from 1.5 to 2.5, revised my P&P and tested it today. Oh yeah, AABB is coming tomorrow.

I thank you as well for posting. I had a spare alarm already in place from when my built-in got fried a few years ago (I never removed them after fixing the built-in). So I changed it from 1.5 to 2.5, revised my P&P and tested it today. Oh yeah, AABB is coming tomorrow.

 

Good luck with your AABB assessment!

 

Donna

I thank you as well for posting. I had a spare alarm already in place from when my built-in got fried a few years ago (I never removed them after fixing the built-in). So I changed it from 1.5 to 2.5, revised my P&P and tested it today. Oh yeah, AABB is coming tomorrow.

Oh Dr. Pepper. Lucky you. SO now you will have no citation  . Good Luck.

Just send Rhogam to the pharmacy!

Just send Rhogam to the pharmacy!

Have tried (unsuccessfully) for 40 years.

I can't change the alarm settings on my old Jewetts either. We also used wireless temperature recording devices in the BB refrigerators that ARE alarmed. What I did was add an additional sensor to my reagent storage shelf with the low alarm range set at 2^oC. It's never gone off!

I can't change the alarm settings on my old Jewetts either. We also used wireless temperature recording devices in the BB refrigerators that ARE alarmed. What I did was add an additional sensor to my reagent storage shelf with the low alarm range set at 2^oC. It's never gone off!

So it is OK to store RHIG in the reagent refrig?

Yes RHIG storage is 2-8C.

But if you are storing Specimen, reagent and RHIG all in same referigerator, must change setting to 2C to 6C and alarm 2.5 and 5.5C

How about continual temperature monitoring/recording? I'm reading the AABB standards (5.1.8.1.3) to say that it only applies to blood and blood components, not derivatives. We just reopened a clinic that wants to stock it, so the question is, is an alarm all we need or do we need a temperature recorder as well?

How about continual temperature monitoring/recording? I'm reading the AABB standards (5.1.8.1.3) to say that it only applies to blood and blood components, not derivatives. We just reopened a clinic that wants to stock it, so the question is, is an alarm all we need or do we need a temperature recorder as well?

 How would you respond or what objective evidence would you provide to meet AABB 5.1.8.1.2  "Tissue and derivatives shall be stored in accordance with the manufacturer's written instructions."?

I see your point, SMW. The other cross references (3.6.1), though, seem to point back to 5.1.8.1.3 which only specifies blood or blood components for the continual monitoring/temp every 4 hrs. I would think storage of reagents and derivatives between 2-8o (or whatever the manufacturer says) and taking the fridge temp daily would suffice. No one has taken us to task before. Anyone else out there have any problems with this?

My two cents - for derivatives temp monitoring, I would think the FDA would be more interested in this process (more than JCAHO or CAP).  You may want to double-check with their regs.

 

Scott

Our reagent fridge is a backup for our blood fridge so we keep the alarm points the same. We also store Rh Ig and Tissues (on a separate shelf) in the same refrigerator as RBCs. All our temp alarms are set for 2.3 and 5.5 (Low/High).

 

Sometimes the chart recorders stop recording (for whatever reason) or have unexplained "gaps". So, I recently purchased USB data loggers for all of our storage devices ($50-100 each depending on type of device). I print out chart, review temps and save data monthly. I have the temp being recorded on the data loggers every 5 minutes. I think this certainly meets the revised standard for continuous monitoring. I don't use them for alarms, just as a backup for the charts for continuous monitoring. Alarms go off on the device itself, plus they are wired to our security desk, who notifies us of any alarm.

 

The data loggers were a much cheaper option than paying thousands for a wireless software continuous monitoring system.