Data Loggers & Transport Coolers

[shelleyk482]

Would those of you who use any type of Data Loggers in conjunction with their transport coolers (those issued to ED, OR, etc) be willing to share just how you use them? Do you use them just for the validation or do you also use them to continuously record the temperature of the products while they are out of the blood bank? Do you attach the data logger to a temperature control bag filled with 10% glycerine that is put in the cooler while recording the temperature? Are there any problems, concerns, advantages, etc that you have seen to using the data logger vs using a standard thermometer in a temperature control bag?

Thanks in advance for your input and assistance.

[bmarotto]

We were just using them for validation. We attached them to a bag of 10% glycerin and loaded the cooler with the minimum load using 600mL transfer packs filled with 325 mL of NaCl. We have twenty-five six unit cooler and four large coolers that can hold up to 20 units. Keeping a data logger in each would be rather expensive plus I would expect some would fall off the bag and get lost.

Our facility has recently implemented a wireless web based temperature monitoring system. I am using one of the temp sensors that has a tether with a metal proble at the end for my cooler validations now. I inserted the probe into one of the ports on the glycerin bag and wrapped it with parafilm. I think this gives a better indication of product temperature than attaching the logger to the surface of the bag.

I let the validation run for 24 hours then print both a graph and a time vs temp data report.

[bmarotto]

I want to add to my above post that outside of annual validation, we have bags of glycerine that we attach Hemotemp stickers to. We keep them refrigerated and put one in each cooler when we transport blood. We record both the temperature at issue and return.

[sgoertzen]

At the AABB meeting in Montreal last week, it was explained at the Assessor Day training session that coolers used for temporary storage (like we use them at my facility in the ED, OR, ICU) must have a temperature "recorded" at least once every 4 hours as per standard 5.1.8.1.2 "For storage of blood products, the temperature shall be continuously monitored and the temperature shall be recorded at least every 4 hours." We have our igloos all validated for 6 hours, use a temp bag inside (take temp at issue and return) and also use HemoTemp indicators on the blood bags, but this apparently still doesn't fulfill the standard. We've decided that we are going to have to buy some loggers that we will program to take the temp every 30 minutes or so, and place one in each igloo at the time it is issued.

Does anyone have some good suggestions on temp loggers that are fairly inexpensive but that perform really well? We have seven Cell-Safe Igloos and on some busy days they are all being used, so we don't want to spend a fortune on loggers.

Thanks! Sheri

sgoertzen@childrenscentralcal.org

[LoungingAround]

Check out www.deltaT.com. Astridge International is the distributor in the US. They have data loggers, temperature shells, and transport boxes that are made to work as a unit. Great set up.

[bmarotto]

What next...will coolers be required to have high and low alarms? This makes me glad we decided to drop our AABB membership about 10 years ago. I was an inspector at the time and saw the writing on the wall. I asked our administration if they were willing to add 1 FTE so I could hire a compliance officer. The answer was no so we dropped AABB membership. I do not think our quality has suffered in the least. As for the cooler issue, over the past year, we replaced all our generic "igloo" type coolers with Thermosafe Blood Coolers. They were all validated for 24 hours and shown to maintain temperature at or below 6 degrees for at least 12 hours. If recording cooler temperature every 4 hours is mandated, I predict many places will revert back to having monitored blood refrigerators in the operating room. I think this practice poses more of a risk to patients than failing to record cooler temperatures every four hours. I would rather see money spent on systems known to improve patient safety such as bedside scanning for sample collection and transfusion verification instead of adding bells and whistles to our transport coolers.

OK, I feel better now.

[Kellpos]

"For storage of blood products, the temperature must be continuosly monitored for 4 hours" is the key. We use coolers in the OR and use them for transport only, not storage. Our coolers are validated up to 8 hours, and if the time approaches 7 hours we will call & have the cooler returned for "fresh" ice if needed.

[John C. Staley]

I want to echo Bevs post. When will the nonsense ever stop.

[bmarotto]

Kellpos...how do you define transport vs storage? Do you use coolers to transport blood to the OR then the OR staff "stores" the blood in a monitored refrigerator? If the blood remains in the cooler the entire 7-8 hours, is that transport or storage? If this is storage, then according to AABB 5.1.8.1.2 "For storage of blood products, the temperature shall be continously monitored and the temperature shall be recorded at least every four hours."

Thanks for the support, John! I expected to be lynched for my radical views. Show me all the patients we have harmed by our cooler negligence and I may reconsider. Maybe I should proclaim myself a maverick, retire from Blood Bank, and run for public office. :handshake

[mobea]

Hi

I attended the Assessor training, have checked in with some others who were there as well, and we did not take away this same message.

During the session, a member of the Accreditation staff discussed the use of coolers and explained that validated coolers could be used for temporary storage without the 4 hour temperature monitoring requirement. At the "Ask the FDA" session on Monday 10/6, an FDA representative concurred with this understanding.

I'll add the qualifying statement - - - that is how it is for now! I understand that, as has been the case for some time, the issue of 'storage vs. transport' is being reviewed.

[davenoso]

Hi everyone - I was also at the assessor's training and "Ask the FDA" sessions in Montreal 10/08, and I agree with mobea's interp. Sounds like very few places are continuously monitoring cooler temp and recording at 4 hours (regardless of how one defines storage vs. transport - although FDA seems to side conservatively with any device not actively being moved as constituting "storage"). AABB's explanation for this new Standard was not clear or definative, in my opinion, and after finding very few workable (and cost effective) solutions on the web or at TXPO, I decided to take a "wait and see" approach since we already validate our coolers to 8 hours and use 1-6C temp dots on all products issued in coolers. I did not attend the "Ask the Standards" session and wonder if this issue was addressed there? Best Regards, Diane

[Kellpos]

Even though blood may remain in our validated coolers up to 8 hours, we consider it as transport, since the majority of blood comes back to us unused.

[shelleyk482]

My thought on this is that if you have an irreversible temperature monitor (such as the Safe-T-Vue) on each unit, is this not the same as taking the temperature continuously? You may not have an exact temperature reading but you are assuring that the temperature of the unit did not exceed the acceptable storage temperature and isn't that the intent of taking the temperature a minimum of once every 4 hours?

Does any one know if HemoTemp is looking at or has changed their irreversible range to 6'C?

[Franklyn]

The goal of voluntary accreditation agencies, like the AABB, is to continually raise the bar and in doing so improve overall quality. Sometimes they get it right and sometimes they don't. On more than one occaision I have found myself chanting "follow the money" to figure out why some rego or other was put in place. Retaining our AABB accrediation has required effort, but once the processes were in place maintaining and moving forward was no big deal.

But to get back on the topic at hand, in our case we decided to avoid the entire storage vs. transport issue and moved from the little (validated) igloos to portable refrigerators with data loggers and alarms. You see, just becasue the blood bank performed due diligence and validated a cooler for 8 hours of storage doesn't mean that the staff in the operating room, where the cooler is sitting, are doing the same. Ever walked into the OR and found your cooler on the floor with the lid open? There goes your validation... We have had folks forget to plug-in the portable refrigerators when they arrived and then tape over the alarm buzzer to quiet it down when it started screaming. So if we are to be thorough and do everything we can to ensure the blood that returns can go back into inventory, we need temperature log data.

The loggers we chose are by "Veriteq" and the sell several flavors. You will pay about double to get one with a NIST certificate, but they are easy to calibrate against a NIST standard when they arrive and save the money. They have an internal and external probe so they can be utilized in a very flexible manner. They are also smaller, cheaper and easier to use than paper chart wheels. There are now a bunch of vendors selling loggers. Look at your application, the $$$ and life cycle (veriteqs have a 10 year battery). We use a probe on an external lead in liquid to monitor temperature as the "air temp" can fluctuate wildly and not acurately reflect the temperature of the stored blood (the compressor kicks on and the air temp plummets).

Of course, just to point out the obvious, nothing will help you when a unit is removed, placed on the counter for an hour and then returned to the cooler/refrigerator. If you don't have a non-reversable indicator (like a hemotemp) you will never be able to detect that. I am looking forward to RFID approval as it will have much of this built in. It will add to the total cost, but we will no longer need to buy anything extra and we won't have to guess.

[NedB]

Thanks guys. Glad I didn't pass up this thread. Will be looking for clarification from FDA and AABB about the coolers.

[jlemmons]

Our coolers are validated for six hours but we only allow them to be kept out of the blood bank for four. This keeps us in compliance and also allows extra time because we usually have to call them two or three time to get them to bring them back so we can send another cooler with fresh coolant.