Summary from “Ask the Standards Committee” at AABB 2009
To quote the Moderator, this was a “familiar topic.” At Session 9417-TC of the 2009 AABB, “Ask the Standards Committee,” the Standards Committee leadership addressed recent changes in the 26th Edition Standards for Blood Banks and Transfusion Services, as well as questions submitted to the committee.
The response to Question #26 from the session (see right), and a follow-up question from the audience both clearly illustrated that blood bankers and transfusion services have long been confused about Standard 220.127.116.11.2 (Storage). This is particularly true with how the standard applies to blood products transported to the OR and held in transport containers. The interpretation of the standard, as explained in this session (and in their response to Question #26), clearly took the view that blood products in coolers are in TRANSPORT, not in STORAGE – as stated by Dr. Price in the session transcript that follows below. And Transportation is actually covered by Standard 18.104.22.168.1 (not 22.214.171.124.2).
Click here to link to the transcript of of this Q & A exchange.
126.96.36.199.2 Storage Conditions
For storage of blood products, the temperature shall be continuously monitored or the temperature shall be recorded at least every 4 hours. (Changed from ‘and’ in 2008 to ‘or’ in 2009)
Containers (e.g. portable coolers) used to transport blood components issued for transfusion shall be qualified and the process validated for the appropriate transport temperature.
Case in point. A question posed by one of the attendees, with a sound of frustration and confusion, again reiterated that many blood banks/transfusion services use 1-6 degrees as the standard for “storage” of blood in validated coolers in the OR, resulting in a great deal of waste if the blood product exceeds 6 degrees. Dr. Price responded by saying that 1-10 is acceptable, because the Standards Committee considers products going to the OR in a validated cooler as TRANSPORT. This is a clear departure from the earlier 2005 FDA interpretation.
Essentially, it was stated that even though 188.8.131.52.2 (Storage) states that temperature shall be monitored or recorded at least every 4 hours, this simply does not apply if you are using a cooler that is validated for the appropriate temperature and time period, since that is considered Transport. The container validation assures that the appropriate temperature is maintained, and thus does not require checking every 4 hours.
Practically speaking, we should keep in mind that the cooler may be opened and closed multiple times over the course of several hours. We know from talking to our blood bank customers that there is a great deal of concern about the blood being maintained at proper temperature once it reaches the OR. Primarily, those two concerns are:
1) blood removed from the cooler and then returned may have exceeded 10 degrees, and
2) improper re-packing of the cooler can result in improper temperature maintenance, particularly units in the upper layer of the cooler.
As Dr. Price stated (in the transcript below), these concerns must be taken into consideration when validating the cooler for such environments.
Judy Ciaraldi, an FDA representative to the Blood Bank Transfusion Committee, acknowledged that the concerns and confusion expressed in 2008 were heard. She stated that in the near future a workshop would be held to explore this topic, and decide which changes and clarifications should be made to the regulations.
Transcript from Session 9417-TC, 2009 “Ask the Standards Committee”
- Thomas H, Price, MD – BBTS Standards Committee Chairman
Puget Sound Blood Center
- Thomas H. Carson, MD – BBTS Standards Committee Incoming Chairman
Children’s Hospital New Orleans
Question #26 (submitted):
“If AABB considers blood products in a cooler in an operating room to be stored products and requires them to be maintained at 1-6 C, do you also require that the temperature be documented at least every 4 hours? If yes, can you offer a suggestion on how a busy service (over 30 coolers) can record temps on coolers that are out of the blood bank for as long as 8 hours?”
Response from Thomas H. Carson, MD, Children’s Hospital New Orleans:
“For the other part of it about storage, that if you have a container that you’ve sent over to OR with blood products, if you have validated that container to maintain the acceptable temperature for a given length of time, be it 4 hours, 8 hours, 12 hours, then you don’t need to monitor it continuously or check every 4 hours.
However, I would say you have to validate container as to how long it will maintain temperature and the containers do require re-validation on a routine basis.”
Follow-Up Question from Audience:
“Now if you are considering the refrigerators in the blood bank storage, and you require monitoring continuous or every 4 hours, so how come that doesn’t apply to the coolers that are considered storage in the OR. I mean, it’s mixed messages.”
Response – Dr. Carson:
“I see what you’re saying, but at this point we really, as Dr. Price said earlier, are not defining, if you will, those containers in the OR as storage. We still view them as being transport.”
“So then, because, I’m wasting a lot of products because I monitor 1-6 (degrees), and you’re saying I should go back to 1-10?”
Response – Dr. Price:
“You don’t have to, 1-6 is fine.”
“No, because if you consider 1-6, sometimes you don’t know what happens in the OR. They open the cooler….then when the cooler comes back it is over 6, I discard the product. So if you don’t address the issue do I still consider it still 1-10, or 1-6 then? If you consider it 1-10 then I don’t waste a lot of products. If you consider it 1-6, then I am wasting a lot of product. And this is what a lot of my colleagues all over having the same problem who have a lot of liver (and) heart transplants, who issue a lot of coolers. Right now I am discarding a lot of products because I am taking it as 1-6. Because in the OR if they open the cooler, you don’t know. Maybe they open it 15 minutes, 20 minutes, they take product, they put it back. I mean, it’s really confusing.”
“So if you have refrigerators in the OR, then that’s storage.
From the Standards point of view, If you’re just talking about these coolers going back and forth, we’re considering that to be transport; but validating that cooler, including in that validation would be some sort of consideration of how often people open it up, and….so in spite of all that stuff you have to validate it, that it’s going to maintain the temperature where you want it.
But at least from that point of view, and you heard what Judy said about that, that it’s being reevaluated by the FDA. But at least from the standards point of view and considering that to be transport, then 1-10 is o.k.”