We recently had an inspection with Joint Commision and were told that FFP after thawing needs to be relabeled as "Thawed Plasma" prior to issuing for transfusion. Has anyone else heard this? I can't find anything about how to relabel or if there are any regulations regarding this. FYI-this would be for issuing within the 6 hour limit.

The Components are as follows (unless something changed that I am not aware of)

FFP (after thawing) Expiration, if issued as FFP:24 hours.

Thawed Plasma Expiration: 5 days from date original product was thawed.

The time frames Liz has posted are my understanding as well.

I am aware of expirations; my question is about the relabeling. Are there any regulations as to how to do it or if it really needs relabeled immediately after thawing?

Pat Distler answered this question in the ISBT area. It only needs an expiration date/time change if you do not intend to relabel it as Thawed Plasma with a 5-day outdate. See: http://www.pathlabtalk.com/forum/showthread.php?2289-ISBT-and-yes-Thawed-Plasma-again/page2&highlight=isbt+thawed+plasma

I have attached some labels for you to use for testing or validation (ISBT only). Also a copy of our procedure.

We hand write the new expiration date on the lower right quadrant.

Each sheet is appropriate for a specific product code. We print them on Avery 5163. (set fit to page to "none".) If you print these labels you must be registered with ICBBA.

You only need to label "thawed plasma" if you are going to keep it for 5 days. That's the FDA guidance (you should call them or check the current labeling guidelines). The FP label may be used if the transfusion is within the 24 hr time - just give new exp date.

The JC standards that go into effect 1/1/12 state that the plasma must be labeled as "thawed plasma". Since the words are not capitalized, I don't think that it refers to Thawed Plasma (with the 5 day exp). It sounds like you need to label the plasma as thawed with the new exp. date/time. Of course, I have been known to be wrong on many occasions!

:confuse:

Yes, and if you are going to use the 24 hour expiration, you must receive a variance from the FDA. I was just cited by the JC for this.

I thought you do not need variance any more. This one is under approved now...You should call FDA on this.

I also think that the variances are no longer needed - a very recent change.

As of July of this year, apparently there was a change again. Which is why I was cited by the JC.

http://www.jointcommission.org/standards_information/jcfaqdetails.aspx?StandardsFAQId=353&StandardsFAQChapterId=104

From what I was able to find out, the FDA initially admitted that the 6 hour expiration in the CFR was probably a clerical error (they were thinking cryo instead of plasma) and they said they were going to waive the variance for that reason. This summer apparently there was a decision to let it stay that way in the CFR, and the JC decided (see link above dated July 1st of this year) that a variance would then still be needed. I just applied for the variance and received it from the FDA a couple weeks ago.

This question was asked at the AABB meeting in San Diego a few weeks ago during the "Ask the FDA" session and it was stated by the FDA that if you want to use FFP post-thaw for up to 24 hours (rather than 6 hours), you must get a variance. Unless something has changed in the last month, a variance is still needed to use the 24 hour expiration. (I know... seems silly)

Wouldn't it be nice if the FDA would just fix this one? finally? which has been the case for at least the last 12-14 years? Why say we all have to do something, then say everybody can ask for a variance to do it differently? Think of all the extra paperwork for everyone concerned. HEAVY sigh!!!!

(I do have the variance and they are easy to get.)

How do you ask FDA for the variance? I have never done so before. But need to on this.

The AABB website has a sample letter. If the link doesn't work, see AABB>Resource Center>Government/Regulatory Affairs>Plasma.

http://www.aabb.org/resources/governmentregulatory/plasma/Pages/resources.aspx

I have a question. When thawing FFP and placing a new label on it with the new exp. date I cross off the old original 12 month exp. date. Is crossing off the original date a no-no with AABB? I can not find this in the technical manual any where. Another Blood Bank said this is "off limits" with AABB. Does anyone know if this is true?????

As long as you are not using the plasma for 5 days, you do not need to relabel. Just cross off the exp date and add the new date and time.

Before we went to ISBT, we had a sticker on which we wrote the new expiration date and affixed it over the expiration date barcode.

This just came today from the AABB:

The Food and Drug Administration has announced publication of a final rule — titled "Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma," effective July 2, 2012 — that updates most of the proposals published in a July 30, 2003, Federal Register notice. Upon the effective date of the rule, several variances to current regulations that many establishments use will no longer be needed, as the updated regulations 1) eliminate the two remaining inconsistencies between the Version 2.0.0 Standard (ISBT 128) and the regulations, and 2) no longer state that frozen plasma should be administered within six hours after thawing.

Mabel, I saw that today too, and thought "sure wish they did that BEFORE my JC inspector came by".

Today from the JC

http://www.jointcommission.org/standards_information/jcfaqdetails.aspx?StandardsFAQChapterId=104&StandardsFAQId=405

By marking out the date and changing it to 24 hours will work for most facilities, but our facility uses a meditech module called BCTA which requires scanning of the four quadrants on the unit face, so all our units must be relabeled.

One more thing to remember and has been discussed before in this forum-- any labels stuck to blood components have to be FDA compliant with regards to the adhesive used. Avery labels are not approved for affixing to blood component bags. Shamrock is one label Co. that I know that has blood bank labels that have approved adhesive (it is stated as such in their catalog). There are probably others.