5 day plasma, one more time

[John C. Staley]

Hopefully this is the last time I bring this topic up. I feel like I'm stuck in the movie Groundhog Day.

For those of you who "convert" your thawed FFP to Thawed Plasma with an extended outdate upto 5 days:

1. Do you change the component label on the bag from an FFP label to a Thaw Plasma Label?

2. If so, where did you get the label and what is the nuemeric barcode number for the product code? I've looked in both UAL and Shamrock and neither have the component label I'm looking for.

3. Also, if you use a computer do you component process the unit from FFP to Thawed Plasma in the computer?

Thanks for your help and patience. I think we might actually be doing this soon.

John

[donellda]

We convert our expired thawed FFPs, after 24 hours to what we call thawed plasma which has an expiration date of 5 days so I'm assuming we are talking about the same product. We do not use a different component label. When we convert the product in our computer system to "thawed plasma" the computer interprets the product barcode as "thawed plasma" rather than FFP. We do have a label that we put on the the plasma that says "Thawed Plasma" and there is a section on the label to write the new expiration date. We do the component processing from "thawed FFP" to "Thawed plasma" in BCP in Sunquest/Misys. Hope this helps.

[bmarotto]

For Codabar, we are using Shamrock label SB-911. It says:

THAWED PLASMA

______mL from

450 mL CPD/CPDA-1

Whole Blood

Store at 1 to 6 C

The product code on the label is 29381.

We use a middle of the road 3 day expiration. We go straight to Thawed Plasma from the time of thawing so we don't have to worry about changing the label and component type in our computer after 24 hours. We have an active hepatobiliary medicine and liver transplant service so it is not unusual to thaw 50 or more units a day. The three day dating has had a dramatic impact on our expiration of thawed plasma products.

ISBT-128 has thawed plasma product codes. We will be printing the 2 quadrant product/expiration date & time labels using the Hematrax system.

[John C. Staley]

Thank you bmarotto. You gave me exactly what I was hoping to find. I looked through a Shamrock catelogue and their website and could not find that but with the numbers it shouldn't be hard.

Thanks again

John

[Eagle Eye]

1) we change the component label from FFP to thawed plasma. we give 5 day expiration from the time of thawing.

2) Right now we are crossing out word fresh frozen and write thawed. and also write expiration date on the unit.

3) wwe also modify FFP in the LIS and call it THPLS. our LIS gives 5 day/96 hrs expiration from the time we modify FFP in the LIS. I ask my techs to modify FFP in the LIS before puting in the waterbath.

[Eagle Eye]

try this site: www.geocities.com/dmpollock .

Looks very good to me. I also downloded design pro 5 limited version. With the help of these two softwares/sites we should be able to create lots of barcode. But big question is.....to make sure you have label control process...

[bmarotto]

I have seen that site and it looks great. As for label control, I have a few suggestions and would welcome any other ideas.

1. Since the documents are word files, once you use a template to design a label and you validate that the label is correct you can password protect the file to prevent someone else from making any changes to it.

2. Once validated, stick one of the labels in a master log and note the date the word file was created and/or modified. Then each time you print additional copies of that label you can document (a) that the file date created/modified matches the master ( a visual comparison against the master label is a match and © the barcode translates correctly.

I don't want to open a can of worms but does the label adhesive have to be FDA approved? I admit we have designed some of our labels and printed them on Avery label stock and have had no problems when used on refrigerated or RT products. We have not used them for frozen products. Any thoughts here?

[Eagle Eye]

I am not sure about adhesive but I read it on AABB forum where there were some comment regarding adhesive????

[Cliff]

I don't want to open a can of worms but does the label adhesive have to be FDA approved? I admit we have designed some of our labels and printed them on Avery label stock and have had no problems when used on refrigerated or RT products. We have not used them for frozen products. Any thoughts here?

Well, as you suspected there are requirements, and the FDA makes them all so easy to find.

I uploaded a document to the FDA files section, Guideline for the Uniform Labeling of Blood and Blood Components. In particular you'll want to read the bottom of page 64, V-II 4 f.

I strongly advise against applying an Avery label directly on the blood product. In the past I had contacted UAL about some special labels they were going to print for me, and they told me they were not approved for direct blood bag adherence. I'd always ask that question of any label vendor, you'll be surprised which ones can't be directly applied.

[bmarotto]

Cliff,

What is meant by direct blood bag adherence? We have used the Avery labels over blank base labels or existing product labels after component modification but not directly onto the plastic of the bag itself.

Bev

[bmarotto]

OK, I read page 64. So if the label is placed OVER a base label, the adhesive must only contain substances that are FDA certified as "Indirect Food Additives".

For labels placed directly on the blood container, the FDA has additional standards and "should be contacted regarding this". So, they can tell us we MUST use barcoded labels but don't feel the need to publish the standards for all to see.

How you compliance folks keep you sanity is beyond me. My Blood Bank does not have a compliance officer and I have no desire to be one. With every passing day, my early retirement is looking like a better idea.

[Eagle Eye]

I ordered coustom label from SHamrock to include product code, ABORH type and facility barcode. They send me the paperowork that there labels are FDA cleared. I am also going to buy blank labels (probably 80/pg) from shamrock to use for pooled product unit number. I am going to use either design pro or geosite to create my labels.

[donellda]

OK, I read page 64. So if the label is placed OVER a base label, the adhesive must only contain substances that are FDA certified as "Indirect Food Additives".

For labels placed directly on the blood container, the FDA has additional standards and "should be contacted regarding this". So, they can tell us we MUST use barcoded labels but don't feel the need to publish the standards for all to see.

How you compliance folks keep you sanity is beyond me. My Blood Bank does not have a compliance officer and I have no desire to be one. With every passing day, my early retirement is looking like a better idea.

Wish I was old to join you in the early retirement. I've just started my job and already greener pastures are beckoning me:cool:

[bmarotto]

I just sent Avery an e-mail explaining that some of us would like to use their labels if they can certify that the adhesive they use meets FDA regulations as an "Indirect Food Additive" I sent them this link from the FDA listing all "Indirect Additives used in Food Contact Substances":

http://www.cfsan.fda.gov/~dms/opa-indt.html

In true FDA fashion, there is this disclaimer:

Please note that by being listed below, no inference should be made about the legality of using any one of these specific substances as an "indirect" food additive. Their presence on this list only indicates that the names of these substances are found (or, in the case of some of the polymers, are implied) in 21CFR parts 175 - 178.

Some of the substances have over 20 reg numbers listed!!!

If Avery is brave enough to take this on and send me an answer, I will share it with everyone. In the meantime, it's "don't ask don't tell" for me.

[bmarotto]

Avery said their labels would not meet the FDA regulation. I have contacted several other label companies and all said the same, even one that advertises a label stock for use in labeling blood bags. That company has a huge disclaimer and requires customers to sign a waiver of liability.

On the bright side, the author of the label website on geocities had this to say:

I am working through our district FDA office. They basically were suprised that the guideline states what it does and they are persuing this internally. I was told not to worry about it in the meantime. As soon as I get documentation I will post it here (AABB message board) and on my label website. (www.geocities.com/dmpollock)

The actual requirement specifically applies to labels added on top of existing labels.

I did not find any reference to adhesives in the ISBT version of FDA's guidelines, so this may become a moot point. The old codabar labeling guidelines which contain the statments will be obsolete.

[kelliott]

I guess I am not surprised about the label adhesive regulation. Because our blood supplier has an unconventional product code system we have been forced to create some of our own barcodes for product codes. Rather than apply them directly to the blood bag we apply the barcode label to a tie tag that we attach to the unit. That is one way to use an Avery label and remain compliant.