ISBT codes for "Thawed Plasma"

[conwaysbb]

As we are a level 2 trauma center, we are looking at going to the 5 day "thawed plasma" as part of our massive transfusion protocol. As I understand it, if you do convert your FFP or 24 H plasma to "thawed plasma" you must then print out a new "thawed plasma" label.

As there are several "thawed plasma" codes and I do get FFP and 24Hr plasma from multiple blood centers is anyone using all the thawed plasma codes or just using one code.

i.e.

code E2702 is for thawed plasma, CPDA-1

code E2710 is for thawed plasma, CP2D

code E2684 is for thawed plasma, CPD

Also, is anyone converting FFP collected from Pheresis to thawed plasma? I do not see any ISBT128 codes to convert these pheresis units to.

[Likewine99]

We use E2702 and we only receive 24 hour plasma. Our HCLL system prints and ISBT bar code with the E2702 product code when we perform the thawing process in the system.

We also are a level 2 trauma center and went to 5 day plasma about 2 years ago. You will be amazed at the decrease in your outdated thawed plasma products.

[Pat Distler]

You are correct that if you convert FFP (or Plasma, Frozen <24 hours) into 5-day thawed plasma, you must relabel it to indicate it no longer has the same level of clotting factors that FFP (or Plasma Frozen <24 hours) has.

There are two options: Label it as THAWED PLASMA or just PLASMA (the frozen equivalent). It makes more sense to used THAWED PLASMA, even though regulations would permit the frozen equivalent.

E2710 is irradiated CPDA-1 plasma. CP2D thawed plasma is E2720.

E2121 is Thawed Apheresis PLASMA|ACD-A/XX/refg

E2289 is Thawed Apheresis PLASMA|NaCitrate/XX/reg

E5642 is Thawed Apheresis PLASMA|CP2D/XX/refg

[Eagle Eye]

As we are a level 2 trauma center, we are looking at going to the 5 day "thawed plasma" as part of our massive transfusion protocol. As I understand it, if you do convert your FFP or 24 H plasma to "thawed plasma" you must then print out a new "thawed plasma" label.

As there are several "thawed plasma" codes and I do get FFP and 24Hr plasma from multiple blood centers is anyone using all the thawed plasma codes or just using one code.

i.e.

code E2702 is for thawed plasma, CPDA-1

code E2710 is for thawed plasma, CP2D

code E2684 is for thawed plasma, CPD

Also, is anyone converting FFP collected from Pheresis to thawed plasma? I do not see any ISBT128 codes to convert these pheresis units to.

We are trauma center and keep thawed plasma in our inventory. We do not use FFP24. We do not convert Apheresis FFP to 5 day plasma. We have different codes in our LIS.

We print Q3 & Q4 (product code & expirartion dt) label for our ISBT units and relabled them after thawing.

[Pat Distler]

I forgot to mention something important for those creating 5-day plasma. You have to be sure that your blood provider is making their apheresis plasma in a closed system to give it a 5 day outdate.

Right now, that isn't very obvious from the labeling--it's just embedded in the product code and not in text on the label. We are changing that to require the words "OPEN SYSTEM" on the label if it applies. But until then, be sure to ask the blood provider. Some apheresis equipment produces plasma in an open system, and it is unsafe to extend the dating on these units to 5 days.

[tricore]

This is the response I received from our blood supplier when I asked aboput changing apheresis fresh frozen plasma into thawed 5 day plasma. This was sent to me in April 2007.

"According to AABB standards, you can not make thawed plasma with an outdate of up to 5 days if the apheresis plasma was prepared in an open system. Currently, ###(as a system) uses two technologies, Baxter Auto-C and Haemonetics PCS-2, to collect a small portion of our transfusable plasma. Unfortunately, these are considered open systems and from an AABB regulatory standpoint, units collected with these machines can not be made in to thawed plasma with an outdate beyond 24 hours. Since we may ship plasma to and from centers depending on need, there is the possibility that any of the hospitals served by ### could get an apheresis plasma collected in an open system eventhough some centers do not use the open technologies to collect plasma. Blood centers currently do not have a practical way to identify, at the time of labeling, which apheresis units were collected in an open system. As a result, if a hospital wants to maintain a 2-5 day thawed inventory of plasma, they will need to convert from plasma collected by whole blood. To complicate matters a bit more, we recently wrote to the AABB asking for clarification on this whole open vs closed issue and they responded with a blanket statement that all apheresis plasma could not be made into thawed plasma. In my opinion, the representative at AABB did not fully answer our question and the statement that all apheresis plasma can not be made into thawed plasma contradicts what is written in the standards, so I am inclined to believe that this issue is still only with open systems. Anyhow, we are in the process of seeking further clarification on this issue from the AABB. I have attached a copy of the email to the AABB standards committee for your information.

Another issue is that eventhough the AABB and the circular of information says it is acceptable to have an outdate of 24 hours for FFP and FP24, the FDA CFR is more strict on the outdate. FDA states that FFP and FP24 have an outdate of 6 hours after thaw. If you want to extend it to 24 hours, you need to have a variance from the FDA. Since there is already a precedence set for allowing the 24 hour variance, the FDA is not likely to turn down any variance requesting the 24 hour outdate, and I have spoken to a few hospital medical directors who have successfully obtained the variance. An alternative to the variance is to simply re-label the plasma as thawed plasma right after it is thawed or after 6 hours. However, most hospitals would rather get the variance to avoid having to re-label. I have attached 2 other emails that explain this issue in further detail and includes a response from the FDA.

Your examples, if I am reading them correctly, are all apheresis plasma. Following both AABB and the FDA regulations, they all have an outdate of 6 hours unless a hospital transfusion service has a variance to keep the FFP label up to 24 hours. If we could tell which units were collected in an open system (which we can't at this time), then those collected on any apheresis technology other than the Auto-C or PCS-2 could be extended to 5 days.

[dmpollock]

The Circular of Information is approved by FDA as far as I know. Here is what it says (from page 19):

Do not use the frozen component if there is evidence of container breakage or of thawing during storage. Plasma must be thawed in a waterbath at 30-37 C or in an FDA-cleared device. If a waterbath is used, thaw FFP in a protective plastic overwrap using gentle agitation. Thawed FFP should be infused immediately or stored at 1-6 C for up to 24 hours. If stored greater than 24 hours, the words “fresh frozen†must be removed.

[bbbirder]

I wanted to re-open this thread to see if anyone had more information on converting Apheresis FFP into Thawed Plasma.

If the Apheresis FFP was made from an open system, shouldn't that be reflected in the ISBT-128 codes? Then you'd know if you could convert it to 5-day or not?

If you are making Apheresis FFP into Thawed Plasma, what are you using for codes for container 1, container 2, etc.?

Thanks,

Linda Frederick

[Pat Distler]

Yes, if Apheresis FFP was made in an open system, it should have an "open" attribute. For example:

E2146 Thawed Apheresis PLASMA|ACD-A/XX/refg|Open

Division codes (7th and 8th positions) can be used for divided plasma. If you want to use container codes, you can request these product codes by using the form on the ICCBBA website (Registered Users Area)

Currently, although the "open" is in the product code, it is not required to be in the human readable text. That will change as soon as the draft version of the US Consensus (version 3) is approved by the FDA.

[bbbirder]

So my supplier sends me E4693 (Apheresis FFP|ACD-A/XX/<=-18C|2nd container) and E4697 (Apheresis FFP|ACD-A/XX/<=-18C|3rd container) and both units have the same DIN.

I want to make both of these into a 5-day product, Thawed Apheresis Plasma/ACD-A... but there is only one product code for this E2121, so I need to figure out a way to assign the correct division code to them to allow my computer system to have unique numbers/products? or request new codes?

It looks like there are individual product codes for the various containers if you are calling it Thawed Apheresis FFP (I assume these have 24 hour outdate) (E4693 --> E4717 and E4697 --> E4721), but not for a 5 day product.

And it looks to me if I make E2555 (PLASMA|CPD/XX/<=-18C|Frozen <=24h) or E7071 (FRESH FROZEN PLASMA|CPD/XX/<=-18C) into Thawed Plasma (5-day) that they both have the same product code (E2684, Thawed PLASMA|CPD/XX/refg)... but then there is E2701 (Thawed PLASMA|CPD/XX/refg|Frozen <=24h). What is the difference?

Thanks for any help,

Linda Frederick

[tricore]

Yes, if Apheresis FFP was made in an open system, it should have an "open" attribute. For example:

E2146 Thawed Apheresis PLASMA|ACD-A/XX/refg|Open

Division codes (7th and 8th positions) can be used for divided plasma. If you want to use container codes, you can request these product codes by using the form on the ICCBBA website (Registered Users Area)

Currently, although the "open" is in the product code, it is not required to be in the human readable text. That will change as soon as the draft version of the US Consensus (version 3) is approved by the FDA.

I can find only one product code for apheresis FFP that indicates it was collected in a open system: E5625 Apheresis FRESH FROZEN PLASMA|ACD-A/XX/<=-18C|Open

Are there others?

[Pat Distler]

You need to carry the 1st and 2nd containers forward into thawed codes:

E5548 Thawed Apheresis PLASMA|ACD-A/XX/refg|1st container

E5549 Thawed Apheresis PLASMA|ACD-A/XX/refg|2nd container

They are no longer FFPs, so you do have to make them "PLASMA".

E2684 would be used for 5 day plasma. E2701 cannot be used for 5-day plasma because of the Frozen <24 attribute. This attribute indicates the presence of some labile clotting factors--something that you cannot claim on the label if you use it more than 24 hours after thawing. E2701 must be used within 24 hours of thawing.

[bbbirder]

Thanks, Pat!

Linda Frederick

[Beverly Morris]

I received the attached list of ISBT codes from ICCBBA. This may help some of you.

Thawed Plasma codes.doc

[skopti]

Thank you all. This thread was educational and informative with regards to plasma and ISBT

[VACASE]

So my supplier sends me E4693 (Apheresis FFP|ACD-A/XX/<=-18C|2nd container) and E4697 (Apheresis FFP|ACD-A/XX/<=-18C|3rd container) and both units have the same DIN.

I want to make both of these into a 5-day product, Thawed Apheresis Plasma/ACD-A... but there is only one product code for this E2121, so I need to figure out a way to assign the correct division code to them to allow my computer system to have unique numbers/products? or request new codes?

It looks like there are individual product codes for the various containers if you are calling it Thawed Apheresis FFP (I assume these have 24 hour outdate) (E4693 --> E4717 and E4697 --> E4721), but not for a 5 day product.

And it looks to me if I make E2555 (PLASMA|CPD/XX/<=-18C|Frozen <=24h) or E7071 (FRESH FROZEN PLASMA|CPD/XX/<=-18C) into Thawed Plasma (5-day) that they both have the same product code (E2684, Thawed PLASMA|CPD/XX/refg)... but then there is E2701 (Thawed PLASMA|CPD/XX/refg|Frozen <=24h). What is the difference?

Thanks for any help,

Linda Frederick

We do 5-day Thawed Plasma and we use the E2121 code as follows:

Frozen code (FFP)

Thawed FFP code (24 hr.)

Thawed Plasma Code (5 day)

E0701V00

E0773V00

E2684V00

E0869V00

E1318V00

E2121V00

E0869VA0

E1318VA0

E2121VA0

E0869VB0

E1318VB0

E2121VB0

There should be additional letters on the end of your product codes to state what containers they came from. We use the E2121 code for our 5-day thawed plasma but we use it for the frozen codes starting with E0869. We have E0869V00, E0869VA0, and E0869VB0. When we modify them to the 5-day plasma we use codes E2121V00, E2121VA0 and E2121VB0 respectively. When I look on the http://iccbba.org/ website they have an ISBT128/Codabar map and the code I see for Apheresis FFP|ACD-A/XX/<=-18C is E0869 and they actually have codes for up to 8 parts (E0869VA0, E0869VB0, etc. up to E0869VH0). I did not see the E4693 or E4697 codes you mentioned but they could be new I guess. At any rate you can use E2121 product code for your 5-day plasmas even if they have the same DIN number because the product codes should have different extensions (e.g. E2121VA0 and E2121VB0).

As far as your question about which thawed plasma code to use for E2555 vs E7071 (which I think is E0701) you would use the E2701 code for the thawed E2555 product I would think because they have the same description of 'Frozen <=24h.' We use E2684 for the thawed E0701 product.

You really need to look at the descriptions and match them up for frozen vs thawed products.

[VACASE]

I’m sorry, my chart didn’t come out to good when I pasted it as a spreadsheet. It should read.

FROZEN CODE THAWED FFP CODE (24 HR) THAWED PLASMA CODE (5 DAY)

E0701V00 E0773V00 E2684V00

E0869V00 E1318V00 E2121V00

E0869VA0 E1318VA0 E2121VA0

E0869VB0 E1318VB0 E2121VB0

[tricore]

You need to carry the 1st and 2nd containers forward into thawed codes:

E5548 Thawed Apheresis PLASMA|ACD-A/XX/refg|1st container

E5549 Thawed Apheresis PLASMA|ACD-A/XX/refg|2nd container

They are no longer FFPs, so you do have to make them "PLASMA".

E2684 would be used for 5 day plasma. E2701 cannot be used for 5-day plasma because of the Frozen <24 attribute. This attribute indicates the presence of some labile clotting factors--something that you cannot claim on the label if you use it more than 24 hours after thawing. E2701 must be used within 24 hours of thawing.

Upon what do you base this statement"E2701 cannot be used for 5-day plasma because of the Frozen <24 attribute. "

Please see this thread on the CBBS web forum.

http://www.cbbsweb.org/enf/2005/thawed_plasma.html

[Scott Hampton]

We are a level I trauma center that also converts FFP to Thawed Plasma immediately. You must use the code that best represents the product, the anticoagulant, and the volume.

As we are a level 2 trauma center, we are looking at going to the 5 day "thawed plasma" as part of our massive transfusion protocol. As I understand it, if you do convert your FFP or 24 H plasma to "thawed plasma" you must then print out a new "thawed plasma" label.

As there are several "thawed plasma" codes and I do get FFP and 24Hr plasma from multiple blood centers is anyone using all the thawed plasma codes or just using one code.

i.e.

code E2702 is for thawed plasma, CPDA-1

code E2710 is for thawed plasma, CP2D

code E2684 is for thawed plasma, CPD

Also, is anyone converting FFP collected from Pheresis to thawed plasma? I do not see any ISBT128 codes to convert these pheresis units to.