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srichar3

Exchange Transfusion Product Code

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Hello Everyone, this is my first post on Pathlabtalk but I have been loitering for a while reading past posts and topics. I've been working in the filed of Haematology and Blood transfusion for the past 17 years, the last 10 of which have been in Blood Bank management. I'm originally from the UK but for the last year have been working out in UAE where the systems are closely aligned with the US, following AABB and CAP standards. 

Previously I dont have any experience of blood pack modifications, as in the UK we are quite spoilt with an exceptional national transfusion service that provides hospital blood banks with pretty much everything they need ready prepared and ready to use. On top of this, although we follow ISBT standards for unit number bar code format, the UK has its own format for product codes. Out here in the UAE we are using ISBT standards for product codes.

What I want to know is when a unit is prepared for neonatal exchange transfusion by diluting PRBC's with AB plasma, what product code is assigned to the newly prepared unit under ISBT product code standards? 

Thanks and sorry for the long winded post.

 

Steve

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Welcome Steve!

This web site:

http://medical.oneblood.org/biologics/distribution/search-and-view-isbt-product-codes.stml

among others, seems to at the least have a listing of the codes available.  It looks like you want code E0272?  You may want to call AABB just to make sure if that is the source that your inspectors use for standards.

Scortt

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Thanks for that but after reading it and googling the descriptions for a better understanding of the product, this has muddied the water further. I found the below document which has various different descriptions but not sure which would be most appropriate between supernatant removed plasma added and plasma reduced plasma added? 

IF The product is made by first removing additive from the Red Blood Cells and then adding blood group-compatible plasma Product is encoded as Red Blood Cells with the Attribute “Supernatant removed/Plasma added”

IF The product is made by removing some of the plasma from Red Blood Cells and then adding blood group-compatible plasma Product is encoded as Red Blood Cells with the Attribute “Plasma reduced/Plasma added

Would the latter be referring to whole blood and the former to PRBC?

https://www.iccbba.org/uploads/bc/26/bc268d3ab8e8533579768db2e3c9e40e/Reconstituted-Red-Blood-Cells.pdf

As in PRBC its mainly additive but still some residual plasma so before are relevant. 

Thanks

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Hi Steve,

Products for exchange transfusion or “reconstituted” products are encoded as red blood cells with the plasma added attribute. When selecting an appropriated ISBT 128 code for these products all applicable core conditions, attributes, and modifiers still apply. For help with the terminology, section 2 of the ISBT 128 Standard Terminology for Medical Products of Human Origin (ST-002) document contains the current blood component terminology and definitions that is used for ISBT 128 product descriptions.

I would be happy to work with you to narrow down the appropriate ISBT 128 product description. If you are able to provide more information about your product, we should be able to determine an appropriate product description code for your product or initiate a request for a new code to be added (if necessary). Please feel free to DM me or contact the ICCBBA office with a description of your processing steps if you wish not to make such information public on these forums.

I also see that the reconstituted red cell guidance was shared earlier in this thread – the short document (also linked here) reflects the current thinking on labeling these products in the US. You may need to refer to your national/local authority for any coding/labeling guidance and requirements for such products in the UAE. You may also need to reference your accrediting organization for any additional requirements.

Kind Regards,
Kaytee from ICCBBA (Organization that maintains and develops the ISBT 128 Coding and Labeling Information Standard)

 

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Hi Kaytee 

Thank you for the information and the offer to help identify the correct code and description. After further reading, the closest description I have come up with is as shown below, however donations here are only 450ml not 500ml. Can the same code be used but the description altered to account for this? Or is the description attached to the code fixed? (I presume it is)

E8989 RED BLOOD CELLS|CPD>AS1/500mL/refg|RBC irradiated|ResLeu:NS|Supernat rem/Plasma added.

The original code I posted above (E5529) would not be allowed as we do not have irradiated plasma out here, and we have no irradiator to irradiate the final prepared unit on site so we are limited to irradiated PRBC only.  

The units we use here are irradiated PRBC's from a 450ml donation in CPD-SAGM (E0438), we then centrifuge the unit and remove as much additive and residual plasma as possible to give an Hct of >.9. The requisite volume of AB plasma (E0701)  is then added to the unit to give a final target Hct of .55. Also the plasma is not leukocyte reduced but the PRBC's are.

Regards Steve

 

Edited by srichar3

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I have also reached out to our blood supplier who gave this responce;

"Hi Steven

I checked in the ISBT 128 table and didn’t find the RBC in SAGM with plasma added, the additive solutions are AS1/AS2..

It’s not only a problem of volume but also the additive solution.

These are the only codes for RBC SAGM 450ml"

So it would appear currently there is no code that is suitable for the products we have available?

 

Product Description Codes

PRODDESCRIPCODE

Class Identifier

Modifier Identifier

PRODDESCRIP0

E0429

C0002

M0000

RED BLOOD CELLS|SAGM/450mL/refg

E0430

C0002

M0000

RED BLOOD CELLS|SAGM/450mL/refg|For mnf:injectable

E0431

C0002

M0000

RED BLOOD CELLS|SAGM/450mL/refg|For mnf:noninjectable

E0432

C0002

M0000

RED BLOOD CELLS|SAGM/450mL/refg|Not for tx or mnf

E0433

C0002

M0000

RED BLOOD CELLS|SAGM/450mL/refg|Open

E0434

C0002

M0000

RED BLOOD CELLS|SAGM/450mL/refg|Open|Irradiated

E0435

C0002

M0000

RED BLOOD CELLS|SAGM/450mL/refg|Open|Irradiated|ResLeu:<5E6

E0436

C0002

M0000

RED BLOOD CELLS|SAGM/450mL/refg|Open|ResLeu:<5E6

E0437

C0002

M0000

RED BLOOD CELLS|SAGM/450mL/refg|Irradiated

E0438

C0002

M0000

RED BLOOD CELLS|SAGM/450mL/refg|Irradiated|ResLeu:<5E6

E0439

C0002

M0000

RED BLOOD CELLS|SAGM/450mL/refg|ResLeu:<5E6

 

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Hello Steve,

You’re very welcome! Also, apologies for the long response below:

It looks like you will need to submit a request for a new code to be added to the database to reflect the description you need for your products. If you can verify that the following description describes your final product, you can go ahead and submit a request for this to be added to our ISBT 128 Product Description Code Database via the ISBT 128 Product Lookup Web Application (please note that you need to be logged into the ICCBBA website to use the program).

  • RED BLOOD CELLS|CPD>SAGM/450mL/refg|RBC irradiated|ResLeu:NS|Supernat rem/Plasma added

You can also use a code that does not indicate irradiated. In the US, the FDA does not allow coding and labeling a partially irradiated product (e.g., only RBCs were irradiated) as a fully irradiated product. A product description code with the “RBC irradiated” attribute or a non-irradiated code can be used. If you wish, you can request the following description – currently there is no non-irradiated code in our database that reflects the description you provided.

  • RED BLOOD CELLS|CPD>SAGM/450mL/refg|ResLeu:NS|Supernat rem/Plasma added

In the meantime, your facility may assign a local code for the description you need until the description is added to our database. The reconstituted red cell guidance (also linked here) briefly mentions using local codes. For more details regarding local codes: section 2.4.3 of the ISBT 128 Standard Technical Specification (ST-001) document and section 3.7 of the Implementation Guide: Use of Product Code [Data Structure 003] - Blood (IG-021) document discusses and provides guidance for using locally assigned codes.

If the codes provided above do not fit your needs, please let me know and we can adjust the description accordingly prior to your request submission.

Kind Regards,
Kaytee

 

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Hi Kaytee

Thank you very much for you help with this, that description seems to match what we need and I will look into getting the request made.

Regards Steven Richards

 

 

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