- Who are the ICCBBA licensed vendors that can provide me with software and label printing services for cellular therapy products?
- After implementing ISBT 128, will I have to re-label all my existing products in my inventory with ISBT 128 labels?
- Is there a deadline as to when my cellular therapy facility will have to implement ISBT 128?
- Who should be on my implementation team?
- What is the minimum information required to appear on a partial label?
- Where can I find the ISBT 128 Cellular Therapy Product Codes that I need? What if I don't find the one that suits my needs?
- How should I label my in-process cellular therapy products?
- How do I label products that are to be used for further processing?
- How should I select/request a Product Description Code for combinations of cells from different donors?
- Which ISBT 128 terminology could I use for identifying an adipose-derived stromal vascular fraction (AD-SVF)?
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A categorized list of ICCBBA-licensed vendors can be found here. Choose from vendors listed in the categories "Labeling (Cellular Therapy)" and/or "MIS/Information Technology." Many of the vendors listed in these sections provide contact information and a brief description of services provided.
You are not required to re-label the units in inventory with ISBT 128 labels at the time you implement ISBT 128.
Currently, AABB, FACT, JACIE, and NMDP require that ISBT 128 terminology be used when labeling cellular therapy products. However, there is no requirement at this time for the use of ISBT 128 bar codes or that the ISBT 128 label design be used on cellular therapy products.
ISBT 128 may affect many departments in a facility. A representative from each affected department should be part of the implementation team to provide insight as to how they will be impacted by the change and to address the specific requirements for their department. The staff involved with administration of the product will need to know where to find specific information located on the new label; the laboratory personnel will need to be familiar with Product Codes when performing modifications; the accounting department will need to understand the products that they will be billing; medical records personnel will also be affected. A recognized team leader should be chosen to spearhead the project.
Partial labels, at a minimum, should contain a unique numeric or alphanumeric identifier, proper name of the product (ISBT 128 Terminology), and intended recipient name and identifier (if applicable), in accordance with FACT/JACIE requirements. In addition there may be other national regulatory requirements that must appear on the label.
A complete list of ISBT 128 Product Description Codes can be found in the Microsoft Access file called ISBT 128 Product Description Code Database located in the password-protected area of the ICCBBA website. Blood, cellular therapy, tissue, and other MPHO Product Description Codes are all listed in the same table. Cellular therapy Product Description Codes begin with an "S" (e.g., S1234). Please note that S0001 through S1121 have been retired. Retired Product Description Codes should not be used to label new products. If there are no current Product Description Codes that fit your needs, you can submit a request for a new code using the online Request Form - Cellular Therapy located in Subject Area section of the ICCBBA website.
In-process products that do not leave a facility do not need to be labeled using ISBT 128. Facilities can choose to follow an ISBT 128 format, using local Product Codes where standardized codes for in-process products do not exist. If a product is collected by one facility and processed by another, the products should be labeled following FACT/JACIE, AABB, and/or Registry Standards, and in compliance with any pertinent regulations.
If these products are intended for further processing and then for administration, they should be handled as described in the above question on in-process products. If these products are not intended for administration, the upper right quadrant should reflect this. Instead of a standard ABO/Rh code, the code "Mr" (for research use only) should be selected. The words "For Nonclinical Use Only" (in the local language) should appear.
You may need to check national regulations, as well as FACT, JACIE and AABB Standards, for additional requirements.
ICCBBA thanks Josh Geary (Dana-Farber Cell Manipulation Core Facility) for providing the following information.
Our laboratory processes a number of products under IND (US FDA) that include cells from different donors. Following the CTCLAG guidelines for creating product description codes, with the understanding that not all information about the product can be coded or included in an ISBT 128 product label, we identified the active component of the product and the intent of the therapy and used this information to request an appropriate product description code. All additional information regarding the identity of the secondary cellular components is indicated in attached or accompanying documentation.
Cells from the donor and the recipient of a hematopoietic stem cell transplant are collected from apheresis or whole blood. Anergy (immune tolerance) is induced in a population of the donor’s lymphocytes by co-culturing them in the presence of inhibitors of T Cell co-stimulation and irradiated lymphocytes from the recipient of the transplant. Regulatory T cells are generated and purified for infusion. The product description code chosen for this product will describe the regulatory T cells, including the attributes “Cultured:Yes” and “T Reg enriched”, but not the “Irradiation:Yes” attribute because the active component of the product is not irradiated.
Malignant Cell, Tumor product is co-cultured with a cell line that is capable of secreting a particular cytokine and subsequently irradiated prior to transfusion. The product description code chosen for this product will describe the Malignant Cell, Tumor including the attributes for cultured and irradiated.
Due to the presence of allogeneic cells or cell lines, either of the following Donation Type codes should be used:
- “4” [Designated] OR
- “6” [Designated, biohazard]
The initial product (obtained by surgical procedures)*
This product would be named “ADIPOSE TISSUE” (classified under the ISBT 128 Tissues category).
Selecting a Subcategory 1 class name*
This product could be named “NC, ADIPOSE TISSUE”.
Example Product Description Code: S1941 = NC, ADIPOSE TISSUE|None/XX/refg|3rd Party Comp:Yes|Other Additives:Yes|Mononuclear cell enriched
Selecting a Subcategory 2 class name*
This product could be named “MSC, ADIPOSE TISSUE”.
Example Product Description Code: S3082 = MSC, ADIPOSE TISSUE|None/XX/refg|3rd Party Comp:Yes|Other Additives:Yes|Thawed Washed|Cultured:Yes
Selecting product attributes*
Product attributes should be selected for coding critical information. While some attributes are more specific—e.g. “10% DMSO” (of the Cryoprotectant attribute group)—others are more general. For example, “Other Additives: Yes” (of the Preparation: Other Additives attribute group) could be selected to account for a number of additives—the details would be included in the product’s accompanying documentation.
*Additional information on AD-SVF, and the rationale behind the selection of ISBT 128 terminology for this type of product, can be found here.