FAQ

Cellular Therapy FAQ

1.

Who are the ICCBBA licensed vendors that can provide me with software and label printing services for cellular therapy products?

2.

After implementing ISBT 128, will I have to re-label all my existing products in my inventory with ISBT 128 labels?

3.

Is there a deadline as to when my cellular therapy facility will have to implement ISBT 128?

4.

Who should be on my implementation team?

5.

What is the minimum information required to appear on a partial label?

6

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?

7.

How should I label my in-process cellular therapy products?

8.

How do I label products that are to be used for further processing?

 

 Cellular Therapy Frequently Asked Questions 

1.

Who are the ICCBBA licensed vendors that can provide me with software and label printing services for cellular therapy products?

 

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".  Contact information and a brief description of the services they provide can be found for each vendor listed. 

 

2.

After implementing ISBT 128, will I have to re-label all my existing products in my inventory with ISBT 128 labels?

 

You are not required to re-label the units in inventory with ISBT 128 labels at the time you implement ISBT 128.

 

3.

Is there a deadline as to when my cellular therapy facility will have to implement ISBT 128?

 

Currently, the 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.

 

4.

Who should be on my implementation team?

 

ISBT 128 will affect many departments in the 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 of 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.

 

5.

What is the minimum information required to appear on a partial label?

 

Partial labels at a minimum should contain a unique numeric or alphanumeric identifier, proper name of 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.

 

6

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?

 

A complete list of ISBT 128 product codes can be found in the Microsoft Access file called "Product Codes Database - Access 2000" located in the password protected area of the ICCBBA website.  You must be logged in to see this.  Blood, cellular therapy, and tissue product codes are all listed in the same table.  The cellular therapy product codes will begin with an "S" (i.e., S1234).  Please note that S0001 through S1121 have been retired.  Retired product codes should not be used to label new products.  If there are no current product codes that fit your needs, you can submit a request for a new code using the online "Request Form - Cellular Therapy Products" located in the registered users' area of the ICCBBA website.  You will need to submit a separate form for each product.

 

7.

How should I label my in-process cellular therapy products?

 

In-process products that do not leave a facility do not need to be labeled with 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, or Registry Standards, and in compliance with any pertinent regulations.

 

8.

How do I label products that are to be used for further processing?

 

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 must check national regulations, as well as FACT, JACIE and AABB Standards, for additional requirements.