Technical FAQs

  1. How do I access the databases and documents available only to licensed facilities?
  2. Where do I find the Product Description Codes that I need?
  3. How do I obtain a new Product Description Code?
  4. What is a local product code?
  5. What are national product codes?
  6. We are doing research on new blood components. How do I get a Product Description Code for these products?
  7. How do I label intraoperatively collected autologous blood?
  8. What is the purpose of the check character? Is the use of the check character an ISBT 128 requirement?
  9. What are Flag characters, and why are they used?
  10. Where can I find ISBT 128 labels for validation?
  11. Is the use of concatenation required?
  12. We are having difficulty getting our scanner to read concatenated ISBT 128 bar codes. What can I do?
  13. Can ISBT 128 be used with 2-D bar codes or RFID tags?
  14. Can I use ISBT 128 bar codes to label a Red Cell product as antigen-negative based on historical antigen testing of the donor?

 

Need to ask a specific question? Email us at iccbba@iccbba.org.


1. How do I access the databases and documents available only to licensed facilities?

Databases (e.g. the ISBT 128 Product Description Code Database) and documents are located in the Tech Library section of the website. Databases and certain documents are only accessible to registered facilities that are current on their annual licensing fees.

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2. Where do I find the Product Description Codes that I need?

Product Description Codes are published in the form of a database—this is the "ISBT 128 Product Description Code Database". Registered facilities can download the database, so long as they are current with their licensing requirements. In addition, the "ISBT 128 Product Lookup Program" can be used to search for existing Product Description Codes.

The ISBT 128 Product Description Code Database gets updated approximately ten times per year. It is essential to update your copy regularly to have the most current ISBT 128 Product Description Codes. You can subscribe to ICCBBA's mailing list to be notified of updates via email.

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3. How do I obtain a new Product Description Code?

To request a new Product Description Code that is not already in the database (and can be described sufficiently with current ISBT 128 terminology), a product request form can be submitted.

Request forms for Product Description Codes can be found on the website and must be completed and submitted online. There are different forms for—blood, cellular therapy, fecal microbiota, in vivo diagnostic MPHO, medical device, human milk, ocular, organ transplant, plasma derivative, reproductive, tissue, tissue engineered, and topical—products. These forms can be found in the Subject Area section of the website:

For further information on how to obtain a new Product Description Code, click here.

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4. What is a local product code?

Local product codes are primarily used for "boutique" or research products. They are also used for in-process products that a system may require to track.

Local codes are defined and maintained by the facility—ICCBBA does not maintain or keep track of these codes.

  • Codes A0000 through D9999 that are not reserved for national use may be used for local codes.
  • Codes beginning with D, and have alpha characters within positions 2-5 (e.g., DAX12), shall be reserved as locally-defined codes.

These codes should ONLY be used where there is not an appropriate international or national code, and when there is good reason why an international code should not be allocated.

If there is any uncertainty whether the code assigned to a product should be—internationally or locally/nationally/regionally—defined, please contact the ICCBBA office.

Local codes are separate from national codes. See FAQ #5 for information on nationally assigned product codes.

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5. What are national product codes?

National product codes are codes reserved by a national agency for use within a country. National agencies may reserve a range of values in the block A–D for national assignment.* Where this is done, it shall be the responsibility of the national agency to ensure that definitions are provided for use within the country and that products bearing such codes are not transferred outside the national boundary.

*The following range of codes are available for assignment by a national authority:

  • Codes beginning with A–C, and have alpha characters within positions 2–5 (e.g., AE134, BT123, CRA12), shall be reserved as national codes.
  • Codes that begin with A–D followed by numeric characters (A0000–D9999) are open for national assignment. National authorities have the responsibility to communicate codes reserved in this range so that it does not conflict with locally assigned facility codes within the same range.

A national authority should assign/approve nationally-defined product codes to ensure products in different categories (e.g., blood, cells, tissues, organs, and human milk) do not assign the same product codes for different products.

National codes are separate from locally assigned facility codes. See FAQ #4 for information on local codes.

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6. We are doing research on new blood components. How do I get a Product Description Code for these products?

ISBT 128 permits any facility (licensed with ICCBBA) to assign a "local code" to products in development. These codes should be made known to blood centers doing the research and any facility or facilities using the new products in clinical trials, etc. Outside of this group, these codes may have a different meaning. See the ISBT 128 Standard Technical Specification (ST-001) for details.

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7. How do I label intraoperatively collected autologous blood?

If the products will be stored in the laboratory, a local code (first letter A-D) should be used. For example, A0001 could be "Intraoperative Washed Red Blood Cells". Other labeling should follow national requirements.

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8. What is the purpose of the check character? Is the use of the check character an ISBT 128 requirement?

The check character (also referred to as check character K) is intended to confirm the accuracy of a manual keyboard entry when the code cannot be scanned. The check character is calculated using the ISO/IEC 7064 modulo 37-2 checksum method—additional information can be found in the ISBT 128 Standard Technical Specification (ST-001):

  • Appendix A.1 provides information on the overall process of calculating the keyboard entry check character.
  • Appendix A.2 provides information pertaining to computer programs for calculating the check character K.

The Quick K Calculator (available on the ICCBBA website at www.iccbba.org/lookup-tools/quick-k-calculator) can be used as a tool to calculate the modulo 37-2 check character.


[The Quick K Calculator shows that the check character on the DIN "A999914123458" is the letter "J".]

When printed, the check character shall be clearly distinguished from the corresponding data content. The check character shall be printed with a box drawn around it:

With regard to the Donation Identification Number (DIN), the check character is based off of the 13-character DIN itself. The DIN’s check character must not include the flag characters as part of the calculation. Appendix A.1 of the ISBT 128 Standard Technical Specification (ST-001) provides an example of calculating the check character for a DIN. The inclusion of the check character with a DIN is an ISBT 128 requirement.

Please see Section 7.4.2 of ST-001 for the "Keyboard Entry Check Character Requirements for ISBT 128 Data Structures Utilizing Code 128" table [RT002] for the applicable data structures in which the Check Character is used.

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9. What are Flag characters and why are they used?

For ISBT 128, flag characters (also referred to as a flag or flags) are used with the Donation Identification Number (DIN) and are intended to be used for added process control when there is a need to differentiate multiple applications of the same DIN.

Flag characters, while part of the data content of the Donation Identification Number (DIN) data structure, are not part of the 13-character DIN itself and do not contribute to unique identification of the product.

There are three types of flag characters:

  • Type 1: A two-character code used for process control and defined by ICCBBA (as shown in the figure below).
  • Type 2: A two-character code used for process control but locally defined.
    • These characters should only be interpreted by the facility that has defined them or within the group of facilities that have agreed on a common definition.
  • Type 3: A weighted ISO/IEC 7064 modulo 37-2 check character on the DIN itself, which acts on the DIN as a secondary check [in addition to the printed Check Character] within the bar code.

Additional information on flags can be found in Section 2.4.1 of the ISBT 128 Standard Technical Specification (ST-001). For examples of the use of flag characters, see Technical Bulletin 7: Use of Flags in the Donation Identification Number for Process Control of Critical Points During Processing and Distribution (IG-010). 


[The "01" flag characters indicate that the label applies to "Container 1" of a set. The interpretation of Type 1 flags and the values allotted for Type 2 and Type 3 flags, can be found in table RT004 (see Section 3.1 of ST-001).]

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10. Where can I find ISBT 128 labels for validation?

Sample bar codes (both valid and invalid), which can be used for validation purposes, can be found in IG-013 Implementation Guide: ISBT 128 Bar Codes: Valid and Invalid Examples and IG-043 Implementation Guide: A Validation Tool for ISBT 128 Data Structures.

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11. Is the use of concatenation required?

Concatenation is a method by which the information held in two bar codes is combined in the scanner into a single string of data before being sent to the host computer. The use of concatenation is encouraged but not required. When set up properly, concatenation can be a powerful process control tool used to ensure information is scanned from the same product label.

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12. We are having difficulty getting our scanner to read concatenated ISBT 128 bar codes. What can I do?

The user’s manual for your bar code scanner should have the information you need (in the form of bar codes) to turn on and off the different types of bar code symbologies and concatenation features. It is recommended that you turn off all other symbologies that are not being used. You may need to contact your bar code scanner supplier if you require additional assistance.

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13. Can ISBT 128 be used with 2-D bar codes or RFID tags?

ISBT 128 data structures can be delivered using a number of different technologies including Code 128 bar codes, two-dimensional (2-D) bar codes, Reduced Space Symbology (RSS) bar codes, wireless radio frequency identification transponders (RFID tags), and EDI messages.

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14. Can I use ISBT 128 bar codes to label a Red Cell product as antigen-negative based on historical antigen testing of the donor?

The ISBT 128 Standard does not create standards for testing. Rather, ISBT 128 provides information on how a product can be labeled or how information should be transmitted electronically. ICCBBA defers to national authorities to determine when a unit may be labeled as antigen-negative—click here* for practices in some countries.

*The information provided in the table is based on an informal survey of ISBT 128 users and may reflect only a single facility within a country.


 

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