Guidance Documents

Implementation Guides

Revised Cellular Therapy Terminology 

This document explains the new terminology and how it impacts the Product Description Code Database. It also includes crosswalk tables that compare the codes from v4.25.0 to the new codes in v4.26.0.

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Use of Product Divisions [Data Structure 032]

The purpose of this document is to provide guidance in the use of Product Divisions [Data Structure 032] so that software may be developed to support it. The new data structure allows encoding divisions of a product greater than 26 first level divisions and 26 second level divisions.

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Use of the Donation Identification Number [Data Structure 001]

The purpose of this document is to provide guidance for the use of the Donation Identification Number [Data Structure 001].

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Use of the Processing Facility Information Code [Data Structure 033]

The purpose of this document is to provide guidance in the implementation and use of the Processing Facility Information Code [Data Structure 033]. This data structure is designed for use by Cellular Therapy and Tissues facilities to convey information about the facility that assigned the Product Code and may include a facility product code assigned by the processing or labeling facility.

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ISBT 128 Facility Identification Number

The purpose of this document is to provide guidance for the use of Facility Identification Numbers found in a number of ISBT 128 data structures.

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Use of Flexible Date and Time [Data Structure 031]

The purpose of this document is to provide guidance in the use of the Flexible Date and Time [Data Structure 031].

This data structure should be used when:

  • Time zone needs to be encoded on the product label
  • The type of time needed is not covered by other data structures
  • Optionally, whenever it is preferred. That is, the Flexible Date and Time Data

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Use of Data Matrix Symbols with ISBT 128 v1.1.0

The purpose of this document is to assist users and software developers to implement Data Matrix two-dimensional (2-D) symbology for delivery of ISBT 128 data structures for blood, cellular therapy, and tissue labeling as well as for patient wristbands. Labeling includes affixed, attached, and accompanying labeling.

Use of the Manufacturer's Data File v1.1.0

The purpose of this document is to provide implementation guidance on the use of the Manufacturers Data File. Specifications pertaining to the Manufacturers Data File are contained in the ISBT 128 Standard Technical Specification and this information must be read for a complete understanding of the subject. Illustrations provided in the document are formatted to provide clarity rather than as copy/paste examples for software development.

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Use of Product Code Data Structure [003] - Blood

The purpose of this document is to provide detailed information about ISBT 128 product coding for Blood. Specifically, it explains:

  • the Product Code Data Structure [003] in detail,
  • the structure of the data base that supports the product description code,
  • how to select an appropriate product description code, and
  • how to request new product description codes.

This will in part replace the Product Code Structure aspect of the Product Code Structure and Labeling Document.

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Use of the Product Code Structure [003] - Tissues  v1.0.0

The purpose of this document is to provide detailed information about ISBT 128 product coding for Tissues. Specifically, it explains:

• the Product Code Data Structure [003] in detail,
• the structure of the data base that supports the product description code,
• how to select an appropriate product description code, and
• how to request new product description codes.

This will in part replace the Product Code Structure and Labeling Document.

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Use of Product Code Data Structure [003] - Cellular Therapy v1.1.0

The purpose of this document is to provide detailed information about ISBT 128 product coding for Cellular Therapy Products. Specifically, it explains:

  • the Product Code Data Structure [003] in detail,
  • the structure of the data base that supports the product description code,
  • how to select an appropriate product description code, and
  • how to request new product description codes
  • Now reflects new CT terminology

This will in part replace the Product Code Structure and Labeling Document

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Use of Product Code Data Structure [003] - Ocular Tissues v1.0.0

The purpose of this document is to provide detailed information about ISBT 128 product coding for Ocular Tissues Products. Specifically, it explains:

• the Product Code Data Structure [003] in detail,
• the structure of the data base that supports the product description code,
• how to select an appropriate product description code, and
• how to request new product description codes.

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Use of Dimensions Data Structure [029] v1.0.0

The purpose of this document is to provide implementation guidance for users and software developers who wish to implement the ISBT 128 Dimensions Data Structure [029].

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Use of Red Cell Antigens with Test History Data Structure [030] v1.1.0

The purpose of this document is to provide implementation guidance for users and software developers who wish to implement the ISBT 128 Red Cell Antigens with Test History Data Structure [030].

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Choosing an On-Demand label Printer v1.0.0

The purpose of this document is to provide guidance for users who wish to procure on-demand label printers.

Technical Bulletins

Technical Bulletin 5:  Bar Code Scanner Implementation of ISBT 128 Concatenation

This technical bulletin describes different types of barcode scanners that may be used for concatenation. Also, it provides solutions for some of the possible errors that may be encountered. 

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Technical Bulletin 7:  Use of Flags in the Donation Identification Number for Process Control of Critical Points During Processing and Distribution

This technical bulletin details innovative ways facilities are implementing the use of flag characters.

Technical Bulletin 8: Specification for ISBT 128 Data Structures to support the secure bedside matching of patient and transfusion/transplantation product identification

This technical bulletin details how hospitals can use ISBT 128 to encode patient identification and how that information may be securely linked to compatible products to improve patient safety. 

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Technical Bulletin 9: Bag Identification Using ISBT 128 and GS1

This technical bulletin provides guidance to blood bag manufacturers, their customers, and software developers on the bar coding of blood bags and their shipping containers.  It deals with the relationship between information held in the GS1 carton codes and the ISBT 128 blood container label codes, and recommends ways to simplify the mapping between this information.

Technical Bulletin 10: Valid and Invalid Bar Codes for use in ISBT 128 Validations

Technical Bulletin 10 contains scannable barcodes that can be used to validate software for reading ISBT 128.  This document includes valid and invalid barcodes to ensure that the software correctly accepts valid barcodes and rejects the invalid ones.

 

Technical Notes

Technical Note 1: Case Conversion

Technical Note 1 highlights the possible errors that can occur in barcode scanning when the computer has the “Caps Lock” feature on.

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Technical Note 2: Length of the Product Code Bar Code and Concatenation

Technical Note 2 explains how shortening the length of bar codes by using Subset C of Code 128 can create problems for concatenation of bar codes.  It explains that users must place such condensed bar codes properly if concatenation is to be successful. 

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Technical Note 4: Manufacturer Catalog Number and Lot Number

Technical Note 4 details how facilities can use ISBT 128 data structures to track which supplies (other than containers) are being used. 

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