Cellular Therapy - Documents

This section consists of documents that pertain to cellular therapy products.

Click here to view the documents pertaining to the revised cellular therapy terminology.

Click here to view example implementation plans. 

Click here to view the Circular of Information for the Use of Cellular Therapy Products. 


 

IN-005 ISBT 128 for Cellular Therapy, An Introduction  PDF

This document provides an overview of the ISBT 128 Standard and how it applies to cellular therapy products. It also describes the elements needed to achieve standardization and how the standard is used to encode information into machine-readable form.

 

ST-004 ISBT 128 Standard Labeling of Cellular Therapy Products v1.1.0 – PDF

This document is intended to help facilities, label vendors, and software developers design appropriate ISBT 128 labels for cellular therapy products. Greater detail is given for labeling than that provided in the ISBT 128 Technical Specification.

 

ST-012 ISBT 128 and the Single European Code (SEC) v1.3.1 – PDF

This document provides specific rules and guidance in the implementation of the SEC for ISBT 128 labeled products. This standard must be read in conjunction with the relevant EC and national legislation and regulatory requirements. It is the responsibility of the tissue establishment (TE) applying the SEC to ensure that labels comply with applicable regulation.

 

IG-022 Implementation Guide: Product Coding [Data Structures 003 and 032] - Cellular Therapy v1.2.0 - PDF

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The purpose of this document is to provide guidance in the use of the Product Code [Data Structure 003] and its supporting database in the coding of cellular therapy products. This document also discusses Product Divisions [Data Structure 032] and its role in traceability when used in conjunction with Data Structure 003.

 

IG-023 Implementation Guide: Use of Product Divisions [Data Structure 032] v1.1.0 – PDF

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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. 

This document is a guidance document to be used in conjunction with the ISBT 128 Standard Technical Specification (ST-001). It provides information about the format and use of the Product Divisions [Data Structure 032] when used in conjunction with the Product Code [Data Structure 003].

 

IG-024 Implementation Guide: Use of Flexible Date and Time [Data Structure 031] v1.1.0 – PDF

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The purpose of this document is to provide guidance in the use of the Flexible Date and Time [Data Structure 031]. This document is a supplement to the ISBT 128 Standard Technical Specification (ST-001). It:

  • Provides specific guidance for cellular therapy, ocular tissue, regenerated tissues, and organ transplantation in the use of the Flexible Date and Time [Data Structure 031].
  • Provides guidance on printing bar codes and text for dates on labels.
  • Addresses some concerns for software developers.

 

IG-031 Implementation Guide: Use of the Processing Facility Information Code [Data Structure 033] v1.1.0 - PDF

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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.

 

IG-038 Implementation Guide: Use of the Global Registration Identifier for Donors [Data Structure 037] v1.0.1 – PDF

This document specifies the format and use of the Global Registration Identifier for Donors (GRID), which is represented in ISBT 128 by Data Structure 037. The guidance has been developed jointly by the WMDA and ICCBBA under the terms of a Memorandum of Understanding.

 

TB-001 Implementing ISBT 128: Guidance on Handling non-ISBT 128 Labeled Collections v1.1.0 – PDF

This document provides advice on the implementation of ISBT 128 in such situations when cellular therapy processors may be receiving some donations that are not identified using ISBT 128.

 

TB-007 ISBT 128 and the Single European Code v1.4.0 – PDF

This document provides information regarding the use of ISBT 128 and the Single European Code (SEC).

 

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Implementation Plan

ISBT 128 Implementation Plan for Cellular Therapy  docx

This document provides a sample ISBT 128 implementation plan concerning cellular therapy. It is intended to assist cellular therapy centers in creating their own ISBT 128 implementation plan.

 

Example Implementation Plan – PDF

This example plan was meant to be comprehensive, and not all steps may be needed by all facilities. Therefore, facilities should use it as a guide or checklist of things to consider rather than attempting to follow it precisely.

 

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Revised Cellular Therapy Terminology

The revised ISBT 128 cellular therapy terminology was implemented in August of 2013. Previous terminology was re-evaluated due to regulatory concerns regarding the use of TC (“therapeutic cell”) terminology. As a result of this review, the terminology was revised to eliminate the “TC” class designation and to create a more consistent format for cellular therapy class terms. The revised terminology also takes into consideration consistency with nomenclature used for tissue products (e.g., removing modifiers). For more details on the reason for the changes, see the presentation by Zbigniew M Szczepiorkowski, MD, PhD, FCAP. The following document pertains to the implemented revised terminology.

TB-010 Revised Cellular Therapy Terminology v1.0.0 – PDF

The purpose of this document is to provide a cross reference to terminology used prior to August 2013 (version 4.25.0 and before) and that used after August 2013 (version 4.26.0 and after). This document is intended to provide users with information that will help them transition from the old terminology to the new and will not be updated as new cellular therapy terminology is added.

 

Supplementary Information:

Action List Strategy - PDF

The Action List Strategy is a suggested list of actions that should be considered when a facility implements the updated ISBT 128 terminology for cellular therapy. 

 

Validation Strategy - docx

The Validation Strategy is intended for facilities that have already implemented ISBT 128 labeling and are seeking to validate only the changes to the terminology, OR have implemented ISBT 128 terminology (not full labeling) and are seeking to validate only the changes to the terminology.

 


Circular of Information

Circular of Information for the Use of Cellular Therapy Products – PDF

Posting Date: July 2016

This circular was prepared jointly by the AABB, America’s Blood Centers, the American Association of Tissue Banks, the American Red Cross, the American Society for Apheresis, the American Society for Blood and Marrow Transplantation, the College of American Pathologists, the Cord Blood Association, the Foundation for the Accreditation of Cellular Therapy, ICCBBA, the International Society for Cellular Therapy, the Joint Accreditation Committee of ISCT and EBMT, the National Marrow Donor Program, and Netcord. Federal law prohibits dispensing the cellular therapy products described in this circular without a prescription.