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ISBT 128 for Cellular Therapy

The goal of ISBT 128 is to globally standardize terminology, coding and labeling for products of human origin. The standardization of terminology is the first step and is the foundation for standardizing coding and labeling. In order to standardize terminology, the International Council for Commonality in Blood Banking Automation, or ICCBBA, convenes advisory boards composed of experts from around the world. For cellular therapy, this group is the Cellular Therapy Coding and Labeling Advisory Group, or CTCLAG. Closely related to CTCLAG is the Tissue Engineered Products Technical Advisory Group, or TEPTAG, which manages codes for products that are either engineered tissues or that reside in a gray zone between cells and tissues. This group is composed of the chairs of the ICCBBA cellular therapy and tissue advisory groups and other knowledgeable individuals. These advisory groups meet regularly through conference calls and face-to-face meetings to develop new terminology and respond to user requests for additional terminology. Once the advisory groups have reached a consensus for newly developed terminology, it is released for comment. After comments have been taken into consideration, the terminology is finalized and becomes part of the ISBT 128 nomenclature for product description.

ICCBBA establishes computer codes for these product description codes and other information needed to describe products of human origin. Lists of these codes are published in databases or reference tables and can be used to encode information in a variety of ways including in linear or two-dimensional bar codes on labels or electronic data exchange.

Labeling is the last stage in the development of a global standard. Labels are affected by languages, various standards-setting organizations, national and supranational regulations, and national preferences. Therefore, on an international level, ISBT 128 is flexible about the text that must appear on product labels. It is rigid, however, on how information must be encoded into bar codes and, with linear bar codes, the exact location of the bar codes on the label.

To provide additional guidance and standardization within a country, national consensus documents may be published. These documents blend requirements from regulatory agencies, pertinent standard-setting organizations, national preferences and the ISBT 128 standard itself. The "United States Consensus Guidance for the Uniform Labeling of Cellular Therapy Products Using ISBT 128" is such a document.

Background

In today's health care environment, there is an ever-increasing focus on patient safety. Regulatory scrutiny abounds, and as a result, cellular therapy establishments are aware of the need to monitor processes and procedures in order to ensure the safety and integrity of their products locally and globally. Terminology for components, reagents and products varies among institutions as well as countries; therefore, it is critically important that any standardization of labeling and terminology be achieved through an international collaborative effort.

The multi-organizational document, Circular of Information for the Use of Cellular Therapy Products, represents a step forward in the standardization of terminology. The COI includes uniform names for labeling and descriptions of cellular therapy products. When applicable, it incorporates the product terminology of ISBT 128.

The AABB Standards for Cellular Therapy Services requires an implementation plan for ISBT 128 labeling. Many cellular therapy facilities are currently using ISBT 128 terminology because it is required by the Standards. CTCLAG is currently encouraging facilities to fully implement ISBT 128, including label design and bar codes.

Frequently Asked Questions

Q: What is the status of the Coding and Labeling Advisory Group?

A: To review the multi-organizational international group meeting summaries and read information about committee representation from each organization, visit the ICCBBA website.

Q: What is the history of ISBT 128?

A: ISBT 128, as the international information standard that defines data structures, barcode placement, product definitions and nomenclature databases for transfusion and transplantation, was first proposed in 1989 by the International Society of Blood Transfusion, or ISBT. AABB, America's Blood Centers and the American Red Cross established the Council for Commonality in Blood Banking Automation, or CCBBA, to implement ISBT 128 in the U.S. In 1994, the ISBT Council joined the group and added international to the name (ICCBBA) to reflect its larger scope. The purpose of ICCBBA was to ensure that the new standard designed around Code 128 would be maintained. For more information, visit the ICCBBA website.

Q: Why do we need ISBT 128 for cellular therapy?

A: Label information is extremely critical in the application of cellular therapy components. Electronic data confirmation can be used to decrease the risk of error in both transcribing and reading this information.

The product label often contains very specific and technical information about the contents, volume, additives, and other key information, in addition to information to identify both donor and recipient. Variations in licensing requirements, language differences and local practice mean the information may not always be presented in the same way. With language differences, varying international label requirements and identifiers often in different languages, errors are likely to occur.

With both potential applications and global suppliers expanding, standardized methods for communicating critical information becomes even more important for patient safety.

Q: Why is bar coding important?

A: Numerous articles in the scientific literature have described the advantages of bar coding for patient safety. Bar coding is an optical machine-readable representation of data about the object to which it is attached. Information which is represented in particular patterns is accessed by the use of a scanner and interpreted by appropriate computer software. The FDA requires bar codes for biologic products, blood and blood components (21 CFR parts 201, 606 and 610).

Q: What should I be doing?

A: You should use the ISBT 128 terminology and develop an implementation plan if you do not already have one. The Resources section on this page contains helpful references. Sample implementation plans, other educational resources and sample labels may be found on the ICCBBA website.

Q: What is the U.S. Food and Drug Administration's perspective on this topic?

A: The FDA has issued numerous regulations and guidance documents on the subject, although it has not specifically addressed cellular therapy products alone.

Q: How do I find the right product codes for the products I manufacture?

A: The first step is to understand the terminology used for ISBT 128. This requires reading the "Standard Terminology for Blood, Cellular Therapy, and Tissue Product Descriptions." This document, found on the ICCBBA website (www.iccbba.org), defines all the terminology used with ISBT 128. Once the terminology is understood, the easiest way to find a product code is by using a tool called ISBT 128 Product Lookup Program. This is available on the ICCBBA website and requires a password for access. Your facility must be registered with ICCBBA to obtain a password.

Sometimes there will not be an existing product code description that fits your product. In these cases, you must request a new product description code from ICCBBA. An online Cellular Therapy Product Description Code Request Form may be found on the ICCBBA website. This is a drop-down menu screen that allows you to select characteristics of the product description you need and submit it to ICCBBA. New product description codes generally take four to six weeks to issue if no new terminology is required. If new terminology is required, the request must be reviewed by an international panel of experts in cellular therapy and ISBT 128 to ensure the terminology requested will receive global consensus. This process will take a little longer. New terminology should be requested directly from the ICCBBA office by sending an email to tech.director@iccbba.org.

Q: Where can I learn more?

A: AABB has published and continues to share educational materials with both its members and the public. Some documents are limited to individual and institutional members as a benefit of membership.

Reference Articles

Slaper-Cortenbach, Ineke; ISBT 128 coding and labeling for cellular therapy products. Cell and Tissue Banking (2010).

Ashford P, et al. Standards for Terminology and Labeling of Cellular Therapy Products. Transfusion 2007: 47: 1319-1327

Ashford P, et al. ISBT 128 Plan for Cellular Therapy Products. Transfusion 2007: 47:1312-1318

 Resources