ISBT 128 for Cellular Therapy

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 their processes and procedures in order to ensure the safety and integrity of their products.

According to a recent article in JAMA, “patient safety system progress is slow and is a cause for great concern. Efforts for improvement must be accelerated.”¹ “When used correctly and consistently, barcoding can reduce manual entry errors by 17%, decrease medication errors by 86%, and provide 100% positive patient identification during blood transfusion,” concluded Douglas and Larabbe in their article “Bring Barcoding to the Bedside.” ² Data collected from transfusion services suggests that one of the most frequent causes of adverse recipient outcomes is mistransfusion occurring as a result of errors in the identification of patients or products and their associated samples. AABB has previously proposed standards for ISBT 128 for use with blood and blood components. Click here for the complete AABB Association Bulletin on ISBT implementation for blood and blood components .

According to the World Marrow Donor Program, in 2004 55 percent of the products shipped for infusion were from outside North America. 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.³

The multiorganizational 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.

Cellular Therapy Coding and Labeling Advisory Group:

In October 2005 the boards of AABB, ASBMT, EBMT, FACT, ICCBBA, ISBT, ISCT, ISCT Europe, JACIE, NMDP, and WMDA jointly formed the Cellular Therapy Coding and Labeling Advisory Group. The group issued a joint statement confirming their support for the international use of ISBT 128 in the coding of cellular therapy products and established an advisory group to identify and resolve related issues.

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

A: The advisory group published its work in Transfusion in July 2007.^3,4  To review the multiorganizational international group meeting summaries, read information about committee representation from each organization, visit the ICCBBA Web site.

Q: What is ISBT 128?

A: ISBT 128 is the international information standard that defines data structures, barcode placement, product definitions and nomenclature databases for transfusion and transplantation. The international standard was first proposed in 1989 by the International Society of Blood Transfusion (ISBT). AABB, America’s Blood Centers and American Red Cross established the Council for Commonality in Blood Banking (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 Web site.

Q: How does it apply to 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.

Often the product label 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. According to statistics from the World Marrow Donor Program, more than half of the products shipped for transplant came from outside North America. With language differences, varying international label requirements and identifiers often in a foreign language, 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 it important?

A: Numerous articles in the scientific literature have described the advantages of bar coding technology for patient safety. The FDA has said bar codes are required for biologic products, blood and blood components (21 CFR parts 201, 606 and 610).

Q: How do bar codes work?

A: This electronic technology is fast, easy to use and relatively inexpensive. The bar code contains information in a “code” that is represented by a pattern of wide and narrow bars (similar to Morse code dots and dashes). The scanner moves a light source across the bar code and light is reflected in different amounts based on the pattern of bars. This data is then interpreted by appropriate computer software.

Q: What happened to “Codabar” technology?

A: Codabar was selected by the American Blood Commission (ABC) in 1979, and while it worked well for its time, it has considerable shortcomings. Specifically, Codabar lacks a check digit, lacks international commonality, and the product code structure is not expandable. Common data structures make writing and maintaining software easier and cheaper. This improves both inventory control and billing procedures.

Code 128 requires a check digit to ensure the message has been scanned correctly, and it has three “self checking” features to ensure each character is scanned correctly. This provides a high level of data security. It is alphanumeric and high density. Widely supported, it is easy to maintain and support. ISBT 128 is a customization of Code 128 which has been specifically designed for blood transfusion and cell therapy needs.

Both Codabar and Code 128 are standard bar code symbologies used by many industries. Symbology standards define the pattern of bars and spaces and how data is encoded into them. Most of these standards are in the public domain.

Q: What should I be doing?

A: You should begin using the new terminology.  You should begin educating hospital and blood center administration, lab directors, medical directors, colleagues and staff on the issue. You also should review the published implementation plan and begin performing internal assessments and surveys to determine logistical issues at your facility. 5 The work group and advisory committee will continue to work on this project, and AABB is striving to make educational efforts an integral part of the final work product. AABB offered an audioconference at no charge to members in parternship with ISCT in August 2007 and administered a survey on ISBT 128 implementation in 2005, and a report summarizing the results concluded that additional materials were needed and offered specific suggestions for facilities moving forward. Finally, check the Web site and follow AABB news regularly for updates.

Q: What is the FDA’s perspective on this topic?

A: The FDA has issued numerous regulations and guidance documents on the subject, although they have not specifically addressed cellular therapy products alone. For a summary of a presentation at the Ninth Annual FDA and the Changing Paradigm for Blood Regulation Conference held in Las Vegas in 2006 click here. The FDA also regularly updates its Web site with slides presented at conferences. Europe has already focused resources on this initiative, and updates may be found at the ICCBBA Web site.

Q: Where can I learn more?

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:

Quick Links:
ICCBBA Web Site
FDA Web Site
ISCT Web Site