ISBT 128 for CT Survey Results
AABB and other organizations conducted a survey to assess the implementation status in cellular therapy facilities. More than 300 participants worldwide responded to the survey, which will help with the development of appropriate educational programs and practical tools to facilitate the transition. See Results
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 the World Marrow Donor Association (WMDA) 2009 Annual Report, in North America, 1490 (44%) of the 3375 bone marrow/peripheral blood progenitor cell donations came from outside North America, 231 of the 1356 cord blood units came from outside North America (17%), and 3010 of the 4731 stem cell products came from North America (64%). This map illustrates the transfer of hematopoietic stem cell products by World Health Organization region.
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 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.
It is expected that the 5th edition of Standards for Cellular Therapy Products Services will require an implementation plan.
Cellular Therapy Coding and Labeling Advisory Group
In July 2010 AABB, and other associations confirmed their support for the international implementation of ISBT 128 for the coding and labeling of cellular therapy products. Read the joint statement.
Q: What is the status of the Coding and Labeling Advisory Group?
A: The advisory group published its work in Transfusion in July 2007. 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 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. 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.
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. Europe has already focused resources on this initiative, and updates may be found at the ICCBBA Web site.
Q: How do I find the right product codes for the products I make?
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. Chapter 3 is about cellular therapy product descriptions. Chapter 6 also should be read as it describes "retired codes"— those terms that are retained for backward compatibility (existing products) but should not be used for naming new products.
Once the terminology is understood, the easiest way to find a product code is by using a tool called Product Lookup Program Version 3. This also is available on the ICCBBA website and requires a password for access. Your facility must be registered with ICCBBA to obtain a password.
The tool can be downloaded onto your computer, along with text files of the ISBT 128 Product Description Code Database, following the instructions that come with the tool under the Help option. Once the program and database files are downloaded, finding a product description code is easy: simply use the drop-down menus to select the characteristics of the product you are making. Then, click on one of two buttons:
- Search Exact, which brings up a product description exactly matching the characteristics you've entered. This will bring up only one product code description (if any).
- Search Inclusive, which brings up all product descriptions and corresponding codes that include (at a minimum) the characteristics you've entered. This will usually bring up several product description codes.
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, too, 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?
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. To learn more about the labeling of Cellular Therapy products, review the handouts from the 2010 AABB Annual meeting session #9403-QE-CT ISBT 128 Cellular Product Labeling. Click here to see the slides from an audioconference on the implementation of ISBT 128 for CT Products.
Reference Articles
http://www.iccbba.org/subject-area/cellular-therapy. Fehily D, Ashford P, Poniatowski S. Traceability of human tissues for transplantation – the development and implementation of a coding system using ISBT 128. Organs and Tissues 2004; 2: 83-88.
Asford 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