ISBT 128 is a global standard for the identification, labeling, and information transfer of medical products of human origin (including blood, cells, tissues, milk, and organ products) across international borders and disparate health care systems. The standard has been designed to ensure the highest levels of accuracy, safety, and efficiency for the benefit of donors, patients, and ISBT 128 licensed facilities worldwide.
Featuring a unique, highly flexible, and comprehensive coding method for every collected product, ISBT 128 provides international consistency to support the transfer, transfusion, or transplantation of medical products of human origin.
More than Identification
Identification, or labeling, of biological products is only one aspect of ISBT 128. ISBT 128 encodes information about biological products in a manner that allows the information to be transferred from one computer system to another in a way that is unambiguous and accurate.
Encoding information is a multi-step process that begins with the selection and definition of terminology. Without clarity at this level, any further attempt at standardization is lost. Obtaining agreement on definitions at the necessary level of detail involves careful analysis and robust consensus. This provides confidence in the consistency of both the information being transferred and the quality of the product described.
These product descriptions are then placed into reference tables. Reference tables convert the clearly defined information into codes suitable for electronic transmission.
Once reference tables are built, it is necessary to define data structures in which to embed the data. Data structures define the technical characteristics necessary for the interpretation of the information. They specify the context and structure and provide links to the appropriate reference tables for conversion of codes to meaningful information.
The delivery mechanism is the means of delivering the electronic information. Probably the best-known delivery mechanism is the linear bar code. There are in fact several types of linear bar codes including the old-fashioned Codabar system that was only capable of encoding numeric information, and Code 128, a bar code standard widely used in coding standards such as GS1 and ISBT 128. Higher capacity delivery systems are available using 2-D or reduced space symbology bar codes. These codes carry much more information in each symbol. More recently, the use of radio frequency identification (RFID) chips is being explored.
It is important to recognize that a range of delivery mechanisms can sit at this level of the hierarchy. The definitions, reference tables, and data structures of ISBT 128 can be delivered as easily in a linear bar code as they can in an RFID tag.
The final element in the coding system is the associated labeling. Although there will be other labeling requirements that fall outside a coding system, an effective coding system needs to consider the physical association between the information and the product. Whether incorporated into a bar code or an electronic tag, there needs to be a mechanism that will ensure correct physical assignment of information to the product and confidence in the association between electronically stored information and eye-readable printed information.
A Unifying Standard
Approved by the ISBT Council in 1994, the ISBT 128 Standard has gained international acceptance. Its use for Cellular Therapy products is supported by the boards of the AABB, ASFA, ASBMT, EBMT, FACT, ISBT, ISCT, ISCT Europe, JACIE, NMDP, and WMDA.
Currently, facilities in more than 77 countries across six continents are registered to use ISBT 128.