ISBT 128 is a global standard for the identification, labeling, and information transfer of medical products of human origin (MPHO) across international borders and disparate health care systems. MPHO includes blood, cells, tissues, human milk, and organ products among others. The Standard is managed by the International Council for Commonality in Blood Banking Automation (ICCBBA).
The International Society of Blood Transfusion (ISBT) working group on automation and data processing began in the early 1990s and was later joined by the AABB, the American Red Cross (ARC), the US Department of Defense,[1] and the Health Industry Manufacturers Association in the development of the symbology which would come to be known as the ISBT 128 international standard.
The acronym ISBT was originally derived from the important role played by the International Society of Blood Transfusion (ISBT) in the development of the standard.[citation needed] Today it expands as International Standard for Blood and Transplant. The number 128 reflects the 128 characters of the ASCII 7 bit character set that the standard uses.[citation needed]
ICCBBA was established in 1995 and given the responsibility for implementation and management of the new standard.[2]
Version 1.0 of the ISBT 128 Standard Technical Specification was first published in 1997, and was intended to replace the ABC Codabar and other similar CODABAR-based standards in use in transfusion medicine at that time with a more secure bar code symbology which contains more information. The current version of the ISBT 128 Standard Technical Specification can be found at the ISBT 128 website [1].
Information transfer involves text on labels, but it also involves information transfer among computer systems. Increasingly, facilities
involved in MPHO operate sophisticated computer systems to enhance safety and efficiency. Transfer of information between such facilities by electronic means ensures accuracy, but can only be effectively achieved in a global context by use of internationally agreed standards to define the information environment.
The ISBT 128 standard provides the specification for many of the elements of the information environment required in transfusion and transplantation. It contains definitions, reference tables, and data structures. Minimum requirements are also defined for delivery mechanisms and labeling. By complying with ISBT 128, collection and processing facilities can provide electronically readable information that can be read by any other compliant system.[3]
ISBT 128 specifies:
The delivery mechanism is the means of delivering the electronic information. Probably the most well-known delivery mechanism is the linear bar code that has been used in blood transfusion practice for many years. There are in fact several types of linear bar codes, including 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-dimensional or reduced space symbology bar codes. These codes can carry much more information in each symbol. Data Matrix has been chosen as the 2-D symbology used with ISBT 128 in labeling applications.
More recently the use of Radio frequency identification (RFID) chips that can carry encoded information is being developed for medical products of human origin.
It is important to recognize that a range of delivery systems can sit at this level of the hierarchy. The standardized terminology, reference tables, and data structures of the information standard can be delivered as easily in a linear bar code as they can in an RFID tag. The standards themselves need to be adaptable in order to make best use of new delivery mechanisms as they are developed.
The final element in the information environment is the associated labeling. Although there will be other labeling requirements that fall outside the information environment described in this document, an effective 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. This latter requirement must not be overlooked in the enthusiasm to embrace remotely re-writable tags.
Following meetings between FACT, JACIE, and ICCBBA, an agreement was reached to support the use of ISBT 128 for coding and labeling cellular therapy products, and this decision has been endorsed by the Boards of major cellular therapy professional organizations.