WHAT IS ISBT 128?

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. Facilities across six continents are registered to use ISBT 128. There are over 5.700 active registered facilities worldwide.

History of the ISBT 128 Standard

The ISBT 128 Standard traces its beginning to the late 1980’s when the blood community recognized that Codabar, developed in the 1970s, was no longer adequate for the complexity needed to effectively describe new blood products. In addition, the increase in the exchange of blood across regions prompted the need for a methodology to provide globally unique donation event identification.

The ISBT Working Party on Automation and Data Processing, with stakeholder input from numerous organizations, including the Council for Commonality in Blood Bank Automation, developed the first specification for ISBT 128. It was approved by the ISBT board in 1994.

ICCBBA was established to maintain and develop the ISBT 128 Standard.

KEY USES OF ISBT 128

Traceability

Globally unique Donation Identification Numbering allows for forward and backward traceability for all Medical Products of Human Origin.

Vigilance & Surveillance

Internationally standardized terminology and product coding can be incorporated into vigilance and surveillance tools to assist with global data sharing.

Interoperability

Loss of critical product information is minimized when products are transferred from one facility to another, including internationally.

WHAT IS THE INFORMATION ENVIRONMENT?

The information environment model describes how ISBT 128 organizes information to achieve standardization for both labeling and electronic messaging for medical products of human origin.

The foundation of the information environment contains standardized terminology, data elements, and reference tables. These layers support the structures, mechanisms, specifications, and standards necessary to print labels and create electronic messages. Below is an interactive graphic with descriptions of each layer.

Data_Information_Pyramid

Electronic Messages
The development of a standardized approach to incorporate ISBT 128 data elements into electronic messages is an important step in improving the communication between healthcare organizations involved in the production and clinical application of MPHO. By adopting this Standard, organizations will be able to benefit from the MPHO-specific standardized terminology and standard reference tables of ISBT 128 in a wide range of contexts and securely transfer more information about MPHO products with far greater flexibility.

Messaging Standard for use in Electronic Messaging
ISBT 128 provides specifications (ST-020 ISBT 128 Standard for XML) for use in electronic messages to convey information regarding MPHO in a consistent and standardized format.

The MPHO Unique Identifier is a single unique instance identifier developed to provide the basic elements of traceability. The MPHO Unique Identifier was developed to store traceability information on any MPHO and provides a single identifier for use in electronic messaging and electronic health records and should be used as the identifier element for the HL7 FHIR BiologicallyDerived Product resource.
This identifier can be created from a standard ISBT 128 label and clearly identifies the specific product being referenced in an electronic message. Specifications for the MPHO Unique Identifier are detailed in ST-026 ISBT 128 Standard for the Medical Products of Human Origin (MPHO) Unique Identifier.

Delivery Mechanisms for use in Labeling
The delivery mechanism is the means of delivering the electronic information encoded within data structures. The most well-known delivery
mechanism is the linear bar code that has been used in blood transfusion practice for many years.
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. 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 must be adaptable to make the best use of new delivery mechanisms, such as Bluetooth Low Energy tags, as they are developed.

URI Mapping Specification for use in Electronic Messaging

To support the transmission of ISBT 128 information via electronic messaging, ICCBBA has developed a dictionary of data elements (ST-027 ISBT 128 Dictionary of Standard Data Elements). The information carried in these elements maps to the same information carried in data structures to ensure that information from either source is consistent. Each data element is identified by a unique resource identifier (URI) in the form of a uniform resource locator (URL).

Data Structures for use in Labeling

Having built reference tables which convert the clearly defined information into codes suitable for use in bar codes applied to product labels, 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 the links to the appropriate reference tables for conversion of codes to meaningful information.
Data structures must be clear and unambiguous and consider any constraints imposed by the anticipated delivery mechanisms. For example, data structures that will be used in linear bar codes are limited in the number of characters they can contain.

Data identifiers indicate the type of information being conveyed within data structures. It is imperative that the appropriate data identifiers are used for each data structure to ensure the correct interpretation of the encoded information.

Reference tables are built to code/decode a single or multiple data elements to provide data compression for use in a data structure. Such tables can be large and complex, and it is essential that they are managed to ensure that they can be modified to meet changes within clinical practices in a manner that maintains their integrity and avoids ambiguity or redundancy.

Reference tables combine a tightly defined structure while allowing the flexibility to accommodate expansion and change in ways that cannot be anticipated.
Successful management of standardized terminology, data elements, and reference tables requires input from both clinical experts in the field and information specialists. The tables are published in a manner that allows all users of the Standard to access the most up-to-date versions in a timely manner.

Together, the standardized terminology, data elements, and reference tables provide the basis for accurately relaying information about medical products of human origin, whether on the label or via electronic data transfer.

Product information and characteristics such as the Donation Identification Number, ABO RhD, and Product Description Code constitute a data element. Data elements can be encoded within data structures suitable for use in bar codes applied to product labels, and they can also be identified by a unique resource identifier (URI) in the form of a uniform resource locator (URL) for use in electronic messaging. Data elements provide a mechanism to unambiguously define pieces of information. The data elements are used to build data structures, and in some instances, more than one data element is needed to encode a data structure.

Example: The product code data structure contains up to 3 data elements: the Product Description Code, the Collection Type, and the Divisions code.

At the base lies the standardized terminology (ST-002 ISBT 128 Standard Terminology for Medical Products of Human Origin) that will ensure a common understanding of terms. ISBT 128 Standard Terminology is the foundation used for both labeling and electronic messaging. Without clarity at this level any further attempt at standardization is lost. Obtaining agreement on standardized terminology at the necessary level of detail involves careful analysis and robust consensus.
ICCBBA ensures that an internationally agreed upon standardized terminology is defined at the required level of granularity. This provides confidence in the consistency of both the information being transferred and the quality of the product described. The standardized terminology is accessible to all users of the standard and ISBT 128 stakeholders.

There are terms regularly used in certain categories of MPHO that require an appropriate level of granularity to clearly convey the characteristics of the product. For blood products, the term ‘leukodepleted’ is routinely understood as meaning the removal of leukocytes from a blood component, however, there are different ways of carrying out such a removal, and differing amounts of residual leukocytes that are used to define leukodepleted. To accommodate these variations, a range of standardized terminology and associated values are required.

Every ISBT 128-labeled product carries a standardized label where product information is encoded in bar codes or electronic tags. Although there will be other labeling requirements that fall outside the coding system, an effective coding system should 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 the 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 rewritable tags.

While highly effective and secure, labeling does have some limitations. In particular, the amount of information that can be encoded on the label depends on the amount of label space available to accommodate bar codes. Thus, as noted in previous sections, ISBT 128 has evolved to allow ISBT 128 information to be transmitted in electronic messages used in healthcare applications in a manner that is compatible with its existing labeling standards, giving the Standard the ability to overcome the limitations of bar codes.

The information environment works together to ensure that accurate ISBT 128 information is encoded within an electronic message or label to accurately identify MPHO products. For such a system to be, and to remain effective, it must be carefully designed and managed. There must be an ongoing dialogue between clinical users, information specialists, and equipment and software vendors to ensure that the Standard continues to support rapidly developing clinical practices, ensures traceability, improves biovigilance efforts, and increases patient safety.

WHO USES ISBT 128?

ISBT 128 USER EXPERIENCE

SOFTWARE DEVELOPER

“In addition to being beneficial for donors, patients, and safety, ISBT 128 has been very beneficial for the vendors of IT systems. It enables several IT systems to coexist in a country or a region, since all exchanged blood products are uniformly labeled and carry all relevant information. ISBT 128 reduces vendors’ cost since we can focus on one standard when implementing the business logic for products and bedside control. We anticipate future standards for interfacing production equipment.”

RENNY SKAGSTAD, CEO, LabCraft AS, Oslo, Norway
INFO SYSTEMS DESIGNER/ INFORMATION ENGINEER

“In Switzerland, ISBT 128 donation numbers are automatically assigned to facilities and product codes are selected based on a national guideline which references the ISBT 128 standard. The product code itself is from the ISBT 128 database managed by ICCBBA. This guarantees, on an international level, the clear understanding of the contents of a blood bag.”

DR. CHARLES MUNK, PhD, Info Systems Designer / Information Engineer, Lausanne, Switzerland

MILITARY HEALTH SYSTEM (MHS)

“The ISBT-128 (Standard) enables interoperability between the US Military Health System (MHS) and Partner Nations where military health facilities are based. The ability to have a common and shared labeling standard between the DoD and our Allied partners is key to enhanced military readiness and the MHS continuum of care.”

CAPT. LESLIE (LES) RIGGS, MSC, USN Chief, Armed Services Blood Program Division, United States

TRANSFUSION SAFETY OFFICER

“Hema-Quebec implemented ISBT 128 in Fall 2007. Our Transfusion Service technologists were happy to finally make full use of it when the Blood Bank computer system became ISBT 128 compatible in April 2008. The rapid and accurate product entry was much appreciated and the expected reduction in entry errors immediately realized. ISBT 128 bar code entry has made it easy to do it right. Noncompliant setting of field defaults such as product groups, codes, or attributes would now take longer and so this doesn’t occur.”

ANN WILSON, MUHC Transfusion Safety, Technologist, Technologiste Chargée de la, Sécurité Transfusionnelle du CUSM, Montréal, Québec, Canada
BLOOD SAFETY & AVAILABILITY OFFICIAL

“The visionaries of the late 1980’s realized the limitations of blood product identification bar codes if the bar codes were not backed by common data elements that could be readily available to all computer systems. The voluntary working groups were led by the vision that blood products should be identifiable anywhere in the world. In a disaster response, and follow-up after the response, traceability is essential.”

JERRY A HOLMBERG, Senior Advisor for Blood Policy, US Department of Health and Human Services Washington, DC, USA

BLOOD SERVICES DIRECTOR

“ISBT 128 has provided us with an organized and consistent system of labeling for our blood and blood components. This has enabled better monitoring and more efficient management of our blood inventory. The unique format of the Donation Identification Number and Product Description Code has also contributed toward blood safety. Ultimately, the change to ISBT 128 has been beneficial to our blood program in Singapore.”

DR. DIANA TEO, Group Director, Blood Services Group, Health Sciences Authority, Singapore

BLOOD BANK DIRECTOR

“ISBT 128 makes sure information is always in the same place so processing steps entered by bar code scanning are accurately reflected. The label is simply more aesthetic.”

DR. JERRY ORLIN, Director, Department of Transfusion Medicine and Apheresis, Rabin Medical Center, Petach Tikya, Israel

COUNTRIES WITH ACTIVE REGISTERED FACILITIES

Dominican Republic
Kuwait
San Marino
Saudi Arabia
Andorra
Ecuador
Latvia
Singapore
Argentina
Egypt, Arab Rep.
Lebanon
Slovakia
Aruba
Estonia
Lithuania
Slovenia
Australia
Finland
Malaysia
South Africa
Austria
France
Malta
Spain
Bahrain
Germany
Mexico
Sweden
Belgium
Greece
Mozambique
Switzerland
Brazil
Honduras
Netherlands
Taiwan, China
Canada
Hungary
New Zealand
Thailand
Cayman Islands
Iceland
Norway
Türkiye
Chile
India
Oman
Ukraine
China
Indonesia
Pakistan
United Arab Emirates
Colombia
Iran, Islamic Rep.
Panama
United Kingdom
Costa Rica
Ireland
Peru
United States
Croatia
Israel
Philippines
Uruguay
Curaçao
Italy
Poland
Vietnam
Cyprus
Japan
Portugal
Czech Republic
Jordan
Qatar
Denmark
Kenya
Romania