ICCBBA is an international non-state actor that manages, develops, and licenses ISBT 128, the international information standard for the terminology, coding and labeling of medical products of human origin. ICCBBA manages the allocation of globally unique identifiers to licensed facilities and maintains the ISBT 128 Standard, international databases for Facility Identification Numbers and Product Description Codes, supporting documentation, and educational materials.
In its efforts to maintain and enhance the ISBT 128 Standard, ICCBBA brings together experts from clinical, scientific, technical, and informatics backgrounds, representatives from scientific and professional societies, and observers from regulatory authorities and industry to review and update the ISBT 128 Standard to ensure it continues to meet the needs of its users.
ICCBBA is a tax-exempt, nonprofit organization as described in Section 501(c)(3) of the US Internal Revenue Code. These regulations stipulate that the organization cannot be organized or operated for the benefit of private interests, and no part of the organization's net earnings may inure to the benefit of any private shareholder or individual. Within its Articles of Association, ICCBBA is required to be organized and operated exclusively for charitable, scientific, and educational purposes.
ICCBBA's Board of Directors and members of its Technical Advisory Groups (TAGs) are volunteers who give freely of their time and effort. ICCBBA has a small staff who manages the technical documentation and databases, promote and support the global implementation of the standard, organize technical meetings, and administer registration and licensing.
HOW IS ICCBBA FUNDED?
ICCBBA operations are funded entirely from licensing fees collected from both facilities using the ISBT 128 Standard and from vendors providing equipment or software that incorporates the standard.
ICCBBA has been ISO 9001 certified since April of 2011 and received ISO9001:2015 certification in March of 2017. A copy of the certificate of registration can be found here.
ICCBBA publishes Activity Reports that chronicle the activities of the organization. The most recent report can be viewed, here.
VISION, MISSION, & PRIORITIES
Global adoption of ISBT 128 for all medical products of human origin (MPHO).
Enhancing patient safety by promoting and managing the ISBT 128 international information standard for use with medical products of human origin.
To manage international information standards for transfusion medicine, transplantation, and other applications of medical products of human origin in support of traceability, biovigilance, and patient safety.
To liaise with health authorities, regulators, scientific and professional societies, user communities, and vendors on standardization in terminology and information technology.
To provide educational programs to promote the value of, and need for, information standards and policies to support traceability and biovigilance.
To provide technical consultation regarding the implementation and management of ISBT 128.
To lead in the continued development of common data structures for information technology, data processing, exchange and transfer, and labeling for medical products of human origin.
ICCBBA QUALITY OBJECTIVES
• comply with requirements and continually improve the effectiveness of the quality management system.
• specify the requirements for both our suppliers and our processes with respect to quality, cost, performance, safety and reliability.
• provide our staff with the necessary education, training and system support to enable them to meet our customer requirements at all times.
• ensure the recruitment of the right number of staff with the required qualifications, experience and skills.
• ensure that every member of staff recognizes his/her responsibility for quality management.
• ensure that effective and efficient purchasing processes are defined and implemented.
• act responsibly toward our social, professional, environmental, and ethical responsibilities.
• ensure that applicable legal and regulatory requirements are met by both our suppliers and our own staff.
• define the customer requirements to be met and work towards enhancing customer satisfaction.
• ensure that we maintain an international consultative network that covers all areas of activity.
• ensure appropriate consultation with networks during the introduction of new products and services or significant changes to products and services.
BOARD OF DIRECTORS
ICCBBA is governed by a volunteer Board of Directors comprised of leading experts in blood transfusion, cellular therapy, and tissue transplantation from around the world. Board positions are advertised publicly and Board members normally serve six-year terms. The current Board of Directors has members from Belgium, Egypt, Germany, India, Italy, Singapore, the United Kingdom, and the United States. To read more about each board member, click on their profile picture.
BOARD OF DIRECTORS &
THEIR ROLE IN LICENSING FEES
There is growing recognition of the importance of a single global standard for the coding and labelling of medical products of human origin, and of the unique position of ISBT 128 to fulfil this role. The ISBT 128 Standard is well established and widely endorsed and is already in use in over 5,000 facilities in over 77 countries.
ICCBBA was created specifically for this role in 1994 in order to both manage the ISBT 128 Standard and to ensure its availability to the global healthcare community in a cost effective manner.
The unique structure of the organization delivers these objectives through an effective separation of responsibilities between the Board of Directors and the Executive Director and staff. The Board is responsible for governance which includes approval of the budget and fee schedule. The Executive Director and staff are responsible for operational management.
The Board of Directors is comprised of volunteers from the user or regulator community and in many cases Board members are themselves managing organizations that are ISBT 128 users. Board Members receive no remuneration, and serve for a maximum of seven years. Replacements are identified through a public recruitment process and ICCBBA is fortunate to have many internationally recognised experts as past or current Board Members.
The governance role of the Board ensures that ICCBBA is managed in an effective and efficient manner and is appropriately staffed and funded whilst at the same time ensuring a fee structure that is fair and appropriate. As Board Members receive no remuneration, and have no long term association with ICCBBA (max 7 years) they can maintain the necessary balance and independence to ensure stakeholders receive good value for money.
In this way the ICCBBA Board of Directors has ensured that ICCBBA has developed in a sustainable and responsible manner since its creation in 1994, and will continue to ensure effective controls and efficiencies as ISBT 128 moves forward as the International Standard for Blood and Transplant.