1. Does my facility need to register with ICCBBA?
Registration and licensing with ICCBBA are required if you apply ISBT 128 labels. This encompasses facilities that pool, aliquot, or modify products and label them with ISBT 128 bar codes.
Even if it may not be required, your facility may also wish to register and pay licensing fees in order to receive all ISBT 128 documentation and updates and access the password-protected areas of the ICCBBA Website. All new Product Description Codes, other updates and current copies of the ICCBBA databases are maintained in this section. The annual license fee for transfusion services is maintained as low as possible to encourage such facilities to maintain regular contact with ICCBBA and remain fully informed about updates and changes to the ISBT 128 Standard.
2. Where will I find a step-by-step process for registration with ICCBBA?
The registration section of the website presents information about fees and the registration process, as well as a convenient registration form that you can download. The How to Register page provides guidance in the registration process. After completing the Facility Registration Form, you may fax, mail, or email it together with the appropriate licensing fee to the ICCBBA office. Vendors need to complete a separate registration form which can be found here.
3. If the name of my facility changes, will I need to re-register with ICCBBA?
If the name of your facility changes, and the only change is in name, your facility does not need to re-register; the Facility Identification Number (FIN) does not need to change. However, if the change involves more than just a name change (e.g., change in ownership), ICCBBA may assign a new FIN.
4. If my software vendor has an ISBT 128 package available, why do I need to register with ICCBBA?
A software vendor can only go as far as providing you with the capability to use the ISBT 128 Standard. In order to exercise these capabilities of applying an ISBT 128 label, an initial one-time registration fee and an annual licensing fee must be received by ICCBBA. This fee permits your facility to be licensed to use the ISBT 128 data structures. However, if your facility will only be scanning ISBT 128 bar codes (without applying new labels); your software vendor can provide you with updates to the ISBT 128 Product Description Codes Database without your facility having to be registered.
5. Why must I pay to use ISBT 128?
In order to assess the ‘value for money’ of the ICCBBA fees, it is necessary to identify the user community needs that an international standard must deliver. Of particular importance are the following:
1) Stability – users must be confident in the stability of a standard as it is required over for a long term application (EC requirements for data to be stored and traceable for 30 years);
2) User Focus – the user community are the experts in their field and the information standard needs to meet, rather than dictate, their needs;
3) Flexibility – as clinical and scientific knowledge grows there is rapid development with changing information needs. The standard must be flexible enough to accommodate those needs;
4) Responsiveness – with a rapidly developing field the standard needs to be able to respond to user needs in a timely manner;
5) Globalization – the need for a truly international standard with endorsement worldwide;
6) Implementation – a standard is only of value if it is widely used;
7) Compatibility – standards do not work in isolation but need to interface with equipment, software and other standards.
Clearly meeting these needs will have a cost. Stability and flexibility requires a robust organization that can manage the development and maintenance of the standard, and one that is not over dependent on key personnel.
To support its activities ICCBBA charges a licensing fee for the use of the ISBT 128 Standard. As a tax-exempt, non-profit organization, all of this income is directed to achieving the ICCBBA mission: "to enhance safety for patients by managing the ISBT 128 international information standard for use in transfusion and transplantation."
6. My facility collects tissue, processes it, and then distributes the processed unit as a cellular therapy product. What type of facility do we mark on the registration form?
For tissues collected with intent of being processed into a cellular therapy product, please mark Cellular Therapy Collection Facility.