ISBT 128: More than Identification
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ISBT 128 License Fees

 

Blood or Cellular Therapy Facilities that will assign Donation Identification Numbers

Registration Fee: One-time payment of US$200 which includes allocation of the first Facility Identification Number (FIN).  Additional FINs can be requested at US$150 each.

Annual License Fee: Based on the number of whole blood, cellular therapy and apheresis units collected by all facilities included in the registration in the previous year.  The fee is US$0.0118 per unit (US$1.18 per 100 units), with a minimum license fee of $150.

These fees are reduced for facilities that are located in countries with a Human Development Index (HDI) classification of Medium or Low.  For facilities in Medium HDI countries fees are 66% of the above figures.  For facilities in Low HDI countries fees are 33% of the above figures.

Tissue Facilities that will assign Donation Identification Numbers

Registration Fee: One-time payment of US$200 which includes allocation of the first Facility Identification Number (FIN).  Additional FINs can be requested at US$150 each.

Annual License Fee: Based on the number of tissue donation events in the previous year.  The rate depends upon the business status of the organization.  For facilities run on a for-profit basis, or a not-for-profit basis with full cost recovery from purchaser the annual license fee per donation event has not yet been determined.  For not-for-profit organizations that do not recover costs from the purchaser, and rely on government or public funding the fee is US$0.50 per event.  The minimum license fee is US$150

These fees are reduced for facilities that are located in countries with a Human Development Index (HDI) classification of Medium or Low.  For facilities in Medium HDI countries fees are 66% of the above figures.  For facilities in Low HDI countries fees are 33% of the above figures.

Transfusion Labs, Cord Blood Banks or Transplant Facilities that will handle ISBT 128 labeled product but will not assign new Donation Identification Numbers.

Cellular Therapy Collection Facilities

Registration Fee: One time payment of US$200

Annual License Fee: Based on the number of whole blood, cellular therapy and apheresis units collected by all facilities included in the registration in the previous year.  The fee is US$0.0118 per unit, with a minimum license fee of $150.

Cellular Therapy Processing Lab

Registration Fee: One time payment of US$200

 

Annual License Fee: Based on the number of whole blood, cellular therapy and apheresis units collected by all facilities included in the registration in the previous year.  The fee is US$0.0118 per unit, with a minimum license fee of US$150.

Cellular Therapy Infusion Center

Registration Fee: One time payment of US$200

Annual License Fee: US$150

 

These fees are reduced for facilities that are located in countries with a Human Development Index (HDI) classification of Medium or Low.  For facilities in Medium HDI countries fees are 66% of the above figures.  For facilities in Low HDI countries fees are 33% of the above figures.

Plasma Fractionation Facilities

Plasma fractionators use ISBT 128 in a number of ways.  They may process plasma collected by other organizations that is labeled with ISBT 128, they may use ISBT 128 donation identification numbers on plasma they collect themselves, they may use ISBT 128 labeling of final product for distribution to their customers, and they may carry out several of these activities.

A fractionation facility carrying out several activities will need to pay the fee associated with each activity.  The licensing and fee requirements for these various activities are as follows:

Read and interpret ISBT 128 bar codes

Plasma fractionators who read and interpret ISBT 128 donation identification numbers and/or product codes, whether originating from their own collection or from a third party supplier, are required to register with ICCBBA and pay an annual license fee.

Registration Fee: nil

Annual License Fee: $5,000

Label plasma donations with ISBT 128 bar codes

Plasma fractionators who want to use ISBT 128 donation numbers on the plasma that they collect will need to register as collection facilities and be assigned a facility identification number.

Registration Fee: One-time payment of US$200 which includes allocation of the first Facility Identification Number (FIN).  Additional FINs can be requested at US$150 each.

Annual License Fee: Based on the number of units collected in the previous year by all facilities included in the registration. The fee is US$0.0118 per unit (US$1.18 per 100 units), with a minimum license fee of $150.

Label derivatives with ISBT 128

Plasma fractionators who supply product labeled with ISBT 128 are required to register with ICCBBA and pay an annual license fee.

Registration Fee: nil

Annual License Fee: Based on the number of containers (units) of final ISBT 128 labeled products issued by the fractionator in the previous year.  For solvent detergent plasma products the fee is US$0.0118 per unit (US$1.18 per 100 units), with a minimum license fee of $150.  For other plasma derivatives the fee has not yet been determined (contact the ICCBBA office for more information).

Software Vendors

Registration Fee: None

Annual License Fee: Based on number of customers software is provided to: single customer, fee is US$1,000; two to nine customers, fee is US$2,500; ten or more customers, fee is US$5,000.

Other Vendors

Registration Fee: None

Annual License Fee: US$5,000