1. Americas Technical Advisory Group ICCBBA www.iccbba.org ISBT 128 Blood Product Labeling – A Hospital Perspective Americas Technical Advisory Group ICCBBA www.iccbba.org

2. Copyright ICCBBA, Inc Hospitals and ISBT 128 Why Change?  More than just bar coding Standardization of data elements Efficient data transfer Can be used with 2-dimensional barcodes, RFID  Advantages of Standardization Reduce software development time Enable interface and exchange of data (EDI) Process Control  Patient Safety Better traceability because of unique unit identification number Better process control Ability to provide bedside identification of unit and patient Reduces errors and risk/liability

3. Copyright ICCBBA, Inc Does Your Label Look Like This? Machine Readable: Effective: April 26, 2006 Lot (Donor Unit Number and supplier) ABO/Rh Product Name

4. Copyright ICCBBA, Inc Labeling Regulations 21 CFR 606.121(c)(13)(ii-iii) states the container label must bear encoded information in a format that is machine-readable and approved for use by the Director, Center for Biologics Evaluation and Research. Currently, two types of machine-readable label types are recognized by FDA: FDA recognized the use of Codabar (a specific bar code symbology) in 1985; and FDA accepted the use of ISBT 128, version 1.2.0, in 2000. Each label must have at a minimum: (A) A unique facility identifier; (B) Lot number relating to the donor; (C) Product code; and, (D) ABO and Rh of the donor.

5. Copyright ICCBBA, Inc Codabar Labeled Unit

6. Copyright ICCBBA, Inc Why Change? Limitations of Codabar Unit numbers are not unique  Look back - traceability  Consolidating laboratories  Desert Storm experience Susceptible to substitution errors (misreads) Lack of space to incorporate check digits Product code structure was not maintained as new products were created

7. Copyright ICCBBA, Inc US Guideline Specifies how it will be done in the United States Standard approved and published in Federal Register Revision in process – see ICCBBA web site

8. Copyright ICCBBA, Inc New Label

9. Copyright ICCBBA, Inc ISBT 128 Provides unique donation identification Eliminates need to re-number units of blood Supports centralized donor testing Supports international exchange of blood and stem cells

10. Copyright ICCBBA, Inc Product code and unit number are just two of many data structures All data structures have been designed with process control and future growth in mind ISBT 128 is much more than just another labeling system Data structures can be used with two dimensional barcodes and RFID chip technology

11. Copyright ICCBBA, Inc Hospital Transition Coordinate implementation plan and establish contact with blood supplier(s)  Time frame  Product list  Sample labels  Group planning sessions Identify a transfusion service project champion & team Assess transfusion service and other department’s personnel, procedure, equipment and computer needs Review processes and look to include process controls Develop SOP’s Build and validate Educate your staff about the new labeling changes Implement and do a post implementation assessment for continued process improvement

12. Copyright ICCBBA, Inc Other department’s personnel, procedure, equipment and computer needs Any manual or automated system using a Donation Identification Number or blood product code Billing system Medical Records system Report generating systems

13. Copyright ICCBBA, Inc Computerized Facilities Register with ICCBBA Is software upgrade required? Is hardware upgrade required?  Decide if additional Bar code scanners and printers are needed  On-demand printer vs pre-printed labels Will you use the concatenation capability of ISBT 128?

14. Copyright ICCBBA, Inc Registration Information Hospitals that collect or modify blood or blood components by manual or apheresis methods Hospitals that have computer systems Hospitals that apply ISBT 128 labels One time registration fee of $200 Annual license fee of $100

15. Copyright ICCBBA, Inc Why Do I Have To Pay $100 Each Year The fee is determined by the number of unique products you need to identify and your company's gross sales revenue. We suggest you complete the membership application to obtain your company's membership fee. You then have the choice to continue with payment at that time or use your user ID and password to continue at a later datemembership application

16. Copyright ICCBBA, Inc Hospitals and ISBT 128 ISBT 128 is copyright protected by US law and NOT in the public domain Unlike Codabar, ISBT 128 will be maintained through the ICCBBA.

17. Copyright ICCBBA, Inc Where To get ISBT 128 Help  ICCBBA@ICCBBA.ORG (email)  WWW.AABB.ORG  WWW.ICCBBA.ORG - (ATAG –Americas Technical Advisory Group)

18. Copyright ICCBBA, Inc New ISBT 128 Label Questions?