americas technical advisory group iccbba isbt 128 blood product labeling – a hospital perspective...
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ISBT 128 Blood Product Labeling – A Hospital Perspective
Americas Technical Advisory GroupAmericas Technical Advisory GroupICCBBAICCBBA
www.iccbba.orgwww.iccbba.org
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
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Does Your Label Look Like This?
Machine Readable:Machine Readable:
Effective:
April 26, 2006
Lot (Donor Unit Number and Lot (Donor Unit Number and supplier)supplier)
ABO/RhABO/Rh
Product NameProduct Name
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.
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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
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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
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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
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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
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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
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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
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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?
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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
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 date
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.
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Where To get ISBT 128 Help
[email protected] (email)
WWW.AABB.ORG
WWW.ICCBBA.ORG - (ATAG –Americas Technical Advisory Group)