Americas Technical Advisory Group ICCBBA ISBT 128 Blood Product Labeling – A Hospital Perspective...

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


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


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.


Codabar Codabar Labeled Labeled

UnitUnit


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


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


New LabelNew Label


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


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


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


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


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?


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


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


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.


Where To get ISBT 128 Help

[email protected] (email)

WWW.AABB.ORG

WWW.ICCBBA.ORG - (ATAG –Americas Technical Advisory Group)


New New ISBT 128ISBT 128 Label Label

Questions?

Americas Technical Advisory Group ICCBBA ISBT 128 Blood Product Labeling – A Hospital Perspective...

Documents

Transcript of Americas Technical Advisory Group ICCBBA ISBT 128 Blood Product Labeling – A Hospital Perspective...