ISBT Code 128 implementation at a regional blood center.

Area of Science:

• Medical Device Labeling
• Blood Transfusion Services
• Bar Code Symbology

Background:

• ISBT 128 bar code symbology specifications and ICCBBA were established in 1994.
• The FDA recognized ISBT 128 as a standard for uniform blood product labeling by 2000.
• A blood center initiated ISBT 128 implementation, going live in 2003.

Purpose of the Study:

• To detail the implementation process of ISBT 128 bar code symbology in a blood center and associated hospitals.
• To assess the impact and acceptance of the new bar code standard by hospital transfusion services.

Main Methods:

• Communication with hospitals regarding ISBT 128 adoption began in October 2001.
• Development of a Codabar-ISBT cross-reference, FDA approval sought and received for label format, and ordering of donor identification labels.
• Integration testing, departmental process flowchart development, labeling change approval, and staff training were conducted prior to implementation.

Main Results:

• Implementation proceeded smoothly with minimal issues, though some analyzers experienced a high "no-read" rate.
• Hospitals dedicated an average of 18 hours to preparation, 14 hours to validation, 4 hours to documentation, and 8 hours to training.

Conclusions:

• ISBT 128 bar code symbology was successfully implemented within the blood center and partner hospitals.
• Hospital transfusion services adapted and generally accepted the new bar code symbology with minor adjustments.