ISBT Code 128 implementation at a regional blood center

Application specifications for ISBT 128 bar code symbology and the International Council for Commonality in Blood Bank Automation (ICCBBA) were created in 1994. By June 2000, the FDA considered ISBT 128 a standard for uniform labeling of blood and blood components. Our blood center initiated a change process for ISBT 128 implementation and "went live" in 2003.

The intention to adopt ISBT 128 symbology with hospitals was actively communicated in October 2001. A Codabar-ISBT label cross-reference book was developed, FDA approval for the fullface label format in April 2002 was requested, and FDA approval was received in March 2003. In December 2002, donor identification labels and number sets were ordered, and an integration test plan was subsequently developed with departmental process flowcharts for each of the nine affected departments. Each step was tested, the labeling changes were approved in May 2003, training was completed in June 2003, and ISBT bar code symbology was implemented on July 1, 2003. A written survey was sent to hospital transfusion services in April 2004.

Implementation went smoothly except for an unanticipated high rate of "no-reads" on some analyzers in the testing lab. The hospitals spent an average of 18 hours preparing for changes, 14 hours on validation, 4 hours on documentation and procedure development, and 8 hours on training.

ISBT bar code symbology was successfully implemented. Hospital transfusion services made some adjustments and, overall, readily accepted the new bar code symbology.