News
HIT News in the Blood Banking Industry
The United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT-128 has been accepted.
Background: since the year 2000 the FDA, Center for Biologics Evaluation and Research (CBER ) has recognized and accepted the use of the “ United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT-128 and thus amended 21 CFR 606.121 (c ) (13 ) to require the use of “machine-readable” code. According to the FDA final rule titled; Bar Code Label Requirements for Human Drug Products and Biological Products published in 2004, all blood to be transfused must contain FDA approved machine-readable symbols as of April 2006.
Recent Developments: the American Association of Blood Banks (AABB) in Bulletin #05-12 on Oct. 12, 2005 reaffirmed its continued commitment to the new ISBT-128 bar code standard. The accreditation required time line set for Blood Banks and Transfusion Services is: Nov. 1, 2006 for a written implementation plan and May, 1, 2008 full ISBT-128 implementation.
This standard is managed by the non-profit corp. the International Council for Commonality in Blood Banking Automation (ICCBBA) and a the last meeting in Oct. 2005 the Americas Technical Advisory Group (ATAG) sub-committee of the ICCBBA approved for submission to the editorial board an addition to the next version of the standard a to include a standardized ISBT-128 label/tag for transfusion compatibility plus a standardized two bar code patient ID wristband for transfusion verification. The ID band bar codes encode the hospital identification number and patient date of birth.
Adopting the standard: the American Red Cross (ARC), which controls about 46% of the blood collected in the US announced that it will be replacing the ABC Codabar bar code symbology with the new ISBT-128 code. This planned transition will begin according to the ARC in the summer of 2006 for all their regions.
Richard Kriozere, President of Digi-Trax Corporation said “This patient safety initiative which began in 1989 demonstrates the need to persevere in the pursuit of improved quality outcomes through Auto-ID standards initiatives such as bar coded patient identification. Bringing “machine-readable” identification to bedside is an essential element if healthcare is to improve point-of-care testing, medication administration, specimen collection and transfusion verification”.
These actions by the blood banking community ought to encourage the efforts of the HIMSS bar coding sub-committee to continue its efforts to establish “machine-readable” bar code and/or RFID standards in all areas of healthcare delivery for improving patient safety and operational efficiency.
