A director of a blood program on the East coast reports that his facility has converted to ISBT-128 labeling of blood products. However, some hospital transfusion services in his area still utilize the Codabar system (but not the ISBT-128 system) and are requesting that ISBT-128 labeled units also have an attached tag bearing a product code in codabar, so that they can scan the unit. The inquiring colleague personally feels that it would increase the risk of a labeling error if such a practice were adopted. He would like to know how other blood product suppliers who have implemented ISBT-128 barcode labeling are handling hospital customers whose blood bank laboratory information systems still use Codabar blood product labeling. He would also like to know how hospitals that receive ISBT-128 barcode labeled blood products integrate those products into a Codabar system/inventory.

The following comments have been received.

ADDENDA Aug. 25, 2004

1. Kathy Arthur, Hospital Relations at Community Blood Center (CBC) of Kansas City (attribution used with permission) reports that CBC implemented ISBT 128 labeling on July 1, 2003, and that all 76 hospitals served by the CBC prepared in advance for the conversion. She adds that all customer hospitals have the capability of accepting both Codabar and ISBT labeled products. For exporting to facilities unable to accept ISBT 128 labeled products they relabel with Codabar if requested. She adds that for those who are interested, there will be oral and poster presentations on CBC's implementation process at the AABB annual conference in Baltimore.

ADDENDA Sept. 29, 2008

2. The e-Network Forum should be aware of a DRAFT of Version 3.0.0 of the US Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128. There will be a 60 day comment period (until December 1). Comments should be sent to uscomments@iccbba.org.

This document describes the requirements for labeling with ISBT 128 in the United States, and should take FDA and AABB requirements into account. The international document (ISBT 128 Standard Technical Specification) describes the international requirements. The international document covers exactly where the bar codes are placed on a label, what information must be in the bar codes, how that information is encoded and other things that are globally standardized. However, the international document does not, for example, specify exactly what words appear on the label. This is to allow for differing languages and regulatory requirements. Therefore, each country must decide for itself the issues that are not part of international standard. This US document covers those areas.

FDA has published previous versions of the US Consensus standard as an FDA Guidance Document. Therefore it is important that it be reviewed carefully. If FDA again publishes this as a FDA Guidance Document, it could conceivably be used for comparison when facilities submit ISBT 128 labels for their review.

Please submit comments to the e-Network Forum.

Ira A. Shulman, MD
CBBS e-Network Forum Editor & Moderator