Labeling

Overview

Labeling requirements and bar code technology are playing an increasingly important role in the transfusion medicine and cellular therapy communities. Labels and bar codes — machine-readable representations of information — include critical information necessary to accurately identify, store, ship, track, and distribute blood and cellular therapy products. The technology has been shown to reduce facility operating costs while increasing the efficiency, traceability, accuracy, and safety of the products and the manufacturing processes.

There are two types of product labeling language approved for use by the Food and Drug Administration — Codabar and ISBT 128. The FDA's bar code rule does not specify which language should be used, only that machine-readable information must be available. Each label must have information that contains, at a minimum, a unique facility identifier, a lot number relating to the donor, a product code, and the ABO and Rh of the donor. The requirements are applicable to all blood and blood components, including autologous units collected within a hospital and to all aliquots, syringes and pools. AABB's Standards and Accreditation program requires facilities to comply with ISBT 128 labeling for blood and blood products. In addition, the international cellular therapy community has developed plans to use ISBT 128 bar code symbology as well.

Because labeling requirements and bar code scanning are considered to be an important step in reducing transfusion errors, AABB works with federal regulators to advance the use of this technology for positive identification of the patient and the product or component at the patient's bedside.

Recent Actions

3/30/17
AABB, America's Blood Centers (ABC) and the American Red Cross (ARC) submitted joint comments to the Food and Drug Administration in response to the agency's January 2017 draft guidance, “Labeling of Red Blood Cell Units with Historical Antigen Typing Results.” The organizations expressed support for the draft recommendations to label red blood cells based on the results of historical antigen testing from two previous donations, without requiring antigen-typing the current donation.