approved in the United States for treatment of patients with hereditary AT deficiency in connection with surgical or obstetrical procedures

or when they suffer from thromboembolism. 108 AT-III is an inhibitor of clotting factors IX, X, XI, XII, and thrombin. Patients with plasma levels less than 50 percent of normal are at risk of thrombosis. A new recombinant AT concentrate (rhAT) produced using transgenic technology has been developed by GTC Biotherapeutics (Framington, MA) on a compassionate-use basis. rhAT is produced by transgenic goats expressing recombinant human AT in their milk, under the control of the betacasein promoter. It is purified from the milk and concentrated. Initial studies using rhAT have indicated effective support for AT-deficient patients who undergo surgery and that it is a suitable alternative to pdAT. No antibodies have been produced against rhAT in studies to date and adverse events, which are minimal, include spontaneously resolving skin hyperpigmentation at the site of drug infusion. Table 114 provides a comprehensive list of blood component characteristics.

Labeling of Components
Once the component has been made, it must be labeled in accordance with AABB Standards, FDA regulations, and ISBT (International Society of Blood Transfusion) Code 128. The latter system is an adaptation of the conventional coding system known as Code 128. This code has been adapted for use in blood transfusion services throughout the world by the ISBT109; hence ISBT 128. The donation number comprises 14 characters that contain information relating to the country, the center of origin, the year of collection, a sequential number, and a check character. Each ISBT 128 donation number is unique on a worldwide basis. Each blood bank or transfusion service should have its own protocol for labeling components. The original unit, its components, or any modifications thereof must be identified; serologic results of the unit must be reviewed, and the appropriate labels attached in such a way that is clear and readable to the naked eye. If a change must be made to the unit such as a modification of the expiration date, the handwritten change must be legible. The unique identifier of the unit, the ABO and Rh type, expiration date, and component labels must be checked with a second person. There must be a method in place linking the respective donor to the unit. The donor must be classified as autologous (Fig. 1114) or volunteer (Fig. 1115). The maximum number of unique identifiers that may be