A hospital transfusion service in Los Angeles is planning to relabel thawed FFP as thawed plasma and then storing the thawed plasma for up to four more days in the refrigerator, if the thawed FFP cannot be issued and transfused within 24 hours of being prepared. However, before implementing this relabeling and product storage strategy, the hospital desires to use product labels that are compliant with established regulations. The Los Angeles hospital transfusion service inquired as to the process to obtain the appropriate CODABAR codes. According to Pat Distler (who is a California blood banker and nationally recognized expert in blood product codes), "assignment of CODABAR codes is done through the AABB, and if someone would like a code they should request it (e-mail is best) from Frank Berry who works at the AABB national headquarters". As it turns out, not all products will be assigned a national standard code. Generally, the product has to be one that the FDA would consider licensing or one that is shipped through a short supply agreement (recovered or source plasma). However, according to Pat, products which outdate in 24 hours or less are generally not assigned a national code, since they are unlikely to be shipped across a state line. For products that are not assigned national, standardized codes, there is a series of product codes (27100 through 29599) that have been reserved for local use. Facilities are free to use any of these codes for products that do not have a national code. The hospital transfusion service in Los Angeles who initiated this discussion was informed by the AABB that "because it [the thawed plasma] is not a product that the FDA would license, it cannot be assigned a standardized Codabar code. Local codes (select from the numbers 27100 to 29599) should be used (in the future, ISBT 128 will give standardized codes to all products, not just those that can be licensed)."

The following response was received.

ADDENDA Mar. 5, 2002

1. A blood banker at a Blood Transfusion Service of the Leiden University Medical Centre indicates that they published an evaluation of coagulation activities in stored thawed FFP (Smak G et al., Transfusion 1993;33:735). Since that time they thaw (in a shaking water bath at 37 C) about 15 to 20 units of group O or group A FFP each weekday and issue these units on the basis of oldest first to their mostly surgical departments. They report issuing about 20 units per day and their thawed stock is 60 units, with the average unit issued within 3 days of thawing. This is well within the 14 days maximum that they set up in 1993. Since starting this approach they report having issued about 60,000 units in this way with no reported major reactions or problems caused by, for example, by prekallikrein activators or angiotensins. According to the responding blood banker, their suppliers, the Dutch National Blood Bank, use the international and national ISBT 128 labeling codes. However, for whatever reasons, they do not recognize thawed plasma as a separate entity and, as far as the reporting blood banker is aware, there is no national code for it. Thus, the responding blood banker says that they have their own hospital coding system for upwards of 100 different "unique" blood products.

ADDENDA Dec. 16, 2006

2. A colleague in Pennsylvania reports that their transfusion service is planning to extend the shelf life of Thawed FFP from 24 hours to 5 days. The inquiring colleague is aware that many transfusion services currently use 5 day stored THAWED PLASMA but has not been able to find a product code or stock label that can be used for this product. What type of codabar label is being used by others for labeling THAWED PLASMA?

ADDENDA Dec. 21, 2006

3. A colleague in San Bernardino, California reports that in her experience, Thawed Plasma with a 5 day expiration date can be labeled "Plasma" with the product code 18401. She acknowledges that while this is technically for frozen plasma, the FDA does not require a "thawed" product code be used. Only the expiration date needs to be changed. She adds that alternatively, a local code (27100-29599) may be used for Thawed Plasma.

4. According to a Lead Clinical Lab Scientist in Donor Processing at a community hospital in Newport Beach, California, thawed Plasma products are listed on the last two pages of the Codabar/ISBT 128 conversion list with Codabar Product Code listed as "LOCAL". She adds that in her experience, once a decision is made regarding a product code number, standard red and white Codabar product labels can be obtained as a reasonably priced custom item from Shamrock Scientific Specialty Systems, Inc. Bellwood, Illinois.

ADDENDA Dec. 26, 2006

5. A Technical Supervisor of a Blood Bank in a sunbelt state reports that they obtain Thawed Plasma labels from a catalogue of Chek-Lab Inc. (630-896-0574; email: cheklab@xnet.com) that includes three pertinent Codeabar commonality codes. All three labels are designated as 'custom' labels.

Code:
18500: Thawed Plasma 225 +/- 25 mL from 450 mL CPD Whole Blood. Store at 1 to 6C.
18500: Thawed Plasma ___ mL from 450 CP2D Whole Blood. Store at 1 to 6C.
18500: Thawed Plasma ___ mL from 500 ml CPD Whole Blood. Store at 1 to 6C.

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