Barcode facility ID

[bmarotto]

I'll start the ISBT discussion.

In codabar, the facility ID that is barcoded is usually the FDA registration number. From what I have seen of ISBT-128, the facility ID is incorporated into the donor ID number (the four numbers after the country letter code). The donor ID number is barcoded. I have seen FDA registration/license numbers on ISBT-128 labels but they are eye readable and not barcoded.

Assuming the unique facility ID part of the donor ID number barcode is acceptable, what do we do when we modify (irradiate, freeze, wash, divide, etc) and relabel a product that was not collected at our facility? Does the facility ID barcode apply to the collection facility only or to the facility that further modifies the product as well? I purchased the Hematrax software and can print my facility name and registration number on the processing message part of the label, but I can not find an option to print a barcode.

[Richard Kriozere]

Checked with expert...when you modify and you print with Hema Trax in the lower right quadrant your reg. # and Lic. No. in eye read format only. That is below the CMV testing data and Bar Code. There is no ISBT128 bar code required for the " Further Processing By" portion of the label.

Richard

[bmarotto]

Thanks for checking Richard. I didn't expect Hematrax to print the registration number in barcode format if that is not the ISBT standard. I am concerned about how the FDA will reconcile their approval of ISBT-128 with their regulation that the facility ID be machine readable. We should not be in the position of having to add yet another label with our barcoded registration number when we modify and relabel a product collected elsewhere.

Does anyone know the official FDA position on which facility ID must be machine readable; the collection facility, the facility that modified and relabels, or both?

[Richard Kriozere]

I suggest you run your question by Ken Zemann at CBER. His email is zemann@cber.fda.gov or call 301-827-6145. I suspect there is no geography available.

[bmarotto]

I e-mailed CBER. I'll post back when I get a reply.