ISBT Again

[lef5501]

I'm getting a little confused with all this ISBT labeling. Our lab is not FDA nor AABB accredited, only CAP. Do we still need to worry about registering with ICCBBA and do we need to get pooled labels for our cryo? Our BB system already prints a bar code label for the unit number(pools, aliquots), but do we still need the facility identifier? Just not sure how far we need to go if we are not FDA accredited and don't collect products.

[TOBYCAT]

You are not the only one confused. I was wondering the same thing. We are

only CAP also.

[Richard Kriozere]

All blood establishments that manufacture, process. repack, or relabel blood or blood components intended for transfusion and regulated under the Federal Food, Drug and Cosmetic Act or Public Health Service Act are required to use "machine-readable" codes. Currently both Codabar and ISBt128 are FDA acceptable. The regulation for products subject to the rule include all components intended for transfusion; see 21 CFR 606.121©(13)

You can ask at regulatory@aabb.org, www.iccbba.com, or www.fda.gov/cber/faq/barcodefaq.htm.

Who is your software vendor and do they provide the facility to print ISBT128? If you receive blood or blood products from American Red Cross or others they will be switching to ISBT128 so you will certainly need to read/scan ISBT128 bar codes.

PS according to AABB the applicability of the bar code rule to hospital transfusion services is not determined by their FDA registration status. Non registered are impacted if they pool Platlets or Cryoprecipitated AHF for ease of transfusion or aliquot blood components. They don't need to FDA register but must comply with rule.