Is the facility name required to be on the compatibility/component tag?  If so, which regulatory agency requires this and where can I find it?

I think it's a general requirement with all regulatory agencies that every report have the facility name on it. I believe that all pharmaceutical labels must have the facility name on it, so I would imagine that blood tags fall under the same requirement. If patient information or a patient with blood is hanging is transferred, the receiving facility must know where that information/blood came from in order to integrate that into their own documentation. If the documentation doesn't have a facility identifier on it, that's going to be hard to do.

 

CAP GEN.41096 says: "The paper or electronic report includes the following elements...1. Name and address of testing laboratory...". The unit tag on your blood product would be considered a report.

CAP GEN.41077 talks about integrating outside lab reports..."if such results are integrated, the name and address of the outside laboratory must be available in the primary reporting system, and there must be an indication available to the person viewing such results that the results originated from an outside laboratory...."

 

Can anyone else cite JC, FDA or CLIA regs for this?

^{I don't think it would be Blood Bank specific but it a regulation for all lab reports, which I believe this would qualify as.}

The CMS standards for a laboratory test report can be found in 42CFR493.1291.

42CFR493.1291.pdf

The CMS standards for a laboratory test report can be found in 42CFR493.1291.

42CFR493.1291.pdf

 

Thanks for posting this.........I knew someone out there would have this at their fingertips!

Thanks. We are having a problem with our new LIS company not including the hospital name on their standard tags, which forces us to pay to have them customized so that we have our name and address on them.  We are trying to make a case that that should be standard because it is required.

Both of our hospital systems use preprinted tags with the hospital name preprinted. The rest of the  information (patient name, record number, unit number, etc) are printed by computer system.

I have never thought of a bag tag as a report.  Our bag tag is a peel off label from our transfusion record.  The transfusion record has the facility on it.  I am not sure about our tag but I think not.