Where does the "DONOR UNTESTED" phrase go on ISBT-128 units? We collect autologous units for in-house use only and do not perform any disease testing. I can find no way to add that phrase using HemaTrax. Is using the AUTOLOGOUS USE ONLY, BIOHAZARDOUS an option? It seems that should be reserved for use if the patient tests positive.

I am curious as to why you need this statement. We also draw autologous for in-house use only and they are untested. We are inspected by the FDA and have never had an issue with not having this statement on our units. I agree that it is not available in HemaTrax.

AABB Reference Standard 5.1.6A-Requirements for Labeling Blood and Components. Item 23 Phrase "Donor Untested", if applicable*. *Footnote states: Donor not tested for evidence of infectious diseases.

From CAP Transfusion Medicine checklist:

Autologous units that are reactive or positive for ANY infectious disease marker, including a serologic test for syphilis, must be labeled with a "BIOHAZARD" label in addition to the usual labeling. Units that are prepared on site and are not tested must be labeled “DONOR UNTESTED.”

Thank you! This is why I work in LIS and NOT the Blood Bank (anymore). But I am setting up Hema-Trax and Digi-Trax so your comment caught my eye. If I find out anything from Digi-Trax I will post.

Thanks again,

Laura

We have been using our own DONOR UNTESTED labels but I was hoping there was a way to have the Hematrax Software print it on the full-face label rather than having to add a separate label.

Most facilites that are interfaced with HemaTrax are using Intended Use "1" Autologous Use Only Biohazardous for Untested Auto units. Although it sounds misleading, wouldn't you consider any tissue or blood specimen biohazardous unless otherwise tested?

Up until several years ago we did label our autologous units "Biohazardous". When the AABB/CAP standards added the "Untested Donor" requirement for untested autologous units, we switched. Any thoughts on using the BIOHAZARDOUS statement with HemaTrax...is it acceptable to me more stringent in labeling or do we have to follow the requirements exactly?

You could create the phrase in Hematrax under special testing on the Expiration Date window.

I don't think I know where to add new Special Testing information?? I don't see it in the Maintenance. Would it be possible to just build it for that particular product code in the label maintenance?

Thanks Joy...I was able to add it as a Special Test comment.

You can add it to the SpcTst.txt file in Program Files>Hematrax Standalone. Follow the format for what is already in that file (probably CMV Neg and CMV Pos) and give it next number in sequence. Save the updated SpcTst.txt file. This is what mine looked like:

CMV Negative=N0008,Negative for antibodies to CMV

CMV Positive=N0009,Positive for antibodies to CMV

DONOR UNTESTED=N0010,DONOR UNTESTED

After you do this, log back in to Hemtatrax and it should be in the Special Testing dropdown box. I have the standalone version. If you are interfaced with your BB computer system, please consult with Digi-Trax to make sure this change will not cause a problem.

OH! I get it! Thank you! I was just in those Program Files for the default to "V" instead of "0". I should have realized. Long week.

Thanks again!

The problem I am seeing with doing this is that I am getting a barcode - that I cannot read of course. But those Special Testing "N" numbers are the designation from ICCBBA for the Special Testing General Database. So N0010 already has a defined Special Testing assigned comment (something about HLA antibodies). Not really sure if this matters since we can't send our untested autos outside of the institution but I wanted to make others aware.