hmust1 Posted July 27, 2007 Share Posted July 27, 2007 Currently, we label every unit of packed cells with an "ABO/Rh Confirmed" label upon performing the ABO/Rh retype. Is this necessary?? Our label is large and takes up much of the space needed for other more pertinent labels, i.e. antigen typing.If the AABB Technical manual says, "routine tests performed to ensure the safety of the unit need not be on the label if they are listed in the Circular of Information..." and the Circular says, "Testing of a sample of donor blood is performed before units of blood or blood components are distributed for routine transfusion," are they talking about the blood type sample collected at donation...or the testing we perform to recheck the type before placing the unit into our inventory?I have worked in a large blood bank/trauma center that did not label packed cells after doing the recheck...but I've seen the labels on packed cells from lots of other facilities. Was my former employer non-compliant...or are the rest of us performing label-overkill??Thanks!Heather Link to comment Share on other sites More sharing options...
Cliff Posted July 27, 2007 Share Posted July 27, 2007 Currently, we label every unit of packed cells with an "ABO/Rh Confirmed" label upon performing the ABO/Rh retype. Is this necessary??Hi Heather, I don't think you'll find any requirement that indicates is required, so I vote, it's not. On another note, are the labels you are using approved for direct adherence to a blood product? Link to comment Share on other sites More sharing options...
hmust1 Posted July 27, 2007 Author Share Posted July 27, 2007 Cliff,I wasn't looking to open yet another can of worms! :-)Well...I just checked the fine print in the catalog that I order from and it says, "All our blood labels are not intended for direct application on blood bags. Secure these labels to base labels when using on blood bags."What does this mean?? Is it an adhesive issue? Or an FDA labeling issue?Thanks,Heather Link to comment Share on other sites More sharing options...
Cliff Posted July 27, 2007 Share Posted July 27, 2007 Sorry, it's a problem I ran in to a long time ago.The adhesive on the label "may" leach into the product, clearly not desirable.See page 64 of the attached Guideline for the Uniform Labeling of Blood and Blood Components, and the referenced CFR, 21.175.105.21cfr175105.pdfunilabel.pdf Link to comment Share on other sites More sharing options...
Lcsmrz Posted July 28, 2007 Share Posted July 28, 2007 I can't think of a requirement either, although your process has to make sure that units gets retyped before use. Think what would happen if your computer system went down just after the units were entered as received. We segregate our incoming units on the quarantine shelf until retyped.We attach our label to one of the slits on the side, flagging the label on the unit, rather than stick it to the unit face or back. Another site I worked at flagged it around the pigtail at the top. We had a rather unreliable computer system at one time, so we retained the use of the retype label for comfort. However, I'm dropping the customized label with our facility name, as soon as the current stock runs out. It would be controlled as any other label, but I can't think of a reason to spend the extra money for the custom printing and the minimum order. Link to comment Share on other sites More sharing options...
Mabel Adams Posted July 30, 2007 Share Posted July 30, 2007 You can also do something as simple as place a tiny colored dot on the base label that your procedure designates as signifying visually that the retype was done. We used to do this with a half inch round label which we dated and initialed. Link to comment Share on other sites More sharing options...
OPUS104 Posted July 30, 2007 Share Posted July 30, 2007 Same as Mabel at the last hospital I worked. very handy...very simple Link to comment Share on other sites More sharing options...
David Posted July 30, 2007 Share Posted July 30, 2007 RE: label adhesive, I have a copy of an email from a FDA Investigator, Thomas Nojek, saying "...there are no FDA compliance issues with placing Avery labels on blood products..." dated August 2006 which I believe I got from this site. Have I missed something? Link to comment Share on other sites More sharing options...
Mabel Adams Posted July 31, 2007 Share Posted July 31, 2007 I remember this also, but searching this site for Thomas Nojek doen't bring up any other matches. AABB is down still so I can't search it. Link to comment Share on other sites More sharing options...
Eagle Eye Posted July 31, 2007 Share Posted July 31, 2007 Follow the link for FDA reply regarding Avery labels. http://www.geocities.com/dmpollock/adhesive.pdf I think you have to use copy and paste function. Link to comment Share on other sites More sharing options...
rcurrie Posted August 1, 2007 Share Posted August 1, 2007 There is no requirement to label a unit as ABO/Rh confirmed. You can handle that quite nicely with your computer system. Those of us who predate computers remember the little label pink you could buy and place around the pigtail, but those days are gone. We do it by physical quarantine and computer. You could actually perform the recheck at the time you do the compatibility testing, as long as your system prevents you from issuing a unit that hasn't been reconfirmed.BC Link to comment Share on other sites More sharing options...
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