I am ready to change our policy to do an immediate spin crossmatch along with each Gel IgG crossmatch so satisify "to detect ABO incompatibality". Although we have not been doing it for about 10 years, now I see no alternative. Any suggestions?

Shall testing blood unit's ABO and Rh group and twice testing patient's ABO and Rh be replacement of IS??

I am ready to change our policy to do an immediate spin crossmatch along with each Gel IgG crossmatch so satisify "to detect ABO incompatibality". Although we have not been doing it for about 10 years, now I see no alternative. Any suggestions?

I give up! Even though I know that between my gel crossmatches and computer the ABO incompatibility would be detected, as of yesterday we are doing IS on all patients. I don't do electronic XM and don't see an alternative.

And so it goes.........

Who said it had to make sense?

:confuse::sarcastic:sarcastic

Now there is the new problem. If I order an IS crossmatch in our BBIS (Soft) it will print a compatible label. How do you get around that?

I am also about to implement the ISxm when doing gel IgG - even though validation of IgG xm detects ABO incompatibility. Can't fight the FDA even though the standard in the CFR states that compatibility testing has to detect ABO incompatibility . . . sometimes they can't see the forest for the trees.

I agree with you KKidd.

Now there is the new problem. If I order an IS crossmatch in our BBIS (Soft) it will print a compatible label. How do you get around that?

You should be able to turn off that label print in the hosparams. Of course you may have to have soft do it for you.

can you bill for both IS and Gel xms?

merry x-mas

Ok, I guess I missed something with regard to the FDA...this is what happens when you don't get to visit the site much.

Why do you have to perform an I.S. crossmatch on patients for whom you perform a GEL crossmatch? Even in places where I have used the electronic crossmatch, on those patients requiring a coombs crossmatch, we still did not perform an I.S. crossmatch.

Brenda Hutson, CLS(ASCP)SBB

It's because the gel is not renowned (shall we say) for picking up ABO incompatibilities (although, that having been said, I, and several other posters on this site, have never had any problems whatsoever in this area; nuff said?).

I think Ortho needs to come out and change their IFU and revise limitation.

This is too much for all of us to include IS for all Gel crossmatches...

Unfortunately, I have had the other experience. Sat down behind another tech, to complete crossmatches, pulled cards out of centrifuge and they were completely compatible. When I looked at the cards for the pt type, the patient was B pos. Tech had written A pos and crossmatched A pos units. I can only pray that this would have been caught, with all of our other checks in place before the pt got the blood. But this was enough to convince me.

Unfortunately, I have had the other experience. Sat down behind another tech, to complete crossmatches, pulled cards out of centrifuge and they were completely compatible. When I looked at the cards for the pt type, the patient was B pos. Tech had written A pos and crossmatched A pos units. I can only pray that this would have been caught, with all of our other checks in place before the pt got the blood. But this was enough to convince me.

Mostly it was wrong dispensing. Electronic cross match,presence of historical blood group, second sample test or repeat test (ABO &Rh) of the same sample shall detect this discrepancy also. However IS is the best choice to detect ABO mismatch due to any reason.

Did u repeat the cross match done by that colleague?

Edited December 26, 201014 yr by khalidm3

Unfortunately, I have had the other experience. Sat down behind another tech, to complete crossmatches, pulled cards out of centrifuge and they were completely compatible. When I looked at the cards for the pt type, the patient was B pos. Tech had written A pos and crossmatched A pos units. I can only pray that this would have been caught, with all of our other checks in place before the pt got the blood. But this was enough to convince me.

That is enough to convince me too!!!!!!!!!!!!

I think Ortho needs to come out and change their IFU and revise limitation.

This is too much for all of us to include IS for all Gel crossmatches...

Ortho or an other manufacturer using LISS cannot change IFU, LISS has some minus points. Moreover IS is a second check on our work. If we perform it is appreciable. It is better than other choices (electron cross match).

Edited December 26, 201014 yr by khalidm3

But....it is all over the AABB that Gel was sent to the FDA for approval using an IS crossmatch

It's because the gel is not renowned (shall we say) for picking up ABO incompatibilities (although, that having been said, I, and several other posters on this site, have never had any problems whatsoever in this area; nuff said?).

Gel or LISS???

Gel.

LISS was "accused" of this as well, after some work by Sandy Holburn, but this work was never reproduced by other workers (as far as I know).

OK, will someone point me to the CFR reference we are discussing here please? Most of what I have been able to find in FDA searches has been related to electronic cross match. Is this the case, or have I missed something.

We use Sunquest, but the IS crossmatch detemines compatibility. When we have an incompatible IgG gel we have to result the IS as incompatible then deal with a QA failure. It is usually only a probel with warm autos.

OK, will someone point me to the CFR reference we are discussing here please? Most of what I have been able to find in FDA searches has been related to electronic cross match. Is this the case, or have I missed something.

21CFR 606.151©

There is not a single word about IS in this CFR. An other document other than ask FDA in FDA 2010?

21CFR 606.151©

Thanks David

So what is everyone going to do about clinically insignificant cold/room temperature antibodies that we avoid doing an IS crossmatch on and go straight to gel to get our compatible crossmatch? I'm referring to those anti-M antibodies that are not detected at AHG but create havoc at IS. Will we be forced to use M negative units for these patients?

Reference the CLIA Network Newsletter July-August 2009 (US Dept of Health and Human Services). On page 2 of the newsletter is a section of 'Frequently Asked Questions' and the requirement (or not) of the immediate spin crossmatch is question #1 or 2. The answer to the question references 21CFR 606.151 (a) through (e), with specific attention called to section ©, which is the immediate spin crossmatch section. The answer then states that failure to perform an immediate spin crossmatch with gel testing should be cited as out of compliance with rule D5551. (Gel testing was specifically included in the answer.) CLIA inspectors have been specifically told to cite labs not performing IS crossmatches with gel (this comes directly from a CLIA inspector).

If you get Medicare reimbursement, CLIA rules.

Doesn't mean we have to like it! ;>

Edited December 28, 201014 yr by AMcCord