IS Crossmatch with Gel IgG Crossmatch

[Eagle Eye]

We perform Elecronic/Computer crossmatches.

We perform Gel Crossmatch and do not perform Immediate Spin (IS) crossmatches, when the patients have antibodies (Historical or current).

Our computer system logic will alert the user to discrepancies between the donor ABO/Rh and that of recipient ABO/Rh. Blood group confirmatory test is done on patients with a second sample (if the patient has no history of blood type in our computer system) and retype the donor units. If blood is needed urgently before second sample ABORh confirmation, we can only issue Group 'O' red cells.

At our last join CAP/AABB inspection the issue of IS crossmatch was raised by the inspector (CLIA reference) , but we were not cited because of electronic/computer crossmatches.

you wouldn't perform computer crossmatch when patient has antibodies? isn't it?

[DPruden]

Our computer system logic will not allow the selection of ABO incompatible units regardless of the patient's antibody status, it doesn't just alert us, you can not choose an incompatibile unit. If the only purpose of the IS crossmatch is to identify ABO incompatbility and the computer system covers this, then why is an IS crossmatch needed?

[Eagle Eye]

This is the same argument I have but looks like it will not fly with regulatory agencies...

Also we will need to cover computer downtime issues.

[CPSHAN56]

Hello Everyone,

What is everyone doing once they have found a positive IS crossmatch, but the gel crossmatch is negative. I can go ahead and prove there is a "cold antibody", but that does not prove ABO compatibility. We already re-type our donor units, and preform two ABO/Rh on two separate patient specimens. Can we give type specific units, or do we have to transfuse group O. Seems to me, if we must perform IS crossmatch to verify ABO compatibility then if the IS crossmatch is incomplatible we should be transfusing group O. Thoughts? Help!

[Malcolm Needs ☆]

Bit of a nasty this one, because most "cold" auto-antibodies have an element of anti-H in them (i.e. anti-HI and/or anti-Hi), as well as anti-I and/or anti-i.

Of course, what ABO red cells have the strongest expression of the H antigen? Why, group O of course!

Howver, I see no other way around this, than by giving group O (unless, of course, you have an endless supply of Oh donors, who also happen to be adult ii)!!!!!!!!!!!!!!!!!!!!!!!!!

:devilish::devilish:

[tlorme]

This is a CMS regulation, not FDA. What happens if you get a CLIA citation? Is one citation enough to hold up your CLIA approval status? I think we need to INSIST on some logic and reasonable judgment on this. It says that the ABO compatible status must be assured. If you demonstrate that your computer system is designed to disallowed ABO incompatible units to be selected, and you show that you confirm the ABO of all donor units received, and you reconfirm the ABO of all patients, then I would argue (hard) that this is demonstrating ABO compatibility. There are many ways to do so and ISXM is but one. Also, if you have validation data on the GEL implementation where you have tested AB (including A2B) units with group A and B recipients, and demonstrated incompatibility, you have additional data to prove that your Gel method detects ABO incompatibility. One thing is for certain. If we all kill ourselves to implement something that does not add to patient safety but does add to health care costs, things will just get more rediculous. I vote for civil disobedience on this one.

I'm totally wiht you!!

[Brenda K Hutson]

My impression just from reading this Thread (which may be erroneous given I have not had time to spend investigating this issue) is that what is now being asked/ required of us is that for patients requiring a coombs crossmatch (so antibody patients), we must also perform an I.S. XM. But I am not under the impression (which may be erroneous on my part) that Electronic Crossmatches are now going to be useless because we must also perform an I.S. XM on patients who qualify for the Electronic Crossmatch (with a computer system that has been validated per FDA requirements to perform an Electronic Crossmatch). If we are being told that we must perform an I.S. XM in addition to an Electronic XM, then the Electronic XM has now become worthless.

But then that same rationale should follow for coombs crossmatches at Facilities who do perform Electronic crossmatches (FDA validated) in that you perform the coombs phase to rule-out any other clinically significant antibodies (and/or missed antibodies; without addressing the issue of whether or not that AHG XM would pick up an ABO incompatibility); but upon entering those results in your FDA approved Electronic XM computer, it is still checking for ABO compatibility.

If an Institution is not "officially" performing Electronic Crossmatches (as we are not yet), we are stuck (for now) with the I.S. XM in addition to the coombs crossmatch when applicable. But for those using the Electronic Crossmatch, even when testing antibody patients; it seems to me that should cover the requirement (or again, we have just thrown out the Electronic XM).

Brenda Hutson, CLS(ASCP)SBB

We are doing electronic crossmatches. We have Soft and it does not allow selection of ABO incompatible units. This feels like a step backwards.

[Brenda K Hutson]

So to "put it all together" (FDA; CLIA; I.S.; GEL; Ortho)....

The letter from Ortho states it is a CLIA regulation, based on FDA CFR 606.151(a) thru (e). Specifically, © states: Procedures to demonstrate compatibility between the donor's cell type and the recipient's serum or plasma type.

Question is: Where does the Electronic XM fit in here given that this is rather vague (in my view). I still believe the Electronic XM would be an acceptable alternative to an I.S. XM. After all, that is the whole point!

Again, my humble opinion.

Brenda Hutson, CLS(ASCP)SBB

Just received a FYI from Ortho regarding the AHG IgG MTS cards and the requirement for determining ABO compatibility. Ortho's stance is the same at this point as the CLIA interpretation; the AHG IgG cards can be used for AHG crossmatches to detect antibodies of the IgG class. They do indicate that they are aware of their "customer's desire to use the AHG IgG cards to satisfy the requirements for the detection of ABO incompatibility concurrent to the detection of clinically significant antibodies". Also says they, Ortho, are "looking at several options involving the detection of ABO incompatibility in gel". Anxious to see how quickly Ortho comes up with something that will satisfy the requirements by using the AHG IgG card. We are settling in with the IS tube crossmatch for now.

[Brenda K Hutson]

I wish I could!

Sorry, are my "redundant" questions annoying people?? If so, I made just have to "read when I can" and not respond.

Brenda Hutson, CLS(ASCP)SBB

Brenda,

you need to visit this site more often!!!!!!

There a whole article from AABB accessor in AABB news....

I was thinking to add IS as one of the detail under my gel crossmatch...as doing IS separatly there are so many problem...

1) If we order IS on same unit..unit will be in crossmatch ...can we bill the patient again..No.

2) Peinting a TAG ...so many problem..I do not think i will order IS again in computer instead will find a way to change the way gel crossmatch is set up in computer...which will solve all other problem.

[Malcolm Needs ☆]

Read when you can and respond PLEASE Brenda.

[Deny Morlino]

Brenda,

I must agree with Malcolm... please continue to read and respond. Your perspective is normally inclusive of some angle I have not considered up to that point, and I appreciate the perspective.

[hughes]

Are you charging patients for both an IS crossmatch and igG gel? Also, how are you ordering and resulting, we have Cerner Millenium and it seems I cannot order an IS XM and IgG gel XM on the same, what we call accession numbers?

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

[Yanxia]

Maybe I have not the right to say anything about this topic, because I have not read the all thread before me,I just read some .

In my understanding to do the IS XM apart from Gel XM is to detect the ABO compatibility, if just so, why not to do the ABO typing instead of IS XM.

[Deny Morlino]

Yanxia,

I will get on my "soapbox" and gripe a little bit first. It seems the message coming from the people who make the decisions about the rules and regulations is that we are not qualified and too careless to choose the appropriate unit blood type for the patient. OK, done venting now. Looking at this logically, the purpose of the IS crossmatch is to assure ABO compatibility. I agree with you that it seems logical to just perform an ABO on the patient and choose the appropriate blood type (my feelings exactly). I guess this is an extra check to assure the appropriate donor unit was crossmatched to the appropriate patient. As the number of CLSs decreases, the volume of work per person increases. A busier tech is more prone to make an error. I guess this is an attempt to minimize the potential for this particular error. Anyone else have a different perspective on this topic?

[Steven Jeff]

You are correct Deny the purpose of the IS cross-match is to asure ABO compatibility, but at the same time that is an extra procedure for the busy blood banker to do. As has been mentioned in earlier posts the computer system will alert/prevent you from selecting ABO incompatible units for cross-matching often more effectively than a IS cross-match i.e. my computer sytem makes a lot of noise!!

In the UK all the units provided by the NHSBT transfusion service are guaranteed to be the ABO group as labeled on the pack. We do not check the ABO groups of the donor units. I understand this is not the case in all countries. That may also be another reason for the IS cross-match.

Steve

:)

[Yanxia]

Thanks, Deny and Steven!

[Eagle Eye]

Are you charging patients for both an IS crossmatch and igG gel? Also, how are you ordering and resulting, we have Cerner Millenium and it seems I cannot order an IS XM and IgG gel XM on the same, what we call accession numbers?

yes. with cerner we can not order IS XM and IgG gel XM on same accession#.

can you give separate accession#...no as accession# is tied to specimen which is same for both crossmatches.

basically you can not order both crossmatches on same patient....so many LIS issues, putting units in crossmatch, billing patient twice, if you order separate accession# you are not connecting to same specimen...etc.

What I think will work is adding additional detail IS to PDM table under your gel crossmatch...I do not think you can use the same detail from your IS XM as it will have interpretation attached to it...I believe if we add required detail(IS) to Gel crossmatch it will work.....we will have to try it. I haven't tried it yet....will try it next week.

[JLF]

I have built my Coombs crossmatch test with an IS and an AHG response. That way the label prints after AHG phase result is entered.

Our cost of test takes into consideration both phases and there is only one charge assessed. As IgM antibodies react most effectively at RT, IS is best way to detect. That being said, we detect room temp antibodies in Gel all the time.

[Mabel Adams]

It appears the rulemakers believe that the IS xm is capable of 100% accuracy in detecting ABO incompatibility. I think the computer software is more reliable considering the number of weak reverse types I have seen compared to the number of ABO matching computer failures I have seen. If we choose to validate gel for ABO incompatibility, we only have to make sure it is as effective as IS xm, not 100% effective.

[mhc]

It appears the rulemakers believe that the IS xm is capable of 100% accuracy in detecting ABO incompatibility. I think the computer software is more reliable considering the number of weak reverse types I have seen compared to the number of ABO matching computer failures I have seen. If we choose to validate gel for ABO incompatibility, we only have to make sure it is as effective as IS xm, not 100% effective.

I agree with you that there is misguided thinking on the part of the rulemakers. But right now, you will be cited by AABB, CMS and CAP if you do not use an IS (or buffered gel card) along with your IgG gel XM. I think that we should begin lobbying these organizations and provide documentation that a validated computer system is more effective and safer than an IS XM for detecting ABO incompatibility. Once they have hard data, I hope that they would change this requirement. I think that's our only recourse now.

[Mabel Adams]

Does anyone have statistics on the percent of ABO incompatible units IS xming could be expected to detect? I suppose the frequency of weak reverse types would be a good indicator. I have a feel for it but no statistics.

[janet]

Does anyone have statistics on the percent of ABO incompatible units IS xming could be expected to detect? I suppose the frequency of weak reverse types would be a good indicator. I have a feel for it but no statistics.

I agree Mabel .... how can one trust I.S. crossmatches to pick up incompatibilities in patient's with weak reverse groupings - those with computer systems that warn about discrepancies are safest.

It seems silly to do an I.S. crossmatch with your gel if you have a computor system with that capability!!

[Brenda K Hutson]

We do not use SOFT (though the rest of the Lab does; but that is a story for another Thread). But in the system we use, we can enter the I.S. results in the same row as the GEL results so it only prints a tag once; and only when the "entire" row is complete and Verified.

Brenda Hutson

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?

[Brenda K Hutson]

Actually, since the performance of an I.S. XM with a GEL XM is the new part, my concern is the opposite (so I have been auditing GEL crossmatches); I am concerned my staff will perform the GEL XM (when appropriate) and forget to do the I.S.

NOTE: A couple of people did forget the I.S. the first month or two; with "reminders," there have been no recent ommissions.

Brenda Hutson

I would be afraid that someone would do the IS and print a compatibatible label and then "forget" to do the IgG gel and then an incompatible unit can be issued. Until I figure something out I have a paper log of IS crossmatches when an IgG gel crossmatch is done. We only have a couple a day but need to get rid of the logs. We have AABB/CAP any day so I hope this gets us by.

[Mabel Adams]

If we can prove that the sensitivity and specificity of ABO compatibility is better via computer software than IS xm, no one should be able to argue too much with the logic. Specificity is poorer with IS xm because of cold agglutinins and rouleaux. Sensitivity is worse because of weak reverse types. If we do 100 tests in the software with no failures and compare with 100 serological tests we should at least be able to prove equality if not superiority.