IS Crossmatch with Gel IgG Crossmatch

[ABQ bloodbanker]

In regards to perfoming both an IS and GEL XM, I built a new XM test in our computer that has both reactions and only one interpretation, and it crosses the interface only once and bills for only the GEL XM. Still haven't gone live with it yet, but reading all of the responses, I reckon we will soon....

[ABQ bloodbanker]

I would do a prewarmed XM for a cold or clin insign cold.....

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?

[Joanne P. Scannell]

We use Sunquest.

XM (Crossmatch) = I.S. (Immediate Spin) + TS (Transfusion Status)

So, when a unit is allocated, this is what we see as 'basic required'.

I.S. - we put in the result.

If positive due to cold agglutinin, interpretation is 'CMBT = Compatible by Blood Type'.

If not done, result = ND, interpretation = ND. This is defined as acceptable in the maintenance.

IF more testing is required, e.g. Gel Crossmatch, then that is added as a test to the units.

I have built 'tests', XMTS, XALB, XNP, etc. for all the 'complete crossmatches' we do, MTS, ALBumin, No Potentiator, etc.

TS is resulted 'Ok' or Not Ok' ... but you knew that.

Yes, FDA requires I.S. crossmatch. This was originally set up to catch ABO Incompatibility/Mistakes (the only other reasons being cold agglutinin or rouleaux, neither of which are clinically significant). In today's world of rechecks, this is just redundant ... I'm hoping the FDA will catch up someday.

[bbonnema]

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.

[DPruden]

We are not doing electronic crossmatch, but our computer system will not allow the selection of ABO incompatible units. The computer system was validated to this effect. Shouldn't that count for the ABO compatibility portion of the crossmatch?

[khalidm3]

We are not doing electronic crossmatch, but our computer system will not allow the selection of ABO incompatible units. The computer system was validated to this effect. Shouldn't that count for the ABO compatibility portion of the crossmatch?

I do not think so, It is not an alternate to IS specially if u r using LISS Coombs-Column. We have same options like u in our system (locally created) and it is under trial these days.

[sshel55]

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.

[Eagle Eye]

I have the same thing and I am ready to go with the fact that our computer tabels are set to detect ABO incomatibility(I am also planning to do mini validation for Gel crossmatch to see if it detects ABO incompatibility). I may implement IS for computer downtime. If all of us are blindly going to accept this and implement IS....I do nto know, this doesn't make sense.

We are not doing electronic crossmatch, but our computer system will not allow the selection of ABO incompatible units. The computer system was validated to this effect. Shouldn't that count for the ABO compatibility portion of the crossmatch?

[khalidm3]

Three years ago I had 2 A Donors having weak B antibodies, which were not detected by Gel but we got "+" reaction in tube using the same cells I had used with Gel and local prepared cells also. I reported to local DiaMed Support and there rep (a MT) performed the tests himself and he also observed same finding. He promised to contact his head office but no feed back.

At that time I missed to do x-match.

[jcdayaz]

In my humble opinion, there will always be certain cases that don't follow the rules(so to speak).

We do electronic crossmatches on any patient needing blood that does not have any antibody "issues". It works GREAT for us!

[khalidm3]

In my humble opinion, there will always be certain cases that don't follow the rules(so to speak).

We do electronic crossmatches on any patient needing blood that does not have any antibody "issues". It works GREAT for us!

Actually I wanted to say that in this way some times we may miss some anti bodies by GEL-column(e.g. ABO or k) and it can be a threat to a patient

Edited December 29, 2010 by khalidm3

[LaraT23]

In any Blood Bank there is the possibility, though no one likes to admit it, that we can mis-label or mis-pipette. An immediate spin XM does not guarantee this will not happen and in my opinion does not make the whole process any safer. I have done a small study in house and the gel picked up ABO incompatibility 100% of the time with 15 patients sampled. I just like to think about what it is we are hoping to accomplish for each thing we do.

[khalidm3]

Lara123

In our centre we do not do IS but if we perform it; it will be counter check for miss-pipetting for testing or miss-labelling of the unit.

[Frances Haas]

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

[Frances Haas]

We buy our units from United Blood Services and do the ABO recheck upon delivery into our stock. That takes care of any worry about incorrectly labeled units.

[carolyn swickard]

Does anyone happen to know how this all may relate to Immucor's solid phase IgG xms? We do I.S. crossmatches for all pts without an antibody, but do some solid phase crossmatches on our ECHO when we have an antibody with sceened, antigen negative units. We do not do I.S xms if we have done the coombs phase xms.

[bclavette]

the MTS IgG gel card WILL detect an ABO incompatibility...

[jcdayaz]

Lara123

In our centre we do not do IS but if we perform it; it will be counter check for miss-pipetting for testing or miss-labelling of the unit.

As Lara123 stated very well, even with that IS crossmatch there is the potential for mistakes made by your Technologists.

We are all human and are fallible.

[jcdayaz]

Hey Malcolm,

I got the right "fallible" this time!:cool:;)

[bbonnema]

Thanks, that is what I was looking for. Do you happen to have Soft Bank? I think I can do something similar but now someone brought up the issue of clinically insiginificant cold antibodies and now I suppose rouleaux that will give a positive IS. I knew this was not going to be easy. Right now I have a paper log since we could have AABB/CAP as soon as 1/4.

[David Saikin]

Does anyone happen to know how this all may relate to Immucor's solid phase IgG xms? We do I.S. crossmatches for all pts without an antibody, but do some solid phase crossmatches on our ECHO when we have an antibody with sceened, antigen negative units. We do not do I.S xms if we have done the coombs phase xms.

I would anticipate that the "governing" pundits will eventually make certain that solid phase users are also compliant with their interpretation of the CFR21 606.151.c - which states that compatibility testing must assure ABO compatibility (does not reference IS xm).

[AMcCord]

Does anyone happen to know how this all may relate to Immucor's solid phase IgG xms? We do I.S. crossmatches for all pts without an antibody, but do some solid phase crossmatches on our ECHO when we have an antibody with sceened, antigen negative units. We do not do I.S xms if we have done the coombs phase xms.

In validating the crossmatch function with solid phase, I ran an ABO mismatched donor (should be incompatible) on 6 or 8 patients. 1 of those mismatches crossmatched as compatible with Capture while the IS XM was 3+ incompatible. The patient in question typed completely normally as a B by Echo and tube - he did not have a weak backtype. The unit in question was an A, which also typed completely normally. The unit did not have a positive DAT. The patient did not have an antibody, cold or auto or otherwise. The crossmatch repeated as compatible by Capture. The AHG phase is not a 100% reliable way to detect ABO compatibility, whatever your method.

[BloodBank]

As far as my understanding when I validated Electronic Crossmatch is that one does not need to perform IS XM if your computer system is validated to ensure the detection of ABO incompatibility and prevents release of such units. In other words per logic table set in the computer, it does not allow us to select ABO incompatible red blood cells whether it is IS or Gel XM. So there is a mechanism to detect ABO incompatibility as long as computer system is used to select and issue.

I may have to change computer downtime procedure for Gel/AHG XM to include IS XM in addition to Gel/AHG XM.

[Beverly Morris]

Our gel AHG crossmatch includes an IS phase. We bill both CPT codes 86920 and 86922, which is allowed. We instituted that with gel implementation in 2007. In April of 2009, following research done by the University of Michigan and in-house validation, we dropped the IS phase in gel but not tube PeG AHG crossmatching. We have reinstuted the IS phase based on the response of the CLIA inspector at the AABB meeting. Our Ortho rep sent us the following:

"We are waiting on the response from our company, it is in the works. I would also like to point out that inspecting agencies do not necessarily inform us (manufacturers, transfusion facilities, etc.) ahead of time when they are planning to change how they view certain test applications by any method. Also there can be considerable variation between individual inspectors. OCD cannot 'make sure' they are all covered. Even asking the same question of the inspecting agency today may not make sure all bases are covered for the future. We are very discouraged by all of these changes as well. As soon as I get the official letter, I will make sure you have it. Thank you for your questions and I will pass this along with the other requests for such a letter."

I have also asked our LIS vendor, SCC, for confirmation that the SoftBank Version 23.2 does all the system checks for ABO compability when the AHG crossmatch is requested. Currently, our version prompts that the "patient is not eligible for ELXM" when an AHG crossmatch is requested. That response is also pending. You cannot bill ELXM CPT 86923 together with 86922.

[richardsonj]

In validating the crossmatch function with solid phase, I ran an ABO mismatched donor (should be incompatible) on 6 or 8 patients. 1 of those mismatches crossmatched as compatible with Capture while the IS XM was 3+ incompatible. The patient in question typed completely normally as a B by Echo and tube - he did not have a weak backtype. The unit in question was an A, which also typed completely normally. The unit did not have a positive DAT. The patient did not have an antibody, cold or auto or otherwise. The crossmatch repeated as compatible by Capture. The AHG phase is not a 100% reliable way to detect ABO compatibility, whatever your method.

We recently set up our Echo analyzer in 2010. When they were here teaching us, the technicians told us we needed to have a check method on our AHG crossmatches because solid phase "may not" detect an ABO incompatibility. They quoted the AABB technical manaul. This information can be found on page 453 (16th edition) under Antiglobulin Crossmatch in the first paragraph. "Although tube and column agglutination AHG crossmatches will also detect ABO incompatibility, the AHG crossmatch in solid phase may not. An additional procedure is required to verigy ABO compatibility, such as the IS or computer crossmatch." Since we do not have the electronic crossmatch, we do an IS with every AHG crossmatch performed on our Echo analyzer.