Gel XM's and ABO Incompatibility detection

[ABQ bloodbanker]

Howdy Blood Bankers!

I am wondering what everyone is doing regarding the CLIA regulation change that happened last Sept, saying that IgG gel crossmatches do not detect IgM antibodies (i.e. anti-A or anti- and that you must also perform an Immediate spin XM, electronic XM in addition to performing the gel XM. This has just come up in our laboratory, and before we implement a change in how we perform our crossmatches for our patients with antibodies:cries:, I would like to see if there is any alternatives out there. We are currently inspected by CAP and AABB, but I'm sure the CLIA regulations are somewhere in there. I personally performed a "mini" validation of the IgG gel cards, and yes, they do detect ABO incompatibility, but I've been told that that may not be relevant. Any ideas???

[David Saikin]

I validated my gel xm's to detect ABO incompatibility. I guess I'll fight that battle when it comes my way. The only invalid xm occurred with a pt with no detectable ABO isoagglutinins.

[AMcCord]

There is another thread going that has been discussing this - 'IS with AHG Crossmatch'. The tail-end of the discussion has an attachment of a 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 testiing should be cited as out of compliance with rule D5551. (Gel testing was specifically included in the answer.)

If your facility takes money from Medicare, you are required to meet CLIA requirements. Our CLIA inspections are done by the state. We actually had a visit from them (the state) - Surprise! - last year shortly after our CAP inspection. Apparently they pick a percentage of CAP inspections to follow up on to check up on how well the inspection was done and to make sure that the facility is CLIA compliant. The CAP inspection is supposed to be covering the CLIA issues (?? I guess??). So...that's what I know about it. We do, by the way, perform immediate spin crossmatches for all - including when we used gel.

[David Saikin]

If you look at that CFR section 21CFR 606.151 ©: it says NOTHING about IS xm. What it does state is that you have to have procedures to demonstrate compatability between the donor cells and the recipient serum/plasma.

[AMcCord]

If you look at that CFR section 21CFR 606.151 ©: it says NOTHING about IS xm. What it does state is that you have to have procedures to demonstrate compatability between the donor cells and the recipient serum/plasma.

You are right about that, but apparently Health and Human Services doesn't read the same words we can.

[Likewine99]

We have written our SOP to reflect that the truth tables in the computer system check for donor/recipient ABO compatibility at time of product selection and that if an inappropriate donor ABO unit is selected you will receive a warning.

In the event the system is down and you perform a gel XM you are required to also perform an IS XM as part of computer downtime SOP.

[LShirley]

When I first heard of this reg, I did some testing on random patient samples of all blood types. All good except for the Group B patients. Two Group B patients had detectable anti A1 in reverse type, but both were "compatible" with AB donors when tested in gel. I was very surprised at this.

I'm hoping to get away with stating that our LIS will not allow incompatible donor units to be allocated instead of having to perform IS crossmatches. The LIS is less likely to make an error than a human. We do AHG crossmatches on the ProVue for patients with alloantibodies. Otherwise, we use electronic crossmatch. Performing IS crossmatches leaves you open to a host of other problems like rouleaux, cold autoantibodies, etc that I would just as soon not know about.

[khalidm3]

There is no published data that LISS Coombs Gel Card detects ABO incompatibilities or it does not?

[Winter]

Since 21CFR 606.151© states that compatibility testing shall include:

c) Procedures to demonstrate incompatibility between the donor's cell type and the recipient's serum or plasma type., how can CLIA inspectors argue that a validated computer system that detectes incompatibility between donor and recipeint types doesn't meet this requirement?

[AMcCord]

Since 21CFR 606.151© states that compatibility testing shall include:

c) Procedures to demonstrate incompatibility between the donor's cell type and the recipient's serum or plasma type., how can CLIA inspectors argue that a validated computer system that detectes incompatibility between donor and recipeint types doesn't meet this requirement?

I know that they are applying it to folks who do a gel crossmatch (or other type of serologic crossmatch probably) without an immediate spin crossmatch.

I don't know one way or the other whether they are applying it to the electronic crossmatch - I wouldn't think it would be necessary there.

Edited December 30, 2010 by AMcCord

[rravkin@aol.com]

It appears froms the posts given on this thread that there is no clear understanding that Gel will reliably detect ABO incompatiblity; irregardless of private validation processes. Is there anything in the Gel insert that claims reliable detection of ABO incompatibility? If not then these regulations, which are in place to protect and give some assurance to patients and their treatment, are valid and should be followed through IS or Comp crossmatch in addition to Gel, which ever is acceptable.