QC antibody panels

[the kid]

Was given a deficiency at CAP inspection this week for not QCing expired ab panels. THought it odd that there is no mention to QC the current ab panel. Seems like just a leap of faith the the ab panel in use is what it is, uncontested.

I would like to challenge this ruling?

I have seen previous discussion on this matter.

Seems as if there are 2 schools of thought.

Anyone succesfully challenge this policy?

[L106]

I would ask CAP what Inspection Checklist Item # addresses this, then read the item carefully. Does it say anything about perforning QC on expired reagents/panels but not on indated reagents/panels?

Personally, I can kind of see where they are coming from (ie: you want to make sure the antigen in question is still viably reactive since the panel is beyond its expiration date.) However, I don't think I have ever encountered "loss of antigens" when using panels that were one and two months beyond their expiration date.

[LaraT23]

This is the specfic question that I have used when inspecting other facilities to justify needing to QC expired panel cells:

TRM.31250 Phase II N/A YES NO

Are all reagents used within their indicated expiration date?

NOTE: Rare reagents may be used beyond their expiration date if appropriate positive and negative controls are run each day of use and react as expected. This exception is permitted by the FDA. This does NOT apply to reagents that are readily available. The laboratory should establish criteria defining which reagents are considered “rare.”

Hope this helps.

PS if not considered "rare" you absolutely cannot use them beyond the expiration date.

[L106]

Thanks, Lara. Funny how I have always zeroed in on "rare reagents" as expired special antisera (and not given a lot of thought about a panel that's a few days beyond its expiration.) What I have always done in the past in to document on the expired panel worksheet that we were aware that it was expired and approved for use by the BB Supervisor. I now understand that if we use an expired panel cell to rule out Anti-E (for example), we should type that expired panel cells with Anti-E to assure that it reacts positively. However, we will still be unable to type the expired panel cells for many of the things we are trying to "rule out", since we don't have Anti-Lu(a), Anti-Kp(a), Anti-Cw, etc.

Interesting that no inspector has ever challenged us on this issue, but I will ammend our procedure so we will be in good shape for our next inspection. Thanks!

[Mary**]

That sounds awfully expensive and time consuming!:excited:

[keisterkid]

We did a study a few years ago that showed antigen integrity was maintained in our panels for 3 months post expiration (Immucor, Ortho and Medion panels). After 3 months the Duffy antigens and S antigen got remarkably weaker. A potential problem, we think, was that we were using commercially prepared antisera and not a human source that was "manipulated" to give a 2+ reaction with known antigen positive cells. We felt the data could be skewed because the commercially prepared would be the strongest reacting, not typical of a patient's antibody.

[shelleyk482]

You should definitely fight the deficiency. The supervisor at our sister hospital called CAP concerning this and the answer she got today was that QC was NOT required for expired cell panels. The person she spoke to said that personnally she thought it was a good idea but the standard was not intended to be applied to expired cell panels.

[Lcsmrz]

I use expired panels to select cells to increase my rule-outs or my confidence in a specificity. I would not use them as a sole determinant in a transfuse / don't transfuse situation.

I run "QC" on an expired panel for my own comfort, so I can sleep better at night, not because it's required.

[tbostock]

Have never used an expired panel, since they are "readily available". I have always interpreted the regs about using expired reagents to refer to rare antisera only. But the comment says that the Lab can determine what rare is, so I guess you could argue that.

[LaraT23]

Let me just clarify that the institution I was inpecting also did not QC their panels that were in use. Here, We run our CORQC antisera against the expired select cell to make sure there is no change in reaction strength. That is all. I like to make sure that a once 4+ cell has not become a 2-3+ cell. I don't really try to figure which reactions have petered out, I just don't use that one again.

So, my decison was recommendation on the expired QC and cited the dificiencty on the panels in use. So, hopefully that clears things up a bit.

[tbostock]

There is no regulation requiring QC on in use panels, correct?

[LaraT23]

Here is the CAP standard:

TRM.30000 Phase II N/A YES NO

Is there documentation of ongoing evaluation by the laboratory director or designee of all of the following?

1. Control results of routine procedures

2. Reactivity of reagents

3. Instrument function checks

4. Temperature records

NOTE: Quality control data must be reviewed and assessed at least at monthly intervals by the laboratory director or designee.

How can reactivity be reviewed if no QC is done

And the manufacturer insert:

CONTROL OF ERROR

1. A control consisting of the serum and autologous red blood cells prepared according to the ID-Micro Typing

System package insert should be tested in parallel with 0.8% RESOLVE Panel A. A positive reaction indicates

patient abnormality which must be resolved before the test results can be interpreted.

2. For quality assurance, 0.8% RESOLVE Panel A should be tested periodically with weak antibodies.

so there must be some QC done

[tbostock]

Oh, that explains it...I'm not CAP accredited. Thanks, Lara.

[Mary**]

The package insert only suggests testing with weak antibodies.

[bbbirder]

I know you are discussing CAP regulations, but I thought I'd toss in CLIA regs for panels (but this one doesn't cover expired):

§493.1271 Standard: Immunohematology.

(a) Patient testing.

(a)(1) The laboratory must perform ABO grouping, D(Rho) typing, unexpected antibody detection, antibody identification, and compatibility testing by following the manufacturer’s instructions, if provided, and as applicable, 21 CFR 606.151(a) through (e).

Interpretive Guidelines §493.1271(a)(1)

When condition level deficiencies in Immunohematology are in any or all phases of testing, use D5026.

There are no daily quality control requirements for reagent red cell panels used in antibody identification. Panel quality control is a combination of serological test results, such as: strength of reactions and patient phenotype; statistical probability, patient’s medical history; and laboratory standard of practice (i.e., how the laboratory handles compatibility testing for patients with unexpected antibodies). However, the QC requirements pertaining to new batch, lot, shipment of identification systems at §493.1256(e)(1) must be met.

[angelmed]

Let me just clarify that the institution I was inpecting also did not QC their panels that were in use. Here, We run our CORQC antisera against the expired select cell to make sure there is no change in reaction strength. That is all. I like to make sure that a once 4+ cell has not become a 2-3+ cell. I don't really try to figure which reactions have petered out, I just don't use that one again.

So, my decison was recommendation on the expired QC and cited the dificiencty on the panels in use. So, hopefully that clears things up a bit.

We have always use paralell testing to compare the results from one kit to the other. Recently, we started to also use the corQC serum when the kit was received and then when we needed to check the reactivity of the expired selective cells before using them. The package insert on the corQC does not mention what antibodies are in the contol. Today one of my cells from the new kit was negative with corQc serum. I am thinking maybe the CorQc dose not have an antibody to match any of the antigens in that cell. The paralell testing worked with that cell and it happened to be positive. Immucor has not returned my call. So , what do you think?

[LaraT23]

So strange how we got into a discussion about this and then I spoke to my staff and medical director and did some testing on my own.

What I found to change:

1. We use a diluted anti-D to do panel Qc once when they are received and once when they are withing 72 hours of expiration date. we use a 1:8 dilution so that we don't get hemolysis. Anything stronger and you will

2. We dropped CorQC and now make up our own using an ABP unit and the diluted anit-D mention just above. We then cross QC reagents ( i.e. use the Anti-A Qc'd with the ABP unit to then Qc both the A cell and the B cell, so that you have a negative).

3. For select cells, we also use a dilution of a single pos for which the cell is heterozygous, like an E,e cell will get a 1:3 dilution of the E sera for QC. That way we use less antisera, we are meeting the weak antibodies required by the manufacturer and we can tell if the hetero cell still picks up antibody after storage.

So thanks so much for the great discussion really made me think!

[Barbarakym]

I called Ortho, the supplier for our antibody panels. We are a small lab and have 1 gel panel and 1 tube panel IN DATE. Ortho replied to my question of if their panels were validated past expiration date (also says that in their pkg insert), why did they say QC was needed periodically and what that meant.

Their answer was that there was no way of knowing what happened to the reagent from when it left their place to when it arrived at our place and periodically did NOT mean day of use OR every day....but at any period you wanted to define. Since their worry was shipping, we have made it our policy to QC before it is put in use (which would be soon after arrival). On our expired panels we DO run the same QC on the day of use. This is written in our procedure. Rule outs are meant to confirm what we think we know and are never the SOLE basis of making decisions. Our IN-DATE panel is our main tool.

QC we run....again per ORTHO, is a WEAK antibody (as they specify) they recommended FYa. We run a panel ( FYa+ FYb+) cell with a dilute (1:20) anti- fya prepared from our in date Anti-Fya anti-sera. We do this on arrival and on any expired panel we use for select cells of any type.

The reasoning is this cell will be most likely to degrade first on that particular panel. We run only this reagent. Other cells we are rulling out we may not have anti-sera to (we have limited anti-sera, the most common C.S ones).

Other reagent integrity inspection is required...IE: not hemolyzed.

[goodchild]

Have never used an expired panel, since they are "readily available". I have always interpreted the regs about using expired reagents to refer to rare antisera only. But the comment says that the Lab can determine what rare is, so I guess you could argue that.

I agree, panels are readily available but the cells you get on them can vary greatly. The fact that not every panel has the R1R1 Fya- Jka- cell that you need or whatever can turn an expired panel cell into a "rare reagent" at my facility.

Edited October 1, 2010 by goodchild
grammars.