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CMCDCHI

Daily Reagent QC requirements

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CAP states:  "There are records of acceptable reactivity and specificity of typing sera and reagent cells on each day of use, including a check against known positive and negative cells or antisera, or manufacturer's instructions for daily quality control are followed."  Immucor package inserts for several reagents do not include instructions for a negative control.  Do we follow what Immucor suggests or add in a negative control too?  We currently test antisera against eachother for our daily QC, but are considering changing to Immucor corQC, but noticed there is no negative control for some reagents.  For those of you using corQC, how do you address this?  thanks!

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We keep 3% screening cells as well as our 0.8% screening cells. Most of the time our 3% screening cells suffice; however, on occasion, we find a cell negative for the anti-sera we're using on one of our panels or expired panels. Hope that helps!

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We do not run a negative control unless specifically instructed to by the package insert.  We use corQC and haven't had a problem, the only individual reagent that we have that even recommends a negative control is the anti-D.

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Just be wary -- a particular manufacturer's insert may not state that you need to run a particular control, but if your regulator requires one, you better have a better excuse than "they do not tell us to do it".  Inspectors always consider manufacturer's directions as minimum requirements. 

Scott

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We got cited on this for not running negative controls on Anti-A, Anti-B and Anti-AB, but  I challenged it because it states "including a check against know positive and negative cells or antisera, or manufacturer's instructions for daily quality control are followed."

The citation was removed.

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on some of the immucor that does not require a negative QC, I have thought about this and I think it is because for example when you do a negative tube screen you would use check cells to QC the negative result which is inherent in the test.

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We were cited by CMS for not having negative control for Anti A, Anti B, Referencecells and Selectogens 1-3.

We had just had our AABB/CAP inspection with no issues and felt we followed Immucor package insert. 

I would add negative QC because it is simple and I could not win the battle

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I switched us to the Quotient QC kit for tube testing. It gives you a negative control for anti-A, -B, -A,B and -D. I freeze aliquots of AB plasma from patients for a negative control for A and B cells. My negative antibody screen control is a sample run the previous day on the Echo that had a negative screen - and it also serves as part of method comparison for antibody screens.

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On ‎10‎/‎24‎/‎2017 at 1:52 PM, CMCDCHI said:

Thanks for your responses!  I asked at AABB and was told that the CFRs require a negative control.  

Did they say where in the CFR?

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Oh dear, whatever happened to common sense?

If you are testing  an antibody screen, for example, why do you need a negative control?  The majority of your samples will give a negative result.  So you know that the negatives are working.  But you DO need a positive control to make sure  that the reagents are working.  similarly, if you have an anti-k reagent, where are you going to get a k-neg cell to use as a control each time (in a normal lab)?  For ABO, if you have an A, a B and an O you have covered everything, even the reverse group, as with the A and the B one of the reverse group cells will be negative each time.....

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Really, then you don't run an auto-control with new AB Pos patients becayse A, B and O cover "everything".

Its going to come down to what your regulator pulls up regarding whatever standards they use: FDA, CAP, etc.  Granted, some of them do not make sense when you think of "science" stuff like serology and phyisiology, but you have to pass those inspections! 

Has anyone ever talked an inspector out of something that they have a standard for?

Scott

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if your laboratory is CLIA licensed, as most labs in the US are, you are required to follow the CLIA regulations.

The CFR requires a negative control. It is found in the CLIA regulations 42 CFR 493.1256 Standard: Control Procedures. 

42 CFR 493.1256 (c)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section.

(d)(3) At least once each day patient specimens are assayed or examined perform the following for -
(i) Each quantitative procedure, include two control materials of different concentrations;
(ii) Each qualitative procedure, include a negative and positive control material.

Further down in that section, there are requirements to test controls before resuming patient testing when a complete change of reagents is introduced... to rotate control material testing among all operators who perform the test, and to test control materials in the same manner as patient specimens.

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On ‎09‎/‎29‎/‎2017 at 12:21 PM, Kim D said:

We were cited by CMS for not having negative control for Anti A, Anti B, Referencecells and Selectogens 1-3.

We had just had our AABB/CAP inspection with no issues and felt we followed Immucor package insert. 

I would add negative QC because it is simple and I could not win the battle

Classically the Feds have only required positive controls with the exception of anti-D QC which also requires negative controls.  If you go into CFR used by CMS you probably will find that they require a pos and neg control for all moieties being tested.

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7 hours ago, galvania said:

Oh dear, whatever happened to common sense?

If you are testing  an antibody screen, for example, why do you need a negative control?  The majority of your samples will give a negative result.  So you know that the negatives are working.  But you DO need a positive control to make sure  that the reagents are working.  similarly, if you have an anti-k reagent, where are you going to get a k-neg cell to use as a control each time (in a normal lab)?  For ABO, if you have an A, a B and an O you have covered everything, even the reverse group, as with the A and the B one of the reverse group cells will be negative each time.....

Daily QC kits include antisera for a positive control. For purposes of method comparison I also run a specific number of positive antibody screens from the Echo by tube using all the testing methods we utilize (LISS, Peg, and saline AGT).

 

When I was a student, I won't say how long ago, we had a plexiglass rack that held in excess of 40 tubes that were used for blood bank QC. Then over time the number of tubes needed for QC dwindled down to a single handfull. Now we are headed back in the other direction. My QC currently requires 27 tubes, but I just passed an inspection, so it's all good...I guess.

Edited by AMcCord

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