QC of manual-tube panels- a poll

[Karrieb61]

I am taking a poll- what do you do to QC current (not expired) panels? We have a procedure currently that calls for one panel cell to be checked against an IgG sebsutuve antisera  and one panel cell to be checked against an IgM sensitive antisera weekly as a check for "deterioration of the panel". Curious as to what you do. Thanks

[Karrieb61]

OK, maybe never mind on this. I should have trolled through this site first and just found a discussion from 2009 that addresses this. However , maybe someone knows of a newer standard that requires a weekly check on panel cells (as random as it may be?)

[R1R2]

OK, maybe never mind on this. I should have trolled through this site first and just found a discussion from 2009 that addresses this. However , maybe someone knows of a newer standard that requires a weekly check on panel cells (as random as it may be?)

 No new standard that I know of. I would drop this practice. 

[Auntie-D]

We do a Fy(a) control on the first panel of the day using 3 positive cells and we do a Fy(a) positive and negative control with every panel we do.

[Karrieb61]

Anyone else? Thanks

[ElinF]

We perform QC with our Positive QC reagent (ortho confidence) on receipt of the new gel panel.  We only perform QC on the tube panels if we need to use a cell for rule out. 

[Karrieb61]

ElinF, does this mean that Ortho sells a specific product to test all the cells in your gel panel? If there is no standard for this, are you doing it only because you feel better if you do or have a medical director who requires you to? Just curious. We end up performing  QC of sorts of specific panel cells when we do antigen typing of patients and donors using specific panel cells as our pos or neg control. We do several of these a month on various panel cells with various antigens. Seems to me that if an inspector asked about this, we would have proof of doing a "periodic" check of the cells per the manufacturers insert (which is not a requirement anyway).

[Dansket]

The ORTHO Confidence Antibody contains anti-D and anti-c. So it will test all the cells in a panel. We use it to QC the panels on ProVue.

Edited December 22, 2014 by Dansket

[Karrieb61]

Thanks Dansket, we don't have Ortho Gel but its nice to know what's out there

[David Saikin]

I qc my 3% cells with a positive control in gel, as that is the modality I use.  Rarey will I set up a tube panel.  I use Immucor's CorQc antibody diluted 1:20 but am considering using it at 1:100.  Wating to get cited for not running a negative.  I have been qc'ing panels this way for over 30 yrs. (running only with a postive serum).

Edited December 23, 2014 by David Saikin

[tbostock]

We run a diluted antibody for the antibody screen.  We also perform a negative control.  We do this for all methods (tube, gel, solid phase) that we use.

 

We do not QC each panel; it is not required by the regulatory agencies.

[David Saikin]

Terri - I wonder at the wording in the CAP Standards esp the words reagent red cells. . . of course they go on and directly state antibody detection cells but it would be tough to argue out that abid cells are NOT reagent cells.  Just a comment.  I agree with you.

[cthherbal ☆]

I have worked in 7 hospitals over my career (US) and only 1 of 7 hospitals ran a K+/K- panel cell (with anti-K antisera) upon receipt.

 

We do not QC panel cells- here is my rationale:

 

Antibody detection (screening cells) are QC'd daily. Antibody Identification (Panel cells) are essentially QC'd each time you perform a panel (your patient sera/plasma serves as your QC) as you typically have positive and negative cells for rule in/rule out. Any patients reacting with all panel cells we send to a reference laboratory for ID. If you truly QC'd panel cells you would have to do each antigen (pos and neg) to prove all panel cells are viable for any patient that may come along, with any antibody specificity, within that 4-6 week period that the cells are being used. We do not carry all the antisera in our inventory. Does anyone has the time (or resources) for this? An exception is if you use expired panel cells (for rule outs), pos and neg cells (again patient or antisera can be used) must be tested per CAP to prove panel cells are still working properly for that particular antibody. 

 

-Colleen Hinrichsen

[Auntie-D]

Cthherbal - GMP states that QC must be independent. You cannot state that a postive patient equals a confirmed control. Controls prove that there is a result to a certain titre and the sensitivity of the cells are not decreasing - we should be recording the reaction strengths and comparing to ensure reactivity isn't decreasing. Whether this is a requirement or not matters nothing to me - it is good practice. It will eventually change when an inspector picks up on it nationally.

[Sandy L]

_{If in the U.S., here is from CLIA regarding QC of panel cells:}

 

 

_{§493.1271(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. Negative}

 

_{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.}

 

Edited December 26, 2014 by Sandy L

[cthherbal ☆]

Thanks, Sandy L. So, if our antibody ID system is gel, then QC is performed daily.

[JHH1999]

As a reagent manufacturer one of the requirements is to ensure products work as intended over the shelf life of the product when in the end users hands. This includes ensuring the product is able to withstand shipping. Manufacturers perform stability testing of these products to a greater extent than most end users would be cabable of repeating. This would include making sure red cells antigens are viable. Daily QC of red cell panels by the end user is not necessary in my opinion and a waste of time and resources.

[SMILLER]

I think the only real question for AB panel QC, no matter how it is or is not done, (or whether or not it is a waste of time), is: is it necessary per regulations? 

 

In the US, whether or not CAP or JCAHO has a specific standard on the AB panel QC issue, the key regulatory phrase for ANY Lab QC requirement is :  _{following the manufacturer’s instructions}.  So I think all most of us need to do is check the inserts with your particular products.  If you are somehow satisfying that for recommended QC, you should be OK.

 

Scott

[mollyredone]

_{I agree with Scott.  A CAP inspector tried to cite us for not doing negative controls with our A,B antisera, but we showed the package insert and it is not required.  It is required for Anti-D.}