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QC on Panels


Kathyang

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As of right now we do not QC our panels, we have both Gel and Tube panels and we do QC out gel and tube screening cells.

 

I went through our different manufactures panel IFU I have the following questions and thoughts.

 

Ortho says "should be tested periodically with weak antibodies"

 

1)  What is periodically?  Defined as repeatedly at regular time.  Is this once for each panel?  or one a day, week, month or year? Or what?

2) Weak, how weak 1+?

3) Antibodies - how many, all of them?  Only clinically significant or what?

 

Bio-Rad says "Suitable controls should be included in each test run."

 

1) Each test run?  Meaning with each panel run?  That could be a couple times a day....

 

Immucor -  Says “the reactivity of the red blood cells may be checked periodically by testing antigens likely to deteriorate, such as Lea, with a weakly reactive antibody of the same specificity.

 

Still says periodically but is more specific about the antibody.

 

Quotient-Alba says "Quality Control is essential and should be performed in accordance with local, state and federal regulations.

 

This one is wide open

 

 

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OK, I bit the bullet and asked CAP:

 

 

For COM.30450, the intent is to check a new lot and/or shipment of reagents before use in patient testing in order to confirm that proper shipment conditions were followed (to the best of the lab’s ability), and that the new lot of reagents gives the same results that your old lot did. This applies to all reagents, routine and rare. As COM.30450 includes below, external QC materials tested on the previous lot, and compared to the same material tested on the new lot, is acceptable. Reagent cells can be tested against an antibody of known reactivity; again the intent being to be sure the level of reactivity with your new lot is within acceptability to the reactivity of your old lot.

 

 

Question: What does my laboratory need to do to QC antibody panel cells when they are received?

 

Answer: Antibody panel cells are considered critical materials in a transfusion service. Laboratories must follow the requirements in TRM.312441 stating, “New lots of reagents and critical materials are inspected and tested, as applicable, before use, with documentation of acceptance”.

 

The inspection of the reagent involves a visual assessment to check for hemolysis or signs of contamination. The findings must be documented on a inventory log or other quality control record. Quality control of a new antibody panel presents a challenge because it is not feasible to check the reactivity of each antigen on each panel cell. In addition, antibody panels have a short expiration date and many laboratories order multiple panels to ensure that they have sufficient selected cells available for ruling out antibodies. An antibody panel is an investigational tool used to identify the specificity of red cell antibodies and is never used alone when interpreting the results. In addition, laboratories follow defined rules for confirming or ruling out antibodies on the panel, including comparing the results from the panel with the patient’s antigen typing for the antigen of interest, the antibody screening results, patient history, and additional special studies when indicated.

 

For quality control, the laboratory must follow procedures for interpreting the results and follow the manufacturer’s instructions for quality control, at minimum. While not ideal, the laboratory may also use the following processes to check the reactivity of the panel cells:

 

- Confirm the reactivity of one or more panel cell using a reagent antisera or a dilute antibody

 

- Select a known positive and known negative panel cell as the controls when performing an antigen typing

 

- Run a panel with a known antibody prior to use

 

 

- Since the red cell panel is an investigational tool to identify the specificity of red cell antibodies, labs can show that when they confirm the patient for the corresponding antigen and select a known positive and known negative panel cell as the controls, if the positive and negative cells react as they should, the lab would be satisfying this requirement.

 

I hope this helps.

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You got it, Dr. Pepper!  I was cited for this (COM 30450) during my CAP Inspection last fall!

 

We are now performing this "QA" on all incoming RBC panels by testing them with dilute antisera (originally the ALBA-QC antisera, I may change that after reading this and another set of discussions), recording on a perpetual worksheet so it's easy to compare 'old lot to new lot'.  This passed CAP approval.

 

We don't use outdated panels so no "QA" on that end.

(Yes, the quotes are there on purpose.)

I better shut up now.

 

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Interesting: BioRad just changed theirs to say:

For quality assurance the Biotestcell Reagent Red Blood Cells intended for antibody identification should be tested according to any site specific procedures.

And Immucor says "....the reactivity of the RBC may be checked periodically by testing antigens likely to deteriorate, such as Lea, with weakly reactive antibodies of the same specificity. If such antigens are found nonreactive, the product should not be used." Huh, good idea. What about the antigens that we do care about?.

 

I look at the "may", as opposed to "must" or even "should", as meaning this is entirely up to you.

Edited by Dr. Pepper
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  • 1 month later...

Guess what TJC is on it's third day of inspection in our facility and I just got cited for using specific panel cells from expired lots. I did argued that we do QC those expired panell cells but she said it does not matter because the reagent is still expired. So I guess we do have to send out all our ab ids now to our reference lab and let patients wait. 

 

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Me too - definitely challenge - Where do your inspectors come from - Mars? Haven't they worked in the real BB world with all its lovely quirks n jerks. Surely the ID is done to be able to get antigen negative red cells (Sometimes says you) - and these are then crossmatched  against the recipient to ensure compatibility by whatever test/s they are reacting in. If that ain't safe - it's time to take my teddy bear and depart. 

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Guess what TJC is on it's third day of inspection in our facility and I just got cited for using specific panel cells from expired lots. I did argued that we do QC those expired panell cells but she said it does not matter because the reagent is still expired. So I guess we do have to send out all our ab ids now to our reference lab and let patients wait. 

we were cited for same by CAP, were not even running QC on expired panels.

We challenged it. Send response that we only use expired panels to rule out antibodies when we do not have cells from current panels. (eg. in the presence of anti-e or anti-c. we run atleast one e+ or c+ cell from expired panel). It was acceptable. 

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That rather surprises me Eagle Eye, as you are relying on the fact that the antigen on the expired red cells, with which you are ruling out, has not been proved to still be adequately expressed - and most grouping reagents, which could be used to prove this, are far, far stronger than human antibodies.

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  We are inspected by TJC for the lab. They are citing some of the other hospitals in the system using this standard.

 

QSA.05.06.01  The laboratory conducts reactivity testing on the potency and reliability of reagents used for ABO grouping, Rh typing, antibody detection, and compatibility determinations.

2  Each day the procedure is performed, and when a new lot of reagents is first used, the laboratory tests each opened vial of antisera, reactive cells, and reagents for reactivity. The reactivity results are documented.

 

   I guess it depends on the inspector but since we are inspected this year I would like to comply if they are really citing labs.

 

This topic comes up here from time to time.  The issue here (to me anyway) is not whether there is a specific QA standard for AB panels in BB, but whether or not the GENERAL rule about following manufacturer's instructions applies.  Because every package insert I have ever seen says something about periodic QC for AB panels, (as Laurie points out, above).

 

I would be interested to know if anyone else has had a problem with this.  We are FDA and JCAHO inspected and it has never come up here.

 

Scott

In our last JCAHO inspection, this was pointed out by the inspector. That being said we now do QC on the panels when we receive it or before we use it for testing patients and Mid-month (12-16th of the month), since the manufacturer's insert states that it should be tested periodically. Ab Screening cells we test everyday for negative, weak and positive QC.

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We run a pos and neg with dilute anti-K when received and each day of use. Doesn't take much effort and it has passed several very picky inspectors.

 

If using an outdated panel, we run the same routine panel QC, but if a cell is being used as a primary rule out it is supposed to be tested with antisera (we are ID'ing routine type antibodies, not the fun stuff) and be reactive 2+ or greater. Again, it keeps inspectors mollified, if they are inclined to be picky.

Edited by AMcCord
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In our last JCAHO inspection, this was pointed out by the inspector. That being said we now do QC on the panels when we receive it or before we use it for testing patients and Mid-month (12-16th of the month), since the manufacturer's insert states that it should be tested periodically. Ab Screening cells we test everyday for negative, weak and positive QC.

 

I would argue the semantics of antibody detection (screening cells) vs antibody identification (panels). CLIA says something along the lines of, you don't have to do panel QC but follow manufacturer's instructions.

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For those doing QC,  Say you use a Fya to QC

 

1)  Are you QC'ing all 11 cells, or selected positive and negative cells?

2)  If you have more then one panel / method are you QC them also?

 

We are not QC'ing panels yet, we have Ortho C (regular .8% and ficin), and B panels, and a tube panel.  We have a single tech on dayshift, one on second and third shift is a Hemo/BB tech.  I am trying to figure out how we would do this QC daily, and not use up the cells before the panels expired.

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For those doing QC,  Say you use a Fya to QC

 

1)  Are you QC'ing all 11 cells, or selected positive and negative cells?

2)  If you have more then one panel / method are you QC them also?

 

We are not QC'ing panels yet, we have Ortho C (regular .8% and ficin), and B panels, and a tube panel.  We have a single tech on dayshift, one on second and third shift is a Hemo/BB tech.  I am trying to figure out how we would do this QC daily, and not use up the cells before the panels expired.

 

We would use the anti-Fya to QC the cell we are using as a primary rule out. If the reaction is 2+ or greater, the patient results is acceptable. If not, then the result is not valid.

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You got it, Dr. Pepper!  I was cited for this (COM 30450) during my CAP Inspection last fall!

 

We are now performing this "QA" on all incoming RBC panels by testing them with dilute antisera (originally the ALBA-QC antisera, I may change that after reading this and another set of discussions), recording on a perpetual worksheet so it's easy to compare 'old lot to new lot'.  This passed CAP approval.

 

We don't use outdated panels so no "QA" on that end.

(Yes, the quotes are there on purpose.)

I better shut up now.

 

 

Just a question - what does a Perpetual worksheet look like?   Would you be willing to post yours?  May just be semantics, but that one threw me.

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For those doing QC,  Say you use a Fya to QC

 

1)  Are you QC'ing all 11 cells, or selected positive and negative cells?

2)  If you have more then one panel / method are you QC them also?

 

We are not QC'ing panels yet, we have Ortho C (regular .8% and ficin), and B panels, and a tube panel.  We have a single tech on dayshift, one on second and third shift is a Hemo/BB tech.  I am trying to figure out how we would do this QC daily, and not use up the cells before the panels expired.

We do one cell from each panel daily.  We rotate cells everyday, so essentially, each cell gets done about 3 times a month.

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I searched a CLIA site and found this from the following site:

 

 

State Operations Manual

Appendix C - Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services

Table of Contents

(Rev. 140, 05-29-15)

 

(493.1271)

There generally are no daily quality control requirements for reagent red cell panels used in antibody identification. However, we encourage laboratories to follow the manufacturer’s recommendations for QC.

 

I printed this part so if an inspector tries to to say I HAVE to do QC I can show this. I think the red was what was revised in May 2015. I want to do what is good for the patient but I don't want to go overboard and use up all my panel cells trying to satisfy a nebulous requirement.

 

I use Immucor and the manufacturer's insert says "the reactivity may be checked periodically with a weakly reactive antibody." (??) MAY doesn't mean the same as HAVE TO. We get hung up on every word of standards, why not the package insert too?  After reading what Dr. Pepper wrote when he talked to CAP, I included a column on on our antigen typing form to add the panel lot # since we use panel cells for antigen controls. They should work as expected to show the panel is QC'd multiple times weekly. (Thank you Dr. Pepper, it was an easy fix)

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I searched a CLIA site and found this from the following site:

 

 

State Operations Manual

Appendix C - Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services

Table of Contents

(Rev. 140, 05-29-15)

 

(493.1271)

There generally are no daily quality control requirements for reagent red cell panels used in antibody identification. However, we encourage laboratories to follow the manufacturer’s recommendations for QC.

 

I printed this part so if an inspector tries to to say I HAVE to do QC I can show this. I think the red was what was revised in May 2015. I want to do what is good for the patient but I don't want to go overboard and use up all my panel cells trying to satisfy a nebulous requirement.

 

I use Immucor and the manufacturer's insert says "the reactivity may be checked periodically with a weakly reactive antibody." (??) MAY doesn't mean the same as HAVE TO. We get hung up on every word of standards, why not the package insert too?  After reading what Dr. Pepper wrote when he talked to CAP, I included a column on on our antigen typing form to add the panel lot # since we use panel cells for antigen controls. They should work as expected to show the panel is QC'd multiple times weekly. (Thank you Dr. Pepper, it was an easy fix)

 

Semantics are very important. May is optional. Should is equivocal. Must is a requirement.

 

I'm still trying to weed through several old procedures that have inappropriate uses of 'may'/'should' when they're really 'must'.

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Yeah, we used to pipette by mouth and do "sink diffs" too, but times change. 

 

I do agree that accrediting organizations need to give more direction on this one issue though.  With the fees paid to organizations like JCAHO and CAP, it would seem like there has to be some responsible person, knowledgable about actual Lab conditions, who could come up with a sensible, well-defined standard for QC on panels.

 

I mean, don't they keep up with the discussions on PathlabTalk?

 

Scott

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