QC for ABID panels and the Joint Commission

[ElinF]

We were recently surveyed by the Joint Commission. She actually asked me why we don't QC our panels. I was at a loss for words, because I had just posted this question like a month ago and NO ONE said they QC'ed their panels. I actually gave her an answer that some of you guys gave and she seemed ok with that, but leery. She told me to check with our reference lab (which they don't either). We didn't get cited, but I was just surprised!

Anyways, thought I would share.

[ANORRIS]

What was your answer?

[LaraT23]

We do QC our panels. We do a mixture of c and D antisera and also saline on arrival and before we put it in use. Then we run the pos ( D and c ) 72 hours before it expires to confirm all cells still react at the same strength.

[ElinF]

Well, luckily I had posted this question on here a few months ago, and basically used what one of the members here posted.

I asked how we were to go about this, and are we supposed to test each cell for every antigen noted to confirm if they are really positive or negative for the antigen?? We know the system is in working condition because we are QC-ing that and we have never done QC on panels, nor do a lot of people, including our reference lab.

She seemed leery of that, and wanted me to confirm with the reference lab, but we did not get cited.

[ANORRIS]

We do QC our panels. We do a mixture of c and D antisera and also saline on arrival and before we put it in use. Then we run the pos ( D and c ) 72 hours before it expires to confirm all cells still react at the same strength.

What about all the other antigens in those 11 vials?

[LaraT23]

Luckliy the manufacturer says: For quality assurance, 0.8% RESOLVE Panel A should be tested periodically with weak antibodies.

So it seems to me that can be interpreted any way we would like.

[ANORRIS]

We use Ortho confidence control system to QC our screening cells. Can this not be used to QC the panel cells? Or has anyone tried them?

[ANORRIS]

Luckliy the manufacturer says: For quality assurance, 0.8% RESOLVE Panel A should be tested periodically with weak antibodies.

So it seems to me that can be interpreted any way we would like.

SURE DOES:)

[David Saikin]

I qc my panels when I put them into use . . . when I use outdated panel cells I qc them with a Positive and negative serum (actually Immucor's CorQc antibody diluted 1:10 or 1:20 (if 0.8% cells)).

[JOANBALONE]

I agree with Lara.

[Stoogiesfreak]

We had this come up in a CAP inspection also. I called CAP and was told that the antibody ID was considered an extension of the antibody screen and no QC needed performed. That was a few years ago, and things may be different, but is two subsequent inspections that answer was considered valid.

??

John

[Auntie-D]

We had this come up in a CAP inspection also. I called CAP and was told that the antibody ID was considered an extension of the antibody screen and no QC needed performed. That was a few years ago, and things may be different, but is two subsequent inspections that answer was considered valid.

??

John

All reagents for use MUST be validated daily - this includes panels. You are controlling the reagent's functionality not the method. This of it like a shop - you buy a potato and a cucumber at the same time - just because the potato is fine 2 weeks later doesn't mean that the cucumber will be...

[Stoogiesfreak]

Aunti-D -

Just relaying what CAP told me. I don't disagree that panels need QC, just stating what CAP relayed during an interpretation the CAP checklist question.

John

[ABQ bloodbanker]

We QC our antibody panels before use with a diluted anti-D and just confirm that all cells that should react do and those that should not react don't. Once the panel expires and we use it for selected cells, I require a positive cell to be run to ensure the cells are still reacting. I figure if the entire panel is being stored the same, and one antibody reacts, they all should... Not the perfect system, but there is no way to test everything...

[Auntie-D]

Aunti-D -

Just relaying what CAP told me. I don't disagree that panels need QC, just stating what CAP relayed during an interpretation the CAP checklist question.

John

Maybe the CAP person didn't understand?

[Sandy L]

For those in the USA and complying with CLIA standard 493.1271 (QC requirement for immunohematology), here is the CLIA interpretive guideline that I found and it addresses antibody identification:

§493.1271(a)(1) Guidelines:

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.

[rbayliff]

I had asked our reference lab how they QC'd their panels (each antigen?) and they pointed out that the manufacturer left it pretty open for interpretation, but they just used a weak antibody and ran a panel, proving that the panel was able to identify a known antibody.

[SMILLER]

Regarding inspections, we are more worried about the FDA than otherwise.

Has anyone actually looked at thier manufacturer's recommendations, or we all just assuming that they have "left it open for interpretation"?

We are using Ortho for gel and Immucor for tube AB ID, and both inserts say that the Panels "should be tested periodically with weak antibodies". I doesn't seem reasonable to interpret this as meaning that no QC need be done at all.

[mollyredone]

We are using Ortho for gel and Immucor for tube AB ID, and both inserts say that the Panels "should be tested periodically with weak antibodies". I doesn't seem reasonable to interpret this as meaning that no QC need be done at all.

I see what you mean. In the course of identifying patient antibodies, you will run across weak antibodies naturally.

[Barbarakym]

I called Ortho ( we use manual gel method). Their insert also says their panels are validated for much longer than expiration date. So I asked why they added the QC tested 'periodically' to their insert a few yrs back ( was not originally there). Their response to me is that they had no control of how it was shipped or stored. True. They also said periodic needed NOT daily. Or day of use.

So to follow ' periodically' a BB needs to define and follow only that they choose to define as periodic. Probably should justify this somehow in procedure. Weakest Ab in panel cell per Ortho is Fya/Fyb cell.

What I decided and justified in procedure: QC with Dilute Ab (1:10 or 1:20 to give no more than 2+ reaction. Tested against a Fya+ /Fyb + cell. If it is positive it is ok to use. I don't care if it does not react. I agree with CLIA interpretation. AB I'd is combination of much analysis. AB can only be ruled out with positive reactions.

After receipt of panel QC no further QC is done while in date. But once expired we use as 'rare cells' as used to rule out when in date panel does not have all the cells we need. Each out of date panel that is used is QCd per FDA and AABB ruled of 'day of use, exp reagents ok if QC is done day of use'. Again with a positive Fya/Fyb cell. Each expired panel. 1 wk Ab tested on day of use.

[John C. Staley]

Just being the devil's advocate here (I have been accused of being the Devil on more than one occasion).

So...... testing 1 cell for 1 antigen tells you that the other 9 to 15 cells are just fine for all of the antigens they are reported being positive for? I still contend that this is just smoke and mirrors to make someone think we are doing something worthwhile. I have to agree that if you are forced to do something like this by an inspecting/regulatory agency you need to figure out the easiest and cheapest way to make them comfortable.

[Malcolm Needs ☆]

Pithy and straight to the point as ever John - and, as ever, absolutely correct!

[Barbarakym]

Yes. The theory, per Ortho, is that if the panel is showing signs of degradation it will show up on the weakest cell first. They have validated panel extensively before shipping.

ABID is extremely subjective anyway. How many positives and negatives and separation of antibodies present is all up to individual lab. If you get a consistent pattern for a specific antibody showing on your daily QCd ABS reagent you are just confirming what is there.

My opinion anyway. So far not questioned by any inspector.

[Stoogiesfreak]

Hi Malcolm,

You ever think about moving to the States? We could use you!

Regards,

John

[Malcolm Needs ☆]

Bit too old now I think John.