1:4 dilution of anti-Fya on the day of putting into use and on the day of expiration...

We use 1:9 dilution of QC antisera (anti-D & anti-c) upon arrival / prior to use. "Periodically" and "weak antibodies" are way too vague...

Why can't they just be treated like the screening cells? Run a positive and negative control day (same that you use for the screen) of use.

21 hours ago, Eagle Eye said:

1:4 dilution of anti-Fya on the day of putting into use and on the day of expiration...

Continuing my earlier thread: That approach doesn't check those cells that are Fy(a-).

14 hours ago, pinktoptube said:

Why can't they just be treated like the screening cells? Run a positive and negative control day (same that you use for the screen) of use.

Are you suggesting that one tests every panel cell every day of use ?

16 hours ago, Christy Spence said:

We use 1:9 dilution of QC antisera (anti-D & anti-c) upon arrival / prior to use. "Periodically" and "weak antibodies" are way too vague...

Again, continuing my earlier thread: Rh antigens are very stable and may not be representative of deterioration of other antigens.

7 hours ago, exlimey said:

Are you suggesting that one tests every panel cell every day of use ?

Maybe test a cell of the panel and rotate it each day of use.

I'm not trying to be funny; but if Ortho requires the lab to QC the panel periodically why do the panels have an expiry date. I mean it has been pointed out in several threads that the manufacturers QC and stability testing and requirements must far exceed what a lab could do or be expected to do. Am I missing something?

3 hours ago, Ensis01 said:

I'm not trying to be funny; but if Ortho requires the lab to QC the panel periodically why do the panels have an expiry date. I mean it has been pointed out in several threads that the manufacturers QC and stability testing and requirements must far exceed what a lab could do or be expected to do. Am I missing something?

An interesting twist ! One could look at it that way.

Red cell products ultimately do deteriorate and that's why they must have an expiration date. Hemolysis is often the first visual clue. However, that doesn't mean that all of the antigens have suddenly become unrecognizable; it just means some of the older cells in the vial have popped. Studies have been published demonstrating that antigens remain stable many days/weeks after official expiration.

Manufacturers do have oodles of stability data - both static (in-house) and following shipping. Typically a unit of red cells that is turned into a red cell product has at least an eight-week expiration. This allows for manufacturing and shipping to the end users who then usually have five-weeks left on the expiration. In reality, those expiration dates could be longer, but the manufacturers deliberately give themselves a buffer period, just in case.

The wildcard in this whole process and issue upon which the regulatory agencies focus is shipping. How do the end users know that something horrible didn't happen to the material ? An unanswerable question. Even though the manufacturers have shipping stability data, they can't possibly foresee and test every odd, weird situation. One could argue that Ortho have less faith in their shipping process than other suppliers, hence the requirement for periodic QC.

We've written our policy to state that we run a "positive" cell on each panel we run each day.  For example, if we have Fya patient, then we run the patient sample on a FYa positive cell on each rule out panel run.  This way we are testing stability of panels throughout the life of each panel.  In addition, we are testing different antigens throughout the week because we are a large facility with lots of antibody identifications being done.   I know it seems a bit of a simple interpretation of the rule.  We are currently in our CAP inspection window, so hopefully this is acceptable to our next inspector. 

On ‎3‎/‎9‎/‎2017 at 6:20 AM, mollyredone said:

What we do is use the current cells for our QC for our antigen typing, using a heterozygous cell as a positive control for whatever antigen we are testing.  That seems periodic to me.

This covers 3% panel cells, but what about any 0.8% panels? We currently have 7 indated 0.8% panels and three 3% indated panels. We had to add additional panels to our standing order since we can no longer use out-dated panel cells!

1 hour ago, lehooke1 said:

 

On 3/9/2017 at 6:20 AM, mollyredone said:

What we do is use the current cells for our QC for our antigen typing, using a heterozygous cell as a positive control for whatever antigen we are testing.  That seems periodic to me.

This covers 3% panel cells, but what about any 0.8% panels? We currently have 7 indated 0.8% panels and three 3% indated panels. We had to add additional panels to our standing order since we can no longer use out-dated panel cells!

 

Do you perform all your antigen typing in tubes?  We validated our Fya and Fyb in gel, so that is what we use for antigen typing and QC'ing the 0.8% panel cells.

Yes, we currently perform all of our antigen typing in tube. Thanks for the clarification!

On ‎3‎/‎20‎/‎2017 at 7:51 AM, exlimey said:

Continuing my earlier thread: That approach doesn't check those cells that are Fy(a-).

we select Fya neg and Fya double dose cell to run with the dilution...to meet package insert requirement....

 

On 3/22/2017 at 10:30 AM, lehooke1 said:

 

Yes, we currently perform all of our antigen typing in tube. Thanks for the clarification!

 

You could also concentrate your 0.8% cells to 3% by using 4 drops of cells, spinning, decanting and adding one drop of saline, then test it in tubes.

15 hours ago, Eagle Eye said:

we select Fya neg and Fya double dose cell to run with the dilution...to meet package insert requirement....

 

Apologies in advance, I don't have Ortho package inserts handy. Does the insert actually suggest using an Fy(a+b-) panel cell?

Edited March 27, 20178 yr by exlimey
Clarification

On 3/27/2017 at 6:08 AM, exlimey said:

Apologies in advance, I don't have Ortho package inserts handy. Does the insert actually suggest using an Fy(a+b-) panel cell?

What is your process for panel QC?

23 hours ago, AMcCord said:

What is your process for panel QC?

Don't do any. I use panels, but I don't work in a clinical laboratory.

On 3/9/2017 at 2:07 PM, exlimey said:

Unfortunately, I'm not surprised. I would consider myself lucky to get an inspector who even knows blood groups.

I always wonder whether the CV of test would qualify as the test for element of uncertainty.  We do not have that in USA.  I've asked aeround and no ones seems to even know what I am talking about.

2 hours ago, exlimey said:

Don't do any. I use panels, but I don't work in a clinical laboratory.

You wouldn't get away with that now in the UK.  The accrediting people have got more and more severe, and would quite happily take your legs off at the knees now (figuratively speaking)!

1 hour ago, Malcolm Needs said:

You wouldn't get away with that now in the UK.  The accrediting people have got more and more severe, and would quite happily take your legs off at the knees now (figuratively speaking)!

Perhaps some clarification is in order. I'm in the US but am not subject to the clinical regulations that apply to hospitals and blood centers that do clinical work on patients (or donors). Those regulations, often with the addition of local/state riders, are "enforced" by a number of government entities and surrogates.

My facility is not "accredited" by any agency, but instead we are licensed by the FDA for the specific work that we do. The FDA inspect us (as well as our internal auditors) using a completely different set of criteria.

Without getting into the details, we were told by a CAP 'inspector' that we must run QC on the panel, that using the QC results from our Antigen Typing QC doesn't count.  So, we started running the full panel with reagent QC Antisera upon receipt.  n.b. The 'Lab General' section of CAP, which BB is bound to as well, states that QC must be done on EVERY reagent upon receipt.

THEN, two years later for the next CAP, the 'inspector' tells us to 'stop this, it is non-sense!'.  *^&%)W%*

We didn't ... because of that 'Lab General' rule.

After reading all your replies and ideas, I think I'm going to revise our 'QC' to testing a few cells (rather than all of them) with diluted antisera, Fya+b- and Fya-b-, including the Ficin panel. 

Keep talking ... we need a 'standard' thought about this!

I called CAP about this subject about 2 years ago (Specifically- TRM.31250 and COM.30450)

1. I was told first to follow manufacturer's package insert. We use Immucor and my way of thinking, MAY do QC doesn't mean HAVE TO. I could argue with an inspector.

2. I asked what should we do to a new set of panel cells to meet CAP standards. I was told you must document visual inspection of shipping conditions. Did the panels arrive under cool conditions, was the shipping container damaged, do they appear hemolyzed, etc. No other QC must be performed before use. Since we use these panels as pos and neg controls through out the life of the panel, this can be used as QC. I had a form of incoming reagents, I added a column to address shipping conditions as acceptable or unacceptable with a blip at the bottom about what is acceptable or not to cover my bases. I added a column to my Ag typing form to add the panel # used for positive and negative controls.

3. I asked about QC on expired panel cells. These are considered as rare and only used for complicated ID. Use in-date first and only use expired if in-date panels are not sufficient. No QC is required on expired panels, however the panel cell must be acceptable (not hemolyzed). I was sited for using expired panels 2 CAPs ago and it was expunged.

4.I also asked about IQCP on panels on same call just to make sure. NO IQCP is necessary. (This was back when IQCP was new and nobody knew what was going on)

She stated that all of this had to be written in your policies and procedures and there must be documentation of being done. She said the difference is antibody detection and antibody identification. Detection systems (screening cells) must have QC done on day of use. Antibody identification (panels) are different and do not require the same level of QC. It sounded very reasonable.  

I called a different time and asked about comparison of new lot numbers specifically of all antisera. I was told then that we did not have to compare old lot numbers to new lot numbers because we do QC on each day of use. The QC must pass or the antisera can't be used. Again documentation. You didn't do it if you didn't write it down.

 

i cannot remember we do in-dated panel cells QC in the reference lab use antiserum . Just as Debbiel mentioned the panel cells must be visually qualified.

we use them to do antibodies identification, then get the result, use reagent antiserum to confirm the antigen is absence on the auto cells if DAT is neg( if we have those reagent), then use two antigen pos cells and two antigen neg cells to confirm the antibodies again.

the panel cells express a lot of antigens , some of them are rare and it is hard to get the specific antiserum, i think it is hard to QC those antigens during the life span of the panel.