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DH41785

Use of expired panel cells

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Hello Blood Bank World,

I am having a tough time figuring out the requirements to be able to use expired panel cells as part of a workup. I started as supervisor at my current place of work less than a year ago and I cannot find any mention of or documentation that expired panel cells are appropriate or what steps to take in any procedure. Currently, the techs are using expired panel cells. They are antigen typing the cell for Fya antigen to prove the cell is reactive with an antigen that is known to be less stable with length of storage.

Where I worked before, we had to antigen type the out of date cell for the antigen that we were using the cell to rule out. EX: Using cell to rule out M in the presence of Anti-S, type the cell for M antigen to prove that the specific antigen is still reactive on the expired cell. This option makes more sense to me.

Does anyone know which way is correct? I'm currently updating the procedure to write it in officially. Also, I've seen mention of a validation needing to be performed, does anyone know what kind of validation, if any, is necessary? I have no record of validation being performed either.

HELP!

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CAP All Common 30400 was recently revised;  Transfusion service laboratories may use rare reagents (ie, rare antisera and selected panel red cells to determine the specificity of red cell antigens and antibodies) beyond their expiration date if appropriate positive and negative controls are run each day of use and react as expected. The laboratory must have in-date reagents for routine antigen typing and antibody panel testing.

I suppose the validation could document how long those cells could be used past expiration...a week; two weeks, etc.

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Good morning- I have always followed the CLIA / CMS / CFR guidelines, which requires us to follow the manufacturer's instructions. When you read the inserts, the reagents we are using clearly state do not use beyond expiration. I don't consider expired panel cells to be acceptable, as many QC for reactivity, but don't test for each antigen trying to include or exclude. It is an old practice, the same as not QCing upon receipt, and noting reactivity of any kind to show acceptable performance. We have not had any additional expense nor identification issues with using in dated reagents in our Transfusion Service. I have trouble not citing folks when I see old outdated panels filling banks on inspections. 

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People have long used expired antisera and panels.  You just need to run controls.  Which brings one to the question....what are appropriate controls?  That has never been clearly defined.  Some people antigen type the cells tested for the antigen(s) for which they are using the cell (i.e. if using it to rule-out Anti-E, they type it for E to make sure it is still reactive).  I was taught a variation on the theme.  That is, to run a  Positive Control Cell, which is a cell that is positive for the suspected/ known antibody and which reacts then at the same strength.  For example, let's say you suspect the patient has Anti-Jka (that is what another panel seems to indicate) but you need to run a cell on another panel to rule-out Anti-E (so a Jka-E+ cell).....your control cell would be a cell that is Jka positive and it should then react at the same strength as the Jka positive cells you have run on another panel.  

So, a couple of possible options.....again, CAP just says controls have to be run, but does not clarify what those controls should be.

Brenda Hutson, MT(ASCP)SBB

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Brenda,

So glad you gave some possibilities about how to QC an expired panel. We actually have been doing something similar for several years. In your example, when we needed to use an expired panel to rule out E we would use the patient's plasma with a Jka+E= panel cell to prove the panel would detect the antibody we suspected as proof it was viable to use. Looks like it would be just as easy to use Jka antisera and officially meet the standard. 

I groaned when I saw they revised the standard because, at first glance, I thought we would have to QC the antigen we were trying to rule out or in and we don't have all rare antisera listed on a panel. I like the way you think about how to meet the standard but still have some wiggle room. Wiggle room is always a good thing

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Well, not sure the wiggle room is "right" since no one has said anything specific, other than run positive and negative controls.  So just throwing out some methods I have used in various places throughout the years.  If you use the antisera method, you could easily run a positive and negative control cell for the antigen you are trying to detect or rule-out.  In the other method, the cell with the known antibody would be your positive control and the rule-out cell would be your negative control (provided it was in fact negative).  

Brenda

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On ‎6‎/‎22‎/‎2020 at 3:00 PM, DH41785 said:

Hello Blood Bank World,

I am having a tough time figuring out the requirements to be able to use expired panel cells as part of a workup. I started as supervisor at my current place of work less than a year ago and I cannot find any mention of or documentation that expired panel cells are appropriate or what steps to take in any procedure. Currently, the techs are using expired panel cells. They are antigen typing the cell for Fya antigen to prove the cell is reactive with an antigen that is known to be less stable with length of storage.

Where I worked before, we had to antigen type the out of date cell for the antigen that we were using the cell to rule out. EX: Using cell to rule out M in the presence of Anti-S, type the cell for M antigen to prove that the specific antigen is still reactive on the expired cell. This option makes more sense to me.

Does anyone know which way is correct? I'm currently updating the procedure to write it in officially. Also, I've seen mention of a validation needing to be performed, does anyone know what kind of validation, if any, is necessary? I have no record of validation being performed either.

HELP!

As you see from the posts here, there are various opinions of what to do. 

Correct =The regulatory agencies do state to run some sort of controls, etc. 

You are in charge, therefore you do what you believe is best within the guidelines when there are gray areas like this.  If you believe you should change the protocol to 'QC for the Antigen', then do that.

Validation?  You have criteria, I'm sure, for the cells passing inspection for use.  I venture to say that most hospitals don't keep reagent RBCs more than a month or two past their outdate.  It would be interesting to hear about that.  If you are running QC for the tested antigen 'Day of Use', that's your validation that the cell is still working for your purpose.  (I maintain that 'validation' is needed for situations where QC is not going to be run, e.g. You validate the time a box will hold a temperature so you don't have to take the temperature every time.)

We do validate that a new panel is ok by running QC Antisera with them when they arrive.  I've had inspectors tell me I must do this and I've had inspectors tell me to stop.  Hmmm … I do what I am comfortable with, i.e. err on the side of caution.

We don't use outdated panels … too many issues. 

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We do not perform QC on our panel when they arrive and haven't gotten any issue with the inspection.

We keep our expire panel of 10,16 and 20 cells for like 3-6 months to use for those rare rule in/out.  Antigen typing is performed on selected cell that we trying to rule in/out for the specific antigen. Recently last year, we decide that panel expired within 1-3 months did not need to be antigen type but it is still a bit of a gray area. When in doubt, just antigen type for your peace of mind.

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