I just moved to the position of supervisor at this blood bank and I found that they freeze their in date antisera that they don't use very often, i.e. anti-Fya, anti-S, etc.

 

Anyone else do this?  Is there a reason behind this?

 

The techs told me that they do this as a throw back from a long gone supervisor.  

 

My inclination is that since this is not in the package insert, this is violating the package insert and shouldn't be done prior to use for in date antisera.

 

Side note: they run QC once a day, but this equates to almost everytime they use this antisera because they use it so often.

 

Comments?

 

Thanks!

Jen

Well with that sort of turnover, that sounds like a real waste of time to me as well as a horrible source of error.

My inclination is that since this is not in the package insert, this is violating the package insert and shouldn't be done prior to use for in date antisera.

 

I think you are right with that.  Is this written up in your procedures as well?  I would make a few changes.  Lab practices that are done "just because" should be looked at very closely!

 

Scott

If you are using the antisera so frequently it does not make a lot of sense to freeze/thaw it on a daily basis.  The only time I freeze antisera is when it outdates.  Even if used in frequently, it is good til the expiration date (and may still be used afterwards as long as qc is valid when testing is performed.

If you do anything that is not on the package insert (such as freeze the antisera) and something goes wrong, you are liable, not the company who sold it to you, as you then become the producer.

 

Also, many antisera have a small amount of albumin in them, and freezing does funny things to albumin.

Yes I would cease and desist, for all the reasons above. 

 

100% in agreement with Scott's comment: your new job is to look at everything and evaluate all old practices and determine:

Are they in line with the regs and package inserts?

Are they now considered best practice, or is this just an old thing that we keep doing?

Does it add value?

Does it add unnecessary cost to the organization?

Is it delaying care by doing unnecessary procedures?

 

It's very uncomfortable to get people out of their comfort zones, but it's very important to do it when needed.

Yes I would cease and desist, for all the reasons above. 

 

100% in agreement with Scott's comment: your new job is to look at everything and evaluate all old practices and determine:

Are they in line with the regs and package inserts?

Are they now considered best practice, or is this just an old thing that we keep doing?

Does it add value?

Does it add unnecessary cost to the organization?

Is it delaying care by doing unnecessary procedures?

 

It's very uncomfortable to get people out of their comfort zones, but it's very important to do it when needed.

 

I like your list Terri.

So do I!

 

Donna

Thank you all for your comments.  I was in agreement with everyone, but I didn't want to just change that if there was a reason that I was unaware of.

 

Thanks all!

Prior to changing anything get some good data on exactly why you want to change something.  Make sure you get "buy in" from the techs, or as much buy in as you can get.  

 

Teri's list is excellent.  If you don't get buy in from the techs, they will revert back to the way things used to be.  Ask me how I know this?

Many rapid serology kits that allow you to freeze specimens if not tested immediately also caution to "avoid repeated freeze/thaw cycles". This would indicate some kind of potential deterioration. And well said Terri.

How could you possibly know this Likewine?

 

Just out of curiousity, how were the reagents handling this freeze/thaw process? Was there an observable decline in graded QC scores?

This brings up a question for me: how do you QC a red cell from an expired panel if it is needed for rule outs? I have only done this once in my life (a while ago) but always wondered. Do you make some sort of dilution with anti-serum?

Off the top of my head I remember that §493.1271(a)(1) has a note: 

 

"Rare reagents, e.g. anti-Jkb, and anti-Leb, etc. are sometimes used beyond the expiration
date; this is acceptable only if adequate controls are used and the reactivity and
specificity of the reagents are documented."

 

I thought I remember somewhere else specifically mentioning positive and negative controls.

I would think you should use in date antisera to QC red cells from expired panels.  We always use a negative and  a positive cell that is heterozygous for QC.  But maybe if you QC'd expired antisera with in date red cells at the same time that would qualify.  We typically just use expired red cells as additional rule out cells.

I would think you should use in date antisera to QC red cells from expired panels.  We always use a negative and  a positive cell that is heterozygous for QC.  But maybe if you QC'd expired antisera with in date red cells at the same time that would qualify.  We typically just use expired red cells as additional rule out cells.

 Yes, I agree. When using the indated antisera, my positive control had a 4+ reaction. I was wondering if some sort of a dilution of the antisera (producing a weaker antibody) would give a more valid positive reaction with the outdated panel cell.

Thanks for your input!

If you are using the antisera so frequently it does not make a lot of sense to freeze/thaw it on a daily basis.  The only time I freeze antisera is when it outdates.  Even if used in frequently, it is good til the expiration date (and may still be used afterwards as long as qc is valid when testing is performed.

On a slightly different note David, I found while doing work review, that a tech had accidentally used expired antisera. Her controls worked. I assumed that this should result in a BPDR even though the controls worked. Am I wrong about that? Thanks!

On a slightly different note David, I found while doing work review, that a tech had accidentally used expired antisera. Her controls worked. I assumed that this should result in a BPDR even though the controls worked. Am I wrong about that? Thanks!

 

FDA will view it in light of your internal procedures. Our procedure indicates that expired reagents should only be used in rare circumstances. Using expired reagents accidentally would require a BPDR: RT-63-06.

 

There's some verbiage about this in the CAP checklist.

 

TRM.31250 "Rare reagents may be used beyond their expiration date if appropriate positive and negative controls are run each day of use and react as expected.  This exception is permitted by the FDA.  This does NOT apply to reagents that are readily available.  The laboratory should establish criteria defining which reagents are considered 'rare.'"

This antisera was not exceptionally rare; it was anti-Jkb. So I do not think this qualifies for the exception.

also, the patient who recieved the units was getting Jkb negative red cells prophylactically so that he would not make the antibody, so I do not feel that we put a patient in danger. However, if I understand the FDA guidance correctly, we still have an obligation to report a breach in which the safety, purity, or potency of a distributed product may be affected. I feel that this qualifies as such an event. Agreed?

Thanks.

 

FDA will view it in light of your internal procedures. Our procedure indicates that expired reagents should only be used in rare circumstances. Using expired reagents accidentally would require a BPDR: RT-63-06.

 

There's some verbiage about this in the CAP checklist.

 

TRM.31250 "Rare reagents may be used beyond their expiration date if appropriate positive and negative controls are run each day of use and react as expected.  This exception is permitted by the FDA.  This does NOT apply to reagents that are readily available.  The laboratory should establish criteria defining which reagents are considered 'rare.'"

I agree the situation you described merits BPDR.

 

I don't think every use of expired reagents requires BPDR as long as your internal policy was followed; but, that's my interpretation of the FDAs viewpoint. Anyone else have thoughts/experience?

You must follow the package instructions for the anti-sera and it clearly states storage at 1-10C.  I don't care if you are doing QC on previously frozen antisera and if I was your CAP inspector you would get cited for improper handling of reagents because your procedure must state how to handle reagents and you would have to document that the storage is in the freezer.
I recommend you stop this bad practice.