Jump to content

Expired Panel Cells


Recommended Posts

I just finished listening to an ARC webinar that included accred reps from CAP, AABB, and CLIA. A question regarding use of expired panel cells was brought up and answered by the reps with, what sounded to me like, some hesitation. CLIA added that we are required to add a disclaimer with each test report in which expired panel cells was used. Something along the lines of it not being an FDA approved reagent, yada yada yada...AND that this will be considered an LDT. Yes, the dreaded laboratory developed test. Have any of you ditched the use of expired panel cells altogether? Are you currently validating as an LDT, including using the disclaimer on each test result? I guess this CLIA person threw me for a loop.

Christy

Link to comment
Share on other sites

When I came to my current hospital they were using expired panel cells.  I got rid of the practice because of the QC issue and having to maintain a policy for when to use and not use expired panel cells.  I am glad that I did because this issue looks like it is turning into a problem.  So as of about 6 months ago, we do not use expired panel cells for any reason.  I would rather give antigen negative blood for an antibody I cannot rule out or send the specimen out to the reference lab if we have multiple antibodies that cannot be ruled out.

How did the CAP and AABB reps answer this question?

Link to comment
Share on other sites

They presented 4 webinars on10-7-16.  They did say they would eventually get posted to Success. 

The one that had this topic was "Ask The Expers: Quesiton and Answer with Blood Bank Inspector"s.  They had resp from CLIA, CAP and AABB.  The CLIA person stated this and cited CLIA interpretive guideline 42 CFR 494.1271(a)(1), saying that using expired reagents is not following manufacturer's instructions and thus an LDT.

Link to comment
Share on other sites

2 hours ago, Marianne said:

They presented 4 webinars on10-7-16.  They did say they would eventually get posted to Success. 

The one that had this topic was "Ask The Expers: Quesiton and Answer with Blood Bank Inspector"s.  They had resp from CLIA, CAP and AABB.  The CLIA person stated this and cited CLIA interpretive guideline 42 CFR 494.1271(a)(1), saying that using expired reagents is not following manufacturer's instructions and thus an LDT.

So, it that just one single CLIA person's opinion?  Individual inspectors vary as to their personal interpretations within CLIA, CAP and AABB!

Link to comment
Share on other sites

AABB and CAP didn't respond to the CLIA rep's comments. We use expired panel cells for rule outs only and run controls with each cell (anti-sera and diluent for gel). Since we are a smaller facility, we rely on this practice as we do not stock more than 1 in date panel. If they decide to go down this road, I'm afraid we will be sending workups to the reference lab more often. I have no interest in LDTs!

And as far as I know, reference labs have been trying to get some sort of exception for their use of expired reagents.

Link to comment
Share on other sites

I just got inspected by JC and got hit on my Ortho panels. They recommended I do QC with a diluted anti-D on each panel to ensure the panel is working according to manufacturer recommendations. I've been looking into this for a bit now and I plan on making the the following change to my process. This process is the same for both my in date panel cells and expired cells. 

Ultimately, the reason for all of this is to prove red cell viability. We all perform quality control on our screen cells; I use a QC kit. We then test a patient that happens to demonstrate one or multiple reactions on the detection phase. This patient sample is now used to QC our panel cells. We basically validated our patient with cells that were QC'd. 

When running the patient (QC sample) against the panel cells, we will detect positive reactions, proving the viability of the cells. When doing additional rule outs, I will also select a cell that is positive for the suspected antibody, to ensure I also get a positive reaction there. Basically, every panel I use will have at least one positive reaction to prove red cell viability.

If no reactions are noted, I will have a troubleshoot guide (repeat testing, try a different panel, repeat AB screen, antigen type panel, etc...).

I plan on using this same process to prove red cell viability in expired red cells. I think this is safer than doing random QC for a limited number of antibodies, you are ensuring the reactions on the QC'd screen cells are reacting on the panel each time you have a positive antibodies vs. "Should periodically perform quality control on panel cells" as stated by the manufacturer. 

As far as the disclaimer goes, I think I will wait for something more concrete for these inspectors. I am currently working on responding to JC with this process and see if they are in agreement.  
 

Link to comment
Share on other sites

We also do something similar to Seraph44. If we start with ECHO and then move to Gel or tube, we choose a positive panel cell to prove that the antibody could be detected using a different method.

I called CAP a year or so back about doing QC on panel cells in general but expired panel cells in particular. As far as doing QC on indate panels, each time we use panel cells as controls for antigen typing, you are performing QC on the panel. The control cells should react as expected. However this has to be documented. So.... I redid my antigen typing form and included the panel lot # used to perform the controls. If it is not documented, you didn't do it. So in the life of a panel, it should have QC performed several times without much effort. As far as expired panels, we do not have to do QC to prove the antigen worked. It must be written in our procedure that indate panel cells are used first and expired cells are only used to confirm or ruleout. The expired panel cells would be considered rare or difficult to obtain since we couldn't find exactly what we needed in the indate ones. Also you must follow manufacturers package insert so if it says you must do QC, you must do QC.

I certainly hope they don't change this to where it is a LDT to use expired panel cells. Who thinks up these things? Do they try to make our lives miserable?

Link to comment
Share on other sites

I wonder about using a patient known to have atypical antibodies qualifying as an adequate positive control.  Antigen-antibody reactions vary drastically, dependent on the type and quantity of both the antibodies and antigens in question.  The point being that a panel that produces a positive for a known anti-K (that particular vial has RBCs that are "viable" for the K antigen), is not necessarily going to detect  any other antibody.  It would be like saying that if your QC for a potassium  checks that everything else on a Basic Metabolic Panel must be OK.

Having said all that, it is obviously impractical to QC every cell we use for every antigen that appears on it--we certainly do not even come close to that using commercial QC antisera with our screening cells every day.  But when we consider using expired cells--even for "just rule-outs"--I can kinda see the regulator's point about whatever QC we justify using would be considered a lab-developed technique.

Scott

 

Link to comment
Share on other sites

  • 3 weeks later...
  • 2 weeks later...

I wonder about using a patient known to have atypical antibodies qualifying as an adequate positive control.  Antigen-antibody reactions vary drastically, dependent on the type and quantity of both the antibodies and antigens in question.  The point being that a panel that produces a positive for a known anti-K (that particular vial has RBCs that are "viable" for the K antigen), is not necessarily going to detect  any other antibody.  It would be like saying that if your QC for a potassium  checks that everything else on a Basic Metabolic Panel must be OK.

Scott,

So probably what should be done is to run antisera (expired or not!) on a cell positive for the one you are trying to rule out and if it's positive and your patient is negative, you could rule that antibody out.  If you are trying to rule in an antibody and the cell you selected is positive then that would be adequate without a control.  Do you agree?

Link to comment
Share on other sites

Yes, that always seemed reasonable to me too.  From comments above, it appears that at least some inspectors would agree that that is a good way to justify using expired reagents, at least for rule-in/rule outs.

However, I believe there are still a number of places that do bother doing ANY QC on panels, much less on individual vials for specific antigens, expired or not.

Scott

Link to comment
Share on other sites

  • 2 weeks later...
  • 3 weeks later...

God is Great,

Beer is Good,

Some Regulations are Crazy...

Why not use outdated sera and cells for screening and then use the 1 in-date bottle to retest and use as test of record?

What about rare red cells and sera from commercial or patients that may be frozen in liquid nitrogen and used to help with antigen and antibody problems?  Of course you would run controls.

Where have all the blood bankers gone?  Who is writing these regs.?  Have they been out of the lab too long?
There are patients waiting for us and our results.....

I will step off my soapbox now.

Good Luck to all and to all Good Luck.

Link to comment
Share on other sites

27 minutes ago, mrmic said:

Why not use outdated sera and cells for screening and then use the 1 in-date bottle to retest and use as test of record?

What about rare red cells and sera from commercial or patients that may be frozen in liquid nitrogen and used to help with antigen and antibody problems?  Of course you would run controls.

Where have all the blood bankers gone?  Who is writing these regs.?  Have they been out of the lab too long?
There are patients waiting for us and our results.....

Could NOT agree more!

Edited by Malcolm Needs
Link to comment
Share on other sites

1 hour ago, mrmic said:

Why not use outdated sera and cells for screening and then use the 1 in-date bottle to retest and use as test of record?

What about rare red cells and sera from commercial or patients that may be frozen in liquid nitrogen and used to help with antigen and antibody problems?  Of course you would run controls.

Where have all the blood bankers gone?  Who is writing these regs.?  Have they been out of the lab too long?
There are patients waiting for us and our results.....

Sometimes I think that the "regulators" feel obliged to fix problems that don't exist. Does anyone recall a rash of patient morbidity/mortality due to the use of expired reagents in the blood bank arena?

That being said, the use of such material should be restricted to those with the appropriate knowledge and expertise.

Link to comment
Share on other sites

I just have to observe here (being a mere generalist) that when an inspector finds us using ANY expired  reagent or control anywhere else in the Lab, we would certianly be cited---regardless of any evidence of a "rash of patient morbidity/mortality due" to its use.

It seems odd that we expect less oversight for an area within the lab where the potential outcome of even one mis-interpretation of a test outcome could mean life or death for our patients.

 

Just sayin'...

 

Scott

Link to comment
Share on other sites

Create an account or sign in to comment

You need to be a member in order to leave a comment

Create an account

Sign up for a new account in our community. It's easy!

Register a new account

Sign in

Already have an account? Sign in here.

Sign In Now
  • Recently Browsing   0 members

    • No registered users viewing this page.
  • Advertisement

×
×
  • Create New...

Important Information

We have placed cookies on your device to help make this website better. You can adjust your cookie settings, otherwise we'll assume you're okay to continue.