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Validation of expired panel cells


lab217

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I was wondering how other facilities manage using outdated panel cells.  In our facility we not only do a DAT on the cells used but also antigen type for the antigen we are trying to rule out.  This is very time consuming.  In the hospital I worked previously we did a positive cell and a negative cell along with the cell being tested and if the performance was as expected, we deemed the expired panel "usable".

Any advice is greatly appreciated!

 

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Not quite sure what the DAT is adding to the mix.   I could see if you are using AHG antisera but even then, the negative control would not be negative.   A positive DAT may also interfere with RT antisera (rare but possible) but then again, the negative control would not be negative. If controls work you should be good to go. 

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  • 1 month later...

TJC is in the house right now and I was just cited for using expired panel cells. She said that even is we did a QC on expired panel cells it is still expired and you can not use it. I tried explaining it to her but the word EXPIRED to her means do not use it at all.

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I'm not sure how you're using them at your institution, but I would point the TJC assessor in the direction of the CLIA interpretive guidelines, recently updated (effective January 9, 2015):

 

§493.1271 Standard: Immunohematology

(a) Patient testing. (a)(1) The laboratory must perform ABO grouping, D (Rho) typing, unexpected antibody detection, antibody identification, and compatibility testing by following the manufacturer’s instructions, if provided, and as applicable, 21 CFR 606.151(a) through (e).

 

When in-date reagents are unavailable, it may become necessary to frame written policies for their temporary use beyond their expiration dates until non-expired supplies become available. Under no circumstances, however, should a laboratory adopt policies that would allow for the regular use of expired reagents.

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This is getting a little ridiculous.  With good controls showing the antigen is still reactive (either the pt or antigen reagents), expired panels should be OK to use for additional ruleouts only, as we have done for decades.  You don't use them for the initial work, but ruleouts surely are OK? 

 

Haven't we recently had several discussions on how to do controls on these older panels just for this use - and now we can't use them at all???  I am only able to keep one panel on site at a time - that is not always going to allow for all ruleouts.  We keep our panels for up to 3 months only and run a positive control on the panel to show the antigen being tested for is still detectable. 

 

CAP did have a specific standard that allowed an exception for the use of RARE antigen typing reagents only (the really expensive ones) that passed controls on day of use.  TJC does not have that same exemption and I have wondered what they would do with Blood Bank reagents.  Doesn't sound encouraging.  We will be inspected by TJC this year (our 2nd time), so I guess I will find out.

 

None of the rest of our routine reagents are expired and we do not use expired RBC reagents either for routine testing.

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I was asked about the quality control of panel cells by a TJC inspector last year, but it was to verify whether or not we were in compliance with the manufacturers recommendations. I was not asked if we used expired panel cells. I agree with cswickard; we have been doing using expired panel cells for rule-outs for decades. 

One of my previous employers, who is a tertiary care medical center did a study to confirm reactivity of antigens on panel cells expired for up to 3 months and deemed these acceptable. They no longer use panel cells more than 3 months out of date. 

I think the inspectors who are citing blood banks for using expired cells say it is a violation of the manufacturers package insert. JC standard 05.05.01 addresses reagents in the blood bank and nothing is explicitly stated about the use of out of date cells.

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I asked TJC this question, and here is their response:

 

Hi,

In looking through the Standards it sounds clear we can't use expired reagents (QSA 2.14.1 EP5, QSA 2.13.1 EP8) and also that each vial needs to be tested each day of use.

So my questions are:

1. For a blood bank that performs complicated antibody identification, are we allowed to develop a policy that allows for the use of expired reagents? These would not be for routine use, but only for complicated antibodies when indated reagents aren't available.

2. For antibody panel cells, are we required to test each vial each day of use? If yes, could you propose a viable plan for doing QC on an example panel of 12 cell with 15 or more identified antigens? Clearly to QC all of these vials would not be effective.

Thank you

The Joint Commission response:

Question #1 Yes but only for complicated antibodies. The FDA [21CFR606.65(e)] still permits the use of “expired” reagents that are considered rare, like anti-U or anti-Le(a).

It does not apply to reagents readily available like anti-K and so forth.

The Joint Commission (and AABB) standards require that reagents (in-date or for only those rare cases stated above expired, if used) when used, perform as expected with regard to quality control.

Question #2: Currently the Joint Commission standard addressed each vial of reagent should be qc’d,

Standard QSA.05.06.01 EP 2 is written as follows:
"Each day the procedure is performed, and when a new lot of reagents is first used, the laboratory tests each opened vial of antisera, reactive cells, and reagents for reactivity. The reactivity results are documented."

The cells used for antibody identification are reagent red cells (reactive cells) . The standard requires quality control each day of patient testing.

Regarding a recommended process, unfortunately, the Standards Interpretation Group does not maintain a database of examples or forms or best practices. We would recommend that you check with professional groups for guidelines and best practice such as the the AABB (American Association of Blood Banks).

I hope you will find this information helpful.  If you have additional questions, please visit our website and complete the online question submission form.   Please indicate if you are accredited by The Joint Commission when completing the form.

Here is the link to our website: https://web.jointcommission.org/sigsubmission/sigsubmissionform.aspx

  

 

Please understand that full compliance with the intent of the standards may only be assessed during an onsite survey.

Updates to The Joint Commission accreditation and certification requirements are published in the Perspectives Newsletter and via our weekly on-line newsletter.  Your organization's Accreditation Coordinator has access to the Perspectives Newsletters.  You may also sign up to receive the "Joint Commission Online" newsletter electronically via email by registering at the following website: 
http://www.jointcommission.org/thickbox/NewsletterSignUp.aspx?KeepThis=true&TB_iframe=true&height=480&width=640

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Thanks Cliff, glad you got a (somewhat) clear response from our JCAHO friends. 

 

It looks like in the US, JCAHO is clearly saying that although you can use expired reagents in very limited situations, they cannot be used for routine things like helping to rule out an anti-E for example.  However, from the comments above under this thread, it appears that this is common practice.

 

Likewise, they seem to be saying that they expect QC to be done on panels that "The standard requires quality control each day of patient testing."  It seems as if this practice is NEVER followed.  Some have commented that they QC when first put into use and whatever they choose to define as "periodic", but I do not think anyone is going to QC a panel each time it is used.

 

They do appear to be vague on what would be considered a "recommended process".  I guess we will just have to wait for our next inspection to see if they are getting serious with the issue of panel QC.

 

Scott

 

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Yes Cliff - thanks for asking and posting - BUT - I still find this answer ambiguous and hard to interpret.  I know what they THINK they want - but what will they accept that is more doable (because frankly, rescreening an entire panel is just not doable).

 

From the sounds of that QSA standard - QSA.05.06.01 EP 2 - I will now have to go back to QCing both of my reagent racks everyday instead of rotating the QC between the racks after making sure that both racks have matching lot#s, as we have done for several years now with no problems from the inspectors. 

 

Joint Comm gets more citations from their QSA standards than any other section, I think.  I only received the ImmunoHematology section from my boss - obviously I need to go find the rest of the Standards they could get us on.  Thanks for the links too, that is not an easy site to navigate from my limited experience.

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Seems like they really didn't answer the 2nd question. Yes, it "should" be tested: every cell, every day of use. But check with someone else about how to do it? Hmmmm....

 

That was essentially my take. "Ask AABB for best practice" and the best practice is to follow manufacturer's recommendations, which says nothing about testing each vial every day of use. I'm glad our laboratory accreditation isn't through TJC for that standard alone. People complain about QC documentation for CAP, I can't even imagine the world people like Cliff live in for reagent management. On the other hand, you are probably very good at inventory management because of the extra work.

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Only  57 more shifts and I will no longer have to worry about this nonsense.  For those of you who do, I feel truly sorry.  The insanity seems to keep getting worse with each passing year and new set of bureaucrats.  Maybe I could be a consultant for some of these agencies.  They certainly need some common sense guidance.  :disbelief:

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John, I do wish you would offer your services to TJC and other agencies. They have a severe lack of knowledge when it comes to BB issues. We would bow down and pay you hommage. Blood Bankers across the country would sing your praises. Your name would be spoken with reverence. (I know it is getting deep)

 

I was cited by CAP in 2013 for using expired panel cells. I challenged it and said we did not use them routinely, only as an aid in identification when the in-date panels couldn't provide what was needed to complete an ID. I also started having my people run a positive with the patient's serum on the same panel to show that the antibody would be detected using the method (gel or tube). It was expunged, thank goodness. I think CAP has a much better understanding of the situation than TJC. 

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But if the same situation occurred with say, a troponin in Chemistry, where you say to the inspecter "we only use outdated QC to validate the troponins when our regular QC doesn't work", you would be cited, I think, without a doubt. 

 

And yet we routinely use expired panel cells to rule out atypical antibodies, many of which if present, might cause a delayed hemolytic reaction.

 

Just always seems odd to me.

 

Scott

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Right, quite different.  Being non-compliant with a Troponin could mean that your cardiac work-ups may be a bit off.  But with a missed atypical antibody, you are looking at a possible delayed transfusion reaction.

 

I agree with John that an inspector would consider the latter alot more serious!  (not sure it needs a cliche for emphasis though!)

 

Scott

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Scott, I'm a little confused on just what you are saying here.   I'm old and slow and you seem to have lost me.

 

We, and I believe most of the folks on this forum, routinely QC any expired panels cells when using them to aid in the identification of a patient's antibodies.  That QC entails both a positive and negative control for the antigens we are concerned with.  I'm fairly confident few, if any of us, simply pull an expired panel off the shelf and start testing with selected cells without making sure they will work for us as expected.  The use of these cells and the results of the QC are documented thoroughly.  I simply don't understand how any knowledgeable inspector can fault this practice.

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