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CAP checklist TRM.31250 Reagent Expiration Dates


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Does this mean that US regulated laboratories are unable to use panel cells beyond their expiration date even if the facility has a defined policy for exceptions?

 

See checklist below:

 

TRM.31250 Reagent Expiration Dates Phase II

All reagents are used within their indicated expiration date.

NOTE: Rare antisera may be used beyond their expiration date if appropriate positive and negative

controls are run each day of use and react as expected.

For laboratories not subject to US regulations, expired reagents may be used only under the following

circumstances: 1.The reagents are unique, rare or difficult to obtain; or 2. Delivery of new shipments

of reagents is delayed through causes not under control of the laboratory. The laboratory must

document validation of the performance of expired reagents in accordance with written laboratory

policy.

Evidence of Compliance:

✓ Written policy for evaluating reagents that are used beyond their expiration date AND

✓ Documentation of attempts to obtain in-date reagents

REFERENCES

1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments

of 1988; final rule. Fed Register. 2003(Jan 24):7164 [42CFR493.1252(d)]

2) Food and Drug Administration. Guide to inspections of blood banks, 1994(Sep)

3) Food and Drug Administration. Current good manufacturing practice for blood and blood components. Equipment. Supplies and reagents.

Washington, DC: US Government Printing Office, 1999(Apr 1):[21CFR606.65(e)]

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We have in our policy that we can use expired panels for rule-outs if QC is run and is acceptable. We've never run into a problem for having this policy. There may be a cell on a panel that could help identify or rule out an antibody that isn't available on the current panel. We QC the panel by antigen typing the cell or cells we're using with anti-sera for the rule-outs we need.

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We were cited for this at our last CAP inspection. We primarily use Echo automation for antibody ID and then use Gel and/or tube testing as backup. The CAP inspector was very insistent that we absolutely could never use expired panel cells no matter what. We would never use an expired panel as the primary ID for an antibody. We only use them to help us rule-in or rule-out when we have multiple antibodies or if we have a suspected KpA or JsA since there may only be one cell on a panel. No amount of talking coud convince her.

 

I rewrote my procedures to indicate that Echo was the most sensitive, followed by Gel and then tube testing. If we were using a less sensitive method to ID we would include a positive cell to prove the antibody could be identified using the less sensitive method. I indicated that indate panels were used first and expired panel cells were used only for ruling-out or ruling-in as an aid for ID. I sent the writeups off with a wing and a prayer and expected the worst. CAP dropped it as if I had never been cited for it. Whew!!

 

If they hadn't dropped it, I would be stuck sending some of my workups to the local national reference lab which uses expired panels and doesn't do QC which is exactly what we had been doing. (I checked) That would have been ironic to say the least.

 

We don't keep rare antisera such as anti-k, -LuA, -KpA, -JsA, etc. so how do other hospitals do QC on expired panel cells? In addition to that, our panel cells usually don't have much volume by the time they are expired. You need three drops of cells to test and do QC and we are sometimes sucking up the dregs out of the bottle.

 

By the way, I have been enjoying this site for years but this is the first time I have written a response.

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I have used expired panel cells since 1980 . . .  and never had a problem, never been cited (bite my tongue) by AABB, CAP,FDA or CMMS.  My policy is to run positive and negative controls when I run outdated cells -- we put those results right on the antigram.  You can never have enough cells if you do extensive abids.  I purchase 3 panels (only one is 0.8%) and keep 3 outdated of each.  Since I use gel I get good utilization of the volumes in the 3% panels.

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We were cited for this at our last CAP inspection. We primarily use Echo automation for antibody ID and then use Gel and/or tube testing as backup. The CAP inspector was very insistent that we absolutely could never use expired panel cells no matter what. We would never use an expired panel as the primary ID for an antibody. We only use them to help us rule-in or rule-out when we have multiple antibodies or if we have a suspected KpA or JsA since there may only be one cell on a panel. No amount of talking coud convince her.

 

I rewrote my procedures to indicate that Echo was the most sensitive, followed by Gel and then tube testing. If we were using a less sensitive method to ID we would include a positive cell to prove the antibody could be identified using the less sensitive method. I indicated that indate panels were used first and expired panel cells were used only for ruling-out or ruling-in as an aid for ID. I sent the writeups off with a wing and a prayer and expected the worst. CAP dropped it as if I had never been cited for it. Whew!!

 

If they hadn't dropped it, I would be stuck sending some of my workups to the local national reference lab which uses expired panels and doesn't do QC which is exactly what we had been doing. (I checked) That would have been ironic to say the least.

 

We don't keep rare antisera such as anti-k, -LuA, -KpA, -JsA, etc. so how do other hospitals do QC on expired panel cells? In addition to that, our panel cells usually don't have much volume by the time they are expired. You need three drops of cells to test and do QC and we are sometimes sucking up the dregs out of the bottle.

 

By the way, I have been enjoying this site for years but this is the first time I have written a response.

 

Welcome to the group!

 

We have a similar policy. We QC the expired panel for the antigen we are trying to rule out/in, if available. We have the same question that you have when it comes to antigens with rare antisera.

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We do use expired panel cells and wrote this practice into the procedure. The techs are required to prove reactivity of the cell by testing with the appropriate antisera prior to use. (i.e. if trying to r/o Jka, the cell is tested with Jka antisera to prove it will work as expected and the antigen has not deteriorated.). Alana

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This goes along with the New/Revised All Common Checklist

 

 

**NEW/REVISED** 07/29/2013

COM.30400 Reagent Expiration Date Phase II

All reagents and media are used within their indicated expiration date.

NOTE: The laboratory must assign an expiration date to any reagents and media that do not have

a manufacturer-provided expiration date. The assigned expiration date should be based on known

stability, frequency of use, storage conditions, and risk of deterioration.

 

For laboratories not subject to US regulations and military laboratories in overseas locations, expired

reagents may be used only under the following circumstances: 1) The reagents are unique, rare or

difficult to obtain; or 2) Delivery of new shipments of reagents is delayed through causes not under

control of the laboratory. The laboratory must document verification of the performance of expired

reagents in accordance with written laboratory policy.

 

Laboratories subject to US regulations must not use expired reagents.

 

Evidence of Compliance:

Written policy for evaluating reagents and media lacking manufacturer's expiration date

REFERENCES

1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments

of 1988; final rule. Fed Register. 2003(Jan 24):7164 [42CFR493.1252(d)]

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This goes along with the New/Revised All Common Checklist

 

 

**NEW/REVISED** 07/29/2013

COM.30400 Reagent Expiration Date Phase II

All reagents and media are used within their indicated expiration date.

NOTE: The laboratory must assign an expiration date to any reagents and media that do not have

a manufacturer-provided expiration date. The assigned expiration date should be based on known

stability, frequency of use, storage conditions, and risk of deterioration.

 

For laboratories not subject to US regulations and military laboratories in overseas locations, expired

reagents may be used only under the following circumstances: 1) The reagents are unique, rare or

difficult to obtain; or 2) Delivery of new shipments of reagents is delayed through causes not under

control of the laboratory. The laboratory must document verification of the performance of expired

reagents in accordance with written laboratory policy.

 

Laboratories subject to US regulations must not use expired reagents.

 

Evidence of Compliance:

Written policy for evaluating reagents and media lacking manufacturer's expiration date

REFERENCES

1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments

of 1988; final rule. Fed Register. 2003(Jan 24):7164 [42CFR493.1252(d)]

Except that the Transfusion Checklist has a separate item about rare antisera. The question is - do expired panel cells fall under that checklist question? We once got cited for not having a policy defining rare antisera. So we wrote one that defined it and included expired panel cells for rule outs in that procedure. Our last CAP inspector said we were fine for that.

 

I would think that the area specific checklist trumps the all common checklist if there's a discrepancy between checklist questions.

Edited by Sophie1210
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I just got cited for this checklist item. When I spoke with CAP, this was the response:

 

TRM.31250 If expired reagents are used you must clarify that they were unavailable from the manufacturer at the time of use.

(I was speaking to her about antigen typing sera, not RBC's)

 

She stated that we must document in our records why we had to use the expired reagents (ex: on back order from manufacturer). I explained to her that we use expired RBC panel cells for rule outs ONLY and that we QC the panel with each use.  She was okay with that statement, but anti-sera had to be within date even if we had QC that gave expected results, UNLESS it was on backorder or unavailable.

 

So if hope this helps someone with this checklist item.

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  • 2 weeks later...

Yikes! In past years antigen typing sera could be used beyond expiration as long as there was a policy for QC. We consider them to be "rare" partially as an expense. Yes they are available from the manufacturer, but they are very expensive. Private Lear Jets are also readily available from a manufacturer, but they are rare because few people can afford them!

We will be eating some expense to get our rack in-date within the next few weeks. Our CAP window will be opening soon.

We also use expired panel cells for rule-outs.....in fact a recent CAP Survey we had to use expired panel cells to identify an anti-U....nothing in-date was helpful.

Sounds like another case of a non-technical person making rules they don't understand.

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Using expired antisera and panel cells is and has been standard practice for years in my experience. It has become more sound with additional QC people are now doing. If ever cited for this I would push back. Provide scientific rationale and a risk evaluation for what you are doing. These are tools used to solve problems. Without them your hands are tied and patients may not receive compatible blood. A bigger risk.

 

No matter what you call them (inspectors, investigators, assessors) they all have opinions and you may not be about to change their mind during the inspection. What they may cite you for during an inspection can be disputed in your response. The repsonse is typically reviewed by others.

 

Some of these things are just driving up the cost of health care without improving actual patient care.

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