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COM.30450 New Reagent Lot Verification


DFields

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"New reagent lots...are checked against old..or concurrently with being placed into service."

This is a new CAP Common checklist question as of 7/31/12 (Phase II) and it goes on to state for qualitative tests, minimum cross-checking is to include retesting at least one know positive and one known negative sample form the old lot against the new.

Are other Blood Banks doing lot to lot testing, including patient samples?

What about for fetal screen and Kleihauer Betke?:cries:

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"New reagent lots...are checked against old..or concurrently with being placed into service."

This is a new CAP Common checklist question as of 7/31/12 (Phase II) and it goes on to state for qualitative tests, minimum cross-checking is to include retesting at least one know positive and one known negative sample form the old lot against the new.

Are other Blood Banks doing lot to lot testing, including patient samples?

What about for fetal screen and Kleihauer Betke?:cries:

There is every chance that the UK may be to blame for this.

The MHRA, our equivalent of CAP (for want of a better way of putting it - maybe Mafia is the correct word, I don't know) have had high level meetings with people in the USA, and they have exchanged ideas as to how to make our job even more difficult and beaurocratic (sorry, "safer", and with a higher degree of "quality", I meant to write), and we have had this rule in the UK now for some years. I would not be surprised, therefore, if they have infected your Quality System.

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For Fetal screen ...we do lot to lot relase on the day of receipt. run controls from old kit & run controls from new kit on the day of receipt. We also run QC every time we do fetal screen...The reson for doing on the dya of receipt is...while back we had a kit where positive control was very weak/negative and we ended up making our on positive control for a month.

All other reagents we do lot to lot relase before puting into use.

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  • 3 years later...

Would anyone want to share their fetal screen parallel testing procedure? And what about elutions- do these kits need to be compared lot to lot? Another issue- does anyone use Safe-t-vues and do you do validations or some sort of lot to lot comparison when a new lot is received?

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  • 2 years later...

I need some clarification/help. What blood bank reagents need lot to lot comparison. Is it just the kits? Or all reagents? Would any of you be willing to share your forms. Thanks for your help. Looking at COM.30450

New reagent lots and shipments are checked against old reagent lots or with suitable reference material before or concurrently being placed in service – Daily QC of ABO, Rh, Antibody Screen satisfy the intent of the checklist item provided acceptance criteria are defined and outcome of results are recorded – May not apply to panel cells (see TRM.31241) – Does apply to kits (such as fetal maternal screen test kits)

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I run a positive and negative control for everything that comes in except the elution kit. As an example, anti-A would be checked against the current lot of A1, A2 and B cells in use. New screening cells are run against the positive QC antisera in use and a current patient sample w/ a negative antibody screen. Determine what is acceptable - results have to match +/- one grade level, or whatever works for you.

We test the fetal bleed screen kit by parallel testing of the cells from the old kit (pos and neg controls, indicator cells) with the antibody from the new kit plus testing the cells from the new kit with the antibody from the old kit. That's 4 tubes. Set an acceptable range  of rosettes counted for the controls to match from the old kit to the new kit.

Keep it simple.

 

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We just implemented testing Fetal Screens old lot to new lot.  I don't think Safe-T-Vue would need Lot -to Lot verification under this standard since it is not a reagent.  However, to meet other requirements, it would need to be inspected to verify that it meets supply qualifications

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22 hours ago, AMcCord said:

We test the fetal bleed screen kit by parallel testing of the cells from the old kit (pos and neg controls, indicator cells) with the antibody from the new kit plus testing the cells from the new kit with the antibody from the old kit. That's 4 tubes. Set an acceptable range  of rosettes counted for the controls to match from the old kit to the new kit.

Keep it simple.

This is what we do to crosscheck the fetal bleed kit, also.  The fetal stain (Kleihauer-Betke) just requires pos and neg control slides.

We made a change a few years ago after COM.30450 came out -- when I read it, I didn't do anything because I didn't think it dealt with blood bank.  Our inspector had other ideas!  Change was then made, and we have been crosschecking all reagents on arrival in the lab against those reagents already in use.  When I did a recent CAP inspection, the lab argued that this item states "suitable reference material" may be used -- and that would be a positive and a negative control.  I called CAP to clarify and was told that checking new lots of reagents with a positive and a negative control is all that is needed.  Yes, I'm going to revise my procedures back to how they use to be!  I should have challenged that deficiency from a few years ago -- but live and learn.

We do, however, check our new screening and panel cells with the old screening and panel cells when the new sets are received.

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I would check with CAP again before reverting to your old procedure.  I called them a while back and was told it only applied to Fetal Screen Kits and parallel testing was required.  I also listened to a webinar where this was discussed and they said running old QC on the new lot or a previous lot patient was required for CAP.  I have found in the past that you may get different answers to a question depending on who you talk to at CAP.  I often write an email instead of calling and then I have their explanation on record for my inspection.  

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  • 2 months later...

I also called CAP in regarding this standard. It has been a while

  • I was told we only had to compare kits such as the fetal screen kits. She said basically if there were positive and negative controls in a kit, we had to compare new with old. We did not have to compare elu-kits because there are no controls with the kit and all reagents used to test the eluate have been QC'd that day. I also heard this on a CAP webinar about the most common deficiencies a year or two ago.
  • With regards to rare and not so rare antisera, we did not have to compare these at all because we do QC on day of use. I think she said something about FDA standards for potency. If they don't work, you don't use them.
  • With regards to panels, we do not need to do QC on panels when they arrive or compare new to old. The new panels are made up of different donors from the old one, not a good comparison.  Panels must be visually inspected for proper shipping conditions and documented this has been done. No other QC is required. She said if we use the panel cells as positive and negative controls when we perform antigen testing, you are actually performing pos and neg QC several times before the panel expires with no effort. A light bulb went off at this point. I have a new incoming reagent form we use and I added a column about the shipping conditions as acceptable or not acceptable with a legend below stating what is OK and what is to be rejected. We still use a paper form for rare antigen testing since it just works better for us. I added a column to insert the panel lot number used for controls and if the panel was visually acceptable when used. Bingo! I have documentation regarding visual inspections upon arrival and on day of use and can show panels used for antigen typing reacted as expected.

It helps when you get to speak to a BB person at CAP.

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