QC of reagents on receipt

[LJS]

What do you do for QC of blood bank reagents at receipt?  I think our current process is a little over the top and wanted to know what others are doing.

Thanks for your input.

[David Saikin]

I QC reagents before I put them into use; usually not upon receipt.

[jshepherd]

Yes, upon opening or adding to the in-use rack, not on receipt. 

[John C. Staley]

On 5/13/2022 at 8:53 AM, David Saikin said:

I QC reagents before I put them into use; usually not upon receipt.

Just a thought but, might that not be a little problematic if there is an issue with the reagents? 

I know it's one of those "what if" questions that never happens but I couldn't help my self.  To be honest, it's been long enough I don't remember what we did but something tickles the back of my brain making me think we did some form of on receipt QC but I'm certain it was not overly extensive or burdensome.

[Ensis01]

Visual inspection, review package insert for changes, log-in and QC when opened

[jayinsat]

On 5/13/2022 at 8:34 AM, LJS said:

What do you do for QC of blood bank reagents at receipt?  I think our current process is a little over the top and wanted to know what others are doing.

Thanks for your input.

My guess is the reason your process is "a little over the top" is because, like us, we were cited for non-compliance with COM.30450 New Reagent Lot and Shipment Confirmation of Acceptability - Nonwaived Tests Phase II New reagent lots and shipments are checked against previous reagent lots or with suitable reference material before or concurrently with being placed in service CAP checklist item. According to this checklist you must do one of the following:

Examples of suitable reference materials for qualitative tests include:

• Positive and negative patient specimens tested on a previous lot; 
• Previously tested proficiency testing materials; 
• External QC materials tested on the previous lot (eg, antigen testing kit controls, immunohematology antisera and reagent red cells) 
• Control strains of organisms or previously identified organisms for microbiology reagents used to detect or evaluate cultured microorganisms; 
• If none of the above options is available, control material provided by the assay manufacturer with the new test kit.

For our regular antisera (anti-A, B, D), reagent red cells (A1 cells, B cells), we can prove that the new lot is tested using pos/neg controls used on previous lot in accordance with the first option. This is easily verifiable on both the analyzers and our manual recording of daily reagent rack QC.

For Fetal Screen kits, we started testing the new lot against the controls from the old lot upon receipt of the new kit. This is in accordance with the first option, or using a previously tested specimen in accordance with the 2nd option. This is documented on a manual log. It seems to me that, primarily, the fetal screen test kit is where inspectors have caught us on this checklist item.

Hope this helps

[mcgouc]

We inspected and checked manufacturer’s directions on receipt.  For the reagents we used daily, we did “duplicate” QC on the old and new lot of  any reagent expiring or running out that day and switched to the new lot. Our policy described exactly what was required from our regular QC to run on the old and new lot for each reagent to get a positive and negative control.  All new lots were segregated until tested.   Since we did not use the fetal screen daily, we did the double checking on arrival so we did not forget and let the old lot expire before doing it.  

[David Saikin]

On 5/17/2022 at 9:20 AM, John C. Staley said:

Just a thought but, might that not be a little problematic if there is an issue with the reagents? 

 

I've never had a problem w BB reagents not working (except when I set them up to fail).  I have seen problems with reactivity not on par with usual results.  Contacting vendor discovered a change in the formula at production. 

[AMcCord]

On 5/18/2022 at 7:35 AM, jayinsat said:

My guess is the reason your process is "a little over the top" is because, like us, we were cited for non-compliance with COM.30450 New Reagent Lot and Shipment Confirmation of Acceptability - Nonwaived Tests Phase II New reagent lots and shipments are checked against previous reagent lots or with suitable reference material before or concurrently with being placed in service CAP checklist item. According to this checklist you must do one of the following:

Examples of suitable reference materials for qualitative tests include:

• Positive and negative patient specimens tested on a previous lot; 
• Previously tested proficiency testing materials; 
• External QC materials tested on the previous lot (eg, antigen testing kit controls, immunohematology antisera and reagent red cells) 
• Control strains of organisms or previously identified organisms for microbiology reagents used to detect or evaluate cultured microorganisms; 
• If none of the above options is available, control material provided by the assay manufacturer with the new test kit.

For our regular antisera (anti-A, B, D), reagent red cells (A1 cells, B cells), we can prove that the new lot is tested using pos/neg controls used on previous lot in accordance with the first option. This is easily verifiable on both the analyzers and our manual recording of daily reagent rack QC.

For Fetal Screen kits, we started testing the new lot against the controls from the old lot upon receipt of the new kit. This is in accordance with the first option, or using a previously tested specimen in accordance with the 2nd option. This is documented on a manual log. It seems to me that, primarily, the fetal screen test kit is where inspectors have caught us on this checklist item.

Hope this helps

Above is what we do with traditional reagents, including the fetal screen (lot to lot comparison as above). Automated reagents are QC'd when the lot is opened using the QC material we were using with the old lot. 

We inspect for appearance and shipping condition, check inserts, and document that for all reagents when received.

[DebbieL]

There was a FAQ on the CAP site a few years ago that basically said BB did not have to do lot to lot testing, that our regular QC was sufficient. I know the exception was fetal kits or other kits that had positive and negative controls as part of the kit.  I was concerned about this standard regarding our regular reagents after it was revised so I wrote to CAP so I could get an understanding if things had changed so we did have to start doing lot to lot. This was my answer for my question about COM.30450

The way I read this we do not have to do lot to lot except for something like a fetal kit. You can perform QC on the day of use. Part of our QC is to check the shipment upon arrival, is the appearance normal, did it arrive at the proper temp, was the shipping container damaged, etc. 

I like having an answer in writing with the CAP logo if an inspector seems like they are going to site me. I can whip the email out and show them. Might help, also might make them mad.