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Reagent QC


goodchild
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I have a deep and sincere hatred for our reagent QC forms but I'm also trapped in the box and unsure of how to revise them and still capture all of the information I need (not that it's easily communicated with the ones we have now...).

None of our QC is tracked in the LIS - it's all paper forms for documentation.

 

Is anyone else willing to share what they have to give me some inspiration? I would be extremely grateful !!

 

Secondly, how do all of you set up your QC program for things that are done every day without fail and others that are done for day of use only? 

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I do gel testing.  I took and photocopied all the cards I use and put them on paper.  we enter the results right on the card picture and enter the lot number in the large space under the individual tubes.  Policy is that day staff performs the daily QC every day regardless of whether there are orders or not.  Day-of-use is usually the rare antisera which has its own QC form (wish I could get all my staff to comprehend hetero- vs homozygous). Not being computerized - fetal bleed screen and KB controls are entered directly on the BB work record log.  I also keep tube ABORh reagents - usually for a STAT type during a trauma - policy is those reagents do not need QC unless the gel type differs when it is complete. 

Edited by David Saikin
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What is your LIS system?  I was able to get BB QC in the computer.  We use the old Ortho QC programmer, but will be switching the Ortho Confidence system soon.  I was able to get both in a worksheet format and result via a spreadsheet that looks exactly like our old paper copies.  We are Meditech 6.0.

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Yes, I would investigate if you can do this in your LIS.  Yes, it would be a lot of work, but much easier once it's built.

 

We put our daily QC on a QC template that is resulted every day.  Then we have other tests that are only done on day of use that can be manually added to that template when needed.

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We document our QC on an Excel spreadsheet.  It's in the computer, but I also print it out weekly or monthly, etc.  I was trying to attach the file to this reply, but couldn't figure it out, so I uploaded it to the library under forms, daily QC template.  Let me know if it works.  I also do my equipment log that way, temp, gel centrifuge speed, etc.

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In the BBIS or the LIS is the best place but if you can't get the IT people to do it I agree with mollyredone, Excel spreadsheet is the way to go.

 

Once you get the hang of the Excel spreadsheet, if you have the option to save on a "lab shared drive" you could skip printing, mark your review on the sheet and save it with a date in the file name and you'd have all you need to keep almost any inspector happy.  

 

And IT most likely backs up all of that stuff daily so you'd be safe

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We do have a shared drive for that. We do still print it out, but I may look into just reviewing it on the computer. We do a worksheet for each week, and then put them all together in a monthly file, with a tab for each week. We also check the reagent lot, and then copy and paste for the next row, highlighting short dated reagents in yellow for awareness.

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I'll have to have a look at that Excel spreadsheet. I'm filled with questions.

 

It doesn't seem like it would fly with FDA because documentation wouldn't be indelible.

 

Someone could go and change the spreadsheet later and there's no way of seeing an audit trail or anything like that. Things could also get overwritten accidentally and not realized at the time.

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Since it is on the computer, you can see the last date it was modified.  Granted, it could be changed anytime during the month before it's over, but after that a later modified date would show up.  What's to keep people from redoing "indelible" QC sheets if they discover two months later the wrong lot was used?

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Since it is on the computer, you can see the last date it was modified.  Granted, it could be changed anytime during the month before it's over, but after that a later modified date would show up.  What's to keep people from redoing "indelible" QC sheets if they discover two months later the wrong lot was used?

 

I only just realized how rude I must have come across, I didn't mean to be. I was kind of 'talking' my questions out loud.

 

At our facility, if someone tried to completely redo QC sheets, it would have to be a collaborative effort of all of the techs involved. That would end up being at least four techs for weekly QC worksheets.

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