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comment_81679

Here is my daily QC form. We use 2 racks of reagents each day. We only actually QC one rack each day alternately and check the other rack to make sure the reagents match. Once the lot numbers are written, we just put check marks in the boxes if the lot # is on the rack. One rack has Anti-D4 and the other has Anti-D5 and we QC both each day. The blank lines are in case a new lot # is added during the week. I have added the things we don't QC (*) everyday just so there is a record of what could have been used. It gets a bit confusing on the saline cubes.... The cube has an expiration but once it is opened it has a month expiration. So OCD me wants both expiration dates on the sheet. They write the cube expiration in the designated spot and then write the month expiration in the square under the day opened. A little confusing when trying to write about it. It is a bit over the top but hopefully no one can ding me for not doing enough.

We do positives and negatives on all reagents. Hope you can get something out of it to help you.

QC003 Daily Reagent QC (1902).docx

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  • David Saikin
    David Saikin

    I always preferred running positive and negative controls.  FDA only requires that for anti-D (and gel).  I also dislike the attitude of doing the minimum.  We QC our gel and tube reagents w pos

  • David Saikin
    David Saikin

    Those are 2 distinct systems.  They each need to be qc's day of use.

  • SMILLER
    SMILLER

    I don't think that is correct about dumbing down to manufacturer's recommendations.  I believe the regs read that at a minimum, manufacturer's requirements for things like QC be followed.  CLIA/JCAHO/

comment_81681
On 2/26/2021 at 8:55 AM, Theresa Garcia said:

Do you have a written procedure by any chance:?

 

It was attached to their post, it's a clickable download.

comment_81686

Here is the procedure that goes along with the form we made up. 

TS03.1025 Daily Reagent QC - Copy.docx

comment_81718

Since we have both manual procedures and QC and automated procedures and QC, we have left our manual QC with just the recommended "positive" controls.  Since the ECHO runs 3 QC reagents and winds up with a "positive" and a "negative" for all of the reagents (usually the same lot numbers in both sets) we thought that was enough.  We are FDA and Joint Comm. and they have been happy so far. 

  • 9 months later...
comment_82795

Looking to streamline manual tube and gel QC documentation in a computer program. It is labor intensive to write lot numbers /exp, cards, for both test methods. If anyone has a computer program to share  much appreciated.

comment_82806

I have very limited experience with using XLS spreadsheets set up for this. Advantage you can get the expiry date to highlight when close. You will have to consult with QA first to ensure they are happy. Be warned though, clerical errors will still occur and will potentially remain undetected for long periods. Thorough checking means little saved time overall. 

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