We recently implemented an Ortho Vision in our lab and are now performing manual gel method as a "secondary" method. If we are using the same lot numbers of reagent red cells and gel cards on the instrument and on the manual bench, do we need to QC both methods? Or is the QC on the instrument sufficient?

Personally I always considered the human interaction to be part of the equation for performing QC.  I don't recall anything that specifically stated that but I could not see where the human was not an integral part of the process.  So in my lab the manual method would be QC'd as well. Your secondary methods only need to be QC'd on the day of use.  

Yes you need to qc both as they are separate testing systems.  I fought this battle in the past and had to contact my regulatory agency to  get confirmation that both are necessary.  As I told my boss, that's why you pay me - to know stuff like this.

QC on Vision is sufficient. If all reagents and card lots are the same, the only difference is if the analyzer pipettes or a tech, it is all the same methodology. I verified this with CAP. We have had a Vision and manual gel since 2016, running QC on Vision only. We do also use the tube method and QC that separately as it is a different methodology. Curious as to which regulatory agency states Gel methodology is different if manually pipetted?

So in that case John, does each tech have to do their own QC because the human factor varies amongst humans. We view the Vision as just a hard working tech that works 24/7 and rarely takes vacation and that always scans its specimen barcodes without fail (the specimen verification is the human part of the equation I feel safer having the Vision performing).

We use DiaMed tech. Manual work is read using the Banjo card reader. Reagents are all scanned into the IH.com software to give a full audit trail - user, batch numbers, expiry.

Unless the QC has been performed (identical to the analyser) and read the results have a QC watermark across them.

On 4/26/2022 at 11:15 AM, NancyC said:

QC on Vision is sufficient. If all reagents and card lots are the same, the only difference is if the analyzer pipettes or a tech, it is all the same methodology. I verified this with CAP. We have had a Vision and manual gel since 2016, running QC on Vision only. We do also use the tube method and QC that separately as it is a different methodology. Curious as to which regulatory agency states Gel methodology is different if manually pipetted?

JCAHO in California.  I agree with this only because the manual QC not only qcs you gel cards but your manual pipets, manual pipetting and your mts centrifuge.  It is a different system.  However, if CAP says what you are doing is fine you should have that documented because if I was inspecting you I would cite.

 

 

Please forgive my ignorance.....but do the regulations require facilities to "perform QC" on the reagents or the assay ?

On 4/26/2022 at 11:15 AM, NancyC said:

QC on Vision is sufficient. If all reagents and card lots are the same, the only difference is if the analyzer pipettes or a tech, it is all the same methodology. I verified this with CAP. We have had a Vision and manual gel since 2016, running QC on Vision only. We do also use the tube method and QC that separately as it is a different methodology. Curious as to which regulatory agency states Gel methodology is different if manually pipetted?

Here is my response from CAP today, 4/28/2022:

 

Good afternoon David;

Thank you for contacting the CAP. Each test platform/system must have QC performed each day of testing. Regardless of the lots of reagents, the two systems you mentioned are separate. When I worked in the Blood Banks, we used the same Immucor reagents for the Echo instrument and the bench. We still performed the QC for each system. If you have any further questions, please feel free to reach out. Happy Lab Week!

Linda Whaley, MLS (ASCP)
Take a tour of our accreditation resources!

On 4/28/2022 at 5:54 AM, RichU said:

We use DiaMed tech. Manual work is read using the Banjo card reader. Reagents are all scanned into the IH.com software to give a full audit trail - user, batch numbers, expiry.

Unless the QC has been performed (identical to the analyser) and read the results have a QC watermark across them.

We do the same using the same reagents (but called Bio-Rad) and the SAXO (similar to the Banjo, i think).  Our reagents are all scanned into the IH-Com when using the SAXO reader - as long as the IH-500 uses the same reagents the QC flag is absent.

sandra

20 hours ago, exlimey said:

Please forgive my ignorance.....but do the regulations require facilities to "perform QC" on the reagents or the assay ?

We QC the reagents.  The assay gets the QA treatment during its implementation.

3 minutes ago, David Saikin said:

We QC the reagents.  The assay gets the QA treatment during its implementation.

Thank you, David. As I suspected. So why do two test systems using the same lot numbers of reagents need to be subjected to daily QC ? Let the debate begin.....

58 minutes ago, exlimey said:

Thank you, David. As I suspected. So why do two test systems using the same lot numbers of reagents need to be subjected to daily QC ? Let the debate begin.....

When you say assay, that is, to me, a test, like Type and Screen.   Yes, we are using the same reagents but they are being used differently (automation vs manual).  Your QC in this instance validates the entire test system. 

On 4/29/2022 at 11:30 AM, David Saikin said:

When you say assay, that is, to me, a test, like Type and Screen.   Yes, we are using the same reagents but they are being used differently (automation vs manual).  Your QC in this instance validates the entire test system. 

But, but, but....you said "We QC the reagents". The equipment/instruments are qualified and deemed functional through calibration/certification/validation, and presumably, preventative maintenance.