Need clarification. Does daily QC on the Provue satisfy the reg for performing daily QC on manual gel as long as the autopipettes,centrifuge, and temperatures are checked? At the present, manual gel QC is done only if the Provue is down.

we run daily QC on manual gel as well as Both ProVue everyday.

We Qc both the ProVue and the manual gel daily. We also check to make sure the same lot numbers for all reagents and gel cards are used at both stations daily. We post on the provue the lot numbers in use (and QC'ed) each day. On the blood bank hand off communication log, each shift verifies the lot#'s they are using has been QC'ed. We keep the next lot of reagents and gel cards in a seperate reagent refigerator and will not bring them into the active reagent refrigerator until they have been qc'ed. We have many generalist and this system has been working well for us.

I think you need to qc using both modalities. Your provue proves the cards work but you need to verify your MTS centrigute/heat block too.

The regulations state that QC must be performed "...each day of use." So when you state that you only do manual QC if Provue is down--are you stating that manual gel testing is NOT done if Provue is working? If that is the case, you are compliant but remember that if the Provue goes down, QC on manual gel must be done before you do any patient testing.

Thanks, Bill. No. I am stating that QC is not performed on manual gel ever unless the Provue is down, but, manual gel testing is done most days. Antibody ID testing is done in manual gel and we have an antibody of some kind every day. Also, we have some Tech's who do not use the Provue at all and only do manual gel when they work the bench, an issue I believe needs to be corrected. At the end of the day, however, it seems we need to make the necessary changes to be compliant. There is a patient on the other side that deserves the best care we can provide.

Yes. You need to implement manual gel QC ASAP as you do not know if the reagents are working as expected with manual gel technique. It's diffrent methodology or just like using different instrument in chemistry to do same test...

Sorry- I miss the logic ...if you are performing reagent QC and use the exact same gel cards and reagents (such as screening cells) whether sitting with it in front of you, or allowing the ProVue to do it-what are you going to find by performing duplicate QC? We have several centrifuges and incubators, if only one set is used for QC-what about all the others that are used during the day? That is instrument QC and is done separately. We used to do both too, but have now stopped the practice because it wasn't necessary-so this string threw me off a little.

I agree with Shelby56 for the reasons she posted.

JB

I agree with Shelby - for your initial QC you are QCing the reagents, card and cells so only need to use the one method.

The analyser should be QC'd daily (does not need to be separatate to the initial daily QC) and for manual technique you should have a weak positive and negative control with *each batch* to control the technique and make sure the reagents/cards/cells are behaving as expected. This is a completely separate issue to controlling the reagents - both need to be done.

Edited October 13, 201113 yr by Auntie-D
Expanded

As I stated above - you may have proved the reagents work, but you have not verified your cerntrifuge(s) and heat blocks (which must,by manufacturer's insert) be verified each day of use.

Sorry- I miss the logic ...if you are performing reagent QC and use the exact same gel cards and reagents (such as screening cells) whether sitting with it in front of you, or allowing the ProVue to do it-what are you going to find by performing duplicate QC? We have several centrifuges and incubators, if only one set is used for QC-what about all the others that are used during the day? That is instrument QC and is done separately. We used to do both too, but have now stopped the practice because it wasn't necessary-so this string threw me off a little.

Related question: is there any regulation that QC (manual) must be done prior to any patients if not already done within that 24 hrs? Machines will not let you process but manual there is no such external Checks.

Yes- we do that also- for each daily-but not by the reagent QC- ty for your comment.

Is there a TJC or AABB or CAP regulation that Daily QC must be done prior to any portents being done once 24 hrs from last QC has been done? I have tried to standardize the time we do QC to be sure we have done QC within 24 hrs but some oldtimers ,including my supervisor , say anytime that day. Which could mean variables from 24-32 hours between QC.

Is there a TJC or AABB or CAP regulation that Daily QC must be done prior to any portents being done once 24 hrs from last QC has been done? I have tried to standardize the time we do QC to be sure we have done QC within 24 hrs but some oldtimers ,including my supervisor , say anytime that day. Which could mean variables from 24-32 hours between QC.

As long as no samples are processed before the QCs are done then there shouldn't be a probelm. My SOP states that they QCs need to be done before the first batch of the day - if that first batch is at 3pm then the QC is done at 3pm. But then we're still manual... It would be good practice to do the QC first thing in the morning to allow any analyser problems to be resolved.

If any of my staff were running samples after a prolonged period of inactivity I would be displeased...

In my last job when we were using Diamed analysers we used to do a weak positive control for each batch that went on the analyser - not QCing the reagents but the technique, as you would do for manual. I did think that this was bordering on OTT though...

We are manual and do work as it comes in. With my supervisors (lab, I am BB super) belief it does not matter if QC is done 32 hrs after 8 hrs of work as long as it is recorded somewhere on that calendar day. To over rule her I need some type of regulation.

We are manual and do work as it comes in. With my supervisors (lab, I am BB super) belief it does not matter if QC is done 32 hrs after 8 hrs of work as long as it is recorded somewhere on that calendar day. To over rule her I need some type of regulation.

I'm in the UK so not much help there... It's hard convincing people but it is just good practice to do a QC after a period of inactivity. I'll see what our MHRA state...

Edit - it just states 'must be robustly controlled'...

Edited October 18, 201113 yr by Auntie-D

I agree with Shelby - for your initial QC you are QCing the reagents, card and cells so only need to use the one method.

The analyser should be QC'd daily (does not need to be separatate to the initial daily QC) and for manual technique you should have a weak positive and negative control with *each batch* to control the technique and make sure the reagents/cards/cells are behaving as expected. This is a completely separate issue to controlling the reagents - both need to be done.

Please define *each batch*. My definition is every time manual card testing is performed just like with some serologcal testing, i.e., Mono or RA. Or is it allowed to define a "batch" as an 8 hour or 24 hour time?

Is it allowed to define a "batch" as a 24 hour time frame?

Sorry for the duplication. it's an ID10T error.

Please define *each batch*. My definition is every time manual card testing is performed just like with some serologcal testing, i.e., Mono or RA. Or is it allowed to define a "batch" as an 8 hour or 24 hour time?

For manual testing every batch means every time you do a set of G&S - be this 10 patients or just one. Manual method should always be QC'd each time. Not 8 or 24 hours. Batch testing is completely different than reagent testing which can be done every 24 hours. I don't know about over the pond but in the UK our guidelines state that each day reagents must be controlled and each batch of samples must have a positive and negative control.

Do you mean to say you run QC for blood typing and screening with every batch??

For manual testing every batch means every time you do a set of G&S - be this 10 patients or just one. Manual method should always be QC'd each time. Not 8 or 24 hours. Batch testing is completely different than reagent testing which can be done every 24 hours. I don't know about over the pond but in the UK our guidelines state that each day reagents must be controlled and each batch of samples must have a positive and negative control.

Do you mean to say you run QC for blood typing and screening with every batch??

Yes, according to UK MHRA regulations a weak positive and negative control MUST be run with every batch of manual testing done. A full ABOD screen isn't done, just a positive and a negative cell to confirm the method and equipment.

"Each day of use" is how most US regs define reagent QC frequency. It's not measured in hours because it is not thought to be that critical. Most places I know allow a stat to be performed before the QC for the day is done. You are balancing risks. When was the last time you saw BB reagent fail QC? How likely is that extra hour (or 8) to make a difference? If no one conataminates them or abuses them, they are quite robust. Instruments and computers can't make judgment calls so thier QC schedules are rigid. If we were in Chemistry with the stability of our reagents we would probably do QC once a month! Not that I am advocating that, but the frequency of QC should have some vague association with how often (and how quickly) the reagents and equipment could deteriorate.