ACT Plus Liquid QC

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We perform EQC every 8 hrs and liquids are weekly on our ACT Pluses.  It's been that way since I started in this role, and I never really questioned it.  I'm implementing another non-waived test and in completing all the requirements that go with that, it got me thinking about tests already in place.  I don't see why I cannot move the liquid QCs to monthly.  I have plenty of data to use for my IQCP to justify it and I've not found where Medtronic states they want it monthly.  If my thinking is correct, there must be others who perform the LQC monthly?  Appreciate your thoughts!

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Hi, Anita. I implemented a IQCP. Therefore QC is performed every 30 days. 

You cannot perform less QC than what is required by the manufacturer. As long Medtronic does not require "weekly" QC, you can go to monthly QC. Write it into you IQCP and have your Lab Director review and approve it. 

Is this the Medtronic ACT Plus?  The ACTtrac Operator's manual says the frequency liquid QC may be reduced to every 7 days.  So you can't push it past that, unfortunately. 

Ok, I don't think I have the ACTrac Operator's manual.  The Operator's manual I have says ACT Plus.  I'll have to look online for that or request that from Medtronic.  That was what I was struggling with, was where they stated a weekly frequency.  Thank you!

Happy to help!  The ACT Plus has a device operator's manual, cartridge IFUs, ACTtrac operator's manual, and CLOTtrac QC IFUs.  It's a lot!

I've stuck with weekly in order to keep my operators competent for proficiency sample handling. Recently caught a bad shipment of QC and monthly would have missed that for far longer.

Plus, I can't wrap my head around less than q8 hours for any kind of coag testing. Weekly seems too little to me... but daily would be cost prohibitive.

Thank you Ken.  I did finally get a hold of the ACTtrac Operator's Manual and as Danielle replied, it was there that QC frequency was addressed - "...(CLIA) requires 2 levels of quality control for coagulation testing every 8 hours that a device is used for patient testing. This may be accomplished using liquid controls or a combination of liquid and electronic controls. Frequency of liquid control testing may be reduced to every 7 days and with change in cartridge lot number following completion of the appropriate validation process and upon approval of the medical director for point-of-care testing."   

The other thing to look at is your state requirement.  Some states have different QC requirements, so just check them to make sure the frequency isn't required more than the manufacturer.

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Anita Belanger
almost 2 years ago
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