Frequency of ACT QC (Hemochron Sig Elite)

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How often are you (liquid) QC'ing your Hemochron ACT cartridges?


Right now our nurses run two levels of liquid QC weekly on every device, but I see that the package inserts state that the manufacturer recommendation is only every 30 days or each new shipment or lot. I don't see a requirement for liquid QC specified in the Signature Elite operator manual.


If I update my SOP and IQCP, can I run the QC myself (q30 days and new lots/shipments) on one device only and take this responsibility away from my nurses? I don't see a real-life need or manufacturer requirement to run QC on every device in my facility weekly. This would save a ton of material, money, time and paperwork; not to mention the time and energy spent training staff on running QC.


Thanks!

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We actually run it every day of patient testing. Since it is a moderately complex test, this is a CAP requirement unless there is an IQCP. We chose not to pursue an IQCP for this test for a few reasons, one of which is our patient population-pediatrics. Running the controls each day of testing shows that the analyzer is working properly. When we have kids with extremely high H/H, that can cause issues. TPN use can also cause issues.


Since we are also under CAP, it is supposed to be the end user that performs the QC. I will run checks on new shipments before putting them into use, otherwise it falls on the department to perform the controls prior to the first case of the day.

Debra,


ACT is a coagulation test.  Shouldn't the QC be run every 8 hours without IQCP? 


 


Ken,


You need to do risk assessment (as part of the IQCP).  If the risk is minimum, yes, you can run liquid QC monthly.  Per CAP, end users must run QC.

Hi Ken,


We run external QC in POCT when we get a new lot of cartridges or QC.  The units do external QC every month on their instruments.  We have QC lockout on all our Sigs to make sure they do it. 


Check your state regs to make sure they don't have any requirements on how often QC needs to be done in addition to the monthly.  Some states used to require it to be done every week.

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Ken Charpie
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