External iSTAT Liquid QC frequency

Hello Andy, 
You can check with you lab or hospital accreditation requirements when manufacture does not have define criteria for liquid QC.
We are accredited by CAP and we follow below requirements for iSTAT liquid quality control, we perform QC for any new shipment, new lot and Monthly as per our IQCP.

We do compare old lot and new lot for it's allowable error.

Hope this helps!!

@charmi sakhvala,

Thanks for info on your process! I have a question about your monthly...are you QCing every lot monthly?

We also run per shipment/cartridge type (regulations). We included in our IQCP monthly refrigerator storage checks. Abbott had something in their manual about running level 1 control to check creatinine/Chem8 and level 3 on glucose cartridges. Although the scenario we operate under does not require this, we incorporated it into our IQCP. Those departments with refrigerators that do not contain these cartridges we take one they do hold and rotate the level of control performed each month. 

We have an IQCP and we are in Maryland and perform QC every week because of a state regulation.  Does anyone from Maryland know if that COMAR state regulation for single use devices is still required?  When I visit the regulation it just says "repealed" not sure what that means.

@Andi Y, we perform monthly quality control all open lot numbers in use.

Our IQCP is written for new lot/current lot QC on shipments or same lot, different shipment before use and then monthly QC on all lots in use. If those exist in the POC Lab supply, then we perform that QC on our loaner instruments so those are ready to go. All our areas that utilize ACT, CG4 or CG8 are required to run monthly QC on all the lots present in their areas.

Andy,
You are correct Abbott only requires monthly liquid QC for waived tests. I think over the years only their Creatinine cartridge is still waived. Years ago, we adjusted our IQCP to not do monthly liquid controls on our non-waived cartridges. We had 6+ years of data that showed we never had a cartridge fail liquid quality control. Our system has been through at least 4 rounds of CAP inspections since the change was made. Make sure you have plenty of data to back up your IQCP change. We run liquid QC with every new lot or shipment. Lot to lot is performed with liquid QC versus a previous lot in our bulk storage. The internal simulator is set to run every 8 hours on all our i-STATs. Our hospital is large and we go through a lot of cartridges, and we rarely have more than one lot number at the end of the month and that lot is QC'd with the lot to lot QC. We do monthly cartridge orders as well. For our Creatinine cartridges we will QC all lot numbers monthly but our ACT, CG8+ or CG4, PT+, and CHEM 8 don't get every lot Qc'd every month. Hope this helps.

Thanks everyone for your input and procedures! I am still green and learning as a POCC. I don't want to do something that is deemed non-compliant. 

@Mike Barrett
You bring up a good point about IQCP's. Is an IQCP required for this instance since there is nothing from the manufacture stating anything about monthly QC? Or is this something that can be just changed in my policy?

Thanks again everyone,
Andy

Andy,
IQCP's are a whole different conversation string we could have, but long story short yes, an IQCP is required for the i-STAT. In your RISK assessment and Quality control sections are where you can or can't justify running monthly controls based on your situation. It is really dependent on each Health System's practices. If we kept larger volumes of cartridges in our bulk storage where we had multiple lots for longer periods of time I don't think we would have made the change even though Abbott doesn't require it. Your IQCP is important to justify your practice to inspectors. Policy change would not be enough, but your policy needs to reflect your IQCP. Very few non waived tests don't require an IQCP.