IQCP ISTAT

I would answer the question as Yes.  Since the manufacturer has no instruction on the frequency of LQC, their instructions allow you to do as you deem appropriate.

I agree with what Marcia said.  Also, just finished day 30 of my IQCP for iSTAT ACT Celite, so I'm really hoping it would be eligible!  Lots of cartridges and QC material to complete the plan.

I sent the same question to CAP. Katherine I am finishing up ACTk.

This is how our system interprets that:
Does the manufacturer allow for external QC to be run LESS frequently than required by CAP/CLIA (daily)?  YES, they allow you to run it less frequently because there IS no requirement.  Therefore (based on the algorithm you provided) you would make an IQCP based off your initial risk assessment, to include liquid vs. electronic control.   For us, that looks like new lot/shipment liquid QC and that is all.  Might look like something else based on your risk assessment and director approval. 

Abbott is notorious for being non-committal about QC or anything else that might be regulated. Since they do not make a recommendation/suggestion, I believe that you are free to determine for yourself if the system is eligible for an IQCP. I would challenge any CAP surveyor to be able to provide evidence to the contrary.

Admittedly, we are surveyed by COLA, but we have successfully used IQCPs for iSTAT for a number of years now and have never had an issue with the surveyors. The IQCP itself, if properly presented, should be able to stand alone as evidence that the testing system is appropriate for IQCP usage.

To those of you that are doing new lot/new shipment only for your IQCP, what kind of documentation do you have to support that? For those of you that are doing monthly QC, what do you do if a cartridge lot QC is missed during the monthly QC? 

Hi Ms. Tan. Thank you for asking that question. I am also interested in what type of documentation is used for lot to lot comparisons. I assume a spreadsheet would be used. Right?

Russell, I have already uploaded a spreadsheet another person from here shared with me for lot to lot on the ISTAT.  It's really easy to fill out and not to time consuming.  Check it out!

Marilou we just print off our results for New Lot/Shipment I review them and our lab manager reviews them again.  That process worked for years!  We weren't doing lot to lot and an inspector tried to give us a citation 2 years ago.  I was pretty mad because lot to lot was not indicated in my IQCP.  I got this spread sheet and am doing more that what is required because I never want to be questioned again.

Hi Russell and Kimmy,
Yes for lot to lot i just created a spreadsheet and used the total allowable error as the acceptability criteria. 
My question is about the IQCP and the frequency of QC on the istat. To those that do the new lot, new shipment QC only, what documentation were used to support that. I know for some that are doing monthly QC, they had done 30 days of QC. If there’s an IQCp failure like qc is missed and not ran during the monthly QC, what corrective action is done?  

Marylou-for the New shipment only we went thru the process of daily QC for a month then Monthly QC for a year (this was dictated by Lab Director).  We had 19 ISTAT and 5 departments that used the ISTAT.  A packet was put together and distributed every month to every department when a designated RN would run the testing on the instrument with every lot of cartridges they were using.  I was not a part of this process this occurred before I was even employed in my facility.  Once we were able to prove that working stock of cartridges as long as they are maintained in the correct temperature environment still produced the same results we switched to new lot and shipment only QC.  Because it was set up the way it was it was never missed.  The istat middleware can force QC to be ran at certain time intervals also if that helps to prevent a miss.  

Thank you so much Kammy. That was very helpful.