Istat precision.

So we got cited for not doing precision on istats when we got new ones. We were under the assumption that we didn’t need to. So it is com 40310. We have 90 meters spread throughout multiple locations. Would you go back and do precision on all meters? Or just new ones?

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Call me....I just finished the write up for the same thing.......


Deanna Bogner

I would challenge that as it says for “Each test”, not each analyzer.  With that being said, we do a mini-precision for each new analyzer.

We tried that but even abbot says at start up if a new meter we should do a precision of two levels of qc 2 days in a row. We even chalegened it with cap and they said the same thing.
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I second Andrea. The Abbott stuff says "recommended but you must follow the inspection agency of choice."

 CAP requires it on a new ISTAT as if the method was never validated. I just got my accreditation letter today on what I sent.  we did a full validation.

This is one reason we are looking at TJC for POCT. for a 6 hospital system, this is really expensive and totally unnecessary.


Deanna Bogner 210-297-9657  

We started to kill two birds with one stone  - every 6 months when we do the CLEW update, we run one level of QC for every analyte on every iSTAT, then crunch that as both our iSTAT to iSTAT method comparison, and our precision. If we have any new iSTATs they get thrown into that mix. Perhaps not quite meeting the intention, but so far has worked well for us. 

When I get a replacement or new analyzer I do the electronic simulator for 2 days along with QC of the analytes that the analyzer will be doing against another analyzer doing those same cartridges. I list that as my precision based off of our lab policy and I've been good so far. I do like Silka's plan but so far I only have 8 istats but more are coming. I usually run QC after I do the CLEW updates as well but its just to have monthly QC done as per our lab policy. Maybe I'll call that my comparison and precision!

Inga, I am cheap - I worked for an organization that constantly was forcing us to cut costs and looking at ways to cut out unnecessary QC or other processes before looking into cutting staff. in order to save the jobs of my POC team, I was more than willing to combine steps and reduce cartridge use as much as possible, haha


Beware....I was cited for something similar. They wanted accuracy and precision and Cal Ver for a replacement instrument. To answer the citation, I had to do a full validation as if the method was brand new.

(Cal ver, accuracy, precision for two days with two lots and accuracy as per POCT policy)


I have 90 ISTAT and yes....more are coming.

Deanna Bogner 210-297-9657

to all,

Yep...I am where Silka is now....looking to preserve cartridges and tech time before people are cut. For us, it may mean an inspection agency move.


Deanna Bogner 210-297-9657 

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