COM. 04250

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Our facility was cited for not comparing all of our POC instruments and only using a subset. Does anyone have a template they could share with me on how their site is handling this? I think I have an idea of how to make it possible but not sure what it would look like?

Thanks!

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On our ISTATs we run a control twice/year-L1 first half and L3 second half. We run it on the cartridges/ISTATS each department utilizes, with our loaners being tested on all cartridge types. Successfully correlation is a "Pass" result (we use eVAS).  We then snip our results from Telcor QML and attach them to a Word document.

We do two comparison studies.  One with our back up i-STATs to our primary i-STAT. We use 5 months of QC data to do the comparison.  We have 20 i-STATs.  We have a Primary i-STAT that all other i-STATs get compared to (we also use it for incoming QC, lot to lot, all new i-STAT validations etc).  The primary i-STAT never leaves POC.  So, we compare the 19 back up i-STATs QC for the last 5 months to the 1 primary i-STATs QC.  We complete this comparison by each individual cartridge (depending on what is used in the department).  

Then we compare the primary i-STAT to the Main Lab instruments as a separate study using patient samples.  

Hope this helps :)

Hi there. This will need to revolve around what device and testing that you are speaking about. The examples for iStat are great. You can use the QC that is ran at the CLUE updates, so long as the QC level and lot number are the same. Using QC material is especially good for when you have devices that do not require a calibration verification, such as a clotting time test (ACT). For those devices that do require a calibration verification, you can use that data to correlate. We have used CAP cross check, linearity studies and QC in past years. I am happy to help but would need more context.

Erika
deatone@bronsonhg.org

For those of you using iSTAT QC--same lot QC/cartridges, are you just saying that if all compared iSTATs passed QC (using eVAS) then comparison OK, or are you putting any tighter limit of acceptable comparison? 

Erica, this is in relation to the i-STATs. Were use the QCC but not for every single i-STAT. I think it may be better to go the route of QCs! We use a mix of Coag + Chemistry + Blood Gas catridges.

Kim, our inspectors told me that the EVAS P/F was not acceptable as our facility needs to come up with a specific criteria that the i-STATS should compare, such as 2% variance.

We compare using the CLIA total allowable errors and drop the QC in EP Evaluator.  Note: make sure your Medical Director approves. 
CLIA TOTAL ALLOWABLE ERROR GUIDELINES 2022-14513- 7.11.22 - Shortcut.lnk
CLIA TOTAL ALLOWABLE ERROR TABLE 7.11.22 - Shortcut.lnk

Hi Ren:
We use CAP crosscheck for our I-stats, ABL90's and GEM 100 (ACT+).  

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Ren Bage
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