6 month correlation between iSTAT meters requirement

We do correlate all of our ISTATs every 6 months. Initially we did not until we got word from an area hospital that was cited (CAP) for not doing so. We run level 1 control the first part of the year and then level 3 the second half of the year. 

I don't think you are making extra work for yourself.  Below is the method comparison plan my facility uses.  It was developed after long discussions with CAP.  

We have 49 i-STAT's.  One is deemed as the primary i-STAT and never leaves the lab; we use it for all lot-to-lot testing, coming QC, troubleshooting etc.  The primary i-STAT is a part of every quality requirement and is considered the "standard" all of the other i-STAT's are compared.  The primary i-STAT is compared to the main lab analyzers every 6 month.  

The other 48 i-STAT's are compared (every 6 mo) to the primary i-STAT using QC.  We data mine the last 6 months of monthly i-STAT QC for all 48 back up i-STAT and the 1 primary i-STAT and we compare them in EP Evaluator using the total allowable error (TEa) determined/approved by the Medical Director.  

CAP response May 2023 REcomparison iSTAT.docx

IF you are CAP see the attached answer 

I have 120 ISTAT and counting.....
We have an ISTAT in every lab we call "The Boss". This is the ISTAT that has linearity and initial QC for all cartridge types in used performed upon it for CLEW.  

After "The Boss" passes in all areas, we perform QC on every ISTAT for the cartridge type it performs post CLEW. We use "The Boss" to perform the correlation to the reference method. 

If the Controls are within manufacture ranges, the comparison is acceptable. 

we follow the same process as Lori's system

How many data points are you using to compare between two instruments? We have been using three samples per instrument and thinking that may be extra work? Is anyone only using just a one to one on each instrument? 

We are revalidating the iStat for the OR but having issues with the EG7+ cartridges, the pO2 and pCO2 correlation. They hardly correlate to the main lab Nova Prime Plus. Any ideas? How do you go about the 8% TAE from CAP? What % do you use? How many samples? We run 5 patients on the main iStat.