Semi annual comparisons
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How many samples is everyone running for their semi-annual method comparisons? (iSTAT vs GEM)
Thanks!
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I don't believe there is a regulatory required number or recommendation. Its up to the facility and MD. I've seen places use 1 sample. We use 10.
We use a lot more for our initial validation/correlation (~50)
I use 10 comparisons plus whatever duplicates were run during the 6 months. Sometimes I end up with more than 20 data points
Sometimes we get orders sent to the main lab at the same time as the POC test. For example a Chem8+ was ordered at POC but a Comprehensive Metabolic panel was also ordered at the same time. We can only charge the patient once, so the Chem8+ was deleted as duplicate; or a troponin is already ordered with he other chemistry test but a troponin was done at POC. I gather those data from the middle ware and from the EMR and use them for comparison. Instead of doing them all at one time, I collect data during the 6 months.
The advantage of doing this is, you can catch if there is a problem occurring or trending. You can catch if there was a problem because you changed lot numbers of reagents or QC. Or a problem is occurring with your instruments.
Doing all comparisons in one sitting will depend on your instrument or reagent lot number that day.