I-Stat IQCP and i-Stat Method Validation procedures
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We are using I-Stat as our backup Chemistry method in the laboratory, so moderately complex. Just curious if anyone has an IQCP and method validation procedure they’d like to share. I have used the Abbott I-Stat IQCP template but want to make sure there is not any other ideas/thoughts on the IQCp that I may have overlooked.
Also does anyone have a procedure written for how they validate a new analyzer? What other procedures should I have written for the I-stat prior to inspection? We have a procedure for use that is relatively general as to how to perform testing for the various cartridges and am working on an IQCP, I just feel like I should have more procedures written for this but I’m not sure what!!
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Courtney,
Glad you found the IQCP resources on the Abbott website - I found them more than adequate for writing our IQCP here at our facility. I really just fleshed them out with our facility specifics of things like environment, QC frequency, etc., but I felt their documents went above and beyond,
I believe there are Technical Bulletins in the Abbott iSTAT Manual with suggestions about how to validate iSTAT methods as well as just a new handheld. Have you looked there? I think they have been around at least a year if not a bit longer.