ISTAT Replacement/New Validation
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This is the first ISTAT that I have had to replace. I used Abbott's performance verification document to verify the ISTAT.
I crunched my numbers/results for the precision and go my CV but I don't know what I should use to verify that it is acceptable. Abbott's performance verification document just says to verify that the result is within range of the Value assignment sheet. What do you guys use?
Performed Precision, Accuracy, Comparison, Linearity.
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I make sure all my info is in the Middleware. We are using RALS. I run the Cal/Ver. Make sure its all within the limits by Verification in RALS. Print off my Linearities and take them to the pathologist for sign off.
If you need to you can collect 5-10 random samples and run a little comparison with a current working ISTAT to show that the two are working the same.
The comparison and Cal\VER need to be ran on all cartridges that you facility uses. This is what we do at my facility. If you have any other questions let me know.
Kammy
Thanks Kammy.
It is the acceptable limits for the precision CV that I have questions about.
Our facility has is set up in our IQCP that as long as the result are within the Manufacturer's limits (which are in eVAS), slopes of each analyte for the Cal/Ver are between 0.8-1.2 (ideal 0.9-1.1), and comparison TEA limits are met the device is operating appropriately.
Sorry I misread your question.
I think this is acceptable for ISTAT please correct me if I am wrong as we haven't had any issues with inspectors. I had a nightmare inspection last year as two POC inspectors inspected out facility. They dug thru everything and only found one issue where Pathologist didn't sign attestation page on a CAP survey.
Hi Kammy and Sylvia,
Thank you for the great information. I understand how this is done for the analytes in the CG8+ and Chem8 cartridges. I used a serial dilution of pharmaceutical heparin for the Kaolin ACT.
I need to verify the replacement iSTAT analyzers for the PT/INR cartridge. There is no CalVer solution available for PT/INR. What would you use in this case?
Jose
Acceptability I use data innovations TEa limits. Or CAP has published limits of acceptability as well.