Istat replacement instrument

Hi Hannah, 

Up until recently, we were performing a small precision study and correlation between the new analyzer and our primary iSTAT. However recently the FDA changed the classification of the iSTAT making it an actual Chemistry analyzer. Because of this, we are now evaluating our entire procedure and will be increasing our Correlation, Precision and adding a Linearity study. I would recommend checking with your regulatory agency on what their requirements are. We received a letter from TJC letting us know they will start inspecting the new iSTAT process immediately at our next inspection. 

I recommend reaching out to your Abbott rep and getting a tip sheet on this.  They give out clear step by step instructions on this.

I just talked to Abbott beginning of June and I will share what they recommend, it's very minimal. So basically, what we do at my site is follow this - but we combine reportable range within the accuracy samples for ACTc since there is no cal material.

I would check if your facility or system has a system policy regarding this. I can share some of my blank validation/verification forms or an example if needed, just let me know :)

Hi, Sarah :) I am interested in viewing your blank forms and an example, please? I tried sending you an email, but not sure if your facility can receive "outside" emails. My email address is Brenda.Pena@MHSHealth.com. Thank you!

Hi Sarah, I would appreciate if you can share the blank form. My email is hadeyemi@bridgepointhealthcare.com.
Thank you.