iSTAT heparin reponse curve

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Is anyone using a heparin response curve as part of their 6 month iSTAT linearity studies?  Historically our department has done them, but we are questioning its usefulness as a linearity.  Thank you in advance!

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The heparin response curve is for the APTT on coagulation analyzers. The ISTAT only does INR's. I would not do it on the analyzer it has no purpose. Happy Holidays.

I do these on our Hemochrons (for ACT testing, both ACT+ and ACT-LR) and have found it useful when addressing concerns from our Cath Lab operators when devices are questioned. Our JCAHO inspector in 2019 cited us for not performing these prior to 2019. Doesn't sound like any other accrediting agency is looking for this, though. Depends on how they want to interpret the regs.

I also like that these studies are some of the most challenging ones I complete. I like working with pharmacy and our cardiac staff on issues that come up and I feel like a scientist with my heparin dilutions at the beginning and my donor curves at the end. 

I should have included that we use our iSTATs for INR as well as ACT-K cartridges.  :)

Are you under CAP?

Yes, we are under CAP

We don't do linearity/AMR verification for the ACT. The standard states you don't have to do it for Coag testing.

@Ken Charpie LOL I get you about having fun with dilutions!

I do after the software update on my ISTATs. I base it on POC. 08150 and POC.08300. I use the Abbott ISTAT for ACT's only. I think it is recommended by Abbott but not required. Just thermal probe check post software update is required but would the software update be "change of a critical instrument component". I do not do it with lot number change of cartridges. 

Plus, like Ken mentioned- you get to visit pharmacy for heparin!

I used to do this but it is no longer required by CAP.  We use iSTAT only here.  I think you need to ask - what is your purpose in doing.  POC .08600 does not require for coag.   But maybe you are doing for a method to method.  Then would you do every device? Or just one iSTAT with ACT in general using 5 cartridges to make 5 points?   Previously we used Hemochron in cath lab and iSTAT in surgery and I did this as for AMR but also served as method to method.  Through many years of doing - I learned results depended on lot and source of heparin as well as reagent cartridges/device.  The Hemochron did not "match" the iSTAT nor the Hemochron match each other.  Would definitely be appropriate as part of implementation if you were just starting ACT on a new device type.  I discontinued as did not think it useful or proved any accuracy in the end, just took time.  During a CAP inspection in 2020 was initially cited for not doing but call to CAP verified it was not a citation.  

Patsy,
What standard did you speak with CAP for clarification with during the 2020 inspection? No method to method. And our ISTAT is for ACT-celite only. 

Does anyone have a step-by-step guide on how to do a heparin response study? We're about to go live with iSTAT Kaolin and would like to do one for our method validations. 

Hi Miranda - the iSTAT system manual has a great step by step procedure. 

Attaching the pdf - just ctrl F for heparin linearity!

i-STAT 1 System Manual i-STAT 1 Procedure Manual Art 714446-00AA.pdf

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