i-STAT clews/Jams
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When you download the new clews for the i-STAT, do you run a validation to see if the new software is accurate? We just updated the clews and are currently doing a validation. Or do you only do a 6 month validation?
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Silka,
Great summary- but actually if you are inspected by CAP- CAP does not consider the PT/INR a clot based test so cal/verf is required. However Abbott does not have a cal/verf linearity kit for the PT/INR and CAP does not have a linearity survey as well.
so per CAP here are the options:
Karen, do you have something in writing from CAP that states they do not consider the INR test to be a clot based method?
We only run ACT on i-stat. Is there any calibration or verification for this test that anyone knows of? Also is the external simulator only required with a CLEW update per manufacturer?
Thanks.
I just love it that CAP makes the rules that PTINR needed to be cal verified with WHAT?
No vendor makes cal ver material and how can Proficiency Material verified
that the calibration is good when in itself is an unassayed sample.
Let us not JUST go through the motion. CAP has to rethink all these things they are making us do.
Does it really improve the quality of our work just because
we can show some document that we did cal ver even though it is flawed.
Yes- I have an email from Joan Kosiek
Dear Karen,
The ISTAT for PT/INR is not considered a clot based test. With that said, since there is no material provided by Abbott for the cal verification, the laboratory must use alternative sources. After the CLEW updates, the laboratory must verify that the calibration is still stable. (Sometimes the updates include linearity information). If the laboratory director approves the process of using patient PT samples to verify the calibration, it would be acceptable.
I hope this information is helpful to you.
Regards,
Joan
Joan K. Kosiek, MS,MT(ASCP)SH,MB
Technical Analyst, CAP Accreditation Programs
College of American Pathologists
325 Waukegan Road, Northfield, IL 60093
jkosiek@cap.org
Tel: 800-323-4040 ext. 7316 Dir: 847-832-7316 Fax: 847-832-8316
Web: cap.org
Pet, I have been a CAP inspector for 12 years and have never in my life heard of CAP stating the iSTAT PT/INR is not a clot based coag method. I want that in writing. I have never even considered citing someone for that. Also what is at play here is PEER inspectors, I think that is the major issue.
Karen, thanks for sending that letter from Joan. I am still picking my jaw up from off the floor. We do not use the INR cartridges, but that is still a very surprising stance she is taking.
As far as calibration verification after the CLEW, iSTAT does not require as long as you have shown (with your initial primary validation) that the software does not affect the ranges.
I do perform cal/verf after each CLEW Update. In my 38 years I had not seen issues with the ranges. However with one of the CLEW updates last year we had issues with the CREA cartridge ranges with creatinine yet the CHEM8 crea range was not affected. I think we pick up issues with the manufacturer's ranges rather than the iSTAT itself.
Is Joan new at CAP? It seems like something drastic has changed in the past year or two on how they are answering these types of questions.
No she has been there for years.
That's just sad, you would think by now she would have figured out how the iSTAT works.
Abbott maintains that all i-STAT analyzers that pass the electronic simulator are equivalent. However, what has changed is that as of October 2022 there is no longer a "...manufacturer's claim for equivalence of individual assay-specific sensors". Please refer to the sensor equivalence letter attached.