CHEM8 and CG4 Blue cartridge

Where did you find this Dean? POC ALL COMMON?

Dean,

When it comes to non-waived tests/instruments, you need to do a full verification on each instrument, plus writing a summary of the experiments.  It is very costly.

But i-stat is actually a reader not an analyser.

Since all reagent testing take place inside esch cartridge, One would say, the cartridge is the test method that needs validation not the reader?

Abbott says as long as simulator teat passes any

i-Stat is as good as the other one.

What is groups thought ?

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But i-stat is actually a reader not an analyser.

Since all reagent testing take place inside esch cartridge, One would say, the cartridge is the test method that needs validation not the reader?

Abbott says as long as simulator teat passes any

i-Stat is as good as the other one.

What is groups thought ?

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Dean,

Have the Abbott rep send you the company procedure titled iSTAT system performance verification protocol, and then look at the verification of additional handhelds section.

I added that Abbott bulletin to the group file cabinet 720619-00E ISTAT VERIFCATION NEW AND REPLACEMENTS.

I spoke with Abbott concerning whether there's any differences between the analytes measured on one cartridge compared to another. The rep stated to view the cartridge & test information sheets found on the Abbott point of care website.

Within the insert, there will be a "Cartridge Comparison" or sometimes it's found under "Performance Characteristics" section

For example Creatinine states:

"The performance characteristics of the sensors are equivalent in all cartridge configurations. System difference analysis was performed on 39 patient samples using the i-STAT CHEM8+ and i-STAT Crea cartridges."

Our hospital is switching from EG7 to EG6 so we figured for Creatinine it states the sensors are equivalent so we shouldn't have to recalibrate or do further correlation studies if they have already been done prior on the EG7 for creatinine. If they are not comparable and are found to measure differently, than this section will not state they are equivalent and we should likewise inquire further as to the testing methodologies.

Not sure if that helps.

Alayna,

This makes sense to me but apparently not to FDA

Since it was the same reagent and test method in blue vs white cartridge of Chem8.

Also any time you change reagents wheather it is the containers, vender, etc , CAP requires you to validate that the change has not affected the test result. I believe you need to validate the creat cartridge just becuse it is a different vendor item# than chem8+ cartridge.

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Thank you Sylvia.  Based on what Abbott has written, they are following the CAP guidelines and considering each analyzer a testing platform.

This pretty much does away with the thought/argument of the analyzer being a reader and the cartridge as the test platform.  Not that we all realize that the handheld is just the computer(reader), and the cartridges the reagent pack.  I am sure that CAP has been arguing this for decades, and this was their "Gotcha" moment.

We had always been using the Chem8 and CG4 for validations on each new analyzer anyway, and Eurotrol for the linearity studies (with the hyperbaric for the high end of the pO2).  Each analyzer has L1 and L3 tested in duplicate for day 1 and day 2 for accuracy, and the same for precision using an already validated iStat analyzer for the reference. Each analyzer usually takes (took) about one box of each (Chem8/CG4), barring any difficulties. Twice a year (usually after the CLEW) we also do analyzer to analyzer using the main lab instrumentation as the reference.  The linearity is (was) entered into EP Evaluator (now we just use the app in Telcor/QML) to create the graphs.  Everything is reviewed and signed off by the POCC and supervisor, then scanned and filed online for quick access and the hard copies placed in binders "JIC".  So, we have always had our validations and summary.  Yes, our POCC has always mentioned what Abbott has previously stated, but this way was always safer as that is what laboratorians/scientists had always been taught to do.  Now, we already can show CAP every piece of data and if we choose to go in the direction of an LDT we also already have our IQCP setup.

Sometimes not taking the easy, and cheaper, route is better.  Seriously, this is what got Abbott in hot water in the first place.  They did not follow the FDAs SOP when designing a "new" cartridge template and submit it to the FDA for approval.  Some MBA didn't want to pay the FDA $1M for their blessing, and it came back to bite them.  If someone does not understand the cost of changing a platform, check out the history of Elite Pharmaceutical (ELTP) on their Sequextox opiod.  The amount of money that this little company doled out to the FDA every time that they didn't like what was submitted for approval almost bankrupted this company.  So, some bean counter is to blame for what we are deal with currently.  I am sure that some Abbott scientist was saying "But we have to" and was gagged.

Never forget about Elizabeth Holmes and Theranos.  Some business savvy entrepreneur thought that she was smarter than the FDA.  She knew nothing about LDTs and that was her undoing.  The Scientific Method and document, document, document is what was drilled into us.  More is always better.  CLIA is the baseline, this is why hospital laboratories have always said "We are doing more than what CLIA says".

Sorry, soapbox ... over … LOL

Sam,

We do the same for new/ exchange reader as well using i-stat calver five levels calibration and two days of duplicate QC for both 1&3 and three patient comparison between lab i-stat and new/ exchange i-stat .

We also used to do linearity using Calver for all istats after clew change but I was planning to change it to select few for that purpose.We also do 6 months correlation using QC data between lab istat and all the other istats. Now I also do correlation between lab analyser and lab istat but I am not required since our POC has its own CLIA and CAP number separate from main lab.

But with all that we still can not use istat CG4 and CHEM 8 as LDT since the operators are not qualified for HIGH complexity nonwaived testing therefore not good for point of care use.

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So if I am moving from one white cartridge type to another (the EG7 to EG6), and loosing one analyte iCa. Do I still need to do correlation studies again per analyte for this cartridge? Abbott stated I did not, and I am not referencing the FDA I am asking in reference to CAP and Joint Commission. If the cartridge structure is not changing, and Abbott themselves says the manufacture insert should tell me if performance characteristics are equivalent... do I still need to redo correlation studies?

In the eyes of CAP and Joint isn't their advice to follow what the manufacture instructions?

Every 6 months I do correlation studies per analyte(not per cartridge) and I do cal/ver per new analyzer, on analyzers with questionable errors, and two analyzers every 6 months. I follow my Cal/Ver with two levels of QC. 

Am I being complaint?

That is our understanding and our plan. But Cap seems to always be reinterpreting things and I feel there is a difference of opinions here. Your best bet is to call cap directly

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So please help me out with this one.

Abbott says when you use the EC8+, CG8+,EG7+ and EC6+ the ABG part makes it moderately complex.  But if you use it only for the Chems and H&H it is waived- Is this correct?

When I called they said the only waived cartridges were the Crea and the Glucose.

My understanding is the complexity pertains to the entire cartridge. You can't pull out specific analytes and change the complexity. So no, not running the ABG does not change it to waived.

Same as the EPOC cartridge.

My Abbott rep said they were not allowed to suggest what we should do or that we should change to a different cartridge.