POCT Mod-Complex Cal Ver/AMR on multiple devices

Hello James,

POC.08300 Calibration Verification Criteria doesn't allow an opt out.

But..

POC.085500 AMR Verification allows for a sampling to be performed.

When in doubt, I ALWAYS call CAP. They should be able to clarify this for you. Just make sure you get a name, reference number and record the date/time of the call.

Thanks Amanda, and I did just call CAP to clarify.

No 'subset' allowance for Cal Ver.  So if device is performing mod-complex testing, it needs cal ver performed minimum every six months, every device. 

If you are doing something separate for AMR ver (not part of your cal ver), you are allowed a subset.

Thanks!

You could do cal ver on a subset and then verify your other instruments using QC review- per POC.08500 AMR verification may be inferred by other approaches...

Also, for iSTAT I consider the cartridge to be the testing device.

If we are talking about iSTAT specifically, there is no way you need to run calibration verification on every handheld every six months. At my previous employer we had 226 iSTATs, can you imagine? Hahahaha - that would have cost us about $2 million in cartridges and cal ver materials.  Speaking for iSTAT specifically, you need to verify calibration of every analyte every six months, and it is recommended that you use more than one handheld to accomplish this - not only because its way faster, but because you will also have included several EQC runs in the background. 

For CAP - question POC.08300 states that you must ESTABLISH CRITERIA for calibration verification - meaning, you need to state in a policy somewhere how you do it for every non-waived device, how often, and how do you know it passed? 

Question POC.08500 is where you see a caveat for single use devices - this is where iSTAT falls, where a subset is perfectly fine. 

Finally, as with all things, CAP usually defers to the manufacturer recommendations - and for iSTAT, Abbott does not require calibration verification at all (see Technical Bulletin entitled "Calibration Verification and the i-STAT System".

For the iSTAT - the "device" is the cartridge - or more specifically, the analyte sensor on the cartridge. Handhelds are not "instruments".

When I posed the question just today to CAP - I made all that clear - iSTAT, 50+ devices, mod-complex testing.  Their answer did not change and the CAP representative I spoke to also conferred with a second person at CAP.

POC.08500 pertains to AMR verification (not cal ver) and allows for a subset.  It is my understanding that just because AMR is often covered by what you are doing to cover Cal Ver, that does not negate the Cal Ver requirements.

Under POC.08300, yes it lists "establish criteria" for cal ver, including "manufacturer's recommendations."  But the last bullet point says "at least every six months".  "At least" means minimum CAP requirement, no?

I know that Abbott/iSTAT claims "the cartridge is the analyzer/device", but my point is the CAP standard does not speak to that point as justification for an opt-out.

Trust me, I believe the requirement as written is over the top and unnecessary (especially when you are into hundreds of devices), but I asked for interpretation from the folks that have the final say on the standard (and that is not Abbott) and this is what I was told. 

For the benefit of the group, maybe someone else could call CAP and pose the same question, using those points for justification,  and share the response here?

I'm happy to reach out to CAP - I always ask questions via email, so that I have their response in writing for my next inspection. I will let you know what they say.

With that said, I have been a CAP inspector for over 10 years, and these are not new questions - they have always been in the checklist written this way. At the beginning of the chapter Calibration Verification is defined:

"CALIBRATION VERIFICATION: The process of confirming that the current calibration settings for each ANALYTE remain valid for a test system."

POC.08300 Under Evidence of Compliance, it states Written policy defining the method, frequency and limits of acceptability of cal/verf for each instrument/test system

So wouldn't the iSTAT quality to be a test system? The cartridges are the test not the analyzer.  Abbott states if you run the simulator and they pass that all analyzers are equivalent. 

Our policy states the following. Showed this to our CAP inspector last month and she was fine with it. She quizzed me about this issue and also wanted to know about the AMR related to the I-Stat analyzer. The following statement below helped me with answering the AMR question.

Policy states:

It is Abbott Point of Care Inc's. position that it is the cartridges, or more specifically, the sensors, rather than the analyzers that should be subject to the six-month check on the accuracy of the reportable range, and supports Abbott Point of Care Inc's. claim that all analyzers that pass the Electronic Simulator test are equivalent.

When multiple analyzers are to be used at a facility, Abbott Point of Care Inc. recommends including at least two analyzers in any performance verification studies so that statistics reflect the "system."

The combination of unit-use cartridges, inherently stable electronics of the analyzer, and reliability of the Electronic Simulator check provides the stability needed for a point-of-care testing system and reduces the need for frequent stability or calibration verification checks.

Calibration verification with matrix-appropriate material of known analyte value is performed bi-annually.

• Calibration verification is performed by the point of care coordinator.
  
  
  
  • Before a new i-Stat analyzer is put into use
  
  
  • At least every six months on at least two analyzers being sure to test each sensor
  
  
  • Anytime the i-Stat meter has been repaired
  
  
  • When controls begin to reflect an unusual trend or are consistently out of range
  
  
  
  


• The reportable range of each instrument is verified by  the point of care coordinator.


• Calibration/verification materials for the i-STAT generally span the measurement range of most analytes, hereby also validating the Analytical Measurement Range. If the calibration/verification materials for a particular analyte do not span the range, additional materials are used to validate the AMR. 

Alayna - playing devil's advocate here - was your inspector from CAP (employed by CAP) or were they a hospital/peer inspector? 

I would agree with all the supportive information you've provided, including the manufacturer's attestations about the 'alternative' nature of the iSTAT system with regard to calibration and any verifications thereof.  If I were your inspector, having familiarity with iSTAT, I would accept the justification and move on.  The question is, would CAP?     Again, trying to hold CAP accountable for the somewhat vague parameters of the standard, and minimize the need for "interpretation."

The inspector was a hospital/peer inspector. Though we did have a CAP official onsite also. I do two istat calibrations every 6 months, or more if maintenance is needed. My inspector was more worried about the AMR and how it was covered with regards to the  I-Stat.

I think a CAP inspector has to follow the recommendations of the manufacture.

I have the above listed in my policy and the technical bulletin posted in my I-Stat calibration folder. Since I-Stat recommends at least two analyzers in any performance verification that is also what I choose to use for my calibration studies.

From technical bulletin:

"When multiple analyzers are to be used at a facility, Abbott Point of Care Inc. recommends including at least two analyzers in any performance verification studies so that statistics reflect the "system.""

POC08100 

Calibration must be performed following manufacturer's instructions, at minimum, including the number, type, and concentration of calibration materials and criteria for acceptable performance.

A "recommendation" from the manufacturer is not the same as a "requirement." Just sayin".....

Deanna Bogner

We technically do calibration verification for each iSTAT we receive back from service or new ones purchased using just 2 cartridges to cover the analyte spectrum.  Then the AMR every six months on a subset as POC.08500 describes on each cartridge type we have in house.  We do not do every iSTAT, every cartridge, every level, every six months.  IQCP backs this up and we've had no issues with CAP.   

Can anyone answer if 6 month cal ver is required on the iStat? We are Joint Commission inspected and we had the inspector say it wasn't necessary. I have seen other comments alluding to this on other forums.