![]() The inspector was a hospital/peer inspector. If the calibration/verification materials for a particular analyte do not span the range, additional materials are used to validate the AMR. Calibration/verification materials for the i-STAT generally span the measurement range of most analytes, hereby also validating the Analytical Measurement Range.The reportable range of each instrument is verified by the point of care coordinator.When controls begin to reflect an unusual trend or are consistently out of range.Anytime the i-Stat meter has been repaired.At least every six months on at least two analyzers being sure to test each sensor.Before a new i-Stat analyzer is put into use.Calibration verification is performed by the point of care coordinator.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.Ĭalibration verification with matrix-appropriate material of known analyte value is performed bi-annually. recommends including at least two analyzers in any performance verification studies so that statistics reflect the "system." When multiple analyzers are to be used at a facility, Abbott Point of Care Inc. claim that all analyzers that pass the Electronic Simulator test are equivalent. 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. The following statement below helped me with answering the AMR question. She quizzed me about this issue and also wanted to know about the AMR related to the I-Stat analyzer. Showed this to our CAP inspector last month and she was fine with it. 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.įor 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 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. "At least" means minimum CAP requirement, no? 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". 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. POC.08500 pertains to AMR verification (not cal ver) and allows for a subset. Their answer did not change and the CAP representative I spoke to also conferred with a second person at CAP. ![]() When I posed the question just today to CAP - I made all that clear - iSTAT, 50+ devices, mod-complex testing. Question POC.08500 is where you see a caveat for single use devices - this is where iSTAT falls, where a subset is perfectly fine.įinally, 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".įor the iSTAT - the "device" is the cartridge - or more specifically, the analyte sensor on the cartridge. 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.įor 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? 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. If we are talking about iSTAT specifically, there is no way you need to run calibration verification on every handheld every six months.
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