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I am from a Hospital System that is inspected by CAP, JACO, and CLIA for their different Labs. We are trying to align our policies and are wondering if it is really a requirement for us to perform Calibration Verification on our iSTATs as the manufacturer states that "replacement and newly purchased analyzers are delivered with factory calibration. The Electronic Simulator is superior to calibration verification or control solutions in assuring that the analyzer's most important function is within factory specifications."
In the attached CLIA document it states that an exception to the Cal Ver requirement is if the instrument is factory or manufacturer calibrated.
Does anyone use CAP, JACO, or CLIA and NOT do Cal Vers for their iSTATs? Not sure if we can get away with it for CLIA but not for the other two.
Per JC / CAP via CLIA the Cal/Ver must be performed within the facility of the licensure address. The manufacturer's Cal/Ver (which you wouldn't have the documentation of) doesn't count. You will be cited if you don't do it at each CLIA licensure address.
This means if the Lab has a CLIA licensure and uses iSTAT's and the Respiratory dept has their own CLIA licensure which also uses iSTATs.... both depts would have to do their own Cal/Ver's.
Keishla, even though CAP essentially repeats the CLIA statement regarding cal ver, you are still left with the requirement of validating AMR, which CAP does require twice annually: image.png
Thanks everyone. That's what I thought. We are currently doing them twice a year as well but I am getting a bit of push back when I mentioned that we must also do it during triggering events including reagent lot changes. CAP states in POC.08300: Calvers must be done every 6 months and at triggering events which includes, "at changes of reagent lots, unless the user can demonstrate that the use of different lots does not affect the accuracy of patient/client results."
When I spoke to CAP about this, they mentioned that I would need to prove that going from one lot to another does not affect patient results by simply using the same CalVer materials on two different lots of cartridges just once. We try to keep our sites standardized but I have sites that are refusing to do this because they are CLIA and do not think it should apply to them.
However, CLIA also states: A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes.
So, I am wondering if that is something your sites have done.
We run a patient sample on the OLD vs New LOT of cartridges to address that with defined acceptance criteria. This is included on the QC form used to QC all new LOT/Shipments received prior to patient use.
When I spoke to CAP about this, they mentioned that I would need to prove that going from one lot to another does not affect patient results by simply using the same CalVer materials on two different lots of cartridges just once. We try to keep our sites standardized but I have sites that are refusing to do this because they are CLIA and do not think it should apply to them.
However, CLIA also states: A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes.
So, I am wondering if that is something your sites have done.