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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This year I'm planning to do a validation after each clew update which should both validate the new software and satisfy the 6-month validation requirement.
Last time I checked with Abbott (about 2 yrs ago), they said you only need to run an external simulator to check the CLEW. But I schedule my 6 month cal/vers to be done right after the CLEW updates as well, for efficiency and piece of mind.
I used to download the new software about the 15th of the month,
and do the calibration within a week afterwards.
If I do the timing correctly, we do our QC on the 15th of each month so it also checks the QC for all cartridges after the software update.
With Joint Commission , I do not have to do calibrations on i-STAT cartridges anymore.
TJC don’t require calibrations on i-STATs anymore. CAP still does.
Pet- I would be careful regarding calibration verification as CMS and CLIA also still require them. Just a thought...
I understand what you are saying but results of i-STAT cannot be changed
no matter how often and many times you do the calibration.
They are not like the big Main lab analyzer that is the calibration is shifted patient results shift.
The testing element is the cartridge not the instrument.
The i-STAT is just a voltage reader. It does its calibration of the cartridge every time you do a test.
I am sure Joint Commission has conferred with CMS before the standard was issued.
Maybe it is about time the CLIA regs is revised.
It is so outdated, we do things to comply with the regs even though they do not make sense.
Let us get to the electronic age. We don’t mix chemicals in test tubes anymore
according to our last JOINT inspector (September) you are required to run a cal/ver each time you update the CLEW. We were cited for not doing so last June of 2017.
My question is do you have to do so on each meter with each different cartridge that you use?
It should be stated in your IQCP. We do a subset of meters. Perform CalVer on each sensor not cartridge. For us we would test on Chem8 and G3. That also covers the sensors in
EG7.
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Bill,
We were inspected August 2018. It was an initial TJC inspection since we just switched from CAP to TJC.
The inspector told us we do not have to do CAL Ver anymore because i-STATs cannot be calibrated.
This will really save us a lot of time and money. This December is the first time I do not feel stressed out
since I did not have to do Cal Ver on my i-STATs anymore. I just did Comparison testing.
The following TJC standard was cited.
QSA.02.03.01Element #3, Note #3 under /calibration certification is performed every 6 months: “
Calibration is not required on instruments that are manufacturer-calibrated and/or tests
that are considered non-quantitative.
This exception only applies to those instruments that cannot be calibrated after implementation.”
Is this a new standard? Updating the software will not change
the calibration of the cartridges anymore than if you do cal ver every 6 months.
I went into a full investigation on this topic. I am CAP, DOH and Joint Commission accredited. I called CAP, and they said a 6 month calibration verification on every meter for every cartridge type is required every six months. When CLEWS/JAMS are updated, the only thing required by Abbott is an electronic simulator to validate the update. Most facilities tend to just do their calver at the same time (as do I).
According to CMS (https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/som107ap_c_lab.pdf) on page 192, CAL/Ver is no longer required on devices that cannot be calibrated. That being said, CAP may have different (more stringent) requirements.
I have spoken with CAP too and the following addition to my protocol allowed for Calibration to be done every 6 months on at least two analyzers. I have the following documentation on hand if an inspector wants to see it.
CALIBRATION:
For cartridges, calibration is automatically performed as part of the test cycle on each cartridge type, except coagulation and immunoassay cartridges. Operator intervention is not necessary.
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.
In response to Alayna: I don't understand how CAP can give different answers to the same question. I did bring up the "cartridges, or more specifically, the sensors, rather than the analyzers that should be subject to the six-month check..." and they said someone was sited for not completing Cal Ver every six months on all meters with all cartridge types. And, this was just last month.
I am only referencing from a previous inspection, I did not place a call today. As long as your protocol matches manufacture instructions you are good, and meet other CAP requirments.
The CAP checklist references POC 08300 as recommended by the manufacture and at least every six months. Its essential to have it written in your defined method and have I-Stats documentation on hand to prove compliance.
This discussion is making my head hurt. A few things to consider:
1. Unless the person that inspected you is actually employed by CAP, then they are nothing more than a PEER inspector, just like any one of us and it is entirely possible you were cited for something that is incorrect. Get the info from the horses mouth so to speak. Most POC CAP inspectors are peers, and may not know the regs as well as they should.
2. Start with the manufacturer -what do they require? Abbott does not require calibration verification every six months. They provide a guideline for calibration verification of new handhelds, but that is it.
3. Read the CLIA guidelines that Marcia just posted - those are baseline. If you are a CLIA site, all you need to do is follow manufacturer instructions. Abbott states all you do after CLEW is perform the external sim and record the Thermal Probe Check.
4. Many of us also choose to perform our semi-annual validations after the CLEW for the sake of convenience and timing. Not because we are required to do so. It is just easier to combine steps if I have to get hands on every handheld in my organization.
5. If you are a CAP site - calibration verification DOES NOT have to be performed on every handheld. It has to be performed on the "test system". The test system is defined as the combination of a handheld, and a sensor. In other words, you just run the cal ver one time for every sensor type used at your facility, excluding coag sensors since cal ver is not required for coag methods. For example, even if you have 45 iSTATs at your facility, you only need to run the cal ver on one. Now, I run 5 levels, and find it much faster to line up 5 iSTATs and perform one level on each handheld, but that is just me.
6. If you have more than one iSTAT, you have to perform iSTAT to iSTAT method comparison every six months. We do this by performing one level of QC after the CLEW update, on every handheld, for every sensor type used in that area. Then I crunch that as precision for each analyte.
7. If you also have another device or method in the same facility that performs the same test, then you need to perform iSTAT to that other method comparison every six months. We do this on one handheld as well, or even better - we do chart look-backs from ED patients typically, since many of those are run in the lab simultaneously.
8. Accuracy can be calculated from your calibration verification data. If you use EP Evaluator, this is very easy, just select calibration verification and accuracy on your Alternate Quantitative Method Comparison study.
In conclusion - after a CLEW update you are only required to perform an electronic simulator, press the period button, and record the Thermal Probe Check. If you are like most POC coordinators, and pressed for time, then it is recommended to do your six month validations at the same time.