POC Blood Gas QC
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For those of you who use blood gas cartridges for the i-STAT, how often do you perform liquid QC? Our internal electronic simulator is set at every 8 hours. This particular cartridge will be used very infrequently, and actually has not been used except during validation, training, and QC. I want to ensure we are complying with TJC standards. Abbott does not mention external QC requirements. Can we establish our own blood gas QC frequency that we include in our IQCP?
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In our IQCP we have our electronic QC set up every 8 hours of patient testing, our liquid controls are being ran once a month on a set schedule after doing the risk assessment. Call your Abbott sales rep or tech support ( talk to one of the field implementations manager); the recommendation from Abbott is monthly liquid QC for the iSTATs.
Abbott does not require monthly liquid QC. Yes, you can write an IQCP that supports your own schedule for liquid QC. I highly recommend reading the Abbott system manual, all of the answers to your questions are in there. I know its a big book - but it is extremely comprehensive.
Silka,
The particular protocol regarding the system performance verification,validation and QC cannot be found in the iSTAT manual nor the procedure manual. You have to specifically request these from the abbott tech support.
It is my wording that is wrong( it is not a requirement but a recommendation from Abbott.)
Oh, I've been digging through that system manual! 638 pages, I believe. I thought we could have our own liquid QC schedule, but I just wanted to double check with others. There are a couple people here who think it has to be done every 8 hours since the analytes include blood gases.
The monthly QC is checking the storage of the istat cartridges not the istat itself.
Jessica R, go on pointofcare.abbott.com, then you can locate the electronic copy of the most recent revision of the system manual. You will want the Technical Bulletin entitled "The i-STAT System Manufacturer's Quality System Instructions". For blood gas cartridges there is no requirement to run liquid QC at all - ever. You can determine through your own quality processes whether or not you think there is value to running it. Note that they do recommend it for WAIVED tests only, and that is because the FDA likely would only agree to designating those cartridges as waived as long as Abbott agree'd to add that language about QC. It is pretty specific that those rules only apply to waived test cartridges.
CAP no longer requires lot/shipment or 30 day liquid QC either - it says follow your IQCP.
Also from Chapter 20: "i-STAT's microfabrication production processes are inherently capable of
creating sensors with highly reproducible characteristics. For the
measurement of blood gases, electrolytes and chemistries, this means that the
i-STAT System requires only a one-point calibration, using a calibrant solution
packaged in the cartridge, to meet the demanding requirements for clinical
accuracy. As described in the Quality Control section of the i-STAT System
Manual, the calibrant solution is also used to verify the integrity of the sensors
as a key component of the quality system. "
Yes, I read Chapter 20. Thanks for the info!
Silka–From Chapter 20: "An Electronic Simulator, which mimics the electrical characteristics of the signals produced by the sensors, is inserted into the handheld analyzer on a daily basis." The wording "inserted into" makes it sound like they are referring to the External Simulator. We don't use the external simulator daily. We rely on the internal simulator. I was thinking it means external or internal, but the words inserted into are throwing me off. What do you make of it?