Istat QC

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What does everyone do with Istat Monthly QC?  (I have an IQCP)
- Do the operators run QC on all of the cartridges used on all of the Istats on their unit?
- Do the operators run QC on all of the cartridges (and lots- if there are more than one on the unit) but not all of the Istats?
    * If this is the process, do the units vary the Istats used each month?
- What frequency do you run the internal simulator?
- What frequency do you run the external simulator?
- Are any of you from NYS?

Thank you in advance for your responses, 
Tilly Sisti

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i-STAT Monthly QC Guidelines (IQCP-Based)

  • Liquid QC must be performed monthly on all in-use cartridge lots.
  • It is not required to run QC on every cartridge type across all i-STAT devices each month.
    • Instead, you may implement a rotating schedule to ensure all devices are included over time.
  • In Device Editor (DE), you can configure each i-STAT to:
    • Require external simulator use and set the desired frequency.
    • Enable or disable internal simulator checks, depending on your policy.
  • All QC practices must comply with:
    • Manufacturer recommendations (Abbott).
    • State and federal regulations (e.g., CLIA, CAP, NYS if applicable).
    • Your facility’s IQCP risk assessment and documentation.

- Do the operators run QC on all of the cartridges used on all of the Istats on their unit?
    Operators run QC on all the cartridges on all of the i-STATs on their unit monthly. With the exception of the ER, most units only have one or 2 i-STATS.

- Do the operators run QC on all of the cartridges (and lots- if there are more than one on the unit) but not all of the Istats?
    * If this is the process, do the units vary the Istats used each month?
     Operators run QC on all cartridges. They typically only have one lot on their unit and that is the lot that is QCd. I QC any new shipment (typically a different lot) when they come in.
- What frequency do you run the internal simulator?
     8 Hours
- What frequency do you run the external simulator?
   Every 6 months, every new device, and for troubleshooting.

- Are any of you from NYS?
     No!

Refer to how you wrote your IQCP process as it is your policy that will cover your practice. If you have not defined it work with your group and have your Medical director approve your IQCP stipulating how you will do your internal QC process. When inspected you will refer to your approved policy and you will be examined on your IQCP.

Sincerely,
Alma
“Far and away the best prize that life offers is the CHANCE to work hard at work worth doing” – Theodore Roosevelt

Alma Calzado-Knudson, MBA, CLS, MT (ASCPi & AMT)
Manager, Lab Quality and Point of Care Testing
Student Education Coordinator
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• alma.calzadoknudson@enloe.org
“Together you and I will Each Accomplish More as we WORK towards achieving a common goal – Patient Safety and Satisfaction”

Hello, we are validating a new iStat device with Chem8+ cartridges. Is anyone using Internal/External simulators as a satisfaction for a daily QC requirements?
We are thinking to use internal simulator before each patient, External simulator every Monday, and liquid QC for each shipment. As a back up, we are running daily/weekly liquid QCs for IQCP. Here is what the manual said: "The Electronic Simulator, external and internal, is a quality control device for the analyzer’s cartridge signal-reading function. It simulates two levels of electrical signals that stress the analyzer’s cartridge signal detection function both below and above measurement ranges. While the analyzer performs internal electronic checks and calibration during each test cycle, the Electronic Simulator test provides an independent check on the ability of the analyzer to take accurate and sensitive measurements of voltage, current and resistance from the cartridge. An analyzer will pass or fail this electronic test depending on whether or not it measures these signals within limits specified in the analyzer software. The schedule for the Electronic Simulator can be customized to meet local, state, or national accreditation requirements. A reminder message for the operator to run the external simulator can be set by the number of hours or tests on the i-STAT 1 Analyzer. The schedule for the automatic internal Electronic Simulator can be set by the number of hours or tests on the i-STAT 1 Analyzer. For details and lockout options, see the Customization section of this manual. "

We perform monthly QC per our IQCP. POC performs the checks on any new
shipments of cartridges and controls. The operators run the monthly
controls using all of the cartridges normally used in their area. They
rotate the instruments and operators. The internal simulator is set to run
once per 8 hour period if any samples are processed. The external
simulator and temp probe checks are done immediately after the 6 month
software update.

Thank you all- as always, this was very useful information!

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Autilia Sisti
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