IQCP for coag

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We are implementing i-STAT ACT testing at one of our hospitals, and I have a question about IQCP. Since coag needs QC every 8 hours, are you doing your liquid QC every 8 hours for the IQCP? This is for a cath lab, that most likely is going to have on QC per day, but possibly 2. I don't anticipate that there will be a need for the 3rd QC occurrence. How have others handled the IQCP for coag tests?

3 Replies

Leah Landis

Wed Jul 17, 2024 at 4:40PM

No need for liquid ACT QC every 8 hours - we only run liquid QC with each new lot/shipment and every 30 days. The internal electronic simulator runs every 8 hours of patient testing, triggered by inserting a cartridge. If the software detects that 8 hours has elapsed since the last electronic simulator test (internal or external) it will automatically perform the internal test before the patient sample is tested. Each internal electronic simulator run verifies signals consistent with both very low and very high concentrations of each analyte. So even if it's only triggered once a day, high and low levels are covered. QC lockout is utilized to prevent running a cartridge after a failed internal electronic simulator test. We've never had an inspector take issue with this. Good luck with your implementation!

Alexandr Markevich

Wed Jul 17, 2024 at 4:43PM

hello Kathleen, we are using Hemochron for ACT, and our liquid QC is done every 28 days (Cath lab as well), EQC is every 8 hours (instrument self check).
For IQCP, i thought you can establish your own processes and guidelines to ensure quality results with your POC instrument in accordance with manufacturer recommendations/requirements. Hopefully it helps.

Kimberly Arnesen

Wed Jul 17, 2024 at 6:27PM

We have Hemochron ACT in Cath lab and have a IQCP

Internal Quality Control
Analyzer automatically performs both levels of Internal QC every 8 hours.
Results are transmitted to Telcor. If QC does not pass criteria (as given by the manufacturer) or is missed due to turning off analyzer, the analyzer will lock out user until QC is performed and passes. Results are reviewed by the POCC.
External Quality Control: Levels Normal and Abnormal
Monthly and with each new lot/shipment. Additional QC performances may include- troubleshooting and/or training/retraining operators.
Analyzer locks out if 30 day QC is not performed. Acceptable external QC ranges determined by the manufacturer are scanned into analyzer. If QC fails the analyzer will lock out and require repeat testing prior to patient testing. Results are transmitted to Telcor where they are reviewed by the POCC.

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IQCP for coag