POC Controls

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Hi Everyone,
I'm hoping some of you would be willing to share how to handle new lots of QC material. Are you performing QC every shipment, every lot number change, etc.? Specifically referring to assayed control material.
We QC new lot of cartridges/test cards so I'm specifically referring to QC material only.

Thank you in advance!

3 Replies

Stephanie Johnson

Mon Nov 22, 2021 at 8:22AM

For new lot numbers of Quality control material, we run it on the instrument first to ensure the new lot results appropriately prior to releasing for use. We document this in RALS as all of our instruments are interfaced.

Pet Maniquis

Mon Nov 22, 2021 at 9:20AM

WE run the new lot of QC material and check if the values we got are within their acceptable ranges listed on their Value Assigned list. . We like the values we get on the new lot of QC to be close to the mean. For i-STAT, I run at least 5 data points to calculate the mean.
For other analyzers where the tests are not so expensive, we run at least 10-20.

Marisa Waibel

Mon Nov 29, 2021 at 4:09PM

Thank you Stephanie and Pet!

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