CAP standard COM.30450

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"New reagent lots and shipments are checked against previous lots or with suitable reference material before or concurrently with being placed in service."

How do you satisfy this requirement with the iSTAT instrument and a blood gas cartridge?
We just started using the CG8+ cartridge. 

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I would say that it is NA since the devices are not calibrated and there is no requirement by the manufacturer.
Below is a description of the intent of the question from the checklist.

The purpose of this check is to confirm that the use of new analytic reagent lots and shipments
do not affect patient results. Matrix interferences between different lots of reagents may impact
the calibration status of instruments and consistency of patient results
. Improper storage
conditions during shipping of reagents may have a negative impact on their ability to perform or
exhibit the same levels of reactivity as intended.
The minimum extent of the reagent check is described below; however, the check must be at
least as extensive as described in the manufacturer's instructions. The laboratory may determine
the number of specimens tested.

Liquid QC is ran with each new shipment of cartridges received new lot or current lot being used.

We run liquid QC on both the new shipment of cartridges and the current lot in use.  We compare results and determine acceptability based on 50% CAP Total allowable error (this is my facility's preference) before putting new cartridges in use.

Do you have a form that you fill out for the 50% CAP Total allowable error?

We run CalVer levels 1, 3 and 5 for each shipment of cartridges.  All results go into a running spreadsheet where we can compare with the previous cartridge lots.

Yes, we use a form to record the results obtained from the new and current lots.  The form also indicates (in a table) the error allowed for each analyte based on our system's preference and we indicate whether the results are acceptable or not.  We then forward to our Medical Director for approval.

Would you be willing to share that form? 

ashlee.byquist@hannibalregional.org 

We don't have an iStAT so I was referring to our GEM-5000 which has LQC included with every cartridge. So, for our purpose it is NA.
What do you do if the results don't match? Can you calibrate an iSTAT  if the values don't match?

No, you cannot calibrate the i-STAT, only perform calibration verification which we do every 6 months.  If results do not fall within my system's preference of error, and after all troubleshooting efforts have been exhausted, we would quarantine the lot in question and request a replacement lot from Abbott. I will say that in 2 years of being in this role, I have not had an issue with new lots being comparable.

Would you be willing to share the form you use? 

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Ashlee Byquist
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