EPOC system verification for total precision

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We currently have an epoc blood gas analyzer in use in our lab.  We purchased an additional epoc for use as a backup.  I am currently trying to put together system verification plan for the new epoc.  My question is concerning the total precision.  We are inspected by CLIA.  We currently run two levels of liquid controls once a month on the current epoc. I would like to do this on the backup epoc once it is passed verification.  Do I have to perform a 31 day study on the new epoc running two levels of liquid controls every day to ensure my total precision or can I perform seven consecutive days of two levels of liquid controls daily, then run two levels of liquid controls once a week for four weeks?  

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Hi Darla, I think you need to come up with a verification plan for new instruments that you bring on (since you already have the method comparison complete for the epoc test method) and have it approved by the laboratory director. If you already have an IQCP in place to allow for the 30 day QC, then you shouldn't have to repeat it on every new instrument for 30+ days. You should only have to repeat testing for whatever amount of time you designated in your plan and have approved by the lab director.

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Darla Bridges
over 1 year ago
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