Instrument validation testing personnel
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Aloha all,
Can you tell me who performs your instrument validations (calibration verification, correlation etc) Is it-
1. Self (POCT coordinator)-if yes, how do you maintain your competency assessment element#1 direct observations of routine patient test performance, including patient prep, if applicable, and specimen collection, handling, processing and testing.
or
2. Testing personnel-if yes, what is their job title and are they designated staff or does this duty rotate?
Mahalo for your insight.
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I perform the correlations and cal/ver as the POCC. I have Super Users (that are qualified as Technical Consultants) to directly observe them for my nonwaived testing areas.
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For me it depends on the instrument. I do the Cal/Ver on the iStats and glucometers, but for the AVOXimeter and Rapidpoint 500s I have the users perform it. This is just what works best for me.
We have the lab staff do the validations, we also run correlations with our instrument.
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POCC perform Cal and Cal Ver. We maintain DO through patient testing or blind sample testing each nursing Director or nurse educator are responsible for their units.
We build that into our order contract. The company that we are getting the instrument from comes in and performs all those things needed before we start using them. When I get the data back from them I get the Medical Lab Director to sign off on it and put the instrument into use.
After we have set the instrument up with the Director sign off, I do all required cal/vers. My thought is that this is testing the instrument and not staff.
We have programs that do both. Mostly, we have the POCC perform all calibrations/validations. One hospital has the testing personnel perform them all.
My objective when performing validation are:
1. To confirm our ability to perform the test which includes POCT staff performance of the test (after I've I'm done with validation panel).
2. Validate the performance characteristic (accuracy/sensitivity & specificity)
3. And to demonstrate that the method is fit for purpose
Is method comparison or correlation part of your validation?