Mod complex assessment "monitoring and recording"

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Good morning, 
 
I have a question regarding competency for mod complex testing. Specifically for the “Monitoring, recording, and reporting of test results” for the initial assessment. We thought a blind sample could be used for this piece but now believe we must track a real patient test performed by a new operator to use as their initial assessment. 
 
The issue we run into is; some operators will be training on the EPOC for example then not touch it again for months. They have access “just in case” they need it. 
 
Are there any other options for the “monitoring, recording etc.” that can be used other than a literal patient test that is run and charted by the operator? Specifically, for EPOC, AVOX 1000E, and iSTAT. 
 
Thanks!
Jake

2 Replies

Hi Jake,
The initial assessment is NOT required.  Refer to GEN.55505.  The first assessment is within 7 months from the start of testing, which can be done in the 4th, 5th, or 6th month. 
GEN.55450, For testing personnel, prior to starting patient/client testing and prior to reporting patient/
client results for new methods or instruments, each individual must have the training and be
evaluated for demonstration of the skills required for proper test performance...  Evaluation is not the same as assessment, per Jean Ball (CAP manager); therefore, a blind sample after training would be sufficient.  

For initial training with us in POC Lab, we have the coworkers run a "patient sample" as well as a QC sample.  The patient sample is usually a sample that we have pulled from our Core Laboratory for training purposes.  

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Jake Fray
almost 3 years ago
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