POC.07484

This standard seems to refer you back to the IQCP. 
What does your IQCP have to say about the trending for failures etc.?

Do you review your QC in a middleware? This will at least satisfy this for the repeated user error QC. Anything more extensive than that will probably need a formal investigation for result accuracy.

We document our corrective actions in our middleware, just like Tori has suggested. It may be limited to repeat QC OK or instrument taken out of service. Some of our devices have their own management system. Since we are talking about QC here, I am documenting the corrective action in the location that I pull my reports from. For Radiometer devices, that is AQURE. Another example is epoc and that is in EDM. But for the devices that I pull my reports from in Telcor, I document it there in the notes section of the QC data. Even if the instrument has lockout features, you still need to evaluate and document. 

Hope this helps!
Erika

Thanks everyone!

We have our middleware (Telcor) set to flag out of range QC as an exception so that it is brought to the POCC's attention.  From there, a comment is added to speak to the remedial action, and the reports generated at end of month from Telcor will include those comments.  Between that and the fact that all devices are on QC lockout whenever possible (AVOX would be an example of where it's NOT possible), that should be more than adequate.

Thank you; we are new to Telcor so I will look into that.

Anita, there is a box to check to include those comments on reports - make sure you check it because I believe the default is to have it unchecked.