Hi, Are there guide line for how often QC needs tested? Most say follow the instruments manufacturer suggestions.
But sometimes that seemed too far apart. –
As far as I know, there are no international guidelines detailing how often QC should be run. There may of course be country-specific regulations in a specific territory. In general, it is up to a lab’s QA Officer to set the frequency of QC runs, and ensure that adequate quality control takes place.
Any guidelines that do exist tend to be vague. For example, a lab seeking accreditation to ISO 15189 is simply told that it should have an internal quality control program to verify the quality of the patient test results produced. The standard makes no mention of required frequency, other than to say the frequency should be sufficient to detect error in the analytical process when error occurs.
Therefore, it may not be sufficient to simply follow manufacturers’ recommendations, as these will not take into account the frequency of running the test in question (ie, whether it’s a daily/weekly test etc), and will also not take into account the number of samples processed by the lab.
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