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comment_60605

Can anyone tell me if and where in the CAP check list it states that the lab manager must be proficient in working all areas of the lab?

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  • David Saikin
    David Saikin

    It does not say that . . . in fact I don't believe any regulatory agency requires Management to be competent in any area of the lab - as long as they do not perform any testing.  If they test, they ha

comment_60611

You could say that it depends on how your job descriptions / organizational chart / quality plan is established.

Is the laboratory manager an administrative position?

Or are they considered a general supervisor/technical consultant designee for testing areas?

Have a look at GEN.53600 & GEN.53625.

Then have a look at CLIA Subpart M §493.1413 (Standard; Technical consultant responsibilities) and §493.1463 (Standard: General supervisor responsibilities)

comment_60617

It does not say that . . . in fact I don't believe any regulatory agency requires Management to be competent in any area of the lab - as long as they do not perform any testing.  If they test, they have to have a competency.

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