Waived Testing Lab Director Requirements

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Does anyone have a list of the requirements for waived testing lab director?  I know there are not any defined requirements like for moderate and high complexity.  However, I am looking for who can servce as the medical director on the CLIA License.

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laboratory-personnel-qualifications (3).pdf
Hi Ashley,

I'm not sure what state you are located in, but I was able to download this from the Illinois Department of Public Health website.

From Joint Commissions:

For waived testing, there are no federally defined qualifications for the Laboratory Director in the Clinical Laboratory Improvement Amendments (CLIA). The individual should have the technical knowledge and experience required to oversee the specific laboratory testing performed.

I would reach out to your CLIA office.  I have and for waived testing in my state they basically stated it could be anyone as long as the clinic followed the manufacturer's instructions.

Hi Ashley,
I had to check about this for Dominion and I find out whoever that files the application for CLIA certificate of waiver can put their name as the director of laboratory.
I guess as long as they can read the SOP and follow it, they are considered qualified.
 


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ashley Pabey
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