Multiple CLIA certificates, same Medical Laboratory Director
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Our small hospital owns 6 practices that each have their own CLIA certificate as required. Currently, the Medical Laboratory Director listed for each one is one of the providers at each practice. Our CEO has expressed interest in having the Practice Manager being listed as the Medical Laboratory Director on all of them. This means that her name would be on 5 separate CLIA certificates. Does anyone know if there is a limit to how many CLIA certificates one can be listed on as the director?
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It is my understanding that you can be the lab director of no more than 5 different CLIA licenses.
Short answer - For non waived testing-yes. exceptions apply. review the link
https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/brochure7.pd
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First, are these waived or non-waived locations? If non-waived, does the practice manager even qualify to be the director? If it's a board certified pathologist or equivalent, the max number of non-waived locations is 5, but waived sites is unlimited in my state. You need to call your own state department of health and ask them. That's what they are there for.
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Thanks for all the information. Some are waived, some are PPM. She is not currently listed as director on any of the certificates, only Providers are. We will keep them this way and just have everything sent to her attention (renewals, etc.). Both the PPM and Waived certificates have Physicians listed as the directors.
Hi Susan,
On your addendum post: "We will keep them this way and just have everything sent to her attention (renewals, etc.). Both the PPM and Waived certificates have Physicians listed as the directors."
We have 40+ CLIA Certificates which are non-lab and MDs are on as the CLIA LDs (some go back 30 or so years). In the initial applications, each clinic had used their physical address as their business address. Each (different) Practice Manager was responsible for catching the fee coupons then getting them processed for check printing/sending plus the receipt of the renewal certificates. A constant mess.
Recently we changed all the CLIAs under non-lab MDs to be received by one Manager (sadly, it's me because my boss did not want to ask a single Practice Manager to handle all the paperwork for their colleagues).
Good job on your end for doing it so quickly!
A lab medical director can only direct five ( 5 ) non-waived labs ;
For waived I think 15 (?). I am not sure about this number but director can direct more waived labs .