California Lab Resgulations
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I am in WA but I have another entity that is under our national group that is reaching out to me for a licensing question but it's in CA.
Basically they want to have a highly complex license for a ambulatory site and are running into push back. I am not sure they understand the regulations that would be needed but wanted to check to see if CA has anything "special".
There would be a mobile laboratory van that would do the testing but not hold the CLIA and the Ambulatory site that it will be attached to would.
Any thoughts on this? I am very leary since I am not sure they have the appropriate people in place for oversight.
Basically they want to have a highly complex license for a ambulatory site and are running into push back. I am not sure they understand the regulations that would be needed but wanted to check to see if CA has anything "special".
There would be a mobile laboratory van that would do the testing but not hold the CLIA and the Ambulatory site that it will be attached to would.
Any thoughts on this? I am very leary since I am not sure they have the appropriate people in place for oversight.
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Anastasia, is the Ambulatory site thinking of applying for a CLIA of Accreditation?
Then the testing (for whatever reason..off-label, LDT?) they will perform in a mobile testing site using testing personnel to meet criteria to perform high level complexity testing, and also staff for the other CLIA roles needed for high complexity testing performed in CA?
Sorry if I am confused.
So it's a ambulatory site where the provider (dermatologist) that is coming in wants to so the complete MOH testing onsite...well actually it will be a mobile laboratory van in the parking lot that is the testing laboratory but they were told they cannot hold the CLIA.
I am very leary of the whole setup and so it the person I talked to. It sounds like a recipe for disaster to me.
I've got one of those in a DERM clinic in an ambulatory (that also has a PPM Certificate for POCT WT and microscopes for PPMPs, and that PPMP is held by a Derm MD). The MDs running/overseeing that MOHs service are not Pathologists. It's a Certificate of Compliance.
The original MOHs lab has been on the Galveston med school campus for many years - sits in a campus building which is 'outpatient'; does not involve Pathology, run by Dept of Derm and is a Certificate of Compliance. The Derm clinic (which is not 'the MOHS lab' service) performs their WT point of care testing and PPMP tests off of a PPM CLIA Certificate held by a Pathologist for all the point of care testing in that building.
Just an FYI, Anastasia!