CLIA Checklist
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Anyone know how to go about getting a CLIA checklist for POCT?
I know CAP has one, should the lab be able to get one (or something similar) from CLIA if they are accredited by CLIA??
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Just to be clear on the terms/language:
CLIA does not accredit. They define laboratory standards that are then enforced locally by on-site survey by your state's BOL (Bureau of Laboratories) - ONLY if you have no accreditor. Accreditors for lab testing are CAP, Joint Commission, and formerly, COLA. All have deemed status to enforced CLIA regulations, as their checklists define. But I have never seen a POCT-specific "checklist" from CLIA, as we have come to know them. They define requirements by test complexity (waived, non-waived) or category (chemistry, microbiology), but not by where they are done (central lab or POC).
Yes, I worded that poorly. We are not CAP accredited. We are rural and are CLIA certified. I know CAP has a checklist, I was just wondering if CLIA had anything like it.
Suggestions for maybe a starting point for a "checklist" or something close?
if you go to cms.gov/CLIA there are lost of helpful bulletins.
CLIA don’t have a checklist like CAP. CLIA checklist is the CLIA regs.
Just read the regs line by line and make sure you have all that is required.