SevenExcellence Body Fluid pH CLIA Complexity
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Good morning. My Lab is considering adding body fluid pH to our menu. We are looking at the SevenExcellence.
Can anyone tell me what the CLIA complexity is? I think I have read every piece of literature out there and cannot find anything.
Thanks :)
Can anyone tell me what the CLIA complexity is? I think I have read every piece of literature out there and cannot find anything.
Thanks :)
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When I look up CLIA complexity the first place I go is the FDA Website:CLIA - Clinical Laboratory Improvement Amendments (fda.gov), https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/Search.cfm?sAN=0. But "Body Fluids" is not a selectable analyte on the website. And there are so many products which test for pH.
Next I look at the very difficult to read Title 42 Chap 4 SubchapterG part 493.15, c, 1, vii specifically states urinalysis for pH beng waived. Again that is not all body fluids and there is no wording for Body fluids, pH testing in the waived portions of the law. eCFR :: 42 CFR Part 493 -- Laboratory Requirements
After that I look at the "Tests Granted Waived Status Under CLIA" which contains CPT codes. In that document, CPT 83986QW Page 16. https://www.cdc.gov/clia/docs/tests-granted-waived-status-under-clia.pdf uses the term "Body Fluid". Winner Winner Waived.
This is a quick help when researching test possibilities.