Breathalyzer/Smokerlyzer
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We have a rehab unit looking to purchase a breathalyzer that is waived, and a smokerlyzer that is waived, if available. When I research these, there is a list of CLIA waived breathalyzers, but not smokerlyzers, because the literature on some web sites claim that breath is not a specimen regulated by CLIA, but if this is true how can we have CLIA waived breathalyzers? This is in NY state.
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Beware of websites. There is one in particular where the actual NAME of the site is "CLIAWAIVED", so every item has a watermark across it that says that "CLIAWAIVED" - but it is actually the website "claiming" it as one of their items - not necessarily the true CLIA status of the item. Maybe that's what you're seeing. I have reported this to various vendors who have their non-waived equipment on this site without their knowledge.
To my knowledge, breath is not a specimen regulated by CLIA.
Thank you James,
I should have been more specific. I have a list of waived Breathalyzers, given to me from New York State department of Health. But I cannot find any Smokerlyzers listed and the smokerlyzer vendors state that breath is not a valid CLIA specimen type. How can breath be OK for Alcohol testing, but not smoking?
Gotcha.
Page 5 on this link indicates that breath testing for alcohol and H. pylori is exluded. Does not specify anything about smoke testing, but I think it would be safe to assume it is excluded as well??
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/R882OTN.pdf