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Jake Fray posted a reply on Re: CLIA waived breath alcohol test device - va...

Monday, May 10, 2021 at 5:13 PM

Said: Hello, We asked about this during our 2018 JC inspection and they told me that breath isn't a measurable body substance so it doesn't follow CLIA rules for validation. I asked after I was cited on pH paper used for...

Karen Updegraff posted a new Topic

Monday, May 10, 2021 at 4:59 PM

CLIA waived breath alcohol test device - validation needed?

Trying to cover all the bases here. I know breath alcohol testing isn't POC per se, but it is on our CLIA permit. What type of validation plan and what type of sample would be used to validate a new BAT device? Thank you in advance for everyone's input.

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Kurt Kemp has joined the group.

Monday, May 10, 2021 at 3:02 PM

Kurt is Point of Care Coordinator works at Shannon Medical Center

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Vicki Strahan has joined the group.

Monday, May 10, 2021 at 9:54 AM

Vicki

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Deborah Willems has joined the group.

Sunday, May 9, 2021 at 12:15 PM

Deborah is MT(ASCP) POCT Educator works at Hutchinson Regional Medical Center