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Max Mauch posted a reply on Re: CLIA 12/28/24 Technical Consultant interpre...

Thursday, Jan 30, 2025 at 2:06 PM

Said: COLA certified Laboratory. I called in to COLA for clarification on this, and they are stating that any RN degree does not qualify as a TC, even if the RN degree would pass the credit requirements for course work. This is pu...

Danielle Keogh posted a new Topic

Thursday, Jan 30, 2025 at 2:00 PM

CLIA 12/28/24 Technical Consultant interpretation

I am looking through the qualifications as of 12/28/24 in eCFR :: 42 CFR 493.1411 -- Standard; Technical consultant qualifications. We have RNs that perform competency assessments for moderate complexity POC tests currently. Looks like nursing degree is not sufficient now and we need to assess their transcripts for the required biology and...

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Glen McDaniel posted a reply on Re: NOVA: New Lot Validation

Thursday, Jan 30, 2025 at 1:49 PM

Said: Best practices are from industry experts basically, so I always start with regulatory standards, then CLSI. But for some things it can be CDC or professional standards. E.g. for blood culture contamination we have used 3% for a long tim...

Karin Gehringer posted a reply on Re: NOVA: New Lot Validation

Thursday, Jan 30, 2025 at 1:46 PM

Said: You have to do a "Performance Verification" study not a "Validation" study. There's a difference between these two. Performance Verification is for waived tests. Nova StatStrip is waived, so when a new lot of reagents is put into use, y...

Liz Reed liked a reply on topic Re: NOVA: New Lot Validation

Thursday, Jan 30, 2025 at 1:42 PM