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Glen McDaniel posted a reply on Re: NOVA: New Lot Validation
Thursday, Jan 30, 2025 at 1:05 PM
Said: We don't. I agree with others here that as a waived system new lot verification, or lot-to-lot comparability is not required by CLIA or CAP. We do the full validation of course when bringing on a new fleet of meters. We do l...
Danyel Olson posted a reply on Re: NOVA: New Lot Validation
Thursday, Jan 30, 2025 at 1:02 PM
Said: CAP does not have a requirement to do anything and neither does TJC that I'm aware of. Unless the manufacturers instructions advise something, it's not required. That being said, we generally follow the generic "best laboratory practice...
Jeremy MacDonald posted a reply on Re: NOVA: New Lot Validation
Thursday, Jan 30, 2025 at 1:01 PM
Said: Liz, for new LOT of Strips: run both levels of QC 5 times and enter this into a spreadsheet that includes the previous LOT number's QC x̄.I'll email you our spreadsheet that automatically grades it once the data i...
Danyel Olson posted a new Topic
Thursday, Jan 30, 2025 at 12:59 PM
iSTAT hs-TnI cartridge - pediatrics
Anyone else out there using iSTAT cTnI in a pediatric population? Got the notice today about the transition to the new hs-TnI. Here's the 510K K240984. I'm trying to get my hands on the IFU.
We currently do not have a main lab method in place - never have due to fairly low volumes. We want to transition all troponin I testing to the main lab but it got cut from the budget this year. But I certain...
We currently do not have a main lab method in place - never have due to fairly low volumes. We want to transition all troponin I testing to the main lab but it got cut from the budget this year. But I certain...
Amanda Casavant posted a reply on Re: NOVA: New Lot Validation
Thursday, Jan 30, 2025 at 12:49 PM
Said: HelloIf we are discussing the glucometer strips then as a waiver test under CAP & CLIA no validation is required. Not sure about TJC rules regarding waived testing. This is all I do before placing a new lot ...
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