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Shalon Pescalia posted a new Topic

Wednesday, Nov 23, 2022 at 9:14 AM

AMR Gem 5000 validation

Hello everyone,
i am new to this group and would like to ask for everyone expertise please. We're validation the Gem5000 but on AMR values particularly > for the O2Hb, MetHb and COHb. Any suggestions? we're using Telcor as well.

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Max Mauch posted a reply on Re: 6-month comparison for waived?

Wednesday, Nov 23, 2022 at 9:07 AM

Said: Jennifer,Yes, that is how I read it too. Only non-waived need a comparison. Waived tests would still need PT or Alternative assessment.

Cindy Sorensen posted a reply on Re: I-STAT Troponins

Wednesday, Nov 23, 2022 at 9:03 AM

Said: We are CAP certified and I think with them it becomes a lab developed test if you continue to use them. They haven't weighted in yet but Abbott is talking with them.

Contessa Hall posted a reply on Re: I-STAT Troponins

Wednesday, Nov 23, 2022 at 8:55 AM

Said: That's what I posted- that is the letter the FDA required Abbott to send out to their customers

Jennifer Toncray posted a new Topic

Wednesday, Nov 23, 2022 at 8:54 AM

6-month comparison for waived?

We have a Coag Clinic that uses CoagSense, which is waived. They do fall under CAP currently. When I was reading over the checklists for the CAP standards, I am under the impression that you only need to do 6-month comparisons with the lab for non-waived testing. Is this correct?

Thank you all for being so helpful!

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