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Mary Bowles posted a reply on Re: i-STAT New lot of Liquid QC (Tricontrols)

Friday, Jan 27, 2017 at 11:28 AM

Said: : "Well said James! I would only add that whatever one's policy is regarding acceptable QC ranges (accepting assayed values, or running multiple tests and crunching numbers to tighten the range).....just be sure that your process is describ...

James Beck posted a reply on Re: i-STAT New lot of Liquid QC (Tricontrols)

Friday, Jan 27, 2017 at 11:12 AM

Said: : "I run them once, when first received, as they are assayed controls. Sounds like something that might be considered best practice, but I can't think of a regulation that is tied to, with those kind of specifics. An unassayed control would,...

Michelle Villas posted a reply on Re: i-STAT New lot of Liquid QC (Tricontrols)

Friday, Jan 27, 2017 at 10:45 AM

Said: : "My last lab director had me do this for new lot of controls. take the mean and SD and compare to value assignment sheets. I think that was just an extra step she wanted to do. when you do get new lots of QC for the istat, what are the ...

Kevin Gein joined the group.

Friday, Jan 27, 2017 at 9:23 AM

Kevin is AE works at Roche

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Pet Maniquis posted a reply on Re: i-STAT New lot of Liquid QC (Tricontrols)

Friday, Jan 27, 2017 at 8:30 AM

Said: : "An item we have to contend with next year. Don’t POCCs have enough to worry about! After IQCP, here comes another one. Has anyone been made aware of this new Federal Regs 21 CFR Part 866. I am forwarding this to you regarding the ...