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Tonya Sabin posted a reply on Re: JACO Officially listed i-STATs as a Blood A...

Tuesday, Sep 8, 2026 at 1:47 PM

Said: Hello all,I just wanted to circle back to this discussion. In April we found out about this change (our JC inspection was in Feb), then found out CMS was coming the following week for review. We wanted to get ahead o...

Kimberly Arnesen posted a reply on Re: Siemens DCA Replacement Validation Protocol

Tuesday, Sep 8, 2026 at 1:15 PM

Said: Hi,for new or replacement waived test instruments we have a validation summary page we use for all our devices with device info, serial number, date device was checked and tagged by Biomed, and that initial QC was performed and pass...

Rachel Donner posted a new Topic

Tuesday, Sep 8, 2026 at 10:08 AM

Siemens DCA Replacement Validation Protocol

We need to set up a replacement DCA for one of our outpatient clinics. DCA HA1cs as a new platform were initially validated over 10 years ago and included extensive validation testing (accuracy, precision, comparison, linearity). Given that the DCA HA1c is a waived test and we are regulated by CLIA/CAP, do you have any recommendations for replacement instrument validation protocols? We contacted the manufacturer and they said to follow our internal regulatory protocol (which would be...u...

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Dharati Patel liked a topic hs-Tnl verification- precision criteria

Tuesday, Sep 8, 2026 at 9:00 AM

hs-Tnl verification- precision criteria

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Anil Chokkalla posted a reply on Re: hs-Tnl verification- precision criteria

Monday, Sep 7, 2026 at 11:16 PM

Said: To meet the 4th universal definition of "high sensitivity" cardiac troponin assay, I would utilize <=10% CV at the 99th percentile upper reference limit. This limit could also be applied for i-STAT hs-TnI Controls Levels 1-3....