validation for a new iSTAT handheld

Hi Ashlee,

What I do to validate a new iSTAT via CG8 and ACT-k:
3 patients on CG8 and ACT-k against the reference meter
CG8 controls in duplicate for 2 days
CG8 Cal/Ver 1x only
ACT-k controls in duplicate for 2 days

Per Abbott iSTAT procedure manual (page 13 and page 15), all that's needed to validate a replacement handheld is to run the external simulator. We used to do a validation that included Cal-Ver, duplicate runs of QC, and patient correlations but now we only run each level of QC per cartridge and run the external simulator. 

To validate a new iSTAT, we proceed with the following:
Day 1: External Simulator, Calibration Verification (1x), run 3 levels of tricontrols in duplicate.
Day 2: External Simulator, run 3 levels of tricontrols in duplicate, run one patient correlation in duplicate.

Since the assays already had initial validation, we do an abbreviated one for new devices.
- External Simulator
- Calibration Verification 1x on those cartridges that have that.  For ACT-K, we would follow the Heparin Linearity procedure in the Abbott technical bulletin.  We started doing this because CAP says you need to do reportable range on every device for validation and this was the best way to accomplish that.
- QC in duplicate over 2 days
- 5 patient correlations with low, normal and high values to be included