ACT iSTAT testing

Ok, to clarify, you line all up all of your istats and run 5 QC runs of each level and compare them every six months. 

What is ARM verifications? I've never heard this term. Thanks!
Jake

We validate new iSTATs for ACT by drawing 5 donors and comparing the ACT result to a predicate iSTAT. We also complete a 5 day QC study (2 Levels, once a day for 5 days). 
We do not run Cal Ver material, but Eurotrol just came out with CueSee Coag that could be used.

Every 6 months:  compare one Hepline kit sample between the HMS Plus and the i-Stat, compare one sample of same lot # QC on every i-Stat.  When I worked at a hospital that didn't have another ACT method, I just did the QC comparison.

Replacement i-Stat:  run 2 replicates of 2 levels of QC on 2 days (ex. Day 1 = level 1 twice and level 2 twice, Day 2 = level 1 twice and level 2 twice), run 3 patient samples on the new analyzer and an existing analyzer and use the semi-annual method comparison criteria to evaluate.

No calibration verification, AMR verification, or linearity studies.

AMR = Analytical Measurement Range.
All analyzers have a manufacturer defined test range (AMR) that they can test for.

Example: a manufacturer of a analyzer that tests for Hemoglobin might *claim* the analyzer can accurately measure sample levels between 0.9 g/dl and 25.0 g/dl.... you must prove this claim by running a linearity that it is accurate between this range... OR you must modify the AMR to something you can prove it is accurate to.   I've had to modify AMR ranges of tests on several analyzers because they either are not accurate for the entire range or linearity material isn't available to prove the claimed range.
Coag tests are exempt from validating the AMR every 6 months by CAP.

For our 6 month comparison we use quality control data. We use the same lot over a time period and use data to compare analyzers. 

We follow CAP guidelines and per CAP POC.08600 AMR verification is not required for clot-based coagulation tests, platelet function tests, and
other tests where output is a unit of time or arbitrary reporting unit (rather than measured analyte concentration). For a new device you would need to complete accuracy, precision studies. Depending on your medical director how many samples you need for the method comparison /accuracy (usually 10-20) but up to their discretion. 

I correlate all our ISTAT ACT devices 2x/year with patient samples compared to a reference ISTAT that we keep in POC Lab.  I can't do all the samples on all devices at the same time, so I usually do them per area.  For example, I compare all the Cardiac Cath ISTATs to the reference, then I move to some Heart Hospital floors and do those against a new patient sample on the reference, etc.  I enter the results into EP Evaluator.

For new devices, the method is already validated so we do a "mini" validation.  We run the external simulator and get the thermal probe reading.  I perform a linearity using a Heparin Linearity procedure that Abbott has in their manual.  I do this because it is listed in as needed to perform Reportable Range in COM.40300, but I do not do this again every 6 months as it is listed as not required to do an AMR in POC.08600.  We then run QC in duplicate over 2 days for Precision.  5 patient correlations are run against the reference ISTAT with the % difference calculated.  Our TAE for ACT is 12%.