ACT-LR Survey Failure - API

I would call API and asked if they have the same sample leftover. They usually have some leftover samples that you can order with $, if it was not expired. And you can retest the sample. 

Echo what Jenny suggested.  Otherwise, you've covered the obvious areas, clerical, QC, and instrument.  With Hemochron ACT, the nature of how both the QC and PT samples are made and have to be prepared, survey failures are almost always sample-handling related.  Nature of the beast.  If it's only one sample of multiple that failed, and you've shown that the operator can successfully perform QC, it's not a sample handling issue that needs to be addressed with the operator, and you as the POCC have done your due diligence.  Only a very unreasonable inspector would disagree with that.

I agree with those above.

If you could share what value you got in the testing and what was the expected range for the value.  The reason I asked is often with the ACT testing, there is a twostep preparation of the sample.  Often the first step is to hydrate the sample, then dilute it with the Calcium Chloride to have a final solution.  That is how the CAP sample needs to be prepared prior testing.  Hopefully the sample preparation was done in accordance to the instructions.

Based on your information, if QC came in and no clerical errors, that that would rule out application of the sample, device and consumable (pre-analytical, analytical and post-analytical steps).  The next step would be to rule out the sample. 

I think the two-step process would just apply to a tube-type ACT test, where there is a diluent and a CaCl2 solution.  Hemochron LR method would be a cartridge test, where the PT is packaged pretty much like the DirectCheck QC vials.