Medtronic ACT Plus - Linearity

We are JCAHO-certified and use the Hemochron Signature Elites. In 2019 we were cited for not having performed bi-annual linearity (heparin response) correlations prior to 2019. I had begun performing them that year just prior to being inspected. The JCAHO inspector stated that because the manufacturer (originally ITC) had created a heparin response correlation procedure for use for validation, we were expected to perform this twice annually as with other moderate complexity testing. We don't validate AMR with it; we validate instrument correlation. We also don't use a kit; I spike donor blood across the therapeutic range and test all devices concurrently. It's quite a process, but this is the least precise point of care test device I have and seeing this data twice a year helps when Cath Lab gets heparin resistant patients and starts questioning the devices.

But JCAHO cites us on many things that CAP probably never would. Good luck in your decision making.

It is looking like we do not need to do the linearity on the ACT Plus.  Of course I will follow up with our Medical Director to get his input.  

Do you all do any sort of Calibration verification for these instruments?  They do not require user calibration so I was unsure if this requirement would pertain to them at all.  We have been just typing up a document with all of the QC precision data, instrument correlation data, PT results, etc. for this requirement to show that the instrument is accurate and functioning properly.