ACT Reportable Range Verification

This was my initial thought, as well. But do you still feel that it isn't required when you look at COM.40300? This makes me think that it is required for everything implemented aft 2009, at least once. Am I overthinking?

We do it for initial validations for ISTAT and Medtronic HMS Plus.  For ISTAT, we use the Abbott Heparin Linearity procedure.  For HMS Plus, we use the Hepline kit from Medtronic.  We do this to meet COM.40300.  We do not do any 6-month AMR's since POC.08600 has that comment.

Thank You. I had done a Heparin Linearity with our previous instruments but had never done the 6-month. I was hoping to get information on the process (mainly materials) that others used for the initial verification. I appreciate your help. Do you happen to know how high the Hepline kit goes? Thanks Again!!

Looking at the COM.40300, it states to perform those studies "as applicable" and in COM.40475, it states if a validation or verification study was not performed or missing required components, the checklist requirement must be cited. I was not in Point of Care at the time of our initial validation but our written summary states it is exempt from reportable range studies since it is a clot-based method (they missed citing the actual requirement 🥴). The performance verification plan from Werfen does not include performing it either though. Unless your medical director or SOP states otherwise, I wouldn't sweat it. Are you all performing reportable range verification for PT and PTT in the laboratory? Those tests would be exempt too.

The hepline kit will depend on the normal donor.  We use many of the same lab coworkers willing to donate to our cause and usually get a range of 150-800 sec on the ACT.

Amber is correct, it is not required.  Reach out to your Werfen application consultant for assistance.

I would not take the word of a vendor on what is needed or required to meet any regulatory requirement. I've had many... lets call them "debates" with vendors and even after citing the specific regulation from Checklist requirements to only hear: "Well, we have other facilities that don't do that".   My response: "I don't care."
Call your Regulatory office,  explain the exact issue and get an official answer, ask for an email response as well as proof for the future if desired.  I do this.