HMS- Medtronic

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Hello 
Does anyone have the HMS Medtronic? Im was wondering if anyone could share how they established the AMR and  Reference ranges for all cartridges.
In addition, what are you using for QC for all HPT, HDR, and ACT? What are you doing for linearity, verifications, cross-checks, or any method-to-method?  

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I can answer some of your questions, however any initial AMR testing/validation study was done before I took this role, so I am not sure how that was done.
For QC we use the Medtronic heparin assay controls for the HPT cartridges. The QC is specific to the color of the HPT cartridges you use. For the ACT, we use ClotTrac HR  Normal and Abnormal controls. As far as I know, there are no controls for the HDR cartridge.
We do semi-annual comparisons between the 3 instruments that we have, using either a patient sample or a ClotTrac control.
We are CAP accredited and they do not require AMR for clot-based coagulation tests.
I found the technical service rep at Medtronic to be extremely helpful. Feel free to PM me if you need any other details.

Hi Patricia. Thank you for your answer! (I had the same question as Fatimah)
We have four HMS analyzers and are also CAP accredited. For HDR, you mentioned you use patient samples for instrument comparison. Do you get volunteers for fresh blood samples? We're trying to figure out how to do a comparison for the slope result on the HDR. We don't have any acceptability criteria for it or fresh samples to do a comparison with. In the past, we've just gathered data from a period of 6 months and used a bar graph to visualize comparability over time.  

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Fatimah Ali
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