Medtronic HMS Plus HDR qc

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I’m trying to make sense of what my predecessor put in our procedure to “QC” the heparin dose response test on the HMS plus.

It says since there’s no specific controls, patient results were taken to establish a normal range, and any patients that result out of that range are retested using a fresh sample- for quality control purposes.

Does anyone else do this? I can’t find anything about it in the operator’s manual.
Or is there anything else people are doing for quality control for the HDR test?

Thank you.

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I'm not sure what your predecessor meant either....would be interested to see if anyone else is doing something for the HDR qc.
We run the HepTrac Electronic QC daily.
We run liquid QC (CLOTtrac and Heparin controls) for the HR-ACT and HPT tests. We did validation studies, so we only run the liquid QC with new lot/shipments of cuvettes and every 30 days if that lot is still in use.

Here you go, straight from our SOP:

At present time, there is no commercial control available which adequately addresses quality control of the HDR cartridge.   An alternative control is to record all patient results in the Heparin Dose Response Cartridges Log and regularly trend for consistent long-term performance.   This calculation is performed monthly and a new range is established approximately every 45-50 patient values. The range is recorded in the Heparin Dose Response Cartridges log by POC Lab.  If the patient HDR slope falls outside the calculate range established by this trending, the patient’s HDR is to be retested by Perfusion to verify that result.

We use the HDR logs supplied by Medtronic.  Each sheet has room for 25 results.  So once 2 of those are filled up, we calculate the new patient range.  We calculate:
1) Average of those results
2) STDEV
3) Average slope +/- 12% (as 12% is our ACT allowable tolerance), this range is tighter than #6
4) Current 3 SD
5) Our historical 3 SD (we calculate that every 2 years and it doesn't deviate much)
6) Then we calculate the new slope range by taking the average in #1 and subtracting the historical 3sd for the low limit and then the average by adding the historical 3 SD for the high limit.  That range gets written on the next 2 HDR sheets.  If a patient is outside this range, then the Perfusionist is supposed to repeat to verify.  We have never seen anyone be below that low range, but occasionally we do on the high end.  Our patient range is usually anywhere from 17-171 to 37-191 and in between.

 

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