Medtronic HMS Plus proficiency testing?
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I'm bringing in 3 Medtronic HMS Plus analyzers into the CVOR. This analyzer performs ACT, Heparin assays of varying concentration levels and HDR (High Dose Response to heparin)
For those of you that already have this system: I have found proficiency testing for the ACT without any difficulty. I can not find any for the Heparin assays or HDR testing however. How are you doing proficiency testing for them?
Using QC would seem pointless, you would need to tell the performing staff which cartridge to use and all QC clots on channel 4. Spiking samples would be very difficult to complete given the 60 seconds to test requirement and location of the meters being in 3 different OR's.
How did you perform this proficiency testing?
Thanks,
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What did you find to do the ACT proficiency testing?
We use the CAP survey CT-1 for the Medtronic ACT and CT-5 for the iSTAT ACT.
I also contacted API who has for the Medtronic ACT and HMS plus:
Program info:
212 ACT - 5 samples
917 ACT - 2 samples
J17 ACT -verification Program - 2 samples.
unfortunately neither has anything for the Heparin assay or HDR cartridges for the Medtronic HMS plus.
Jeremy,
We use a Hepline kit, which can be ordered from Medtronic, for the Heparin Assay alternative PT testing. (I also use the hepline kit for the linearity on the istat ACT at the same time.) The kit comes with 5 vials containing 1-5 u of heparin. We have to have a volunteer donor for 30ml of blood, not the ideal but it works.
We haven't found anything yet for the HDR for QC or PT but I haven't found anyone that has. The Medtronic HDR QC plan just seems ridiculous.
We use the Hepline kit also for alternative PT testing. Also keep track of the patient slopes for the HDR. And use the CAP CT-1 PT.
Hi Jeremy,
We use the Medtronic HMS Plus analyzers. There is no proficiency material available for the HMS Heparin procedure. As recommended by the manufacturer, we purchase the HEPline Kit from Medtronic and perform twice a year. The kit consists
of 5 tubes which contain increasing concentrations of heparin from 1 to 5 U/mL when fresh whole blood is added to a final volume of 5 mL. The Catalog number is 313-50
We perform the CAP CT1 proficiency survey twice a year for ACT.
We use the Medtronic Hepline kit as well!
We used the HEPline kit for our linearity for ACT. I wasn't aware you could also use it for the Heparin assays but it does make sense.
Kerri: "ridiculous" I couldn't agree with you more. I fail to understand how a test with no associated QC got past the FDA. Between this and the TEG 6s that requires Donor for the normal QC and is very sensitive to the donor using any drugs or supplements....
Thanks
HAHAHAHA...oh yea the TEG is a whole different ballgame :)
Hi everyone!
We also use the CAP survey CT-1 for ACT and keep track of the patient slopes for the HDR. For the Heparin Assay alternative PT testing, we developed our own procedure using fresh spiked samples from a donor ,based on Medtronic recommendations for the targets of the specific cartridges we use at our organization (see table below). We perform this linearity test on a biannual basis, and coordinate this task with the perfusionist team, to have the two instruments available to run the test on both instruments at the same time. Sometimes, we may need to come as earlier as 4:30 am to get the linearities done before the OR procedures start.
As you can see in the table below, we also run a ACT test with every heparin cartridge to compare these results with the heparin results at the different concentrations. Obviously, at a heparin concentration of 4.4 and 5.0, your ACT will be out of the instrument reportable range, however, it gives you the assurance that you have applied the correct heparin concentration.
At first look, it seems like it is lot of work, however, it is a good back-to-basic lab process that we enjoy performing. After 5 years or more of doing it, we have developed good pipetting skills and the process goes smooth every time.
Hope this helps!
Heparin Conc. U/mL
Heparin Conc. Mg/kg Result
100 U of Stock Heparin mL
Blood mL
ACT
Cartridge
0
0.0
0.000
5.000
Y
Red
1
0.7
0.050
4.950
Y
Red
3
2.2
0.150
4.850
Y
Silver
4
2.9
0.200
4.800
Y
Silver
6
4.4
0.300
4.700
Y
Green
7
5.0
0.350
4.650
Y
Green
Thank you all, good info. :)