Medtronic ACT plus QC frequency

We perform liquid QC weekly (beginning of work week-Monday) and EQC every 8 hours.  We set it to "Warn" not "Lockout" in case of emergent cases.  If cases are still on going around 1400, we run QC right after.  The CCL RNs also run EQC before they leave for the day, in case they get called in.

EQC every 8 hours.  LQC every new cuvette lot and/or shipment.  There is no place I see where the manufacturer requires weekly LQC.

The ACTtrac operator's manual states: "In the US, CLIA requires 2 levels of QC for coagulation testing every 8 hours that a device is used for patient testing.  This may be accomplished using liquid controls or a combination of liquid and electronic controls.  frequency of liquid controls may be reduced to every 7 days and with change in cartridge lot number following completion of the appropriate validation process and upon approval of the medical director for point of care testing."

Hello.

My manual is from 2015 and states:

Use of Cartridges and Controls

Please refer to the specific cartridge and control package inserts for additional detailed warnings and precautions regarding use. Treat all blood samples as potentially infectious.

The package insert for the cartridges does not state weekly QC.  It only states that it is used to verify instrument and cartridge performance.  If used in place of EQC, must be done every 8 hours.  If EQC is used, follow the current regulatory agency requirements.

We were inspected in 2018 and had no issues with each new lot/shipment.

We have an IQCP for the HMS. We perform external QC weekly and each new shipment. The HepTrac electronic QC is run every 8 hours.

We also perform with each new lot number and eqc every 8 hours of patient testing.

What is everyone doing for the HDR cartridge QC? Our current method involves tracking slope values for 50 patients and re-evaluating the min/max and mean after 50 patients. These new values are then ‘used’ as the acceptable slope range for the next 50 patients. I think we should be using the data to calculate stand deviations, not just using the the current data’s min and max as the acceptable range. But what do you do when you get a patient slope that is out of range? Statistically 5% of your results will fall outside of 2SDs. Do you accept one out as a random error? I am not an expert with the HMS. I appreciate any insight! Thank you!

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Hi Ruth,

Admittedly I don't know too much about HDR either. But since HDR is a modified HR-ACT test could you use your ACT liquid QC data to calculate acceptable HDR slope ranges?

I would be curious of what Medtronics would have to say.

Would anyone be willing to share their procedure for the Medtronic HMS plus ACT?  My hospital has purchased 3 instruments and Perfusion will be using them.  I am not familiar with this instrument so any insight will be great!

Thanks!

Shea Woodward

Hi All

This is my first post and I am a newbie POCC. HMS is problematic and I recently thoroughly looked at our IQCP and made multiple contact attempts with Medtronic. I have some PDF's I can share that Medtronic sent me. You can use 20 samples for HDR slope and do this annually. Medtronic suggested using employees, but go figure how are we ever able to collect sample and test in 60 seconds? So as with everyone else we use 20 patients and do a 2SD range. I have this set up in excel to punch in the 20 results and the SD and mean populates.

Make sure the perfusionist document all cartridge lots and when they use. Keep logs in Surgery/OR. As long as you have all this documented then you have it all covered come inspection. LMK if u want me to share my logs etc...

Lastly did anyone know that Medtronic has a Hep Line linearity kit? But you will need to collect 30 mls of blood(maybe from a poor performing CLS) for this kit. We dont do this and I was wondering if anyone does?

Thx

Lisa

We have used the Hep line kit in the past every 6 months for AMR validation/cal ver. We no longer use it. It is more convenient than making your own heparin dilutions, but it is very tetchy to perform. You do have to collect 30-35 ml of blood, and you need to immediately put the measured amounts into the tubes with the heparin dilutions. The blank, of course, needs to be measured immediately. It takes 2-3 people to make sure everything gets done, and you need to have everything in the same place. It actually does a dose-response curve, and our medical directors agreed that it was not necessary to do 

HMS Plus Validation of Perfm Specs 2 (2).pdf HMS PLUS 4 0 SOP NCCLS.doc

Here are a couple of files to help with HMS.

  HI ALL: Some details below that may help you!

Hi Lisa,

I'm starting a new thread about your HDR slope questions.

N=20 is a common number for minimal statistical significance. S ome hospitals use additional slopes (up to 50) if the average slope differs more than 12% from the previous year.

Slope studies are performed on non-surgical patients who are willing to donate 3ml of blood. Typically it's OR and Lab personnel, or anyone else POC can recruit!  Samples are collected typically in the Lab in the HMS syringe on the end of a 21 or 23 gauge butterfly. You definitely do not vacu-tainer into a tube.

The HMS must be in the Lab so you can initiate the HDR within 60 seconds of the draw.

I hope this helps clarify some of the details and logistics.

Ben Smith

Medtronic Clinical Specialist-HMS/ACT

Cell: 415-640-8226