CAP POC.07520

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Hi all,
I was wondering if any of you had the MedTronic HMS Plus instrument that uses the HDR cartridge in your facilities? How are you handling the POC.07520 Alternative Control Procedures standard? Since there is no commercially available QC to order what are you doing in your facilities for "alternative mechanism to detect immediate errors and monitor test system performance over time"? Our CAP Challenge does not address this cartridge, so I am looking for ideas for how you are managing to meet this standards in your facilities. We are including in our IQCP a monthly testing patient specimen in duplicate but wondering if there is something else we could be doing to meet this standard. Interested to hear some of your ideas and practices. 
Thanks!
Christina Okuma

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Christina,
Yes, we use the HMS Plus and HDR cartridge.  I had this very same issue when attempting to set up the system, (HPT, ACT and HDR cartridges).  I called several facilities about how they were addressing this and ultimately ended up calling CAP regarding this because I didn't like the answers.  I explained the situation to CAP and was told that as long as we were following the manufactures recommendations for monitoring the system we would be fine.  I emailed a summary of the specific situation to CAP requesting a responce back as documentation of this for reference if it is ever questioned.

So we basically do a Xbar (average all HDR test results) and review the against the mean per manufacture recommendations.

we use the Medtronic ACT II / Plus for ACT, and the HR cartridges. On each day of use, they run the two levels of the electronic QC (ACTtrac 100 device) and weekly, they run lab-provided Precision Biologic Norman and Heparin Controls.  The precision biologic controls - 80 vials / slat are stored at -70, then thawed and sent out weekly. CRYOchek Normal + CRYOcheck Heparin. 

The package insert recommends trending the results looking for inconsistencies.  
Attachment.
HDR package insert.jpg

Hello, I used this at my previous job, we were a CAP laboratory. I have a policy for the alternate assessment for both the HPT and HDR. If you want to email me I will be happy to send it to you.  cdougan@pathassociates.com  

Hi Christina,
We calculate the slope every 50 patients and check for trends or issues with the HDR cartridges. 
Erin

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