Validation of Waived INR meters

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Hello POC enthusiasts!!


We have 15 Roche Coaguchek XS Plus meters coming to the clinic. What is the best way to validate all 15 at once? I need to know the what's, where's, why's and how's. The Coaguchek XS Plus are waived. Any advice will be greatly appreciated.


 


Thank you,


Julie Brim, MT (CLS) MS


Point of Care Supervisor, Vancouver Clinic


 


360-253-1403 OFFICE
360-397-2043  SALMON CREEK OFFICE
360-921-8996  MOBILE
700 NE 87th Ave., Vancouver, WA 98664
jbrim@tvc.org

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Hi,


In my previous life we got in Coaguchek meters.  To validate we went to the phlebotomy station where the patient were getting the INRs drawn. We had them draw into a syringe (instead of into the blue top). Using a transfer device, we filled the blue top and used the leftover blood in the syringe to dose the Coaguchek meters that were all set up and ready to get dosed with blood on the strips. We wrote down the Coaguchek results on a log next to each meter. The blue tops were processed as normal and sent to the lab for testing. We looked up the INRs to compare to the Coaguchek results. I don't know how many Coagucheks you could do off the syringe, you might have to split into a couple of groups. I know it's not quite comparing capillary blood to plasma, but we didn't want to ask patients for a fingerstick and a venous draw (they would have to sign a consent). Results compared well as I recall.

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Julie Brim
almost 6 years ago
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