Resulting Out PT/INR results
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Someone told me about this and I want to understand if this is true or I misunderstood
I was informed that reporting out the PT results, makes a waived PT/INR device nonwaived. Is that true?
I have never heard that before.
If a device is an FDA cleared waived device, reporting the output of the device does not change the classification of the device.
If my understanding is correct, INR results are the results most clinicians use.
The PT results are not standardized and has little utility.
I'm not sure what the individual who told me that is valid, but any insight would be welcomed.
When reporting out PT/INR results, do you only report out the INR results at your facility?
Should the PT results be suppressed in the patient medical record? Does it have any utility?
Thank you all for any insight that you can provide.
I was informed that reporting out the PT results, makes a waived PT/INR device nonwaived. Is that true?
I have never heard that before.
If a device is an FDA cleared waived device, reporting the output of the device does not change the classification of the device.
If my understanding is correct, INR results are the results most clinicians use.
The PT results are not standardized and has little utility.
I'm not sure what the individual who told me that is valid, but any insight would be welcomed.
When reporting out PT/INR results, do you only report out the INR results at your facility?
Should the PT results be suppressed in the patient medical record? Does it have any utility?
Thank you all for any insight that you can provide.
1 Reply
Jo, I had never heard that reporting the PT seconds changes the CLIA-waived status, but I will say that our sites that report a POC PT-INR do indeed suppress the PT-seconds value to limit confusion over the value when compared with non-POC testing.
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