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I just discovered that one of our clinics that operates under a CLIA Certificate of Waiver is attaching a comment to hemoglobin results listing an estimated hematocrit. They are getting the hemoglobin with a Hemocue (waived) so that is fine, but they are using a chart provided by Hemocue to determine an estimated hematocrit. Is this ok under a Cert of Waiver? Never a dull moment!
Interesting. As long as it is clearly reported as an estimated value, I am thinking it should be OK, especially since it is derived from a legitimately waived status test. But perhaps it's best to check with CLIA or your BoL. (State)
That is very interesting. Does HemoCue state that the hemoglobin has been validated as a calculated value? If not, I don't think that would be appropriate unless your staff did a validation to confirm the accuracy of calculation. Especially if this is used for treatment or diagnostic purposes.
Jake, did you mean to say is hematocrit validated as a calculated value? If so, I am not familiar with any requirement to validate any calculated parameter as long as it is clearly labeled as such, so that it is not confused with a test measured directly. That would be why things like method or instrument validations are restricted to only measured tests, and not calculated values. I would think the same logic would follow with this, but I may be wrong.
Here is the chart from Hemocue. I've emailed the CLIA offices in both MO and IL, but it usually takes a while to hear back.Hemocue Hb to Hct conversion chart.pdf
I heard back from both CLIA offices and they agreed that the testing is inappropriate under a CLIA Cert of Waiver because the Hemocue's FDA approved package insert does not mention determining a estimated hematocrit with the hemoglobin result. So basically it would be using the device off label.