Reference Range and Waived Testing
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Hi,
Our waived clinics have adopted a new HbA1c instrument and the manufacturer insert has a reference range for HbA1c that is different from our current accepted range.
Do we have to adjust our range to the manufacturer’s?
We are CLIA accredited for waived testing only.
Thanks!
Our waived clinics have adopted a new HbA1c instrument and the manufacturer insert has a reference range for HbA1c that is different from our current accepted range.
Do we have to adjust our range to the manufacturer’s?
We are CLIA accredited for waived testing only.
Thanks!
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Best course of action would be to run a comparison study between the old and new instruments. You may find there is a clinically significant difference in results between the two platforms. This would then require the reference range to be modified for the new platform when you go-live with it.
You will want to have your documentation of how you determined what your reference range will is, (and signed by your Medical Director).
For instance, our reference range for HbA1c goes as low as 3.5% but the instrument only reads as low as 4%. Our options are to change our reference range, report out less than 4% if the instrument indicates so, or cancel the test and suggest testing via an alternative method.
If the stated manufacturer's AMR only when down to 4.0 but you reported the 3.5 that would make it high complexity. Easiest solution to prevent this is to have it report <4.0 and yes, change your reference range. I wouldn't cancel the test, it would have already been ran, costs accrued.... and you'd likely be giving them the result <4.0 without any documentation to the effect. I would have a canned comment added to the effect if it was required to have more specific result than the <4.0, XX test should be ordered.