Total transcutaneous bilirubin instrument

Our L/D unit has one as well - but we do not oversee it.  I believe this falls into the same category as breathalyzer testing - because there is no actual specimen the lab does not oversee it.  I would double check with your accrediting agency.

Kate

Our L/D department has one too. We do not manage it. 

Same as above. Since there is no "sample" its not considered a POCT.

Yup. We have a slew of them in- and out-patient. We do not include as 'laboratory-based point of care'.

'CLIA Exempt' label used to be used for these nonFDA classified for complexity since there is no specimen, not a 'lab test' (another hot topic has been breath hydrogen testing in GI).  

In addition to (deemed) accreditation on the clinical use/nursing use side of these devices, if KY has additional state regs on lab testing, that may be something to look at. 

Good luck! 

We have multiple ones at our sites also but we don't oversee it in POCT.