Transcutaneous neonatal bilirubin (TcB)

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I know this has been discussed before, but our sites are starting to discuss the possibility of using TcB for our outpatients, after a change in handling bilirubinemia has come out. I'm thinking that I remember that, though the device (Draeger) reads up to 20, there was a policy or something that said any bili over 8 or 9 had to be followed up with a serum bili. While I know that transcutaneous testing is not under CLIA, we would like to have some POCT oversight. If your organization is using TcB, can you let me know how it's handled? Do you trust the device up to 20, or is there a cutoff where a lab bili needs to be done? Is your POCT department handling this in any way?
Thanks in advance for any help.

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HI Kathleen,
Where did you find that it was not under CLIA?  I just received a request yesterday from our NICU department to bring this in house.  I too have the same questions you do and will begin the investigation of this meter.

Since it doesn't involve taking a specimen from the patient, it doesn't fall under the CLIA rules. This is similar to a pulse oximeter that goes on the finger and reads the patient O2. It's also similar to breath alcohol tests, which also are not considered as "specimens" by CLIA.
I think many organizations will begin looking into this, due to the recommendations from American Academy of Pediatrics to monitor newborn bilirubin. 

Hi,   I am the POC specialist for several pediatric clinics that use the Drager JM 105 transcutaneous meter.  We are considering putting it on RALS, that is in line with your previous discussion about the fact that it is not considered a  lab device since there is no specimen collected.  That decision is in discussion phases. I was wondering if anyone does have it interfaced through RALS and what that experience has been.
The way that our system currently works is the test is ordered and run by the nurses in the office after they do the daily checker check and record those results.  Patient results are logged on a separate logsheet and is then manually input into EPIC via their enter/edit function.  Those results in EPIC are charted on a graph automatically,  it is the result in mg/dL  graphed against the patient age in hours.  It is followed by a list of guidelines from American Academy of Pediatrics dated 2004.  
Keep the discussion going!  Thanks!

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Kathleen David
over 2 years ago
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