Drager JM105 bilirubin jaundice meter

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Does anyone oversee this meter in their hospital nursery unit? Is it CLIA waived? I cannot find any indication it has a CLIA status.
I just discovered our nursery has been using it and now they want to interface it, to our RALS system, so they can discontinue manual charting.
In my opinion, if it is not CLIA waived, it is not a lab device. I don't believe they have ever compared to the lab. Don't know if they even send off for
regular calibration. If you do oversee, can you share your procedure, training checklists, etc? Do you bill for it?
Thanks!
Deborah Martuch
deborah.martuch@hf.org

6 Replies

Kathleen David

Fri Mar 03, 2023 at 1:30PM

Because it's transcutaneous, CLIA does not consider it a specimen, and therefore it is not under CLIA (like a pulse oximeter for O2). Our sites have been using it for years, and have recently asked us if they can interface it with Telcor. We don't have anything to do with it at this point, and if we interface it we still wouldn't monitor it. I believe some sites do compare the device with the lab, but we do not. If there is billing going on, it's a manual process, and something we would have to consider if we do interface the devices.

Anita Belanger

Fri Mar 03, 2023 at 1:40PM

This has also come up at my facility. What Kathleen stated is correct; there is no specimen. There is also no PT material. We held firm that this is not a laboratory test.

Sandra Bijani

Fri Mar 03, 2023 at 2:12PM

The nurseries use it at our facility and we do not manage their procedures or training. It does run throughTelcor (changing later this year) and Sunquest LIS to Epic HIS. I've been blessed with QML oversight. It's been painful but I'll preface this with the fact that we are on a really old version of QML and newer may play better.

They use an average 5 readings but if the analyzer turns off (dead battery or time out) between readings, it will send across 2 or 3 results causing flags and it never fails that the one recorded in the flowsheet (does not get rid of the charting here) is not the one that Telcor put through.
Nearly a year ago, none of the computers hooked up to the download stations were working properly. We had a LOT of results to manually order and result until IS finally got it resolved.
Staff scanning in PID for OID, sometimes another patient's PID for OID.
If no OID was entered, Telcor sends it through to Sunquest and in Telcor it looks successful (accession number is populated). Then they call because the result is not in the Lab results. We found the OID was still pending. I periodically pull all tests in Results and check for a blank OID. It'll flag for a bad one but not a missing one, go figure. Just got back from vacation and there are four so I'll go into the LIS and enter our unknown operator number.
image.png
Patient ID scanning issue - Worked with our IS team but could never resolve why check digits sometimes scan in and other times don't (same meter, same download computer). AND, if the check digits don't display, the last number is missing off the patient ID so they've been taught to complete a TCB Test Result card to send if the check digits don't show or if the result doesn't display in Epic (as with the missing OIDs above).

If you do go this route, I would suggest that someone in nursing admin be in charge of monitoring the JM105 system in Telcor.

Sherilyn Solanick

Fri Mar 03, 2023 at 3:19PM

It is not a CLIA regulated test. Our lab does not train or take care of it. I have also held firm that it is not a lab test.

Brystal Romero

Mon Mar 06, 2023 at 11:21AM

Glad to hear other facilities are also keeping this out of the POC Scope. We have also decided not to manage this device.

Angie Yost

Mon Mar 06, 2023 at 11:52AM

We are in the process of interfacing this device with RALS. Since it is not a CLIA regulated lab test, we will not be overseeing it, but are simply interfacing it to avoid manual test result entry.

As more and more medical devices become interfaceable, I imagine this will come up more often. I can foresee all the vital signs eventually charting directly. Whether this will be an interface shared with POC is yet to be seen.

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Drager JM105 bilirubin jaundice meter