Drager JM105

My predecessor had bilirubinometers  in POC. Then during my first inspection, the inspector asked a lot of questions and conferred with CAP about the meters.  It was determined that the device was akin to stethoscopes and sphygmomanometers and there is no QC or PT available, so the devices do not need to be governed by the lab.
Please check with your regulatory agency and find out if there is a standard to cover them.

We currently use the Drager JM-105 at our hospital and the outlying community clinics with pediatrics. Our POC team does oversee even though it's not CLIA regulated. We connect through RALS at this time.

We have them routed through RALS and overseen by POC mostly as a courtesy. They work OK, there's periodic issues with the device connecting to the Drager software (which is only available on CD lol). Honestly, I need to re-assess how we manage them because the previous POCC set them up like a true POC device - which causes problems since it doesn't have an operator lockout feature or anything.