TEG/ROTEM in Peds

Hi,
in our pediatric hospital, lab leadership decided that the rotems would be in blood bank and all testing would be done there by lab staff.  They are interfaced to the ORs so they get to see all the graphs as the samples are being tested.  We considered a few years ago to move them to the ORs and have the OR staff do the testing but after issues with QC performance, we moved them back to blood bank.   That may be an option for your facility if they fall under the LDT category under the new FDA rule

Hi Martha, I hadn't paid much attention to the LDT issue before because I didn't think we had anything that applied.  My understanding (and I could totally be incorrect) is that any LDT will have to go through FDA submission.  Please correct me if I'm wrong anyone because I would love to be educated on this lol.

From what I understand is devices used on pediatric patients will fall into the "Unmet Needs" category and will not be subject to the full set of regulations.

We don't currently have this testing at POC but had been considering it. We would likely place the devices in the lab. Or, like Lois said, it may fall into a different category altogether. There's so much unknown yet. I've listened to a couple great webinars about it but no one has all the answers and are waiting for CLIA to provide clearer communication.