TEG6S Method Validation

We recently brought on the HN cartridge and 1 new TEG6s. We already were performing the Global cartridge on 4 TEG6s' and that validation was before my time. We treated it as though it were an entirely new method. We treated one instrument as our primary instrument and then compared our other 4 instruments to it. Our policy has us run 40 patient specimens, and QC over a couple of days. 

Question for TEG 6S users--is it performed in the lab or are you using it as POC? We have it but is a hybrid, Anesthesia MD runs in the OR but it is not interfaced, the lab enters the results into SunQuest, so lab oversee them. Lab runs samples from the rest of the house.  OR wants POC to oversee the TEG and have it like the iSTAT. They do not want to do QC--say their colleagues only do 1x per quarter?? I am not involved, probably going to be, so just trying to see what everyone else is doing.  What is your IQCP? 

We have TEG6s in our OR, but our lab runs ROTEMs. Our Tegs are interfaced. All the operators have access to TEG Manager. The OR is responsible for running all the QC; new lot/new shipment/ every 30 days/new operators. POC just runs 6-month correlations.  

Cory-Interfaced with RALS/Telcor or does the TEGs interface directly to your HIS? Does POC dept do training/competency, or do you have a technical consultant in the OR?  OR is running QC once per month--do you use these QC values to compare your instruments to your "reference TEGs" Sorry for multiple questions, I do not have a lot of knowledge with this instrument. Who buys/stores reagents? Who in OR is running the test--CRNA, Anesthesiologist, Perfusion, RN, OR tech???

Interfaced with RALS/Telcor or does the TEGs interface directly to your HIS? Teg Manager directly interfaces with Telcor
Does POC dept do training/competency, or do you have a technical consultant in the OR?  We have a technical consultant in the OR who previously was the consultant for the TEG5000. Someone from Haemonetics came onsite to train him, POC, and the initial staff training.
OR is running QC once per month--do you use these QC values to compare your instruments to your "reference TEGs" Yes, for our correlations we use QC and compare all the instruments and verify that our values are falling within the SD range recommended by Haemonetics
Who buys/stores reagents? The departments at our site are responsible for purchasing and storing supplies. POC will assist, but it is not our responsibility
Who in OR is running the test--CRNA, Anesthesiologist, Perfusion, RN, OR tech??? Perfusion uses the TEG for ECMO, otherwise ANES techs perform the majority of testing. And others have access to TEG Manager.

We did not correlate TEG5000 to TEG6s when we originally validated.  We treated it as a new method completely.  Our TEG6s used as POC devices in CVOR are interfaced through Telcor.  We onlly have 4 Perfusionists that run these and they do sign off on training and competency right now, but I need to double check that again witht he new CLIA reg updates.  QC is run 1 time each month on all 3 devices.  One is the "reference" that new lots of cartridges and QC are run on.  We used manufacturer ranges.
TEG6s is also used in our Main Lab and is not interfaced to the HIS, but I don't have any idea of why not.  I feel like that should have been done when implemented.
Since we provide the extensive oversight that is necessary, the Lab gets the revenue for this testing and buys the supplies.