TEG 6S

Hi Tiffany!

We are going to be validating the TEG 6S in a few weeks. Send me an email:

ruth.harmala@mghs.org 

Ruth Harmala, MLS (ASCP)^CM

Point of Care Coordinator, Laboratory

UP Health System-Marquette

(906) 225-7492

Hey Tiffany and Ruth,

  We have been trying to get our TEG6 implementation/validation since July.  We are having difficulty getting TEG Manager and our LIS (Beaker/Epic) to communicate.  At this point we have determine that the clinicians will either have to enter demographic information before testing, pre order all specimens or put the results in afterwards.  We are hesitant to release an instrument into the OR/Trauma unit when so much of the work and resulting is manual.  What LIS systems do you guys have and how about you. 

Best,

 Melissa Burland   

Our OR is wanting to implement the TEG6 at our facility also. We would like for the instrument to be in the main lab and have results viewable on the large monitors in the OR suites, although the OR has other plans!!! Just wondering how/where everyone is planning to put this instrument and if at true POC with OR staff, how are you going to manage it?? Cartridges are very expensive and FDA has not approved for trauma use yet. Our plan is to use DI and Sunquest to interface to EPIC

Thanks!!

Kim

We implemented the TEG recently.  The manufacturer gave us specific instructions on  their validation procedure and they also crunched the data (this was a blood bank test so I was not involved).  To validate our normal range we took "extra" blue tops on "normal" (tonsillectomy, ear tubes...) kiddos in OR who where having blood drawn anyway.

We keep the instrument here in the lab and the OR sends us the blue top samples for their TEG patients.

Tracy

We run the TEG 5000 in the core lab. As the 6S is only approved for use with CV OR we will be keeping the 6S in the lab for now as well, and it may be moved to POC in the future. Currently we do not have the TEG manager interfaced with our LIS or EMR. We enter the demographics manually into the TEG manager with each test and print the report when the tracing is complete. We result 'TRACING COMPLETE' into the LIS and the report is scanned into the EMR as a lab report.

The OR and ED can view the TEG as it is running remotely on monitors in their department. I'm not sure what our plan is when we move to the new TEG manager...I imagine we will probably keep our process the same for now as we have other larger IT projects right now with our moving to a brand new lab.

Kim, do  you have Roche's Data Innovations or a different software? 

Yes the main lab uses Roche DI, and at POC we use RALS. RALS is not able to connect to TEG, so another reason we would like main lab to take ownership of this instrument.  Our lab IT person has been researching the connectivity piece so I am not completely sure how DI functions. 

I think our IT is in the same situation.  If we, by some miracle, find a way to interface through our DI system, I will let you know. May be we can provide some help (no promises though  ).

We had been told by the vendor that we would be able to use TEG Manager to interface directly to Epic. For our Point of Care middleware, we use Telcor. Our lab will be updated in 2020 to Epic Beaker, so hopefully both ITs will be able to figure out how to get it to communicate successfully with the current set up and the future.

We will be conducting the vendors validation process along with our more robust validation process for the new instruments, - between / within run precisions, and correlations. We just don't currently perform platelet mapping on the TEG 5000 in either the lab or point of care, so we are unsure how to conduct correlations or if there needs to be something performed to show correlation other than the test comparisons to the new instruments to each other. If that makes sense.

I don't completely trust Haemonetic sales reps.  We were told that it would connect to Epic no problem.  They even mentioned that our parent site was already connected and live.  (this was before I took over this role, so I am not sure why that was not confirmed before the contract was signed).  Come to find out, our parent site still has the TEGs in the boxes because they do not want to risk running them without the interface connected. 

As far as performing validations, we have TEG 5000s in the lab and based on studies and literature from the vendor we are not conducting a method comparison.  When I have these questions I always call CAP for verification.  I think because you are not currently performing that testing, you do not have to do a method comparison.  But I am still new at this.

Hi,

Where is it stated that the TEG S is only approved in the CV OR?  I can't seem to find anything online.  We are only just beginning the discussion of implementation of TEG or ROTEM and who will be performing the test.  Currently, our Trauma Team in ED wants to have the test.

Stacie

It has not been approved for Trauma only approved for cardiovascular but they have submitted to FDA for clearance. I had a demo last week.

Here is the statement from my TEG rep concerning the TEG 6:

I understand you are seeking FDA approval information for the TEG 6s. The below link is the 510(k) approval letter for the TEG 6S device (formerly called CORA):

TEG 6s Global Hemostasis 510k Letter and Decision Summary K150041.pdf

The indications for use is "with adult patients where an evaluation of their blood hemostasis properties is desired. Hemostasis evaluations are commonly used to assess clinical conditions in cardiovascular surgery and cardiology patients to assess hemorrhage or thrombosis conditions before, during and following the procedure." 

Hi JoAnn,

Thank you for sharing!

Stacie

Good morning! We have 2 Teg6S's in our OR and we are working on instrument comparisons. Would anyone be willing to share their process and or forms?

I can be reached at jessica.lang@stelizabeth.com

Thanks in advance!!

Jessica

We just found out we are getting this in the ORs. The manual says that a normal control should be drawn from a donor. So for those of you that have this test, are you or the ORs drawing someone every day for that? How long was it before you had an IQCP?