Intraosseous specimen on ISTAT

The i-STAT can only be used with arterial and venous whole blood. Any other specimen type would be considered high complexity.

 I spoke with the rep that was teaching EZIO to the nurses. I happened to be next to them at an ER training day.

The documentation for the EZIO at one time showed the differences between the marrow results and the venous ranges that all of us are used to. Sodium in particular is very different. The ISTAT will run it.

We caught them using IO specimens once with a CBC being sent with a BMP. The results looked like a leukemia, and both specimens were rejected.

While the ISTAT itself is not approved for IO specimens....IT WILL run them......

Deanna Bogner

We went through this debate a year or so ago only because we found out that it had been used for some time behind our backs. Anyway, debate between ED/Trauma and my supervisor and medical director result on this compromise: if IO is the only way to obtain a sample the cartridge to be run is the CG8. The source of OTH is supposed to be used. Using OTH prevents the results from entering our EMR because of the blood gas associated with the CG8 (there most like will be *** also because of the actual sample itself). The docs have immediate access to the results but not in the EMR. A correction form is to be sent to the lab with 2 identifiers and that this was IO. We will manually enter the results, attaching a comment regarding the IO source and then release the results to the EMR. We will then credit the charges since IO is not an approved source for the ISTAT.

The ISTAT will try to perform a test on any fluid sample that is put into the cartridge.  This type of sample would need to be worked up as a Laboratory Developed Test per CAP or JC standards.  It would also be considered high complexity. Even though you may not charge for this test,  if a physician is acting upon these results and they are put in the EMR, I do not see how anyone could get around the CAP regulations unless the inspectors do not know this is happening.

This falls under our Medical Director who signed off on the policy. IO is only to be used in extreme cases (which I have a feeling it is at every institution utilizing ISTAT or other meters, behind closed doors.) We went for years not knowing it was happening. Many of those results probably did not make it to the EMR since like others said, the results are not good and can star out or fail to give calculated results. We just tried to deal with the issue that will continue whether we know about it or not. Believe me, much debate occurred. The docs did much article research also. If you know ISTAT, it is not the matter of the lab giving the result-the results are available bedside.

My medical director would not allow this testing to occur at this facility unless there was LDT documentation so thorough that he felt he could without a doubt defend the test to regulatory and/or legal entities based on the studies. 

  If you cannot impress upon your ED clinical staff the implications of what they are doing (given the regulatory obstacles everyone has cited here), I wouldn't be above ratting out my own ED department to CLIA, so they hear it from the top what they are risking.  I think you're really setting yourself up for trouble here. 

Our ED on occasion has run the iSTAT on IO blood.  According to what I've read it is basically venous blood so could be run.  I found some info that NA, K, TCO2, CA could be affected.  Ivy

I would argue that regardless of scientific literature, if IO specimens are not explicitly stated as an allowable specimen by the manufacturer you will need to validate as an LDT and follow high complexity testing regulations.

If providers are running IO specimens "under the table" then your only options are to pull testing or again, validate as an LDT and follow high complexity testing regulations. This is understandably a very tough position to be in depending on whom you are arguing against.

We ran into this last year as well and decided to proceed as Debra explained.  The issue with a LDT is that you need to validate it.  There is no feasible way to do a validation on the specimen type.  Not only will it be problematic to find volunteers for IO specimen collection, the patient population is patients in shock.  There is really no way to validate the test for the sample type and patient population.  This is really last-ditch effort to get any working knowledge on a patient that is near death.  All of our physicians/pathologists are aware of the risk of running a non-validated test and have chosen to sign off on the policy regardless.

We have not actually had any testing and hope not to!  We will not charge for the testing.