CMS S&C 15-11 Off-Label/Modified Use of Waived BGMS

Is it moderately complex to use a venous sample on the i-STAT using the GLU cartridge? Does it make a difference if its a venipuncture venous sample or if it is a venous central line draw?  Thanks for your help. 

The Hemocue Glucose 201 or 201 DM analyzer  is another option to concider, rather than the I-Stat or lab analyzers. This analyzer can still be done via fingerstick since its done via a glucose dehydrogenase method and a photometeric detection. Coorelation studies in several published reports state that this analyzer coorelates well with lab analyzers and its a lot cheaper then the I-Stat.

The iSTAT CHEM8+ cartridges are waived. In a cardiac and/or pulmonary event 

nursing collects a venous sample and performs a BMP using iSTAT CG8+. A glucose only 

cartridge on the iSTAT would be considered moderately complex and nursing would be 

disalowed from performing the test.

Is anyone using the I-STAT for BhCG in their ED? If so, how reliable are the results? The ED Medical Director wants to start using it, but I need some feedback from people who are using it including the pros and cons. Thank you

Claudia Leblanc

Is it your local policy that nursing cannot perform a moderately complex test?

That's interesting Alayna.  I was under the impression that capillary blood from a critically ill patient cannot be tested on any poct method.

That is correct. Nursing cannot perform moderate complexity testing. Our MRI

technicians perform capillary creatinine testing using the NovaStat Sensor which is 

moderately complex. We had to provide diplomas for each staff member performing the 

test to our accrediting agency. Nursing service does not perform any moderate complex

testing.

Hemocue wrote me this in an email " HemoCue glucose does not have any patient-type limitations and can be used in all areas of the hospital (e.g., such as the ER, ICU or NICU)." Fingersticks with Meters aren't allowed the Hemocue and I-Stat are analyzers. Istat can even use capillary samples as quoted in their email: "The i-STAT glucose cartridge can use capillary, venous or arterial samples.   All are whole blood and not considered off label."  I've written both CMS and CAP and confirmed as long as we abide by the analyzers limitations we could use the Hemocue and be in compliance.

Unfortunatly we did neither and my hospital has choosen to wait out this storm, though I don't see this going away any time soon.

The i-Stat and Hemocue are considered analyzers, not meters.  The fingerstick on critically ill patients is only a restriction on meters.

Keep in mind that the Chem8 cartridge is only waived if the sample is collected in a Na or Li Heparin vacutainer.

These are not "critically ill" patients. They are in for an MRI scan. Even though it is

considered moderately complex capillary specimens are acceptable for creatinine 

measurement on the NovaStat Sensor. For glucose testing in "critically ill" patients

the NovaStat glucose meter can be used, but it must be a venous or arterial whole blood 

sample.

We are aware and nursing uses Li Heparin containers.

Our instituttion has not defined critically ill. (Not my choice - admin's decision) We have modified the sample collection part of our Accu-Chek policy to indicate any pateint with compromised perfusion should not have a POC Accu-Chek glucose performed and the blood glucose should be tested with our EPOC analyzer (mod complex, venous or arterial samples only). Epoc is a Point-of-Care device that has been approved for use in critically ill patients.

Remember that with "critically ill" patients it's the fingerstick WB (sample) that's problematic not the device.