Use of the Abbott I STAT Analyzer in a mobile setting between Nursing Homes

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Cardiology has approached the lab to partner with them. The request is for their staff to use the I STAT  on a given day  at multiple nursing homes.  The analyzers and cartridges will travel with the Cardiology staff when they visit the patients in the SNF. The cartridges that they are interested in is BNP and CHEM8. What should I be aware of from CLIA/Regulatory, Transport of the device and cartridges, Training, etc to determine if it a pathway to go down? 
Any insights and thoughts will be appreciated.


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We used PT/INR meters in Home Health in a similar way.  We needed to apply for a mobile CAP number.  I am not sure of all the details but we needed this to be able to use the meters at traveling locations.  If you call CAP they can walk you thru it.  it was not an additional number but a change to our existing number.

Hey Mark! (Small world!! How are things in Meriden? )Those cartridges would be considered moderately complex, so you will need to do orientation, 6 month competency and then 12 month competency for the operators. Also, the CLIA license needs to include moderate complexity. We only use the iSTAT for creatinine testing, which is waived. For POCT similar to what your cardiology group wants to do on the iSTAT, we use the Siemens EPOCs.  They are also moderately complex, and we only use them here in our hospital, where the CLIA license covers moderately complex testing.  

Hi Mark!!  Another thing with the CHEM8+ cartridge - capillary blood is not an acceptable sample type per Abbott:

"If capillary whole blood is a required sample type at your facility for the cartridges listed above, it is recommended that your facility evaluates the potential to transition testing to an alternate i-STAT cartridge or an alternate test method that supports the use of capillary whole blood. Abbott will notify customers when the products are available for use with capillary whole blood again.

The listed cartridges may continue to be used with venous and/or arterial whole blood samples."

Ignore the caveat if staff are planning on drawing venous samples to test!

Take care,

Kate

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Mark Dalidowitz
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