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Said: UMMM...on the Nova 'statement'...if one is using one of the devices under the 'cross out' in the picture in a clinically acceptable manner under a written policy which clearly identifies under which conditions to use and to NOT use the ...

Said: Yup, that's correct! It would always have been considered high-complexity testing, but the change in CLIA makes it so a BSN is no longer allowed to perform that high-complexity testing. So as long as you're testing within the manufactur...

Said: so it is still lab defines critical ill (with director approval) and as long as do not use meter beyond critical ill definition, really no issuesbut if we use the meter for what is defined as critically ill then = high complex testi...

Said: Yes, Patsy, as the CLIA final rule is written, this would be accurate for any platform that has not been FDA-approved for use with critically ill patients. That's because using a testing method in a way it's not been approved for is "of...