Ann Silverio POCC RUMC Staten Island NY

Hi Ann, 

  To clarify, if you perform a validation study for using the meter in any capacity that is not validated by the manufacturer, then that moves the test to HIGH complexity, not moderate.

I had no other choice but to perform my own validation studies on the Abbott PXP meter for use with critically ill patients with my previous employer. We defined "critically ill" as all patients in any ICU. We excluded ED because those patients are not being monitored for diabetes control in that location, if they are DKA they are admitted to ICU. Once we defined critically ill, we performed a lookback study over two years where all ICU's in all 17 of our hospitals where a patient had an AM glucometer test in tandem with their morning run Comp or Basic. We ended up with thousands of data points. From that data we were able to calculate analytical and clinical sensitivity and specificity. I prepared a poster around that data actually. The data looked excellent, and validated our meter for use in our specific critically ill patient populations for our ICU's. 

Phase 2 was notifying nursing that now that the meter can be used with critically ill patients, that doesn't necessarily mean that they SHOULD use it for them, and it requires a higher level of critical thinking to determine if that testing is ok for that specific patient. As a result, the test has moved to HIGH COMPLEXITY for those departments. All testing operators in the ICU's would need to have a Bachelor Degree in a life science, or we would need to evaluate transcripts for appropriate credit in biology and chemistry course work. Luckily, many of our larger hospitals are Magnet, and had over 80% BSN nurses. It was painful, but can be done.