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Accu-Chek Inform II users- how did your institution define Critically Ill
Accu-Chek Inform II users- how did your institution define Critically Ill
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Hi Everyone,
Here at Main Line Health in PA, we are using the Accu-Chek Inform II (POCT) knowing that had not been approved for use in the critically ill. The system administration chose to define 'critically ill' as 'any patient boarding in an ICU bed' back in 2016 making it a high complexity test according to the FDA. This necessitated, that in the ICU units, only nurses (BSN or with the designated education) could perform fingerstick glucose testing on ICU patients (critically ill). With the changes that CMS made in the document issued 12/2023, a nursing degree (BSN) no longer qualifies them to perform high complexity testing as it is no longer considered equivalent to a biology degree.
As the lab administration starts to consider all options to address this change, the POCCs have been asked to find out how other hospitals who are still using the Accu-Chek Inform have defined their 'critically ill' population.
I would really appreciate any and all responses to this request.
Melissa Willcox MT ASCP POCC Main Line Health willcoxm@mlhs.org
This is how the Accuchek standard defines 'critically ill' at our facility. There is a hard stop in EPIC that will not allow Accuchek results to upload to the EMR if they meet this criteria.
I know I'm resurrecting an old thread here, but we are coming up on our glucometer contract renewal and using it as an opportunity to revisit our critically ill glucose testing policy. In doing so, we've been looking back at the original FDA executive summary which speaks specifically to capillary samples being the issue. So my question is, do the same rules apply to venous and arterial samples in critically ill patients? Is it a device issue, or a sample type issue? In other words, can we run venous and arterial blood on the Inform II in these patients, or are all sample types restricted?
I believe the Nova StatStrip meters are FDA approved for use with all samples types for "critically ill" patients, including capillary samples. Unfortunately, the other glucometers are not approved for use with any sample type for "critically ill" patients, making it off label and high complexity to use with that patient demographic.
