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

It is the device though because the companies that make the meters did not use "critically ill" patients in the studies submitted to the FDA. Nova did but only venous and arterial samples in the adult populations and also capillary in the Neonate.  This is why Nova got the pass whereas Abbott and Roche did not. 

Use of the Hemocue for fingerstick (capillary) specimens may not be prohibited by their vendor statements but does not mean that they are any less susceptible to the same interferences associated with capillary specimens in critically ill (hypotensive) patients. Enforcement of the regulation may be relatively recent but the issues have been known for awhile. From a regulatory standpoint, the hemocue may let you get away with capillary specimens in critically ill patient but Im not convinced that it fixs the problem.

DA, I really respect this point of view and thanks for saying it!

Yesterday our POC Team were 'walking'/touring a new campus/new hospital with nursing management, looking for where glucose meters should be located.  In the discussion about putting a glucose meter in the OR, when I said something like 'remember to train/hit on 'critically ill patients', the ED Med Surg NM who has been working quite some time at the mother ship campus hospital said 'what do you mean?' The POC Director said something like 'the issues which have always been related to dosing from capillary'. Educating staff never ends on using ANY glucose meter!

Hemocue doesn't use the words "critically ill" but it does address the limitations in using FSWB as it states, "In cases of severe hypotension and peripheral circulatory failure, glucose measurement from capillary samples may be misleading. In such circumstances, it is recommended that glucose analysis be made using venous or arterial whole blood.

How are hospitals doing glucose determinations for NICU critically ill patients in regards to blood collection and testing methods? 

Thank you and happy Friday

I have been reviewing this discussion thread. James Wallen, your statement:

"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."

Is this just your institution's policy? Nursing can perform moderately complex if trained and 6 methods of competency are assessed.