The CMS regulates all laboratory testing (except research) on humans in the United States through regulations established by the Clinical and Laboratory Improvement Amendments (CLIA) of 1988...
No POC BGM has ever been cleared by the FDA for critically ill patients.11 Therefore, these devices are being used “off-label” in the ICU, operating room, recovery room, and emergency department...
In contrast to the off label use of drugs, the off label use of laboratory methods is against the regulations. More from the article:
The CMS recently became aware that POC BGMs are being used in hospitals off-label and is ready to enforce the prohibition of their off-label use, according to 2 recent letters from the New York State Department of Health.
Despite the fact that virtually all hospitals have been doing this for decades and it has become a standard of care, CMS has only recently become aware of it!! Well that illustrates how profoundly out of touch they are with what really goes on at the “point of care.”
According to one of the authors in the accompanying video CMS is poised to cite or even shut down hospitals. The authors propose a moratorium on further regulatory action.
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