Off-Label Use

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Does anyone have a written guideline, educational tool for staff/physicians, or any other resources regarding off-label use of test systems?  I have recently performed re-education with staff and physicians that if they stray from the manufacturer's package insert that it makes the testing highly complex and their CLIA certificate type does not support that type of testing.  I am working on creating a permanent guideline that defines off-label use, the requirements to hold a highly complex license, and the consequences of not performing testing within the scope of license.


 


Thanks in advance :)

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Raychel Rusnak
almost 8 years ago
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