Interfering Substances / Regulatory Requirements - Fora GD20FM01 Operations & Procedures Manual

Interfering Substances
Interfering substances depend on the concentration. The interfering substances listed
below may produce elevated glucose test results (up to concentration levels noted).
Regulatory Requirements
The Clinical Laboratory Improvement Amendments (CLIA) has classifi ed tests of blood glucose as
tests that are waived. For all entities that conduct one or more tests, including waived tests
on materials derived from the human body for the purpose of providing information for the diagnosis,
prevention or treatment of any disease or impairment of, or the assessment of the health
of human beings, CLIA has stated that the entity conducting the tests shall meet certain Federal
requirements. If any entity conducts tests for the aforementioned purposes, then the entity, under
CLIA, is considered to be a laboratory and thus must register with the CLIA Program.
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