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Self-testing and point-of-care testing of blood
glucose has been classified by the Clinical
Laboratory Improvement Amendments (CLIA) as a
waived test. CLIA requires all entities that perform
even one test, including waived tests, [on materials
derived for 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] to meet
certain Federal requirements. If an entity performs
tests for these purposes, it is considered under CLIA
to be a laboratory and must register with the CLIA
program.
Waived laboratories must meet the following
requirements:
• Complete the Clinical Laboratory Improvement
Amendments of 1988 (CLIA) Application for
Certification. Form CMS-116. The form and
instructions on completing and mailing the form
are found on http://www.cms.hhs.gov/CLIA/06
How_to_Apply_for_a_CLIA_Certificate_Including_
Foreign_Laboratories.asp#TopOfPage.
• Pay applicable certificate fees biennially.
• Follow manufacturer’s test instructions, including
instructions for Quality Control, maintenance, and
storage instructions.
Upon approval of Form CMS-116, a Certificate of
Waiver is forwarded to the laboratory.
For more information on the CLIA program, see
http://www.cms.hhs.gov/CLIA/.
For a comprehensive look at waived testing, see
http://www.cdc.gov/mmwr/preview/mmwrhtml/
rr541a1.htm.
TRUE METRIX
®
PRO System Comprehensive Resource Guide (GDH-FAD Enzyme) CLIA Requirements 5
CLIA Requirements