McKesson TRUEresult - Regulatory Requirements - CLIA

Regulatory Requirements - CLIA
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/rr5413a1.htm
.
TRUEresult
®
Quality Assurance / Quality Control Manual
9