Is your service in compliance with CLIA?

 

Does your service do blood glucose testing on patients by using a glucometer or blood glucose test strips?  If you do, you need to make sure you have a Certificate of Waiver from CLIA (Clinical Laboratory Improvement Amendments of 1988).

CLIA requires all entities that perform even one test, including waived test 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" 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.

The CLIA application collects information about a laboratory's operation, which is necessary to determine the type of certificate to be issued and the fees to be assessed.

Below is the internet address to the Centers for Medicare & Medicaid Services.    http://www.cms.hhs.gov/clia/

Go to this page and then click on “How to Apply for a CLIA Certificate, Including Foreign Laboratories” on the left hand side of the page.

This page has information about CLIA requirements and also the CMS-116 form and instructions to fill out.  Once sent in and approved, you will be billed $150.00 every 2 years for the Certificate of Waiver.

 

Mail or fax your Certificate of Waiver form to:

 

Minnesota Department of Health

Licensing & Certification Section

85 East Seventh Place, Suite 300

Box 64900

St. Paul, MN 55164-0900

Phone:  651-215-8704

Fax:      651-215-8709

Contact:  Linda Traster

E-mail    Linda.traster@state.mn.us

 

If you have questions, please call us at the Regional Office.