Alcohol Testing AlcoScreen BreathScan QED A150 Breathalyzers Home Alcohol Test Kits Adulteration Basic Metabolic Status Creatinine Serum Test I-STAT Controls Cancer Screening Cardiac Markers Clinical Chemistry Reagents Cholesterol Cholestech LDX Supplies Cholestech LDX Cassettes CardioChek-Medical CardioChek-Home Creatinine Testing CLIA Waived Drug Tests Diabetes Testing Bionime Glucose Meter CONTOUR Glucose Meter Drug Test Dip Cards ACON Drug Testing Kits Fastect II 1-Panel Drug Tests Fastect II 4-Panel Drug Testing Instant-View Drug Tests QuikTox Drug Test RapidTOX Drug Test Drug Testing Controls Drug Testing Cups CLIAwaived Inc. Cup EZ Split Cup iCup QuickScreen Cup ToxCup DrugCheck Cup Drug Testing Generic Single Dip Cards Single Drug Cassettes Multi Panel Dip Card Multi-Line Cassettes EZ Split Drug Test Cups Drug Testing Hair Drug Testing Other Adulteration Buprenorphine Oxycodone Propoxyphene Saliva Supplies Steroid Fecal Occult Testing Glucose Testing HemoCue Supplies HemoCue VET Supplies Hemoglobin/Hematocrit Testing H. Pylori Testing Infectious Disease Testing Chlamydia HIV/AIDS Herpes Influenza/FLU Legionella Mono RSV Vaginalis Ketone Testing Lab Supplies Cole-Parmer Eppendorf Fisher Safety Labnet-Digital Dry Baths Sigma-Aldrich Lead Testing Medical Supplies MicroAlbumin Testing Monthly Specials Drug Test Kits Monthly Specials Clinical Tests Nebulizers Nicotine Testing Ovulation Testing Oximeters Pregnancy Testing CLIAwaived Inc. Cassette Dip Strip Controls Prothrombin Monitoring Professionals Home Use PT/INR Products Thyroid Testing Urinalysis Testing Bayer Products 1-11 Parameter Strips Mission Urinalysis Vaginalis Testing CPT Codes-Reimbursement Drug - Clinical Testing Catalogs

About CLIA

CLIAwaived.com
11578 Sorrento Valley Road, Suite 25/26
San Diego, CA 92121
Telephone: 858-481-5031, Email: info@cliawaived.com
      
CLIAWaived.com has provided many helpful links below for your review. If you need any help locating or purchasing a CLIA waived device please contact us by email at info@cliawaived.com or call us toll free at 888-882-7739.

Background about CLIA
The Clinical Laboratory Improvement Amendments of 1988 (CLIA) law specified that laboratory requirements be based on the complexity of the test performed and established provisions for categorizing a test as waived.Tests may be waived from regulatory oversight if they meet certain requirements established by the statute. On February 28, 1992,regulations were published to implement CLIA. In the regulations, waived tests were defined as simple laboratory examinations and procedures that are cleared by the FDA for home use, employ methodologies that are sosimple and accurate that mistakes are unlikely and negligible; or pose no reasonable risk of harm to the patient if performed incorrectly. To view a listing of waived tests click one of the links below:
Waived tests
Waived Analytes

Who regulates the CLIA Program?
CMS (Center for Medicare and Medicaid Services) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). In total CLIA covers approximately 175,000 laboratory entities. The Division of Laboratory Services, within the Survey and Certification Group, under CMS has the responsibility for implementing the CLIA Program.

Does my office or company need to apply for a certificate?
CLIA requires that all entities that perform even one test, including a waived test on ..."materials derived from the human body for the purpose of providing information for diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of, human beings" to meet certain Federalrequirements. If any entity performs tests for these purposes, it is considered under CLIA to be a laboratory and must register with the CLIA program.

How do I apply for a CLIA Certificate?
CLICK HERE (new window will open)

Download the CLIA application
CLICK HERE (new window will open)

How do I contact my state office?
CLICK HERE (PDF - new window will open)