CLIA Waived

Waived Tests are defined to:

Employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or
Pose no reasonable risk of harm to the patient if the test is performed incorrectly;
Are cleared by the Food and Drug Administration for home use.

Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988 establishing quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed.
A laboratory is any facility that does laboratory testing on specimens derived from humans to give information for the diagnosis, prevention, treatment of disease, or impairment of, or assessment of health.
CLIA is user fee funded; therefore, regulated facilities cover all the costs of administering the program.
Centers for Medicare & Medicaid Services (CMS) assumes primary responsibility for financial management operations of the CLIA program.
The categorization of commercially marketed in vitro diagnostic tests under CLIA is the responsibility of the FDA. This categorization includes the process of assigning commercially marketed in vitro diagnostic test systems to one of three CLIA regulatory categories based on their potential for risk to public health:
waived tests
tests of moderate complexity
tests of high complexity
CLIA categorizations will also be announced in Federal Register Notices, which will provide opportunity for comment on the decision. FDA may reevaluate and recategorize these tests based upon the comments received in response to the Federal Register Notices.
FDA will revise as necessary criteria for waivers, moderate and high complexities.

A1CNow+® is classified as a CLIA waived test by the FDA.
A CLIA certificate is required any time a clinical laboratory test is performed; however, performance of waived category tests requires only a CLIA Certificate of Waiver.
Labs that perform waived testing must enroll in the CLIA program by obtaining the certificate, pay the certificate fee every two years, and follow the manufacturer’s instructions in performing clinical lab tests.
To apply for a Certificate of Waiver, go to www.cms.hhs.gov/clia, download CLIA application form (CMS-116), follow the instructions provided, and send it to the appropriate state agency.
A list of state agency addresses is also available on the internet at www.cms.hhs.gov/clia.

The ADA recommends that healthcare professionals use A1C point-of-care testing for timely decisions on therapy changes [2]
Giving diabetes patients on-the- spot feedback on their A1C number may result in a 1% point reduction in their A1C [3]
A 1% point reduction lowers the risk of serious complications by 40% [1]

Centers for Disease Control and Prevention. National diabetes fact sheet: general information and national estimates on diabetes in the United States, 2002. Atlanta, GA:
U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, 2003.
Standards of Medical Care in Diabetes - 2008. Diabetes Care, Volume 31, Supplement 1, January 2008.
Daniels, E. et al, Point of Care Testing to Improve Glycemic Control.Intl J or Health Care Quality Assurance 2008; 21 (3): pp. 325-335.
Data on file; Evaluation of the A1CNow SELFCHECK with lay-users. August 2008.
* Study results with healthcare professionals showed that the accuracy of A1CNow+ with fingerstick samples was, on average, 99%. This means that, on average, a true 7.0% A1C could read approximately 6.9%A1C. An individual A1CNow+ result may differ by as much as -1.0% A1C to +0.8% A1C from the true result. This represents the 95% confidence limits of a Bland-Altman plot.
Miller CD et al., Rapid A1C availability improves clinical decision-making in an urban primary care clinic. Diabetes Care 2003; 26:1158-1163.
Cagliero E et al., Immediate feedback of HbA1C levels improves glycemic control in type 1 and insulin-treated type 2 diabetic patients.
Diabetes Care 1999; 22: 1785-1789.