What Is CLIA?
Often we are asked by distributors why it is important for a test to be CLIA-Waived. Well to answer that question it is first best to explain what CLIA stands for. The Clinical Laboratory Improvement Amendments of 1988 specifies that laboratory requirements must be based on the complexity of the test performed. As a result, they established provisions for categorizing a test as Waived.
If tests meet the requirements set by this statute, then they may be waived from regulatory oversight. On February 28, 1992, regulations were published to implement CLIA.
Waived tests were defined as simple laboratory procedures that are cleared by the FDA for home use and that incorporate methodologies that are so easy and accurate that it is unlikely that mistakes would occur. Another requirement is that they would pose no reasonable risk of harm to a patient if they were performed incorrectly.
ALFA’s CLIA-waived products
The majority of ALFA products are CLIA-waived. We make rapid IVD testing as easy as can be. Interested to place an order? Let us help. Call (877) 204-5071 and reach out to our dedicated customer service team who are happy to help you.
Do I Need A CLIA-Waived Test?
CLIA requirements do apply to entities that perform testing 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 Federal requirements. If the tests are performed for these purposes, the organization doing so is considered under CLIA to be a laboratory and must register with the CLIA program. In these instances, the advantage of using a “CLIA Waived” test is that it “waives” you from having to comply with a long list of laboratory requirements (such as quality control, training, etc).
CLIA regulations do not apply to settings such as Correctional (i.e. jails, prisons, probation, courts, etc.) or even Workplace markets. However CLIA-Waived tests can still be sold to them as if they were not Waived at all. As distributors typically sell to multiple end user markets, having a selection of CLIA-Waived tests is advantageous as it avoids limiting their sales avenues.
Additional information on CLIA can be found at http://www.fda.gov/cdrh/clia/cliaWaived.html.
For state by state reimbursement fee schedule go to www.cms.hhs.gov.
How ALFA Can Help?
At Alfa Scientific, our key area of focus is in Drugs of Abuse Testing. As such, we have several “novel” products which would be of interest to any distributor competing in the Drugs of Abuse market.