A Clinical Laboratory Improvement Amendment (CLIA) Certificate of Waiver is a certification that allows a facility, primarily laboratories, to legally examine a person through waived tests in order to assess health, diagnose, and determine treatment.
- A Clinical Laboratory Improvement Amendment (CLIA) Certificate of Waiver is a certification that allows a facility, primarily laboratories, to legally examine a person through waived tests in order to assess health, diagnose, and determine treatment. Each CLIA Certificate of Waiver includes a ten-digit CLIA number, issued by the U.S. Department of Health and Human Services, that identifies each separate certificate.
What is a CLIA certificate for?
The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certified by the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing. Each agency has a unique role in assuring quality laboratory testing.
How do I get a CLIA Certificate of Waiver?
You can enroll your laboratory in the CLIA program by completing an application (Form CMS-116) available on the CMS CLIA website or from your local State Agency. Send your completed application to the address of the local State Agency for the State in which your laboratory is located.
What are the 3 types of CLIA waivers?
CLIA regulatory requirements classify testing into three categories: high complexity, moderate complexity and waived.
What is the purpose of CLIA waived tests?
Waived testing is laboratory testing that employs specific test methods designated under the Clinical Laboratory Improvement Amendments (CLIA) of the Food and Drug Administration (FDA) as “waived.” Waived testing is designated by CLIA as simple tests that carry a low risk for an incorrect result.
Who needs a CLIA waiver?
CLIA certification is required for facilities that test clinical specimens for the purpose of diagnosis, treatment, or prevention of disease. If your facility only collects specimens to be sent out for testing at another facility, then CLIA certification is not required for your facility.
What does CLIA accreditation mean?
In 1988, the US government passed the Clinical Laboratory Improvement Amendments act (CLIA 88 or CLIA), which specified regulations and standards for all facilities in the United States that perform laboratory testing on human specimens for health assessment or the diagnosis, prevention, or treatment of disease.
What tests are considered CLIA waived?
What are CLIA waived tests?
- Employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible.
- Use unprocessed specimens (whole blood or oral fluid)
- Pose no reasonable risk of harm to the patient if the test is performed incorrectly.
- Are cleared by the FDA for home use.
What is an example of a CLIA waived test?
As defined by CLIA, waived tests are “simple laboratory examinations and procedures that have an insignificant risk of an erroneous result.” Examples of waived tests include: dipstick urinalysis, fecal occult blood, urine pregnancy tests, and blood glucose monitoring.
Do you need a CLIA certificate to draw blood?
Q: If I’m only doing blood draws, do I need a CLIA number? A: No. A: The law requires that all laboratories performing testing, no matter what type of testing they are performing, must have a certificate and obtain a CLIA number.
Who is exempt from CLIA?
“CLIA-exempt” formally refers to a laboratory (not a test system) and means a laboratory that has been licensed or approved by a state where CMS has determined that the state has enacted laws relating to laboratory requirements that are equal to or more stringent than CLIA requirements, and the State licensure program
How does CLIA certification work?
CMS surveyors conduct a survey (inspection) and determine that the laboratory is compliant with the applicable CLIA requirements. This type of certificate is issued to a laboratory that performs nonwaived (moderate and/or high complexity) testing.
How long does it take to get CLIA certification?
Depending on your state health department, it can take between 4-12 weeks to receive your CLIA certificate. The CLIA certificate of waiver is necessary for state and federal compliance, and provides the benefit of facilitating provider reimburse- ment for the use of CLIA-waived tests.
What does CLIA mean?
“CLIA” is the acronym for the Clinical Laboratory Improvement Amendments of 1988. This law requires any facility performing examinations of human specimens (e.g., tissue, blood, urine, etc.) for diagnosis, prevention, or treatment purposes to be certified by the Secretary of the Department of Health and Human Services.
What is the first step for a CLIA waived test?
You can enroll your laboratory or testing site in the CLIA program by completing an application (Form CMS-116 ) available on the CMS CLIA website or from your local State Agency. Send your completed application to the address of the local State Agency for the State in which your laboratory or testing site is located.