Quick Answer: What Does CLIA Mean?

How do I know if a CLIA number is valid?

You may verify your CLIA certification level and effective dates at: https://www.cms.gov/Regulations-and- Guidance/Legislation/CLIA/CLIA_Laboratory_Demographic_Information..

What does it mean to be CLIA certified?

Having a CLIA certificate demonstrates that OralDNA® Labs meets the federal regulations for clinical diagnostic testing, ensuring quality and safety in the laboratory and laboratory results. Further, a laboratory can pursue a higher level of quality by becoming accredited by a recognized accreditation agency.

Who needs CLIA certification?

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 cover?

CLIA applies to all laboratories that examine “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” (42 Code of Federal Regulations [CFR] § 493.2).

What does a CLIA waived test mean?

As defined by CLIA, waived tests are simple tests with a low risk for an incorrect result. They include: Certain tests listed in the CLIA regulations. Tests cleared by the FDA for home use.

What is CLIA and what is its purpose?

In general terms, the CLIA regulations establish quality standards for laboratory testing performed on specimens from humans, such as blood, body fluid and tissue, for the purpose of diagnosis, prevention, or treatment of disease, or assessment of health.

What tests are CLIA waived?

Waived tests include test systems cleared by the FDA for home use and those tests approved for waiver under the CLIA criteria. Although CLIA requires that waived tests must be simple and have a low risk for erroneous results, this does not mean that waived tests are completely error-proof.

Is LabCorp CAP certified?

Investor overview top menu. BURLINGTON, N.C. –(BUSINESS WIRE)–Jan. 9, 2013– Laboratory Corporation of America ® Holdings (LabCorp®) (NYSE: LH) today announced the recent accreditation of its Biorepository by the College of American Pathologists (CAP).

What are the different types of CLIA certificates?

Certificate of Waiver.Certificate for Provider-Performed Microscopy Procedures (PPMP)Certificate of Registration.Certificate of Compliance.Certificate of Accreditation.

What are cap requirements?

Program Benefits CAP Laboratory Accreditation helps laboratories: Maintain accuracy of test results and ensure accurate patient diagnosis. Meet required standards from CLIA, FDA and OSHA. CAP requirements commonly exceed the standards, bolstering patient care and safety.

Do you need a CLIA license to draw blood?

Q: If I’m only doing blood draws, do I need a CLIA number? A: No. You do not require a CLIA number if the facility only collects specimens and performs no testing.

Why is CLIA important?

Why Is CLIA Important? CLIA established quality standards for laboratories to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test is performed. CMS data indicates that CLIA has helped to improve the quality of testing in the United States.

What is the difference between CAP and CLIA?

In general, CAP has more specialty-specific quality standards than other accreditation organizations. While the requirements across all organizations with accreditation authority differ slightly, they all represent adherence to a higher standard of quality than with CLIA compliance alone.

How long does it take to get CLIA certified?

4-12 weeksDepending 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.

How much does a CLIA license cost?

The fee for a Certificate of waiver is $150.

How do I get a CLIA card?

How Do I Get a CLIA Card?Must have completed CLIA’s State of the Industry Course located on the CLIA site under the “My Training” tab and click on “Online Learning Courses”Must have completed KHM Travel Group’s Getting Started Agent Basics Education.More items…•

Why was CLIA created?

Overview: In the wake of reports of inaccurate results from Pap smears intended to detect cervical cancer, Congress enacted the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to ensure the accuracy and reliability of all laboratory testing.

What are the 3 levels of CLIA testing?

The basis of the complexity of CLIA tests are categorized into three levels: waived tests, moderate and high complexity.

How do I get CLIA certified?

How do I apply for a CLIA certificate? The CLIA application (Form CMS-116) is available online. Send your completed application to the address of the local State Agency for the State in which your laboratory is located. Additionally, check with your State Agency for any other state- specific requirements.

How do I get a CLIA waiver?

To qualify for a certificate of waiver, your lab must only perform tests that have received the CLIA waived status. If you meet this requirement, simply fill out the application form CMS-116 at the CMS website or from your state health. The COW is valid for two years.