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Louisiana Department of Health & Hospitals | Kathy Kliebert, Secretary

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Statewide Initiatives



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Common Questions - Clinical Laboratory Improvement Amendments (CLIA)

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If our laboratory only collects specimens which are sent to a reference laboratory for testing, do we need a CLIA certificate?
If we do not bill Medicare or Medicaid for reimbursements, do we still need a CLIA certificate?
If we only do one or two tests in a year, do we still require a CLIA certificate?
We are opening a second location for our practice. Do we need a separate CLIA number for that site?
How do I apply for a CLIA certificate?
Who is required to sign the CLIA application form (Form CMS-116)?
Do I need to send payment with my initial CLIA application?
Does Louisiana have state licensure for clinical laboratories?
Our facility does not perform testing; however, we would like to bill for testing that we reference to an outside laboratory. Can we obtain a CLIA certificate for this?
I have an out-of-state laboratory that will perform testing on patient specimens from Louisiana. Do I need a license from Louisiana to perform this testing?
We are an out-of-state company that would like to perform health screens in your state. Do we require a CLIA certificate in the state of Louisiana?
Our facility maintains a CLIA certificate for testing performed at our site; however, we would periodically like to perform health screenings at various locations in our community. Does our CLIA cover this?
My laboratory performs urine drug screening for employment purposes. Is CLIA required?
Who can qualify as the laboratory director for a Certificate of Provider Performed Microscopy Procedures (PPM)?
What are the CLIA requirements for waived testing?
Are there personnel requirements for waived testing?
Where can I find more information on performing waived testing?
Where can I find a list of the waived testing?
How long does it take after submission of a CLIA application to get the certificate?
When can I expect receipt of my certificate once renewal fees are paid?
How can I obtain a replacement certificate?
How long does it take to receive a replacement certificate?
How can I renew my CLIA certificate if I have not received a renewal notice form CMS?
Does Louisiana require a physician order to perform laboratory testing?
Can laboratory test results ordered by a physician be given directly to the patient?
Medicare and/or Medicaid are denying my claims for laboratory testing. What should I do?
Does the state of Louisiana require licensure for laboratory personnel and phlebotomist?
How do I file a complaint relative to laboratory testing in a Louisiana laboratory?
Does CLIA have a checklist of requirements to assist with maintaining compliance?