Frequently Asked Questions

If our laboratory only collects specimens which are sent to a reference laboratory for testing, do we need a CLIA certificate?

No.  CLIA is only required for those facilities that actually perform testing on-site.  CLIA is not required for specimen collection.  However, if you perform even a simple test such as a finger-stick glucose, you are required to have a CLIA certificate.

 

If we do not bill Medicare or Medicaid for reimbursements, do we still need a CLIA certificate?

Yes.  CLIA is a federal requirement that is not contingent upon whether you are Medicare and/or Medicaid providers and bill for laboratory services.

 

If we only do one or two tests in a year, do we still require a CLIA certificate?

Yes.  CLIA is required even if only one test is performed in a year.

We are opening a second location for our practice. Do we need a separate CLIA number for that site?

Yes.  A CLIA certificate is required for each separate physical location where testing is performed with four exceptions.  If it is for a temporary testing site, governmental facility, or a non-profit facility, you qualify for more than one site on a single CLIA certificate IF the facilities perform no more than 15 different moderate and/or waived tests per certificate.  If it is for a hospital, each location must be located at contiguous buildings on the same campus within the same physical location or street address and under common direction to qualify for multiple sites under the same CLIA certificate.

How do I apply for a CLIA certificate?

To apply for a CLIA certificate you must complete a CLIA application (Form CMS-116) according to the instructions provided and a List of Tests Performed in the Facility.

Who is required to sign the CLIA application form (Form CMS-116)?

The CLIA application form must be signed by the laboratory director, the owner, or an authorized representation of the facility.

Do I need to send payment with my initial CLIA application?

No.  Do not send money to the Louisiana State CLIA Program.  Once the application information is entered into the CMS system, a fee coupon is generated by CMS based on the specific certificate type.  Fees must then be submitted to CMS.

Does Louisiana have state licensure for clinical laboratories?

No.  There are not state laws in Louisiana regulating clinical laboratories.  Louisiana follows the CLIA regulations.

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?

No.  A CLIA number is NOT a billing number.  You can only be certified for testing that you actually perform on site.  For Medicare (as well as others), only the laboratory performing the testing should bill for the testing.

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?

No.  There are no state laws in Louisiana regulating laboratories.  There is only CLIA.  As long as the laboratory that is performing the testing is CLIA certified in the state where the testing is performed, there are no other certificates or licenses required.

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?

If your base of operations is located in a different state and is CLIA certified in that state for the testing performed, additional CLIA certification in Louisiana is not required.  Additionally, notification is required of each screening event conducted in our state.  You should submit in writing the following:

 

Name of the facility where the screening will occur

Address of the facility where the screening will occur

Date that the screening will occur

List of tests that will be performed

Name and phone number of a contact individual for the screening

A copy of the CLIA certificate that the screening is performed under

 

You may submit the information via email to alexa.little@la.gov or fax to 225-342-9349.

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?

As long as the certificate type you maintain is applicable to the testing you perform at the health screenings, the certificate will cover this testing.   The locations of the health screenings would be considered temporary testing sites. 

My laboratory performs urine drug screening for employment purposes. Is CLIA required?

CLIA is not required for laboratories performing drug testing for employment purposes only.  The Louisiana regulations for this type of testing can be found in L.A. R.S. 49:1001-1021.  The Louisiana Department of Health does not regulate Urine Drug Screening Laboratories.  CLIA only applies if the patients are being sent for treatment as a result of such testing.

Who can qualify as the laboratory director for a Certificate of Provider Performed Microscopy Procedures (PPM)?

Only a physician (MD, DO, and DPM), a dentist, and a midlevel practitioner (licensed physician assistant, nurse practitioner or nurse midwife) qualify as a laboratory director for a Certificate of PPM.  Only these individuals can perform PPM procedures under this certificate.  Other individuals can only perform this testing under a Certificate of Compliance or a Certificate of Accreditation. See the Center for Disease Control (CDC) resources for more information PPMP.

What are the CLIA requirements for waived testing?

Certificate of Waiver laboratories must enroll in the CLIA program, pay applicable certificate fees biennially, and follow the manufacturer instructions specific to the waived testing performed in the facility.

Are there personnel requirements for waived testing?

No.  There are no personnel requirements for waived testing. 

Where can I find more information on performing waived testing?

The Centers for Disease Control (CDC) has a program specific for waived testing called Ready? Set? Test!  This program will provide further information and guidance on waived testing.

Where can I find a list of the waived testing?

The Centers for Medicare & Medicaid Services (CMS) provides a List of the Waived Testing along with the applicable CPT codes for each test.

How long does it take after submission of a CLIA application to get the certificate?

A CLIA application cannot be processed until all the requested information is complete and correct.  A completed application is processed into the CMS system as soon as possible upon receipt.  The CMS system will generate a fee coupon with the certificate fees the following Saturday.  This coupon should be received in about 2 – 3 weeks.  Once the coupon is received and the certificate fees are paid, it will take another 2 -3 weeks to receive your certificate.  Total time for receipt of a certificate is usually 4 – 6 weeks.

When can I expect receipt of my certificate once renewal fees are paid?

Although the fees to renew the certificate for Certificates of Waiver, Certificate of PPM, and Certificate of Accreditation are mailed to the facility six months prior to the expiration date, the certificate for the next cycle will not be sent to the facility until just prior to the expiration date of the current cycle.  CMS will print the new certificate approximately one month prior to the expiration date.  Therefore, you can expect to receive it one to two weeks prior to the expiration date.  If you have not received your certificate by the expiration date of the certificate, contact the Louisiana CLIA Program at alexa.little@la.gov or (225) 342-9349.

How can I obtain a replacement certificate?

Replacement certificates are sent by CMS.  However, CMS will generate only one replacement certificate per laboratory.  To request a replacement certificate you should contact the Louisiana State CLIA Program at alexa.little@la.gov or (225) 342-9324.

How long does it take to receive a replacement certificate?

Replacement certificates come from CMS.  It takes approximately 2 – 3 weeks after the request is submitted to receive the replacement certificate.

How can I renew my CLIA certificate if I have not received a renewal notice form CMS?

If you have lost or misplaced your fee coupon, you can still submit your payment without it.  To submit a payment you should make a check payable to CLIA LABORATORY PROGRAM in the amount that is owed for your specific certificate type.  Mail the check to:

 

CLIA LABORATORY PROGRAM

PO BOX 530882

ATLANTA, GA  30353-0882

 

Make sure you write the CLIA number clearly on the front of the check to ensure it gets credited to your account.

 

Does Louisiana require a physician order to perform laboratory testing?

No.  CLIA regulations allow patients to have tests performed by certified laboratories without a physician order.  This is known as Direct Access Testing (DAT).  There are no state laws in Louisiana that prohibit this.  However, there are certain restrictions in Medicare and in some insurance coverage that disallows tests not ordered by physicians.  Therefore, some individual laboratories within the state may have their own restrictive guidelines relative to ordering tests.  

Can laboratory test results ordered by a physician be given directly to the patient?

Test results ordered by a physician can be given only to the ordering physician.  Results can only be released to another individual with written authorization from the ordering physician.

Medicare and/or Medicaid are denying my claims for laboratory testing. What should I do?

Both Medicare and Medicaid require facilities that bill for laboratory testing to be CLIA certified.  When denials are received, you should first check that you are submitting the correct CLIA number.  You should next verify that you are submitting the correct CPT code or if the CPT code requires a QW modifier.  A current list of CPT codes is provided by CMS.   Since the CLIA Program is not a part of the billing process, CLIA can only verify that you have a valid CLIA certificate; and that the testing you are performing is allowed under your certificate type.  Other issues with billing must be addressed directly with Medicare and/or Medicaid.

Does the state of Louisiana require licensure for laboratory personnel and phlebotomist?

Yes.  All laboratory personnel and phlebotomist in the state of Louisiana must obtain a clinical laboratory personnel license appropriate for their level of expertise.  Personnel licensure is not administered by the CLIA Program.  You should contact the Louisiana State Board of Medical Examiners regarding personnel licensure.

How do I file a complaint relative to laboratory testing in a Louisiana laboratory?

Complaints can be submitted either in writing or via telephone to the Louisiana CLIA Program.  To submit in writing, there is no specific form or format that must be submitted.  You should include as many specifics relative to the complaint as you can including the name and address of the facility the complaint is against.  You may remain anonymous; however, if you provide your name and contact information, a response will be sent when the complaint investigation is complete.  To submit in writing send to:

 

CLIA Laboratory Program

PO Box 3767

Baton Rouge, LA  70821

You may also submit in writing via email to alexa.little@la.gov or fax to (225)342-9349.

To submit via telephone you should call (225)342-9324.

Does CLIA have a checklist of requirements to assist with maintaining compliance?

No.  There is no checklist available.  To assist with compliance issues you should reference the CLIA regulationsAppendix C, Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services will also be helpful as it outlines the CLIA survey process.  A list of items to be reviewed during a CLIA survey can be found in the Survey Information Packet.

Where can I obtain further information about CLIA?