Clinical Laboratory Improvement Amendments (CLIA)

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.

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

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

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.

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.

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

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.

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

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.

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.

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.

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. 

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.

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.

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.

No.  There are no personnel requirements for 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.

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.

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.

A new certificate can be generated at any time throughout a certificate cycle. Refer to the CLIA Fees for associated fees for duplicate certificates. To request a certificate you should submit written request including the facility name and CLIA ID to alexa.little@la.gov.   

CMS issues certificates after the associated fee has been received. It takes approximately 2-3 weeks to receive certificates by mail.

Yes. All active CLIA certificates are accessible for review using CMS Laboratory Demographic Lookup (QCOR) .

Laboratories can also voluntarily enroll in electronic certificate and fee coupon issuance by including an email address on the CMS-116 application and checking the box electing to “RECEIVE FUTURE NOTIFICATIONS VIA EMAIL”.

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 3056

PORTLAND, OR 97208-3056

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

CMS now has the capability of accepting electronic payment or credit card transactions.

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.  

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

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. 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.

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.

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.

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

No.  There is no checklist available.  To assist with compliance issues you should reference the CLIA regulations.  Appendix 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.

Information regarding CLIA can be accessed from the:

Centers for Medicare & Medicaid Services (CMS) website.

The Center for Disease Control (CDC) website.