CLIA (Clinical Laboratory) Program
The federal CLIA law (Clinical Laboratory Improvement Amendment) mandates that any laboratory testing of a human specimen may only be performed by facilities that are properly certified under federal regulations. The Missouri CLIA program oversees this certification program in our state and carries out certain inspections of laboratories on a routine basis, as well as investigating complaint allegations.
To contact the CLIA Program you may contact us by email at CLIA@health.mo.gov or by telephone at 573-751-6318. Many of the most frequently asked CLIA questions (FAQ) are listed below.
How do I obtain a CLIA certificate application?
Applications and other helpful information can be found at the following link:
Where do I send my CLIA application?
- Mail: DHSS - Bureau of Diagnostic Services
PO Box 570
Jefferson City, MO 65102
- E-mail: CLIA@health.mo.gov
- Fax: 573-751-6158
How long does it take to receive my certificate?
Certificates will arrive in 4-6 weeks.
How much does a Certificate of Waiver, PPM, COC/COA cost?
Costs for CLIA certificates are as follows:
- Certificate of Waiver -- $180 every two years
- PPM -- $240 every two years
- COC and COA costs are based on the number of tests that the lab performs in a year. COA will have an additional cost for accreditation.
Initial COC and COA CLIA certificates include a $100 registration fee along with a compliance fee that is based upon test volumes.
Should I send my payment with the application?
Don’t send payment with your application. Once the application has been entered into the database, an invoice will be sent to you. Payment should be mailed to:
CLIA Laboratory Program
PO Box 3056
Portland, OR 97208-3056
Include your CLIA number with payment to ensure it is credited properly.
I paid my fee and I have not received my certificate?
CLIA fees are billed 6 months in advance and the certificate will be mailed 30 days prior to your current expiration date.
I paid my CLIA fee, but it’s not showing as paid in the CMS system. Why is this?
It takes approximately 2 weeks for payments to appear in the system. If it doesn’t appear after 3 weeks, please send us a copy of the front and back of your canceled check. Always include your facility name and CLIA number.
What do I need to do for a change ownership?
Please notify the Missouri CLIA Program by requesting the change on letterhead. Also include the previous federal tax ID number along with the new federal tax ID number.
How do I make changes to my certificate - such as name and/or address of facility?
Requests for name or address changes can be sent to the program on facility letterhead. Be sure to include your CLIA number, previous facility name or previous facility address along with the new information.
How do I make a lab director change to my CLIA certificate?
- If it is a Certificate of Waiver (COW), send us a letter, fax or email including the CLIA number, the previous lab director and the new lab director’s name.
- If it is for a Provider Performed Microscopy (PPM) Certificate, you must send the following:
- a copy of the CMS 116 application, and
- a copy of the Missouri State License of the physician or the mid-level practitioner.
- If it is for a Certificate of Compliance (COC) or Accreditation (COA), you must send the following:
- a copy of the CMS 116 application
- a copy of the director's Missouri State License,
- a copy of the director's resume or credentials, and
- State Board Certificates or degrees showing the qualification of that person to be the director of a moderate or high complexity lab.
For an existing Certificate of Accreditation (COA), you must send the above documents to your accrediting organization.
I do not have a lab; why am I being billed $180.00 for a waiver?
A Certificate of Waiver (COW) is required if you are performing blood glucose, urine dips, or any other simple office test where you obtain a specimen and provide the patient a result that is used for diagnosis or treatment.
If I am only drawing blood or collecting specimens do I need a CLIA certificate?
No CLIA certificate is required for this type of activity.
Does Missouri have a licensure requirement for laboratories or to perform testing?
Missouri does not have a licensure requirement for laboratories.
I need to make a status change, what do I do?
Complete a new CMS 116 form and send to the Missouri CLIA Program.
My claims are being rejected and not being paid for laboratory test performed?
Your CLIA certificate must be current, if it is closed or inactive you will not be paid for tests performed. If your certificate is current and claims are being denied, call your intermediary and check your billing codes to ensure you are using the right code for the type of test that your lab is performing. Be sure that the tests billing code also matches the type of CLIA certificate that the lab is certified for, either Certificate Of Waiver, PPM, Moderate Complexity or High Complexity Certificates. The CLIA state office does not deal with billing issues.