Missouri

Missouri Department of Health and Senior Services, Public Health Division. Clinical Laboratories. 
https://health.mo.gov/safety/clia/pdf/cliaprogram.pdf

(1) 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.

(a) Applications and other helpful information can be found at the following link:
http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html

(b) Costs for CLIA certificates are as follows:

• Certificate of Waiver — $248 every two years
• PPM — $297 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 $123 registration fee along with a compliance fee that is based upon test volumes.

(c)  How to make Lab Director change requests:

• 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.

(d) Missouri does not have a licensure requirement for laboratories.

Online Access to CLIA Certificates

CMS is now making CLIA certificates available online at no cost via the QCOR Lookup Tool.  All certificates generated after September 27, 2023 should be available for download.  Click HERE to access the Tool and choose “CLIA Laboratory Lookup” from the left menu bar (2nd option from the top).  When you click the entry for the laboratory, a box containing the laboratory information and a link to the certificate will pop up in a new window.