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      CLIA Waiver Application Process

      What is CLIA?

      • CLIA (Clinical Laboratory Improvement Amendments) regulates laboratory testing and requires clinical laboratories to be certified by the Center for Medicare and Medicaid Services (CMS) before they can accept samples for diagnostic testing.
      • Not all laboratory testing requires full CLIA certification. Clinics may apply for a certificate of waiver for tests categorized as “simple laboratory examinations and procedures that have an insignificant risk of an erroneous result.”
      • List of Waived Tests: CLIA - Currently Waived Tests
      • In order to perform diagnostic tests including those that are waived, all facilities must fill out Form CMS-116.
      • CLIA Form 116 (04/20)

      CLIA Waiver Application Process

      CLIA Waiver – PAGE 1

      Section I.
      • Under “General Information,” select “Initial Application”
      • Pharmacy Information – name, address
      • Federal Tax ID Number
      • Name and contact information of PIC

      Section II.

      • Select “Certificate of Waiver”

      CLIA Waiver – PAGE 2

      Section III.
      • Under “Type of Laboratory” select “Pharmacy”

      Section IV.

      • List the hours of operation of the pharmacy

      Section V. 

      • It is recommended to select “No” under multiple testing locations

      CLIA Waiver – PAGE 3

      Section VI
      • List all waived diagnostic tests that your facility will be performing
      • Estimate the number of tests your facility will perform in a 12-month period

      Section VII

      • Leave this section blank

      CLIA Waiver – PAGE 4

      Section VIII
      • Leave this section blank

      CLIA Waiver – PAGE 5

      Section IX
      • Under “For Profit” select “Proprietary”

      STATE SURVEY AGENCIES (CLIA CONTACT LIST) (cms.gov)

      Section X

      Submitting CLIA Waiver

      • Mail the CLIA form to your State Agency (see example below). Wait 10-14 days for response (response time may be longer depending on the State agency).

      Unified State Laboratories California Department of Public Health

      Division of Science Laboratory Field Services 320 W 4th St STE 890

      Los Angeles, CA 90013-2398

      • “Once the completed Form CMS-116 has been returned to the applicable State agency and it is processed, a fee remittance coupon will be issued. The fee remittance coupon will indicate your CLIA identification number and the amount due for the certificate...” This statement is directly from the directions page of the CLIA Waiver application.
      • Once the “fee remittance coupon” (payment) is paid, you will be able to confirm with CMS and begin testing.

      CLIA Waiver Requirements

      • Pay certificate fee every 2 years
      • Follow the manufacturer’s instructions for the waived tests your facility is performing
      • Notify your state agency of any changes in ownership, name, address or Laboratory Director within 30 days, or if you wish to add tests that are more complex

      Supporting Resources