Federal CLIA (Clinical Laboratory Improvement Amendment) Program

 

The New Jersey Department of Health (NJDOH), under contract with the Centers for Medicare & Medicaid Services (CMS), administers the Clinical Laboratory Improvement Amendments of 1988 in New Jersey to ensure quality laboratory testing.

CLIA requires every facility that tests human specimens for the purpose of providing information for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of a human being to meet certain Federal requirements. CLIA applies to any facility performing laboratory testing as outlined above, even if only one or a few basic tests are performed, and there is no charge for testing. Although all clinical laboratories must be properly certified to receive Medicare or Medicaid payments, CLIA has no direct Medicare or Medicaid program responsibilities. In addition, the CLIA legislation requires financing of all regulatory costs, including inspections, through fees assessed to affected laboratories.

All laboratories that test human specimens must apply for a CLIA Certificate by completing Form CMS-116, CLIA Application for Certification. This form collects information about your laboratory's operation and is necessary to assess fees, to establish baseline data and to fulfill the statutory requirements for CLIA. This information will provide the laboratory surveyor an overview of your laboratory's operation if it is subject to onsite survey. All information should be based on your facility’s laboratory operation as of the date of the completion of the form.

Additional CLIA information (Select from the overview menu).

When the completed CMS-116 form is received by NJDOH:

  • The information will be entered in to the CMS/Aspen Web CLIA computer system.
  • A CLIA identification number will be generated and given to you.
  • You will receive a remittance coupon for the amount due for the CLIA Certificate and Compliance Fee, if applicable.
  • Upon receipt of payment, an appropriate CLIA Certificate (Certificate of Waiver, Provider-Performed Microscopy Procedures or Registration Certificate) will be mailed to you.

CLIA payment must be mailed to:

CLIA Laboratory Program, PO Box 3056, Portland, OR 97208-3056

Please do not send the payment to NJDOH.

For additional information or questions, please call 609-406-6824.

 

Last Reviewed: 9/20/2019