New Jersey State Licensing Requirements
National Links
- Nationwide Laboratory Director Regulations
- Dec. 28, 2024 CLIA Changes effective Dec. 28, 2024
- Nationwide High Complexity Requirements
- CE Courses for Laboratory Directors
- Online Access to CLIA Certificates QCOR (See below)
- Pay your CLIA fess at Pay.gov
- Forms CMS116 Application
- eCFR 42 CFR Part 493
- State Operations Manual
State-Specific CLIA Applications
New Jersey Department of Health, Public Health Division. Clinical Laboratories.
https://pub.njleg.gov/bills/2016/S1000/976_R1.HTM
(1) The New Jersey Department of Health (NJDOH), 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.
(2) All laboratories that test human specimens must apply for a CLIA Certificate by completing Form CMS-116, CLIA Application for Certification.
- List of Waived Tests
- Waived Tests Booklet
- Training Courses for Waived Tests
- Provider-Performed Microscopy Procedures (PPMP) Booklet
When the completed CMS-116 form is received by the NJ CLIA Program:
- The information will be entered into the CMS/ASPEN CLIA database.
- A CLIA identification number will be generated and provided to you along with payment and further instructions.
- You will receive a fee coupon from CMS for the amount due. Please note that payments ARE NOT made to the NJ CLIA Program nor NJDOH.
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.