New Jersey CLIA and State Lab Requirements

Does New Jersey require a state lab license on top of CLIA?

New Jersey licenses clinical laboratories and collection stations, one license per location, renewed every calendar year. The Act does not apply to a facility whose only testing is point-of-care testing, and the operating rules exclude labs holding a federal Certificate of Waiver, yet the fee rule still lists a waived-only license.

• Clinical laboratory license
• Issued by New Jersey Department of Health, Clinical Laboratory Licensing Program

Citation: N.J.S.A. 45:9-42.26 et seq.; N.J.A.C. 8:44, 8:45

Who is exempt in New Jersey?

Research-only labs, federal labs, licensed blood banks, certain corrections and treatment-program urine screens, and facilities whose only testing is point-of-care testing. The operating rules in N.J.A.C. 8:44 do not apply to labs holding a federal Certificate of Waiver.

Citation: N.J.S.A. 45:9-42.27(i), 45:9-42.33; N.J.A.C. 8:44-2.2(b)

What does New Jersey charge?

$200 to $400 per specialty per year, set by the lab's total employees; collection station $200 per site; $100 late fee for renewals after December 31; $100 to replace a license after an address change (as of October 2026).

• Waived: $200 per site per year for a waived-only license, where one is required (as of October 2026)

Citation: N.J.A.C. 8:45-1.3

How often does a New Jersey lab registration renew?

• Renews every year
• Due Licenses expire December 31 each year; renew through the lab's own myNJ portal account (ALiS) by December 31 to avoid late fees.

Where does a New Jersey CMS-116 go?

• New Jersey Department of Health, Clinical Laboratory Improvement Service (CLIS)
• Email: CLIAlab@doh.nj.gov
• Phone: (609) 718-8072