The Department of Health requests that all laboratories operating in the State, including those that only perform CLIA waived tests and may be located in healthcare facilities such as doctors’ offices, urgent cares, nursing home/rehabilitation facilities, ambulatory surgical centers, pharmacies, mobile testing units, schools, drug/alcohol rehabilitation centers, correctional facilities, etc. continue to report COVID-19 (SARS-CoV-2) tests to the New Jersey Department of Health’s Communicable Disease Services (CDS). 

Dear Laboratory Directors and Owners:

With the ending of the federal public health emergency on May 11, 2023, the Department of Health, Clinical Laboratory Improvement Services (CLIS), is reminding all clinical laboratories of their responsibility to report the results of communicable disease testing to CDS, as required by CLIS’s licensing rules at N.J.A.C. 8:44-2.11.  The disease reporting requirements set out in N.J.A.C. 8:44-2.11 are independent of any SARS-CoV-2 test result reporting mandate set by the federal government during the federally declared Public Health Emergency.  Therefore, New Jersey licensed clinical laboratories conducting SARS-CoV-2 testing will still be required to report SARS-CoV-2 test results to CDS after the federal public health emergency ends. 

WHAT, WHEN, and HOW: Laboratories must continue to report positive results from antigen tests, and both positive and negative results from all molecular tests (e.g. PCR).   Results for SARS-CoV-2 testing should be made by Electronic Laboratory Reporting (ELR), by direct web entry into the Department’s Communicable Disease Reporting and Surveillance System (CDRSS) (https://cdrss.nj.gov) or by SimpleReport (https://www.simplereport.gov/) by the close of the next business day  following the day on which the result is obtained. 

Thank you for your continued cooperation with the Department.

Programs include:

Blood Bank Licensing Program

The Blood Bank Licensing and Regulatory Compliance Program under the Clinical Laboratory Improvement Services is responsible for protecting the health and safety of blood donors and transfusion recipients ensuring the safe and effective collection and transfusion of blood and blood products, as well as an adequate and safe blood supply in New Jersey.  The program ensures the collection, testing, preparation, storage, transport, and administration of blood and blood components comply with State and Federal regulations as well as guidance documents.

Clinical Laboratory Licensing Program

The Clinical Laboratory Licensing Program provides New Jersey State licensure to collection stations and clinical laboratories performing patient specimen collection and testing.

NJ CLIA Program

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

Enforcement Actions

The Clinical Laboratory Improvement Services (CLIS) under the Public Health and Environmental Laboratories Division is charged, by statute, with protecting the health and safety of New Jersey residents through licensing, inspecting, investigating, and enforcing clinical laboratories and blood banks’ continued compliance. CLIS also investigates complaints received from the public.

News/Current Events/Stay Informed

All New Jersey Clinical Laboratory Owners and Directors:

Under the New Jersey Clinical Laboratory Improvement Act (the Act), N.J.S.A. 45:9-42.45 to -42.49, P.L. 2021, c. 454 as amended by P.L. 2022, c.44, clinical laboratories licensed to operate in New Jersey must meet the recently enacted requirements. The new enactments require: 1) clinical laboratories to record and report certain patient demographic information, namely race, ethnicity, sexual orientation and gender identity; 2) clinical laboratory electronic medical records systems and manual requisition forms to include demographic data entry features; and 3) clinical laboratories to implement cultural competency training programs. The new statutory requirements take effect on January 18, 2023, with the exception of the recording and reporting requirements for sexual orientation and gender identity, which take effect on June 18, 2023.

For more information about the requirements, please read the following memorandum:

Sexual Orientation and Gender Identity (SOGI) for Clinical Laboratories Guidance Memo (FINAL AMENDED)

SOGI FAQ's (FINAL AMENDED)

N.J.S.A. 45:9-42.45 to -42.49 et seq.

If you have any questions or comments, please email CLIS@doh.nj.gov and include your full name, facility’s name and CLIS ID number.