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.

 

Clinical Laboratory Licensing Program Objectives:

  • Develops New Jersey Administrative Codes for licensing and operation of clinical laboratories and collection stations which reflect current, best practices and which meet or exceed applicable federal regulations;

  • Inspects licensed laboratories and collection stations to ensure accuracy and reliability of patient test results.  Inspections are conducted by clinical laboratory evaluators to ensure that the operations of the laboratories and collection stations comply with the respective New Jersey Administrative Code; and

  • Investigates errors and complaints which jeopardize the health and safety of patients.

  • Reviews records of and/or assesses patient testing, equipment maintenance, quality
    control, staffing levels, medical records, observes testing procedures as well as patient care and interviews staff.  An inspection may take one or more days.

Revocation of Collection of Station Waiver
Effective August 25, 2022

The revocation of the collection site waiver was signed by the Commissioner of the New Jersey Department of Health and is effective August 25, 2022.  The clinical laboratories who have collection sites, including mobile vans and drive-thru collections, operating under this waiver must come into compliance by August 25, 2022 with the original licensing requirements found at N.J.A.C. 8:44-2.14 specifically for the physical location and the layout for collection set out at N.J.A.C. 8:44-2.14 (b)(2)-(6).  N.J.A.C. 8:45-1.3 lists the licensure fee of $200 for each collection station.

Clinical laboratories intending to proceed with specimen collection at a site currently operating under the collection station waiver must: meet the physical location and layout for collection; complete the CL-18 Application for a collection station license; and submit the license collection fee of $200 before August 25, 2022.

If you have questions or concerns, please call (609) 406-6830 or email Joan.Mikita@doh.nj.gov.

Monkeypox

CDC has published its FDA-approved testing protocol, Non-variola Orthopox Generic Real-Time PCR Test procedure.  FDA has also authorized the use of additional reagents and automation to increase the testing capacity of the LRN laboratories and CDC-designated commercial laboratories using the CDC test.  CDC said that controls are available from NIST and Twist Biosciences and primers/probes are available from BEI resources as well as contrived samples.  Currently, NJ PHEL does not have clinical specimens available for laboratories to use for verification studies.

Please refer to the FDA guidance documents and Template for Developers of Molecular Diagnostic Tests for Monkeypox.  Additional information and instructions will be forthcoming.  NJ-licensed laboratories must obtain approval from CLIS before any patient testing can begin.

Addtional information can be found at:
Information For Laboratory Personnel | Monkeypox | Poxvirus | CDC

BEI:
Advanced Catalog Search (beiresources.org)

 

Laboratory Reporting Requirements

To report ALL blood lead results, please contact:

Childhood Lead Program (<17 years of age)
Siobhan Pappas, Ph.D. Coordinator, Childhood Lead Program
Siobhan.pappas@doh.nj.gov
609-633-2937

 

OR

 

Occupational Health (Adults, ≥16 years of age)
Marija Borjan, PhD, MPH
Research Scientist II, Occupational Health Surveillance Unit
Marija.Borjan@doh.nj.gov
609-913-5105

Last Reviewed: 9/26/2022