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Clinical Laboratory Improvement Service

clis staff The Clinical Laboratory Improvement Services (CLIS) in the Public Health and Environmental Laboratories is statutorily charged with two goals and critical responsibilities: 

  • Protecting the health and safety of blood donors and transfusion recipients; and,
  • Ensuring that clinical laboratories providing testing of bodily specimens to aid in the prevention, diagnosis or treatment of diseases or the assessment of medical conditions produce accurate and reliable test results.

CLIS seeks to fulfill its mandated responsibilities by developing New Jersey Administrative Code rules for the licensing and operation of blood banks and clinical laboratories which reflect current best practices and which meet or exceed applicable federal regulations; by serving as the designated state agency for the certification and inspection of clinical laboratories under the federal Clinical Laboratory Improvement Amendments (CLIA) of 1988; by investigating hemolytic transfusion reactions, errors and complaints which jeopardize patient and donor health and safety; and, when necessary, may impose enforcement actions against blood banks and clinical laboratories.

Clinical Laboratory Licensure and Proficiency Testing Review

Rules and Statutes

Laboratory Reporting Requirements

Forms: Clinical Laboratory Licensure and Proficiency Testing Review Forms

Blood Bank Licensure and Regulatory Compliance

Rules and Statutes

Other:

  • 2012 Annual Statistical Summary of Blood Use in New Jersey [pdf 458k]
  • Blood Bank Inspection Checklist [pdf 102k]

Forms: Application for a Blood Bank License, Annual Statistics, Error/Accident and Transfusion Reaction Reports, Personnel Qualification Appraisal, and License Fees.

CLIA 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 even if you are not charging 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.

Consequently, 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.

To obtain CMS-116 (with Instructions for Completion of Form, Guidelines for Counting Tests for CLIA, Tests Commonly Performed and Their Corresponding Laboratory Specialties and Subspecialties), go to http://www.cms.hhs.gov/cmsforms/downloads/cms116.pdf

For additional CLIA information, go to the CMS website: http://www.cms.hhs.gov/clia and make selection from the Overview Menu.

Please return the completed CMS-116 form to:

FedEx/UPS

Bhavna Patel
Clinical Laboratory Evaluator, CLIS
Public Health, Environmental Laboratories and Agricultural Laboratories
3 Schwarzkopf Drive
Ewing , New Jersey 08628

OR

USPS

NJDOH (CLIA Program)
PO Box 361
Trenton, New Jersey 08625

 

When the completed CMS-116 form is received by the State Agency Office listed above, the information will be entered in to the CMS/Aspen Web CLIA computer system and a CLIA identification number is generated and given to you. Consequently, 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 530882
ATLANTA, GA 30353-0882

PLEASE DO NOT SEND THE PAYMENT TO THE STATE AGENCY.

If you need additional information or if you have any question, please call 609-406-6824.

Adobe reader You will need to download the latest version of Adobe Acrobat Reader in order to correctly view and print PDF (Portable Document Format) Files.

 


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Last Modified: Wednesday, 08-Oct-14 10:46:12