Clinical Laboratory Licensure and Proficiency Testing Review Forms
Blood Bank Licensure and Regulatory Compliance
Rules and Statutes
Forms: Application for a Blood Bank License, Annual Statistics, Error/Accident and Transfusion Reaction Reports, Personnel Qualification Appraisal, and License Fees.
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:
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.
If you need additional information or if you have any question, please call 609-406-6824.