Blood Bank Licensing Program

Rules and Statutes

Additional Resources

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

Clinical Laboratory Improvement Services

The Clinical Laboratory Improvement Services (CLIS) in the Public Health and Environmental Laboratories is charged, by statute, with two goals and critical responsibilities: 

  • Protecting the health and safety of blood donors and transfusion recipients
  • Ensuring that clinical laboratories produce accurate and reliable test results.

To carry out these objectives, CLIS:

  • Develops New Jersey Administrative Code rules for licensing and operation of blood banks and clinical laboratories which reflect current best practices and which meet or exceed applicable federal regulations
  • Serves as the designated state agency for certification and inspection of clinical laboratories under the federal Clinical Laboratory Improvement Amendments (CLIA) of 1988
  • Investigates hemolytic transfusion reactions, errors and complaints which jeopardize patient and donor health and safety
  • When necessary, imposes enforcement actions against blood banks and clinical laboratories


Last Reviewed: 10/9/2018