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; and
  • When necessary, imposes enforcement actions against blood banks and clinical laboratories.
Annual Statistical Summary of Blood Use in New Jersey

The Blood Bank Licensing Program compiles data received from blood donor collection centers, hospitals, transfusion only service facilities (i.e., surgical and dialysis centers, Long Term Acute Care(LTAC)/Specialty Care facilities) umbilical cord blood (UCB) and hematopoietic progenitor cell (HPC) / peripheral stem cell collection services, Perioperative Autologous Blood Collection/Administration (PABCA) services, and brokers annually to generate a summary report the following year for use of those entities providing the data.  The report provides an overall picture of the various product collections, transfusions, discards, and adverse events relating to transfusion and/or collection in NJ facilities. The report is available by clicking the link in the orange box to the left under Additional Resources.

The report contains both a narrative summary and numerous charts and tables presented as the number of units (i.e. blood, blood components, UCB, HPC and APBCA) collected, distributed, transfused, and/or discarded with reasons, as well as the number and type of recipient adverse reactions and error/accidents reported to CLIS.

CLIS makes only one conclusion from the data review – NJ imports more blood from licensed out of state blood donor collection centers to meet the transfusion needs of patients within the state.

CLIS staff review each and every error/accident and adverse reaction that is reported as they are reported and follows up with the facility involved for further information or corrective actions, as needed.

Comments on the value and usefulness of this report are welcomed.

Last Reviewed: 1/3/2019