The Blood Bank Licensing and Regulatory Compliance Program under the Clinical Laboratory Improvement Services is responsible for protecting the health and safety of blood donors and transfusion recipients ensuring the safe and effective collection and transfusion of blood and blood products, as well as an adequate and safe blood supply in New Jersey. The program ensures the collection, testing, preparation, storage, transport, and administration of blood and blood components comply with State and Federal regulations as well as guidance documents.
Blood Bank Licensing Program Objectives:
- Develops New Jersey Administrative Codes for licensing and operation of blood banks which reflect current, best practices and which meet or exceed applicable federal regulations;
- Inspects licensed blood banks to ensure consistent, high-quality testing and the safety of patients and donors. Inspections are conducted by clinical laboratory evaluators to ensure that the operations of the laboratories and blood banks comply with the respective New Jersey Administrative Code; and
- Investigates errors and complaints which jeopardize the health and safety of patients and donors as well as adverse reactions to transfusions and/or donations.
- Reviews records of and/or assesses patient and donor testing, equipment maintenance, quality control, staffing levels, medical records, observes testing procedures as well as patient/donor care and interviews staff. An inspection may take one or more days. The inspector(s) will cite deficiencies (i.e., non-compliance with the applicable rules) and the blood bank must submit a written plan of correction, within 10 business days, detailing how those deficiencies were corrected with supported evidence and monitored to ensure the deficient practices do not recur.
