N.J. Admin. Code § 8:8-13.2

Current through Register Vol. 56, No. 24, December 18, 2024
Section 8:8-13.2 - Definitions

For the purpose of this subchapter, the terms listed below shall be defined and interpreted as follows:

"Allogeneic" means the collection of HPC for subsequent transplantation to a recipient other than the donor. The term "allogeneic" is also known as homologous.

"Autologous" means the removal and storage of HPC from a donor for subsequent reinfusion into the same person. The term "autologous" is also known as autogeneic.

"Collection and processing service" means an organizational entity that collects or processes HPC or performs both functions.

"Cord blood" means blood in the placenta and umbilical cord that may be rich in HPC.

"Designee" means an individual designated by the medical and/or laboratory director in writing, who is qualified by education, training and/or experience to assume his/her duties for specific aspects of the collection/processing service.

"First degree blood relative" means a parent, child, or sibling.

"Hematopoietic progenitor cells (HPC)" means pluripotential cells that may be capable of self-renewal and differentiation into any mature blood cells, which are present in peripheral blood and placental/cord blood.

"Hematopoietic progenitor cell blood bank" means an operation engaged in HPC collection, processing, storage, distribution and/or transplantation that shall be referred to as blood banks or HPC blood banks in N.J.A.C. 8:8-13.

"Human leukocyte antigens (HLA)" are proteins located on the surface of the white blood cells and other tissues of the body that are used for typing in allogeneic transplants to determine histocompatibility between donor and intended recipient.

"Manipulated HPC" means HPC obtained after one or more processes have been performed to intentionally purge or enrich the starting material.

"Processing" means all tests and procedures required in preparing and identifying the HPC products as to their suitability for therapeutic, prophylactic or other in vivo or in vitro purposes.

"Recipient" means any person who receives a transplantation of HPC.

"System" means the organizational structure, responsibilities, policies, processes, procedures, and resources established by the licensee to achieve the requirements of these rules.

N.J. Admin. Code § 8:8-13.2