N.J. Admin. Code § 8:8-1.2
For the purpose of this chapter, the terms listed below shall be defined and interpreted as follows:
"AABB Standards" means the "Standards for Blood Banks and Transfusion Services," 23rd Edition (2004), incorporated herein by reference as amended and supplemented and the "Standards for Cellular Therapy Product Services," First Edition (2004), incorporated herein by reference as amended and supplemented, both of which publications are published by the American Association of Blood Banks, 8101 Glenbrook Road, Bethesda, MD 20814-2749, (301) 907-6977, www.aabb.org.
"Accident" means a non-preventable occurrence.
"Additive solution system" means blood preservative systems designed primarily for the extended storage of red blood cells. These systems utilize a second preservative solution for red cell storage in addition to the anticoagulant solution necessary for whole blood collection.
"Allogeneic" means the collection of blood or blood components for subsequent transfusion to an individual other than the donor. The term "allogeneic" is also known as homologous.
"Autologous donation/transfusion" means the collection of blood and blood components from a donor/recipient for subsequent reinfusion into the same individual. The term "autologous" is also known as autogeneic.
"Blood bank" means any commercial or noncommercial activity involving the handling of blood or plasma, intended to be used for therapeutic or prophylactic purposes, which participates in any of the following operations: collection, processing, storage, distribution or administration of blood.
"Blood components" means those preparations that are separated from whole blood and are intended for use as final products for therapeutic purposes, for further manufacturing, or as products used for in vitro testing.
"Broker" means procuring, selling and distributing of blood, blood components or blood products without engaging in processing, alteration or other manipulation of the blood component.
"Center for Biologics Evaluation and Research (CBER)" means the U.S. Food and Drug Administration (FDA), Department of Health and Human Services.
"Clinical practitioner" means a physician currently licensed to practice in New Jersey; an advanced practice nurse currently certified under the New Jersey Advanced Practice Nurse Certification Act; or a physician assistant licensed under the Physician Assistant Licensing Act, acting within the rules governing those professions. Where authorized under this chapter, clinical practitioners shall be permitted to order transfusions and procedures related to the collection or donation of blood and blood products. Advanced practice nurses shall order only according to specific written joint protocols established with the collaborating physician and physician assistants, according to specific protocols established with the supervising physician.
"Closed system" means a system in which the blood container is not entered or air introduced.
"Code of Federal Regulations" means the current Code of Federal Regulations, as amended and supplemented, Title 21, parts 600 through 640.
"Collection" means the procedure for obtaining blood by donor or recipient phlebotomy.
"Commissioner" means the Commissioner of New Jersey State Department of Health and Senior Services or his or her duly authorized agent.
"Crossing over" means the transfusion of a donation of blood and/or blood components, originally collected for autologous transfusion, to a recipient other than the original donor/recipient.
"Cytapheresis" means the procedure in which blood is removed from the donor, certain cellular elements are separated, and the remaining formed elements and residual plasma are returned to the donor.
"Department" means the New Jersey State Department of Health and Senior Services.
"Designated donor" means a donor that is selected by a recipient for transfusion to this recipient at a later date.
"Designee" means an individual designated by the blood bank director and who is qualified by education, training and/or experience to assume the blood bank director's duties and authority for specific aspects of the blood bank.
"Directed donation" means an allogeneic donation where the blood or blood component is collected from a designated donor.
"Distribution" means the transfer of blood or blood components from one blood bank facility to any other location for processing or storage or for the purpose of providing the blood for therapeutic, prophylactic or in vitro purposes.
"Donor" means and includes any individual from whom blood or components are collected by a blood bank.
"Error" means a preventable occurrence.
"FDA regulations" means 21 C.F.R. Parts 600 through 680, incorporated herein by reference, as amended and supplemented.
"Health system" means a multidivisional hospital with a blood bank and no more than three satellite blood bank facilities.
"Hemapheresis" means the process of separating freshly drawn whole blood into various blood components and products, some of which are retained while the remainder are reinfused into the donor.
"HIV antigen" means the Human Immunodeficiency Virus antigen.
"HIV-1" means the Human Immunodeficiency Virus type 1.
"HIV-2" means the Human Immunodeficiency Virus type 2.
"Industrial manufacturer" means any person engaged in collection and/or procurement of blood and blood components for manufacture or preparation of biological products or reagents.
"Key person" means individuals designated by the blood bank director.
"Licensee" means a person holding a license in accordance with 26:2A-2 et seq. and this chapter.
"Mobile unit" means a moveable, transient unit that is used to collect blood and/or blood components from donors not at the blood bank permanent location.
"Person" means a natural person, partnership, association, corporation, institution, agency, or other similar type entity responsible for the operation of a blood bank as defined by 26:2A-2 et seq. and this chapter.
"Phlebotomist" means an individual who obtains blood from donors and/or patients by venipuncture.
"Plasmapheresis" means the procedure in which blood is removed from the donor, the plasma is separated from the formed elements and the formed elements are returned to the donor.
"Preparation" means the method used to manufacture blood and blood components.
"Processing" means all tests and procedures required to prepare and identify the blood and blood products as to their suitability for therapeutic, prophylactic or other in vivo or in vitro purposes.
"Proficiency testing" means the structured evaluation of laboratory methods that assesses the accuracy and reliability of processes, procedures, equipment, supplies and reagents.
"Pyrogen-free" means a system free from any material capable of causing a febrile response.
"Reagent" means a substance used for any in vitro purpose.
"Recipient" means any person who receives a transfusion of whole blood or blood components.
"Satellite blood bank" means a facility, which is part of a health system and does emergency or limited blood banking activities.
"Service" means any of the functions outlined in the Blood Bank License Application form supplied by the Department.
"Significant step" means any step that would be necessary to reconstruct, from the record alone, the procedures performed and who performed them.
"Standard operating procedures (SOP)" means a collection of written individual instructions and policy guidelines with a specific step by step description of how an activity is to be performed.
"Standards of the American Association of Blood Banks" means the current standards, as amended and supplemented, of the American Association of Blood Banks, National Office, 8101 Glenbrook Rd., Bethesda, MD 20814-2749.
"Storage" means the holding of blood or blood components in connection with collection, and/or processing prior to distribution or transfusion.
"System" means the organizational structure, responsibilities, policies, processes, procedures, and resources established by the licensee to achieve the requirements of these rules.
"Therapeutic phlebotomy" means the removal of whole blood from a donor for the purpose of medical treatment.
N.J. Admin. Code § 8:8-1.2
See: 18 N.J.R. 2280(a), 19 N.J.R. 356(b).
Added definition HIV.
Amended by R.1989 d.246, effective 5/15/1989.
See: 21 N.J.R. 407(a), 21 N.J.R. 1412(a).
"Autologous donation/transfusion" amended.
Definitions added for "Crossing over", "Designated donor", "Directed donation", "Homologous donation", "HIV", "Key person", "Mobile unit", "Preparation", "Service", "Significant step", "Stationary collection site", "Subsidiary blood bank", "Surrogate testing".
Amended by R.1994 d.350, effective 8/1/1994.
See: 26 N.J.R. 1057(a), 26 N.J.R. 3171(a).
Amended by R.2005 d.283, effective 10/3/2005.
See: 36 N.J.R. 4261(a), 37 N.J.R. 3815(a).
Added "AABB Standards", "Allogeneic", "Center for Biologics Evaluation and Research (CBER)", "Clinical practitioner", "Designee", "FDA regulations", "Industrial manufacturer", "Licensee", "Person", "Proficiency testing", "Standard operating procedures (SOP)" and "System" definitions; rewrote "Autologous donation/transfusion", "Blood bank", "Directed donation", "Mobile unit", "Phlebotomist", "Plasmapheresis", "Satellite blood bank" and "Storage" definitions; substituted the term "Broker" for "Brokerage" and rewrote the definition; deleted "Homologous or allogenic donation" and "Office of Biologics" definitions.