New Jersey Administrative Code › Title 8 - HEALTH › Chapter 8 - COLLECTION, PROCESSING, STORAGE AND DISTRIBUTION OF BLOOD › Subchapter 1 - GENERAL PROVISIONS › Section 8:8-1.2 - Definitions

Current through Register Vol. 56, No. 14, July 15, 2024
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.