Therapeutic Goods Order No. 88 - Standards for donor selection, testing, and minimising infectious disease transmission via therapeutic goods that are human blood and blood components, human tissues and human cellular therapy products
5. Interpretation5. Interpretation
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Turn the raw legal text into a practical explanation grounded in Therapeutic Goods Order No. 88 - Standards for donor selection, testing, and minimising infectious disease transmission via therapeutic goods that are human blood and blood components, human tissues and human cellular therapy products.
allogeneic use means the use of blood, blood components, tissues or cellular therapy products that are removed from one person and applied to another person.
antimicrobial means the ability of a substance to kill or inhibit growth of microorganisms.
aseptic technique means the technique that consists of measures used to prevent contamination by microorganisms.
asystole means the reference time for cardiac death. A documented pronounced time of death is used as asystole when life-saving procedures have been attempted and there were signs of, or documentation of, recent life (e.g. agonal respirations, pulse-less electrical activity). If death was not witnessed, ‘asystole’ must be determined by reference to the last time that the person was known to be alive. Asystole will be ‘cross clamp time’ if the tissue donor was also a solid organ donor.
autologous use means the use of blood, blood components, tissues or cellular therapy products that are removed from and applied to the same person.
bioburden has the same meaning as in the Act.
blood means whole blood collected from a single human donor and processed either for transfusion or further manufacturing.
blood components means components of blood (red cells, white cells, platelets, plasma) that can be prepared by centrifugation, filtration and freezing, but not including haematopoietic progenitor cells.
blood donation centre means a site licensed under Part 3-3 of the Act for the collection of blood, blood components or haematopoietic progenitor cells.
cell(s) means individual cells or a collection of cells when not bound by any form of connective tissue.
collection means removing human blood, blood components, cells, or tissue from a donor.
cornea only donors means persons who donate ocular tissue that will be released for the specific purpose of corneal transplantation.
critical material means all materials or supplies used in the manufacture of therapeutic goods which could have a direct impact on the quality, safety or function of the final goods.
cryopreserved means suspended in a medium containing a suitable cryoprotectant and cooled according to a method which has been validated to allow maintenance for long periods.
default standard has the same meaning as in the Act.
domino donor means a person who by receiving an organ transplant donates the removed organ or tissue for allogeneic use.
donor means any source, whether living or deceased, of blood, blood components, cells or tissues.
extrinsic microbial contamination means contamination of blood, blood components, tissues or cellular therapy products caused by compromised processing.
Division 5. Interpretation - Therapeutic Goods Order No. 88 - Standards for donor selection, testing, and minimising infectious disease transmission via therapeutic goods that are human blood and blood components, human tissues and human cellular therapy products - 5. Interpretation | Zoe
haematopoietic progenitor cells means cells that are primitive multipotent cells capable of self-renewal as well as differentiation and maturation into all haematopoietic lineages.
HBsAg means Hepatitis B surface antigen.
HBV means Hepatitis B virus.
HCV means Hepatitis C virus.
HIV means Human Immunodeficiency Virus.
HPC means haematopoietic progenitor cells.
HPC-A means haematopoietic progenitor cells- apheresis.
HPC-C means haematopoietic progenitor cells-cord.
HPC-M means haematopoietic progenitor cells-marrow.
HTLV-1 means Human T-Lymphotropic Viruses type 1.
HTLV-2 means Human T-Lymphotropic Viruses type 2.
intrinsic microbial contamination means contamination of the blood, blood components, tissues or cellular therapy products with microorganisms already present in the starting material.
knowledgeable historian means a person who is knowledgeable about the donor’s medical and social history, if the donor is deceased or unable to participate in an interview. A knowledgeable historian may be a person who is, or persons who are, able to provide relevant information about a donor’s medical and social history, and may include the donor's next of kin or the nearest available relative, a member of the donor's household, another person with a relationship with the donor (e.g. carer, friend, partner), or the donor's treating physician.
manufacture has the same meaning as in the Act.
microbial means microorganisms including, but not limited to, bacteria, fungi, Mycoplasma and Rickettsia, but does not include viruses or prions.
NAT means Nucleic acid Amplification Technique.
physical assessment means a clinical inspection of a living or deceased potential donor to determine suitability of the person to be a donor and may include, but is not limited to, assessing the relevance of any abrasion/laceration, bruise/haematoma, fracture, tattoo, piercing, scars, skin lesion, surgical incision or other distinguishing external feature that may be indicative of a behaviour or lifestyle, or suggestive of any risk factor in relation to a relevant communicable disease.
processing means any activity involved in preparation, manipulation, preservation for storage, and packaging of a blood, blood component, tissue or cell therapy product.
QC means quality control.
quarantine means the status of starting or packaging materials, intermediate, bulk or finished products isolated physically or by other effective means whilst awaiting a decision on their release or refusal.
recipient means a person who receives blood, blood components, cells or tissues by infusion or implantation.
Register has the same meaning as in the Act.
Note “Register” under the Act means the Australian Register of Therapeutic Goods maintained under section 9A.
risk of prion disease means where a donor has been exposed to the putative causative agent(s) of any one of the family of pathogenic transmissible spongiform encephalopathies through the following means:
(a) genetic (familial), or
(b) environmental, which includes donors who have lived in or visited England, Scotland, Wales, Northern Ireland or the Isle of Man for a cumulative period of six months or more, between 1st January 1980 and 31st December 1996 inclusive, or
(c) iatrogenic, which includes donors who have received a transfusion or injection of blood or blood components while in England, Scotland, Wales, Northern Ireland or the Isle of Man at any time since 1st January 1980 onwards
specified microorganism means a microorganism of clinical significance which, if isolated from the blood, blood components, cells or tissues , necessitates rejection of the product for therapeutic use.
storage means maintaining a substance, material or product under appropriate controlled conditions.
tissue means all constituent parts of the body formed by cells.
transport means the transfer within or between premises of a substance, material or product under appropriate controlled conditions.
trained interviewer means a person who is trained in interviewing skills and is an employee of, or who has a contractual arrangement with, a person engaged in the collection or manufacture of human blood and blood components, human tissues and human cellular therapy products.
trained assessor means a person who is trained in the physical assessment of donors or potential donors of human blood and blood components, human tissues or human cellular therapy products and who is an employee of, or has a contractual arrangement with, a person engaged in the collection or manufacture of human blood and blood components, human tissues or human cellular therapy products.
TSE means transmissible spongiform encephalopathy.