National Blood Authority Australia

Annual Report 2010–11

appendicies

APPENDIX 12. GLOSSARY OF TERMS AND ACRONYMS

ACRONYMS

EMA European Medicines Agency HBV Hepatitis B virus JBC Jurisdictional Blood Committee MSAC Medical Services Advisory Committee (Australia) PRP platelet-rich plasma
AABB American Association of Blood Banks
ABDR Australian Bleeding Disorders Registry
ABS Australian Bureau of Statistics
ACHS Australian Council on Healthcare Standards
ACSQHC Australian Commission on Safety and Quality in Healthcare
AD Alzheimer’s disease
AHCDO Australian Haemophilia Centre Directors’ Organisation
AHMAC Australian Health Ministers’ Advisory Council
AHMC Australian Health Ministers’ Council
AHP Approved Health Provider
ANAO Australian National Audit Office
ANZSBT Australian and New Zealand Society of Blood Transfusion
ARCBS Australian Red Cross Blood Service (the Blood Service)
ARCS Australian Red Cross Society
AWA Australian Workplace Agreement
BARDA Biomedical Advanced Research and Development Authority (USA)
BPAC [FDA] Blood Products Advisory Committee (USA)
CAFA CSL Australian Fractionation Agreement
CDC Centers for Disease Control and Prevention (USA)
CFS Chronic Fatigue Syndrome
CoE Council of Europe
CSL Limited (CSL Ltd, CSL) Now the name of a private company; the name derives from its earlier existence as the Commonwealth Serum Laboratories
CTEPC Clinical, Technical and Ethical Principal Committee
DEHP Di(2-ethylhexyl)phthalate
DIF dual inactivation and nanofiltration
DoD Department of Defense (USA)
DoHA Australian Department of Health and Ageing
ESA Erythropoiesis (red blood cell) stimulating agent
EU European Union
FDA Food and Drug Administration (USA)
FEIBA Factor Eight Inhibitor Bypass Agent
FFP/FP fresh frozen plasma/frozen plasma
FOI Freedom of Information
FTC Federal Trade Commission (USA)
GSK GlaxoSmithKline
GST goods and services tax
H1N1 Pandemic influenza 2009 (‘swine flu’)
H5N1 avian influenza
HAC Haemovigilance Advisory Committee
HCV Hepatitis C virus
HFA Haemophilia Foundation of Australia
HHS Department of Health and Human Services (USA)
HIV human immunodeficiency virus
HmA Haemophilia A
HmB Haemophilia B
HSMA Health and Safety Management Arrangements
IDMS Integrated data management system
Ig immunoglobulin
IPS Information Publication Scheme
ITP Idiopathic thrombocytopenic purpura
IU International unit
IV intravenous
IVIg Intravenous immunoglobulin
IVF in vitro fertilisation
KPI key performance indicator
kWh kilowatt hour
LIS Laboratory information system (of AHPs)
ME Myalgic encephalomyelitis
MMN Multifocal motor neuropathy
MSM men who have sex with men
MVEV Murray Valley encephalitis virus
NBA National Blood Authority
NATA National Association of Testing Authorities (of Australia)
NBSCP National Blood Supply Contingency Plan
NHLBI National Heart, Lung and Blood Institute (USA)
NHMRC National Health and Medical Research Council
NHS National Health Service (UK)
NIAID National Institute of Allergy and Infectious Diseases (part of NIH)
NICE National Institute for Health and Clinical Excellence (UK)
NICRWG National IVIg Criteria Review Working Group
NIH National Institutes of Health (USA)
NIMS National IVIg Management System
NMF National Managed Fund
NNDSS National Notifiable Diseases Surveillance System
NPBMSC National Patient Blood Management Steering Committee
NPPSpa [collaboration of] National plasma product supply planners
NPSA National Patient Safety Agency (UK)
NSP&B National Supply Plan and Budget (Australia)
NTI National Trauma Institute (USA)
OBFM Output based funding model
OHS Occupational Health and Safety
ORBS Ordering and Receipting Blood System
PBM Patient blood management
pd plasma-derived
PID primary immunodeficiency disease
PRT pathogen reduction technology
RCPA Royal College of Pathologists of Australasia
rFVIIa recombinant Factor seven (A)
rFVIII recombinant Factor eight (clotting factor)
rFIX recombinant Factor nine (clotting factor)
RNA Ribonucleic acid
SaBTO Advisory Committee on the Safety of Blood, Tissues and Organs (UK)
SES Senior Executive Service
TACO Transfusion-associated circulatory overload
TGA Therapeutic Goods Administration (Australia)
TOPPS Trial of prophylactic platelets study (UK-led study)
TRALI Transfusion related acute lung injury
TTP Thrombotic thrombocytopenic purpura
UCLA University of California Los Angeles
vCJD variant Creutzfeldt-Jakob Disease
vWD von Willebrand disease
WADA World Anti-Doping Agency
WHO World Health Organization
WNV West Nile virus
XMRV Xenotropic Murine Leukaemia Virus-related virus

GLOSSARY OF TERMS

Acquired hypogammaglobulinaemia See http://www.nba.gov.au/ivig/pdf/criteria.pdf
Acquired immunodeficiency syndrome See http://www.nba.gov.au/ivig/pdf/criteria.pdf
Albumin The main protein in human blood and the key to the regulation of the osmotic pressure of plasma. It is extracted from blood and manufactured into an intravenously administered product
allogeneic transfusion A transfusion of product taken from different individuals of the same species
amino acids One of the 21 building blocks of protein
anaemia A medical condition in which the haemoglobin is less than normal. For men, anaemia is typically defined as haemoglobin level of less than 13.5 gram/100ml and in women less than 12.0 gram/100ml
anti-Rh(D) immunoglobulin therapy The provision of product containing Anti-Rh(D) immunoglobulin, to prevent Rhesus sensitisation in Rh(D) negative females at or below child-bearing age
apheresis A procedure in which blood is cycled out into a machine, one or more components are selectively removed, and the remainder of the blood is reinfused back into the donor
assay An analysis undertaken to determine the presence of a substance and the amount of that substance
bleeding disorders Diseases that cause abnormal or exaggerated bleeding and poor blood clotting
blood products Products manufactured from donated blood
Blood Service The Australian Red Cross Blood Service
capillary leak syndrome A rare medical condition where the number and size of the pores in the capillaries are increased which leads to a leakage of fluid from the blood to the interstitial fluid, resulting in low blood pressure, oedema and multiple organ failure due to limited perfusion
Chagas disease An infection caused by a protozoan parasite (Trypanosoma cruzi) that can result in acute inflammatory skin changes
Chikungunya A disease resembling dengue fever, seen mainly in Africa, the Indian subcontinent, and Southeast Asia, caused by an arbovirus transmitted by Aedes mosquitoes
Chronic fatigue syndrome A complex disorder characterized by profound fatigue that is not improved by bed rest and that may be worsened by physical or mental activity
Chronic inflammatory demyelinating polyneuropathy See http://www.nba.gov.au/ivig/pdf/criteria.pdf
critical bleeding Major haemorrhage that is life threatening and is likely to result in the need for massive transfusion and/or haemorrhage of a smaller volume in a critical area or organ (e.g. intracranial, intraspinal or intraocular), resulting in patient morbidity or mortality
Cytomegalovirus A member of the herpesvirus group
Dengue A disease caused by a family of viruses that are transmitted by mosquitoes. It is an acute illness of sudden onset that usually follows a benign course with symptoms such as headache, fever, exhaustion, severe muscle and joint pain
Desmopressin A drug used to treat mild von Willebrand’s disease
diagnostic reagent products Products used in blood typing and cross matching
Direct Orders (previously known as Jurisdictional Direct Orders) Arrangements implemented by the NBA with suppliers to facilitate the purchase of IVIg for the treatment of conditions not satisfying the Criteria
Erythropoietin A substance produced by the kidney that leads to the formation of red blood cells in the bone marrow
follow-on biologics A term used to describe officially-approved subsequent versions of innovator biopharmaceutical products made by a different sponsor following patent and exclusivity expiry on the innovator product
fractionation Blood plasma fractionation refers to the general processes of separating the various components of blood plasma
fresh whole blood Fresh blood contains red blood cells, white cells and platelets suspended in a straw-coloured liquid known as plasma
Guillian-Barré syndrome See http://www.nba.gov.au/ivig/pdf/criteria.pdf
Haemoglobin A molecule in red blood cells that transports molecular oxygen
haemoglobin-based oxygen carriers A type of blood substitute
Haemophilia A Classic haemophilia: an inherited blood coagulation disorder that results from a quantitative deficiency of Factor VIII, a blood clotting protein necessary for normal coagulation
Haemophilia B An inherited blood coagulation disorder similar to haemophilia A but caused by a quantitative deficiency of Factor IX
haemostasis The cessation of bleeding through clot formation, platelet plug formation and vasoconstriction
haemovigilance A set of surveillance procedures covering the transfusion chain, intended to collect and assess information on unexpected or undesirable effects resulting from the therapeutic use of labile blood products, and to prevent their occurrence or recurrence
Hereditary angiodema A rare genetic disorder caused by a deficiency in a blood protein, that can cause rapid swelling of the face and other parts of the body
human leucocyte antigen The human leucocyte antigen system (HLA) is the name of the major histocompatibility complex (MHC) in humans
Hyperimmunes Products used to provide rapid passive immunity in the post exposure period
Hypoproliferative thrombocytopenia See http://www.nba.gov.au/ivig/pdf/criteria.pdf
Idiopathic thrombocytopenic purpura See http://www.nba.gov.au/ivig/pdf/criteria.pdf
IgG2 levels See http://www.nba.gov.au/ivig/pdf/criteria.pdf
immune replacement therapy See http://www.nba.gov.au/ivig/pdf/criteria.pdf
immune tolerance induction See http://www.nba.gov.au/ivig/pdf/criteria.pdf
immunodeficiency diseases See http://www.nba.gov.au/ivig/pdf/criteria.pdf
in-country reserve A contractual requirement for blood product suppliers to the NBA for maintenance of a specified volume of product in Australia
infectious window period The time between first infection and when a test can reliably detect that infection. In antibody-based testing, the window period is dependent on the time taken for sero-conversion
intravenous immunoglobulin A product provided under the national blood arrangements to reduce susceptibility to infections and manage many immune system disorders
iron deficiency A common disorder, sometimes nutritional, which results in anaemia as iron is necessary to make haemoglobin
issues/issuage The volume of a particular product provided to Approved Health Providers in a jurisdiction under the National Blood Arrangements
jurisdiction A signatory to the National Blood Agreement. This includes the Australian Government and all state and territory governments
lean body weight dosing Dosing regimes using lean body weight calculations
leucodepletion The removal of white cells from a blood product
leucocytes/leukocytes White cells in the blood
Malaria An infectious disease transmitted by the bite of an infected Anopheles mosquito
massive transfusion In adults, ‘massive transfusion’ may be defined as a transfusion of half of one blood volume in 4 hours, or more than one blood volume in 24 hours (adult blood volume is approximately 70 mL/kg). In children, ‘massive transfusion’ may be defined as a transfusion of more than 40 mL blood/kg.
mg Milligram
monoclonal antibody Monospecific antibodies that are all identical, arising from a single lymphocyte cell clone
National Blood Agreement The Agreement signed by all governments in 2003 that sets out the objectives for governments for the management of the blood sector
National Blood Supply Contingency Plan A plan approved by ministers to coordinate an appropriate response to a shortage of blood or blood products
National Product Price List The price of all products supplied under the national blood arrangements approved by ministers
national reserve products Products held in the national reserve managed by CSL to mitigate against an interruption to supply
National Supply Plan and Budget The agreed volume of products to be supplied under the national blood arrangements approved by ministers
nitric oxide scavenging An adverse impact of blood substitutes
nucleic acid testing A biochemical technique used to detect a virus or a bacterium
off-label use The practice of prescribing pharmaceuticals for an unapproved indication, in an unapproved age group, unapproved dose, or unapproved form of administration
orphan drug designation A pharmaceutical agent that has been developed specifically to treat a rare medical condition (referred to as an ‘orphan disease’)
output-based finding model A funding arrangement whereby the supplier is paid for product receipted, rather than on a grant basis
Parvovirus B19 A virus infection characterised by low-grade fever, fatigue, a ‘slapped cheeks rash’ and a rash over the whole body. Parvovirus B19 can temporarily decrease or halt the body’s production of red blood cells, causing anaemia
pathogen inactivation technology Pathogen inactivation is a method for treating blood products that inactivates existing or unknown pathogens that may be present in blood components
patient blood management The process of improving the status of the patient’s own blood using non-transfusion methods with the consequence that transfusions and the associated risks of transfusion are avoided
Peptides A molecule consisting of two or more amino acids
perioperative settings The period of time extending from when the patient goes into hospital, clinic, or doctor’s office for surgery or a procedure, until the time the patient is discharged
pharmacokinetic dosing indicators Dosing levels indicated by evidence from pharmacokinetic studies
plasma The liquid part of the blood and lymphatic fluid, which makes up approximately half of its volume. Blood plasma contains antibodies and other proteins. It is taken from donors and made into products for a variety of blood-related conditions
platelets An irregular, disc-shaped element in the blood that assists in blood clotting. During normal blood clotting, the platelets clump together (aggregate)
prion An infectious agent composed primarily of protein
prion filtration The removal of prions from blood
prophylaxis A treatment designed and used to prevent an episode or worsening of disease from occurring
r The prefix ‘r’ means recombinant
recombinant products Synthetic or manufactured blood products (as opposed to products derived from plasma)
red blood cells The blood cell that carries oxygen. Red cells contain haemoglobin and it is the haemoglobin which permits them to transport oxygen (and carbon dioxide)
Rh(D) haemolytic anaemia Anaemia due to haemolysis, the abnormal breakdown of red blood cells either in the blood vessels or elsewhere in the body
Rh(D) haemolytic disease An alloimmune condition that develops in a foetus, when the IgG molecules (one of the five main types of antibodies) produced by the mother pass through the placenta
sequaelae A pathological condition resulting from a prior disease, injury, or attack
Sickle cell disease A type of anaemia associated with the presence of haemoglobin S
Specific Antibody Deficiency See http://www.nba.gov.au/ivig/pdf/criteria.pdf
Thrombosis The formation or presence of a thrombus (a clot of coagulated blood) in a blood vessel or cardiac chamber
tolerisation Some patients with haemophilia have antibodies (inhibitors) to transfused clotting factors (e.g. Factor VIII). Tolerisation is a treatment regimen aiming to reduce or eliminate those inhibitors
toll manufacturing agreements Arrangements in which a firm with specialised equipment processes raw materials or semi manufactured goods for another company. In the blood sector these arrangements are used to process plasma from specific countries into products for that country
transfusion-transmitted infection An infection that can be transmitted via transfusion
variant Creutzfeldt-Jakob disease A rare, degenerative, fatal brain disorder in humans
vasoconstriction Narrowing of the blood vessels resulting from contracting of the muscular wall of the vessels
von Willebrand disease An inherited bleeding disorder in which a clotting protein called von Willebrand factor is deficient or defective
West Nile virus The mosquito-borne virus that causes West Nile fever
Xenotropic murine leukaemia virus A virus from the Retroviridae family and the genus gammaretrovirus. It has a single-stranded RNA genome that replicates through a DNA intermediate
Yellow fever An acute systemic illness caused by a virus from the Flavivirus genus