NSW Health Pathology

Site

NSW Health Pathology Royal Prince Alfred Hospital Laboratory

Accreditation No.

2146

Site No.

2139

Date of Accreditation

16 Dec 1986

Address

14 - 96 Missenden Road
Camperdown, NSW 2050
Australia

Contact

Ms Wafa Jeha P: +61 (02) 87385082

Availability

Services available to external clients

Supervision

GX (General)

Scope of Accreditation

ISO 15189 (2012)

Human Pathology

Medicare expiry date

08 Dec 2023

Last Activity Date

08 Dec 2020

Service Product Determinant
Chemical pathology - Analysis of drugs for toxicological (non-legal) purposes and ingested or absorbed toxic chemicals Blood; Plasma; Serum Ethyleneglycol (monoethylene glycol, MEG); Methanol
Blood; Swabs; Urine Snake venom detection
Plasma; Serum Caffeine
Methadone
Nordothiepin
Thiocyanate
Plasma; Serum; Urine Ethanol
Urine Amphetamines; Benzodiazepines; Cannabinoids; Cocaine; Opiates
Methadone metabolites
Diquat; Paraquat
Chemical pathology - Biochemical genetic services - Amino acid quantitation Cerebrospinal fluid (CSF); Plasma; Serum; Urine Alanine; Arginine; Asparagine; Aspartic acid; Citrulline; Glutamic acid; Glycine; Histidine; Isoleucine; Leucine; Lysine; Methionine; Ornithine; Phenylalanine; Serine; Taurine; Threonine; Tryptophan; Tyrosine; Valine
Chemical pathology - Biogenic amines Plasma Adrenaline; Noradrenaline
Urine Serotonin
Chemical pathology - Detection and/or quantitation of drugs for therapeutic monitoring Blood Sirolimus; Tacrolimus
Cyclosporin
Everolimus
Plasma; Serum Itraconazole; Lamotrigine; Posaconazole; Quinine; Thiopentone; Vigabatrin; Voriconazole
Amikacin; Carbamazepine; Cefoxitin; Digoxin; Gentamicin (cidomycin, septopal, genticyn, garamycin); Lithium; Paracetamol (acetaminophen); Phenobarbitone; Phenytoin (dilantin); Salicylate; Theophylline; Tobramycin; Valproate (valproic acid, epilim); Vancomycin
Amitriptyline; Clomipramine; Clonazepam; Clozapine; Desipramine; Dothiepin (dosulepin); Doxepin; Fluoxetine; Gabapentin; Imipramine; Mianserin; Norclomipramine; Norclozapine; Nordoxepin; Norfluoxetine; Nortriptyline; Perhexiline; Topiramate
Methotrexate
Plasma; Serum; Urine Cotinine
Chemical pathology - Detection and/or quantitation of tumour markers Cerebrospinal fluid (CSF); Plasma; Serum Neuron specific enolase (NSE)
Plasma; Serum Chromagranin A - Gen I
CA125 antigen (CA125); CA15-3 antigen (CA15-3); CA19-9 antigen (CA19-9); CA72-4 antigen (CA72-4); Carcinoembryonic antigen (CEA); Prostate specific antigen (PSA); Prostate specific antigen (PSA) - Free; Thyroglobulin
Human chorionic gonadotropin (hCG)
Chemical pathology - Determination of hormones and hormone binding proteins (other than thyroid function tests) Plasma Renin
Glucagon
Vasoactive intestinal peptide (VIP)
Adrenocorticotropic hormone (ACTH)
CopeptinCopeptin has replaced Vasopressin. Notified as part of 2019 OLN. Review at next assessment.
Plasma; Serum C-peptide; Calcitonin; Gastrin; Growth hormone; Prolactin
Cortisol; Dehydroepiandrosterone sulfate (DHEAS); Follicle stimulating hormone (FSH); Luteinising hormone (LH); Oestradiol; Parathyroid hormone (PTH); Progesterone; Sex hormone binding globulin (SHBG); Testosterone - Free; Testosterone - Total
Leptin
Ghrelin
Adiponectin
Pancreatic polypeptide (PP)
Macroprolactin
Insulin
Plasma; Serum; Urine Aldosterone
Saliva Cortisol
Serum 17α-Hydroxyprogesterone
Insulin-like growth factor 1 (IGF-1, somatomedin C)
Urine Cortisol
Chemical pathology - Diagnosis and management of diabetes mellitus Blood Glycated haemoglobin (HbA1c)
Glycated haemoglobin (HbA1c)
Plasma; Serum Fructosamine
Chemical pathology - Further investigation of cardiac function Plasma; Serum N-Terminal-pro b-type natriuretic peptide (NT-proBNP)
Troponin T
Serum Creatine kinase (CK) isoenzymes
Chemical pathology - Further investigation of lipid profiles for diagnosis of types III and IV hyperlipidaemia Plasma; Serum Apolipoprotein A; Apolipoprotein B; HDL - Quantitation; LDL apolipoprotein B; LDL direct (LDLD); Lipoprotein subclasses; Unesterified cholesterol (UC) lipids; VLDL cholesterol; VLDL triglycerides
Serum Lipoprotein subclasses
Chemical pathology - Further investigation of renal and/or hepatic function Plasma; Serum α1-Antitrypsin
Lactate dehydrogenase (LDH) isoenzymes
Alkaline phosphatase (ALP) isoenzymes
Caeruloplasmin; Prealbumin
Plasma; Serum; Urine Bile acids
Urine Oxalate
Chemical pathology - Haem related pigments and precursors (excluding porphyria) Cerebrospinal fluid (CSF) Xanthochromia
Chemical pathology - Investigation and determination of hepatic, cardiac, bone, skeletal muscle and other profiles and metabolic studies Blood Acetylcholinesterase (RCAC)
Blood; Plasma; Serum Acetylcholinesterase (RCAC); Butyrylcholinesterase (BChE)
Cerebrospinal fluid (CSF) Chloride; Glucose; Lactate; Protein - Total
Cerebrospinal fluid (CSF); Serum Angiotensin converting enzyme (ACE)
Plasma Ammonia
Plasma; Serum Bilirubin - Direct
Alanine aminotransferase; Albumin; Alkaline phosphatase; Amylase; Aspartate aminotransferase; Bilirubin - Total; Butyrylcholinesterase (BChE); C-reactive protein (CRP); Calcium - Total; Chloride; Cholesterol - LDL; Cholesterol - Total; Cholinesterase; Creatine kinase; Creatinine; Glucose; High sensitivity C-reactive protein (CRP); Lactate dehydrogenase (LDH); Lipase; Magnesium; Phosphate; Potassium; Protein - Total; Sodium; Soluble transferrin receptor (sTFR); Triglycerides; Urate; Urea; γ-Glutamyltransferase
Bicarbonate
Plasma; Serum; Urine Osmolality
Urine Microalbumin
Albumin; Amylase; Calcium - Total; Chloride; Creatinine; Glucose; Magnesium; Phosphate; Potassium; Protein - Total; Sodium; Urate; Urea
Chemical pathology - Investigation for folate deficiency Plasma; Serum Folate
Chemical pathology - Investigation of maternal markers to detect foetal abnormality Plasma; Serum Free β-human chorionic gonadotropin (free β-hCG); Placental growth factor (PGF, PLGF); Pregnancy associated plasma protein A (PAPP-A)
Human chorionic gonadotropin (hCG) - Total; Oestriol - Unconjugated; α-Fetoprotein (AFP)
Chemical pathology - Investigation of porphyria Blood; Plasma Porphyrins - Total
Faeces Faecal coproporphyrin iii/i isomer ratio; Porphyrin faecal components; Porphyrins - Total
Urine Porphobilinogen (PBG); Porphyrin urine components; Porphyrins - Total; δ-Aminolevulinic acid (δ-ALA)
Chemical pathology - Iron studies Plasma; Serum Ferritin
Iron; Transferrin
Chemical pathology - Markers of bone metabolism Plasma; Serum Bone-specific alkaline phosphatase - Ostase
Urine n-Telopeptide (NTx)
Deoxypyridinoline (DPD)
Chemical pathology - Quantitation of blood gases and other measurements (performed on the same specimen) Blood Base excess; Bicarbonate; Calcium - Ionised; Carboxyhaemoglobin; Chloride; Glucose; Haematocrit (packed cell volume, PCV); Haemoglobin (Hb); Lactate; Methaemoglobin (MetHb); Oxygen saturation (sO2); Oxyhaemoglobin; Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); Potassium; Sodium; pH
Base excess; Bicarbonate; Calcium - Ionised; Carboxyhaemoglobin; Chloride; Creatinine; Glucose; Haematocrit (packed cell volume, PCV); Haemoglobin (Hb); Lactate; Methaemoglobin (MetHb); Oxygen saturation (sO2); Oxyhaemoglobin; Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); Potassium; Sodium; pH
Chemical pathology - Quantitation of precursor and intermediary metabolites Plasma; Serum Free fatty acids - Total; β-Hydroxybutyrate
Amino acids; Homocysteine
Urine Amino acids; Cystine; Homocysteine; HydroxyprolineHomocystine as well as homocysteine
Chemical pathology - Quantitation of vitamin B markers Plasma; Serum Holotranscobalamin (active vitamin B12)
Chemical pathology - Quantitation of vitamins Blood Pyridoxine (vitamin B6, pyridoxal, pyridoxamine); Riboflavin (vitamin B2); Thiamine (vitamin B1)
Plasma; Serum Carotenoids
Cobalamin (vitamin B12)
Ascorbic acid (vitamin C); Retinol (vitamin A); Tocopherol (vitamin E)
25-Hydroxyvitamin D
Urine Niacin metabolites
Chemical pathology - Tests for thyroid function Plasma; Serum Thyroxine (T4) - Free
Thyroid stimulating hormone (TSH); Thyroxine (T4) - Free; Triiodothyronine (T3) - Free
Chemical pathology - Trace element analysis Blood; Liver; Plasma; Urine Copper
Blood; Other body fluids Magnesium
Blood; Plasma; Urine Selenium; Zinc
Blood; Urine Arsenic; Cadmium; Lead; Manganese; Mercury; Thallium
Manganese
Liver; Urine Iron
Plasma Bromide; Molybdenum
Aluminium
Plasma; Urine Cobalt
Chromium
Urine Antimony; Iodine; Nickel
Immunopathology - Detection and/or quantitation and/or characterisation of autoantibodies Plasma; Serum 21-Hydroxylase antibodies (21-OHAA)
Anti-insulin antibodies
Anti-thyroglobulin antibodies (Tg); Anti-thyroid peroxidase antibodies (TPO)
Anti-glutamic acid decarboxylase antibodies (GAD); Anti-islet cell antigen 2 antibodies
Anti-thyroid receptor antibodies
Immunopathology - Quantitative and/or qualitative investigation of proteins Plasma; Serum α1-Antitrypsin phenotype
Retinol binding protein
Infertility and pregnancy tests including assisted reproductive technology - Diagnosis of pregnancy Plasma; Serum Detection of human chorionic gonadotropin (hCG)
Microbiology - Bacteriology - Detection of pathogenic bacteria Urine pH

ISO 15189 (2012)

Human Pathology

Medicare expiry date

08 Dec 2023

Last Activity Date

08 Dec 2020

Service Product Determinant
Haematology - Assessment of haemolysis or metabolic enzymes (red cell enzyme assays) Blood Glucose-6-phosphate dehydrogenase (G6PD)
Haematology - Bone marrow examination Bone marrow Examination of aspirated material; Histological examination
Haematology - Diagnosis of thalassemia Blood Examination of haemoglobin H (HbH); Haemoglobin A2 (HbA2) - Quantitation; Haemoglobin F (HbF) - Quantitation
Haematology - Examination of blood films by special staining Blood Heinz bodies; Malaria
Bone marrow Iron
Urine Haemosiderin
Haematology - Foetal haemoglobin in maternal circulation Blood Feto-maternal haemorrhage (FMH) estimation
Haematology - Full blood examination Blood Differential number; Erythrocyte count (red blood cell count, RBCC); Haemoglobin (Hb); Leucocyte count (white blood cell count, WBCC); Morphology; Platelet count; Red blood cell distribution width (RDW); Red blood cell index or indices; Reticulocytes
Haematology - Haemostasis related analysis (including special coagulation testing and platelet function tests) Blood Collagen binding activity; Platelet aggregation; Platelet function (PFA); Platelet specific antibodies
Factor XIII; Von Willebrand factor (vWF); Von Willebrand factor (vWF) activity - Ristocetin co-factor assay
Activated partial thromboplastin time (APTT); Activated protein C (APC) resistance; Anti-Xa activity; Anti-thrombin III; Apixaban - Anti-Xa; D-dimer; Dabigatran; Echis test; Factor II; Factor IX; Factor IX inhibitor; Factor V; Factor VII; Factor VIII; Factor VIII inhibitor; Factor X; Factor XI; Factor XII; Factor XIII; Fibrinogen; International normalised ratio (INR); Lupus anticoagulant; Mixing studies - APTT; Protein C and protein S; Reptilase time; Rivaroxaban - Anti-Xa; Thrombin time (TT); Von Willebrand factor (vWF) activity - Ristocetin co-factor assay; Von Willebrand factor (vWF) antigen - Quantitation
Haematology - Investigation of haemolysis Blood Haemoglobin (Hb)
Hereditary spherocytosis
Haematology - Limited blood examination Blood Erythrocyte (RBC) sedimentation rate (ESR)
Immunopathology - Characterisation of leucocyte surface antigens (including immunophenotyping) Blood CD34
Paroxysmal nocturnal haemoglobinuria (PNH) surface markers
Blood; Bone marrow; Cerebrospinal fluid (CSF); Fresh tissue Leukaemia screen; Lymphoma screen
Immunopathology - Procedures related to the collection, processing, storage and issue of human haemopoietic progenitor cells Blood Enumeration of CD34+ cells
Microbiology - Serology of infection - Microbial antibody and/or antigen detection and/or quantitation Blood Infectious mononucleosis

ISO 15189 (2012)

Human Pathology

Medicare expiry date

08 Dec 2023

Last Activity Date

08 Dec 2020

Service Product Determinant
Haematology - Investigation of haemolysis Blood Cold agglutinins
Immunohaematology - Blood group antibody detection Blood Duffy system; Kell system; M and N factors; Other blood group systems; Rh phenotypes
Immunohaematology - Blood grouping Blood ABO; RhD
Immunohaematology - Determination of compatibility of blood donor units Blood Direct antiglobulin test (DAT, direct Coombs test); Examination for blood group antibodies; Group checks of patient and donor; Identification of detected antibodies
Immunohaematology - Identification and quantitation of blood group antibodies Blood Antibody elution; Antibody titration; Other blood group antibodies; Red blood cell phenotyping
Immunohaematology - Investigation of blood transfusion reactions Blood products Antibodies
Immunohaematology - Storage and distribution of blood and blood components Blood products Issue and release of blood and blood products for transfusion

ISO 15189 (2012)

Human Pathology

Medicare expiry date

08 Dec 2023

Last Activity Date

08 Dec 2020

Service Product Determinant
Chemical pathology - Further investigation of renal and/or hepatic function Serum Tryptase
Haptoglobins
Chemical pathology - Haem related pigments and precursors (excluding porphyria) Serum β2-Microglobulin (B2M)
Chemical pathology - Investigation and determination of hepatic, cardiac, bone, skeletal muscle and other profiles and metabolic studies Cerebrospinal fluid (CSF) Albumin
Serum C1 esterase inhibitor
Immunopathology - Detection and/or quantitation and/or characterisation of autoantibodies Cerebrospinal fluid (CSF) Anti-neuronal antibodies
Serum Rheumatoid factor
Anti-HMGCR (3-hydroxy-3-methylglutaryl coenzyme A reductase)
Anti-RNA polymerase III antibodies (ARA, RNAP); Anti-cyclic citrullinated peptide antibodies (CCP); Anti-deamidated gliadin antibodies; Anti-double stranded DNA antibodies (dsDNA); Anti-glomerular basement membrane antibodies (anti-GBM); Anti-myeloperoxidase antibodies (MPO); Anti-proteinase 3 antibodies (PR3); Anti-tissue transglutaminase antibodies (tTG)
Anti-extractable nuclear antigen antibodies (ENA)
Anti-cardiolipin antibodies (ACA); Anti-extractable nuclear antigen antibodies (ENA)
Anti-extractable nuclear antigen antibodies (ENA); Anti-ganglioside antibodies (GD1b); Anti-histone antibodies (AHA); Anti-liver antibodies; Anti-myositis antibodies; Anti-neuronal antibodies; Anti-ribosomal P protein antibodies
Anti-F actin antibodies; Anti-adrenal cortex antibodies; Anti-cardiac antibodies; Anti-endomysial antibodies (EMA); Anti-gastric parietal cell antibodies (GPC/PCA); Anti-liver-kidney microsomes antibodies (LKM); Anti-mitochondrial antibodies (AMA, AMA M1, AMA M2); Anti-neuronal antibodies; Anti-neutrophil cytoplasmic antibodies (ANCA); Anti-nuclear antibodies (ANA); Anti-pemphigoid antibodies; Anti-pemphigus antibodies; Anti-skeletal muscle antibodies; Anti-smooth muscle antibodies (SMA)
Immunopathology - Detection of immunoglobulin E specific antibodies (to potential component testing (purified native and/or recombinant allergens)) Serum Ara h2 - Peanut; Omega-5-gliadin - Wheat; Ovomucoid - Egg
Immunopathology - Detection of immunoglobulin E specific antibodies (to potential drug allergens) Serum Amoxicillin; Amoxicilloyl group; Ampicilloyl group; Cefaclor; Chlorhexidine; Morphine; Penicilloyl G; Penicilloyl V; Suxamethonium (succinylcholine)
Immunopathology - Detection of immunoglobulin E specific antibodies (to potential epidermal and animal protein allergens) Serum Animal mix; Cat dander; Cow dander; Dog dander; Horse dander
Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [egg and fowl] allergens) Serum Chicken; Egg white; Egg yolk
Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [fish, shellfish and molluscs] allergens) Serum Blue mussel; Codfish; Crab; Lobster; Salmon; Seafood mix; Shrimp; Tuna
Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [fruit and vegetable] allergens) Serum Apple; Avocado; Banana; Kiwi; Tomato
Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [meat] allergens) Serum Beef; Meat mix; Pork
Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [milk] allergens) Serum Cheese - Cheddar type; Cheese - Mould type; Cow milk
Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [miscellaneous] allergens) Serum Baker's yeast; Staple food mix; Yeasts
Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [seeds, legumes and nuts] allergens) Serum Almond; Barley; Brazil nut; Buck wheat; Cashew nut; Cereal mix; Coconut; Corn; Hazelnut; Lupin seed; Macadamia nut; Nut panel; Oat; Peanut; Pecan nut; Pinenut; Pistachio; Rice; Rye; Sesame seed; Soy bean; Walnut; Wheat
Immunopathology - Detection of immunoglobulin E specific antibodies (to potential grass pollen allergens) Serum Bahia grass; Barley; Bermuda grass; Grass mix; Johnson grass; Kentucky blue; Kentucky plane (June) grass; Meadow grass; Paspalum grass; Perennial rye grass; Rye grass; Timothy grass
Immunopathology - Detection of immunoglobulin E specific antibodies (to potential insect allergens) Serum German cockroach
Immunopathology - Detection of immunoglobulin E specific antibodies (to potential microorganism allergens) Serum Alternaria alternata; Aspergillus fumigatus; Cladosporium herbarum; Penicillium chrysogenum (formerly Penicillium notatum); Mould mix
Immunopathology - Detection of immunoglobulin E specific antibodies (to potential mite allergens) Serum Dermatophagoides farinae house dust mite; Dermatophagoides pteronyssinus house dust mite; House dust - Hollister Stier; House dust mite mix
Immunopathology - Detection of immunoglobulin E specific antibodies (to potential occupational allergens) Serum House dust; Inhalant panel; Latex; Mould mix
Immunopathology - Detection of immunoglobulin E specific antibodies (to potential tree pollen allergens) Serum Acacia; Eucalyptus; Melaleuca; Olive; Tree mix
Immunopathology - Detection of immunoglobulin E specific antibodies (to potential venom allergens) Serum Common wasp (yellow jacket) venom; Honey bee venom; Paper wasp venom
Immunopathology - Detection of immunoglobulin E specific antibodies (to potential weed pollen allergens) Serum Common ragweed; Goosefoot; Lamb’s quarters; Mugwort; Nettle; Plantain - English; Ribwort; Russian thistle; Saltwort (prickly); Weed mix
Immunopathology - Investigation of natural killer cell release from target cells Blood Natural killer (NK) cell number
Natural killer (NK) cell cytotoxicity; Natural killer (NK) cell degranulation
Immunopathology - Quantitation of complement proteins Serum Total haemolytic complement
Complement components C3 and C4
Immunopathology - Quantitative and/or qualitative investigation of proteins Cerebrospinal fluid (CSF) Oligoclonal bands
Immunoglobulin G (IgG) - Kappa
Serum Eosinophil cationic protein
Detection and quantitation of free kappa and free lambda light chains
Detection and amount of paraproteins
Cryofibrinogen; Cryoglobulins
Urine Characterisation of paraproteins; Detection and amount of paraproteins
Immunopathology - Quantitative investigations of immunoglobulins and immunoglobulins subclasses Serum Total immunoglobulin E
Immunoglobulin subclasses; Total immunoglobulin A; Total immunoglobulin D; Total immunoglobulin G; Total immunoglobulin M
Immunopathology - Single HLA antigen typing Blood HLA-B5701
Immunopathology - Tests of cellular immunity - Lymphocyte function tests Blood Lymphocyte function; Proliferation by antigens; Proliferation by mitogens
T-lymphocyte, B-lymphocyte and natural killer (TBNK)
Microbiology - Molecular biology - Microbial genotyping Plasma Human immunodeficiency virus type 1 (HIV-1) sequencing for drug resistance
Microbiology - Molecular biology - Quantitation of microbial nucleic acids Cerebrospinal fluid (CSF); Plasma Human immunodeficiency virus (HIV) RNA viral load
Human immunodeficiency virus (HIV) RNA viral load
Microbiology - Mycobacteriology - Tests for antigen lymphocyte stimulation Blood Mycobacterial antigen lymphocyte stimulation
Microbiology - Serology of infection - Microbial antibody and/or antigen detection and/or quantitation Blood; Serum Human immunodeficiency virus (HIV) p24 antigen; Human immunodeficiency virus type 1/2 (HIV-1/2) 1/2 antibodies
Serum Human T-lymphotropic virus type I/II (HTLV-I/II)
Aspergillus spp. total antibody; Avian precipitins (bird fancier's disease); Farmer's lung precipitins
Human immunodeficiency virus type 1/2 (HIV-1/2) 1/2 antibodies
Human immunodeficiency virus (HIV) p24 antigen

ISO 15189 (2012)

Human Pathology

Medicare expiry date

08 Dec 2023

Last Activity Date

08 Dec 2020

Service Product Determinant
Molecular genetics - Assay for defined mutation or polymorphism (including pharmacogenetic testing) - Targeted genes Blood Thiopurine methyltransferase (TPMT)
Molecular genetics - Bioinformatic analysis FASTQ files Primary analysis - Conversion of instrument file to FASTQ or FASTA file; Secondary analysis - Alignment and variant calling; Tertiary analysis - Data annotation and interpretation
Molecular genetics - DNA extraction Blood; Cytology samples; Formalin fixed paraffin embedded tissue sections; Fresh tissue; Frozen tissue; Tissues Viable DNA
Cytology samples; Formalin fixed paraffin embedded tissue sections; Fresh tissue Sample assessment and identification
Molecular genetics - DNA fragment size analysis Blood; Cytology samples; Formalin fixed paraffin embedded tissue sections; Fresh tissue Fragment size DNA determination; Sample identification using microsatellite DNA markers
Molecular genetics - DNA sequencing Extracted DNA Sequenced DNA by Sanger sequencing
Molecular genetics - Genetic testing for chimerism and mosaic gene variants (cancer and somatic mosaicism) - Targeted genes Cytology samples; Formalin fixed paraffin embedded tissue sections; Fresh tissue Melanoma; Metastatic colorectal carcinoma; Non-small cell lung cancer and other tumours
Molecular genetics - Genetic testing for chimerism and mosaic gene variants (cancer and somatic mosaicism) - Targeted panels for non-inherited (somatic) DNA/RNA changes Cytology samples; Formalin fixed paraffin embedded tissue sections; Fresh tissue Melanoma; Metastatic colorectal carcinoma; Non-small cell lung cancer and other tumours
Molecular genetics - Investigation of constitutional genetic variants - Diagnostic testing - Targeted genes Blood Huntington's disease
Butyrylcholinesterase (BChE)
Hereditary haemochromatosis
Apolipoprotein E genotyping
Hereditary fructose intolerance
Molecular genetics - Investigation of constitutional genetic variants - Diagnostic testing - Targeted panels for inherited (germline) DNA/RNA changes Blood Porphyria
Variant haemoglobins and rare thalassaemias; α-Thalassaemia; β-Thalassaemia
Familial hypercholesterolemia
Molecular genetics - Predictive genetic testing - Targeted genes Blood Familial hypercholesterolemia
Variant haemoglobins and rare thalassaemias; α-Thalassaemia; β-Thalassaemia
Huntington's disease
Porphyria
Butyrylcholinesterase (BChE)
Hereditary haemochromatosis

ISO 15189 (2012)

Human Pathology

Medicare expiry date

08 Dec 2023

Last Activity Date

08 Dec 2020

Service Product Determinant
Immunopathology - Detection and/or quantitation and/or characterisation of autoantibodies Serum Anti-intrinsic factor antibodies (IF)
Anti-Saccharomyces cerevisiae antibodies (ASCA)
Microbiology - Bacteriology - Detection of pathogenic bacteria Aspirates; Bacterial isolates; Biopsy specimens; Blood; Bronchoalveolar lavage; Bronchoalveolar washings; Cerebrospinal fluid (CSF); Cervical swabs; Cord tissue; Dry swabs; Ear swabs; Enteric swabs; Eye swabs; Faeces; Fine needle aspirates (FNA); Fluids; Gastric aspirate; Gastric biopsy; General swabs; Genital specimens; Genital swabs; Human breast milk; IV catheters; Infusates; Intra-uterine contraceptive device (IUCD); Nasal swabs; Nasopharyngeal aspirate; Nasopharyngeal swabs; Operative specimens; Oral sites including teeth; Plasma; Platelet concentrates; Post-operative wounds; Pus; Rectal swabs; Red cell concentrates; Respiratory specimens; Respiratory swabs and/or washings; Skin; Skin swabs; Sputum; Stem cells; Superficial sites; Synovial fluid; Throat swabs; Tissues; Urethra; Urine; Vaginal swabs; Wound swabs Bacteria; Casts; Crystals; Epithelial cells; Erythrocytes (red blood cells, RBC); Leucocytes (white blood cells, WBC)
Blood Pathogenic identification and antibiotic susceptibility
Cerebrospinal fluid (CSF) Pathogenic identification and antibiotic susceptibility
Fluids Pathogenic identification and antibiotic susceptibility
Genital swabs Pathogenic identification and antibiotic susceptibility
Respiratory specimens Pathogenic identification and antibiotic susceptibility
Synovial fluid Pathogenic identification and antibiotic susceptibility
Throat swabs Pathogenic identification and antibiotic susceptibility
Tissues Pathogenic identification and antibiotic susceptibility
Urine Legionella antigen
Bacteria; Blood; Casts; Crystals; Epithelial cells; Pathogenic identification and antibiotic susceptibility; Proteins; pH
Streptococcus pneumoniae antigen
Wound swabs Pathogenic identification and antibiotic susceptibility
Microbiology - Bacteriology - Detection of pathogenic bacteria for epidemiological infection control surveillance Axilla swabs; Faeces; Groin swabs; Infection control swabs; Nasal swabs; Rectal swabs; Wounds Carbapenem resistant Enterobacteriaceae (CRE); Methicillin resistant Staphylococcus aureus (MRSA); Vancomycin resistant Enterococci (VRE)
Microbiology - Environmental investigations and/or infection control Bacterial isolates; Microbial nucleic acids; Non-human clinical isolates Detection and characterisation of organisms (including identification and typing); Organism characterisation for patient management; Phylogenetic analysis
Blood transfusion bags; Gastrointestinal endoscopes; Vascular catheter tips Bacterial growth - Sterility; Bacterial organism identification - Acinetobacter; Bacterial organism identification - Legionella spp.; Bacterial organism identification - Carbapenem resistant Enterobacteriaceae (CRE); Bacterial organism identification - Extended spectrum β-lactamases (ESBL); Bacterial organism identification - Gram negative multi-drug resistant organisms (MRO); Bacterial organism identification - Heterogenous vancomycin-intermediate Staphylococcus aureus (hVISA); Bacterial organism identification - Metallo-β-lactamase (MBL) carbapenemase; Bacterial organism identification - Methicillin resistant Staphylococcus aureus (MRSA); Bacterial organism identification - Vancomycin resistant Enterococcus (VRE)
Microbiology - Molecular biology - Bioinformatic analysis DNA sequences; RNA sequences Primary analysis - Conversion of instrument file to FASTQ or FASTA file; Secondary analysis - Alignment and variant calling; Tertiary analysis - Data annotation and interpretation
Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (bacteria) Bacterial isolates Pan-bacterial 16s
PorA
Bacterial isolates; Blood; Sterile site Enterococcus faecium; Fem gene; MecA gene; Van A/B
Blood; Cerebrospinal fluid (CSF) Neisseria meningitidis
Cervical specimen; Genital swabs; Rectal swabs; Urine; Vaginal swabs Mycoplasma genitalium
Cervical specimen; Liquid based cytology specimens; Rectal swabs; Throat swabs; Urethral swabs; Urine; Vaginal swabs Chlamydia trachomatis; Neisseria gonorrhoeae
Neisseria gonorrhoeae
Cervical swabs; Genital swabs; Rectal swabs; Urine; Vaginal swabs Mycoplasma genitalium macrolide resistance
Nasopharyngeal swabs Bordetella pertussis
Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (fungi) Bronchoalveolar lavage; Cerebrospinal fluid (CSF); Respiratory swabs; Sterile site Pneumocystis jirovecii
Isolates Candida spp.; Cryptococcus gattii; Cryptococcus neoformans
Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (mycobacteria) Aspirates; Bronchoalveolar lavage; Cerebrospinal fluid (CSF); Respiratory specimens; Tissues; Urine Mycobacterium tuberculosis
Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (viruses) Amniotic fluid; Aspirates; Blood; Cerebrospinal fluid (CSF); Serum; Tissues; Urine Cytomegalovirus (CMV)
Amniotic fluid; Aspirates; Bronchial washings; Bronchoalveolar lavage; Cerebrospinal fluid (CSF); Nasal aspirates/washes; Nasal swabs; Nasopharyngeal aspirate; Sputum; Sterile site; Throat swabs Adenovirus; Coronavirus; Enterovirus; Human metapneumovirus; Human parechovirus; Influenza A virus H3N2; Influenza A virus H1 - 2009 pandemic strain; Influenza B virus; Parainfluenza virus type 1/2/3/4; Respiratory syncytial virus (RSV); Rhinovirus; Varicella zoster virus (VZV)
Amniotic fluid; Blood; Serum; Tissues Parvovirus B19
Blood Epstein-Barr virus​​​​
Cytomegalovirus (CMV)
Blood; Eye swabs; Respiratory specimens Adenovirus
Blood; Urine BK virus
Bronchial washings; Bronchoalveolar lavage; Endotrachael aspirate; Nasal swabs; Nasopharyngeal aspirate; Nasopharyngeal swabs; Sputum; Throat swabs Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Bronchoalveolar lavage; Nasopharyngeal and throat swab; Nasopharyngeal aspirate Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Bronchoalveolar lavage; Nasopharyngeal aspirate; Nasopharyngeal swabs; Sputum; Throat swabs Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Cerebrospinal fluid (CSF) Enterovirus; Epstein-Barr virus​​​​; Herpes simplex virus type 1 (HSV1); Herpes simplex virus type 2 (HSV2); Human parechovirus; Varicella zoster virus (VZV)
Cerebrospinal fluid (CSF); Respiratory specimens Enterovirus; Epstein-Barr virus​​​​; Herpes simplex virus type 1 (HSV1); Herpes simplex virus type 2 (HSV2); Human parechovirus; Varicella zoster virus (VZV)
Liquid based cytology specimens Human papilloma virus (HPV)
Nasal aspirates/washes; Nasal swabs; Nasopharyngeal swabs; Throat swabs Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Nasal swabs; Nasopharyngeal swabs; Oropharyngeal swabs Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Nasal swabs; Nasopharyngeal swabs; Throat swabs Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Nasopharyngeal aspirate; Throat swabs Influenza A virus; Influenza B virus; Respiratory syncytial virus (RSV)
Serum Hepatitis B virus (HBV) DNA
Hepatitis C virus (HCV) viral RNA; Hepatitis C virus (HCV) viral load - Qualitative
Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids by whole genome sequencing Bacterial isolates; Microbial nucleic acids Microbial identification; Resistance; Virulence
Microbiology - Molecular biology - Environmental and/or infection control Bacterial isolates; Microbial nucleic acids; Non-human clinical isolates Organism characterisation for patient management; Pathogenic identification and antibiotic susceptibility; Phylogenetic analysis
Microbiology - Molecular biology - Microbial DNA and/or RNA extraction Isolates Viable DNA for sequencing
Microbiology - Molecular biology - Microbial DNA and/or RNA sequencing Extracted DNA; Extracted RNA Sequenced DNA utilising massively parallel sequencing technologies
Microbiology - Molecular biology - Microbial genotyping Serum Hepatitis C virus (HCV) RNA genotypes 1-6
Microbiology - Molecular biology - Microbial genotyping by whole genome sequencing studies DNA Bacteria
Microbiology - Molecular biology - Public health investigation and/or monitoring Bacterial isolates; Microbial nucleic acids; Non-human clinical isolates Detection and characterisation of organisms (including identification and typing); Organism characterisation for patient management; Phylogenetic analysis
Microbiology - Mycobacteriology - Detection and identification of mycobacteria Other body fluids; Respiratory specimens; Sputum; Tissues; Urine Mycobacteria identification
Microbiology - Serology of infection - Microbial antibody and/or antigen detection and/or quantitation Cerebrospinal fluid (CSF); Serum Cryptococcus spp.
Plasma; Serum Hepatitis D virus (HDV)
Cytomegalovirus (CMV) IgG avidity; Cytomegalovirus antibody (anti-CMV) IgG; Cytomegalovirus antibody (anti-CMV) IgM; Epstein-Barr virus nuclear antigen IgG antibody; Epstein-Barr virus viral capsid antigen IgG antibody; Epstein-Barr virus viral capsid antigen IgM antibody; Measles IgG antibody; Measles IgM antibody; Mumps virus IgG antibody; Mycoplasma pneumoniae IgM antibody; Rubella IgG antibody; Syphilis Treponema pallidum antibody; Toxoplasma spp. IgG antibody; Toxoplasma spp. IgM antibody; Varicella zoster virus IgG antibody
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody
Hepatitis A virus antibody (anti-HAV) - IgM; Hepatitis A virus antibody (anti-HAV) - Total; Hepatitis B virus core antibody (anti-HBc) - IgM; Hepatitis B virus core antibody (anti-HBc) - Total; Hepatitis B virus envelope antibody (anti-HBe); Hepatitis B virus envelope antigen (HBe Ag); Hepatitis B virus surface antibody (anti-HBs); Hepatitis B virus surface antigen (HBs Ag); Hepatitis B virus surface antigen (HBs Ag) - Confirmatory; Hepatitis C virus antibody (anti-HCV)
Serum Hepatitis E virus (HEV) IgG; Hepatitis E virus (HEV) IgM
Syphilis Treponema pallidum antibody
Herpes simplex virus (HSV) IgG; Herpes simplex virus (HSV) IgM
Hepatitis C virus (HCV)
Brucella spp.
Streptococcal anti-DNAse B (anti-streptodornase) antibody; Anti-streptolysin O (ASOT)
Varicella zoster virus IgM antibody
Hydatid antibody
Parvovirus B19 IgG antibody; Parvovirus B19 IgM antibody
Dengue virus​​​​
Amoebae
Helicobacter pylori
Legionella spp.
Microbiology - Virology - Detection of pathogenic viruses Faeces Adenovirus; Rotavirus

ISO 15189 (2012)

Human Pathology

Medicare expiry date

08 Dec 2023

Last Activity Date

08 Dec 2020

Service Product Determinant
Molecular genetics - Assay for defined mutation or polymorphism (including pharmacogenetic testing) - Targeted genes Blood Factor V Leiden; Nucleic acid analysis for known variants; Prothrombin variant
Blood; Bone marrow Calreticulin
Molecular genetics - Genetic testing for chimerism and mosaic gene variants (cancer and somatic mosaicism) - Targeted panels for non-inherited (somatic) DNA/RNA changes Blood Quantitation of donor and recipient bone marrow derived cells in a transplant recipient

ISO 15189 (2012)

Human Pathology

Medicare expiry date

08 Dec 2023

Last Activity Date

08 Dec 2020

Service Product Determinant
Anatomical pathology - Cytopathology - Cervical cytological investigation for abnormalities, precancerous or cancerous changes or conditions Liquid based cytology specimens from cervix Human papilloma virus cytological examination; Cytological examination; Review and reporting of cervical cytological material
Anatomical pathology - Cytopathology - Gynaecological (non-cervical) cytological investigation for abnormalities, precancerous or cancerous changes or conditions Liquid based cytology specimens from cervix Cytological examination; Review and reporting of gynaecological (non-cervical tissue) cytological samples
Anatomical pathology - Cytopathology - Immunocytochemical investigation (on non-paraffin embedded cellular preparations) Fixed cytological smears Detection of antigenic targets - Various
Anatomical pathology - Cytopathology - Non-gynaecological cytological investigations of body fluids, exudates, washings and brushings from non-squamous mucosal sites for the detection of malignancy Aspirates; Bronchial lavage; Cerebrospinal fluid (CSF); Other body fluids; Sputum; Tumour tissue; Urine; Washings or brushings from other sites Cytological examination; Review and reporting of cytology samples
Anatomical pathology - Cytopathology - Non-gynaecological cytological investigations of nipple discharge or smears from squamous mucosal sites for the detection of cancerous or precancerous changes Anus smears; Lip smears; Mouth smears; Nipple discharge; Nose smears; Semen; Skin smears Cytological examination; Review and reporting of cytology samples
Anatomical pathology - Cytopathology - Non-gynaecological cytological investigations on samples obtained via fine needle aspiration biopsy Fine needle aspirates (FNA) Cytological examination; Review and reporting of fine needle aspiration samples
Anatomical pathology - Tissue pathology - Examination of biopsy material Formalin fixed tissue; Fresh tissue Review and reporting of biopsy material to identify or exclude morphological abnormalities
Anatomical pathology - Tissue pathology - Gene probes using paraffin fluorescence in-situ hybridisation (FISH) Formalin fixed paraffin embedded tissue sections Detection of nucleic acid targets - Various
Anatomical pathology - Tissue pathology - Gene probes using paraffin in-situ hybridisation techniques (chromogenic/silver) Formalin fixed paraffin embedded tissue sections Detection of nucleic acid targets - Various
Anatomical pathology - Tissue pathology - Immediate frozen section diagnosis Fresh tissue; Sentinel node; Smears; Tissue imprint Intra-operative consultation and examination of biopsy material
Anatomical pathology - Tissue pathology - Immunohistochemical (immunofluorescence) investigation Fresh tissue; Frozen tissue Detection of antigenic targets - Various
Anatomical pathology - Tissue pathology - Immunohistochemical investigation Fixed cytological smears; Formalin fixed paraffin embedded tissue sections; Fresh tissue; Frozen sections of fresh tissue Detection of antigenic targets - Various
Molecular genetics - Genetic testing for chimerism and mosaic gene variants (cancer and somatic mosaicism) - Targeted genes Formalin fixed paraffin embedded tissue sections BRAF mutation analysis; EGFR mutation analysis; KRAS mutation analysis; NRAS mutation analysis

ISO 15189 (2012)

Human Pathology

Medicare expiry date

08 Dec 2023

Last Activity Date

08 Dec 2020

Service Product Determinant
Chemical pathology - Quantitation of blood gases and other measurements (performed on the same specimen) Blood Base excess; Bicarbonate; Calcium - Ionised; Carboxyhaemoglobin; Chloride; Creatinine; Glucose; Haematocrit (packed cell volume, PCV); Haemoglobin (Hb); Lactate; Methaemoglobin (MetHb); Oxygen saturation (sO2); Oxyhaemoglobin; Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); Potassium; Sodium; pH

ISO 15189 (2012)

Human Pathology

Medicare expiry date

08 Dec 2023

Last Activity Date

08 Dec 2020

Service Product Determinant
Chemical pathology - Quantitation of blood gases and other measurements (performed on the same specimen) Blood Base excess; Bicarbonate; Calcium - Ionised; Carboxyhaemoglobin; Chloride; Creatinine; Glucose; Haematocrit (packed cell volume, PCV); Haemoglobin (Hb); Lactate; Methaemoglobin (MetHb); Oxygen saturation (sO2); Oxyhaemoglobin; Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); Potassium; Sodium; pH

ISO 15189 (2012)

Human Pathology

Medicare expiry date

08 Dec 2023

Last Activity Date

08 Dec 2020

Service Product Determinant
Chemical pathology - Quantitation of blood gases and other measurements (performed on the same specimen) Blood Base excess; Bicarbonate; Calcium - Ionised; Carboxyhaemoglobin; Chloride; Creatinine; Glucose; Haematocrit (packed cell volume, PCV); Haemoglobin (Hb); Lactate; Methaemoglobin (MetHb); Oxygen saturation (sO2); Oxyhaemoglobin; Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); Potassium; Sodium; pH

ISO 15189 (2012)

Human Pathology

Medicare expiry date

08 Dec 2023

Last Activity Date

08 Dec 2020

Service Product Determinant
Chemical pathology - Quantitation of blood gases and other measurements (performed on the same specimen) Blood Base excess; Bicarbonate; Calcium - Ionised; Carboxyhaemoglobin; Chloride; Glucose; Haematocrit (packed cell volume, PCV); Haemoglobin (Hb); Lactate; Methaemoglobin (MetHb); Oxygen saturation (sO2); Oxyhaemoglobin; Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); Potassium; Sodium; pH

ISO 15189 (2012)

Human Pathology

Medicare expiry date

08 Dec 2023

Last Activity Date

08 Dec 2020

Service Product Determinant
Chemical pathology - Quantitation of blood gases and other measurements (performed on the same specimen) Blood Base excess; Bicarbonate; Calcium - Ionised; Carboxyhaemoglobin; Chloride; Glucose; Haematocrit (packed cell volume, PCV); Haemoglobin (Hb); Lactate; Methaemoglobin (MetHb); Oxygen saturation (sO2); Oxyhaemoglobin; Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); Potassium; Sodium; pH

ISO 15189 (2012)

Human Pathology

Medicare expiry date

08 Dec 2023

Last Activity Date

08 Dec 2020

Service Product Determinant
Chemical pathology - Quantitation of blood gases and other measurements (performed on the same specimen) Blood Base excess; Bicarbonate; Calcium - Ionised; Carboxyhaemoglobin; Chloride; Glucose; Haematocrit (packed cell volume, PCV); Haemoglobin (Hb); Lactate; Methaemoglobin (MetHb); Oxygen saturation (sO2); Oxyhaemoglobin; Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); Potassium; Sodium; pH
Base excess; Bicarbonate; Calcium - Ionised; Chloride; Creatinine; Glucose; Haematocrit (packed cell volume, PCV); Haemoglobin (Hb); Lactate; Oxygen saturation (sO2); Partial pressure of alveolar oxygen (PAO2); Partial pressure of carbon dioxide (pCO2); Potassium; Sodium; Urea nitrogen; pH

The only data displayed is that deemed relevant and necessary for the clear description of the activities and services covered by the scope of accreditation.

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