NSW Health Pathology

Site

NSW Health Pathology Randwick Hospital Campus Laboratory

Accreditation No.

2206

Site No.

2199

Date of Accreditation

30 Jun 1987

Address

Level 4 Campus Centre, 320 - 346 Barker Street
Randwick, NSW 2031
Australia

pathology.health.nsw.gov.au

Contact

Mrs Ivy Fong P: +61 (02) 93829106

Availability

Services available to external clients

Supervision

GX (General)

Scope of Accreditation

ISO 15189 (2012)

Human Pathology

Medicare expiry date

30 May 2023

Last Activity Date

04 Mar 2021

Service Product Determinant
Anatomical pathology - Cytopathology - Cervical cytological investigation for abnormalities, precancerous or cancerous changes or conditions Cervical smear; Liquid based cytology specimens from cervix 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; Vaginal smears; Vault smears; Vulval smears Cytological examination; Review and reporting of gynaecological (non-cervical tissue) cytological samples
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; Urine; Washings or brushings from other sites 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; Smears Review and reporting of biopsy material to identify or exclude morphological abnormalities
Anatomical pathology - Tissue pathology - Immediate frozen section diagnosis Fresh tissue; Smears; Tissue imprint Intra-operative consultation and examination of biopsy material
Anatomical pathology - Tissue pathology - Immunohistochemical (immunofluorescence) investigation Fixed cytological smears; Formalin fixed paraffin embedded tissue sections; Fresh tissue Detection of antigenic targets - Various
Formalin fixed paraffin embedded tissue sections; Fresh tissue Detection of antigenic targets - Various
Anatomical pathology - Tissue pathology - Mortuary facilities Body; Body parts Assessment - Level 2 mortuary
Anatomical pathology - Tissue pathology - Non-coronial autopsy services Body; Body parts Autopsy service and reporting

ISO 15189 (2012)

Human Pathology

Medicare expiry date

30 May 2023

Last Activity Date

04 Mar 2021

Service Product Determinant
Microbiology - Bacteriology - Detection of pathogenic bacteria Bacterial isolates Salmonella spp.; Shigella spp.; Pathogenic identification
Pathogenic identification and antibiotic susceptibility
Streptococcus group B screening; Pathogenic identification and antibiotic susceptibility
Streptococcus group B screening; Pathogenic identification and antibiotic susceptibility
Streptococcus pneumoniae
Blood Bacteria; Cultured pathogens identification; Pathogenic identification and antibiotic susceptibility; Pathogenic microorganisms
Blood; Cerebrospinal fluid (CSF); Ear swabs; Eye swabs; Fluids; Genital swabs; Nasal swabs; Respiratory specimens; Sputum; Throat swabs; Urine; Wound swabs Antigenic detection; Bacteria; Cultured pathogens identification; Epithelial cells; Erythrocytes (red blood cells, RBC); Leucocytes (white blood cells, WBC); Pathogenic identification and antibiotic susceptibility
Blood; Cerebrospinal fluid (CSF); Faeces; Fluids; General swabs; Sputum; Tissues; Urine Escherichia coli - Enterohemorrhagic (EHEC); Pathogenic identification
Faeces Bacteria; Cultured pathogens identification; Pathogenic microorganisms
Clostridiodes difficile; Clostridium difficile glutamate dehydrogenase
Fluids Crystals; Erythrocytes (red blood cells, RBC); Leucocytes (white blood cells, WBC)
Urine Bacteria; Casts; Epithelial cells; Erythrocytes (red blood cells, RBC); Glucose; Leucocytes (white blood cells, WBC); Proteins; pH
Legionella pneumophila; Legionella antigen
Streptococcus pneumoniae antigen
Microbiology - Bacteriology - Detection of pathogenic bacteria for epidemiological infection control surveillance Bacterial isolates Methicillin resistant Staphylococcus aureus (MRSA); Vancomycin resistant Enterococci (VRE)
Microbiology - Environmental investigations and/or infection control Blood transfusion bags; Spore strips/capsules Bacterial growth - Sterility
Environmental swabs Bacterial organism identification - Methicillin resistant Staphylococcus aureus (MRSA)
Microbiology - Mycobacteriology - Detection and identification of mycobacteria Isolates Other pathogenic bacteria to genus level or species level
Microbiology - Mycology - Detection, isolation and identification of yeasts and fungal elements Blood; Bronchial lavage; Bronchial washings; Cerebrospinal fluid (CSF); Ear swabs; Eye swabs; Fluids; Genital swabs; Respiratory specimens; Sputum; Throat swabs; Urine; Wound swabs Fungi identification; Yeasts identification
Blood; Cerebrospinal fluid (CSF); Ear swabs; Eye swabs; Fluids; Genital swabs; Isolates; Nasal swabs; Respiratory specimens; Sputum; Throat swabs; Urine; Wound swabs Fungi identification; Yeasts identification
Microbiology - Parasitology - Detection of ova, cysts and parasites Faeces Amoebae
Cryptosporidia; Giardia spp.
Cysts; Ova; Parasites

ISO 15189 (2012)

Human Pathology

Medicare expiry date

30 May 2023

Last Activity Date

04 Mar 2021

Service Product Determinant
Chemical pathology - Analysis of drugs for toxicological (non-legal) purposes and ingested or absorbed toxic chemicals Plasma; Serum Ethanol
Urine Amphetamines; Barbiturates; Benzodiazepines; Cannabis; Cocaine; Methadone; Opiates
Chemical pathology - Biogenic amines Blood 6-Mercaptopurine metabolites
Plasma 3-Methoxytyramine; Metanephrine; Normetanephrine
Urine 5-Hydroxyindoleacetic acid (5-HIAA); Homovanillic acid (HVA); Vanillylmandelic acid (VMA)
Catecholamines; Metanephrine; Normetanephrine
Chemical pathology - Detection and/or quantitation of drugs for therapeutic monitoring Blood; Serum Cyclosporin; Everolimus; Sirolimus; Tacrolimus
Plasma; Serum Lithium
Clozapine
Amikacin; Carbamazepine; Gentamicin (cidomycin, septopal, genticyn, garamycin); Paracetamol (acetaminophen); Phenobarbitone; Phenytoin (dilantin); Salicylate; Tobramycin; Valproate (valproic acid, epilim); Vancomycin
Digoxin
Serum Methotrexate
Chemical pathology - Detection and/or quantitation of tumour markers Serum Thyroglobulin
Chemical pathology - Detection of faecal occult blood Faeces Blood
Chemical pathology - Determination of hormones and hormone binding proteins (other than thyroid function tests) Plasma; Serum Dehydroepiandrosterone sulfate (DHEAS); Luteinising hormone (LH); Oestradiol; Progesterone; Sex hormone binding globulin (SHBG); Testosterone
Proinsulin
Anti-Mullerian hormone (AMH)
17α-Hydroxyprogesterone; Androstenedione; Dihydrotestosterone
Adrenocorticotropic hormone (ACTH)
Serum Aldosterone; Insulin-like growth factor 1 (IGF-1, somatomedin C)
C-peptide; Cortisol; Growth hormone; Insulin; Parathyroid hormone (PTH); Procalcitonin; Prolactin
Dehydroepiandrosterone (DHEA)
Urine Cortisol
Chemical pathology - Diagnosis and management of diabetes mellitus Blood Glycated haemoglobin (HbA1c)
Plasma; Serum Fructosamine
Chemical pathology - Dynamic tests Sweat Sweat chloride
Sweat conductivity
Chemical pathology - Further investigation of cardiac function Plasma; Serum Troponin T
Chemical pathology - Further investigation of lipid profiles for diagnosis of types III and IV hyperlipidaemia Plasma; Serum HDL - Quantitation
Chemical pathology - Further investigation of renal and/or hepatic function Plasma; Serum Uric acid
Serum Bile acids - Quantitative
Chemical pathology - Haem related pigments and precursors (excluding porphyria) Cerebrospinal fluid (CSF) Xanthochromia
Plasma; Serum Myoglobin
Chemical pathology - Investigation and determination of hepatic, cardiac, bone, skeletal muscle and other profiles and metabolic studies Ascitic fluid; Drainage fluid; Pleural fluid Albumin; Cholesterol - Total; Glucose; Lactate dehydrogenase (LDH); Protein - Total; Triglycerides
Cerebrospinal fluid (CSF) Glucose; Lactate; Lactate dehydrogenase (LDH); Protein - Total
Faeces; Serum; Urine Osmolality
Plasma Ammonia
Plasma; Serum Angiotensin converting enzyme (ACE)
Alanine aminotransferase; Albumin; Alkaline phosphatase; Amylase; Aspartate aminotransferase; Bicarbonate; Bilirubin - Any fractions; Bilirubin - Total; C-reactive protein (CRP); Calcium - Total; Chloride; Cholesterol - LDL; Cholesterol - Total; Creatine kinase; Creatinine; Glucose; Lactate; Lactate dehydrogenase (LDH); Lipase; Magnesium; Phosphate; Potassium; Protein - Total; Sodium; Triglycerides; Urate; Urea; γ-Glutamyltransferase
Urine Albumin; Calcium - Total; Chloride; Creatinine; Magnesium; Phosphate; Potassium; Protein - Total; Sodium; Urate; Urea
Chemical pathology - Investigation for folate deficiency Plasma; Serum Folate
Chemical pathology - Investigation of malabsorption - Quantitation of solid tissue enzymes Intestinal tissue Lactase; Maltase; Sucrase
Chemical pathology - Investigation of maternal markers for pre-eclampsia Serum FMS-like tyrosine kinase 1 - Soluble; Placental growth factor (PGF, PLGF)
Chemical pathology - Investigation of maternal markers to detect foetal abnormality Plasma; Serum Free β-human chorionic gonadotropin (free β-hCG); Pregnancy associated plasma protein A (PAPP-A)
Chemical pathology - Iron studies Plasma; Serum Iron; Transferrin
Serum Ferritin
Chemical pathology - Markers of bone metabolism Plasma; Serum Procollagen type 1 N-terminal propeptide (P1NP)
Chemical pathology - Quantitation of blood gases and other measurements (performed on the same specimen) Blood Base excess; Bicarbonate; Calcium - Ionised; Carboxyhaemoglobin; Chloride; Glucose; Haemoglobin (Hb); Lactate; Methaemoglobin (MetHb); Oxygen saturation (sO2); Oxyhaemoglobin; Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); Potassium; Reduced haemoglobin; Sodium; pH
Base excess; Bicarbonate; Calcium - Ionised; Carboxyhaemoglobin; Chloride; Creatinine; Glucose; Haemoglobin (Hb); Lactate; Methaemoglobin (MetHb); Oxygen saturation (sO2); Oxyhaemoglobin; Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); Potassium; Reduced haemoglobin; Sodium; pH
Pleural fluid pH
Chemical pathology - Quantitation of precursor and intermediary metabolites Plasma Homocysteine
Free fatty acids - Total; β-Hydroxybutyrate
Chemical pathology - Quantitation of vitamin B markers Serum Holotranscobalamin (active vitamin B12)
Methylmalonic acid (MMA)
Chemical pathology - Quantitation of vitamins Plasma; Serum Cobalamin (vitamin B12)
Serum Vitamin K
Vitamin D
Retinol (vitamin A); Tocopherol (vitamin E)
Chemical pathology - Tests for thyroid function Plasma; Serum Triiodothyronine (T3) - Reverse
Serum Thyroid stimulating hormone (TSH); Thyroxine (T4) - Free; Triiodothyronine (T3) - Free
Immunopathology - Detection and/or quantitation and/or characterisation of autoantibodies Plasma; Serum Anti-glutamic acid decarboxylase antibodies (GAD); Anti-islet cell antibodies (ICA)
Anti-thyrotropin receptor antibodies (TSHR)
Serum Anti-thyroglobulin antibodies (Tg); Anti-thyroid peroxidase antibodies (TPO)
Immunopathology - Quantitative and/or qualitative investigation of proteins Faeces Elastase
Infertility and pregnancy tests including assisted reproductive technology - Diagnosis or follow up of threatened abortion and/or diagnosis of ectopic pregnancy Plasma; Serum Human chorionic gonadotropin (hCG) - Quantitative total

ISO 15189 (2012)

Human Pathology

Medicare expiry date

30 May 2023

Last Activity Date

04 Mar 2021

Service Product Determinant
Cytogenetics - Detection of defined, unbalanced chromosomal abnormalities by in-situ hybridisation techniques Amniotic fluid; Blood; Bone marrow; Chorionic villus tissue Cytogenetic analysis and reporting; Pathogenic copy number changes
Cytogenetics - Karyotype detection of balanced and/or unbalanced chromosome abnormalities Amniotic fluid; Blood; Bone marrow; Chorionic villus tissue; Other body fluids; Other tissues - Non-malignant Cytogenetic analysis and reporting; Pathogenic copy number changes
Amniotic fluid; Blood; Chorionic villus tissue Aneuploidy detection for chromosomes
Amniotic fluid; Blood; Chorionic villus tissue; Other body fluids; Other tissues - Non-malignant Absence of heterozygosity; Cytogenetic analysis and reporting; Pathogenic copy number changes
Blood; Bone marrow; Chorionic villus tissue; Other body fluids; Tissues Cytogenetic analysis and reporting; Pathogenic copy number changes

ISO 15189 (2012)

Human Pathology

Medicare expiry date

30 May 2023

Last Activity Date

04 Mar 2021

Service Product Determinant
Chemical pathology - Diagnosis and management of diabetes mellitus Blood Glycated haemoglobin (HbA1c)

ISO 15189 (2012)

Human Pathology

Medicare expiry date

30 May 2023

Last Activity Date

04 Mar 2021

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; Haemoglobin (Hb); Lactate; Methaemoglobin (MetHb); Oxygen saturation (sO2); Oxyhaemoglobin; Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); Potassium; Reduced haemoglobin; Sodium; pH

ISO 15189 (2012)

Human Pathology

Medicare expiry date

30 May 2023

Last Activity Date

04 Mar 2021

Service Product Determinant
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 Cytological examination
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
Haematology - Diagnosis of thalassemia Blood Haemoglobin H (HbH) inclusions
Examination of haemoglobin H (HbH); Haemoglobin A2 (HbA2) - Quantitation; Haemoglobin F (HbF) - Quantitation
Haematology - Examination of blood films by special staining Blood Malaria
Haematology - Foetal haemoglobin in maternal circulation Blood Presence of foetal red blood cells
Haematology - Full blood examination Blood Differential number; Erythrocyte count (red blood cell count, RBCC); Haematocrit (packed cell volume, PCV); Haemoglobin (Hb); Leucocyte count (white blood cell count, WBCC); Platelet count; Red blood cell index or indices; Reticulocytes
Erythrocyte count (red blood cell count, RBCC); Leucocyte count (white blood cell count, WBCC); Morphology; Platelet count
Haematology - Haemostasis related analysis (including special coagulation testing and platelet function tests) Blood Platelet aggregation
Plasma Heparin induced thrombocytopenia (HITT) - Confirmatory; Platelet aggregation; Serotinin release assay - C14
Activated partial thromboplastin time (APTT); Anti-Xa activity; Anti-Xa activity - Clexane - Low molecular weight heparin; Anti-Xa activity - Unfractionated heparin; Anti-thrombin III; Apixaban - Anti-Xa; Circulating coagulation factor inhibitors; D-dimer; Dabigatran; Danaparoid sodium; Factor II; Factor IX; Factor V; Factor VII; Factor VIII; Factor VIII inhibitor; Factor VIIIc; Factor X; Factor XI; Factor XII; Fibrinogen; Fondaparinux - Anti-Xa; International normalised ratio (INR); Lupus anticoagulant; Protein C and protein S; Prothrombin time (PT); Thrombin time (TT); Von Willebrand factor (vWF) antigen - Quantitation
ADAMTS-13 activity
Platelet aggregation
Factor XIII
Immunoglobulin G (IgG) platelet surface antibodies
Factor XIII
Plasma; Serum Platelet specific antibodies
Haematology - Investigation of haemoglobinopathy (excluding thalassemia) Blood Presence of flocculation
Haemoglobin S (HbS) - Presence
Haemoglobin bands
Haematology - Investigation of haemolysis Urine Presence of intravascular haemolysis
Haemoglobin (Hb); Haemosiderin
Haematology - Limited blood examination Blood Erythrocyte (RBC) sedimentation rate (ESR)
Bronchoalveolar lavage; Cerebrospinal fluid (CSF); Pericardial fluid; Peritoneal fluid; Pleural fluid Haemopoietic/non-haemopoietic cells
Immunopathology - Characterisation of leucocyte surface antigens (including immunophenotyping) Blood; Bone marrow; Disaggregated tissues specimen; Fresh tissue; Serous fluid Assessment of lymphoid cell populations; Assessment of myeloid cell populations; B-cell; Blast cells; CD10; CD103; CD117; CD11b; CD11c; CD123; CD13; CD138; CD14; CD15; CD16; CD19; CD1a; CD2; CD20; CD200; CD22; CD23; CD235a; CD25; CD27; CD3; CD30; CD33; CD34; CD36; CD38; CD4; CD41a; CD42a; CD45; CD5; CD56; CD57; CD61; CD64; CD7; CD71; CD79a; CD79β; CD8; FMC7; HLA-DR antigen; Kappa light chains; Lambda light chains; Myeloperoxidase; Plasma cell; Surface immunoglobulin (sIg); T-cell receptor aβ (TCRab); T-cell receptor γδ (TCRgd); Terminal deoxynucleotidyl transferase (TdT)
Immunopathology - Procedures related to the collection, processing, storage and issue of human haemopoietic progenitor cellsReceives products from AN 17095 Sydney Children Hospital Apheresis Unit Bone marrow; Cord blood; Haemopoietic progenitor cells Enumeration of CD34+ cells
Microbiology - Parasitology - Detection of ova, cysts and parasites Blood Malaria
Microbiology - Serology of infection - Microbial antibody and/or antigen detection and/or quantitation Blood; Plasma; Serum Infectious mononucleosis

ISO 15189 (2012)

Human Pathology

Medicare expiry date

30 May 2023

Last Activity Date

04 Mar 2021

Service Product Determinant
Molecular genetics - Assay for defined mutation or polymorphism (including pharmacogenetic testing) - Targeted genes Blood Blood borne tumours
Thrombophilia
Molecular genetics - Bioinformatic analysis DNA sequences 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 Amniotic fluid; Blood; Tissues DNA storage for future analyses
Blood Viable DNA for sequencing
Cheek swabs Viable DNA for sequencing
Molecular genetics - DNA sequencing Amniotic fluid; Blood; Tissues Sequenced DNA by Sanger sequencing
Blood Sequenced DNA utilising massively parallel sequencing technologies
Molecular genetics - Estimation of risk of inheritance of an unknown mutation (Bayesian and linkage calculations) Amniotic fluid; Blood; Chorionic villus; Mouth swabs Fragile X
Molecular genetics - Heterozygous loci determinations Amniotic fluid; Blood; Bone marrow; Chorionic villus Congruence between two samples - Bone marrow engraftment, maternal cell contamination and identity testing
Molecular genetics - Investigation of constitutional genetic variants - Carrier testing - Targeted genes Amniotic fluid; Blood; Chorionic villus; Mouth swabs Spinal muscular atrophy; Veno-occlusive disease with immunodeficiency; α-Thalassaemia; β-Thalassaemia
Amniotic fluid; Blood; Chorionic villus; Saliva Ashkenazi Jewish; Craniosynostosis; Cystic fibrosis
Blood; Chorionic villus Duchenne-Becker muscular dystrophy
Blood; Mouth swabs β-Thalassaemia
Spinal muscular atrophy
Molecular genetics - Investigation of constitutional genetic variants - Diagnostic testing - Targeted genes Amniotic fluid; Blood; Chorionic villus Craniosynostosis; Skeletal dysplasia; Veno-occlusive disease with immunodeficiency; β-Thalassaemia
Cystic fibrosis; Duchenne-Becker muscular dystrophy; Saethre-Chotzen syndrome; Solid tumours; Spinal muscular atrophy; α-Thalassaemia
Blood; Chorionic villus Duchenne-Becker muscular dystrophy
Blood; Chorionic villus; Mouth swabs Fragile X
Blood; Mouth swabs β-Thalassaemia
Molecular genetics - Investigation of constitutional genetic variants - Diagnostic testing - Whole exome sequencing studies for inherited (germline) DNA/RNA changes Amniotic fluid; Blood; Chorionic villus; Extracted DNA; Mouth swabs; Products of conception (POC); Saliva; Tissues Medical exome
Blood Medical exomeAnalysis and Interpretation of exome variants
Molecular genetics - Predictive genetic testing - Targeted genes Amniotic fluid; Blood; Chorionic villus Limb-girdle muscular dystrophy; Mowat-Wilson syndrome; Solid tumours; Tuberous sclerosis
Molecular genetics - Prenatal genetic testing (excluding non-invasive prenatal [genetic] screening) Amniotic fluid; Blood; Chorionic villus β-Thalassaemia
Craniosynostosis; Skeletal dysplasia; Veno-occlusive disease with immunodeficiency; β-Thalassaemia
Fragile X
Cystic fibrosis; Skeletal dysplasia
Duchenne-Becker muscular dystrophy; Mowat-Wilson syndrome; Saethre-Chotzen syndrome; Spinal muscular atrophy; α-Thalassaemia
Amniotic fluid; Blood; Chorionic villus; Saliva Cystic fibrosis
Blood; Chorionic villus Duchenne-Becker muscular dystrophy

ISO 15189 (2012)

Human Pathology

Medicare expiry date

30 May 2023

Last Activity Date

04 Mar 2021

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

ISO 15189 (2012)

Human Pathology

Medicare expiry date

30 May 2023

Last Activity Date

04 Mar 2021

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; Haemoglobin (Hb); Lactate; Methaemoglobin (MetHb); Oxygen saturation (sO2); Oxyhaemoglobin; Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); Potassium; Reduced haemoglobin; Sodium; pH

ISO 15189 (2012)

Human Pathology

Medicare expiry date

30 May 2023

Last Activity Date

04 Mar 2021

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

ISO 15189 (2012)

Human Pathology

Medicare expiry date

30 May 2023

Last Activity Date

04 Mar 2021

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

ISO 15189 (2012)

Human Pathology

Medicare expiry date

30 May 2023

Last Activity Date

04 Mar 2021

Service Product Determinant
Microbiology - Serology of infection - Microbial antibody and/or antigen detection and/or quantitation Blood; Plasma; Serum Dengue virus IgG antibody; Dengue virus IgM antibody; Dengue virus NS1 antigen
Cerebrospinal fluid (CSF) Toxoplasma gondii
Cerebrospinal fluid (CSF); Plasma; Serum Syphilis Treponema pallidum antibody
Cerebrospinal fluid (CSF); Serum Cryptococcus spp.
Fluorescent Treponemal antibody
Plasma; Serum Coxiella burnetii (Q-fever) IgA phase 1 antibody; Coxiella burnetii (Q-fever) IgG phase 1 antibody; Coxiella burnetii (Q-fever) IgG phase 2 antibody; Coxiella burnetii (Q-fever) IgM phase 2 antibody
Parvovirus B19 IgG antibody; Parvovirus B19 IgM antibody
Legionella longbeachae antibody
Neisseria meningitidis clonal complex (CC) IgM antibody; Neisseria meningitidis outer membrane protein (OMP) IgM antibody
Mumps virus IgG antibody; Varicella zoster virus IgG antibody
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody
Helicobacter pylori IgG antibody
Syphilis Treponema pallidum antibody
Human T-lymphotropic virus type I/II (HTLV-I/II)
Human immunodeficiency virus (HIV) p24 antigen
Chlamydial spp. IgM antibody; Chlamydial group IgA antibody
Legionella pneumophila total antibody
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody
Human immunodeficiency virus type 1/2 (HIV-1/2) 1/2 antibodies
Cytomegalovirus (CMV); Cytomegalovirus (CMV) IgG avidity; Cytomegalovirus antibody (anti-CMV) IgM; Epstein-Barr virus nuclear antigen; Epstein-Barr virus nuclear antigen IgG antibody; Epstein-Barr virus viral capsid antigen; Epstein-Barr virus viral capsid antigen IgG antibody; Epstein-Barr virus viral capsid antigen IgM antibody; Hepatitis A virus antibody (anti-HAV) - IgG; Hepatitis A virus antibody (anti-HAV) - IgM; 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) - Quantitative; Hepatitis C virus (HCV); Hepatitis C virus antibody (anti-HCV); Human T-lymphotropic virus type I/II (HTLV-I/II); Human immunodeficiency virus (HIV); Rubella IgG antibody; Rubella IgM antibody; Syphilis Treponema pallidum antibody; Toxoplasma spp. IgG antibody; Toxoplasma spp. IgM antibody; Toxoplasma
Hepatitis C virus (HCV); Hepatitis C virus antibody (anti-HCV)
Human T-lymphotropic virus type I (HTLV-I); Human immunodeficiency virus (HIV) subtype O; Human immunodeficiency virus type 1/2 (HIV-1/2) 1/2 antibodies
Measles IgG antibody
Adenovirus IgG antibody; Entamoeba histolytica IgG antibody
Serum Brucella total antibody; Salmonella paratyphi AH total antibody; Salmonella paratyphi AO total antibody; Salmonella paratyphi BH total antibody; Salmonella paratyphi BO total antibody; Salmonella typhi H total antibody; Salmonella typhi O total antibody
Echinococcus granulosus total antibody
Leptospira IgM antibody
Epstein-Barr virus viral capsid antigen IgG avidity index
Adenovirus total antibody; Brucella total antibody; Campylobacter jejuni; Coxiella burnetii (Q-fever) total antibody; Cytomegalovirus (CMV) total antibody; Enterovirus total antibody; Herpes simplex virus antibody (anti-HSV) - Total; Influenza A virus; Influenza B virus; Measles total antibody; Mumps virus total antibody; Parainfluenza virus type 1 total antibody; Parainfluenza virus type 2 total antibody; Parainfluenza virus type 3 total antibody; Respiratory syncytial virus (RSV) total antibody; Varicella zoster virus total antibody; Yersinia 03 total antibody
Anti-streptolysin O (ASOT)
Streptococcal anti-DNAse B (anti-streptodornase) antibody
Bordetella pertussis IgA; Bordetella pertussis IgG
Mycoplasma pneumoniae IgM antibody
Mycoplasma total antibody
Cytomegalovirus antibody (anti-CMV) IgM; Herpes simplex virus type 1 antibody (anti-HSV1) - IgM; Herpes simplex virus type 2 antibody (anti-HSV2) - IgM; Measles IgM antibody; Mumps virus IgM antibody; Rubella IgM antibody; Varicella zoster virus IgG antibody; Varicella zoster virus IgM antibody
Herpes simplex virus type 2 antibody (anti-HSV2) - IgG; Herpes simplex type 1 antibody (anti-HSV1) - IgG

ISO 15189 (2012)

Human Pathology

Medicare expiry date

30 May 2023

Last Activity Date

04 Mar 2021

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; Haemoglobin (Hb); Lactate; Methaemoglobin (MetHb); Oxygen saturation (sO2); Oxyhaemoglobin; Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); Potassium; Reduced haemoglobin; Sodium; pH

ISO 15189 (2012)

Human Pathology

Medicare expiry date

30 May 2023

Last Activity Date

04 Mar 2021

Service Product Determinant
Chemical pathology - Diagnosis and management of diabetes mellitus Blood Glycated haemoglobin (HbA1c)

ISO 15189 (2012)

Human Pathology

Medicare expiry date

30 May 2023

Last Activity Date

04 Mar 2021

Service Product Determinant
Haematology - Investigation of haemolysis Blood; Serum Cold agglutinins
Donath-Landsteiner antibody
Immunohaematology - Blood group antibody detection Blood; Plasma Duffy system; Kell system; M and N factors; Other blood group systems; Rh phenotypes
Immunohaematology - Blood grouping Blood; Plasma ABO; RhD
ABO; RhD
Immunohaematology - Determination of compatibility of blood donor units Blood; Plasma 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 Red blood cell phenotyping
Antibody absorption; Antibody elution
Direct antiglobulin test (DAT, direct Coombs test)
Blood; Plasma Other blood group antibodies; Rh
Plasma; Serum Antibody titration
Immunohaematology - Investigation of blood transfusion reactions Blood; Blood products Antibodies; Contamination - Microbiological
Immunohaematology - Issue and release of blood and blood product for transfusion Blood; Blood products; Cryoprecipitate; Fresh frozen plasma (FFP); Platelets Issue and release of blood and blood products for transfusion
Immunohaematology - Storage and distribution of blood and blood components Blood; Blood products; Cryoprecipitate; Fresh frozen plasma (FFP); Platelets Issue and release of blood and blood products for transfusion

ISO 15189 (2012)

Human Pathology

Medicare expiry date

30 May 2023

Last Activity Date

04 Mar 2021

Service Product Determinant
Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (bacteria) Bronchoalveolar lavage; Nasopharyngeal aspirate; Nasopharyngeal swabs; Sputum Bordetella parapertussis; Bordetella pertussis; Chlamydophila pneumoniae; Haemophilus influenzae; Legionella pneumophila; Mycoplasma pneumoniae; Streptococcus pneumoniae
Cervical swabs; Genital swabs; Liquid based cytology specimens; Nasopharyngeal swabs; Rectal swabs; Urethral swabs; Urine Mycoplasma genitalium macrolide resistance; Mycoplasma genitalium
Cervical swabs; Rectal swabs; Throat swabs; Urine; Vaginal swabs Chlamydia trachomatis; Neisseria gonorrhoeae
Faeces Campylobacter spp.; Clostridioides difficile toxin; Listeria spp.; Salmonella spp.; Shigella spp.; Yersinia pestis
Genital swabs; Liquid based cytology specimens; Urine Mycoplasma genitalium; Mycoplasma hominis; Neisseria gonorrhoeae; Ureaplasma parvum; Ureaplasma urealyticum
Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (protozoan parasites) Amniotic fluid; Plasma Toxoplasma gondii
Eye swabs; Ocular fluid Acanthamoeba spp.
Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (viruses) Amniotic fluid; Blood; Bronchoalveolar lavage; Cerebrospinal fluid (CSF); Plasma; Serum; Tissues; Urine Human herpes virus type 6/7/8 (HHV6/7/8)
Human herpes virus type 6/7/8 (HHV6/7/8)
Amniotic fluid; Blood; Bronchoalveolar lavage; Cerebrospinal fluid (CSF); Plasma; Serum; Urine Cytomegalovirus (CMV)
Amniotic fluid; Blood; Nasal swabs; Serum; Throat swabs; Urine Rubella virus
Blood Ebola virus
Human T-lymphotropic virus type I (HTLV-I)
Blood; Bone marrow; Medullary plasma; Plasma; Serum Parvovirus B19
Blood; Bronchial lavage; Cerebrospinal fluid (CSF); Eye swabs; Faeces; Nasopharyngeal aspirate; Nasopharyngeal swabs; Ocular specimens; Plasma; Tissues; Urine Adenovirus
Adenovirus
Blood; Bronchoalveolar lavage; Cerebrospinal fluid (CSF); Plasma; Tissues Epstein-Barr virus​​​​
Blood; Plasma; Urine BK virus
Blood; Serum; Urine Zika virus
Bronchial lavage; Cell culture; Cerebrospinal fluid (CSF); Cutaneous smears; Gynaecological smears; Mucus smears; Nasal aspirates/washes; Nasal swabs; Nasopharyngeal and throat swab; Nasopharyngeal aspirate; Nasopharyngeal swabs; Ocular specimens; Plasma; Skin lesions; Skin swabs; Throat swabs; Throat wash Herpes simplex virus (HSV); Varicella zoster virus (VZV)
Bronchial washings; 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; Cell culture; Cerebrospinal fluid (CSF); Cutaneous smears; Gynaecological smears; Mucus smears; Nasal swabs; Ocular specimens; Skin lesions; Skin swabs; Throat swabs; Throat wash Herpes simplex virus (HSV); Varicella zoster virus (VZV)
Bronchoalveolar lavage; Cell culture; Cerebrospinal fluid (CSF); Faeces; Nasopharyngeal aspirate; Nasopharyngeal swabs Enterovirus
Bronchoalveolar lavage; Nasopharyngeal aspirate; Nasopharyngeal swabs Influenza A virus; Influenza A virus H1/H; Influenza A virus H3; Influenza B virus; Influenza virus H1N1 - Swine
Adenovirus; Hepatitis E virus (HEV); Human bocavirus 1, 2, 3, 4 (HBoV1, 2, 3, 4); Human coronavirus NL63; Human coronavirus OC43; Human metapneumovirus; Influenza A virus; Influenza B virus; Parainfluenza virus type 1/2/3/4; Respiratory syncytial virus (RSV) A/B; Rhinovirus
Middle Eastern respiratory syndrome coronavirus (MERS-CoV)
Bronchoalveolar lavage; Nasopharyngeal aspirate; Nasopharyngeal swabs; Oropharyngeal swabs; Sputum Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Cadaveric donor; Plasma Hepatitis B virus (HBV) DNA; Hepatitis C virus (HCV) viral RNA; Human immunodeficiency virus type 1 (HIV-1) RNA
Cadaveric donor; Plasma; Serum Hepatitis B virus (HBV) DNA; Hepatitis C virus (HCV) viral RNA; Human immunodeficiency virus type 1/2 (HIV-1/2) antigen
Cerebrospinal fluid (CSF); Faeces Human parechovirus
Cerebrospinal fluid (CSF); Plasma; Serum Yellow fever virus
Cerebrospinal fluid (CSF); Plasma; Urine John Cunningham virus (JC)
Faeces Adenovirus; Astrovirus; Bocavirus; Enterovirus; Norovirus; Rotavirus; Sapovirus
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 swabs; Urine Measles virus
Plasma Human immunodeficiency virus type 1 (HIV-1) RNA
Plasma; Serum Hepatitis C virus (HCV) viral load - Qualitative
Hepatitis B virus (HBV) DNA
Microbiology - Molecular biology - Microbial genotyping Cervical swabs Human papilloma virus (HPV)
Plasma; Serum Hepatitis C virus (HCV) RNA genotypes 1-6; Hepatitis C virus (HCV) subtypes
Microbiology - Virology - Detection of pathogenic viruses Nasal swabs; Nasopharyngeal aspirate; Nasopharyngeal swabs Influenza A virus; Influenza B virus; Respiratory syncytial virus (RSV)

ISO 15189 (2012)

Human Pathology

Medicare expiry date

30 May 2023

Last Activity Date

04 Mar 2021

Service Product Determinant
Microbiology - Bacteriology - Detection of pathogenic bacteria Bacterial isolates Antibiotic susceptibility; β-Lactamase
Neisseria gonorrhoeae outer membrane protein (OMP); Cultured pathogens identification
Azithromycin minimum inhibitory concentration (MIC); Ceftriaxone minimum inhibitory concentration (MIC); Ciprofloxacin minimum inhibitory concentration (MIC); Gentamicin (cidomycin, septopal, genticyn, garamycin) minimum inhibitory concentrations (MIC); Pathogenic identification and antibiotic susceptibility; Penicillin minimum inhibitory concentration (MIC); Rifampicin minimum inhibitory concentration (MIC)
Antibiotic susceptibility
Neisseria meningitidis polysaccharide capsule antigen; Cultured pathogens identification
Cultured pathogens identification; Glucose; Maltose; Polysaccharase; Saccharose; Tributyrinesterase; β-Galactosidase; β-Lactamase; γ-Glutamylaminopeptidase

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