National Association of Testing Authorities, Australia
Scope of Accreditation
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
Contact
Mrs Ivy Fong P: +61 (02) 93823202
Availability
Services available to external clients
Supervision
GX (General)
Scope of Accreditation
Anatomical Pathology
ISO 15189 (2022)
Human Pathology
Medicare expiry date
31 May 2026
Last Activity Date
12 Jul 2023
| 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); Ocular specimens; 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 - Gene probes using paraffin in situ hybridisation techniques (chromogenic/silver) | Formalin-fixed paraffin-embedded (FFPE) tissues | Detection of nucleic acid targets - Various |
| 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 | Formalin-fixed paraffin-embedded (FFPE) tissues; Fresh tissue | Detection of antigenic targets - Various |
| Anatomical pathology - Tissue pathology - Immunohistochemical investigation | Fixed cytological smears; Formalin-fixed paraffin-embedded (FFPE) tissues; 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 |
Bacteriology
ISO 15189 (2022)
Human Pathology
Medicare expiry date
31 May 2026
Last Activity Date
12 Jul 2023
| Service | Product | Determinant |
|---|---|---|
| Microbiology - Bacteriology - Detection of pathogenic bacteria | Bacterial isolates | Salmonella spp.; Shigella spp.; Pathogenic identification |
| Streptococcus pneumoniae | ||
| Pathogenic identification and antibiotic susceptibility | ||
| Pathogenic identification and antibiotic susceptibility | ||
| Streptococcus group B screening; Pathogenic identification and antibiotic susceptibility | ||
| Blood | Bacteria; Cultured pathogens identification; Pathogenic identification and antibiotic susceptibility; Pathogenic microorganisms | |
| Blood; Cerebrospinal fluid (CSF); Ear swabs; Eye swabs; Fluids; General swabs; Genital swabs; Nasal swabs; Ocular specimens; Respiratory specimens; Sputum; Throat swabs; Tissues; Urine; Wound swabs | Bacteria; Cultured pathogens identification; Epithelial cells; Erythrocytes (red blood cells, RBC); Leucocytes (white blood cells, WBC) | |
| Blood; Cerebrospinal fluid (CSF); Faeces; Fluids; General swabs; Sputum; Tissues; Urine | Escherichia coli - Enterohemorrhagic (EHEC); Pathogenic identification | |
| Faeces | Clostridioides difficile; Clostridium difficile glutamate dehydrogenase | |
| Bacteria; Cultured pathogens identification; Pathogenic microorganisms | ||
| Fluids | Crystals; Erythrocytes (red blood cells, RBC); Leucocytes (white blood cells, WBC) | |
| Urine | Legionella pneumophila; Legionella antigen | |
| Bacteria; Casts; Epithelial cells; Erythrocytes (red blood cells, RBC); Glucose; Leucocytes (white blood cells, WBC); Proteins; pH | ||
| Streptococcus pneumoniae antigen | ||
| Microbiology - Bacteriology - Detection of pathogenic bacteria for epidemiological infection control surveillance | Bacterial isolates | Carbapenem resistant Enterobacteriaceae (CRE); Carbapenemase-producing Enterobacterales (CPE); Methicillin resistant Staphylococcus aureus (MRSA); Vancomycin resistant Enterococci (VRE) |
| Carbapenem resistant Enterobacteriaceae (CRE); Carbapenemase-producing Enterobacterales (CPE); Methicillin resistant Staphylococcus aureus (MRSA); Vancomycin resistant Enterococci (VRE) | ||
| Microbiology - Environmental investigations and/or infection control (Clinical non-human testing) | Blood transfusion bags; Spore strips | Bacterial growth - Sterility |
| Bacterial growth - Sterility | ||
| MRO screening swabs | Bacterial growth - Sterility; Bacterial organism identification - Carbapenemase-producing Enterobacterales (CPE); Bacterial organism identification - Carbapenemase-producing Pseudomonas (CPP); Bacterial organism identification - Methicillin-resistant Staphylococcus aureus (MRSA); Organism characterisation for patient management | |
| Bacterial growth - Sterility; Bacterial organism identification - Carbapenemase-producing Enterobacterales (CPE); Bacterial organism identification - Carbapenemase-producing Pseudomonas (CPP); Bacterial organism identification - Methicillin-resistant Staphylococcus aureus (MRSA); Organism characterisation for patient management | ||
| Microbiology - Mycobacteriology - Detection and identification of mycobacteria | Isolates | Culture and limited identification |
| Mycobacteria identification | ||
| Microbiology - Mycology - Detection, isolation and/or identification of yeasts and/or fungal elements | Blood; Cerebrospinal fluid (CSF); Ear swabs; Eye swabs; Fluids; General swabs; Genital swabs; Nasal swabs; Ocular specimens; Respiratory specimens; Skin scrapings; Sputum; Throat swabs; Tissues; Urine; Wound swabs | Fungi identification; Yeasts identification |
| Fungi identification; Yeasts identification | ||
| Microbiology - Parasitology - Detection of ova, cysts and parasites | Faeces | Cysts; Ova; Parasites |
Chemistry
ISO 15189 (2012)
Human Pathology
Medicare expiry date
31 May 2026
Last Activity Date
12 Jul 2023
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Detection and/or quantitation of drugs for therapeutic monitoring | Plasma; Serum | Clozapine |
ISO 15189 (2022)
- This facility complies with the relevant National Pathology Accreditation Advisory Council (NPAAC) requirements.
Human Pathology
Medicare expiry date
31 May 2026
Last Activity Date
12 Jul 2023
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Analysis of drugs for toxicological (non-legal) purposes and ingested or absorbed toxic chemicals | Plasma; Serum | Ethanol; Paracetamol (acetaminophen) |
| 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) | |
| Metanephrine; Normetanephrine | ||
| Catecholamines | ||
| Chemical pathology - Detection and/or quantitation of drugs for therapeutic monitoring | Blood; Serum | Cyclosporin; Everolimus; Sirolimus; Tacrolimus |
| Plasma; Serum | Lithium | |
| Digoxin | ||
| Amikacin; Carbamazepine; Gentamicin (cidomycin, septopal, genticyn, garamycin); Phenobarbitone; Phenytoin (dilantin); Valproate (valproic acid, epilim) | ||
| Tobramycin; Vancomycin | ||
| Serum | Methotrexate | |
| Chemical pathology - Detection and/or quantitation of tumour markers | Ascitic fluid; Pleural fluid | CA125 antigen (CA125); CA19-9 antigen (CA19-9); Carcinoembryonic antigen (CEA); α-Fetoprotein (AFP) |
| Plasma; Serum | CA125 antigen (CA125); CA19-9 antigen (CA19-9); Carcinoembryonic antigen (CEA); Human chorionic gonadotropin (hCG); Prostate specific antigen (PSA); α-Fetoprotein (AFP) | |
| CA15-3 antigen (CA15-3); Human epididymal protein 4; Neuron specific enolase (NSE); Prostate specific antigen (PSA) - Free | ||
| Serum | Thyroglobulin | |
| Chemical pathology - Determination of hormones and hormone binding proteins (other than thyroid function tests) | Plasma | Renin |
| Plasma; Serum | 17α-Hydroxyprogesterone; Androstenedione; Dihydrotestosterone | |
| Proinsulin | ||
| Oestradiol; Testosterone | ||
| Adrenocorticotropic hormone (ACTH) | ||
| Serum | Dehydroepiandrosterone (DHEA) | |
| Insulin-like growth factor 1 (IGF-1, somatomedin C) | ||
| Aldosterone; Insulin-like growth factor 1 (IGF-1, somatomedin C) | ||
| C-peptide; Cortisol; Growth hormone; Insulin; Parathyroid hormone (PTH); Procalcitonin; Prolactin | ||
| Urine | Cortisol | |
| Chemical pathology - Diagnosis and management of diabetes mellitus | Blood | Glycated haemoglobin (HbA1c) |
| Plasma; Serum | Fructosamine | |
| Chemical pathology - Dynamic tests | Sweat | Sweat chloride |
| 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 | Serum | Bile acids - Quantitative |
| 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 | 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 | |
| Drainage fluid | Creatinine | |
| 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 | ||
| Pleural fluid | pH | |
| Amylase; Bilirubin - Total; Lipase; Uric acid | ||
| Serum; Urine | Osmolality | |
| 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; Trehalase |
| 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 | ||
| Chemical pathology - Quantitation of precursor and intermediary metabolites | Plasma | 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 | |
| Retinol (vitamin A); Tocopherol (vitamin E) | ||
| Vitamin D | ||
| 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-thyrotropin receptor antibodies (TSHR) |
| Anti-glutamic acid decarboxylase antibodies (GAD); Anti-islet cell antibodies (ICA) | ||
| 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 |
Cytogenetics Department
ISO 15189 (2022)
- This facility complies with the relevant National Pathology Accreditation Advisory Council (NPAAC) requirements.
Human Pathology
Medicare expiry date
31 May 2026
Last Activity Date
12 Jul 2023
| Service | Product | Determinant |
|---|---|---|
| Cytogenetics - Detection of defined, balanced and/or 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 | Blood; Bone marrow; Chorionic villus tissue; Other body fluids; Tissues | Cytogenetic analysis and reporting; Pathogenic copy number changes |
| Cytogenetics - Molecular karyotype (SNP microarray) detection of 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 | DNA methylation episignatures |
Diabetic Clinic
ISO 15189 (2022)
Human Pathology
Medicare expiry date
31 May 2026
Last Activity Date
12 Jul 2023
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Diagnosis and management of diabetes mellitus | Blood | Glycated haemoglobin (HbA1c) |
Emergency Department
ISO 15189 (2022)
Human Pathology
Medicare expiry date
31 May 2026
Last Activity Date
12 Jul 2023
| 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 |
Haematology
ISO 15189 (2022)
Human Pathology
Medicare expiry date
31 May 2026
Last Activity Date
12 Jul 2023
| 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 A (HbA) - Quantitation; 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 | ADAMTS-13 activity | |
| Immunoglobulin G (IgG) platelet surface antibodies | ||
| Activated partial thromboplastin time (APTT); Anti-Xa - Apixaban; Anti-Xa - Dabigatran; Anti-Xa - Fondaparinux; Anti-Xa - Orgaran; Anti-Xa - Rivaroxaban; Anti-Xa activity; Anti-Xa activity - Clexane - Low molecular weight heparin; Anti-Xa activity - Unfractionated heparin; Anti-thrombin III; Circulating coagulation factor inhibitors; D-dimer; Danaparoid sodium; Factor II; Factor IX; Factor V; Factor VII; Factor VIII; Factor VIII inhibitor; Factor VIIIc; Factor X; Factor XI; Factor XII; Fibrinogen; International normalised ratio (INR); Lupus anticoagulant; Protein C and protein S; Prothrombin time (PT); Thrombin time (TT); Von Willebrand factor (vWF) antigen - Quantitation | ||
| Heparin induced thrombocytopenia (HIT) - Confirmatory; Platelet aggregation; Serotinin release assay - C14 | ||
| Platelet aggregation | ||
| Plasma; Serum | Platelet specific antibodies | |
| Haematology - Investigation of haemoglobinopathy (excluding thalassemia) | Blood | Haemoglobin bands |
| Haemoglobin S (HbS) - Presence | ||
| 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 | CD16; CD19; CD3; CD4; CD45; CD56; CD8 |
| 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) | |
| Lavage | CD3; CD4; CD8 | |
| Immunopathology - Procedures related to the collection, processing, storage and issue of human haemopoietic progenitor cells | 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 |
Molecular Genetics
ISO 15189 (2022)
- This facility complies with the relevant National Pathology Accreditation Advisory Council (NPAAC) requirements.
Human Pathology
Medicare expiry date
31 May 2026
Last Activity Date
12 Jul 2023
| Service | Product | Determinant |
|---|---|---|
| Molecular genetics - Assay for defined mutation or polymorphism (including pharmacogenetic testing) - Targeted genes | Blood | Blood borne tumours |
| Thrombophilia | ||
| Molecular genetics - DNA extraction | Amniotic fluid; Blood; Tissues | Viable DNA for sequencing |
| Blood | DNA storage for future analyses | |
| 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 | Duchenne-Becker muscular dystrophy |
| Amniotic fluid; Blood; Chorionic villus; Mouth swabs | Spinal muscular atrophy; α-Thalassaemia; β-Thalassaemia | |
| Amniotic fluid; Blood; Chorionic villus; Saliva | Ashkenazi Jewish; Craniosynostosis; Cystic fibrosis | |
| Blood; Mouth swabs | Spinal muscular atrophy; β-Thalassaemia | |
| Spinal muscular atrophy | ||
| Molecular genetics - Investigation of constitutional genetic variants - Carrier testing - Whole genome sequencing studies for inherited (germline) DNA/RNA changes | Amniotic fluid; Blood; Chorionic villus; Extracted DNA; Mouth swabs; Products of conception (POC); Saliva; Tissues | Copy number variation (CNV); Indels; Single nucleotide variants (SNVs); Structural variations (SVs) |
| Molecular genetics - Investigation of constitutional genetic variants - Diagnostic testing - Targeted genes | Amniotic fluid; Blood; Chorionic villus | Craniosynostosis; Skeletal dysplasia; β-Thalassaemia |
| Cystic fibrosis; Duchenne-Becker muscular dystrophy; Saethre-Chotzen syndrome; Spinal muscular atrophy; α-Thalassaemia | ||
| Duchenne-Becker muscular dystrophy | ||
| Amniotic fluid; 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 | Copy number variation (CNV); Medical exome |
| Blood | Copy number variation (CNV); Medical exomeAnalysis and Interpretation of exome variants | |
| Molecular genetics - Investigation of constitutional genetic variants - Diagnostic testing - Whole genome sequencing studies for inherited (germline) DNA/RNA changes | Amniotic fluid; Blood; Chorionic villus; Extracted DNA; Mouth swabs; Products of conception (POC); Saliva; Tissues | Copy number variation (CNV); Indels; Single nucleotide variants (SNVs); Structural variations (SVs) |
| Molecular genetics - Predictive genetic testing - Targeted genes | Amniotic fluid; Blood; Chorionic villus | Limb-girdle muscular dystrophy; Mowat-Wilson syndrome; Tuberous sclerosis |
| Molecular genetics - Prenatal genetic testing (excluding non-invasive prenatal [genetic] screening) | Amniotic fluid; Blood; Chorionic villus | β-Thalassaemia |
| Duchenne-Becker muscular dystrophy; Mowat-Wilson syndrome; Saethre-Chotzen syndrome; Spinal muscular atrophy; α-Thalassaemia | ||
| Cystic fibrosis; β-Thalassaemia | ||
| Fragile X | ||
| Duchenne-Becker muscular dystrophy | ||
| Craniosynostosis; Veno-occlusive disease with immunodeficiency; β-Thalassaemia | ||
| Molecular genetics - Screening for an unknown mutation - Whole genome sequencing studies for inherited (germline) DNA/RNA changes | Amniotic fluid; Blood; Chorionic villus; Extracted DNA; Mouth swabs; Products of conception (POC); Saliva; Tissues | Copy number variation (CNV); Indels; Single nucleotide variants (SNVs); Structural variations (SVs) |
| Molecular genetics/Cytogenetics - 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 |
Prince of Wales Hospital (CTICU) POCT
ISO 15189 (2022)
Human Pathology
Medicare expiry date
31 May 2026
Last Activity Date
12 Jul 2023
| 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 |
Prince of Wales Hospital (ICU) POCT
ISO 15189 (2022)
Human Pathology
Medicare expiry date
31 May 2026
Last Activity Date
12 Jul 2023
| 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 |
Prince of Wales Hospital (OT/COS) POCT
ISO 15189 (2022)
Human Pathology
Medicare expiry date
31 May 2026
Last Activity Date
12 Jul 2023
| 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 |
Prince of Wales Private Hospital (ICU) POCT
ISO 15189 (2022)
Human Pathology
Medicare expiry date
31 May 2026
Last Activity Date
12 Jul 2023
| 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 |
Royal Hospital for Women
ISO 15189 (2022)
Human Pathology
Medicare expiry date
31 May 2026
Last Activity Date
12 Jul 2023
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Determination of hormones and hormone binding proteins (other than thyroid function tests) | Plasma; Serum | Anti-Mullerian hormone (AMH) |
| Dehydroepiandrosterone sulfate (DHEAS); Follicle stimulating hormone (FSH); Luteinising hormone (LH); Oestradiol; Progesterone; Sex hormone binding globulin (SHBG) | ||
| Chemical pathology - Investigation of maternal markers for pre-eclampsia | Serum | FMS-like tyrosine kinase 1 - Soluble; Placental growth factor (PGF, PLGF) |
| 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 |
Royal Hospital for Women (Delivery Suite) POCT
ISO 15189 (2022)
Human Pathology
Medicare expiry date
31 May 2026
Last Activity Date
12 Jul 2023
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Investigation and determination of hepatic, cardiac, bone, skeletal muscle and other profiles and metabolic studies | Blood | Lactate |
| 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 |
Royal Hospital for Women (Newborn Care) POCT
ISO 15189 (2022)
Human Pathology
Medicare expiry date
31 May 2026
Last Activity Date
12 Jul 2023
| 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 |
Serology
ISO 15189 (2022)
Human Pathology
Medicare expiry date
31 May 2026
Last Activity Date
12 Jul 2023
| Service | Product | Determinant |
|---|---|---|
| Microbiology - Serology of infection - Microbial antibody and/or antigen detection and/or quantitation | Blood; Cerebrospinal fluid (CSF); Plasma; Serum | Cryptococcus spp. |
| 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 | Fluorescent Treponemal antibody | |
| Cryptococcus spp. | ||
| Plasma; Serum | Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) antibody | |
| Brucella IgG antibody; Brucella IgM antibody | ||
| 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; Zika virus IgG antibody; Zika virus IgM antibody | ||
| Neisseria meningitidis clonal complex (CC) IgM antibody; Neisseria meningitidis outer membrane protein (OMP) IgM antibody | ||
| Mumps virus IgG antibody; Varicella zoster virus (VZV) IgG antibody | ||
| Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) antibody | ||
| 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 | ||
| Herpes simplex virus type 2 antibody (anti-HSV2) - IgG; Herpes simplex type 1 antibody (anti-HSV1) - IgG | ||
| 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 | ||
| Helicobacter pylori IgG antibody | ||
| Anti-streptolysin O (ASOT) | ||
| Measles IgG antibody; Malaria total antibody | ||
| Hepatitis C virus (HCV); Hepatitis C virus antibody (anti-HCV) | ||
| Human immunodeficiency virus (HIV) p24 antigen | ||
| Human T-lymphotropic virus type I/II (HTLV-I/II) | ||
| Chlamydial spp. IgM antibody; Chlamydial group IgA antibody | ||
| Legionella pneumophila total antibody | ||
| Adenovirus IgG antibody; Entamoeba histolytica IgG antibody | ||
| John Cunningham virus (JC) IgG antibody | ||
| Hepatitis E virus (HEV) IgG; Hepatitis E virus (HEV) IgM | ||
| Syphilis Treponema pallidum antibody | ||
| Serum | Leptospira IgM antibody | |
| Brucella total antibody | ||
| Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) neutralising antibody | ||
| Mycoplasma pneumoniae IgM antibody | ||
| Epstein-Barr virus viral capsid antigen IgG avidity index | ||
| Adenovirus total antibody; Campylobacter jejuni; Coxiella burnetii (Q-fever) total antibody; Cytomegalovirus (CMV) total antibody; Herpes simplex virus antibody (anti-HSV) - Total; Influenza B virus; Parainfluenza virus type 1 total antibody; Parainfluenza virus type 2 total antibody; Parainfluenza virus type 3 total antibody; Varicella zoster virus total antibody; Yersinia 03 total antibody | ||
| Echinococcus granulosus total antibody | ||
| Salmonella typhi IgG antibody; Salmonella typhi IgM antibody | ||
| Strongyloides spp.; Strongyloides spp. antibody; Strongyloides IgG antibody | ||
| Bordetella pertussis IgA; Bordetella pertussis IgG | ||
| Enterovirus IgG antibody; Influenza A virus IgG antibody; Respiratory syncytial virus (RSV) 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 IgG antibody; Measles IgM antibody; Mumps virus IgM antibody; Rubella IgM antibody; Varicella zoster virus (VZV) IgG antibody; Varicella zoster virus IgM antibody | ||
| Mycoplasma total antibody | ||
| Streptococcal anti-DNAse B (anti-streptodornase) antibody |
South Eastern Sydney Immunology Laboratory (SESIL)
ISO 15189 (2022)
Human Pathology
| Service | Product | Determinant |
|---|---|---|
| Immunopathology - Characterisation of leucocyte surface antigens (including immunophenotyping)Reporting only | Blood | CD16; CD19; CD3; CD4; CD45; CD56; CD8 |
| Lavage | CD3; CD4; CD8 | |
| Immunopathology - Detection and/or quantitation and/or characterisation of autoantibodies | Serum | Anti-endomysial antibodies (EMA); Anti-gastric parietal cell antibodies (GPC/PCA); Anti-liver-kidney microsomes antibodies (LKM); Anti-mitochondrial antibodies (AMA, AMA M1 and/or AMA M2); Anti-neutrophil cytoplasmic antibodies (ANCA); Anti-nuclear antibodies (ANA); Anti-reticulin antibodies (RCA, ARA); Anti-smooth muscle antibodies (SMA); Anti-tissue antigen antibodies |
| Anti-EJ antibodies; Anti-Ku antibodies; Anti-Mi-2 antibodies; Anti-NXP2 antibodies; Anti-OJ antibodies; Anti-PL-12 antibodies; Anti-PL-7 antibodies; Anti-PML antibodies; Anti-Pm/Scl-100 antibodies; Anti-Pm/Scl-75 antibodies; Anti-Ro-52 antibodies; Anti-SUMO activating enzyme antibodies (SAE); Anti-Sp-100 antibodies; Anti-extractable nuclear antigen antibodies (ENA); Anti-glycoprotein-210 antibodies (GP210); Anti-liver cytosol antibodies (LC-1); Anti-liver-kidney microsomes antibodies (LKM); Anti-melanoma differentiation associated gene 5 antibodies (MDA5); Anti-mitochondrial antibodies (AMA, AMA M1 and/or AMA M2); Anti-signal recognition particle antibodies (SRP); Anti-soluble liver antigen/liver-pancreas antibodies (SLA/LP); Anti-transcription intermediary factor antibodies (TIF1) | ||
| Anti-Jo-1 antibodies; Anti-La antibodies; Anti-Pm/Scl antibodies; Anti-RNA polymerase III antibodies (ARA, RNAP); Anti-Ro-52 antibodies; Anti-Ro-60 antibodies; Anti-Scl-70 antibodies; Anti-Smith antibodies (Sm); Anti-centromere protein B antibodies (Cenp-B); Anti-dense fine speckle 70 antibodies; Anti-fibrillarin antibodies; Anti-histone antibodies (AHA); Anti-nucleosome antibodies; Anti-proliferating cell nuclear antigen (PCNA); Anti-ribonucleoprotein antibodies (RNP); Anti-ribosomal P protein antibodies | ||
| Anti-C1q antibodies | ||
| Anti-Saccharomyces cerevisiae antibodies (ASCA); Anti-U1 ribonucleoprotein antibodies (U1 RNP); Anti-cardiolipin antibodies (ACA); Anti-cyclic citrullinated peptide antibodies (CCP); Anti-deamidated gliadin antibodies; Anti-double stranded DNA antibodies (dsDNA); Anti-extractable nuclear antigen antibodies (ENA); Anti-gliadin antibodies (AGA); Anti-immunoglobulin A antibodies (IgA); Anti-myeloperoxidase antibodies (MPO); Anti-proteinase 3 antibodies (PR3); Anti-tissue transglutaminase antibodies (tTG); Anti-β2-glycoprotein-I antibodies | ||
| Anti-glomerular basement membrane antibodies (anti-GBM) | ||
| Tryptase | ||
| Rheumatoid factor | ||
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential drug allergens) | Serum | Amoxicilloyl group; Ampicilloyl group; Penicilloyl G; Penicilloyl V; Suxamethonium (succinylcholine) |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential epidermal and animal protein allergens) | Serum | Budgerigar feathers; Canary bird feathers; Cat dander; Cat epithelium; Chicken feathers; Cow dander; Dog dander; Duck feathers; Finch feathers; Goose feathers; Horse dander; Parakeet feathers; Parrot feathers; Turkey feathers |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [egg and fowl] allergens) | Serum | Chicken; Egg; Egg white; Egg yolk |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [fish, shellfish and molluscs] allergens) | Serum | Blue mussel; Clam; Codfish; Crab; Lobster; Oyster; Salmon; Scallop; Shrimp; Tuna |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [fruit and vegetable] allergens) | Serum | Apple; Avocado; Banana; Kiwi; Orange citrus; Peach; Pear; Potato; Strawberry; Tomato |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [meat] allergens) | Serum | Beef; Mutton; Pork |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [milk] allergens) | Serum | Casein; Cow’s whey; Milk |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [miscellaneous] allergens) | Serum | Cacao; Omega-5-gliadin; Yeasts |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [seeds, legumes and nuts] allergens) | Serum | Almond; Barley; Brazil nut; Cashew nut; Coconut; Gluten; Hazelnut; Macadamia nut; Maize; 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; Common reed; Johnson grass; Kentucky blue; Meadow 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) |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential mite allergens) | Serum | Dermatophagoides farinae house dust mite; Dermatophagoides pteronyssinus house dust mite |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential occupational allergens) | Serum | Latex |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential tree pollen allergens) | Serum | Acacia; Eucalyptus; Melaleuca; Olive; White pine; Willow salix |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential venom allergens) | Serum | Common wasp (yellow jacket) venom; Honey bee venom |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential weed pollen allergens) | Serum | Common ragweed; Goosefoot; Mugwort; Plantain - English; Scale |
| Immunopathology - Quantitation of complement proteins | Serum | Alternative pathway haemolytic complement; Total haemolytic complement |
| Mannose binding lectin (MBL) pathway | ||
| Factor B; Factor H; Factor I; Other complement components or breakdown product | ||
| Complement components C3 and C4; Other complement components or breakdown product | ||
| Immunopathology - Quantitative and/or qualitative investigation of proteins | Cerebrospinal fluid (CSF) | Albumin |
| Detection and quantitation of free kappa and free lambda light chains | ||
| Cerebrospinal fluid (CSF); Serum | Oligoclonal bands | |
| Plasma | Cryofibrinogen | |
| Plasma; Serum | Cryoglobulins | |
| Serum | α1-Globulin; α2-Globulin; β-Globulin; γ-Globulin | |
| Anti-cytosolic 5´-nucleotidase 1A (Anti-cN1A) | ||
| Immunoglobulin A (IgA) - Kappa; Immunoglobulin A (IgA) - Lambda; Immunoglobulin D (IgD) - Kappa; Immunoglobulin D (IgD) - Lambda; Immunoglobulin E (IgE) - Kappa; Immunoglobulin E (IgE) - Lambda; Immunoglobulin G (IgG) - Kappa; Immunoglobulin G (IgG) - Lambda; Immunoglobulin M (IgM) - Kappa; Immunoglobulin M (IgM) - Lambda; Monoclonal proteins | ||
| Serum; Urine | Detection and quantitation of free kappa and free lambda light chains | |
| Urine | Detection of Bence Jones proteins | |
| Immunopathology - Quantitative investigations of immunoglobulins and immunoglobulins subclasses | Cerebrospinal fluid (CSF) | Total immunoglobulin G |
| Serum | Total immunoglobulin E | |
| Total immunoglobulin D | ||
| Immunoglobulin subclasses; Total immunoglobulin A; Total immunoglobulin G; Total immunoglobulin M | ||
| Microbiology - Serology of infection - Microbial antibody and/or antigen detection and/or quantitation | Serum | Anti-Aspergillus IgG; Anti-avian IgG - Pigeon |
Sydney Children’s Hospital (ICU) POCT
ISO 15189 (2022)
Human Pathology
Medicare expiry date
31 May 2026
Last Activity Date
12 Jul 2023
| 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 |
Sydney Children’s Hospital PoCT
ISO 15189 (2022)
Human Pathology
Medicare expiry date
31 May 2026
Last Activity Date
12 Jul 2023
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Diagnosis and management of diabetes mellitus | Blood | Glycated haemoglobin (HbA1c) |
Transfusion
ISO 15189 (2022)
Human Pathology
Medicare expiry date
31 May 2026
Last Activity Date
12 Jul 2023
| Service | Product | Determinant |
|---|---|---|
| Haematology - Investigation of haemolysis | Blood; Serum | Cold agglutinins |
| 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 |
| Immunohaematology - Determination of compatibility of blood donor units | Blood; Plasma | Direct antiglobulin test (DAT, direct Coombs test); Electronic crossmatch; Examination for blood group antibodies; Group checks of patient and donor; Identification of detected antibodies; Immediate spin crossmatch; Indirect antiglobulin test (IAT) |
| Immunohaematology - Identification and quantitation of blood group antibodies | Blood | Antibody elution |
| Red blood cell phenotyping | ||
| Antibody absorption | ||
| Direct antiglobulin test (DAT, direct Coombs test) | ||
| Blood; Plasma | Other blood group antibodies; Rh | |
| Cord blood | Direct antiglobulin test (DAT, direct Coombs test) | |
| Plasma; Serum | Antibody titration | |
| Immunohaematology - Investigation of blood transfusion reactions | Blood; Blood products | Antibodies; Contamination - Microbiological; Direct antiglobulin test (DAT, direct Coombs test); Examination for blood group antibodies; Group checks of patient and donor; Identification of detected antibodies |
| 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 | Compliance with transport, storage and distribution requirements of blood, products and components |
Virology NAT
ISO 15189 (2022)
Human Pathology
Medicare expiry date
31 May 2026
Last Activity Date
12 Jul 2023
| 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 |
| Cerebrospinal fluid (CSF); Nasal swabs; Ocular fluid; Skin swabs | Haemophilus ducreyi; Lymphogranuloma venereum; Treponema pallidum | |
| Cervical swabs; Genital swabs; Liquid based cytology specimens; Nasopharyngeal swabs; Rectal swabs; Urethral swabs; Urine | Mycoplasma genitalium; Macrolide resistant 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 | |
| General swabs; Liquid based cytology specimens; Urine | Haemophilus ducreyi; Lymphogranuloma venereum; Treponema pallidum | |
| 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 |
| Faeces | Blastocystis hominis; Cryptosporidium spp.; Dientamoeba fragilis; Entamoeba histolytica; Giardia intestinalis | |
| 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 7 (HHV7) |
| Amniotic fluid; Blood; Bronchoalveolar lavage; Cerebrospinal fluid (CSF); Plasma; Serum; Urine | Cytomegalovirus (CMV) | |
| Amniotic fluid; Blood; Lavage; Nasal swabs; Plasma; Serum; Throat swabs; Tissues; Urine | Rubella virus | |
| Blood | Human T-lymphotropic virus type I (HTLV-I) | |
| Ebola virus | ||
| 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; Cell culture; Cerebrospinal fluid (CSF); Cutaneous smears; Gynaecological smears; Mucus smears; Nasal swabs; Ocular specimens; Skin lesions; Skin swabs; Throat swabs; Throat wash | Cytomegalovirus (CMV); Herpes simplex virus type 1 (HSV1); Herpes simplex virus type 2 (HSV2); Varicella zoster virus (VZV) | |
| Blood; Bronchoalveolar lavage; Cerebrospinal fluid (CSF); Plasma | Human herpes virus type 6 (HHV6); Human herpes virus type 8 (HHV8) | |
| 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, COVID) | |
| Bronchoalveolar lavage; Cell culture; Cerebrospinal fluid (CSF); Faeces; Nasopharyngeal aspirate; Nasopharyngeal swabs | Enterovirus | |
| Bronchoalveolar lavage; Nasopharyngeal aspirate; Nasopharyngeal swabs | 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, COVID) | |
| Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) | ||
| 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 | |
| Genital swabs; Liquid based cytology specimens; Urine | Cytomegalovirus (CMV); Herpes simplex virus type 1 (HSV1); Herpes simplex virus type 2 (HSV2); Varicella zoster virus (VZV) | |
| Genital swabs; Oropharyngeal swabs; Rash swabs; Skin lesions; Vesicle swabs; Wound swabs | Orthopox virus group | |
| Monkeypox virus | ||
| Monkeypox virus | ||
| Nasal aspirates/washes; Nasal swabs; Nasopharyngeal swabs; Throat swabs | Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) | |
| Nasal swabs; Nasopharyngeal aspirate; Nasopharyngeal swabs | Influenza A virus; Influenza B virus; Respiratory syncytial virus (RSV) | |
| Nasal swabs; Nasopharyngeal swabs; Oropharyngeal swabs | Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) | |
| Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) | ||
| Nasal swabs; Nasopharyngeal swabs; Throat swabs | Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) | |
| 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 | ||
| Saliva | Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) | |
| Microbiology - Molecular biology - Microbial genotyping | Blood | Human immunodeficiency virus type 1 (HIV-1) proviral DNA |
| Blood; Bronchoalveolar lavage; Cerebrospinal fluid (CSF); Plasma; Semen; Urine | Cytomegalovirus (CMV) | |
| Bronchial lavage; Bronchoalveolar lavage; Cerebrospinal fluid (CSF); Faeces; Nasal swabs | Enterovirus | |
| Bronchoalveolar lavage; Nasal swabs; Nasopharyngeal aspirate; Nasopharyngeal swabs | Influenza A virus | |
| Cervical swabs | Human papilloma virus (HPV) | |
| Plasma; Serum | Hepatitis C virus (HCV) RNA genotypes 1-6; Hepatitis C virus (HCV) subtypes |
WHO Collaborating Centre for STD, Sydney and Neisseria Reference Laboratory
ISO 15189 (2022)
Human Pathology
Medicare expiry date
31 May 2026
Last Activity Date
12 Jul 2023
| Service | Product | Determinant |
|---|---|---|
| Microbiology - Bacteriology - Detection of pathogenic bacteria | Bacterial isolates | Haemophilus spp.; Moraxella catarrhalis; Neisseria spp. |
| Haemophilus spp.; Moraxella catarrhalis; Neisseria spp. | ||
| Antibiotic susceptibility; β-Lactamase | ||
| Azithromycin minimum inhibitory concentration (MIC); Ceftriaxone 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 |
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.
Grey text appearing in a SoA is additional freetext providing further refinement or information on the data in the preceding line entry.
Accreditation No.
2206
Site No.
2199
Print date
25 Nov 2024
END OF SCOPE