National Association of Testing Authorities, Australia
Scope of Accreditation
St Vincent's Pathology (SydPath)
Site
St Vincent’s Hospital
Accreditation No.
2115
Site No.
2108
Date of Accreditation
26 Sep 1986
Contact
Ms Lilian Milis P: +61 (02) 83829133
Availability
Services available to external clients
Supervision
GX (General)
Scope of Accreditation
Division of Anatomical Pathology
ISO 15189 (2022)
Human Pathology
Medicare expiry date
01 Jun 2027
Last Activity Date
13 Apr 2024
| 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 | 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 | 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; Rapid onsite evaluation (ROSE); Review and reporting of fine needle aspiration samples |
| Anatomical pathology - Cytopathology - Testing for the National Cervical Screening Program | Liquid based cytology specimens from cervix | Human papilloma virus (HPV) |
| Cytological examination; Review and reporting of cervical cytological material | ||
| Anatomical pathology - Tissue pathology - Examination of biopsy material | Formalin-fixed tissue | Review and reporting of biopsy material to identify or exclude morphological abnormalities |
| Anatomical pathology - Tissue pathology - Examination of biopsy material by electron microscopy | Fresh tissue | Review and reporting of biopsy material to identify or exclude ultra-structural morphological abnormalities |
| Anatomical pathology - Tissue pathology - Gene probes using paraffin fluorescence in situ hybridisation (FISH) | Formalin-fixed paraffin-embedded (FFPE) tissues | Detection of nucleic acid targets - Various |
| 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 | Intra-operative consultation and examination of biopsy material |
| Anatomical pathology - Tissue pathology - Immunohistochemical (immunofluorescence) investigation | Fresh tissue | Detection of antigenic targets - Various |
| Anatomical pathology - Tissue pathology - Immunohistochemical investigation | Fixed cytological smears; Formalin-fixed paraffin-embedded (FFPE) tissues; Fresh tissue; Frozen sections of 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; Brain - Whole; Organs; Spinal cord; Tissues | Autopsy service and reporting |
Division of Chemical Pathology
ISO 15189 (2022)
Human Pathology
Medicare expiry date
01 Jun 2027
Last Activity Date
13 Apr 2024
| 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; Ethanol; Methadone; Opiates; Oxycodone; Tricyclics | |
| Chemical pathology - Detection and/or quantitation of drugs for therapeutic monitoring | Plasma; Serum | Amikacin; Carbamazepine; Digoxin; Gentamicin (cidomycin, septopal, genticyn, garamycin); Lithium; Methotrexate; Paracetamol (acetaminophen); Phenytoin (dilantin); Salicylate; Tobramycin; Valproate (valproic acid, epilim); Vancomycin |
| Urine | Cotinine | |
| Chemical pathology - Detection and/or quantitation of tumour markers | Plasma; Serum | Thyroglobulin |
| Human chorionic gonadotropin (hCG) | ||
| Free α-glycoprotein sub-unit | ||
| CA125 antigen (CA125); CA15-3 antigen (CA15-3); CA19-9 antigen (CA19-9); Carcinoembryonic antigen (CEA); Prostate specific antigen (PSA); α-Fetoprotein (AFP) | ||
| Prostate specific antigen (PSA) - Free | ||
| Serum | β2-Microglobulin (B2M) | |
| Chemical pathology - Detection of faecal occult blood | Faeces | Haemoglobin (Hb) |
| Chemical pathology - Determination of hormones and hormone binding proteins (other than thyroid function tests) | Plasma | Testosterone - Free |
| Cortisol; Follicle stimulating hormone (FSH); Insulin; Luteinising hormone (LH); Oestradiol; Parathyroid hormone (PTH); Progesterone; Prolactin; Sex hormone binding globulin (SHBG); Testosterone - Total | ||
| Plasma; Serum | Procalcitonin | |
| Adrenocorticotropic hormone (ACTH); Dehydroepiandrosterone sulfate (DHEAS); Erythropoietin (EPO); Growth hormone | ||
| Saliva | Cortisol | |
| Serum | Androstenedione | |
| Insulin-like growth factor 1 (IGF-1, somatomedin C) | ||
| Urine | Cortisol - Free | |
| Chemical pathology - Further investigation of cardiac function | Plasma; Serum | B-type natriuretic peptide (BNP) |
| Troponin I | ||
| 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 | Caeruloplasmin; Haptoglobins; Prealbumin; α1-Antitrypsin |
| Chemical pathology - Haem related pigments and precursors (excluding porphyria) | Blood | Plasma free haemoglobin |
| Cerebrospinal fluid (CSF) | Xanthochromia | |
| Chemical pathology - Investigation and determination of hepatic, cardiac, bone, skeletal muscle and other profiles and metabolic studies | Cerebrospinal fluid (CSF) | Albumin; Chloride; Glucose; Lactate; Lactate dehydrogenase (LDH); Protein - Total |
| Cerebrospinal fluid (CSF); Ear secretions; Nasal secretions; Other body fluids; Plasma; Serum; Urine | β-Trace protein (β-TP) | |
| Cerebrospinal fluid (CSF); Ear secretions; Nasal secretions; Serum | β2-Transferrin | |
| Cerebrospinal fluid (CSF); Other body fluids; Plasma; Serum; Urine | β-Trace protein (β-TP) | |
| Drainage fluid; Peritoneal dialysis fluid; Peritoneal fluid; Pleural fluid | Chylomicron | |
| Drainage fluid; Peritoneal dialysis fluid; Pleural fluid | Albumin; Amylase; Bicarbonate; Calcium - Total; Chloride; Cholesterol - Total; Creatinine; Glucose; Lactate; Lactate dehydrogenase (LDH); Lipase; Magnesium; Phosphate; Potassium; Sodium; Triglycerides; Urea | |
| Faeces | pH | |
| Plasma; Serum | Alanine aminotransferase; Albumin; Alkaline phosphatase; Amylase; Angiotensin converting enzyme (ACE); Aspartate aminotransferase; Bicarbonate; Bilirubin - Any fractions; Bilirubin - Total; C-reactive protein (CRP); Calcium - Corrected for albumin; Calcium - Total; Chloride; Cholesterol - HDL; Cholesterol - LDL; Cholesterol - Total; Creatine kinase; Creatinine; Cystatin C; Glucose; Lactate; Lactate dehydrogenase (LDH); Lipase; Magnesium; Phosphate; Potassium; Protein - Total; Sodium; Triglycerides; Urate; Urea; γ-Glutamyltransferase | |
| Plasma; Serum; Urine | Osmolality | |
| Urine | Ketones; pH | |
| Albumin; Albumin/creatinine ratio (ACR); Amylase; Calcium - Total; Chloride; Creatinine; Glucose; Magnesium; Phosphate; Potassium; Protein - Total; Sodium; Urate; Urea | ||
| Chemical pathology - Investigation for folate deficiency | Blood; Serum | Folate; Red blood cell folate |
| Chemical pathology - Investigation of porphyria | Blood | Haemoglobin - Free |
| Chemical pathology - Iron studies | Plasma; Serum | Iron; Transferrin |
| Ferritin | ||
| Chemical pathology - Markers of bone metabolism | Plasma; Serum | Procollagen type 1 N-terminal propeptide (P1NP); c-Telopeptide (CTx) |
| Chemical pathology - Quantitation of blood gases and other measurements (performed on the same specimen) | Blood | Base excess; Calcium - Ionised; Carboxyhaemoglobin; Methaemoglobin (MetHb); Oxygen saturation (sO2); Oxyhaemoglobin; Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); pH |
| Chemical pathology - Quantitation of precursor and intermediary metabolites | Blood | β-Hydroxybutyrate |
| Chemical pathology - Quantitation of vitamins | Serum | Cobalamin (vitamin B12) |
| Chemical pathology - Tests for thyroid function | Plasma; Serum | Thyroid stimulating hormone (TSH); Thyroxine (T4) - Free; Triiodothyronine (T3) - Free |
| Immunopathology - Detection and/or quantitation and/or characterisation of autoantibodies | Plasma; Serum | Anti-thyroglobulin antibodies (Tg) |
| Rheumatoid factor | ||
| Serum | Anti-double stranded DNA antibodies (dsDNA) | |
| Anti-insulin antibodies | ||
| Immunopathology - Quantitation of complement proteins | Plasma; Serum | Complement components C3 and C4 |
| Immunopathology - Quantitative investigations of immunoglobulins and immunoglobulins subclasses | Plasma; Serum | Total immunoglobulin A; Total immunoglobulin G; Total immunoglobulin M |
| Immunopathology - Tests of cellular immunity - Cytokine assays | Serum | Interleukin 6 |
| Infertility and pregnancy tests including assisted reproductive technology - Diagnosis of pregnancy | Urine | Human chorionic gonadotropin (hCG) |
| 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 (2022)
Legal
Medicare expiry date
01 Jun 2027
Last Activity Date
13 Apr 2024
| Service | Product | Determinant |
|---|---|---|
| Medico legal drug testing AS/NZS 4308:2023, Section 2 Specimen collection, storage, handling and dispatch | Urine | Colour; Creatinine; Temperature; pH |
Division of Clinical Pharmacology and Toxicology
ISO 15189 (2022)
Human Pathology
Medicare expiry date
01 Jun 2027
Last Activity Date
13 Apr 2024
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Biogenic amines | Cerebrospinal fluid (CSF); Serum | Neopterin |
| Serum | Serotonin | |
| Chemical pathology - Detection and/or quantitation of drugs for therapeutic monitoring | Blood; Plasma | Cefazolin; Cefepime; Cefotaxime; Ceftazidime; Ciproflocaxin; Cyclosporin; Everolimus; Flucloxacillin; Fluconazole; Isavuconazole; Itraconazole; Linezolid; Meropenem; Piperacillin; Posaconazole; Sirolimus; Tacrolimus; Voriconazole |
| Cyclosporin; Everolimus; Sirolimus; Tacrolimus | ||
| Busulfan | ||
| Darunavir | ||
| Plasma | 5-Flucytosine; Allopurinol; Amiodarone; Clozapine; Desethylamiodarone; Flecainide; Imatinib; Metformin; Mycophenolic acid; Norclozapine; Oxypurinol | |
| Ethambutol; Isoniazid; Pyrazinamide; Rifampicin | ||
| Chemical pathology - Diagnosis and management of diabetes mellitus | Blood; Plasma; Serum | Glycated haemoglobin (HbA1c) |
Division of Haematology
ISO 15189 (2022)
Human Pathology
Medicare expiry date
01 Jun 2027
Last Activity Date
13 Apr 2024
| 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 |
| 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 | Malaria |
| Heinz bodies | ||
| 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); Morphology; Platelet count; Red blood cell index or indices; Reticulocytes |
| Differential number; Erythrocyte count (red blood cell count, RBCC); Leucocyte count (white blood cell count, WBCC); Morphology; Platelet count | ||
| Haematocrit (packed cell volume, PCV) | ||
| Haematology - Haemostasis related analysis (including special coagulation testing and platelet function tests) | Blood | Multi-plate assay |
| Multi-plate assay | ||
| Platelet function (PFA) | ||
| D-dimer | ||
| Heparin induced thrombotic thrombocytopenia (HITT) | ||
| Platelet aggregation | ||
| Lupus anticoagulant | ||
| Factor VIII inhibitor | ||
| Plasma | Activated partial thromboplastin time (APTT); Mixing studies - APTT; Prothrombin time (PT) mixing studies; Thrombin time (TT) | |
| Activated partial thromboplastin time (APTT); Activated protein C (APC) resistance; Anti-Xa - Dabigatran; Anti-Xa activity; Anti-thrombin III; Circulating coagulation factor inhibitors; Factor II; Factor IX; Factor V; Factor VII; Factor VIII; Factor X; Factor XI; Factor XII; Fibrinogen; International normalised ratio (INR); Mixing studies - APTT; Protein C and protein S; Prothrombin time (PT); Thrombin time (TT) | ||
| Haematology - Investigation of haemoglobinopathy (excluding thalassemia) | Blood | Haemoglobin S (HbS) - Presence |
| Haemoglobin fraction (S, C, D, E) - Quantitation; Haemoglobin instability; Other abnormal haemoglobins | ||
| Haematology - Investigation of haemolysis | Urine | Haemosiderin |
| Haematology - Limited blood examination | Blood | Erythrocyte (RBC) sedimentation rate (ESR) |
| Erythrocyte (RBC) sedimentation rate (ESR) | ||
| Immunohaematology - Blood group antibody detection | Plasma; Serum | Duffy system; Kell system; M and N factors; Other blood group systems; Rh phenotypes |
| Immunohaematology - Blood grouping | Blood; Plasma; Serum | 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 |
| 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; Plasma; Serum | Antibody elution |
| Antibody elution; Red blood cell phenotyping | ||
| Immunohaematology - Investigation of blood transfusion reactions | Blood; Blood products; Plasma | Antibodies; Direct antiglobulin test (DAT, direct Coombs test) |
| Antibodies; Contamination - Microbiological; Direct antiglobulin test (DAT, direct Coombs test) | ||
| Immunohaematology - Issue and release of blood and blood product for transfusion | 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 products; Cryoprecipitate; Fresh frozen plasma (FFP); Platelets | Issue and release of blood and blood products for transfusion |
| Microbiology - Parasitology - Detection of ova, cysts and parasites | Blood | Malaria |
| Microbiology - Serology of infection - Microbial antibody and/or antigen detection and/or quantitation | Plasma | Infectious mononucleosis |
| Molecular genetics - Assay for defined mutation or polymorphism (including pharmacogenetic testing) - Targeted genes | Blood | Factor V Leiden; Prothrombin variant |
Division of Immunopathology and HIV Medicine
ISO 15189 (2012)
Human Pathology
Medicare expiry date
01 Jun 2027
Last Activity Date
13 Apr 2024
| Service | Product | Determinant |
|---|---|---|
| Immunopathology - Quantitative and/or qualitative investigation of proteins | Serum | Detection and quantitation of free kappa and free lambda light chains |
ISO 15189 (2022)
Human Pathology
Medicare expiry date
01 Jun 2027
Last Activity Date
13 Apr 2024
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Further investigation of renal and/or hepatic function | Serum | Tryptase |
| Chemical pathology - Investigation and determination of hepatic, cardiac, bone, skeletal muscle and other profiles and metabolic studies | Serum | C1 esterase inhibitor |
| Chemical pathology - Quantitation of precursor and intermediary metabolites | Plasma | Homocysteine |
| Chemical pathology - Quantitation of vitamin B markers | Serum | Holotranscobalamin (active vitamin B12) |
| Chemical pathology - Quantitation of vitamins | Serum | 25-Hydroxyvitamin D |
| Immunopathology - Characterisation of leucocyte surface antigens (including immunophenotyping) | Aspirates; Blood; Bone marrow; Cerebrospinal fluid (CSF); Disaggregated tissues specimen; Fluids; Fresh tissue; Lavage; Serous fluid | Assessment of lymphoid cell populations; Assessment of myeloid cell populations |
| Blood | Paroxysmal nocturnal haemoglobinuria (PNH) surface markers | |
| Assessment of lymphoid cell populations | ||
| Immunopathology - Detection and/or quantitation and/or characterisation of autoantibodies | Cerebrospinal fluid (CSF); Serum | Anti-N-methyl-D-aspartate receptor antibodies (NMDA); Anti-neuronal antibodies; Anti-thyrotropin receptor antibodies (TSHR) |
| Plasma; Serum | Anti-thyroid antibodies | |
| Serum | Anti-deamidated gliadin antibodies; Anti-intrinsic factor antibodies (IF); Anti-tissue transglutaminase antibodies (tTG) | |
| Anti-extractable nuclear antigen antibodies (ENA) | ||
| Anti-cyclic citrullinated peptide antibodies (CCP) | ||
| Anti-adrenal cortex antibodies; Anti-gastric parietal cell antibodies (GPC/PCA); Anti-liver-kidney microsomes antibodies (LKM); Anti-mitochondrial antibodies (AMA, AMA M1 and/or AMA M2); Anti-neuronal antibodies; Anti-neutrophil cytoplasmic antibodies (ANCA); Anti-nuclear antibodies (ANA); Anti-smooth muscle antibodies (SMA) | ||
| Anti-myositis antibodies | ||
| Anti-myeloperoxidase antibodies (MPO); Anti-proteinase 3 antibodies (PR3); Anti-β2-glycoprotein-I antibodies | ||
| Anti-glomerular basement membrane antibodies (anti-GBM) | ||
| Anti-cardiolipin antibodies (ACA) | ||
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential drug allergens) | Serum | Penicilloyl G; Penicilloyl V |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential epidermal and animal protein allergens) | Serum | Animal mix; Cat dander; Dog dander |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [egg and fowl] allergens) | Serum | Egg; Egg white |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [fish, shellfish and molluscs] allergens) | Serum | Fish mix; Seafood mix; Shrimp |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [milk] allergens) | Serum | Cow milk |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [miscellaneous] allergens) | Serum | Staple food mix; Yeasts |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential food [seeds, legumes and nuts] allergens) | Serum | Cereal mix; Nut panel; Peanut; Soy bean; Wheat |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential grass pollen allergens) | Serum | Bahia grass; Grass mix; Rye grass |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential microorganism allergens) | Serum | Aspergillus fumigatus |
| Immunopathology - Detection of immunoglobulin E specific antibodies (to potential mite allergens) | Serum | Dermatophagoides pteronyssinus house dust mite; 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 venom allergens) | Serum | Common wasp (yellow jacket) venom; Common wasp allergen component; Honey bee venom; Paper wasp allergen component; Paper wasp venom; Venom component |
| Immunopathology - Procedures related to the collection, processing, storage and issue of human haemopoietic progenitor cells | Blood; Haemopoietic progenitor cells | Enumeration of CD34+ cells |
| Immunopathology - Quantitative and/or qualitative investigation of proteins | Cerebrospinal fluid (CSF) | Oligoclonal bands |
| Faeces | Calprotectin | |
| Plasma; Serum | Cryoglobulins | |
| Serum | Oligoclonal bands | |
| Detection and amount of paraproteins | ||
| Albumin; α1-Globulin; α2-Globulin; β-Globulin; γ-Globulin | ||
| Urine | Protein classes | |
| Detection and amount of paraproteins | ||
| Immunopathology - Quantitative investigations of immunoglobulins and immunoglobulins subclasses | Cerebrospinal fluid (CSF) | Total immunoglobulin G |
| Serum | Total immunoglobulin E | |
| Immunoglobulin subclasses | ||
| Immunopathology - Single HLA antigen typing | Blood | HLA-B27; HLA-B5701; HLA-DQ2.2; HLA-DQ2.5; HLA-DQ8 |
| Immunopathology - Tests of cellular immunity - Lymphocyte function tests | Blood | Activation by antigens |
| Microbiology - Molecular biology - Bioinformatic analysis | RNA sequences | Primary analysis - Quality analysis of primary FASTQ or FASTA file (including assembly and mapping of reads to identified references).; 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) | Genital swabs; Rectal swabs; Throat swabs; Urine | Mycoplasma genitalium; Trichomonas vaginalis |
| Neisseria gonorrhoeae | ||
| Chlamydia trachomatis; Neisseria gonorrhoeae | ||
| Macrolide resistant Mycoplasma genitalium | ||
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (viruses) | Cerebrospinal fluid (CSF); Eye swabs; General swabs; Genital swabs; Lip swabs | Herpes simplex virus (HSV); Varicella zoster virus (VZV) |
| Cerebrospinal fluid (CSF); Plasma; Urine | BK virus; John Cunningham virus (JC) | |
| Liquid based cytology specimens | Human papilloma virus (HPV) | |
| Plasma | Hepatitis B virus (HBV) DNA; Hepatitis C virus (HCV) viral RNA; Hepatitis C virus (HCV) viral load - Qualitative; Human immunodeficiency virus type 1 (HIV-1) RNA | |
| Cytomegalovirus (CMV) | ||
| Human immunodeficiency virus type 2 (HIV-2) RNA | ||
| Epstein-Barr virus | ||
| Plasma; Serum | Hepatitis B virus (HBV) DNA; Hepatitis C virus (HCV) viral RNA; Human immunodeficiency virus type 1 (HIV-1) RNA; Human immunodeficiency virus type 2 (HIV-2) RNA | |
| Microbiology - Molecular biology - Microbial DNA and/or RNA extraction | Plasma | Viable RNA for sequencing |
| Microbiology - Molecular biology - Microbial DNA and/or RNA sequencing | Extracted RNA | RNA sequence analysis |
| Microbiology - Molecular biology - Microbial genotyping | Buffy coat; Dried blood spots; Plasma | Human immunodeficiency virus (HIV) co-receptor tropism genotype; Human immunodeficiency virus type 1 (HIV-1) sequencing for drug resistance |
| Plasma | Human immunodeficiency virus type 1 (HIV-1) sequencing for drug resistance | |
| Plasma; Serum | Hepatitis C virus (HCV) RNA genotypes 1-6 | |
| Microbiology - Mycobacteriology - Tests for cell mediated immunity | Blood | Latent tuberculosis |
| Microbiology - Serology of infection - Microbial antibody and/or antigen detection and/or quantitation | Plasma; Serum | Human immunodeficiency virus (HIV) p24 antigen |
| Human immunodeficiency virus type 1/2 (HIV-1/2) 1/2 antibodies; Human immunodeficiency virus type 1/2 (HIV-1/2) antigen | ||
| Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) IgG antibody | ||
| Serum | Cytomegalovirus antibody (anti-CMV) IgG; Cytomegalovirus antibody (anti-CMV) IgM; Epstein-Barr virus IgG antibody; Epstein-Barr virus IgM antibody; Epstein-Barr virus nuclear antigen IgG antibody; 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 B virus surface antigen (HBs Ag) neutralisation; Hepatitis C virus antibody (anti-HCV); Human T-lymphotropic virus type I/II (HTLV-I/II); Rubella IgG antibody; Toxoplasma spp. IgG antibody; Toxoplasma spp. IgM antibody | |
| Cryptococcus spp. | ||
| Dengue virus IgG antibody; Dengue virus IgM antibody; Dengue virus NS1 antigen; Ross River virus IgG antibody; Ross River virus IgM antibody | ||
| Syphilis Treponema pallidum antibody | ||
| Bordetella pertussis IgA; Bordetella pertussis IgG; Helicobacter pylori IgG antibody; Hepatitis A virus antibody (anti-HAV) - IgM; Hepatitis A virus antibody (anti-HAV) - Total; Hepatitis B virus core antibody (anti-HBc) - IgM; Hepatitis C virus antigen (HCV Ag); Herpes simplex virus (HSV) IgM; Herpes simplex virus type 2 antibody (anti-HSV2) - IgG; Herpes simplex type 1 antibody (anti-HSV1) - IgG; Measles IgG antibody; Measles IgM antibody; Mumps virus IgG antibody; Mumps virus IgM antibody; Mycoplasma pneumoniae IgG antibody; Mycoplasma pneumoniae IgM antibody; Parvovirus IgG antibody; Parvovirus IgM antibody; Varicella zoster virus (VZV) IgG antibody; Varicella zoster virus IgM antibody | ||
| Molecular genetics - DNA extraction | Blood | Viable DNA for sequencing |
Division of Microbiology
ISO 15189 (2022)
Human Pathology
Medicare expiry date
01 Jun 2027
Last Activity Date
13 Apr 2024
| Service | Product | Determinant |
|---|---|---|
| Microbiology - Bacteriology - Detection of pathogenic bacteria | Aspirates; Bacterial isolates; Biopsy specimens; Blood; Cerebrospinal fluid (CSF); Ear swabs; Eye swabs; Faeces; Fluids; General swabs; Genital swabs; Isolates; Nasal swabs; Operative specimens; Post-operative wounds; Pus; Rectal swabs; Respiratory specimens; Sputum; Superficial sites; Synovial fluid; Throat swabs; Tissues; Urine; Wound swabs | Cultured pathogens identification; Pathogenic identification and antibiotic susceptibility |
| Aspirates; Biopsy specimens; Cerebrospinal fluid (CSF); Ear swabs; Eye swabs; Faeces; Fluids; General swabs; Genital swabs; Nasal swabs; Operative specimens; Post-operative wounds; Pus; Respiratory specimens; Sputum; Superficial sites; Synovial fluid; Throat swabs; Tissues; Urine; Wound swabs | Bacteria | |
| Aspirates; Biopsy specimens; Cerebrospinal fluid (CSF); Ear swabs; Eye swabs; Fluids; General swabs; Genital swabs; Glass slide; Operative specimens; Post-operative wounds; Pus; Respiratory specimens; Skin; Sputum; Superficial sites; Synovial fluid; Tissues; Wound swabs | Bacteria; Cultured pathogens identification; Epithelial cells; Leucocytes (white blood cells, WBC) | |
| Bacteria; Cultured pathogens identification; Epithelial cells; Leucocytes (white blood cells, WBC) | ||
| Aspirates; Cerebrospinal fluid (CSF); Faeces; Fluids; Genital swabs; Respiratory specimens; Synovial fluid; Urine | Casts; Crystals; Epithelial cells; Erythrocytes (red blood cells, RBC); Leucocytes (white blood cells, WBC); Pathogenic microorganisms | |
| Blood | Antibiotic susceptibility; Bacteria | |
| Faeces | Helicobacter pylori antigen | |
| Clostridioides difficile toxin | ||
| Urine | Blood; Glucose; Ketones; Leucocyte esterase; Nitrite; Proteins; pH | |
| Legionella antigen | ||
| Casts; Crystals; Epithelial cells; Erythrocytes (red blood cells, RBC); Leucocytes (white blood cells, WBC) | ||
| Streptococcus pneumoniae antigen | ||
| Microbiology - Environmental investigations and/or infection control (Clinical non-human testing) | Dialysis waters; Gastrointestinal endoscopes; Vascular catheter tips | Bacterial growth - Sterility |
| Environmental swabs | Bacterial organism identification - Acinetobacter; Bacterial organism identification - Carbapenem resistant Enterobacteriaceae (CRE); Bacterial organism identification - Extended spectrum β-lactamases (ESBL); Bacterial organism identification - Metallo-β-lactamase (MBL) carbapenemase; Bacterial organism identification - Methicillin-resistant Staphylococcus aureus (MRSA); Bacterial organism identification - Vancomycin-resistant Enterococcus (VRE) | |
| Spore strips | Bacterial growth - Sterility | |
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (bacteria) | Blood | Staphylococcus aureus; Methicillin resistant Staphylococcus aureus (MRSA) |
| Cerebrospinal fluid (CSF) | Escherichia coli K1; Haemophilus influenzae; Listeria monocytogenes; Neisseria meningitidis; Streptococcus agalactiae (Streptococcus group B); Streptococcus pneumoniae | |
| Eye swabs; Genital swabs; Urine | Chlamydia trachomatis; Chlamydia trachomatis serovars L1, L2, L2a or L3 (LGV); Mycoplasma genitalium; Mycoplasma hominis; Neisseria gonorrhoeae; Streptococcus agalactiae (Streptococcus group B); Treponema pallidum; Ureaplasma parvum; Ureaplasma urealyticum | |
| Faeces | Campylobacter spp.; Clostridioides difficile; Escherichia coli - Enteroinvasive (EIEC); Listeria monocytogenes; Salmonella spp.; Shigella spp.; Yersinia enterocolitica | |
| Clostridioides difficile | ||
| Nasopharyngeal swabs; Respiratory specimens | Bordetella parapertussis; Bordetella pertussis; Mycoplasma pneumoniae | |
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (fungi) | Bronchoalveolar lavage | Aspergillus spp. |
| Cerebrospinal fluid (CSF) | Cryptococcus gattii; Cryptococcus neoformans | |
| Genital swabs; Urine | Candida albicans | |
| Respiratory specimens | Pneumocystis jirovecii | |
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (mycobacteria) | Respiratory specimens | Mycobacterium tuberculosis |
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (protozoan parasites) | Bone marrow; Tissues | Leishmania spp. |
| Faeces | Blastocystis hominis; Blastocystis spp.; Cryptosporidium parvum; Cryptosporidium spp.; Cyclospora cayetanensis; Dientamoeba fragilis; Entamoeba histolytica; Giardia intestinalis; Giardia lamblia | |
| Liver aspirate | Entamoeba histolytica | |
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (viruses) | Bronchial washings; Bronchoalveolar lavage; Nasal swabs; Nasopharyngeal aspirate; Sputum; Throat swabs | Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) |
| Cerebrospinal fluid (CSF) | Enterovirus | |
| Cytomegalovirus (CMV); Herpes simplex virus 6; Herpes simplex virus type 1 (HSV1); Herpes simplex virus type 2 (HSV2); Human parechovirus; Varicella zoster virus (VZV) | ||
| Eye swabs | Adenovirus | |
| Faeces | Adenovirus F40; Adenovirus F41; Astrovirus; Enterovirus; Human bocavirus 1, 2, 3, 4 (HBoV1, 2, 3, 4); Norovirus G1; Norovirus G2; Rotavirus A; Sapovirus | |
| Genital swabs; Urine | Herpes simplex virus type 1 (HSV1); Herpes simplex virus type 2 (HSV2) | |
| Mouth swabs | Enterovirus | |
| Nasopharyngeal swabs | Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) | |
| Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) | ||
| Nasopharyngeal swabs; Respiratory specimens | Adenovirus; Coronavirus; Human coronavirus 229E; Human coronavirus HKU1; Human metapneumovirus; Influenza A virus; Influenza B virus; Parainfluenza virus type 1/2/3/4; Respiratory syncytial virus (RSV); Rhinovirus | |
| Microbiology - Molecular biology - Surveillance programme for the detection of microbial nucleic acids (viruses) in accordance with Commonwealth and/or State Health protocols | Saliva | Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) |
| Microbiology - Mycobacteriology - Detection and identification of mycobacteria | Blood; Bone marrow; Cerebrospinal fluid (CSF); General swabs; Other body fluids; Respiratory specimens; Sputum; Tissues | Mycobacteria detection |
| Mycobacteria detection | ||
| Isolates | Mycobacteria detection; Mycobacteria identification | |
| Microbiology - Mycology - Detection, isolation and/or identification of yeasts and/or fungal elements | Cerebrospinal fluid (CSF) | Cryptococcus antigen |
| Hair; Nails; Skin scrapings | Fungi identification; Fungi susceptibility; Yeast susceptibility; Yeasts identification | |
| Hair; Nails; Skin swabs | Fungi identification; Fungi susceptibility; Yeast susceptibility; Yeasts identification | |
| Microbiology - Parasitology - Detection of ova, cysts and parasites | Faeces | Amoebae; Cysts; Ova; Parasites |
| Microbiology - Serology of infection - Microbial antibody and/or antigen detection and/or quantitation | Serum | Cryptococcus spp. |
Emergency Department
ISO 15189 (2022)
Human Pathology
Medicare expiry date
01 Jun 2027
Last Activity Date
13 Apr 2024
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Quantitation of blood gases and other measurements (performed on the same specimen) | Blood | Base excess; Calcium - Ionised; Carboxyhaemoglobin; Methaemoglobin (MetHb); Oxygen saturation (sO2); Oxyhaemoglobin; Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); pH |
Genetics
ISO 15189 (2012)
Human Pathology
Medicare expiry date
01 Jun 2027
Last Activity Date
13 Apr 2024
| Service | Product | Determinant |
|---|---|---|
| Molecular genetics - Assay for defined mutation or polymorphism (including pharmacogenetic testing) - Targeted genes | Blood | Factor V Leiden; Prothrombin variant |
ISO 15189 (2022)
Human Pathology
Medicare expiry date
01 Jun 2027
Last Activity Date
13 Apr 2024
| Service | Product | Determinant |
|---|---|---|
| Cytogenetics - Detection of defined, balanced and/or unbalanced chromosomal abnormalities by in situ hybridisation techniques | Bone marrow; Smears; Tissues; Tumour imprints | Cytogenetic analysis and reporting |
| Cytogenetics - Karyotype detection of balanced and/or unbalanced chromosome abnormalities | Blood; Bone marrow; Other tissues - Malignant | Pathogenic copy number changes |
| Cytogenetics - Molecular karyotype (SNP microarray) detection of unbalanced chromosome abnormalities | Blood; Bone marrow; Lymph nodes; Tissues | Cytogenetic analysis and reporting; Pathogenic copy number changes |
| Molecular genetics - DNA extraction | Formalin-fixed paraffin-embedded (FFPE) tissues | DNA storage for future analyses; Viable DNA for sequencing and other molecular assays |
| Molecular genetics - DNA sequencing | Extracted DNA | Sequenced DNA utilising massively parallel sequencing technologies; Somatic whole genome sequencing |
| Molecular genetics - Genetic testing for chimerism and mosaic gene variants (cancer and somatic mosaicism) - Targeted genes | Blood | Qualitative calculation of p190 positive BCR::ABL1 transcripts; Quantitative calculation of p210 positive BCR::ABL1 transcripts |
| Bone marrow | Qualitative calculation of p190 positive BCR::ABL1 transcripts | |
| Molecular genetics - Genetic testing for chimerism and mosaic gene variants (cancer and somatic mosaicism) - Targeted panels for non-inherited (somatic) DNA/RNA changes | Extracted DNA | Copy number variation (CNV); Indels; Multi-nucleotide variants (MNV); Single nucleotide variants (SNVs) |
| Molecular genetics - Screening for an unknown mutation - Targeted panels for non-inherited (somatic) DNA/RNA changes | Blood; Bone marrow | Blood borne tumours; Lymphoid malignancies; Myelodysplastic syndromes; Myeloproliferative neoplasms |
| Formalin-fixed paraffin-embedded (FFPE) tissues | Lymphoid malignancies; Solid tumours | |
| 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 |
ITU North
ISO 15189 (2022)
Human Pathology
Medicare expiry date
01 Jun 2027
Last Activity Date
13 Apr 2024
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Quantitation of blood gases and other measurements (performed on the same specimen) | Blood | Base excess; Calcium - Ionised; Carboxyhaemoglobin; Deoxyhaemoglobin (HHb); Methaemoglobin (MetHb); Oxygen saturation (sO2); Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); pH |
ITU South
ISO 15189 (2022)
Human Pathology
Medicare expiry date
01 Jun 2027
Last Activity Date
13 Apr 2024
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Quantitation of blood gases and other measurements (performed on the same specimen) | Blood | Base excess; Calcium - Ionised; Carboxyhaemoglobin; Methaemoglobin (MetHb); Oxygen saturation (sO2); Oxyhaemoglobin; Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); pH |
Lung Function Laboratory
ISO 15189 (2022)
Human Pathology
Medicare expiry date
01 Jun 2027
Last Activity Date
13 Apr 2024
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Quantitation of blood gases and other measurements (performed on the same specimen) | Blood | Base excess; Calcium - Ionised; Carboxyhaemoglobin; Methaemoglobin (MetHb); Oxygen saturation (sO2); Oxyhaemoglobin; Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); pH |
Operating Theatres
ISO 15189 (2022)
Human Pathology
Medicare expiry date
01 Jun 2027
Last Activity Date
13 Apr 2024
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Quantitation of blood gases and other measurements (performed on the same specimen) | Blood | Base excess; Calcium - Ionised; Carboxyhaemoglobin; Methaemoglobin (MetHb); Oxygen saturation (sO2); Oxyhaemoglobin; Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); 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.
Grey text appearing in a SoA is additional freetext providing further refinement or information on the data in the preceding line entry.
Accreditation No.
2115
Site No.
2108
Print date
26 Dec 2024
END OF SCOPE