National Association of Testing Authorities, Australia
Scope of Accreditation
Monash Health Pathology
Site
Clayton Laboratory – Monash Medical Centre
Accreditation No.
2762
Site No.
2755
Date of Accreditation
17 Nov 1989
Contact
Mrs Kristy De George P: +61 (03) 95943479
Availability
Services available to external clients
Supervision
GX (General)
Scope of Accreditation
Anatomical Pathology
ISO 15189 (2022)
Human Pathology
Medicare expiry date
07 Jun 2026
Last Activity Date
15 Jul 2024
| 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); Ocular specimens; Other body fluids; Sputum; Tumour tissue; Urine; Vitreous specimens; Washings or brushings from other sites | Cytological examination; Review and reporting of cytology samples |
| Anatomical pathology - Cytopathology - Non-gynaecological cytological investigations of nipple discharge or smears from squamous mucosal sites for the detection of cancerous or precancerous changes | Anus smears; Lip smears; Mouth smears; Nipple discharge; Nose smears; Semen; Skin smears | Cytological examination; Review and reporting of cytology samples |
| Anatomical pathology - Cytopathology - Non-gynaecological cytological investigations on samples obtained via fine needle aspiration biopsy | Fine needle aspirates (FNA) | Cytological examination; Review and reporting of fine needle aspiration samples |
| Anatomical pathology - Tissue pathology - Examination of biopsy material | Formalin-fixed tissue; Fresh tissue | Review and reporting of biopsy material to identify or exclude morphological abnormalities |
| Anatomical pathology - Tissue pathology - Examination of biopsy material by electron microscopy | Formalin-fixed tissue; Fresh tissue | Review and reporting of biopsy material to identify or exclude ultra-structural 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 | Intra-operative consultation and examination of biopsy material |
| Anatomical pathology - Tissue pathology - Immunohistochemical (immunofluorescence) investigation | Formalin-fixed paraffin-embedded (FFPE) tissues | Detection of antigenic targets - Various |
| Anatomical pathology - Tissue pathology - Immunohistochemical investigation | Formalin-fixed paraffin-embedded (FFPE) tissues | Detection of antigenic targets - Various |
| Anatomical pathology - Tissue pathology - Mortuary facilities | Body | Assessment - Level 2 mortuary |
| Anatomical pathology - Tissue pathology - Non-coronial autopsy services | Body; Body parts | Autopsy service and reporting |
Biochemistry Unit
ISO 15189 (2022)
Human Pathology
Medicare expiry date
07 Jun 2026
Last Activity Date
15 Jul 2024
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Analysis of drugs for toxicological (non-legal) purposes and ingested or absorbed toxic chemicals | Blood; Clothing; Other body fluids; Swabs; Urine | Snake venom detection |
| Urine | Amphetamines; Benzodiazepines; Cannabis; Opiates | |
| Chemical pathology - Biogenic amines | Plasma; Serum; Urine | 3-Methoxytyramine; Metanephrine; Normetanephrine |
| Chemical pathology - Detection and/or quantitation of drugs for therapeutic monitoring | Blood | Cyclosporin |
| Tacrolimus | ||
| Plasma; Serum | Ethanol | |
| Clozapine; Norclozapine | ||
| Digoxin | ||
| Serum | Amikacin; Lithium; Methotrexate; Paracetamol (acetaminophen); Phenobarbital; Salicylate; Tobramycin; Vancomycin | |
| Carbamazepine; Gentamicin (cidomycin, septopal, genticyn, garamycin); Phenytoin (dilantin); Valproate (valproic acid, epilim) | ||
| Chemical pathology - Detection and/or quantitation of tumour markers | Other body fluids | CA125 antigen (CA125); CA19-9 antigen (CA19-9); Carcinoembryonic antigen (CEA) |
| Thyroglobulin | ||
| Plasma; Serum | CA125 antigen (CA125); CA15-3 antigen (CA15-3); CA19-9 antigen (CA19-9); Carcinoembryonic antigen (CEA); Prostate specific antigen (PSA); Prostate specific antigen (PSA) fractions and derived index; Thyroglobulin | |
| Serum | Human chorionic gonadotropin (hCG) | |
| Serum; Urine | β2-Microglobulin (B2M) | |
| Chemical pathology - Detection of faecal occult blood | Faeces | Blood |
| Chemical pathology - Determination of hormones and hormone binding proteins (other than thyroid function tests) | Plasma | Renin |
| Adrenocorticotropic hormone (ACTH) | ||
| Plasma; Serum | Aldosterone | |
| Anti-Mullerian hormone (AMH); Cortisol; Dehydroepiandrosterone sulfate (DHEAS); Erythropoietin (EPO); Follicle stimulating hormone (FSH); Growth hormone; Insulin; Luteinising hormone (LH); Oestradiol; Parathyroid hormone (PTH); Procalcitonin; Progesterone; Prolactin; Sex hormone binding globulin (SHBG) | ||
| Saliva | Cortisol | |
| Serum | 17α-Hydroxyprogesterone; Androstenedione; Dihydrotestosterone; Testosterone | |
| Oestradiol | ||
| Aldosterone; C-peptide; Insulin-like growth factor 1 (IGF-1, somatomedin C) | ||
| Urine | Aldosterone | |
| Cortisol | ||
| Chemical pathology - Diagnosis and management of diabetes mellitus | Blood | Glycated haemoglobin (HbA1c) |
| Chemical pathology - Dynamic tests | Sweat | Sweat chloride |
| Chemical pathology - Further investigation of cardiac function | Plasma; Serum | B-type natriuretic peptide (BNP); Troponin I |
| Myoglobin | ||
| Urine | Myoglobin | |
| Chemical pathology - Further investigation of lipid profiles for diagnosis of types III and IV hyperlipidaemia | Serum | Lipoprotein a |
| Chemical pathology - Further investigation of renal and/or hepatic function | Plasma; Serum | Prealbumin |
| Serum | α1-Antitrypsin phenotype | |
| Caeruloplasmin; α1-Antitrypsin | ||
| Haptoglobins | ||
| Chemical pathology - Haem related pigments and precursors (excluding porphyria) | Cerebrospinal fluid (CSF) | Bilirubin |
| Chemical pathology - Investigation and determination of hepatic, cardiac, bone, skeletal muscle and other profiles and metabolic studies | Amniotic fluid | Creatinine; Glucose; Potassium; Sodium |
| Ascitic fluid; Peritoneal fluid | Bilirubin - Total; Cholesterol - Total; Creatinine; Sodium; Triglycerides | |
| Albumin; Amylase; Glucose; Lactate dehydrogenase (LDH); Lipase; Protein - Total | ||
| Blood | Ketones | |
| Drainage fluid | Albumin; Amylase; Bilirubin - Total; Cholesterol - Total; Creatinine; Lactate dehydrogenase (LDH); Lipase; Potassium; Protein - Total; Sodium; Triglycerides; Urea | |
| Joint fluid | Glucose; Lactate dehydrogenase (LDH); Protein - Total; Uric acid | |
| Pancreatic cyst fluid | Albumin | |
| Pericardial fluid | Albumin; Glucose; Lactate; Lactate dehydrogenase (LDH); Protein - Total | |
| Peritoneal dialysis fluid | Creatinine; Glucose; Urea | |
| Plasma; Serum | Alanine aminotransferase; Albumin; Alkaline phosphatase; Ammonia; Amylase; Aspartate aminotransferase; Bicarbonate; Bilirubin - Any fractions; Bilirubin - Total; C-reactive protein (CRP); Calcium - Total; Chloride; Cholesterol - LDL; Cholesterol - Total; Creatine kinase; Creatinine; Glucose; HDL - Quantitation; Lactate dehydrogenase (LDH); Lipase; Magnesium; Phosphate; Potassium; Protein - Total; Sodium; Triglycerides; Urate; Urea; γ-Glutamyltransferase | |
| Ferritin; Soluble transferrin receptor (sTFR) | ||
| Pleural fluid | Glucose; Lactate dehydrogenase (LDH); Protein - Total | |
| Albumin; Amylase; Chloride; Cholesterol - Total; Creatinine; Lactate; Lipase; Potassium; Sodium; Triglycerides; Uric acid | ||
| Serum | Angiotensin converting enzyme (ACE) | |
| Cystatin C | ||
| Serum; Urine | Osmolality | |
| Urine | Ammonia; Calcium - Total; Chloride; Creatinine; Glucose; Magnesium; Microalbumin; Phosphate; Potassium; Protein - Total; Sodium; Urate; Urea | |
| Chemical pathology - Investigation for folate deficiency | Serum | Folate |
| Chemical pathology - Iron studies | Plasma; Serum | Iron; Transferrin |
| Chemical pathology - Newborn screening services for the diagnosis of inborn errors of metabolism | Blood | Galactose |
| Chemical pathology - Quantitation of blood gases and other measurements (performed on the same specimen) | Blood | Calcium - Ionised; Carboxyhaemoglobin; Chloride; Creatinine; Glucose; Haemoglobin (Hb); Lactate; Methaemoglobin (MetHb); Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); Potassium; Sodium; pH |
| Chemical pathology - Quantitation of precursor and intermediary metabolites | Plasma; Serum | Homocysteine |
| Chemical pathology - Quantitation of vitamin B markers | Serum | Holotranscobalamin (active vitamin B12) |
| Chemical pathology - Quantitation of vitamins | Plasma; Serum | Cobalamin (vitamin B12) |
| 25-Hydroxyvitamin D | ||
| Retinol (vitamin A); Tocopherol (vitamin E) | ||
| Ascorbic acid (vitamin C) | ||
| Chemical pathology - Tests for thyroid function | Plasma; Serum | Thyroid stimulating hormone (TSH); Thyroxine (T4) - Free; Triiodothyronine (T3) - Free |
| Chemical pathology - Trace element analysis | Plasma; Serum | Copper; Zinc |
| Immunopathology - Detection and/or quantitation and/or characterisation of autoantibodies | Plasma; Serum | Anti-thyroglobulin antibodies (Tg); Anti-thyroid peroxidase antibodies (TPO) |
| Serum | Anti-cyclic citrullinated peptide antibodies (CCP) | |
| Immunopathology - Quantitation of complement proteins | Serum | Complement components C3 and C4 |
| Immunopathology - Quantitative and/or qualitative investigation of proteins | Cerebrospinal fluid (CSF); Other body fluids; Serum | Oligoclonal bands; β2-Transferrin |
| Faeces | Calprotectin | |
| Plasma; Serum | Cryoglobulins | |
| Serum | Protein classes | |
| Detection and quantitation of free kappa and free lambda light chains | ||
| Immunopathology - Quantitative investigations of immunoglobulins and immunoglobulins subclasses | Plasma; Serum | Immunoglobulin G (IgG) subclasses |
| Serum | Total immunoglobulin E | |
| Total immunoglobulin A; Total immunoglobulin G; Total immunoglobulin M | ||
| Infertility and pregnancy tests including assisted reproductive technology - Diagnosis of pregnancy | Blood; Plasma | 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 |
Cytogenetics
ISO 15189 (2022)
Human Pathology
Medicare expiry date
07 Jun 2026
Last Activity Date
15 Jul 2024
| Service | Product | Determinant |
|---|---|---|
| Cytogenetics - Detection of defined, balanced and/or unbalanced chromosomal abnormalities by in situ hybridisation techniques | Amniotic fluid; Blood; Chorionic villus tissue; Other tissues - Malignant; Other tissues - Non-malignant; Paraffin embedded tissue | Chromosomal rearrangement; Cytogenetic analysis and reporting; Pathogenic copy number changes |
| Cytogenetics - Karyotype detection of balanced and/or unbalanced chromosome abnormalities | Amniotic fluid; Blood; Chorionic villus tissue; Other tissues - Non-malignant | Pathogenic copy number changes |
| Blood; Products of conception (POC); Tissues | Pathogenic copy number changes | |
| Cytogenetics - Molecular karyotype (SNP microarray) detection of unbalanced chromosome abnormalities | Amniotic fluid; Blood; Chorionic villus tissue; Other tissues - Non-malignant | Chromosomal rearrangement; Cytogenetic analysis and reporting; Pathogenic copy number changes |
| Blood; Products of conception (POC); Tissues | Cytogenetic analysis and reporting | |
| Molecular genetics - Prenatal genetic testing (excluding non-invasive prenatal [genetic] screening) | Amniotic fluid; Blood; Chorionic villus; Saliva | Fragile X; Y chromosome microdeletion |
Haematology Unit
ISO 15189 (2022)
Human Pathology
Medicare expiry date
07 Jun 2026
Last Activity Date
15 Jul 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; Histological examination |
| Haematology - Diagnosis of thalassemia | Blood | Examination of haemoglobin H (HbH); Haemoglobin A2 (HbA2) - Quantitation; Haemoglobin F (HbF) - Quantitation |
| Haematology - Examination of blood films by special staining | Blood; Bone marrow | Acid phosphatase; Alkaline phosphatase; Haemoglobin H; Haemosiderin; Heinz bodies; Iron; Malaria; Non-specific esterase; Parasites |
| Urine | Haemosiderin | |
| Haematology - Foetal haemoglobin in maternal circulation | Blood | Detection and quantitation of foetal red cells; Feto-maternal haemorrhage (FMH) estimation |
| Haematology - Full blood examination | Blood | Morphology |
| Blood; Fluids | Differential number; Erythrocyte count (red blood cell count, RBCC); Haematocrit (packed cell volume, PCV); Haemoglobin (Hb); Leucocyte count (white blood cell count, WBCC); Mean corpuscular volume (MCV); Nucleated red blood cells (NRBC); Platelet count; Red blood cell distribution width (RDW); Red blood cell index or indices; Reticulocytes | |
| Haematology - Haemostasis related analysis (including special coagulation testing and platelet function tests) | Blood | Platelet function (PFA) |
| Plasma | Activated partial thromboplastin time (APTT); Activated protein C (APC) resistance; Anti-Xa - Apixaban; Anti-Xa - Dabigatran; Anti-Xa - Fondaparinux; Anti-Xa - Rivaroxaban; Anti-Xa activity - Heparin activity; Anti-Xa activity - Low molecular weight heparin; Anti-Xa activity - Unfractionated heparin; Anti-thrombin III; Clauss fibrinogen; Collagen binding activity; D-dimer; Echis test; Factor II; Factor IX; Factor V; Factor VII; Factor VIII; Factor VIII inhibitor; Factor X; Factor XI; Factor XII; Factor XIII; Fibrinogen; Heparin assay; Heparin cofactor II; Heparin induced thrombotic thrombocytopenia (HITT); International normalised ratio (INR); Kaolin clotting time; Lupus anticoagulant; Plasminogen; Plasminogen activator inhibitor; Protein C; Prothrombin time (PT); Thrombin time (TT); Von Willebrand factor (vWF) activity - Ristocetin co-factor assay; Von Willebrand factor (vWF) antigen - Quantitation; β2-GlycoproteinChange to QFA bovine thrombin kit from Siemens Dade thrombin method, for Clauss fibrinogen, on ACL TOP in November 2024. Assess at next RES or annual DTV. | |
| ADAMTS-13 activity; Heparin induced thrombotic thrombocytopenia (HITT); Plasminogen activator; Prothrombin antibodies; Prothrombin fragments 1 and 2 | ||
| Protein S | ||
| Haematology - Investigation of haemoglobinopathy (excluding thalassemia) | Blood | Haemoglobin S (HbS) - Presence; Haemoglobin bands; Haemoglobin fraction (S, C, D, E) - Quantitation; Haemoglobin instability; Other abnormal haemoglobins |
| Haematology - Investigation of haemolysis | Blood; Plasma | Autohaemolysis; Plasma haemoglobin |
| Haematology - Limited blood examination | Blood | Erythrocyte (RBC) sedimentation rate (ESR) |
| Immunohaematology - Blood group antibody detection | Blood | Duffy system; Kell system; M and N factors; Other blood group systems; Rh phenotypes |
| Immunohaematology - Blood grouping | Blood | ABO; RhD |
| Immunohaematology - Determination of compatibility of blood donor units | Blood | Direct antiglobulin test (DAT, direct Coombs test); Examination for blood group antibodies; Group checks of patient and donor; Identification of detected antibodies |
| Immunohaematology - Identification and quantitation of blood group antibodies | Blood; Cord blood | Antibody absorption; Antibody elution; Antibody quantitation - Anti-D, anti-c; Antibody titration; Donath-Landsteiner antibody; Other blood group antibodies; Red blood cell phenotyping; Rh |
| Immunohaematology - Investigation of blood transfusion reactions | Blood products | Antibodies; Contamination - Microbiological |
| Immunohaematology - Issue and release of blood and blood product for transfusion | Blood; 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 | Blood | Infectious mononucleosis |
| Molecular genetics - Investigation of constitutional genetic variants - Diagnostic testing - Targeted genes | Blood | Factor V Leiden; Prothrombin variant |
Haemostasis and Venesection Outpatient Clinic
ISO 15189 (2022)
Human Pathology
Medicare expiry date
07 Jun 2026
Last Activity Date
15 Jul 2024
| Service | Product | Determinant |
|---|---|---|
| Haematology - Haemostasis related analysis (including special coagulation testing and platelet function tests) | Blood | International normalised ratio (INR) |
Hospital in the Home (Mobile PoCT)
ISO 15189 (2022)
Human Pathology
Medicare expiry date
07 Jun 2026
Last Activity Date
15 Jul 2024
| Service | Product | Determinant |
|---|---|---|
| Haematology - Haemostasis related analysis (including special coagulation testing and platelet function tests) | Blood | International normalised ratio (INR) |
Immunopathology
ISO 15189 (2022)
Human Pathology
Medicare expiry date
07 Jun 2026
Last Activity Date
15 Jul 2024
| Service | Product | Determinant |
|---|---|---|
| Haematology - Foetal haemoglobin in maternal circulation | Blood | Feto-maternal haemorrhage (FMH) estimation |
| Immunopathology - Characterisation of leucocyte surface antigens (including immunophenotyping) | Aspirates; Blood; Bone marrow; Cerebrospinal fluid (CSF); Fluids; Fresh tissue; Lavage; Lymphocyte subsets; Serous fluidFluids added as NSV in December 2024. Verification for markers for TRBC1 to be assessed at next RES or annual DTV. | Assessment of lymphoid cell populations; Assessment of myeloid cell populations; Memory B cell subsets; Memory T cell subsets; Memory cells; Naive T-cells; T reg cells; T-cell receptor aβ (TCRab); T-cell receptor γδ (TCRgd) |
| Blood | Eosin-5-maleimide; Paroxysmal nocturnal haemoglobinuria (PNH) surface markers | |
| Blood; Haemopoietic progenitor cells | CD34 | |
| Immunopathology - Detection and/or quantitation and/or characterisation of autoantibodies | Serum | Anti-Ma antibodies; Anti-endomysial antibodies (EMA); Anti-liver-kidney microsomes antibodies (LKM); Anti-neutrophil cytoplasmic antibodies (ANCA); Anti-nuclear antibodies (ANA); Anti-smooth muscle antibodies (SMA)Anti-endomysial antibodies added as NSV June 2024. Verification to be checked at next RES. |
| Anti-cardiolipin antibodies (ACA); Anti-deamidated gliadin antibodies; Anti-double stranded DNA antibodies (dsDNA); Anti-glomerular basement membrane antibodies (anti-GBM); Anti-intrinsic factor antibodies (IF); Anti-myeloperoxidase antibodies (MPO); Anti-parietal cell antibodies; Anti-proteinase 3 antibodies (PR3); Anti-tissue transglutaminase antibodies (tTG); TryptaseAnti-glomerular basement membrane antibodies (anti-GBM) added as NSV in November 2024. Tryptase added as NSV in Jan 2025. Validations to be checked at annual DTV. | ||
| Anti-extractable nuclear antigen antibodies (ENA) | ||
| Anti-extractable nuclear antigen antibodies (ENA); Anti-glomerular basement membrane antibodies (anti-GBM); Anti-glutamic acid decarboxylase antibodies (GAD); Anti-islet tyrosine phosphatase2 (IA2) antibodies; Anti-phospholipase A2 receptor antibodies (PLA2R); Anti-zinc transporter protein 8 antibodies (ZNT8)Anti-GAD antibodies, anti-ZnT8 antibodies and anti-IA2 antibodies added as NSV January 2025. Verifications to be assessed at annual DTV. | ||
| Immunopathology - Investigation and/or assessment of neutrophils - Functional tests | Blood | Phagocytosis; Qualitative assessment of neutrophils for the presence of oxidative pathway defects; Quantitative assessment of oxidative pathways |
Microbiology Department
ISO 15189 (2022)
Human Pathology
Medicare expiry date
07 Jun 2026
Last Activity Date
15 Jul 2024
| Service | Product | Determinant |
|---|---|---|
| Microbiology - Bacteriology - Detection of pathogenic bacteria | Aspirates; Blood; Cerebrospinal fluid (CSF); Faeces; Fluids; General swabs; Genital swabs; Synovial fluid; Tissues; Urine | Bacteria; Casts; Crystals; Erythrocytes (red blood cells, RBC); Leucocytes (white blood cells, WBC) |
| Aspirates; Blood; Cerebrospinal fluid (CSF); Fluids; General swabs; Genital swabs; Nasopharyngeal aspirate; Respiratory specimens; Skin; Sputum; Synovial fluid; Tissues; Urine; Wound swabs | Bacteria; Pathogenic microorganisms | |
| Cerebrospinal fluid (CSF); Fluids; Urine | Erythrocytes (red blood cells, RBC); Leucocytes (white blood cells, WBC) | |
| Faeces | Clostridioides difficile toxin | |
| Campylobacter spp.; Salmonella spp.; Shigella spp.; Vibrio spp.; Yersinia spp.; Pathogenic microorganisms | ||
| Helicobacter pylori antigen | ||
| Campylobacter spp.; Salmonella spp.; Shigella spp.; Vibrio spp.; Yersinia spp.; Pathogenic microorganisms | ||
| Glass slide | Bacteria; Epithelial cells; Erythrocytes (red blood cells, RBC); Leucocytes (white blood cells, WBC) | |
| Isolates | Bacteria; Pathogenic identification; Pathogenic microorganisms | |
| Antibiotic susceptibility; Pathogenic identification and antibiotic susceptibility | ||
| Antibiotic susceptibility; Pathogenic identification and antibiotic susceptibility | ||
| Bacteria; Pathogenic identification; Pathogenic microorganisms | ||
| Urine | Legionella antigen | |
| Microbiology - Bacteriology - Detection of pathogenic bacteria for epidemiological infection control surveillance | Groin swabs; Nasal swabs; Rectal swabs | Carbapenem resistant Enterobacteriaceae (CRE); Methicillin resistant Staphylococcus aureus (MRSA); Vancomycin resistant Enterococci (VRE) |
| Carbapenem resistant Enterobacteriaceae (CRE); Methicillin resistant Staphylococcus aureus (MRSA); Vancomycin resistant Enterococci (VRE) | ||
| Microbiology - Environmental investigations and/or infection control (Clinical non-human testing) | Blood transfusion bags; Dialysis waters; Gastrointestinal endoscopes; Vascular catheter tips | Bacterial growth - Sterility |
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (bacteria) | Bacterial isolates | Staphylococcus spp.; Vancomycin resistant Enterococci (VRE) |
| Pan-bacterial 16s | ||
| Bronchoalveolar lavage; Cervical swabs; Eye swabs; Rectal swabs; Urethral swabs; Urine | Chlamydia trachomatis; Neisseria gonorrhoeae | |
| Endocervical swabs; Vaginal swabs | Chlamydia trachomatis; Neisseria gonorrhoeae | |
| Faeces | Campylobacter spp.; Clostridioides difficile; Clostridioides difficile toxin; Escherichia coli - Enterotoxigenic (ETEC); Escherichia coli STEC stx1/stx2; Salmonella spp.; Shigella spp.; Yersinia spp.; Shiga toxin | |
| Clostridioides difficile toxin | ||
| Nasopharyngeal aspirate | Bordetella parapertussis; Bordetella pertussis; Chlamydia trachomatis; Chlamydophila pneumoniae; Legionella longbeachae; Legionella pneumophila; Mycoplasma pneumoniae | |
| Urine | Chlamydia trachomatis; Neisseria gonorrhoeae | |
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (fungi) | Bacterial isolates | Panfungal 18s |
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (mycobacteria) | Respiratory specimens | Mycobacterium tuberculosis; Mycobacterium rifampicin resistance rpoB |
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (protozoan parasites) | Cervical specimen; Genital swabs; Urine | Trichomonas vaginalis |
| Faeces | Cryptosporidium spp.; Entamoeba histolytica; Giardia lamblia | |
| Cryptosporidium parvum; Cryptosporidium spp.; Entamoeba histolytica; Giardia lamblia | ||
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (viruses) | Aspirates; General swabs; Plasma; Tissues; Vesicle fluid | Adenovirus; Cytomegalovirus (CMV); Enterovirus; Herpes simplex virus (HSV); Varicella zoster virus (VZV) |
| Endotrachael aspirate; Nasal swabs; Nasopharyngeal aspirate; Nasopharyngeal swabs; Sputum; Throat swabs | Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) | |
| Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) | ||
| Endotrachael aspirate; Nasopharyngeal aspirate; Sputum; Throat swabs | Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) | |
| Faeces | Adenovirus; Astrovirus; Norovirus; Norovirus G1; Norovirus G2; Rotavirus; Sapovirus | |
| Nasal aspirates/washes; Nasopharyngeal swabs | Influenza A virus; Influenza B virus; Respiratory syncytial virus (RSV); Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) | |
| Nasal swabs; Nasopharyngeal aspirate; Nasopharyngeal swabs | Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) | |
| Nasopharyngeal aspirate | Adenovirus; Human metapneumovirus; Influenza A virus; Influenza B virus; Parainfluenza virus type 1/2/3/4; Picornavirus; Respiratory syncytial virus (RSV) A/B | |
| Nasopharyngeal swabs | Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) | |
| Plasma | BK virus; Cytomegalovirus (CMV) | |
| Plasma; Urine | Cytomegalovirus (CMV); Enterovirus | |
| Microbiology - Molecular biology - Quantitation of microbial nucleic acids | Blood | Hepatitis B virus (HBV) viral load; Hepatitis C virus (HCV) viral load; Human immunodeficiency virus (HIV) RNA viral load |
| 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 | Ascitic fluid; Aspirates; Biopsy specimens; Blood; Bone marrow; Bronchial washings; Bronchoalveolar lavage; Bronchoscopes; Cerebrospinal fluid (CSF); Ear swabs; Enrichment broth; Eye swabs; Faeces; Gastric lavage; Gastrointestinal fluid; General swabs; Genital swabs; IV catheters; Intra-uterine contraceptive device (IUCD); Isolates; Liquid based swabs; Lymph node fluid; Operative specimens; Oral sites; Other body fluids; Pericardial fluid; Peritoneal fluid; Pleural fluid; Pus; Respiratory specimens; Skin swabs; Sputum; Superficial sites; Synovial fluid; Tissues; Urine; Wound swabs | Mycobacteria detection |
| Ascitic fluid; Aspirates; Biopsy specimens; Blood; Bone marrow; Bronchial washings; Bronchoalveolar lavage; Bronchoscopes; Cerebrospinal fluid (CSF); Ear swabs; Enrichment broth; Eye swabs; Faeces; Gastric lavage; Gastrointestinal fluid; General swabs; Genital swabs; IV catheters; Intra-uterine contraceptive device (IUCD); Isolates; Liquid based swabs; Lymph node fluid; Operative specimens; Oral sites; Other body fluids; Pericardial fluid; Peritoneal fluid; Pleural fluid; Pus; Respiratory specimens; Skin swabs; Sputum; Superficial sites; Synovial fluid; Tissues; Wound swabs | Mycobacteria detection | |
| Ascitic fluid; Aspirates; Biopsy specimens; Blood; Bone marrow; Bronchial washings; Bronchoalveolar lavage; Bronchoscopes; Cerebrospinal fluid (CSF); Ear swabs; Eye swabs; Faeces; Gastric lavage; Gastrointestinal fluid; General swabs; Genital swabs; IV catheters; Intra-uterine contraceptive device (IUCD); Isolates; Liquid based swabs; Lymph node fluid; Operative specimens; Oral sites; Other body fluids; Pericardial fluid; Peritoneal fluid; Pleural fluid; Pus; Respiratory specimens; Skin swabs; Sputum; Superficial sites; Synovial fluid; Tissues; Wound swabs | Mycobacteria detection | |
| Ascitic fluid; Aspirates; Biopsy specimens; Blood; Bone marrow; Bronchial washings; Bronchoalveolar lavage; Cerebrospinal fluid (CSF); Ear swabs; Enrichment broth; Eye swabs; Faeces; General swabs; Genital swabs; IV catheters; Intra-uterine contraceptive device (IUCD); Isolates; Liquid based swabs; Lymph node fluid; Operative specimens; Oral sites; Other body fluids; Pericardial fluid; Peritoneal fluid; Pleural fluid; Pus; Respiratory specimens; Skin swabs; Sputum; Superficial sites; Synovial fluid; Tissues; Urine; Wound swabs | Mycobacteria detection | |
| Urine | Mycobacteria detection | |
| Microbiology - Mycobacteriology - Tests for cell mediated immunity | Blood | Latent tuberculosis |
| Microbiology - Mycology - Detection, isolation and/or identification of yeasts and/or fungal elements | Cerebrospinal fluid (CSF); Plasma; Serum | Cryptococcus antigen |
| Hair; Isolates; Nails; Skin scrapings | Fungi identification | |
| Fungi identification; Fungi susceptibility | ||
| Fungi identification; Fungi susceptibility | ||
| Microbiology - Parasitology - Detection of ova, cysts and parasites | Faeces | Microsporidia |
| Cysts; Ova; Parasites | ||
| Microbiology - Serology of infection - Microbial antibody and/or antigen detection and/or quantitation | Plasma; Serum | Parvovirus IgG antibody; Parvovirus IgM antibody |
| Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) antibody | ||
| Cytomegalovirus (CMV) IgG avidity; Cytomegalovirus antibody (anti-CMV) IgG | ||
| Hepatitis C virus antibody (anti-HCV) | ||
| Measles IgG antibody; Mumps virus IgG antibody | ||
| Cytomegalovirus antibody (anti-CMV) IgG; Hepatitis B virus core antibody (anti-HBc) - Total; Hepatitis B virus envelope antibody (anti-HBe); Hepatitis B virus envelope antigen (HBe Ag); Hepatitis B virus surface antibody (anti-HBs); Hepatitis B virus surface antigen (HBs Ag); Hepatitis B virus surface antigen (HBs Ag) - Confirmatory; Hepatitis C virus antibody (anti-HCV); Human immunodeficiency virus (HIV) p24 antigen; Human immunodeficiency virus type 1/2 (HIV-1/2) 1/2 antibodies; Syphilis Treponema pallidum total antibody | ||
| Serum | Leptospira IgM antibody | |
| Cytomegalovirus antibody (anti-CMV) IgM; Hepatitis A virus antibody (anti-HAV) - IgG; Hepatitis A virus antibody (anti-HAV) - IgM; Hepatitis B virus core antibody (anti-HBc) - IgM; Rubella IgG antibody; Toxoplasma gondii IgG antibody; Toxoplasma gondii IgM antibody | ||
| Strongyloides IgG antibody | ||
| Epstein-Barr virus nuclear antigen IgG antibody; Epstein-Barr virus viral capsid antigen IgG antibody; Epstein-Barr virus viral capsid antigen IgM antibody | ||
| Varicella zoster virus (VZV) IgG antibody; Varicella zoster virus IgM antibody | ||
| Urine | Streptococcus pneumoniae |
MMC Birth Suite
ISO 15189 (2022)
Human Pathology
Medicare expiry date
07 Jun 2026
Last Activity Date
15 Jul 2024
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Quantitation of blood gases and other measurements (performed on the same specimen) | Blood | Calcium - Ionised; Carboxyhaemoglobin; Chloride; Creatinine; Glucose; Haemoglobin (Hb); Lactate; Methaemoglobin (MetHb); Oxyhaemoglobin; Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); Potassium; Sodium; pH |
MMC Emergency Department
ISO 15189 (2022)
Human Pathology
Medicare expiry date
07 Jun 2026
Last Activity Date
15 Jul 2024
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Quantitation of blood gases and other measurements (performed on the same specimen) | Blood | Base excess; Bicarbonate; Calcium - Ionised; Chloride; Glucose; Haemoglobin (Hb); Lactate; Methaemoglobin (MetHb); Oxyhaemoglobin; Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); Potassium; Sodium; pH |
| Base excess; Bicarbonate; Calcium - Ionised; Carboxyhaemoglobin; Chloride; Creatinine; Glucose; Haematocrit (packed cell volume, PCV); Haemoglobin (Hb); Lactate; Oxyhaemoglobin; Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); Potassium; Sodium; pH |
MMC Intensive Care Unit
ISO 15189 (2022)
Human Pathology
Medicare expiry date
07 Jun 2026
Last Activity Date
15 Jul 2024
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Quantitation of blood gases and other measurements (performed on the same specimen) | Blood | Calcium - Ionised; Carboxyhaemoglobin; Chloride; Glucose; Haemoglobin (Hb); Lactate; Methaemoglobin (MetHb); Oxyhaemoglobin; Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); Potassium; Sodium; pH |
| Anion gap; Base excess; Bicarbonate; Calcium - Ionised; Carboxyhaemoglobin; Chloride; Glucose; Haematocrit (packed cell volume, PCV); Haemoglobin (Hb); Lactate; Methaemoglobin (MetHb); Oxygen saturation (sO2); Oxyhaemoglobin; Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); Potassium; Sodium; p50; pHAnion Gap; Haematocrit; Oxygen Saturation; p50 added at instrument replacement changeover. Added as NSV November 2024. Assess at next RES or annual DTV. |
MMC Sleep Apnoea / Respiratory
ISO 15189 (2022)
Human Pathology
Medicare expiry date
07 Jun 2026
Last Activity Date
15 Jul 2024
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Quantitation of blood gases and other measurements (performed on the same specimen) | Blood | Base excess; Calcium - Ionised; Carboxyhaemoglobin; Chloride; Creatinine; Glucose; Haematocrit (packed cell volume, PCV); Lactate; Methaemoglobin (MetHb); Oxyhaemoglobin; Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); Potassium; pH |
MMC Theatre Recovery
ISO 15189 (2022)
Human Pathology
Medicare expiry date
07 Jun 2026
Last Activity Date
15 Jul 2024
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Quantitation of blood gases and other measurements (performed on the same specimen) | Blood | Anion gap; Base excess; Bicarbonate; Calcium - Ionised; Carboxyhaemoglobin; Chloride; Glucose; Haematocrit (packed cell volume, PCV); Haemoglobin (Hb); Lactate; Methaemoglobin (MetHb); Oxygen saturation (sO2); Oxyhaemoglobin; Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); Potassium; Sodium; p50; pHAnion Gap; Base excess; Bicarbonate; Haematocrit; Oxygen Saturation; p50 added at instrument replacement changeover. Added as NSV November 2024. Assess at next RES or annual DTV. |
MMC Ward 32
ISO 15189 (2022)
Human Pathology
Medicare expiry date
07 Jun 2026
Last Activity Date
15 Jul 2024
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Quantitation of blood gases and other measurements (performed on the same specimen) | Blood | Calcium - Ionised; Carboxyhaemoglobin; Chloride; Creatinine; Glucose; Haemoglobin (Hb); Lactate; Methaemoglobin (MetHb); Oxyhaemoglobin; Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); Potassium; Sodium; pH |
MMC Ward 52 South
ISO 15189 (2022)
Human Pathology
Medicare expiry date
07 Jun 2026
Last Activity Date
15 Jul 2024
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Quantitation of blood gases and other measurements (performed on the same specimen) | Blood | Calcium - Ionised; Carboxyhaemoglobin; Chloride; Creatinine; Glucose; Haemoglobin (Hb); Lactate; Methaemoglobin (MetHb); Oxyhaemoglobin; Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); Potassium; Sodium; pH |
Molecular Genetics
ISO 15189 (2022)
Human Pathology
Medicare expiry date
07 Jun 2026
Last Activity Date
15 Jul 2024
| Service | Product | Determinant |
|---|---|---|
| Molecular genetics - Assay for defined mutation or polymorphism (including pharmacogenetic testing) - Targeted genes | Blood | Quantitative calculation of p210 positive BCR::ABL1 transcripts |
| Extracted DNA | Haemochromatosis | |
| FLT3-ITD (internal tandem duplication) mutation; FLT3-TKD (tyrosine kinase domain) mutation; Nucleophosmin 1 (NPM1) mutated AML | ||
| Tissues | Solid tumours | |
| Molecular genetics - DNA extraction | Blood | Viable DNA |
| Viable DNA | ||
| Molecular genetics - DNA sequencing | Blood; Bone marrow; Extracted DNA | Sequenced DNA by Sanger sequencing. |
| Molecular genetics - Genetic testing for chimerism and mosaic gene variants (cancer and somatic mosaicism) - Targeted genes | Blood; Bone marrow | JAK2 V617F mutation; Myeloproliferative disorders |
| JAK2 exon 12 mutation | ||
| Blood; Bone marrow; RNA | Qualitative calculation of p190 and p210 positive BCR::ABL1 transcripts | |
| Leukaemic gene rearrangements; Quantitative calculation of p190 and p210 positive BCR::ABL1 transcripts | ||
| Molecular genetics - Investigation of constitutional genetic variants - Carrier testing - Targeted genes | Blood; Extracted DNA | Haemophilia A; Haemophilia B; α-Thalassaemia; β-Thalassaemia |
| Haemophilia A; α-Thalassaemia; β-Thalassaemia | ||
| Molecular genetics - Investigation of constitutional genetic variants - Diagnostic testing - Targeted genes | Blood; Buccal swabs; Extracted DNA | Angelman syndrome; Beckwith-Wiedemann syndrome; Prader-Willi syndrome; Russell-Silver syndrome (Silver-Russell syndrome) |
| Blood; Extracted DNA | Haemophilia A; Haemophilia B; α-Thalassaemia; β-Thalassaemia | |
| Molecular genetics - Predictive genetic testing - Targeted panels for inherited (germline) DNA/RNA changes | Blood | Beckwith-Wiedemann syndrome; Inherited disorders; Schwannomatosis; Wilms tumour |
| Molecular genetics - Prenatal genetic testing (excluding non-invasive prenatal [genetic] screening) | Amniotic fluid | Beckwith-Wiedemann syndrome; Prader-Willi syndrome |
| Amniotic fluid; Chorionic villus | Haemophilia A; Haemophilia B; α-Thalassaemia; β-Thalassaemia | |
| Molecular genetics - Screening for an unknown mutation - Targeted panels for non-inherited (somatic) DNA/RNA changes | Cytology smears; Formalin-fixed paraffin-embedded (FFPE) tissues | Solid tumours |
| Extracted DNA | Somatic mutation detection | |
| Extracted RNA | Somatic mutation detection | |
| Formalin-fixed paraffin-embedded (FFPE) tissues | Copy number alterations (CNAs); Copy number variation (CNV); Gene fusion; Genomic rearrangements; Indels; Loss of heterozygosity (LOH); Multi-nucleotide variants (MNV); Nucleic acid analysis for specific variants; Single nucleotide variants (SNVs); Solid tumours; Tumour mutation burden (TMB) | |
| Molecular genetics/Cytogenetics - Bioinformatic analysis | Alignment files; DNA sequences; FASTQ files; RNA sequences; TXT files; VCF files | Primary analysis - Conversion of instrument file to FASTQ or FASTA file; Primary analysis - Conversion of instrument file to TXT file; Secondary analysis - Alignment and copy number analysis; Secondary analysis - Alignment and variant calling; Secondary analysis - Copy number analysis; Tertiary analysis - Data annotation and interpretation; Tertiary analysis - Data interpretation |
Monash Children’s Hospital Canopy
ISO 15189 (2022)
Human Pathology
Medicare expiry date
07 Jun 2026
Last Activity Date
15 Jul 2024
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Quantitation of blood gases and other measurements (performed on the same specimen) | Blood | Calcium - Ionised; Carboxyhaemoglobin; Chloride; Glucose; Haemoglobin F (HbF); Lactate; Methaemoglobin (MetHb); Oxyhaemoglobin; Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); Potassium; Sodium; pH |
Monash Children’s Hospital NICU 1
ISO 15189 (2022)
Human Pathology
Medicare expiry date
07 Jun 2026
Last Activity Date
15 Jul 2024
| 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); Oxyhaemoglobin; Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); Potassium; Sodium; pH |
Monash Children’s Hospital NICU 2
ISO 15189 (2022)
Human Pathology
Medicare expiry date
07 Jun 2026
Last Activity Date
15 Jul 2024
| 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); Oxyhaemoglobin; Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); Potassium; Sodium; pH |
Monash Children’s Hospital PICU 1 and 2
ISO 15189 (2022)
Human Pathology
Medicare expiry date
07 Jun 2026
Last Activity Date
15 Jul 2024
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Quantitation of blood gases and other measurements (performed on the same specimen) | Blood | Anion gap; Base excess; Bicarbonate; Calcium - Ionised; Carboxyhaemoglobin; Chloride; Glucose; Haematocrit (packed cell volume, PCV); Haemoglobin (Hb); Lactate; Methaemoglobin (MetHb); Oxygen saturation (sO2); Oxyhaemoglobin; Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); Potassium; Sodium; p50; pHAnion Gap; Haematocrit; Oxygen Saturation; p50 added at instrument replacement changeover. Added as NSV November 2024. Assess at next RES or annual DTV. |
Monash Children’s Hospital Theatre
ISO 15189 (2022)
Human Pathology
Medicare expiry date
07 Jun 2026
Last Activity Date
15 Jul 2024
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Quantitation of blood gases and other measurements (performed on the same specimen) | Blood | Anion gap; Base excess; Bicarbonate; Calcium - Ionised; Carboxyhaemoglobin; Chloride; Glucose; Haematocrit (packed cell volume, PCV); Haemoglobin (Hb); Lactate; Methaemoglobin (MetHb); Oxygen saturation (sO2); Oxyhaemoglobin; Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); Potassium; Sodium; p50; pHAnion Gap; Haematocrit; Oxygen Saturation; p50 added at instrument replacement changeover. Added as NSV November 2024. Assess at next RES or annual DTV. |
Paediatric Diabetes Clinic
ISO 15189 (2012)
Human Pathology
Medicare expiry date
07 Jun 2026
Last Activity Date
15 Jul 2024
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Diagnosis and management of diabetes mellitusAnalyser shared between Paediatric Diabetic Clinic and Young Adults Diabetic Clinic | Blood | Glycated haemoglobin (HbA1c) |
Young Adults Diabetes Service Clinic
ISO 15189 (2022)
Human Pathology
Medicare expiry date
07 Jun 2026
Last Activity Date
15 Jul 2024
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Diagnosis and management of diabetes mellitus | Blood | Glycated haemoglobin (HbA1c) |
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.
2762
Site No.
2755
Print date
05 Feb 2025
END OF SCOPE