National Association of Testing Authorities, Australia
Scope of Accreditation
The Sydney Children's Hospitals Network (Randwick and Westmead) (Incorporating The Royal Alexandra Hospital for Children)
Site
The Children’s Hospital at Westmead – Institute of Pathology
Accreditation No.
2254
Site No.
2247
Date of Accreditation
14 Apr 1987
Contact
Mrs Susan Badman
P: +61 (02) 78253174
Availability
Services available to external clients
Supervision
GX (General)
Scope of Accreditation
Biochemical Genetics
ISO 15189 (2022)
Human Pathology
Medicare expiry date
14 Dec 2024
Last Activity Date
16 Sep 2021
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Biochemical genetic services - Amino acid quantitation | Cerebrospinal fluid (CSF); Plasma | Alloisoleucine; Arginine; Arginosuccinic acid; Asparagine; Citrulline; Cystine; Glutamate; Glutamine; Glycine; Histidine; Homocysteine; Isoleucine; Leucine; Lysine; Methionine; Ornithine; Phenylalanine; Proline; Serine; Taurine; Threonine; Tryptophan; Tyrosine; Valine |
| Dried blood spots | Alloisoleucine; Homocysteine; Isoleucine; Leucine; Methionine; Valine | |
| Plasma | Homocysteine | |
| Urine | Alanine; Arginine; Argininosuccinate; Aspartylglucosamine; Citrulline; Cystine; Glutamine; Glycine; Homocitruline; Homocysteine; Leucine; Lysine; Methionine; Ornithine; Phenylalanine; Phosphoethanolamine; Pipecolic acid; Proline; Serine; Threonine; Tyrosine; Valine; s-Sulfocysteine; β-Albumin | |
| Chemical pathology - Biochemical genetic services for the diagnosis of metabolic and enzymological disorders | Dried blood spots | 2-Methylcitrate; Methylmalonic acid (MMA) |
| Biotinidase | ||
| Dihydropteridine reductase (DHPR) | ||
| Fibroblasts | Long chain 3-hydroxyacyl coenzyme A dehydrogenase (LHCAD); Nicotinamide adenine dinucleotide (NADH) | |
| Carnitine palmitoyl transferase I | ||
| Acylcarnitine profile | ||
| Carnitine uptake | ||
| Fibroblasts; Lymphocytes | Carnitine palmitoyl transferase II | |
| 3-Hydroxypalmitoleylcarnitine (C16:1-OH); Palmitoleic acid (C16:1); Very long chain acyl-coenzyme A dehydrogenase (vLCAD) | ||
| Leucocytes (leukocytes) | Cystine | |
| Leucocytes (leukocytes); Skin fibroblasts | Tissue culture; Tissue protein | |
| Plasma | Methylmalonic acid (MMA) | |
| 7-Dehydrocholesterol | ||
| Acylcarnitine profile; Carnitine - Free; Carnitines | ||
| C22; C24; C26; Phytanate; Pristanate; Very long chain fatty acids (vLCFA) | ||
| Creatine and guanidinoacetate | ||
| Serum | Transferrin isoforms | |
| Urine | Glycosaminoglycans (MPS) | |
| Organic acids | ||
| 2-Deoxyuridine; 5-Aminoimidazole-4-carboxamide ribonucleotide (AICAR); Adenine; Cholestapentanol; Creatine; Glucuronide; Glycerolphosphate; Glycylproline; Guanidinoacetate; Guanosine; Hypoxanthine; Orotate; Piperideine-6-carboxylate; Tetrahydrocannabinolic acid synthase (THCA); Thymidine; Xanthine; n-Acetylneuraminic acid (sialic acid, NANA); s-Adenosine | ||
| Chemical pathology - Investigation and determination of hepatic, cardiac, bone, skeletal muscle and other profiles and metabolic studies | Urine | Creatinine |
Biochemistry
ISO 15189 (2012)
Human Pathology
Medicare expiry date
14 Dec 2024
Last Activity Date
16 Sep 2021
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Detection and/or quantitation of drugs for therapeutic monitoring | Blood | Tacrolimus |
| Plasma | Busulfan; Cyclosporin; Digoxin; Methotrexate |
ISO 15189 (2022)
Human Pathology
Medicare expiry date
14 Dec 2024
Last Activity Date
16 Sep 2021
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Analysis of drugs for toxicological (non-legal) purposes and ingested or absorbed toxic chemicals | Plasma | Ethanol |
| Chemical pathology - Biogenic amines | Cerebrospinal fluid (CSF) | 3-o-Methydopa (3-OMD); 5-Hydroxyindoleacetic acid (5-HIAA); 5-Hydroxytryptophan (5-HTP); Biopterin; Homovanillic acid (HVA); L-Methylfolate (5-MTHF); Neopterin |
| Urine | 3-Methoxytyramine; 3-Methoxytyramine - Free; 5-Hydroxyindoleacetic acid (5-HIAA); Adrenaline; Dopamine; Homovanillic acid (HVA); Metadrenaline - Free; Metanephrine; Noradrenaline; Normetadrenaline - Free; Normetanephrine; Vanillylmandelic acid (VMA) | |
| 1-Methylhistamine; Histamine | ||
| Histamine; Pterins | ||
| Chemical pathology - Detection and/or quantitation of drugs for therapeutic monitoring | Blood | Cyclosporin; Sirolimus; Tacrolimus |
| Plasma | Busulfan | |
| Asparaginase | ||
| Plasma; Serum | Amikacin; Phenobarbitone | |
| Carbamazepine; Gentamicin (cidomycin, septopal, genticyn, garamycin); Paracetamol (acetaminophen); Phenytoin (dilantin); Salicylate; Tobramycin; Valproate (valproic acid, epilim); Vancomycin | ||
| Methotrexate | ||
| Fluconazole; Hydroxyitraconazole; Itraconazole; Posaconazole; Voriconazole | ||
| Serum | Lithium | |
| Chemical pathology - Determination of hormones and hormone binding proteins (other than thyroid function tests) | Cerebrospinal fluid (CSF); Plasma; Serum | α-Fetoprotein (AFP) |
| Plasma; Serum | Cortisol | |
| Procalcitonin | ||
| Chemical pathology - Dynamic tests | Sweat | Sweat chloride |
| Chemical pathology - Further investigation of cardiac function | Plasma; Serum | Troponin I |
| Chemical pathology - Investigation and determination of hepatic, cardiac, bone, skeletal muscle and other profiles and metabolic studies | Ascitic fluid; Peritoneal dialysis fluid | Albumin; Glucose; Protein - Total; Sodium |
| Cerebrospinal fluid (CSF) | Glucose; Protein - Total | |
| Chloride; Lactate; Potassium; Sodium | ||
| Drainage fluid | Creatinine; Protein - Total | |
| Faeces | Chloride; Potassium; Sodium | |
| Faeces; Plasma; Urine | Osmolality | |
| Gastric fluid | Sodium | |
| Plasma | Ammonia; Ferritin; Lactate | |
| Plasma; Serum | Alanine aminotransferase; Albumin; Alkaline phosphatase; Ammonia; Amylase; Aspartate aminotransferase; Bicarbonate; Bilirubin - Any fractions; Bilirubin - Conjugated; Bilirubin - Total; Bilirubin - Unconjugated; C-reactive protein (CRP); Calcium - Total; Carbon dioxide (CO2); Chloride; Cholesterol - HDL; Cholesterol - Total; Creatine kinase; Creatinine; Cystatin C; Globulin; Glucose; High sensitivity C-reactive protein (CRP); Lactate; Lactate dehydrogenase (LDH); Lipase; Magnesium; Phosphate; Potassium; Protein - Total; Sodium; Triglycerides; Urate; Urea; γ-Glutamyltransferase | |
| Amylase isoenzymes | ||
| Pleural fluid | Glucose; Lactate dehydrogenase (LDH); Protein - Total | |
| Urine | Protein - Total | |
| Calcium - Total; Chloride; Creatinine; Glucose; Phosphate; Potassium; Sodium; Urate; Urea | ||
| Chloride | ||
| Creatinine | ||
| Chemical pathology - Investigation for folate deficiency | Plasma | Folate |
| Chemical pathology - Investigation of malabsorption | Faeces | Faecal fat globules |
| Faeces; Urine | pH | |
| Chemical pathology - Iron studies | Plasma; Serum | Iron |
| Chemical pathology - Quantitation of vitamins | Plasma; Serum | Ascorbic acid (vitamin C); Retinol (vitamin A); Tocopherol (vitamin E) |
| Chemical pathology - Tests for thyroid function | Plasma; Serum | Thyroid stimulating hormone (TSH); Thyroxine (T4) - Free; Triiodothyronine (T3) - Free |
| Immunopathology - Quantitative and/or qualitative investigation of proteins | Faeces | Calprotectin |
| 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 |
Camperdown Ward
ISO 15189 (2022)
Human Pathology
Medicare expiry date
14 Dec 2024
Last Activity Date
16 Sep 2021
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Quantitation of blood gases and other measurements (performed on the same specimen) | Blood | Bilirubin - Total; 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 |
Cardiac Catheter Laboratory
ISO 15189 (2022)
Human Pathology
Medicare expiry date
14 Dec 2024
Last Activity Date
16 Sep 2021
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Quantitation of blood gases and other measurements (performed on the same specimen) | Blood | Bilirubin - Total; 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 |
Childrens Short Stay Unit (CSSU)
ISO 15189 (2022)
Human Pathology
Medicare expiry date
14 Dec 2024
Last Activity Date
16 Sep 2021
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Quantitation of blood gases and other measurements (performed on the same specimen) | Blood | Bilirubin - Total; 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 |
Close Observation Unit (COU)
ISO 15189 (2022)
Human Pathology
Medicare expiry date
14 Dec 2024
Last Activity Date
16 Sep 2021
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Quantitation of blood gases and other measurements (performed on the same specimen) | Blood | Bilirubin - Total; 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 |
Cytogenetics
ISO 15189 (2022)
Human Pathology
Medicare expiry date
14 Dec 2024
Last Activity Date
16 Sep 2021
| 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; Lymph nodes; Paraffin embedded tissue; Products of conception (POC); Smears; Tumour imprints | Chromosomal rearrangement; Pathogenic copy number changes |
| Cytogenetics - Molecular karyotype (SNP microarray) detection of unbalanced chromosome abnormalities | Amniotic fluid; Blood; Bone marrow; Chorionic villus tissue; Other tissues - Malignant; Other tissues - Non-malignant; Products of conception (POC) | Absence of heterozygosity; Cytogenetic analysis and reporting; Pathogenic copy number changes; Single nucleotide polymorphism (SNP) genotyping; Uniparental or biparental chromosome inheritance |
| Chromosomal rearrangement; Cytogenetic analysis and reporting; Pathogenic copy number changes | ||
| Molecular genetics - DNA fragment size analysis | Amniotic fluid; Blood; Chorionic villus tissue; Products of conception (POC) | Aneuploidy for chromosomes X and Y; Trisomy 13, trisomy 18, trisomy 21 |
| Blood | Y chromosome microdeletion | |
| Molecular genetics - Genetic testing for chimerism and mosaic gene variants (cancer and somatic mosaicism) - Targeted genes | Blood; Bone marrow; Formalin-fixed paraffin-embedded (FFPE) tissues; Solid tumour tissue - Fresh/frozen | Gene fusion - Solid Tumour |
| Molecular genetics - Screening for an unknown mutation - Targeted genes | Blood; Bone marrow; Formalin-fixed paraffin-embedded (FFPE) tissues; Solid tumour tissue - Fresh/frozen; Tissues | Gene fusion - Solid Tumour |
| Blood; Bone marrow; Formalin-fixed paraffin-embedded (FFPE) tissues; Tissues | Gene fusion - Leukaemia |
Emergency Resus Bay
ISO 15189 (2022)
Human Pathology
Medicare expiry date
14 Dec 2024
Last Activity Date
16 Sep 2021
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Quantitation of blood gases and other measurements (performed on the same specimen) | Blood | Bilirubin - Total; 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 |
Endocrinology Laboratory
ISO 15189 (2012)
Human Pathology
Medicare expiry date
14 Dec 2024
Last Activity Date
16 Sep 2021
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Diagnosis and management of diabetes mellitus | Blood | Glycated haemoglobin (HbA1c) |
| Blood; Plasma; Serum | Glycated haemoglobin (HbA1c) |
ISO 15189 (2022)
Human Pathology
Medicare expiry date
14 Dec 2024
Last Activity Date
16 Sep 2021
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Determination of hormones and hormone binding proteins (other than thyroid function tests) | Plasma | Renin activity |
| Adrenocorticotropic hormone (ACTH) | ||
| Plasma; Serum | C-peptide; Follicle stimulating hormone (FSH); Growth hormone; Luteinising hormone (LH); Prolactin | |
| 11-Deoxycortisol; 17α-Hydroxyprogesterone; Androstenedione; Dehydroepiandrosterone sulfate (DHEAS); Dihydrotestosterone; Progesterone; Testosterone | ||
| Oestradiol | ||
| Insulin | ||
| Insulin | ||
| Insulin-like growth factor 1 (IGF-1, somatomedin C) | ||
| Serum | Parathyroid hormone (PTH); Sex hormone binding globulin (SHBG) | |
| Chemical pathology - Diagnosis and management of diabetes mellitus | Blood | Glycated haemoglobin (HbA1c) |
| Plasma; Serum | Ketones | |
| Urine | Microalbumin | |
| Chemical pathology - Investigation and determination of hepatic, cardiac, bone, skeletal muscle and other profiles and metabolic studies | Plasma; Serum | Ketones |
| Chemical pathology - Markers of bone metabolism | Plasma; Serum | Procollagen type 1 N-terminal propeptide (P1NP); c-Telopeptide (CTx) |
| Chemical pathology - Quantitation of vitamins | Plasma; Serum | 25-Hydroxyvitamin D3; Vitamin D |
| Immunopathology - Detection and/or quantitation and/or characterisation of autoantibodies | Plasma; Serum | Anti-thyroglobulin antibodies (Tg); Anti-thyroid peroxidase antibodies (TPO) |
| Serum | Anti-insulin antibodies | |
| Anti-glutamic acid decarboxylase antibodies (GAD); Anti-islet cell antigen 2 antibodies |
Grace Centre for Newborn Care (GCNC)
ISO 15189 (2022)
Human Pathology
Medicare expiry date
14 Dec 2024
Last Activity Date
16 Sep 2021
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Quantitation of blood gases and other measurements (performed on the same specimen) | Blood | Bilirubin - Total; 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 |
Haematology Department
ISO 15189 (2022)
Human Pathology
Medicare expiry date
14 Dec 2024
Last Activity Date
16 Sep 2021
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Diagnosis and management of diabetes mellitus | Blood | Glycated haemoglobin (HbA1c) |
| Chemical pathology - Quantitation of vitamin B markers | Serum | Holotranscobalamin (active vitamin B12) |
| Cytogenetics - Detection of defined, balanced and/or unbalanced chromosomal abnormalities by in-situ hybridisation techniques | Blood | Pathogenic copy number changes |
| Haematology - Assessment of haemolysis or metabolic enzymes (red cell enzyme assays) | Blood | Erythrocyte (RBC) autohaemolysis; Glucose-6-phosphate dehydrogenase (G6PD); Other erythrocyte metabolic enzymes |
| Haematology - Bone marrow examination | Bone marrow | Examination of aspirated material |
| Haematology - Diagnosis of thalassemia | Blood | Examination of haemoglobin H (HbH); Haemoglobin A (HbA) - Quantitation; Haemoglobin A2 (HbA2) - Quantitation; Haemoglobin F (HbF) - Quantitation; Haemoglobin H (HbH) inclusions |
| Haematology - Examination of blood films by special staining | Blood; Bone marrow; Cerebrospinal fluid (CSF); Urine | Cytochemical indicators; Haemoglobin H; Haemosiderin; Heinz bodies; Iron; Malaria; Morphology; Myeloid differentiation; Myeloperoxidase; Non-specific esterase; Parasites |
| Haematology - Foetal haemoglobin in maternal circulation | Blood; Faeces; Gastric aspirate; Vomitus | 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); Mean corpuscular haemoglobin (MCH); Mean corpuscular haemoglobin concentration (MCHC); Mean corpuscular volume (MCV); Mean platelet volume (MPV); Morphology; 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) | Plasma | Anti-Xa activity - Clexane - Low molecular weight heparin; Anti-Xa activity - Fragmin - Low molecular weight heparin; Anti-Xa activity - Heparin activity; Anti-Xa activity - Low molecular weight heparin; Anti-Xa activity - Unfractionated heparin; Circulating coagulation factor inhibitors; Collagen - Adenosine (COL/ADP); Collagen - Epinephrine (COL/EPI); Factor II; Factor IX; Factor V; Factor VII; Factor VIII; Factor X; Factor XI; Factor XII; Factor XIII; Factor XIII deficiency; Platelet aggregation; Platelet function (PFA); Thrombin anti-thrombin complex (TAT) |
| Activated partial thromboplastin time (APTT); Clauss fibrinogen; Factor XIII - Qualitative; Fibrinogen; Fibrinogen degradation products; International normalised ratio (INR); Mixing studies - APTT; Prothrombin time (PT); Thrombin time (TT) | ||
| Anti-thrombin III; Kaolin clotting time; Protein C; 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; Presence of flocculation |
| Haematology - Limited blood examination | Blood | Erythrocyte (RBC) sedimentation rate (ESR) |
| Immunopathology - Characterisation of leucocyte surface antigens (including immunophenotyping) | Blood | CD34; Chimeric antigen receptor (CAR) T-cells |
| Blood; Bone marrow | CD10; CD117; CD123; CD13; CD14; CD19; CD2; CD20; CD22; CD3; CD33; CD34; CD38; CD4; CD45; CD5; CD56; CD58; CD64; CD7; CD79a; CD8; CD99; DR; Kappa light chains; Lambda light chains; Leukaemia screen; MPO; Minimal residual disease (MRD) | |
| Microbiology - Parasitology - Detection of ova, cysts and parasites | Blood | Malaria |
| Microbiology - Serology of infection - Microbial antibody and/or antigen detection and/or quantitation | Serum | Infectious mononucleosis |
Histopathology/Cytopathology
ISO 15189 (2022)
Human Pathology
Medicare expiry date
14 Dec 2024
Last Activity Date
16 Sep 2021
| Service | Product | Determinant |
|---|---|---|
| Anatomical pathology - Cytopathology - Non-gynaecological cytological investigations of body fluids, exudates, washings and brushings from non-squamous mucosal sites for the detection of malignancy | Aspirates; Cerebrospinal fluid (CSF); Other body fluids; 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 | Review and reporting of biopsy material to identify or exclude morphological abnormalities; Structured reporting |
| 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; Sentinel node; Smears; Tissue imprint | Intra-operative consultation and examination of biopsy material |
| Anatomical pathology - Tissue pathology - Immunohistochemical (immunofluorescence) investigation | Fresh tissue; Frozen tissue | Detection of antigenic targets - Various |
| Anatomical pathology - Tissue pathology - Immunohistochemical investigation | Fixed cytological smears; Formalin-fixed paraffin-embedded (FFPE) tissues | Detection of antigenic targets - Various |
| Detection of antigenic targets - Various | ||
| Anatomical pathology - Tissue pathology - Mortuary facilities | Body; Body parts | Assessment - Level 3 mortuary |
| Anatomical pathology - Tissue pathology - Non-coronial autopsy services | Body; Body parts | Autopsy service and reporting |
| Anatomical pathology - Tissue pathology - Skeletal muscle enzyme histochemistry | Frozen sections of skeletal muscle | Detection of muscle enzyme targets |
Hunter Baillie Ward
ISO 15189 (2022)
Human Pathology
Medicare expiry date
14 Dec 2024
Last Activity Date
16 Sep 2021
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Quantitation of blood gases and other measurements (performed on the same specimen) | Blood | Bilirubin - Total; 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 |
Immunohaematology
ISO 15189 (2022)
Human Pathology
Medicare expiry date
14 Dec 2024
Last Activity Date
16 Sep 2021
| Service | Product | Determinant |
|---|---|---|
| Haematology - Investigation of haemolysis | Blood | Cold agglutinins; Direct antiglobulin test (DAT, direct Coombs test); Haemoglutinin titre; Haemolysin screen; Haemolysin titre; Paroxysmal nocturnal haemoglobinuria (PNH) screen |
| Immunohaematology - Blood group antibody detection | Blood | Duffy system; High titre anti-A and anti-B screening; Kell system; M and N factors; Other blood group systems; Rh phenotypes |
| Immunohaematology - Blood grouping | Blood | ABO; RhD |
| Immunohaematology - Determination of compatibility of blood donor units | Blood | Direct antiglobulin test (DAT, direct Coombs test); Examination for blood group antibodies; Group checks of patient and donor; Identification of detected antibodies |
| Immunohaematology - Identification and quantitation of blood group antibodies | Blood | Antibody elution; Direct antiglobulin test (DAT, direct Coombs test); Donath-Landsteiner antibody; High titre anti-A and anti-B screening; Other blood group antibodies; Red blood cell phenotyping; Rh |
| Immunohaematology - Investigation of blood transfusion reactions | Blood; Blood products | Antibodies |
| Immunohaematology - Issue and release of blood and blood product for transfusion | Blood; Blood products; Cryoprecipitate; Fresh frozen plasma (FFP); Granulocytes; 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); Granulocytes; Platelets | Issue and release of blood and blood products for transfusion |
| Immunopathology - Quantitative and/or qualitative investigation of proteins | Plasma; Serum | Cryofibrinogen; Cryoglobulins |
Immunology
ISO 15189 (2022)
Human Pathology
Medicare expiry date
14 Dec 2024
Last Activity Date
16 Sep 2021
| Service | Product | Determinant |
|---|---|---|
| Immunopathology - Characterisation of leucocyte surface antigens (including immunophenotyping) | Blood | B-cell; CD40; CD40 ligand; Leucocyte adhesion deficiency (LAD) screening; Memory cells; Myeloma screen; Naive B cells; Naive T-cells; Natural killer (NK) cells; Perforin; T reg cells; T-cell receptor aβ (TCRab); T-cell receptor γδ (TCRgd); T-cells; Total lymphocyte number |
| Immunopathology - Detection and/or quantitation and/or characterisation of autoantibodies | Serum | Anti-deamidated gliadin antibodies; Anti-tissue transglutaminase antibodies (tTG) |
| Immunopathology - Investigation and/or assessment of neutrophils - Functional tests | Blood | Qualitative assessment of neutrophils for the presence of oxidative pathway defects |
| Qualitative assessment of neutrophils for the presence of oxidative pathway defects | ||
| Immunopathology - Quantitation of complement proteins | Serum | Complement components C3 and C4 |
| Immunopathology - Quantitative and/or qualitative investigation of proteins | Serum | Amyloid A |
| Immunopathology - Quantitative investigation and/or assessment of neutrophils | Blood | Dihydrorhodamine 123 |
| Immunopathology - Quantitative investigations of immunoglobulins and immunoglobulins subclasses | Serum | 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 | Corynebacterium diphtheriae IgG antibody; Haemophilus influenzae type B IgG antibody; Streptococcus pneumoniae IgG antibody; Tetanus IgG antibody |
| Streptococcal anti-DNAse B (anti-streptodornase) antibody; Anti-streptolysin O (ASOT) | ||
| Molecular genetics - Assay for defined mutation or polymorphism (including pharmacogenetic testing) - Targeted genes | Blood; Bone marrow; Extracted DNA | Immune disorders; Severe combined immunodeficiency disease (SCID) |
| Molecular genetics - DNA sequencing | Blood | DNA sequence analysis |
| Molecular genetics - Genetic testing for chimerism and mosaic gene variants (cancer and somatic mosaicism) - Targeted genes | Blood; Bone marrow; Extracted DNA | Immune disorders |
| Molecular genetics - Investigation of constitutional genetic variants - Carrier testing - Targeted genes | Blood; Bone marrow; Extracted DNA | Immune disorders; Severe combined immunodeficiency disease (SCID) |
| Molecular genetics - Investigation of constitutional genetic variants - Diagnostic testing - Targeted genes | Blood; Bone marrow; Extracted DNA | Immune disorders; Severe combined immunodeficiency disease (SCID) |
Kids Care Centre (KCC)
ISO 15189 (2022)
Human Pathology
Medicare expiry date
14 Dec 2024
Last Activity Date
16 Sep 2021
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Quantitation of blood gases and other measurements (performed on the same specimen) | Blood | Bilirubin - Total; 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 |
Microbiology
ISO 15189 (2022)
Human Pathology
Medicare expiry date
14 Dec 2024
Last Activity Date
16 Sep 2021
| Service | Product | Determinant |
|---|---|---|
| Microbiology - Bacteriology - Detection of pathogenic bacteria | Axilla swabs; Bronchoalveolar lavage; Cerebrospinal fluid (CSF); Cervical swabs; Ear swabs; Eye swabs; Faeces; Fluids; Gastric aspirate; Gastric biopsy; General swabs; Genital swabs; Infection control swabs; Nasal swabs; Nasopharyngeal aspirate; Nasopharyngeal swabs; Pericardial fluid; Perineum swabs; Pleural fluid; Post-operative wounds; Rectal swabs; Respiratory specimens; Sputum; Synovial fluid; Throat swabs; Tissues; Urine; Vaginal swabs; Wound swabs | Pathogenic identification and antibiotic susceptibility |
| Blood | Antibiotic susceptibility; Pathogenic microorganisms | |
| Blood; Pericardial fluid; Pleural fluid; Synovial fluid | Antibiotic susceptibility; Pathogenic microorganisms | |
| Bronchoalveolar lavage; Gastric aspirate; Respiratory specimens; SputumEndotracheal tube aspirate | Pathogenic identification and antibiotic susceptibility | |
| Cerebrospinal fluid (CSF); Fluids; Pericardial fluid; Pleural fluid; Synovial fluidPeritoneal fluid, Peritoneal Dialysis fluid | Antibiotic susceptibility; Erythrocytes (red blood cells, RBC); Leucocytes (white blood cells, WBC); Pathogenic microorganisms | |
| Ear swabs; Eye swabs; Gastric biopsy; General swabs; Nasal swabs; Nasopharyngeal aspirate; Nasopharyngeal swabs; Throat swabs; Tissues | Antibiotic susceptibility; Pathogenic microorganisms | |
| Faeces | Antibiotic susceptibility; Erythrocytes (red blood cells, RBC); Leucocytes (white blood cells, WBC); Pathogenic microorganisms | |
| Genital swabs | Antibiotic susceptibility; Pathogenic microorganisms | |
| Urine | Antibiotic susceptibility; Bilirubin; Blood; Casts; Erythrocytes (red blood cells, RBC); Glucose; Ketones; Leucocyte esterase; Leucocytes (white blood cells, WBC); Nitrite; Pathogenic microorganisms; Proteins; Specific gravity; Urobilinogen; pH | |
| Microbiology - Bacteriology - Detection of pathogenic bacteria for epidemiological infection control surveillance | Axilla swabs; Cervical swabs; Faeces; Groin swabs; Infection control swabs; Nasal swabs; Perianal swabs; Rectal swabs; Throat swabs; Urine; Vaginal swabs; Wounds | Carbapenemase-producing Enterobacterales (CPE); Extended spectrum beta-lactamases (ESBL); Methicillin resistant Staphylococcus aureus (MRSA); Vancomycin resistant Enterococci (VRE) |
| Microbiology - Environmental investigations and/or infection control | Blood transfusion bags; Vascular catheter tips | Bacterial growth - Sterility; Pathogenic identification and antibiotic susceptibility |
| Bacterial growth - Sterility; Pathogenic identification and antibiotic susceptibility | ||
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (bacteria) | Blood; Cerebrospinal fluid (CSF) | Haemophilus influenzae; Neisseria meningitidis; Streptococcus pneumoniae |
| Blood; Cerebrospinal fluid (CSF); Respiratory specimens; Skin swabs; Sterile site; Tissues | Neisseria meningitidis | |
| Blood; Cerebrospinal fluid (CSF); Respiratory specimens; Sterile site | Streptococcus pneumoniae | |
| Bronchial washings; Bronchoalveolar lavage; Dry swabs; General swabs; Nasal aspirates/washes; Nasopharyngeal aspirate; Nasopharyngeal swabs; Nucleic acid; Respiratory specimens; Sputum; Throat swabs; Tissues | Bordetella parapertussis; Bordetella pertussis; Chlamydophila pneumoniae; Haemophilus influenzae; Legionella pneumophila; Mycoplasma pneumoniae; Streptococcus pneumoniae | |
| Bronchoalveolar lavage; Nasopharyngeal aspirate; Nasopharyngeal swabs | Bordetella holmesii; Bordetella parapertussis; Bordetella pertussis | |
| Cerebrospinal fluid (CSF) | Escherichia coli K1; Haemophilus influenzae; Listeria monocytogenes; Neisseria meningitidis; Streptococcus agalactiae (Streptococcus group B); Streptococcus pneumoniae | |
| Cervical swabs; Genital swabs; Urine; Vaginal swabs | Chlamydia trachomatis; Neisseria gonorrhoeae | |
| Faeces | Aeromonas spp.; Campylobacter spp.; Escherichia coli - Enteroinvasive (EIEC); Salmonella spp.; Shigella spp.; Yersinia enterocolitica | |
| Clostridium difficile toxin A; Clostridium difficile toxin B | ||
| Fluids; Sterile site; Synovial fluid; Tissues | Kingella kingae | |
| General swabs; Skin swabs | Staphylococcus aureus; Methicillin resistant Staphylococcus aureus (MRSA) | |
| Throat swabs | Streptococcus spp. | |
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (fungi) | Cerebrospinal fluid (CSF) | Cryptococcus gattii; Cryptococcus neoformans |
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (mycobacteria) | Bronchoalveolar lavage; Sputum | Mycobacterium tuberculosis; Mycobacterium rifampicin resistance rpoB |
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (protozoan parasites) | Faeces | Cryptosporidium spp.; Entamoeba histolytica; Giardia spp. |
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (viruses) | Amniotic fluid; Aspirates; Blood; Bronchial washings; Bronchoalveolar lavage; Cerebrospinal fluid (CSF); Dry swabs; Eye swabs; Faeces; General swabs; Nasal aspirates/washes; Nasopharyngeal aspirate; Nasopharyngeal swabs; Plasma; Respiratory specimens; Sterile site; Tissues; Vitreous specimens | Cytomegalovirus (CMV) |
| Blood; Cerebrospinal fluid (CSF); Faeces; General swabs; Throat swabs | Enterovirus | |
| Blood; Cerebrospinal fluid (CSF); General swabs; Tissues | Epstein-Barr virus | |
| Blood; Faeces; General swabs | Adenovirus | |
| Bronchial washings; Bronchoalveolar lavage; Dry swabs; Endotrachael aspirate; General swabs; Nasal aspirates/washes; Nasopharyngeal aspirate; Nasopharyngeal swabs; Nucleic acid; Respiratory specimens; Sputum; Throat swabs; Tissues | Adenovirus; Enterovirus; Human bocavirus 1, 2, 3, 4 (HBoV1, 2, 3, 4); Human coronavirus NL63; Human coronavirus 229E; Human coronavirus OC43; Human metapneumovirus; Influenza A virus H1 - 2009 pandemic strain; Influenza A virus H1/H; Influenza A virus H3; Influenza B virus; Parainfluenza virus type 1/2/3/4; Respiratory syncytial virus (RSV) A/B; Rhinovirus | |
| Bronchoalveolar lavage; Nasal aspirates/washes; Nasopharyngeal aspirate; Nasopharyngeal swabs; Oropharyngeal swabs; Sputum | Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) | |
| 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) | ||
| Cerebrospinal fluid (CSF) | Cytomegalovirus (CMV); Enterovirus; Herpes simplex virus type 1 (HSV1); Herpes simplex virus type 2 (HSV2); Human herpes virus type 6 (HHV6); Human parechovirus; Varicella zoster virus (VZV) | |
| Cerebrospinal fluid (CSF); Dry swabs; Faeces; General swabs; Sterile site; Throat swabs; Tissues | Human parechovirus | |
| Faeces | Adenovirus | |
| Adenovirus F40; Adenovirus F41; Astrovirus; Norovirus G1; Norovirus G2; Rotavirus A | ||
| General swabs | Human herpes virus type 1/2 (HHV1/2); Varicella zoster virus (VZV) | |
| Herpes simplex virus (HSV); Varicella zoster virus (VZV) | ||
| Nasal aspirates/washes; Nasal swabs; Nasopharyngeal swabs; Oropharyngeal swabs | Influenza A virus; Influenza B virus; Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) | |
| Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) | ||
| Nasopharyngeal aspirate; Nasopharyngeal swabs | Influenza A virus; Influenza B virus; Respiratory syncytial virus (RSV) | |
| Nasopharyngeal aspirate; Nasopharyngeal swabs; Urine | Measles virus | |
| Plasma | BK virus; Herpes simplex virus 6 | |
| Microbiology - Molecular biology - Quantitation of microbial nucleic acids | Blood | Adenovirus viral load; Epstein-Barr virus viral load |
| Cytomegalovirus (CMV) viral load | ||
| Microbiology - Mycobacteriology - Detection and identification of mycobacteria | Ascitic fluid; Aspirates; Blood; Bone marrow; Bronchial washings; Bronchoalveolar lavage; Cerebrospinal fluid (CSF); Faeces; Gastric lavage; Gastrointestinal fluid; General swabs; Isolates; Lymph node fluid; Other body fluids; Pericardial fluid; Peritoneal fluid; Pus; Respiratory specimens; Skin swabs; Sputum; Tissues; Urine; Wound swabs | Mycobacteria detection |
| Microbiology - Mycology - Detection of dermatophytes and other fungi causing cutaneous disease | Skin scrapings | Dermatophyte identification |
| Microbiology - Mycology - Detection, isolation and/or identification of yeasts and/or fungal elements | Blood; Cerebrospinal fluid (CSF); General swabs; Skin scrapings; Sputum; Tissues; Urine | Fungi identification; Fungi susceptibility; Isolation of yeasts and Aspergillus; Yeast susceptibility; Yeasts identification |
| Microbiology - Parasitology - Detection of ova, cysts and parasites | Faeces | Amoebae; Cysts; Ova; Parasites; Worms |
| Amoebae; Cysts; Ova; Parasites; Worms | ||
| Microbiology - Serology of infection - Microbial antibody and/or antigen detection and/or quantitation | Plasma; Serum | Cytomegalovirus antibody (anti-CMV) IgG; 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) - Total; Hepatitis B virus surface antibody (anti-HBs) - Total; Hepatitis B virus surface antigen (HBs Ag); Hepatitis B virus surface antigen (HBs Ag) neutralisation; Hepatitis C virus antibody (anti-HCV) - Total; Human T-lymphotropic virus type I/II (HTLV-I/II) antibody; Human immunodeficiency virus (HIV) p24 antigen; Human immunodeficiency virus type 1/2 (HIV-1/2) 1/2 antibodies; Rubella IgG antibody; Rubella IgM antibody; Syphilis Treponema pallidum total antibody; Toxoplasma gondii IgG antibody; Toxoplasma gondii IgM antibody |
| Hepatitis B virus envelope antibody (anti-HBe); Hepatitis B virus envelope antigen (HBe Ag) | ||
| Serum | Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) antibody | |
| Herpes simplex virus type 1 antibody (anti-HSV1) - IgM; Herpes simplex virus type 2 antibody (anti-HSV2) - IgG; Herpes simplex virus type 2 antibody (anti-HSV2) - IgM; Herpes simplex type 1 antibody (anti-HSV1) - IgG; Measles IgG antibody; Measles IgM antibody; Mumps virus IgG antibody; Mumps virus IgM antibody; Mycoplasma pneumoniae IgM antibody; Varicella zoster virus (VZV) IgG antibody; Varicella zoster virus IgM antibody | ||
| Epstein-Barr virus early antigen 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 | ||
| Adeno-associated virus serotype 9 (AAV9) IgG |
Molecular Genetics
ISO 15189 (2022)
Human Pathology
Medicare expiry date
14 Dec 2024
Last Activity Date
16 Sep 2021
| Service | Product | Determinant |
|---|---|---|
| Molecular genetics - Assay for defined mutation or polymorphism (including pharmacogenetic testing) - Targeted genes | Blood; Bone marrow; Buccal swabs; Dried blood spots; Extracted DNA; Fluids; Formalin-fixed paraffin-embedded (FFPE) tissues; Oral fluid; Plasma; Serum; Tissues | Cystic fibrosis; Deafness |
| Molecular genetics - DNA extraction | Amniotic fluid; Blood; Body fluids; Bone; Buccal swabs; Buffy coat; Dry swabs; Formalin-fixed paraffin-embedded (FFPE) tissues; Hair; Muscle; OraCollect; Plasma; Saliva; Serum; Tissues; Urine | DNA storage for future analyses; Purified PCR product; Viable DNA; Viable DNA for sequencing |
| Molecular genetics - DNA fragment size analysis | Blood; Fluorescent-labelled DNA sequencing reaction product; Oral fluid; Purified DNA; Smears; Tissues | Copy number variation (CNV); DNA fragment size determination |
| Molecular genetics - DNA sequencing | Amniotic fluid; Blood; Buccal swabs; Fluorescent-labelled DNA sequencing reaction product; Formalin-fixed paraffin-embedded (FFPE) tissues; Hair; Muscle; Oral fluid; Purified PCR product; Smears; Tissues; Urine | DNA sequence analysis; DNA sequencing reaction purification step; Sequenced DNA; Sequenced DNA by Sanger sequencing; 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; Bone marrow; Chorionic villus; Extracted DNA; Fluids; Saliva; Tissues | Cystic fibrosis; Estimation of risk |
| Molecular genetics - Heterozygous loci determinations | Amniotic fluid; Blood; Bone marrow; Buccal swabs; Chorionic villus; Extracted DNA; Fluids; Muscle; Oral fluid; Products of conception (POC); Saliva; Tissues | Nucleic acid analysis for specific variants |
| Molecular genetics - Investigation of constitutional genetic variants - Carrier testing - Targeted genes | Blood; Bone marrow; Dried blood spots; Extracted DNA; Formalin-fixed paraffin-embedded (FFPE) tissues; Hair; Leucocytes (leukocytes); Muscle; Oral fluid; Saliva; Skin fibroblasts; Tissues; Urine | Angelman syndrome; Cystic fibrosis; Familial Mediterranean fever; Fragile X; Galactosemia; Intellectual disability; Long chain 3-hydroxyacyl-coenzyme A dehydrogenase (LHCAD) deficiency; Marfan syndrome; Medium chain acyl-coenzyme A dehydrogenase (MCAD); Mendelian disorders; Mitochondrial disorders; Nucleic acid analysis for unknown variants; Ornithine transcarbamylase deficiency; Prader-Willi syndrome; Rare undiagnosed disease; Rett syndrome; Variants in the nuclear genome |
| Molecular genetics - Investigation of constitutional genetic variants - Carrier testing - Targeted panels for inherited (germline) DNA/RNA changes | Blood; Buccal swabs; Dried blood spots; Extracted DNA; Formalin-fixed paraffin-embedded (FFPE) tissues; Hair; Leucocytes (leukocytes); Muscle; Oral fluid; Saliva; Skin fibroblasts; Tissues; Urine | Angelman syndrome; Cystic fibrosis; Familial Mediterranean fever; Fragile X syndrome (FRAXA); Galactosemia; Intellectual disability; Long chain 3-hydroxyacyl-coenzyme A dehydrogenase (LHCAD) deficiency; Marfan syndrome; Medium chain acyl-coenzyme A dehydrogenase (MCAD); Mendelian disorders; Mitochondrial disorders; Nucleic acid analysis for unknown variants; Prader-Willi syndrome; Rare undiagnosed disease; Rett syndrome; Variants in the nuclear genome |
| Molecular genetics - Investigation of constitutional genetic variants - Carrier testing - Whole exome sequencing studies for inherited (germline) DNA/RNA changes | Blood; Buccal swabs; Dried blood spots; Leucocytes (leukocytes); Saliva; Skin fibroblasts; Tissues | Angelman syndrome; Cystic fibrosis; Familial Mediterranean fever; Galactosemia; Intellectual disability; Long chain 3-hydroxyacyl-coenzyme A dehydrogenase (LHCAD) deficiency; Marfan syndrome; Medium chain acyl-coenzyme A dehydrogenase (MCAD); Mendelian disorders; Mitochondrial disorders; Nucleic acid analysis for unknown variants; Rare undiagnosed disease; Rett syndrome |
| Molecular genetics - Investigation of constitutional genetic variants - Diagnostic testing - Targeted genes | Blood; Buccal swabs; Dried blood spots; Extracted DNA; Hair; Leucocytes (leukocytes); Muscle; Oral fluid; Saliva; Skin fibroblasts; Tissues; Urine | Angelman syndrome; Cystic fibrosis; Familial Mediterranean fever; Fragile X; Galactosemia; Intellectual disability; Long chain 3-hydroxyacyl-coenzyme A dehydrogenase (LHCAD) deficiency; Marfan syndrome; Medium chain acyl-coenzyme A dehydrogenase (MCAD); Mendelian disorders; Mitochondrial disorders; Nucleic acid analysis for specific variants; Ornithine transcarbamylase deficiency; Prader-Willi syndrome; Rare undiagnosed disease; Rett syndrome; Tumour necrosis factor receptor associated periodic syndrome (TRAPS); Variants in the nuclear genome |
| Molecular genetics - Investigation of constitutional genetic variants - Diagnostic testing - Targeted panels for inherited (germline) DNA/RNA changes | Blood; Buccal swabs; Dried blood spots; Extracted DNA; Leucocytes (leukocytes); Oral fluid; Purified DNA; Saliva; Skin fibroblasts; Tissues | Angelman syndrome; Cystic fibrosis; Familial Mediterranean fever; Fragile X; Galactosemia; Intellectual disability; Long chain 3-hydroxyacyl-coenzyme A dehydrogenase (LHCAD) deficiency; Marfan syndrome; Mendelian disorders; Mitochondrial disorders; Nucleic acid analysis for unknown variants; Ophthalmic disease; Prader-Willi syndrome; Rare undiagnosed disease; Rett syndrome; Variants in the nuclear genome |
| Molecular genetics - Investigation of constitutional genetic variants - Diagnostic testing - Whole exome sequencing studies for inherited (germline) DNA/RNA changes | Blood; Buccal swabs; Dried blood spots; Extracted DNA; Leucocytes (leukocytes); Oral fluid; Purified DNA; Saliva; Skin fibroblasts; Tissues | Angelman syndrome; Cystic fibrosis; Familial Mediterranean fever; Galactosemia; Intellectual disability; Long chain 3-hydroxyacyl-coenzyme A dehydrogenase (LHCAD) deficiency; Marfan syndrome; Medium chain acyl-coenzyme A dehydrogenase (MCAD); Mendelian disorders; Mitochondrial disorders; Nucleic acid analysis for unknown variants; Ophthalmic disease; Prader-Willi syndrome; Rare undiagnosed disease; Rett syndrome; Variants in the nuclear genome |
| Molecular genetics - Mitochondrial investigation for heteroplasmy of constitutional genetic abnormalities - Diagnostic testing | Blood; Dried blood spots; Hair; Liver; Muscle; Saliva; Urine | Mitochondrial DNA analysis for specific or unknown variants |
| Molecular genetics - Mitochondrial investigation for heteroplasmy of constitutional genetic variants - Carrier testing | Blood; Dried blood spots; Hair; Liver; Muscle; Saliva; Urine | Mitochondrial DNA analysis for specific or known variants |
| Molecular genetics - Predictive genetic testing - Targeted genes | Amniotic fluid; Blood; Buccal swabs; Chorionic villus tissue; Dried blood spots; Formalin-fixed paraffin-embedded (FFPE) tissues; Hair; Nerve biopsy; Oral fluid; Purified DNA; Saliva; Tissues; Urinary sediment | Angelman syndrome; Cystic fibrosis; Fragile X; Galactosemia; Long chain 3-hydroxyacyl-coenzyme A dehydrogenase (LHCAD) deficiency; Marfan syndrome; Medium chain acyl-coenzyme A dehydrogenase (MCAD) deficiency; Mendelian disorders; Mitochondrial disorders; Ophthalmic disease; Prader-Willi syndrome; Rett syndrome; Tumour necrosis factor receptor associated periodic syndrome (TRAPS); Variants in the nuclear genome |
| Molecular genetics - Predictive genetic testing - Targeted panels for inherited (germline) DNA/RNA changes | Amniotic fluid; Blood; Buccal swabs; Chorionic villus; Dried blood spots; Hair; Nerve biopsy; Oral fluid; Purified DNA; Saliva; Tissues; Urinary sediment | Angelman syndrome; Cystic fibrosis; Fragile X; Galactosemia; Long chain 3-hydroxyacyl-coenzyme A dehydrogenase (LHCAD) deficiency; Marfan syndrome; Medium chain acyl-coenzyme A dehydrogenase (MCAD) deficiency; Mendelian disorders; Mitochondrial disorders; Nucleic acid analysis for specific variants; Ophthalmic disease; Prader-Willi syndrome; Rett syndrome; Variants in the nuclear genome |
| Molecular genetics - Prenatal genetic testing (excluding non-invasive prenatal [genetic] screening) | Amniotic fluid; Chorionic villus | Angelman syndrome; Cystic fibrosis; Galactosemia; Long chain 3-hydroxyacyl-coenzyme A dehydrogenase (LHCAD) deficiency; Marfan syndrome; Medium chain acyl-coenzyme A dehydrogenase (MCAD); Mitochondrial disorders; Ornithine transcarbamylase deficiency; Prader-Willi syndrome; Rett syndrome |
| Molecular genetics - Screening for an unknown mutation - Targeted genes | Blood; Bone marrow; Formalin-fixed paraffin-embedded (FFPE) tissues; Solid tumour tissue - Fresh/frozen; Tissues | Gene fusion - Solid Tumour |
| Gene fusion - Leukaemia | ||
| Blood; Buccal swabs; Dried blood spots; Tissues; Urinary sediment | Angelman syndrome; Cystic fibrosis; Dravet syndrome (severe myoclonic epilepsy in infancy); Familial Mediterranean fever; Fragile X; Galactosemia; Long chain 3-hydroxyacyl-coenzyme A dehydrogenase (LHCAD) deficiency; Marfan syndrome; Medium chain acyl-coenzyme A dehydrogenase (MCAD) deficiency; Mendelian disorders; Mitochondrial encephalomyopathy, lactic acidosis and stroke-like episodes (MELAS syndrome); Nucleic acid analysis for unknown variants; Ornithine transcarbamylase deficiency; Phenylalanine hydroxylase deficiency (PKU); Prader-Willi syndrome; Rare undiagnosed disease; Rett syndrome; Severe combined immunodeficiency disease (SCID); Uniparental disomy; Variants in the nuclear genome | |
| Fragile X | ||
| Molecular genetics - Screening for an unknown mutation - Targeted panels for inherited (germline) DNA/RNA changes | Blood; Bone marrow; Buccal swabs; Fresh tissue; Nerve biopsy; Urinary sediment | Angelman syndrome; Cystic fibrosis; Familial Mediterranean fever; Fragile X; Galactosemia; Long chain 3-hydroxyacyl-coenzyme A dehydrogenase (LHCAD) deficiency; Marfan syndrome; Medium chain acyl-coenzyme A dehydrogenase (MCAD) deficiency; Mitochondrial disorders; Nucleic acid analysis for unknown variants; Prader-Willi syndrome; Rett syndrome |
| Molecular genetics - Screening for an unknown mutation - Whole exome sequencing studies for inherited (germline) DNA/RNA changes | Blood; Buccal swabs; Extracted DNA; Formalin-fixed paraffin-embedded (FFPE) tissues; Hair; Nerve biopsy; Oral fluid; Urinary sediment | Angelman syndrome; Cystic fibrosis; Familial Mediterranean fever; Galactosemia; Intellectual disability; Long chain 3-hydroxyacyl coenzyme A dehydrogenase (LHCAD); Marfan syndrome; Medium chain acyl-coenzyme A dehydrogenase (MCAD); Mendelian disorders; Mitochondrial disorders; Nucleic acid analysis for unknown variants; Ophthalmic disease; Prader-Willi syndrome; Rare undiagnosed disease; Rett syndrome; Severe combined immunodeficiency disease (SCID); Variants in the nuclear genome |
| 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 |
Newborn Screening
ISO 15189 (2012)
Human Pathology
Medicare expiry date
14 Dec 2024
Last Activity Date
16 Sep 2021
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Newborn screening services for the diagnosis of inborn errors of metabolism | Blood; Dried blood spots | Acylcarnitine profile; Amino acids; Steroid profile |
| 17-Hydroxyprogesterone; Creatine kinase; Gal-1-p-uridyl transferase; Galactose; Galactose-1-phosphate; Thyroid stimulating hormone (TSH); Thyroxine (T4) - Total | ||
| 2-Aminoadipic semi-aldehyde; Adenine phosphoribosyl transferase; Amino acids; Carbamoyl-phosphate synthetase; Carnitine palmitoyl transferase I; Carnitine palmitoyl transferase II; Carnitine uptake; Carnitines; Citrulline; Cysteine; Cystine; Free fatty acids - Total; Glutarate; Glycosaminoglycans (MPS); Homocysteine; Homocysteine - Total; Hydroxyproline; Hypoxanthine/guanine phosphoribosyl transferase; Iduronate-2-sulfatase; Immunoreactive trypsin; Leucine; Leucine decarboxylation; Long chain 3-hydroxyacyl coenzyme A dehydrogenase (LHCAD); Lysosomal profile; Malonic acid; Methionine; Methylmalonic acid (MMA); Mucopolysaccharides (MPS); Neuraminidase; Oligosaccharides; Ornithine; Palmitoyl protein thioesterase; Peroxisomal enzymes; Phosphoethanolamine; Phosphomannnoisomerase; Phosphomannomutase; Phytanic acid oxidase; Short chain 3-hydroxyacyl coenzyme A dehydrogenase (SCHAD); Sphingomyelinase; Succinylacetone; Sulfamidase; Sulfatase - Total; Tripeptidyl peptidase; Tyrosine; Very long chain acyl-coenzyme A dehydrogenase (vLCAD); Very long chain fatty acids (vLCFA); n-Acetyl-β-glucosaminidase; n-Acetylaspartic acid (NAA); n-Acetylgalactosamine-4-sulfatase; n-Acetylglucosamine-6-sulfatase; s-Sulfocysteine; α-Fucosidase; α-Galactosidase A; α-Glucosidase; α-Iduronidase; α-Mannosidase; α-n-Acetylgalactosaminidase; α-n-Acetylglucosaminidase; β-Galactocerebrosidase; β-Galactosidase; β-Glucocerebrosidase; β-Glucuronidase; β-Hexosamindase - Total; β-Hexosamindase A (MUGS) | ||
| Molecular genetics - Screening for an unknown mutation - Targeted genes | Dried blood spots | Severe combined immunodeficiency disease (SCID); Spinal muscular atrophy |
| Cystic fibrosis; Galactosemia; Medium chain acyl-coenzyme A dehydrogenase (MCAD) deficiency |
Paediatric Intensive Care Unit (PICU)
ISO 15189 (2022)
Human Pathology
Medicare expiry date
14 Dec 2024
Last Activity Date
16 Sep 2021
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Quantitation of blood gases and other measurements (performed on the same specimen) | Blood | Bilirubin - Total; 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 |
| Bilirubin - Total; 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 |
Theatre 5
ISO 15189 (2022)
Human Pathology
Medicare expiry date
14 Dec 2024
Last Activity Date
16 Sep 2021
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Quantitation of blood gases and other measurements (performed on the same specimen) | Blood | Bilirubin - Total; 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 |
Turner Ward
ISO 15189 (2022)
Human Pathology
Medicare expiry date
14 Dec 2024
Last Activity Date
16 Sep 2021
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Quantitation of blood gases and other measurements (performed on the same specimen) | Blood | Bilirubin - Total; 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 |
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.
2254
Site No.
2247
Print date
26 Apr 2024
END OF SCOPE
