National Association of Testing Authorities, Australia
Scope of Accreditation
NSW Health Pathology
Site
NSW Health Pathology Wollongong Hospital Laboratory
Accreditation No.
2810
Site No.
2803
Date of Accreditation
05 Feb 1990
Contact
Mrs Ivy Fong P: +61 (02) 93823202
Availability
Services available to external clients
Supervision
GY (General)
Scope of Accreditation
Anatomical Pathology
ISO 15189 (2022)
Human Pathology
Medicare expiry date
11 Nov 2026
Last Activity Date
18 Sep 2023
| Service | Product | Determinant |
|---|---|---|
| Anatomical pathology - Cytopathology - Non-gynaecological cytological investigations of body fluids, exudates, washings and brushings from non-squamous mucosal sites for the detection of malignancy | Cerebrospinal fluid (CSF); Other body fluids; Sputum; Tumour tissue; Urine; Washings or brushings from other sites | Cytological examination; Review and reporting of cytology samples |
| Anatomical pathology - Cytopathology - Non-gynaecological cytological investigations on samples obtained via fine needle aspiration biopsy | Fine needle aspirates (FNA) | Cytological examination; Rapid onsite evaluation (ROSE); Review and reporting of fine needle aspiration samples |
| Anatomical pathology - 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 - Immediate frozen section diagnosis | Fresh tissue; Sentinel node; Smears; Tissue imprint | Intra-operative consultation and examination of biopsy material |
| Anatomical pathology - Tissue pathology - Immunohistochemical investigation | Formalin-fixed paraffin-embedded (FFPE) tissues; Fresh tissue; Frozen sections of fresh tissue | Detection of antigenic targets - Various |
Chemistry
ISO 15189 (2022)
Human Pathology
Medicare expiry date
11 Nov 2026
Last Activity Date
18 Sep 2023
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Analysis of drugs for toxicological (non-legal) purposes and ingested or absorbed toxic chemicals | Plasma; Serum | Ethanol |
| Urine | Amphetamines; Barbiturates; Benzodiazepines; Cannabis; Cocaine; Opiates | |
| Chemical pathology - Detection and/or quantitation of drugs for therapeutic monitoring | Blood | Cyclosporin; Tacrolimus |
| Plasma; Serum | Carbamazepine; Digoxin; Gentamicin (cidomycin, septopal, genticyn, garamycin); Lithium; Paracetamol (acetaminophen); Phenytoin (dilantin); Salicylate; Valproate (valproic acid, epilim); Vancomycin | |
| Chemical pathology - Detection and/or quantitation of tumour markers | Serum | Human chorionic gonadotropin (hCG) |
| Chemical pathology - Determination of hormones and hormone binding proteins (other than thyroid function tests) | Plasma | Parathyroid hormone (PTH) |
| Plasma; Serum | Cortisol; Procalcitonin | |
| 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 | Troponin T |
| Serum | N-Terminal-pro b-type natriuretic peptide (NT-proBNP) | |
| Chemical pathology - Further investigation of lipid profiles for diagnosis of types III and IV hyperlipidaemia | Plasma; Serum | HDL - Quantitation |
| Chemical pathology - Further investigation of renal and/or hepatic function | Plasma; Serum | Haptoglobins |
| Chemical pathology - Haem related pigments and precursors (excluding porphyria) | Cerebrospinal fluid (CSF) | Xanthochromia |
| Chemical pathology - Investigation and determination of hepatic, cardiac, bone, skeletal muscle and other profiles and metabolic studies | Ascitic fluid | Albumin; Cholesterol - LDL; Glucose; Lactate dehydrogenase (LDH); Protein - Total; Triglycerides |
| Cerebrospinal fluid (CSF) | Glucose; Protein - Total | |
| Drainage fluid | Albumin; Cholesterol - LDL; Creatinine; Glucose; Lactate dehydrogenase (LDH); Protein - Total; Triglycerides | |
| Plasma | Ammonia | |
| Plasma; Serum | Alanine aminotransferase; Albumin; Alkaline phosphatase; Aspartate aminotransferase; Bicarbonate; Bilirubin - Any fractions; Bilirubin - Total; C-reactive protein (CRP); Chloride; Cholesterol - LDL; Cholesterol - Total; Creatine kinase; Creatinine; Glucose; Lipase; Potassium; Protein - Total; Sodium; Triglycerides; Urate; Urea; γ-Glutamyltransferase | |
| Plasma; Serum; Urine | Osmolality | |
| Albumin; Calcium - Total; Chloride; Creatinine; Glucose; Magnesium; Phosphate; Potassium; Protein - Total; Sodium; Urate | ||
| Pleural fluid | Albumin; Amylase; Cholesterol - LDL; Glucose; Lactate dehydrogenase (LDH); Lipase; Protein - Total; Triglycerides; Urate | |
| Serum | Amylase; Lactate dehydrogenase (LDH) | |
| Chemical pathology - Investigation for folate deficiency | Plasma; Serum | Folate |
| Chemical pathology - Iron studies | Serum | Ferritin; Iron; Transferrin |
| Chemical pathology - Quantitation of blood gases and other measurements (performed on the same specimen) | Blood | Anion gap; Base excess; Bicarbonate; Calcium - Ionised; Carboxyhaemoglobin; Chloride; Creatinine; Glucose; Haemoglobin (Hb); Lactate; Methaemoglobin (MetHb); Oxygen saturation (sO2); Oxyhaemoglobin; Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); Potassium; Reduced haemoglobin; Sodium; pH |
| Chemical pathology - Quantitation of vitamin B markers | Serum | Holotranscobalamin (active vitamin B12) |
| Chemical pathology - Quantitation of vitamins | Plasma; Serum | Cobalamin (vitamin B12) |
| Serum | 25-Hydroxyvitamin D | |
| Chemical pathology - Tests for thyroid function | Serum | Thyroid stimulating hormone (TSH); Thyroxine (T4) - Free; Triiodothyronine (T3) - Free |
| Immunopathology - Detection and/or quantitation and/or characterisation of autoantibodies | Serum | Rheumatoid factor |
| Immunopathology - Quantitative and/or qualitative investigation of proteins | Plasma | Cryofibrinogen |
| Serum | Cryoglobulins | |
| Serum; Urine | Albumin; Characterisation of paraproteins; Detection and amount of paraproteins; Protein classes; α1-Globulin; α2-Globulin; β-Globulin; γ-Globulin | |
| Immunopathology - Quantitative investigations of immunoglobulins and immunoglobulins subclasses | Serum | Total immunoglobulin A; Total immunoglobulin G; Total immunoglobulin M |
| Infertility and pregnancy tests including assisted reproductive technology - Diagnosis or follow up of threatened abortion and/or diagnosis of ectopic pregnancy | Serum | Human chorionic gonadotropin (hCG) - Quantitative total |
Diabetic Clinic
ISO 15189 (2022)
Human Pathology
Medicare expiry date
11 Nov 2026
Last Activity Date
18 Sep 2023
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Diagnosis and management of diabetes mellitus | Blood | Glycated haemoglobin (HbA1c) |
Emergency Department
ISO 15189 (2022)
Human Pathology
Medicare expiry date
11 Nov 2026
Last Activity Date
18 Sep 2023
| 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; Creatinine; Glucose; Haemoglobin (Hb); Lactate; Methaemoglobin (MetHb); Oxygen saturation (sO2); Oxyhaemoglobin; Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); Potassium; Reduced haemoglobin; Sodium; pH |
Haematology
ISO 15189 (2022)
Human Pathology
Medicare expiry date
11 Nov 2026
Last Activity Date
18 Sep 2023
| 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 - Examination of blood films by special staining | Blood | Malaria |
| Iron | ||
| Haematology - Foetal haemoglobin in maternal circulation | Blood | Presence of foetal red blood cells |
| Haematology - Full blood examination | Blood | Morphology |
| Differential number; Erythrocyte count (red blood cell count, RBCC); Haematocrit (packed cell volume, PCV); Haemoglobin (Hb); Leucocyte count (white blood cell count, WBCC); 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 | Activated partial thromboplastin time (APTT); Anti-Xa - Apixaban; Anti-Xa - Dabigatran; Anti-Xa - Rivaroxaban; Anti-Xa activity; Anti-thrombin III; D-dimer; Factor IX; Factor VIII; Fibrinogen; International normalised ratio (INR); Protein C and protein S; Prothrombin time (PT); Thrombin time (TT) |
| Platelet function (PFA) | ||
| Kaolin clotting time; Lupus anticoagulant | ||
| Haematology - Investigation of haemolysis | Urine | Haemosiderin |
| Haematology - Limited blood examination | Blood | Erythrocyte (RBC) sedimentation rate (ESR) |
| Immunopathology - Characterisation of leucocyte surface antigens (including immunophenotyping) | Aspirates; Blood; Bone marrow | CD10; CD11c; CD13; CD14; CD15; CD16; CD19; CD1a; CD2; CD20; CD200; CD22; CD23; CD25; CD3; CD30; CD38; CD4; CD45; CD5; CD56; CD57; CD7; CD8; Kappa light chains; Lambda light chains; Myeloperoxidase; Terminal deoxynucleotidyl transferase (TdT) |
| Blood | CD16; CD19; CD3; CD34; CD4; CD8 | |
| Immunopathology - Detection and/or quantitation and/or characterisation of autoantibodies | Serum | Anti-cardiolipin antibodies (ACA) |
| Microbiology - Parasitology - Detection of ova, cysts and parasites | Blood | Malaria |
| Microbiology - Serology of infection - Microbial antibody and/or antigen detection and/or quantitation | Blood; Plasma | Infectious mononucleosis |
Intensive Care Unit
ISO 15189 (2022)
Human Pathology
Medicare expiry date
11 Nov 2026
Last Activity Date
18 Sep 2023
| 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; Creatinine; Glucose; Haemoglobin (Hb); Lactate; Methaemoglobin (MetHb); Oxygen saturation (sO2); Oxyhaemoglobin; Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); Potassium; Reduced haemoglobin; Sodium; pH |
Microbiology
ISO 15189 (2022)
Human Pathology
Medicare expiry date
11 Nov 2026
Last Activity Date
18 Sep 2023
| Service | Product | Determinant |
|---|---|---|
| Microbiology - Bacteriology - Detection of pathogenic bacteria | Bacterial isolates | Pathogenic identification and antibiotic susceptibility |
| Blood | Pathogenic microorganisms | |
| Blood; Cerebrospinal fluid (CSF); Faeces; Fluids; Respiratory specimens; Tissues; Urine; Wound swabs | Pathogenic identification | |
| Ear swabs; Faeces; Fluids; Genital swabs; Nasal swabs; Nasopharyngeal swabs; Pus; Respiratory specimens; Sputum; Superficial sites; Throat swabs; Tissues; Urine; Wound swabs | Streptococcus group B screening; Bacteria; Cultured pathogens identification; Pathogenic microorganisms | |
| Faeces | Clostridioides difficile toxin | |
| Urine | Streptococcus pneumoniae antigen | |
| Bacteria; Casts; Epithelial cells; Erythrocytes (red blood cells, RBC); Leucocytes (white blood cells, WBC) | ||
| Legionella antigen | ||
| Microbiology - Bacteriology - Detection of pathogenic bacteria for epidemiological infection control surveillance | Axilla swabs; Cervical swabs; Faeces; Groin swabs; Nasal swabs; Perianal swabs; Rectal swabs; Throat swabs; Urine; Vaginal swabs; Wounds | Streptococcus group B; Carbapenem resistant Enterobacteriaceae (CRE); Extended spectrum beta-lactamases (ESBL); Methicillin resistant Staphylococcus aureus (MRSA); Vancomycin resistant Enterococci (VRE) |
| Microbiology - Environmental investigations and/or infection control (Clinical non-human testing) | Blood transfusion bags; Environmental swabs; Gastrointestinal endoscopes; Vascular catheter tips | Bacterial growth - Sterility; Bacterial organism identification - Methicillin-resistant Staphylococcus aureus (MRSA); Bacterial organism identification - Vancomycin-resistant Enterococcus (VRE) |
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (bacteria) | Faeces | Clostridioides difficile |
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (viruses) | Cerebrospinal fluid (CSF) | Enterovirus |
| Faeces | Norovirus | |
| Microbiology - Mycobacteriology - Detection and identification of mycobacteria | Blood; Other body fluids; Respiratory specimens; Tissues | Mycobacteria detection |
| Microbiology - Mycobacteriology - Tests for antigen lymphocyte stimulation | Blood | Mycobacterial antigen lymphocyte stimulation |
| Microbiology - Mycology - Detection, isolation and/or identification of yeasts and/or fungal elements | Aspirates; Cerebrospinal fluid (CSF); Hair; Nails; Skin scrapings; Sputum | Fungi identification; Yeasts identification |
| Cerebrospinal fluid (CSF); Serum | Cryptococcus antigen | |
| Isolates | Yeast susceptibility | |
| Microbiology - Parasitology - Detection of ova, cysts and parasites | Faeces | Cryptosporidia; Giardia spp. |
| Parasites | ||
| Microbiology - Serology of infection - Microbial antibody and/or antigen detection and/or quantitation | Plasma; Serum | Hepatitis B virus surface antibody (anti-HBs); Hepatitis B virus surface antigen (HBs Ag); Hepatitis C virus antibody (anti-HCV); Human immunodeficiency virus type 1/2 (HIV-1/2) 1/2 antibodies; Human immunodeficiency virus type 1/2 (HIV-1/2) antigen |
| Measles IgG antibody; Mumps virus IgG antibody; Varicella zoster virus (VZV) IgG antibody | ||
| Serum | Dengue virus |
Operating Theatre
ISO 15189 (2022)
Human Pathology
Medicare expiry date
11 Nov 2026
Last Activity Date
18 Sep 2023
| 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; Haemoglobin (Hb); Lactate; Methaemoglobin (MetHb); Oxygen saturation (sO2); Oxyhaemoglobin; Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); Potassium; Reduced haemoglobin; Sodium; pH |
Special Care Nursery
ISO 15189 (2022)
Human Pathology
Medicare expiry date
11 Nov 2026
Last Activity Date
18 Sep 2023
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Quantitation of blood gases and other measurements (performed on the same specimen) | Blood | Bilirubin - Total; Calcium - Ionised; Carboxyhaemoglobin; Chloride; Deoxyhaemoglobin (HHb); Glucose; Haematocrit (packed cell volume, PCV); Haemoglobin (Hb); Lactate; Methaemoglobin (MetHb); Oxyhaemoglobin; Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); Potassium; Sodium; pH |
Transfusion
ISO 15189 (2022)
Human Pathology
Medicare expiry date
11 Nov 2026
Last Activity Date
18 Sep 2023
| Service | Product | Determinant |
|---|---|---|
| Haematology - Investigation of haemolysis | Blood; Serum | Cold agglutinins |
| Immunohaematology - Blood group antibody detection | Blood; Plasma | Duffy system; Kell system; M and N factors; Other blood group systems; Rh phenotypes |
| Immunohaematology - Blood grouping | Blood; Plasma | ABO; RhD |
| Immunohaematology - Determination of compatibility of blood donor units | Blood; Plasma | Direct antiglobulin test (DAT, direct Coombs test); 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 |
| Red blood cell phenotyping | ||
| Direct antiglobulin test (DAT, direct Coombs test) | ||
| Antibody elution | ||
| Blood; Plasma | Antibody titration | |
| Antibody absorption | ||
| Other blood group antibodies; Rh | ||
| Immunohaematology - Investigation of blood transfusion reactions | Blood; Blood products; Plasma | Antibodies; Contamination - Microbiological |
| Immunohaematology - Issue and release of blood and blood product for transfusion | Blood; Blood products; Cryoprecipitate; Fresh frozen plasma (FFP); Platelets | Issue and release of blood and blood products for transfusion |
| Immunohaematology - Storage and distribution of blood and blood components | Blood; Blood products; Cryoprecipitate; Fresh frozen plasma (FFP); Platelets | Issue and release of blood and blood products for transfusion |
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.
2810
Site No.
2803
Print date
24 Nov 2024
END OF SCOPE