National Association of Testing Authorities, Australia
Scope of Accreditation
Southern.IML Pathology
Sonic Healthcare Pty Ltd
Site
Wollongong Laboratory
Accreditation No.
2760
Site No.
2753
Date of Accreditation
17 Nov 1989
Contact
Availability
Services available to external clients
Supervision
GX (General)
Scope of Accreditation
Wollongong Laboratory
ISO 15189 (2022)
- This facility complies with the relevant National Pathology Accreditation Advisory Council (NPAAC) requirements.
Human Pathology
Medicare expiry date
01 Sep 2027
Last Activity Date
30 Mar 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 | Other body fluids; Sputum; Urine; Washings or brushings from other sites | Cytological examination; Review and reporting of cytology samples |
| 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 | Nipple discharge | Cytological examination; Review and reporting of cytology samples |
| 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 |
| 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 |
| Review and reporting of biopsy material to identify or exclude morphological abnormalities | ||
| 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 |
| Chemical pathology - Detection and/or quantitation of drugs for therapeutic monitoring | Plasma; Serum | Carbamazepine |
| Digoxin; Lithium; Phenytoin (dilantin); Valproate (valproic acid, epilim) | ||
| Chemical pathology - Detection and/or quantitation of tumour markers | Fine needle aspirates (FNA); Tissue aspirate | ThyroglobulinQualitative testing only |
| Plasma; Serum | CA125 antigen (CA125); CA15-3 antigen (CA15-3); CA19-9 antigen (CA19-9); Human chorionic gonadotropin (hCG); Thyroglobulin | |
| Carcinoembryonic antigen (CEA); Prostate specific antigen (PSA); α-Fetoprotein (AFP) | ||
| Serum | β2-Microglobulin (B2M) | |
| Chemical pathology - Determination of hormones and hormone binding proteins (other than thyroid function tests) | Fine needle aspirates (FNA); Tissue aspirate | Parathyroid hormone (PTH)Qualitative testing only |
| Plasma; Serum | Adrenocorticotropic hormone (ACTH); C-peptide; Cortisol; Dehydroepiandrosterone sulfate (DHEAS) | |
| Follicle stimulating hormone (FSH); Insulin; Luteinising hormone (LH); Oestradiol; Parathyroid hormone (PTH); Progesterone; Prolactin; Sex hormone binding globulin (SHBG); Testosterone | ||
| Chemical pathology - Diagnosis and management of diabetes mellitus | Blood | Glycated haemoglobin (HbA1c) |
| Plasma; Serum | Fructosamine | |
| Chemical pathology - Further investigation of cardiac function | Serum | Troponin T |
| Troponin I | ||
| Chemical pathology - Further investigation of lipid profiles for diagnosis of types III and IV hyperlipidaemia | Plasma; Serum | HDL - Quantitation |
| Chemical pathology - Further investigation of renal and/or hepatic function | Serum | α1-Antitrypsin |
| Chemical pathology - Haem related pigments and precursors (excluding porphyria) | Serum | Haptoglobins |
| Chemical pathology - Investigation and determination of hepatic, cardiac, bone, skeletal muscle and other profiles and metabolic studies | Plasma; Serum | Alanine aminotransferase; Albumin; Alkaline phosphatase; Amylase; Aspartate aminotransferase; Bicarbonate; Bilirubin - Any fractions; Bilirubin - Total; C-reactive protein (CRP); Calcium - Total; Chloride; Cholesterol - Total; Creatine kinase; Creatinine; Glucose; Lactate dehydrogenase (LDH); Lipase; Magnesium; Microalbumin; Phosphate; Potassium; Protein - Total; Sodium; Triglycerides; Urate; Urea; γ-Glutamyltransferase |
| Urine | Albumin; Calcium - Total; Chloride; Creatinine; Glucose; Magnesium; Phosphate; Potassium; Protein - Total; Sodium; Urea; Uric acid | |
| Chemical pathology - Investigation for folate deficiency | 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 | Calcium - Ionised; Lactate; Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); pH |
| Chemical pathology - Quantitation of vitamin B markers | Serum | Holotranscobalamin (active vitamin B12) |
| Chemical pathology - Quantitation of vitamins | Plasma; Serum | Vitamin D |
| Serum | Cobalamin (vitamin B12) | |
| Chemical pathology - Tests for thyroid function | Plasma; Serum | Thyroid stimulating hormone (TSH); Thyroxine (T4) - Free; Triiodothyronine (T3) - Free |
| Haematology - Bone marrow examination | Bone marrow | Examination of aspirated material |
| Haematology - Examination of blood films by special staining | Blood | Malaria |
| Haematology - Full blood examination | Blood | Differential number; Morphology |
| Differential number; Erythrocyte count (red blood cell count, RBCC); Haematocrit (packed cell volume, PCV); Haemoglobin (Hb); Leucocyte count (white blood cell count, WBCC); Platelet count; Red blood cell index or indices; Reticulocytes | ||
| Haematology - Haemostasis related analysis (including special coagulation testing and platelet function tests) | Blood | Platelet function (PFA) |
| Plasma | Activated partial thromboplastin time (APTT); D-dimer; Fibrinogen; International normalised ratio (INR); Thrombin time (TT) | |
| Haematology - Limited blood examination | Blood | Erythrocyte (RBC) sedimentation rate (ESR) |
| Immunopathology - Detection and/or quantitation and/or characterisation of autoantibodies | Serum | Rheumatoid factor |
| Anti-cyclic citrullinated peptide antibodies (CCP); Anti-thyroglobulin antibodies (Tg); Anti-thyroid peroxidase antibodies (TPO) | ||
| Immunopathology - Quantitation of complement proteins | Serum | Complement components C3 and C4 |
| Immunopathology - Quantitative and/or qualitative investigation of proteins | Serum; Urine | Protein classes |
| Immunopathology - Quantitative investigations of immunoglobulins and immunoglobulins subclasses | Serum | Total immunoglobulin E |
| 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 | Plasma; Serum | Human chorionic gonadotropin (hCG) - Quantitative total |
| Infertility and pregnancy tests including assisted reproductive technology - Semen analysis (other than post vasectomy) | Semen | Vitality |
| pH | ||
| Volume | ||
| Agglutination; Morphology; Motility; Sperm number | ||
| Liquefaction; Viscosity | ||
| Infertility and pregnancy tests including assisted reproductive technology - Semen analysis for post vasectomy and/or examination of cervical mucus | Semen | Presence of spermatozoa |
| Microbiology - Bacteriology - Detection of pathogenic bacteria | Biopsy specimens; Blood; Cerebrospinal fluid (CSF); Faeces; Fluids; General swabs; Genital swabs; Sputum; Urine | Bacteria; Pathogenic microorganisms |
| Blood | Bacteria; Pathogenic microorganisms | |
| Blood; Cerebrospinal fluid (CSF); Faeces; Fluids; General swabs; Genital swabs; Sputum; Urine | Bacteria; Pathogenic identification and antibiotic susceptibility | |
| Bacteria; Pathogenic identification and antibiotic susceptibility | ||
| Blood; Cerebrospinal fluid (CSF); Fluids; General swabs; Genital swabs; Sputum; Urine | Bacteria; Crystals; Epithelial cells; Erythrocytes (red blood cells, RBC); Leucocytes (white blood cells, WBC) | |
| Faeces | Clostridioides difficile toxin | |
| Urine | Bilirubin; Blood; Glucose; Ketones; Proteins; Urobilinogen; pH | |
| Casts; Crystals; Epithelial cells; Erythrocytes (red blood cells, RBC); Leucocytes (white blood cells, WBC) | ||
| Bilirubin; Blood; Glucose; Ketones; Proteins; Urobilinogen; pH | ||
| Microbiology - Environmental investigations and/or infection control | Gastrointestinal endoscopes | Bacterial growth - Sterility |
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (bacteria) | Bacterial isolates | Van A/B |
| Cervical swabs; Eye swabs; Genital swabs; Rectal swabs; Throat swabs; Urethral swabs; Urine; Vaginal swabs | Chlamydia trachomatis; Neisseria gonorrhoeae | |
| Faeces | Clostridioides difficile | |
| Aeromonas spp.; Campylobacter spp.; Clostridioides difficile toxin; Salmonella spp.; Shigella spp.; Vibrio spp.; Yersinia enterocolitica | ||
| Mouth swabs; Nasal swabs; Nasopharyngeal and throat swab; Nasopharyngeal swabs; Throat swabs | Bordetella parapertussis; Bordetella pertussis | |
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (protozoan parasites) | Blood | Plasmodium falciparum; Plasmodium knowlesi; Plasmodium malariae; Plasmodium ovale curtisi; Plasmodium ovale wallikeri; Plasmodium vivax |
| Faeces | Blastocystis hominis; Cryptosporidium spp.; Cyclospora cayetanensis; Dientamoeba fragilis; Entamoeba histolytica; Giardia lamblia | |
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (viruses) | Nasal swabs; Nasopharyngeal and throat swab; Nasopharyngeal swabs; Throat swabs | Adenovirus; Human metapneumovirus; Influenza A virus; Influenza B virus; Parainfluenza virus type 1/2/3/4; Respiratory syncytial virus (RSV); Rhinovirus |
| Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) | ||
| Nasal swabs; Nasopharyngeal swabs | 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 swabs | Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) | |
| Microbiology - Mycology - Detection, isolation and/or identification of yeasts and/or fungal elements | Nails; Skin scrapings; Sputum; Tissues | Fungi identification; Yeasts identification |
| Fungi identification; Yeasts identification | ||
| Microbiology - Serology of infection - Microbial antibody and/or antigen detection and/or quantitation | Blood | Infectious mononucleosis |
| Plasma; Serum | 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 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 (HCV); Human immunodeficiency virus (HIV); Rubella IgG antibody; Syphilis Treponema pallidum antibody | |
| Hepatitis C virus (HCV) | ||
| Cytomegalovirus antibody (anti-CMV) IgG; Cytomegalovirus antibody (anti-CMV) IgM; Epstein-Barr virus nuclear antigen IgG antibody; Epstein-Barr virus viral capsid antigen IgG antibody; Epstein-Barr virus viral capsid antigen IgM antibody; Herpes simplex virus type 2 antibody (anti-HSV2) - IgG; Herpes simplex type 1 antibody (anti-HSV1) - IgG; Measles IgG antibody; Mumps virus IgG antibody; Mycoplasma pneumoniae; Parvovirus B19 IgG antibody; Parvovirus B19 IgM antibody; Varicella zoster virus (VZV) IgG antibody | ||
| Microbiology - Virology - Detection of pathogenic viruses | Faeces | Adenovirus; Norovirus; Rotavirus |
ISO 15189 (2022)
- This facility complies with the relevant National Pathology Accreditation Advisory Council (NPAAC) requirements.
Legal
Medicare expiry date
01 Sep 2027
Last Activity Date
30 Mar 2023
| Service | Product | Determinant |
|---|---|---|
| Medico legal drug testing AS/NZS 4308:2008, section 2 Specimen collection, storage, handling and dispatch | Urine | Colour; Creatinine; Temperature; 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.
2760
Site No.
2753
Print date
26 Apr 2024
END OF SCOPE
