National Association of Testing Authorities, Australia
Scope of Accreditation
Clinpath Pathology
Sonic Healthcare Pty Ltd
Site
Mile End Laboratory
Accreditation No.
3307
Site No.
3300
Date of Accreditation
23 Dec 1991
Contact
Mr Kiet Quach
P: +61 (08) 83662000
Availability
Services available to external clients
Supervision
GX (General)
Scope of Accreditation
Anatomical Pathology
ISO 15189 (2022)
Human Pathology
Medicare expiry date
30 Sep 2027
Last Activity Date
31 Oct 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; Rapid onsite evaluation (ROSE); 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 |
| Anatomical pathology - Tissue pathology - Gene probes using paraffin in-situ hybridisation techniques (chromogenic/silver) | Formalin-fixed paraffin-embedded (FFPE) tissues | Detection of nucleic acid targets - Various |
| Anatomical pathology - Tissue pathology - Immediate frozen section diagnosis | Fresh tissue | Intra-operative consultation and examination of biopsy material |
| Anatomical pathology - Tissue pathology - Immunohistochemical (immunofluorescence) investigation | Fresh tissue; Frozen tissue | Detection of antigenic targets - Various |
| Anatomical pathology - Tissue pathology - Immunohistochemical investigation | Formalin-fixed paraffin-embedded (FFPE) tissues | Detection of antigenic targets - Various |
Chemical Pathology
ISO 15189 (2022)
Human Pathology
Medicare expiry date
30 Sep 2027
Last Activity Date
31 Oct 2023
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Detection and/or quantitation of tumour markers | Plasma; Serum | CA125 antigen (CA125); CA15-3 antigen (CA15-3); Carcinoembryonic antigen (CEA); Prostate specific antigen (PSA); Prostate specific antigen (PSA) - Free |
| Chemical pathology - Determination of hormones and hormone binding proteins (other than thyroid function tests) | Plasma; Serum | Cortisol; Follicle stimulating hormone (FSH); Insulin; Luteinising hormone (LH); Oestradiol; Parathyroid hormone (PTH); Progesterone; Prolactin; Sex hormone binding globulin (SHBG); Testosterone - Free; Testosterone - Total |
| Serum | Dehydroepiandrosterone sulfate (DHEAS) | |
| Urine | Cortisol | |
| Chemical pathology - Diagnosis and management of diabetes mellitus | Blood | Glycated haemoglobin (HbA1c) |
| Chemical pathology - Further investigation of cardiac function | Plasma; Serum | Troponin I |
| Chemical pathology - Further investigation of lipid profiles for diagnosis of types III and IV hyperlipidaemia | Plasma; Serum | HDL - Quantitation |
| Chemical pathology - Investigation and determination of hepatic, cardiac, bone, skeletal muscle and other profiles and metabolic studies | Cerebrospinal fluid (CSF) | Glucose; Protein - Total |
| Other body fluids; Urine | pH | |
| Plasma; Serum | Alanine aminotransferase; Albumin; Alkaline phosphatase; Amylase; Aspartate aminotransferase; Bicarbonate; Bilirubin - Total; C-reactive protein (CRP); Calcium - Total; Chloride; Cholesterol - Total; Creatine kinase; Creatinine; Glucose; Lactate dehydrogenase (LDH); Magnesium; Phosphate; Potassium; Protein - Total; Sodium; Triglycerides; Urate; Urea; γ-Glutamyltransferase | |
| Urine | Albumin; Calcium - Total; Chloride; Creatinine; Magnesium; Microalbumin; Phosphate; Potassium; Protein - Total; Sodium; Urate | |
| Chemical pathology - Investigation for folate deficiency | Serum | Folate |
| Chemical pathology - Iron studies | Plasma; Serum | Iron; Transferrin |
| Ferritin | ||
| Chemical pathology - Quantitation of vitamin B markers | Plasma; Serum | Holotranscobalamin (active vitamin B12) |
| Chemical pathology - Quantitation of vitamins | Plasma; Serum | Cobalamin (vitamin B12) |
| Vitamin D | ||
| Chemical pathology - Tests for thyroid function | Plasma; Serum | Thyroid stimulating hormone (TSH); Thyroxine (T4) - Free; Triiodothyronine (T3) - Free |
| Immunopathology - Detection and/or quantitation and/or characterisation of autoantibodies | Plasma; Serum | Rheumatoid factor |
| Anti-cyclic citrullinated peptide antibodies (CCP) | ||
| Serum | Anti-gliadin antibodies (AGA); Anti-tissue transglutaminase antibodies (tTG) | |
| Immunopathology - Quantitation of complement proteins | Serum | Complement components C3 and C4 |
| Immunopathology - Quantitative and/or qualitative investigation of proteins | Faeces | Calprotectin |
| 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 of pregnancy | Plasma; Serum | Human chorionic gonadotropin (hCG) |
| Infertility and pregnancy tests including assisted reproductive technology - Diagnosis or follow up of threatened abortion and/or diagnosis of ectopic pregnancy | Plasma; Serum | Human chorionic gonadotropin (hCG) - Quantitative total |
ISO 15189 (2022)
Legal
Medicare expiry date
30 Sep 2027
Last Activity Date
31 Oct 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 |
Haematology
ISO 15189 (2022)
Human Pathology
Medicare expiry date
30 Sep 2027
Last Activity Date
31 Oct 2023
| Service | Product | Determinant |
|---|---|---|
| Haematology - Bone marrow examination | Bone marrow | Examination of aspirated material |
| Haematology - Diagnosis of thalassemia | Blood | Haemoglobin A2 (HbA2) - Quantitation; Haemoglobin F (HbF) - Quantitation |
| Haematology - Examination of blood films by special staining | Blood | Malaria |
| Heinz bodies | ||
| Haematology - Full blood examination | Blood | Haemoglobin H (HbH) inclusions; 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); Prothrombin time (PT) | |
| Haematology - Limited blood examination | Blood | Erythrocyte (RBC) sedimentation rate (ESR) |
| Immunopathology - Characterisation of leucocyte surface antigens (including immunophenotyping) | Blood; Cerebrospinal fluid (CSF); Disaggregated tissues specimen; Lavage | Assessment of lymphoid cell populations; Lymphocyte surface markers; Paroxysmal nocturnal haemoglobinuria (PNH) surface markers |
| Microbiology - Parasitology - Detection of ova, cysts and parasites | Blood | Malaria |
Microbiology
ISO 15189 (2022)
Human Pathology
Medicare expiry date
30 Sep 2027
Last Activity Date
31 Oct 2023
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Investigation of Helicobacter pylori colonisation or eradication | Breath | C14 |
| Microbiology - Bacteriology - Detection of pathogenic bacteria | Blood | Bacteria; Pathogenic microorganisms |
| Blood; Faeces; Fluids; General swabs; Synovial fluid; Tissues; Urine | Bacteria; Pathogenic microorganisms | |
| Bacteria; Pathogenic identification and antibiotic susceptibility | ||
| Bacteria; Pathogenic identification and antibiotic susceptibility | ||
| Bacteria; Pathogenic identification and antibiotic susceptibility | ||
| Bacteria; Pathogenic identification and antibiotic susceptibility | ||
| Blood; Fluids; General swabs; Synovial fluid; Tissues; Urine | Bacteria; Casts; Crystals; Epithelial cells; Erythrocytes (red blood cells, RBC); Leucocytes (white blood cells, WBC) | |
| Faeces | Clostridioides difficile toxin; Clostridium difficile glutamate dehydrogenase | |
| Urine | Blood; Crystals; Epithelial cells; Erythrocytes (red blood cells, RBC); Glucose; Leucocytes (white blood cells, WBC); Proteins; pH | |
| Microbiology - Environmental investigations and/or infection control | Gastrointestinal endoscopes | Bacterial growth - Sterility |
| Spore strips | Bacterial growth - Sterility | |
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (bacteria) | Cervical swabs; Dry swabs; Endocervical swabs; Oropharyngeal swabs; Rectal swabs; Urine; Vaginal swabs | Chlamydia trachomatis; Neisseria gonorrhoeae |
| Cervical swabs; Dry swabs; Oropharyngeal swabs; Rectal swabs; Urine; Vaginal swabs | Neisseria gonorrhoeae | |
| Dry swabs; Nasal swabs; Nasopharyngeal swabs; Sputum; Throat swabs | Mycoplasma pneumoniae | |
| Dry swabs; Nasal swabs; Nasopharyngeal swabs; Throat swabs | Bordetella pertussis | |
| Faeces | Clostridioides difficile | |
| Aeromonas spp.; Campylobacter spp.; Salmonella spp.; Shigella spp.; Yersinia spp. | ||
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (protozoan parasites) | Blood | Plasmodium falciparum; Plasmodium knowlesi; Plasmodium malariae; Plasmodium ovale; Plasmodium vivax |
| Faeces | Blastocystis hominis; Cryptosporidium spp.; Dientamoeba fragilis; Entamoeba histolytica; Giardia lamblia | |
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (viruses) | Aspirates; Bronchoalveolar lavage; Nasopharyngeal swabs; Throat swabs | Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) |
| Bronchial lavage; Combined nose and throat swabs; Nasopharyngeal aspirate; Nasopharyngeal swabs; Saliva; Sputum; Throat swabs | Influenza A virus; Influenza B virus; Respiratory syncytial virus (RSV) | |
| Bronchial lavage; Combined nose and throat swabs; Nasopharyngeal aspirate; Nasopharyngeal swabs; Sputum; Throat swabs | Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) - PCR, RT-PCR | |
| Bronchoalveolar lavage; Nasopharyngeal aspirate; Nasopharyngeal swabs | Adenovirus; Human metapneumovirus; Influenza A virus; Influenza B virus; Parainfluenza virus type 1/2/3/4; Respiratory syncytial virus (RSV) A/B; Rhinovirus | |
| Bronchoalveolar lavage; Nasopharyngeal aspirate; Nasopharyngeal swabs; Sputum; Throat swabs | Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) | |
| Combined nose and throat swabs; Nasopharyngeal swabs | Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) - PCR, RT-PCR | |
| Cutaneous swabs; Mucocutaneous swabs | Herpes simplex virus type 1 (HSV1); Herpes simplex virus type 2 (HSV2); Varicella zoster virus (VZV) | |
| Dry swabs; Nasal swabs; Nasopharyngeal swabs; Throat swabs | Influenza A virus; Influenza B virus; Respiratory syncytial virus (RSV) A/B | |
| Adenovirus; Enterovirus; Human metapneumovirus; Influenza A virus; Influenza B virus; Parainfluenza virus type 1/2/3/4; Respiratory syncytial virus (RSV) A/B; Rhinovirus | ||
| Faeces | Adenovirus; Norovirus; Rotavirus | |
| Nasal aspirates/washes; Nasal swabs; Nasopharyngeal swabs | Influenza A virus; Influenza B virus; Respiratory syncytial virus (RSV) A/B; Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) - PCR, RT-PCR | |
| Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) | ||
| Nasal swabs; Nasopharyngeal swabs | Influenza A virus; Influenza B virus; Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) - PCR, RT-PCR | |
| Nasal swabs; Nasopharyngeal swabs; Oropharyngeal swabs | Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) - PCR, RT-PCR | |
| 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) |
| Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) | ||
| Microbiology - Mycobacteriology - Detection and identification of mycobacteria | Bronchial washings; Bronchoalveolar lavage; Other body fluids; Sputum; Urine | Mycobacteria identification |
| Microbiology - Mycology - Detection, isolation and/or identification of yeasts and/or fungal elements | Nails; Skin scrapings | Fungi identification |
| Fungi identification | ||
| Microbiology - Parasitology - Detection of ova, cysts and parasites | Faeces | Cysts; Ova; Parasites |
| Microbiology - Serology of infection - Microbial antibody and/or antigen detection and/or quantitation | Serum | Cytomegalovirus (CMV); Hepatitis A virus (HAV); 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 C virus (HCV); Human immunodeficiency virus (HIV); Rubella IgG antibody |
| Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) IgG antibody | ||
| Epstein-Barr virus; Syphilis Treponema pallidum antibody; Toxoplasma; Varicella zoster virus (VZV) |
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.
3307
Site No.
3300
Print date
20 Apr 2024
END OF SCOPE
