National Association of Testing Authorities, Australia
Scope of Accreditation
Clinpath Pathology
Sonic Healthcare Pty Ltd
Site
Mile End Laboratory
Accreditation No.
3307
Site No.
24634
Date of Accreditation
Contact
Availability
Services available to external clients
Scope of Accreditation
Withdrawn
Mile End Laboratory
ISO 15189 (2012)
Human Pathology
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Service | Product | Determinant |
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Anatomical pathology - Cytopathology - Cervical cytological investigation for abnormalities, precancerous or cancerous changes or conditions | Cervical smear; Cervical tissue; Liquid based cytology specimens from cervix | Cytological examination; Review and reporting of cervical cytological material |
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 |
Anatomical pathology - Cytopathology - Non-gynaecological cytological investigations on samples obtained via fine needle aspiration biopsy | Fine needle aspirates (FNA) | Cytological examination; Review and reporting of fine needle aspiration samples |
Anatomical pathology - Tissue pathology - Examination of biopsy material | Formalin fixed tissue; Fresh tissue | Review and reporting of biopsy material to identify or exclude morphological abnormalities |
Anatomical pathology - Tissue pathology - Gene probes using paraffin in-situ hybridisation techniques (chromogenic/silver) | Formalin-fixed paraffin-embedded (FFPE) tissues | Detection of nucleic acid targets - Various |
Anatomical pathology - Tissue pathology - Immediate frozen section diagnosis | Fresh tissue | Intra-operative consultation and examination of biopsy material |
Anatomical pathology - Tissue pathology - Immunohistochemical (immunofluorescence) investigation | Formalin-fixed paraffin-embedded (FFPE) tissues | Detection of antigenic targets - Various |
Anatomical pathology - Tissue pathology - Immunohistochemical investigation | Frozen sections of fresh tissue | Detection of antigenic targets - Various |
Chemical pathology - Detection and/or quantitation of tumour markers | Plasma; Serum | CA125 antigen (CA125); CA15-3 antigen (CA15-3); Carcinoembryonic antigen (CEA); Human chorionic gonadotropin (hCG); Prostate specific antigen (PSA) |
Chemical pathology - Determination of hormones and hormone binding proteins (other than thyroid function tests) | Plasma; Serum | Cortisol; Dehydroepiandrosterone sulfate (DHEAS); Follicle stimulating hormone (FSH); Insulin; Luteinising hormone (LH); Oestradiol; Parathyroid hormone (PTH); Progesterone; Prolactin; Sex hormone binding globulin (SHBG); Testosterone - Free; Testosterone - Total |
Chemical pathology - Diagnosis and management of diabetes mellitus | Blood | Glycated haemoglobin (HbA1c) |
Chemical pathology - Further investigation of cardiac function | Plasma; Serum | Troponin |
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 - Investigation of Helicobacter pylori colonisation or eradication | Breath | C14 |
Chemical pathology - Iron studies | Plasma; Serum | Ferritin; Iron; Transferrin |
Chemical pathology - Markers of bone metabolism | Blood | β-Crosslaps (CTX) |
Chemical pathology - Quantitation of precursor and intermediary metabolites | Plasma | Amino acids |
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 |
Corporate OLN (class 3) | Not applicable | Not applicable |
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 | Heinz bodies |
Malaria | ||
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); Platelet count; Red blood cell index or indices; Reticulocytes |
Haemoglobin H (HbH) inclusions; Morphology | ||
Haematology - Haemostasis related analysis (including special coagulation testing and platelet function tests) | Blood | Platelet function (PFA) |
Plasma | Activated partial thromboplastin time (APTT); Anti-thrombin III; D-dimer; Fibrinogen; International normalised ratio (INR); Lupus anticoagulant; Protein C and protein S; 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 |
Immunopathology - Detection and/or quantitation and/or characterisation of autoantibodies | Plasma; Serum | Anti-cyclic citrullinated peptide antibodies (CCP) |
Rheumatoid factor | ||
Immunopathology - Quantitation of complement proteins | Plasma; Serum | Complement components C3 and C4 |
Immunopathology - Quantitative and/or qualitative investigation of proteins | Serum | Cryoglobulins |
Immunopathology - Quantitative investigations of immunoglobulins and immunoglobulins subclasses | Plasma; 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 |
Infertility and pregnancy tests including assisted reproductive technology - Semen analysis (other than post vasectomy) | Semen | Motility |
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 | Blood | Bacteria; Pathogenic microorganisms |
Blood; Faeces; Fluids; General swabs; Synovial fluid; Tissues; Urine | Bacteria; Pathogenic identification and antibiotic susceptibility | |
Bacteria; Pathogenic identification and antibiotic susceptibility | ||
Bacteria; Pathogenic identification and antibiotic susceptibility | ||
Bacteria; Pathogenic identification and antibiotic susceptibility | ||
Bacteria; Pathogenic microorganisms | ||
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) | Dry swabs | Bordetella pertussis |
Dry swabs; Sputum | Mycoplasma pneumoniae | |
Dry swabs; Urine | Neisseria gonorrhoeae | |
Chlamydia trachomatis; Neisseria gonorrhoeae | ||
Faeces | Clostridioides difficile | |
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 |
Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (viruses) | Dry swabs | Adenovirus; Enterovirus; Human metapneumovirus; Influenza A virus; Influenza B virus; Parainfluenza virus type 1/2/3/4; Respiratory syncytial virus (RSV) A/B; Rhinovirus |
Influenza A virus; Influenza B virus; Respiratory syncytial virus (RSV) A/B | ||
Microbiology - Mycobacteriology - Detection and identification of mycobacteria | 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 | Blood | Malaria |
Faeces | Cysts; Ova; Parasites | |
Microbiology - Serology of infection - Microbial antibody and/or antigen detection and/or quantitation | Plasma; Serum | Infectious mononucleosis |
Serum | Epstein-Barr virus; Syphilis Treponema pallidum antibody; Toxoplasma; Varicella zoster virus (VZV) | |
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 | ||
Microbiology - Virology - Detection of pathogenic viruses | Faeces | Adenovirus; Rotavirus |
RCPA training site - General pathology | Not applicable | Not applicable |
ISO 15189 (2012)
Legal
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Service | Product | Determinant |
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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.
3307
Site No.
24634
Print date
29 Mar 2024
END OF SCOPE