Clinpath Pathology

Site

Mile End Laboratory

Accreditation No.

3307

Site No.

3300

Date of Accreditation

23 Dec 1991

Address

21 James Congdon Drive
Mile End, SA 5031
Australia

clinpath.com.au

Contact

Mr Kiet Quach P: +61 (08) 83662070

Availability

Services available to external clients

Supervision

GX (General)

Scope of Accreditation

ISO 15189 (2012)

Human Pathology

Medicare expiry date

30 Sep 2024

Last Activity Date

17 Jun 2021

Service Product Determinant
Clinical governance - Level 2 - Designated person assessment Not applicable Not applicable
Pre-examination processes Pre-analytics Not applicable

ISO 15189 (2012)

Human Pathology

Medicare expiry date

30 Sep 2024

Last Activity Date

17 Jun 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 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 tissue sections 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 tissue sections Detection of antigenic targets - Various

ISO 15189 (2012)

Human Pathology

Medicare expiry date

30 Sep 2024

Last Activity Date

17 Jun 2021

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
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
Infertility and pregnancy tests including assisted reproductive technology - Diagnosis of pregnancy Plasma; Serum Detection of 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 (2012)

Legal

Medicare expiry date

30 Sep 2024

Last Activity Date

17 Jun 2021

Service Product Determinant
Medico legal drug testing AS/NZS 4308, section 2 Specimen collection, storage, handling and dispatch Urine Colour; Creatinine; Temperature; pH

ISO 15189 (2012)

Human Pathology

Medicare expiry date

30 Sep 2024

Last Activity Date

17 Jun 2021

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

ISO 15189 (2012)

Human Pathology

Medicare expiry date

30 Sep 2024

Last Activity Date

17 Jun 2021

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 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/capsules Bacterial growth - Sterility
Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (bacteria) Cervical swabs; Dry swabs; Urine; Vaginal swabs Neisseria gonorrhoeae
Chlamydia trachomatis; Neisseria gonorrhoeae
Dry swabs; Nasal swabs; Nasopharyngeal swabs; Sputum; Throat swabs Mycoplasma pneumoniae
Dry swabs; Nasal swabs; Nasopharyngeal swabs; Throat swabs Bordetella pertussis
Faeces Clostridiodes 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)
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)
Dry swabs; Nasal swabs; Nasopharyngeal swabs; Throat 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
Faeces Adenovirus; Norovirus; Rotavirus
Nasal aspirates/washes; Nasal swabs; Nasopharyngeal swabs Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Microbiology - Mycobacteriology - Detection and identification of mycobacteria Bronchial washings; Bronchoalveolar lavage; Other body fluids; Sputum; Urine Mycobacteria identification
Microbiology - Mycology - Detection, isolation and identification of yeasts and 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 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) IgG antibody
Epstein-Barr virus​​​​; Syphilis Treponema pallidum antibody; Toxoplasma; Varicella zoster virus (VZV)

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