Clinpath Pathology

Site

Mile End Laboratory

Accreditation No.

3307

Site No.

24634

Date of Accreditation

Address

21 Sir James Congdon Drive
Mile End, SA 5031
Australia

clinpath.com.au

Contact

Availability

Services available to external clients

Scope of Accreditation

Withdrawn

ISO 15189 (2012)

Human Pathology

Withdrawn
Service Product Determinant
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 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 Formalin fixed paraffin embedded tissue sections 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
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 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
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/capsules 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 Clostridiodes 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 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 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

Withdrawn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

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