National Association of Testing Authorities, Australia
Scope of Accreditation
Western Diagnostic Pathology
Site
Jandakot Laboratory – Healius Pathology Pty Ltd
Accreditation No.
3158
Site No.
25082
Date of Accreditation
01 Jun 2017
Contact
Availability
Services available to external clients
Supervision
GX (General)
Scope of Accreditation
ISO 15189 (2022)
Human Pathology
Service | Product | Determinant |
---|---|---|
Chemical pathology - Analysis of drugs for toxicological (non-legal) purposes and ingested or absorbed toxic chemicals | Plasma; Serum | Ethanol |
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 | Plasma; Serum | CA125 antigen (CA125); CA15-3 antigen (CA15-3); CA19-9 antigen (CA19-9); Carcinoembryonic antigen (CEA); Human chorionic gonadotropin (hCG); 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) | Plasma | Renin |
Adrenocorticotropic hormone (ACTH) | ||
Plasma; Serum | Growth hormone | |
Insulin | ||
Cortisol; Follicle stimulating hormone (FSH); Luteinising hormone (LH); Oestradiol; Parathyroid hormone (PTH); Progesterone; Prolactin | ||
Dehydroepiandrosterone sulfate (DHEAS); Sex hormone binding globulin (SHBG); Testosterone - Free; Testosterone - Total | ||
Aldosterone | ||
C-peptide; Insulin | ||
Saliva | Cortisol | |
Serum | Insulin-like growth factor 1 (IGF-1, somatomedin C) | |
Anti-Mullerian hormone (AMH) | ||
Chemical pathology - Further investigation of cardiac function | Plasma; Serum | Troponin |
Pleural fluid | N-Terminal-pro b-type natriuretic peptide (NT-proBNP) | |
Serum | N-Terminal-pro b-type natriuretic peptide (NT-proBNP) | |
Chemical pathology - Further investigation of lipid profiles for diagnosis of types III and IV hyperlipidaemia | Plasma; Serum | HDL - Quantitation |
Serum | Lipoprotein a | |
Chemical pathology - Further investigation of renal and/or hepatic function | Plasma; Serum | α1-Antitrypsin |
Haptoglobins | ||
Chemical pathology - Investigation and determination of hepatic, cardiac, bone, skeletal muscle and other profiles and metabolic studies | Ascitic fluid; Drainage fluid; Pleural fluid | Albumin; Amylase; Cholesterol - Total; Creatinine; Glucose; Lactate dehydrogenase (LDH); Lipase; Potassium; Protein - Total; Sodium; Triglycerides; Urea |
Cerebrospinal fluid (CSF) | Glucose; Protein - Total | |
Plasma; Serum | Alanine aminotransferase; Albumin; Alkaline phosphatase; Amylase; Aspartate aminotransferase; Bicarbonate; Bilirubin - Any fractions; Bilirubin - Total; Calcium - Total; Chloride; Cholesterol - HDL; Cholesterol - Total; Creatine kinase; Creatinine; Glucose; High sensitivity C-reactive protein (CRP); Lactate dehydrogenase (LDH); Lipase; Magnesium; Phosphate; Potassium; Protein - Total; Sodium; Triglycerides; Urate; Urea; γ-Glutamyltransferase | |
Plasma; Serum; Urine | Osmolality | |
Serum | Calcium - Ionised | |
Urine | Amylase; Calcium - Total; Chloride; Creatinine; Glucose; Magnesium; Microalbumin; Phosphate; Potassium; Protein - Total; Sodium; Urate; Urea | |
Chemical pathology - Investigation for folate deficiency | Plasma; Serum | Folate |
Chemical pathology - Investigation of Helicobacter pylori colonisation or eradication | Breath | C13; C14 |
Chemical pathology - Investigation of functional intestinal disorders | Breath | Hydrogen/methane |
Chemical pathology - Investigation of maternal markers to detect foetal abnormality | Serum | Free β-human chorionic gonadotropin (free β-hCG); Pregnancy associated plasma protein A (PAPP-A) |
Chemical pathology - Iron studies | Plasma; Serum | Ferritin |
Iron; Transferrin | ||
Chemical pathology - Markers of bone metabolism | Plasma | c-Telopeptide (CTx) |
Serum | Procollagen type 1 N-terminal propeptide (P1NP) | |
Chemical pathology - Quantitation of vitamins | Plasma; Serum | Cobalamin (vitamin B12) |
1,25-Dihydroxyvitamin D; 25-Hydroxyvitamin D | ||
Chemical pathology - Tests for thyroid function | Plasma; Serum | Thyroid stimulation immunoglobulins |
Thyroid stimulating hormone (TSH); Thyroxine (T4) - Free; Triiodothyronine (T3) - Free | ||
Immunopathology - Detection and/or quantitation and/or characterisation of autoantibodies | Plasma; Serum | Anti-thyroglobulin antibodies (Tg) |
Anti-cyclic citrullinated peptide antibodies (CCP) | ||
Anti-thyroid peroxidase antibodies (TPO) | ||
Rheumatoid factor | ||
Immunopathology - Quantitation of complement proteins | Plasma; Serum | Complement components C3 and C4 |
Immunopathology - Quantitative and/or qualitative investigation of proteins | Faeces | Calprotectin; Elastase |
Plasma; Serum | Cryoglobulins | |
Serum | Detection and quantitation of free kappa and free lambda light chains | |
Albumin; Detection and amount of paraproteins; α1-Globulin; α2-Globulin; β-Globulin; γ-Globulin | ||
Serum; Urine | Characterisation of paraproteins | |
Urine | Albumin; Detection and amount of paraproteins; α1-Globulin; α2-Globulin; β-Globulin; γ-Globulin | |
Immunopathology - Quantitative investigations of immunoglobulins and immunoglobulins subclasses | Plasma; Serum | Total immunoglobulin A; Total immunoglobulin G; Total immunoglobulin M |
Total immunoglobulin E | ||
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 |
Microbiology - Mycobacteriology - Tests for cell mediated immunity | Blood | Interferon-γ (IFN-γ) release assays; Latent tuberculosis |
Microbiology - Serology of infection - Microbial antibody and/or antigen detection and/or quantitation | Plasma; Serum | Hepatitis A virus (HAV); 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; Syphilis Treponema pallidum antibody; Toxoplasma |
Helicobacter pylori | ||
Cytomegalovirus (CMV); Hepatitis B virus core antibody (anti-HBc) - Total |
ISO 15189 (2022)
Human Pathology
Service | Product | Determinant |
---|---|---|
Anatomical pathology - Cytopathology - Gynaecological (non-cervical) cytological investigation for abnormalities, precancerous or cancerous changes or conditions | Vaginal smears; Vault smears | Cytological examination; Review and reporting of gynaecological (non-cervical tissue) cytological samples |
Anatomical pathology - Cytopathology - Non-gynaecological cytological investigations of body fluids, exudates, washings and brushings from non-squamous mucosal sites for the detection of malignancy | Cerebrospinal fluid (CSF); 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 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 |
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 - Cytopathology - Testing for the National Cervical Screening Program | Liquid based cytology specimens from cervix; Liquid based cytology specimens from vaginal vault | Human papilloma virus (HPV); Cytological examination; Review and reporting of cervical cytological material |
Self-collected vaginal swabs | Human papilloma virus (HPV) |
ISO 15189 (2022)
- This facility complies with the relevant National Pathology Accreditation Advisory Council (NPAAC) requirements.
Human Pathology
Service | Product | Determinant |
---|---|---|
Chemical pathology - Diagnosis and management of diabetes mellitus | Blood | Glycated haemoglobin (HbA1c) |
Haematology - Bone marrow examination | Bone marrow | Examination of aspirated material; Histological examination |
Haematology - Diagnosis of thalassemia | Blood | Haemoglobin A2 (HbA2) - Quantitation; Haemoglobin F (HbF) - Quantitation |
Haematology - Examination of blood films by special staining | Blood | 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 |
Differential number; Morphology; Sideroblasts/siderocytes - Perl's iron stain | ||
Haematology - Haemostasis related analysis (including special coagulation testing and platelet function tests) | Blood | Collagen - Adenosine (COL/ADP); Collagen - Epinephrine (COL/EPI) |
Platelet aggregation | ||
Collagen binding activity | ||
Plasma | Activated protein C (APC) resistance; Anti-Xa - Apixaban; Anti-Xa - Rivaroxaban; Anti-Xa activity - Clexane - Low molecular weight heparin; Anti-Xa activity - Fragmin - Low molecular weight heparin; Anti-Xa activity - Low molecular weight heparin; Anti-Xa activity - Unfractionated heparin; Anti-thrombin III; Factor IX; Factor VIII; Factor XI; Factor XII; Lupus anticoagulant; Protein C and protein S; Von Willebrand factor (vWF); Von Willebrand factor (vWF) activity - Ristocetin co-factor assay; Von Willebrand factor (vWF) antigen - Quantitation | |
Activated partial thromboplastin time (APTT); D-dimer; Fibrinogen; International normalised ratio (INR); Prothrombin time (PT); Thrombin time (TT) | ||
Haematology - Investigation of haemoglobinopathy (excluding thalassemia) | Blood | Haemoglobin S (HbS) - Presence |
Haemoglobin fraction (S, C, D, E) - Quantitation; Other abnormal haemoglobins | ||
Haematology - Investigation of haemolysis | Urine | Haemoglobin (Hb); Haemosiderin |
Haematology - Limited blood examination | Blood | Erythrocyte (RBC) sedimentation rate (ESR) |
Microbiology - Serology of infection - Microbial antibody and/or antigen detection and/or quantitation | Plasma; Serum | Infectious mononucleosis |
ISO 15189 (2022)
Human Pathology
Service | Product | Determinant |
---|---|---|
Anatomical pathology - Tissue pathology - Examination of biopsy material | Formalin-fixed 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 investigation | Formalin-fixed paraffin-embedded (FFPE) tissues | Detection of antigenic targets - Various |
ISO 15189 (2022)
Human Pathology
Service | Product | Determinant |
---|---|---|
Immunopathology - Characterisation of leucocyte surface antigens (including immunophenotyping) | Blood; Bone marrow; Cerebrospinal fluid (CSF); Disaggregated tissues specimen; Fluids | CD10; CD103; CD117; CD11b; CD11c; CD13; CD138; CD14; CD16; CD19; CD1a; CD2; CD20; CD22; CD23; CD25; CD3; CD33; CD34; CD38; CD4; CD45; CD5; CD56; CD57; CD7; CD8; HLA-DR antigen; Kappa light chains; Lambda light chains |
Blood; Bone marrow; Disaggregated tissues specimen; Fluids | CD10; CD16; CD19; CD2; CD20; CD22; CD23; CD3; CD38; CD4; CD45; CD5; CD56; CD7; CD8; Kappa light chains; Lambda light chains |
ISO 15189 (2022)
Human Pathology
Service | Product | Determinant |
---|---|---|
Chemical pathology - Detection of faecal occult blood | Faeces | Blood |
Infertility and pregnancy tests including assisted reproductive technology - Semen analysis (other than post vasectomy) | Semen | Agglutination; Morphology; Motility; Sperm number |
Volume | ||
Colour; Viscosity | ||
pH | ||
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; Cerebrospinal fluid (CSF); Faeces; Fluids; General swabs; Sputum; Tissues; Urine | Bacteria; Pathogenic identification; Pathogenic microorganisms | |
Antibiotic susceptibility; Bacteria; Pathogenic microorganisms | ||
Bacteria; Pathogenic microorganisms | ||
Blood; Cerebrospinal fluid (CSF); Fluids; General swabs; Sputum; Tissues; Urine | Bacteria; Casts; Crystals; Epithelial cells; Erythrocytes (red blood cells, RBC); Leucocytes (white blood cells, WBC) | |
Urine | Bacteria; Epithelial cells; Erythrocytes (red blood cells, RBC); Leucocytes (white blood cells, WBC) | |
Microbiology - Environmental investigations and/or infection control (Clinical non-human testing) | Blood transfusion bags; Dialysis waters; Gastrointestinal endoscopes; Vascular catheter tips | Bacterial growth - Sterility |
Environmental swabs | Bacterial organism identification - Acinetobacter; Bacterial organism identification - Carbapenem resistant Enterobacteriaceae (CRE); Bacterial organism identification - Methicillin-resistant Staphylococcus aureus (MRSA); Bacterial organism identification - Vancomycin-resistant Enterococcus (VRE) | |
Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (bacteria) | Blood culture | Methicillin resistant Staphylococcus aureus (MRSA) |
Nasal swabs | Methicillin resistant Staphylococcus aureus (MRSA) | |
Throat swabs; Wound swabs | Methicillin resistant Staphylococcus aureus (MRSA) | |
Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (viruses) | Nasal aspirates/washes; Nasal swabs; Nasopharyngeal and throat swab; Nasopharyngeal swabs; Throat swabs | Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) |
Nasal swabs; Nasopharyngeal swabs | Influenza A virus; Influenza B virus; Respiratory syncytial virus (RSV) | |
Nasopharyngeal aspirate; Throat swabs | Influenza A virus; Influenza B virus; Respiratory syncytial virus (RSV) | |
Microbiology - Mycobacteriology - Detection and identification of mycobacteria | Respiratory specimens | Mycobacteria identification |
Mycobacteria identification | ||
Microbiology - Mycobacteriology - Tests for antigen lymphocyte stimulation | Blood | Mycobacterial antigen lymphocyte stimulation |
Microbiology - Mycology - Detection, isolation and/or identification of yeasts and/or fungal elements | Blood; Hair; Nails; Skin scrapings | Fungi identification |
Fungi identification | ||
Microbiology - Parasitology - Detection of ova, cysts and parasites | Faeces | Cysts; Ova; Parasites |
ISO 15189 (2022)
Human Pathology
Service | Product | Determinant |
---|---|---|
Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (viruses) | Cervical specimen; Genital swabs; Gynaecological smears; Liquid based cytology specimens | Human papilloma virus (HPV) |
ISO 15189 (2022)
Human Pathology
Service | Product | Determinant |
---|---|---|
Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (bacteria) | Cerebrospinal fluid (CSF) | Neisseria meningitidis |
Faeces | Aeromonas spp.; Campylobacter spp.; Clostridioides difficile; Salmonella spp.; Shigella spp.; Yersinia enterocolitica | |
Genital swabs; Urine | Mycoplasma genitalium | |
Chlamydia trachomatis; Neisseria gonorrhoeae | ||
Ureaplasma urealyticum | ||
Nasal swabs; Nasopharyngeal aspirate; Throat swabs | Bordetella parapertussis; Bordetella pertussis | |
Sputum; Throat swabs | Chlamydophila pneumoniae; Legionella longbeachae; Legionella pneumophila; Mycoplasma pneumoniae | |
Tissues | Helicobacter pylori | |
Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (fungi) | Nasal swabs; Sputum; Throat swabs | Pneumocystis pneumoniae |
Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (protozoan parasites) | Faeces | Blastocystis spp.; Cryptosporidium spp.; Dientamoeba spp.; Entamoeba histolytica; Giardia spp. |
Genital swabs; Urine | Trichomonas vaginalis | |
Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (viruses) | Bronchial washings; Nasal swabs; Nasopharyngeal aspirate; Nasopharyngeal swabs; Sputum; Throat swabs | Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) |
Bronchial washings; Nasal swabs; Nasopharyngeal aspirate; Nasopharyngeal swabs; Throat swabs | Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) | |
Cerebrospinal fluid (CSF) | Enterovirus; Herpes simplex virus type 1 (HSV1); Herpes simplex virus type 2 (HSV2); Human parechovirus; Varicella zoster virus (VZV) | |
Dry swabs | Herpes simplex virus (HSV); Varicella zoster virus (VZV) | |
Faeces | Adenovirus; Norovirus; Rotavirus | |
Nasal swabs; Throat swabs | Adenovirus; Human metapneumovirus; Influenza A virus; Influenza B virus; Parainfluenza virus; Respiratory syncytial virus (RSV); Rhinovirus | |
Nasopharyngeal aspirate; Nasopharyngeal swabs | Adenovirus; Human metapneumovirus; Influenza A virus; Influenza B virus; Parainfluenza virus; Respiratory syncytial virus (RSV); Rhinovirus | |
Plasma; Serum | Hepatitis B virus (HBV) DNA; Hepatitis C virus (HCV) viral RNA; Hepatitis C virus (HCV) viral load - Qualitative | |
Microbiology - Molecular biology - Quantitation of microbial nucleic acids | Plasma; Serum | Hepatitis B virus (HBV) viral load; Hepatitis C virus (HCV) viral load |
ISO 15189 (2022)
- This facility complies with the relevant National Pathology Accreditation Advisory Council (NPAAC) requirements.
Human Pathology
Service | Product | Determinant |
---|---|---|
Immunopathology - Quantitative and/or qualitative investigation of proteins | Faeces | Calprotectin; Elastase |
Microbiology - Mycobacteriology - Tests for cell mediated immunity | Blood | Interferon-γ (IFN-γ) release assays |
Microbiology - Serology of infection - Microbial antibody and/or antigen detection and/or quantitation | Faeces | Cryptosporidium antigen; Giardia antigen |
Plasma; Serum | Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) IgG antibody; Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) IgM antibody | |
Adenovirus IgA antibody; Chlamydial pneumoniae IgG antibody; Influenza A virus IgA antibody; Influenza B virus IgA antibody; Parainfluenza virus group IgA antibody; Strongyloides IgG antibody | ||
Cytomegalovirus (CMV); Epstein-Barr virus | ||
Syphilis Treponema pallidum antibody | ||
Bordetella pertussis IgG; Herpes simplex virus (HSV); Measles virus; Mumps virus; Mycoplasma spp.; Parvovirus; Varicella zoster virus (VZV) | ||
Syphilis Treponema pallidum antibody | ||
Serum | Dengue virus NS1 antigen | |
Barmah forest virus IgG antibody; Dengue virus IgG antibody; Dengue virus IgM antibody; Ross River virus |
ISO 15189 (2022)
Human Pathology
Service | Product | Determinant |
---|---|---|
Chemical pathology - Analysis of drugs for toxicological (non-legal) purposes and ingested or absorbed toxic chemicals | Serum | Ethanol |
Urine | Barbiturates; Buprenorphine; Cannabis; Ethanol; Methadone; Phencyclidine |
ISO 15189 (2022)
Legal
Service | Product | Determinant |
---|---|---|
Medico legal drug testing | Urine | Oxycodone |
Medico legal drug testing AS/NZS 4308:2008, appendix A On-site screening procedure | Urine | Amphetamine type substances; Benzodiazepines; Cannabis metabolites; Cocaine metabolites; Opiates |
Medico legal drug testing AS/NZS 4308:2008, section 2 Specimen collection, storage, handling and dispatch | Urine | Colour; Creatinine; Temperature; pH |
Medico legal drug testing AS/NZS 4308:2008, section 3 General laboratory requirements | Urine | General laboratory requirements as described in AS/NZS 4308 |
Medico legal drug testing AS/NZS 4308:2008, section 4 Laboratory screening procedures | Urine | Amphetamine type substances; Benzodiazepines; Cannabis metabolites; Cocaine metabolites; Opiates |
Medico legal drug testing AS/NZS 4308:2008, section 5 Laboratory confirmatory procedures | Urine | 11-nor-δ-9-Tetrahydrocannabinol-9-carboxylic acid; 6-Acetylmorphine; 7-Amino-clonazepam; 7-Amino-flunitrazepam; 7-Amino-nitrazepam; Amphetamines; Benzoylecgonine (ecgonine benzoate); Codeine; Diazepam; Ecgonine methyl ester; Ephedrine; Methylamphetamine; Methylenedioxyamphetamine; Methylenedioxymethylamphetamine; Morphine; Nordiazepam; Oxazepam; Phentermine; Pseudoephedrine (PSE); Temazepam; α-Hydroxyalprazolam |
Medico legal drug testing AS/NZS 4760, section 2 Collection, storage, handling and dispatch | Oral fluid | Handling and dispatch; Sample collection and storage |
Medico legal drug testing AS/NZS 4760, section 5 Laboratory confirmatory procedures | Oral fluid | 6-Acetylmorphine; Amphetamines; Benzoylecgonine (ecgonine benzoate); Cocaine; Codeine; Ecgonine methyl ester; Methylamphetamine; Methylenedioxyamphetamine; Methylenedioxymethylamphetamine; Morphine; Oxycodone; Δ-9-Tetrahydrocannabinol (THC-Δ9) |
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.
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Accreditation No.
3158
Site No.
25082
Print date
27 Nov 2024