National Association of Testing Authorities, Australia
Scope of Accreditation
Territory Pathology
Site
Territory Pathology Darwin
Accreditation No.
3197
Site No.
3190
Date of Accreditation
10 Jul 1991
Address
Royal Darwin Hospital, 105 Rocklands Drive
Tiwi, NT 810
Australia
Contact
Mr Steven McCullough P: +61 (08) 89228087
Availability
Services available to external clients
Supervision
GX (General)
Scope of Accreditation
Anatomical Pathology
ISO 15189 (2022)
Human Pathology
Medicare expiry date
05 Dec 2024
Last Activity Date
08 May 2023
| Service | Product | Determinant |
|---|---|---|
| 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 investigation | Formalin-fixed paraffin-embedded (FFPE) tissues | Detection of antigenic targets - Various |
Chemical Pathology
ISO 15189 (2022)
Human Pathology
Medicare expiry date
05 Dec 2024
Last Activity Date
08 May 2023
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Analysis of drugs for toxicological (non-legal) purposes and ingested or absorbed toxic chemicals | Blood; Swabs; Urine | Snake venom detection |
| Plasma; Serum | Ethanol; Paracetamol (acetaminophen); Salicylate | |
| Chemical pathology - Detection and/or quantitation of drugs for therapeutic monitoring | Blood | Tacrolimus |
| Plasma | Vancomycin | |
| Plasma; Serum | Carbamazepine; Gentamicin (cidomycin, septopal, genticyn, garamycin); Lithium; Tobramycin | |
| Digoxin; Methotrexate; Phenobarbitone; Phenytoin (dilantin); Theophylline; Valproate (valproic acid, epilim) | ||
| Serum | Vancomycin | |
| Chemical pathology - Detection and/or quantitation of tumour markers | Plasma; Serum | Prostate specific antigen (PSA); α-Fetoprotein (AFP) |
| Chemical pathology - Determination of hormones and hormone binding proteins (other than thyroid function tests) | Plasma | Parathyroid hormone (PTH) |
| Plasma; Serum | Follicle stimulating hormone (FSH); Luteinising hormone (LH); Parathyroid hormone (PTH); Prolactin | |
| Cortisol | ||
| Chemical pathology - Diagnosis and management of diabetes mellitus | Blood | Glycated haemoglobin (HbA1c) |
| Chemical pathology - Dynamic tests | Sweat | Sweat chloride |
| Chemical pathology - Further investigation of cardiac function | Plasma | N-Terminal-pro b-type natriuretic peptide (NT-proBNP) |
| Plasma; Serum | Troponin | |
| Chemical pathology - Further investigation of renal and/or hepatic function | Plasma; Serum | Haptoglobins |
| Chemical pathology - Investigation and determination of hepatic, cardiac, bone, skeletal muscle and other profiles and metabolic studies | Cerebrospinal fluid (CSF) | Glucose; Protein - Total |
| Plasma | Ammonia; Lactate | |
| Plasma; Serum | Alanine aminotransferase; Albumin; Alkaline phosphatase; Aspartate aminotransferase; Bilirubin - Any fractions; Bilirubin - Total; C-reactive protein (CRP); Calcium - Total; Carbon dioxide (CO2); Chloride; Cholesterol - LDL; Cholesterol - Total; Creatine kinase; Creatinine; Glucose; HDL - Quantitation; Kt/V calculation; Lactate dehydrogenase (LDH); Lipase; Magnesium; Phosphate; Potassium; Protein - Total; Sodium; Triglycerides; Urate; Urea; γ-Glutamyltransferase | |
| Plasma; Serum; Urine | Osmolality | |
| Urine | Albumin; Chloride; Creatinine; Potassium; Protein - Total; Sodium; Urea | |
| Chemical pathology - Investigation for folate deficiency | Plasma; Serum | Folate |
| Chemical pathology - Iron studies | Plasma; Serum | Ferritin; Iron; Transferrin |
| Chemical pathology - Quantitation of vitamins | Plasma; Serum | Cobalamin (vitamin B12); Vitamin D |
| Chemical pathology - Tests for thyroid function | Plasma | Thyroxine (T4) - Free |
| Plasma; Serum | Thyroid stimulating hormone (TSH); Triiodothyronine (T3) - Free | |
| Serum | Thyroxine (T4) - Free | |
| Immunopathology - Detection and/or quantitation and/or characterisation of autoantibodies | Plasma; Serum | Rheumatoid factor |
| Immunopathology - Quantitation of complement proteins | Plasma; Serum | Complement components C3 and C4 |
| 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) |
Haematology / Immunohaematology
ISO 15189 (2022)
Human Pathology
Medicare expiry date
05 Dec 2024
Last Activity Date
08 May 2023
| Service | Product | Determinant |
|---|---|---|
| Haematology - Assessment of haemolysis or metabolic enzymes (red cell enzyme assays) | Blood | Glucose-6-phosphate dehydrogenase (G6PD) |
| Haematology - Bone marrow examination | Bone marrow | Examination of aspirated material |
| Haematology - Examination of blood films by special staining | Blood | Malaria |
| Haematology - Foetal haemoglobin in maternal circulation | Blood | Detection and quantitation of foetal red cell antigens |
| 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); Nucleated red blood cells (NRBC); Platelet count; Red blood cell index or indices; Reticulocytes |
| Differential number; Morphology | ||
| Haematology - Haemostasis related analysis (including special coagulation testing and platelet function tests) | Plasma | Heparin induced thrombotic thrombocytopenia (HITT) |
| Activated partial thromboplastin time (APTT); Anti-Xa - Apixaban; Anti-Xa - Rivaroxaban; Anti-Xa activity - Low molecular weight heparin; Anti-Xa activity - Unfractionated heparin; Anti-thrombin III; D-dimer; Fibrinogen; International normalised ratio (INR); Lupus anticoagulant; Protein C and protein S; Prothrombin time (PT); Thrombin time (TT) | ||
| Haematology - Limited blood examination | Blood | Erythrocyte (RBC) sedimentation rate (ESR) |
| Immunohaematology - Blood group antibody detection | Blood | Other blood group systems; Rh phenotypes |
| Immunohaematology - Blood grouping | Blood | ABO; RhD |
| Immunohaematology - Determination of compatibility of blood donor units | Blood | Direct antiglobulin test (DAT, direct Coombs test); Examination for blood group antibodies; Group checks of patient and donor; Identification of detected antibodies |
| Immunohaematology - Identification and quantitation of blood group antibodies | Blood | Other blood group antibodies; Red blood cell phenotyping; Rh |
| Antibody titration | ||
| Antibody elution | ||
| Immunohaematology - Investigation of blood transfusion reactions | Blood; Blood products; Plasma | Antibodies; Direct antiglobulin test (DAT, direct Coombs test); Group checks of patient and donor; Identification of detected antibodies |
| Immunohaematology - Issue and release of blood and blood product for transfusion | Blood; Cryoprecipitate; Fresh frozen plasma (FFP); Platelets | Issue and release of blood and blood products for transfusion |
| Immunohaematology - Storage and distribution of blood and blood components | Blood products | Issue and release of blood and blood products for transfusion |
| Immunopathology - Characterisation of leucocyte surface antigens (including immunophenotyping) | Aspirates; Blood; Bone marrow; Cerebrospinal fluid (CSF); Fluids; Fresh tissue; Lavage | CD10; CD103; CD117; CD11b; CD11c; CD13; CD138; CD14; CD15; CD16; CD19; CD1a; CD2; CD20; CD200; CD22; CD23; CD25; CD3; CD33; CD38; CD4; CD45; CD5; CD56; CD64; CD7; CD8; FMC7; HLA-DR antigen; Immunoglobulin G1 (IgG1); Kappa light chains; Lambda light chains; Terminal deoxynucleotidyl transferase (TdT); cMPO |
| Blood | B-cell; Natural killer (NK) cells; T-cells | |
| Immunopathology - Single HLA antigen typing | Blood | HLA-B27 |
| Microbiology - Parasitology - Detection of ova, cysts and parasites | Blood | Malaria |
| Microbiology - Serology of infection - Microbial antibody and/or antigen detection and/or quantitation | Plasma; Serum | Infectious mononucleosis |
| Molecular genetics - Genetic testing for chimerism and mosaic gene variants (cancer and somatic mosaicism) - Targeted genes | Blood | t(9;22) BCR-ABL gene rearrangement |
Microbiology
ISO 15189 (2022)
Human Pathology
Medicare expiry date
05 Dec 2024
Last Activity Date
08 May 2023
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Detection and/or quantitation of tumour markers | Faeces | Blood |
| Microbiology - Bacteriology - Detection and identification of crystalline material | Synovial fluid | Crystal detection and identification |
| Microbiology - Bacteriology - Detection of pathogenic bacteria | Aspirates; Blood; Cerebrospinal fluid (CSF); Faeces; Fluids; General swabs; Genital swabs; Respiratory specimens; Sputum; Synovial fluid; Tissues; Urine | Bacteria; Pathogenic identification |
| Bacteria; Pathogenic microorganisms | ||
| Antibiotic susceptibility | ||
| Aspirates; Blood; Cerebrospinal fluid (CSF); Fluids; General swabs; Genital specimens; Respiratory specimens; Sputum; Synovial fluid; Tissues | Bacteria; Epithelial cells; Leucocytes (white blood cells, WBC) | |
| Aspirates; Blood; Synovial fluid | Bacteria; Pathogenic microorganisms | |
| Aspirates; Cerebrospinal fluid (CSF); Fluids; Synovial fluid | Erythrocytes (red blood cells, RBC); Leucocytes (white blood cells, WBC) | |
| Blood | Bacteria | |
| Faeces | Erythrocytes (red blood cells, RBC); Leucocytes (white blood cells, WBC) | |
| Glass slide | Leprosy (Hansen's disease) | |
| Urine | Bacteria; Casts; Epithelial cells; Erythrocytes (red blood cells, RBC); Leucocytes (white blood cells, WBC) | |
| Streptococcus pneumoniae antigen | ||
| Microbiology - Bacteriology - Detection of pathogenic bacteria for epidemiological infection control surveillance | Axilla swabs; Groin swabs; Nasal swabs | Methicillin resistant Staphylococcus aureus (MRSA) |
| Rectal swabs | Carbapenem resistant Enterobacteriaceae (CRE); Vancomycin resistant Enterococci (VRE) | |
| Carbapenem resistant Enterobacteriaceae (CRE); Vancomycin resistant Enterococci (VRE) | ||
| Microbiology - Environmental investigations and/or infection control (Clinical non-human testing) | Blood transfusion bags | Bacterial growth - Sterility |
| Gastrointestinal endoscopes; Vascular catheter tips | Bacterial growth - Sterility | |
| Bacterial growth - Sterility | ||
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (bacteria) | Aspirates; Bacterial isolates; Blood; Cerebrospinal fluid (CSF) | Burkholderia pseudomallei; Streptococcus pneumoniae |
| Aspirates; Blood; Cerebrospinal fluid (CSF) | Neisseria meningitidis | |
| Aspirates; Genital swabs; Urine | Neisseria gonorrhoeae | |
| Blood; Serum; Urine | Leptospira spp. | |
| Bronchial washings; Bronchoalveolar lavage; Dry swabs; Nasal swabs; Nasopharyngeal aspirate; Nasopharyngeal swabs; Respiratory specimens; Sputum; Throat swabs | Bordetella parapertussis; Bordetella pertussis; Bordetella spp.; Chlamydophila pneumoniae; Chlamydophila psittaci; Legionella longbeachae; Legionella pneumophila; Legionella spp.; Mycoplasma pneumoniae | |
| Dry swabs; Genital swabs; Urine | Chlamydia trachomatis | |
| Neisseria gonorrhoeae | ||
| Faeces | Clostridium difficile toxin B | |
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (fungi) | Bronchoalveolar lavage; Sputum | Pneumocystis jirovecii |
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (protozoan parasites) | Blood; Cerebrospinal fluid (CSF); Plasma; Serum; Urine | Malaria |
| Dry swabs; Genital swabs; Urine | Trichomonas vaginalis | |
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (viruses) | Blood; Cerebrospinal fluid (CSF); Plasma; Serum; Urine | Barmah forest virus; Chikungunya virus - Mauritius strain; Dengue virus 1; Dengue virus 2; Dengue virus 3; Dengue virus 4; Japanese encephalitis virus (JEV); Kunjin virus; Murray Valley encephalitis virus; Ross River virus; West Nile virus; Zika virus |
| Bronchial washings; Bronchoalveolar lavage; Endotrachael aspirate; Nasal swabs; Nasopharyngeal and throat swab; Nasopharyngeal aspirate; Nasopharyngeal swabs; Throat swabs | Adenovirus; Coronavirus; Enterovirus; Human metapneumovirus; Influenza A virus; Influenza A virus H3; Influenza A virus H3N2; Influenza B virus; Influenza virus H1N1 - Swine; Parainfluenza virus type 1/2/3/4; Parechovirus; Respiratory syncytial virus (RSV) A/B; Rhinovirus; Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) | |
| Cerebrospinal fluid (CSF); Dry swabs | Varicella zoster virus (VZV) | |
| Human herpes virus type 1/2 (HHV1/2) | ||
| Dry swabs; Nasal swabs; Nasopharyngeal and throat swab; Nasopharyngeal aspirate; Nasopharyngeal swabs; Sputum; Throat swabs | Influenza A virus; Influenza B virus; Respiratory syncytial virus (RSV) A/B; Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) | |
| Dry swabs; Nasal swabs; Nasopharyngeal aspirate; Nasopharyngeal swabs; Sputum; Throat swabs | Influenza A virus; Influenza B virus; Respiratory syncytial virus (RSV) A/B; Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) | |
| Dry swabs; Nasal swabs; Nasopharyngeal aspirate; Nasopharyngeal swabs; Throat swabs | Influenza A virus; Influenza B virus; Respiratory syncytial virus (RSV) A/B; Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) | |
| Dry swabs; Nasopharyngeal swabs; Urine | Measles virus | |
| Faeces | Adenovirus; Astrovirus; Norovirus; Rotavirus; Sapovirus | |
| Nasal swabs; Nasopharyngeal and throat swab; Nasopharyngeal aspirate; Nasopharyngeal swabs; Sputum; Throat swabs | Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) | |
| Sputum | Adenovirus; Coronavirus; Enterovirus; Human metapneumovirus; Influenza A virus; Influenza A virus H3; Influenza A virus H3N2; Influenza B virus; Influenza virus H1N1 - Swine; Parainfluenza virus type 1/2/3/4; Parechovirus; Respiratory syncytial virus (RSV) A/B; Rhinovirus; Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) | |
| Microbiology - Mycobacteriology - Detection and identification of mycobacteria | Faeces; Other body fluids; Respiratory specimens; Tissues; Urine | Mycobacteria identification |
| Mycobacteria identification | ||
| Other body fluids; Respiratory specimens; Tissues | Mycobacteria identification | |
| Microbiology - Mycology - Detection, isolation and/or identification of yeasts and/or fungal elements | Aspirates; Cerebrospinal fluid (CSF); General swabs; Nails; Respiratory specimens; Skin; Skin scrapings; Tissues | Fungi identification |
| Cerebrospinal fluid (CSF) | Yeasts identification | |
| Cerebrospinal fluid (CSF); Serum | Cryptococcus antigen | |
| Nails; Skin scrapings | Fungi identification | |
| Microbiology - Parasitology - Detection of ova, cysts and parasites | Faeces | Cryptosporidia; Giardia spp. |
| Cysts; Ova; Parasites | ||
| Genital swabs | Trichomonad | |
| Skin scrapings | Scabies | |
| Microbiology - Serology of infection - Microbial antibody and/or antigen detection and/or quantitation | Faeces | Clostridium difficile toxin A; Clostridium difficile toxin B |
| Serum | Cytomegalovirus antibody (anti-CMV) IgG; Cytomegalovirus antibody (anti-CMV) IgM; Hepatitis A virus antibody (anti-HAV) - IgM; Hepatitis A virus antibody (anti-HAV) - Total; Hepatitis B virus core antibody (anti-HBc) - IgM; 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 B virus surface antigen (HBs Ag) neutralisation; Hepatitis C virus antibody (anti-HCV); Human immunodeficiency virus type 1/2 (HIV-1/2) 1/2 antibodies; Human immunodeficiency virus type 1/2 (HIV-1/2) antigen; Rubella IgG antibody; Rubella IgM antibody; Syphilis Treponema pallidum antibody; Toxoplasma spp. IgG antibody; Toxoplasma spp. IgM antibody; Anti-streptolysin O (ASOT) | |
| Cytomegalovirus (CMV) activity index; Helicobacter pylori IgG antibody; Measles IgG antibody; Mumps virus IgG antibody; Varicella zoster virus (VZV) IgG antibody | ||
| Syphilis Treponema pallidum antibody | ||
| Burkholderia pseudomallei | ||
| Human T-lymphotropic virus type I/II (HTLV-I/II) | ||
| Dengue virus IgG antibody; Dengue virus IgM antibody; Dengue virus NS1 antigen | ||
| Syphilis Treponema pallidum antibody | ||
| Urine | Legionella pneumophila antigen |
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.
3197
Site No.
3190
Print date
22 Nov 2024
END OF SCOPE