National Association of Testing Authorities, Australia
Scope of Accreditation
Diagnostic Services Pty Ltd
Sonic Healthcare Pty Ltd
Site
Hobart Pathology
Accreditation No.
2208
Site No.
2263
Date of Accreditation
30 Nov 1987
Contact
Mr Leigh Murfett P: +61 (03) 63343636
Availability
Services available to external clients
Supervision
GX (General)
Scope of Accreditation
Anatomical Pathology
ISO 15189 (2022)
Human Pathology
Medicare expiry date
19 Jul 2026
Last Activity Date
19 Jul 2024
| Service | Product | Determinant |
|---|---|---|
| Anatomical pathology - Cytopathology - Cervical cytological investigation for abnormalities, precancerous or cancerous changes or conditions | Liquid based cytology specimens from cervix | Human papilloma virus cytological examination; Cytological examination; Review and reporting of cervical cytological material |
| Anatomical pathology - Cytopathology - Gynaecological (non-cervical) cytological investigation for abnormalities, precancerous or cancerous changes or conditions | Vaginal tissue | Cytological examination; Review and reporting of gynaecological (non-cervical tissue) cytological 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) | |
| 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; Tissue imprint | Intra-operative consultation and examination of biopsy material |
| Anatomical pathology - Tissue pathology - Immunohistochemical investigation | Fixed cytological smears; Formalin-fixed paraffin-embedded (FFPE) tissues | Detection of antigenic targets - Various |
| Detection of antigenic targets - Various |
Chemical Pathology
ISO 15189 (2022)
Human Pathology
Medicare expiry date
19 Jul 2026
Last Activity Date
19 Jul 2024
| Service | Product | Determinant |
|---|---|---|
| Chemical pathology - Analysis of drugs for toxicological (non-legal) purposes and ingested or absorbed toxic chemicals | Plasma | Alcohol |
| Urine | Alcohol | |
| Chemical pathology - Detection and/or quantitation of drugs for therapeutic monitoring | Serum | Gentamicin (cidomycin, septopal, genticyn, garamycin) |
| Carbamazepine; Cyclosporin; Digoxin; Lithium; Paracetamol (acetaminophen); Phenytoin (dilantin); Salicylate; Tacrolimus; Theophylline; Valproate (valproic acid, epilim); Vancomycin | ||
| Chemical pathology - Detection and/or quantitation of tumour markers | Serum | CA125 antigen (CA125); Carcinoembryonic antigen (CEA); Prostate specific antigen (PSA); Prostate specific antigen (PSA) fractions and derived index |
| Chemical pathology - Detection of faecal occult blood | Faeces | Blood |
| Chemical pathology - Determination of hormones and hormone binding proteins (other than thyroid function tests) | Serum | Cortisol; Dehydroepiandrosterone sulfate (DHEAS); Follicle stimulating hormone (FSH); Insulin; Luteinising hormone (LH); Oestradiol; Parathyroid hormone (PTH); Procalcitonin; Progesterone; Prolactin; Sex hormone binding globulin (SHBG); Testosterone; α-Fetoprotein (AFP) |
| Chemical pathology - Diagnosis and management of diabetes mellitus | Blood | Glycated haemoglobin (HbA1c) |
| Chemical pathology - Further investigation of cardiac function | Serum | N-Terminal-pro b-type natriuretic peptide (NT-proBNP); Troponin T |
| Chemical pathology - Further investigation of renal and/or hepatic function | 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; Serum | Alanine aminotransferase; Albumin; Alkaline phosphatase; Ammonia; Amylase; Aspartate aminotransferase; Bicarbonate; Bilirubin - Any fractions; Bilirubin - Total; C-reactive protein (CRP); Calcium - Total; Chloride; Cholesterol - LDL; Cholesterol - Total; Creatine kinase; Creatinine; Glucose; HDL - Quantitation; Lactate; Lactate dehydrogenase (LDH); Lipase; Magnesium; Phosphate; Potassium; Protein - Total; Sodium; Triglycerides; Urate; Urea; γ-Glutamyltransferase | |
| Urine | Chloride; Potassium; Sodium | |
| Albumin; Ammonia; Calcium - Total; Creatinine; Magnesium; Phosphate; Protein - Total; Urate; Urea | ||
| Chemical pathology - Investigation for folate deficiency | Serum | Folate |
| Chemical pathology - Iron studies | Serum | Ferritin; Iron; Transferrin |
| Chemical pathology - Quantitation of blood gases and other measurements (performed on the same specimen) | Blood | Calcium; Lactate; Partial pressure of carbon dioxide (pCO2); Partial pressure of oxygen (PO2); Potassium; Sodium; pH |
| Chemical pathology - Quantitation of vitamin B markers | Serum | Holotranscobalamin (active vitamin B12) |
| Chemical pathology - Quantitation of vitamins | Serum | 25-Hydroxyvitamin D |
| Cobalamin (vitamin B12) | ||
| Chemical pathology - Tests for thyroid function | Serum | Thyroid stimulating hormone (TSH); Thyroxine (T4) - Free; Triiodothyronine (T3) - Free |
| Immunopathology - Detection and/or quantitation and/or characterisation of autoantibodies | Serum | Anti-gliadin antibodies (AGA); Anti-thyroid peroxidase antibodies (TPO); Anti-tissue transglutaminase antibodies (tTG) |
| Rheumatoid factor | ||
| Anti-nuclear antibodies (ANA) | ||
| Immunopathology - Quantitation of complement proteins | Serum | Complement components C3 and C4 |
| Immunopathology - Quantitative and/or qualitative investigation of proteins | Faeces | Calprotectin |
| Serum | Albumin; Characterisation of paraproteins; Detection and amount of paraproteins; Oligoclonal bands; α1-Globulin; α2-Globulin; β-Globulin; β1-Globulin; β2-Globulin; γ-Globulin | |
| Serum; Urine | Detection and quantitation of free kappa and free lambda light chains; Immunoglobulin A (IgA) - Kappa; Immunoglobulin A (IgA) - Lambda; Immunoglobulin G (IgG) - Kappa; Immunoglobulin G (IgG) - Lambda; Immunoglobulin M (IgM) - Kappa; Immunoglobulin M (IgM) - Lambda; Oligoclonal bands | |
| Immunopathology - Quantitative investigations of immunoglobulins and immunoglobulins subclasses | Serum | Total immunoglobulin A; Total immunoglobulin E; Total immunoglobulin G; Total immunoglobulin M |
| Infertility and pregnancy tests including assisted reproductive technology - Diagnosis of pregnancy | Serum; Urine | 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 | Serum; Urine | Human chorionic gonadotropin (hCG) - Quantitative total |
Client sites
ISO 15189 (2022)
Legal
Medicare expiry date
19 Jul 2026
Last Activity Date
19 Jul 2024
| Service | Product | Determinant |
|---|---|---|
| Medico legal drug testing AS/NZS 4308:2008, appendix A On-site screening procedure - Testing performed at client sites | Urine | Amphetamine type substances; Benzodiazepines; Cannabis metabolites; Cocaine metabolites; Opiates |
Gregory Street Collection Centre (fixed)
ISO 15189 (2022)
Legal
Medicare expiry date
19 Jul 2026
Last Activity Date
19 Jul 2024
| Service | Product | Determinant |
|---|---|---|
| Medico legal drug testing AS/NZS 4308:2008, appendix A On-site screening procedure - Testing performed at permanent fixed sites | Urine | Amphetamine type substances; Benzodiazepines; Cannabis metabolites; Cocaine metabolites; Opiates |
Haematology
ISO 15189 (2022)
Human Pathology
Medicare expiry date
19 Jul 2026
Last Activity Date
19 Jul 2024
| 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; Presence of foetal red blood cells |
| Haematology - Full blood examination | Blood | Morphology |
| Erythrocyte count (red blood cell count, RBCC); Haematocrit (packed cell volume, PCV); Haemoglobin (Hb); Leucocyte count (white blood cell count, WBCC); Morphology; Platelet count; Red blood cell index or indices; Reticulocytes | ||
| Haematology - Haemostasis related analysis (including special coagulation testing and platelet function tests) | Plasma | Activated partial thromboplastin time (APTT); D-dimer; Fibrinogen; International normalised ratio (INR); Thrombin time (TT) |
| Anti-Xa activity | ||
| Haematology - Investigation of haemolysis | Blood | Direct antiglobulin test (DAT, direct Coombs test) |
| Cold agglutinins | ||
| Urine | Haemosiderin | |
| Haematology - Limited blood examination | Blood | Erythrocyte (RBC) sedimentation rate (ESR) |
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (protozoan parasites) | Blood | Plasmodium falciparum; Plasmodium knowlesi; Plasmodium malariae; Plasmodium ovale curtisi; Plasmodium ovale wallikeri; Plasmodium ovale; Plasmodium vivax |
| Microbiology - Parasitology - Detection of ova, cysts and parasites | Blood | Malaria |
| Microbiology - Serology of infection - Microbial antibody and/or antigen detection and/or quantitation | Plasma | Infectious mononucleosis |
Immunohaematology
ISO 15189 (2022)
Human Pathology
Medicare expiry date
19 Jul 2026
Last Activity Date
19 Jul 2024
| Service | Product | Determinant |
|---|---|---|
| Immunohaematology - Blood group antibody detection | Blood | Duffy system; Kell system; M and N factors; 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); Group checks of patient and donor |
| Immunohaematology - Identification and quantitation of blood group antibodies | Blood | Red blood cell phenotyping |
| Antibody elution | ||
| Immunohaematology - Issue and release of blood and blood product for transfusion | Blood; Blood products; 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; Blood products; Cryoprecipitate; Fresh frozen plasma (FFP); Platelets | Issue and release of blood and blood products for transfusion |
Microbiology
ISO 15189 (2022)
Human Pathology
Medicare expiry date
19 Jul 2026
Last Activity Date
19 Jul 2024
| Service | Product | Determinant |
|---|---|---|
| Infertility and pregnancy tests including assisted reproductive technology - Semen analysis (other than post vasectomy) | Semen | Motility; Sperm number; Viscosity; Vitality; Volume |
| 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 | Aspirates; Blood; Cerebrospinal fluid (CSF); Faeces; General swabs; Genital specimens; Sputum; Throat swabs; Urine | Antibiotic susceptibility; Pathogenic microorganisms |
| Bacterial isolates | Pathogenic identification and antibiotic susceptibility | |
| Blood | Cultured pathogens identification | |
| Faeces | Clostridioides difficile toxin | |
| Helicobacter pylori antigen | ||
| Synovial fluid | Crystals | |
| Urine | Epithelial cells | |
| Casts; Epithelial cells; Erythrocytes (red blood cells, RBC); Leucocytes (white blood cells, WBC); Pathogenic microorganisms | ||
| Streptococcus pneumoniae | ||
| Legionella antigen | ||
| Casts; Erythrocytes (red blood cells, RBC); Leucocytes (white blood cells, WBC); Pathogenic microorganisms | ||
| Bilirubin; Glucose; Haemoglobin (Hb); Proteins; Urobilinogen | ||
| Microbiology - Environmental investigations and/or infection control (Clinical non-human testing) | Blood transfusion bags; Environmental swabs; Gastrointestinal endoscopes | Bacterial growth - Sterility |
| Environmental swabs | 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) | Bacterial isolates | Vancomycin resistant Enterococci (VRE) |
| Blood culture | Methicillin resistant Staphylococcus aureus (MRSA); Methicillin susceptible Staphylococcus aureus (MSSA)MRSA and MSSA added as NSV 22/11/2023 | |
| Faeces | Clostridium difficile toxin A; Clostridium difficile toxin B | |
| Genital swabs; Urine | Chlamydia trachomatis; Neisseria gonorrhoeae | |
| Chlamydia trachomatis; Neisseria gonorrhoeae | ||
| Microbiology - Molecular biology - Detection, characterisation and/or quantitation of microbial nucleic acids (viruses) | Liquid based cytology specimens | Human papilloma virus (HPV) |
| Nasopharyngeal and throat swab; Nasopharyngeal swabs | Adenovirus; Human metapneumovirus; Influenza A virus; Influenza B virus; Parainfluenza virus; Respiratory syncytial virus (RSV); Rhinovirus | |
| Adenovirus; Human metapneumovirus; Influenza A virus; Influenza B virus; Parainfluenza virus; Respiratory syncytial virus (RSV); Rhinovirus; Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) | ||
| Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) | ||
| Nasopharyngeal swabs | Influenza A virus; Influenza B virus; Respiratory syncytial virus (RSV) | |
| Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) | ||
| Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID) | ||
| Self-collected vaginal swabs | Human papilloma virus (HPV) | |
| Microbiology - Molecular biology - Microbial DNA and/or RNA extraction | Nasopharyngeal and throat swab; Nasopharyngeal swabs | Viable DNA; Viable RNA |
| Microbiology - Mycobacteriology - Detection and identification of mycobacteria | Other body fluids; Sputum; Urine | Mycobacteria identification |
| Microbiology - Mycology - Detection of dermatophytes and other fungi causing cutaneous disease | Hair; Nails; Skin scrapings | Dermatophyte identification |
| Microbiology - Parasitology - Detection of ova, cysts and parasites | Faeces | Giardia spp.; Cysts; Ova; Parasites |
| Microbiology - Serology of infection - Microbial antibody and/or antigen detection and/or quantitation | Serum | Cytomegalovirus antibody (anti-CMV) IgG; Cytomegalovirus antibody (anti-CMV) IgM; Epstein-Barr virus IgG antibody; Epstein-Barr virus IgM antibody; Epstein-Barr virus nuclear antigen; Measles virus; Mumps virus; Varicella zoster virus (VZV) |
| Syphilis Treponema pallidum total antibody | ||
| Hepatitis A virus (HAV); Hepatitis A virus antibody (anti-HAV) - IgM; Hepatitis B virus core antibody (anti-HBc) - IgM; Hepatitis B virus core antibody (anti-HBc) - Total; Hepatitis B virus surface antibody (anti-HBs); Hepatitis B virus surface antigen (HBs Ag); Hepatitis B virus surface antigen (HBs Ag) - Confirmatory; Hepatitis C virus antibody (anti-HCV); Human immunodeficiency virus (HIV); Rubella IgG antibody; Rubella IgM antibody; Toxoplasma | ||
| Microbiology - Virology - Detection of pathogenic viruses | Faeces | Adenovirus; Norovirus; Rotavirus |
Toxicology
ISO 15189 (2022)
Legal
Medicare expiry date
19 Jul 2026
Last Activity Date
19 Jul 2024
| Service | Product | Determinant |
|---|---|---|
| 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 | 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 4760, section 2 Collection, storage, handling and dispatch | Oral fluid | Handling and dispatch; Sample collection and storage |
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.
2208
Site No.
2263
Print date
26 Nov 2024
END OF SCOPE